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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
For the quarterly period ended January 31, 2025
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
For the transition period from to .
Commission File No. 001-36830
KALVISTA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
|
|
|
Delaware |
|
20-0915291 |
(State or other jurisdiction of incorporation or organization) |
|
(I.R.S. Employer Identification No.) |
55 Cambridge Parkway Suite 901E Cambridge, Massachusetts |
|
02142 |
(Address of principal executive offices) |
|
(Zip Code) |
857-999-0075
(Registrant’s telephone number, including area code)
n/a
Former name, former address and former fiscal year, if changed since last report
Securities registered pursuant to Section 12(b) of the Exchange Act:
|
|
|
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, $0.001 par value per share |
KALV |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes NO
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes NO
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
|
|
|
|
|
|
|
Large accelerated filer |
|
Accelerated filer |
|
|
|
Non-accelerated filer |
|
Smaller reporting company |
|
|
|
|
|
Emerging growth company |
|
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES NO
As of March 7, 2025, the registrant had 49,715,636 shares of common stock, $0.001 par value per share, issued and outstanding.
Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
KalVista Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
January 31, |
|
|
April 30, |
|
|
|
2025 |
|
|
2024 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
167,288 |
|
|
$ |
31,789 |
|
Marketable securities |
|
|
85,915 |
|
|
|
178,612 |
|
Research and development tax credit receivable |
|
|
7,485 |
|
|
|
8,439 |
|
Prepaid expenses and other current assets |
|
|
6,671 |
|
|
|
6,850 |
|
Total current assets |
|
|
267,359 |
|
|
|
225,690 |
|
Property and equipment, net |
|
|
1,807 |
|
|
|
2,227 |
|
Right of use assets |
|
|
5,440 |
|
|
|
6,920 |
|
Other assets |
|
|
1,387 |
|
|
|
567 |
|
Total assets |
|
$ |
275,993 |
|
|
$ |
235,404 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
5,856 |
|
|
$ |
9,107 |
|
Accrued expenses |
|
|
18,315 |
|
|
|
12,398 |
|
Lease liability - current portion |
|
|
1,444 |
|
|
|
1,302 |
|
Total current liabilities |
|
|
25,615 |
|
|
|
22,807 |
|
Long-term liabilities: |
|
|
|
|
|
|
Lease liability - net of current portion |
|
|
4,338 |
|
|
|
6,015 |
|
Deferred royalty obligation |
|
|
100,914 |
|
|
|
— |
|
Total long-term liabilities |
|
|
105,252 |
|
|
|
6,015 |
|
Commitments and contingencies (Note 6) |
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Common stock, $0.001 par value, 100,000,000 authorized |
|
|
|
|
|
|
Shares issued and outstanding: 49,493,210 at January 31, 2025 and 42,521,975 at April 30, 2024 |
|
|
49 |
|
|
|
42 |
|
Additional paid-in capital |
|
|
748,231 |
|
|
|
679,754 |
|
Accumulated deficit |
|
|
(600,946 |
) |
|
|
(469,726 |
) |
Accumulated other comprehensive loss |
|
|
(2,208 |
) |
|
|
(3,488 |
) |
Total stockholders’ equity |
|
|
145,126 |
|
|
|
206,582 |
|
Total liabilities and stockholders’ equity |
|
$ |
275,993 |
|
|
$ |
235,404 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
KalVista Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
January 31, |
|
January 31, |
|
|
|
2025 |
|
|
2024 |
|
2025 |
|
|
2024 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
12,594 |
|
|
$ |
22,523 |
|
$ |
55,818 |
|
|
$ |
60,919 |
|
General and administrative |
|
|
30,346 |
|
|
|
10,628 |
|
|
77,147 |
|
|
|
31,071 |
|
Total operating expenses |
|
|
42,940 |
|
|
|
33,151 |
|
|
132,965 |
|
|
|
91,990 |
|
Operating loss |
|
|
(42,940 |
) |
|
|
(33,151 |
) |
|
(132,965 |
) |
|
|
(91,990 |
) |
Other income (expense), net |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,394 |
|
|
|
684 |
|
|
4,443 |
|
|
|
2,383 |
|
Interest expense related to the sale of future royalties |
|
|
(2,842 |
) |
|
|
— |
|
|
(2,842 |
) |
|
|
— |
|
Foreign currency exchange (loss) gain |
|
|
(983 |
) |
|
|
1,120 |
|
|
(401 |
) |
|
|
277 |
|
Other income |
|
|
1,109 |
|
|
|
2,319 |
|
|
4,794 |
|
|
|
7,335 |
|
Total other income (expense), net |
|
|
(1,322 |
) |
|
|
4,123 |
|
|
5,994 |
|
|
|
9,995 |
|
Net loss before income taxes |
|
|
(44,262 |
) |
|
|
(29,028 |
) |
|
(126,971 |
) |
|
|
(81,995 |
) |
Provision for income taxes |
|
|
4,247 |
|
|
|
— |
|
|
4,247 |
|
|
|
— |
|
Net loss |
|
$ |
(48,509 |
) |
|
$ |
(29,028 |
) |
$ |
(131,218 |
) |
|
$ |
(81,995 |
) |
Other comprehensive (loss) income: |
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation gain (loss) |
|
|
352 |
|
|
|
(46 |
) |
|
390 |
|
|
|
(373 |
) |
Unrealized holding gain on marketable securities |
|
|
367 |
|
|
|
438 |
|
|
2,082 |
|
|
|
1,270 |
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
|
|
(226 |
) |
|
|
(221 |
) |
|
(1,192 |
) |
|
|
(1,130 |
) |
Other comprehensive income (loss) |
|
|
493 |
|
|
|
171 |
|
|
1,280 |
|
|
|
(233 |
) |
Comprehensive loss |
|
$ |
(48,016 |
) |
|
$ |
(28,857 |
) |
$ |
(129,938 |
) |
|
$ |
(82,228 |
) |
Net loss per share to common stockholders, basic and diluted |
|
$ |
(0.92 |
) |
|
$ |
(0.84 |
) |
$ |
(2.70 |
) |
|
$ |
(2.37 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
52,638,888 |
|
|
|
34,723,379 |
|
|
48,522,362 |
|
|
|
34,567,853 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
KalVista Pharmaceuticals, Inc.
Condensed Consolidated Statement of Changes in Stockholders’ Equity
(in thousands, except share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended January 31, 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
Other |
|
|
Total |
|
|
Common Stock |
|
|
Paid-in |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Stockholders' |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Loss |
|
|
Equity |
|
Balance at May 1, 2024 |
|
42,521,975 |
|
|
$ |
42 |
|
|
$ |
679,754 |
|
|
$ |
(469,726 |
) |
|
$ |
(3,488 |
) |
|
$ |
206,582 |
|
Issuance of common stock from equity incentive plans |
|
385,234 |
|
|
|
1 |
|
|
|
3,000 |
|
|
|
— |
|
|
|
— |
|
|
|
3,001 |
|
Release of restricted stock units |
|
174,713 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation expense |
|
— |
|
|
|
— |
|
|
|
3,040 |
|
|
|
— |
|
|
|
— |
|
|
|
3,040 |
|
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(40,443 |
) |
|
|
— |
|
|
|
(40,443 |
) |
Foreign currency translation (loss) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(128 |
) |
|
|
(128 |
) |
Unrealized holding gain from marketable securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,064 |
|
|
|
1,064 |
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(317 |
) |
|
|
(317 |
) |
Balance at July 31, 2024 |
|
43,081,922 |
|
|
$ |
43 |
|
|
$ |
685,794 |
|
|
$ |
(510,169 |
) |
|
$ |
(2,869 |
) |
|
$ |
172,799 |
|
Issuance of common stock from equity incentive plans |
|
36,738 |
|
|
|
— |
|
|
|
294 |
|
|
|
— |
|
|
|
— |
|
|
|
294 |
|
Release of restricted stock units |
|
152,841 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation expense |
|
— |
|
|
|
— |
|
|
|
2,999 |
|
|
|
— |
|
|
|
— |
|
|
|
2,999 |
|
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(42,268 |
) |
|
|
— |
|
|
|
(42,268 |
) |
Foreign currency translation gain |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
166 |
|
|
|
166 |
|
Unrealized holding gain from marketable securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
651 |
|
|
|
651 |
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(649 |
) |
|
|
(649 |
) |
Balance at October 31, 2024 |
|
43,271,501 |
|
|
$ |
43 |
|
|
$ |
689,087 |
|
|
$ |
(552,437 |
) |
|
$ |
(2,701 |
) |
|
$ |
133,992 |
|
Issuance of common stock from equity incentive plans |
|
88,017 |
|
|
|
— |
|
|
|
632 |
|
|
|
— |
|
|
|
— |
|
|
|
632 |
|
Release of restricted stock units |
|
133,692 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Issuance of common stock, net of issuance costs of $0.7 million |
|
6,000,000 |
|
|
|
6 |
|
|
|
55,905 |
|
|
|
— |
|
|
|
— |
|
|
|
55,911 |
|
Stock-based compensation expense |
|
— |
|
|
|
— |
|
|
|
2,607 |
|
|
|
— |
|
|
|
— |
|
|
|
2,607 |
|
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(48,509 |
) |
|
|
— |
|
|
|
(48,509 |
) |
Foreign currency translation gain |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
352 |
|
|
|
352 |
|
Unrealized holding gain from marketable securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
367 |
|
|
|
367 |
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(226 |
) |
|
|
(226 |
) |
Balance at January 31, 2025 |
|
49,493,210 |
|
|
$ |
49 |
|
|
$ |
748,231 |
|
|
$ |
(600,946 |
) |
|
$ |
(2,208 |
) |
|
$ |
145,126 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended January 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
Other |
|
|
Total |
|
|
Common Stock |
|
|
Paid-in |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Stockholders' |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Deficit |
|
|
Loss |
|
|
Equity |
|
Balance at May 1, 2023 |
|
34,171,138 |
|
|
$ |
34 |
|
|
$ |
507,133 |
|
|
$ |
(343,082 |
) |
|
$ |
(3,060 |
) |
|
$ |
161,025 |
|
Issuance of common stock from equity incentive plans |
|
35,313 |
|
|
|
— |
|
|
|
204 |
|
|
|
— |
|
|
|
— |
|
|
|
204 |
|
Release of restricted stock units |
|
60,144 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation expense |
|
— |
|
|
|
— |
|
|
|
3,254 |
|
|
|
— |
|
|
|
— |
|
|
|
3,254 |
|
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(25,317 |
) |
|
|
— |
|
|
|
(25,317 |
) |
Foreign currency translation gain |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
91 |
|
|
|
91 |
|
Unrealized holding gain from marketable securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
392 |
|
|
|
392 |
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(314 |
) |
|
|
(314 |
) |
Balance at July 31, 2023 |
|
34,266,595 |
|
|
$ |
34 |
|
|
$ |
510,591 |
|
|
$ |
(368,399 |
) |
|
$ |
(2,891 |
) |
|
$ |
139,335 |
|
Issuance of common stock from equity incentive plans |
|
18,000 |
|
|
|
— |
|
|
|
128 |
|
|
|
— |
|
|
|
— |
|
|
|
128 |
|
Release of restricted stock units |
|
136,863 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation expense |
|
— |
|
|
|
— |
|
|
|
3,207 |
|
|
|
— |
|
|
|
— |
|
|
|
3,207 |
|
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(27,650 |
) |
|
|
— |
|
|
|
(27,650 |
) |
Foreign currency translation (loss) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(419 |
) |
|
|
(419 |
) |
Unrealized holding gain from marketable securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
440 |
|
|
|
440 |
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(595 |
) |
|
|
(595 |
) |
Balance at October 31, 2023 |
|
34,421,458 |
|
|
$ |
34 |
|
|
$ |
513,926 |
|
|
$ |
(396,049 |
) |
|
$ |
(3,465 |
) |
|
$ |
114,446 |
|
Issuance of common stock from equity incentive plans |
|
36,914 |
|
|
|
— |
|
|
|
283 |
|
|
|
— |
|
|
|
— |
|
|
|
283 |
|
Release of restricted stock units |
|
137,251 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation expense |
|
— |
|
|
|
— |
|
|
|
2,711 |
|
|
|
— |
|
|
|
— |
|
|
|
2,711 |
|
Net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(29,028 |
) |
|
|
|
|
|
(29,028 |
) |
Foreign currency translation loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(46 |
) |
|
|
(46 |
) |
Unrealized holding gain from marketable securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
438 |
|
|
|
438 |
|
Reclassification adjustment for realized gain on marketable securities included in net loss |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(221 |
) |
|
|
(221 |
) |
Balance at January 31, 2024 |
|
34,595,623 |
|
|
$ |
34 |
|
|
$ |
516,920 |
|
|
$ |
(425,077 |
) |
|
$ |
(3,294 |
) |
|
$ |
88,583 |
|
KalVista Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
|
|
|
|
|
Nine Months Ended |
|
January 31, |
|
2025 |
|
2024 |
Cash flows from operating activities |
|
|
|
Net loss |
$(131,218) |
|
$(81,995) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
Depreciation and amortization |
680 |
|
597 |
Stock-based compensation expense |
8,649 |
|
9,172 |
Realized gain from sale of marketable securities |
(1,192) |
|
(1,130) |
Non-cash operating lease benefit |
(58) |
|
(11) |
Amortization of premium on marketable securities |
11 |
|
88 |
Foreign currency exchange loss |
4,015 |
|
596 |
Non-cash interest expense and amortization of issuance costs |
2,924 |
|
- |
Fair value adjustment to derivative liability |
150 |
|
- |
Changes in operating assets and liabilities: |
|
|
|
Research and development tax credit, net |
838 |
|
(6,215) |
Prepaid expenses and other assets |
(77) |
|
906 |
Accounts payable |
(3,579) |
|
(1,778) |
Accrued expenses |
6,314 |
|
5,644 |
Net cash used in operating activities |
(112,543) |
|
(74,126) |
Cash flows from investing activities |
|
|
|
Purchases of marketable securities |
(7,547) |
|
(47,687) |
Sales and maturities of marketable securities |
102,313 |
|
89,475 |
Acquisition of property and equipment |
(153) |
|
(27) |
Capitalized website development costs |
(261) |
|
(294) |
Net cash provided by investing activities |
94,352 |
|
41,467 |
Cash flows from financing activities |
|
|
|
Proceeds from royalty agreement |
97,190 |
|
- |
Issuance costs associated with royalty agreement |
(1,960) |
|
- |
Issuance of common stock, net of offering expenses |
55,911 |
|
- |
Issuance of common stock from equity incentive plans |
3,927 |
|
616 |
Net cash provided by financing activities |
155,068 |
|
616 |
Effect of exchange rate changes on cash and cash equivalents |
(725) |
|
(1,139) |
Net increase in cash and cash equivalents |
136,152 |
|
(33,182) |
Cash, cash equivalents and restricted cash at beginning of period |
31,789 |
|
56,238 |
Cash, cash equivalents and restricted cash at end of period |
$167,941 |
|
$23,056 |
Supplemental disclosures of non-cash activities: |
|
|
|
Right of use assets obtained in exchange for operating lease liabilities |
$267 |
|
$- |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Notes to the Condensed Consolidated Financial Statements (unaudited)
Company Background
KalVista Pharmaceuticals, Inc. (“KalVista” or the “Company”) is a pre-commercial stage pharmaceutical company focused on the discovery, development and commercialization of drug therapies for diseases with significant unmet need. The Company has used its capabilities to develop sebetralstat, a novel, orally delivered, small molecule plasma kallikrein inhibitor targeting the disease hereditary angioedema (“HAE”).
The Company has filed a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) seeking marketing approval of sebetralstat as the first oral, on-demand therapy for HAE, with a Prescription Drug User Fee Act (“PDUFA”) notification date of June 17, 2025.
The Company has submitted a Marketing Authorization Application (“MAA”) for sebetralstat to the European Medicines Agency (“EMA”), which currently is being reviewed by the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) under the centralized licensing procedure for all 27 Member States of the European Union, as well as the EEA countries Norway, Iceland and Liechtenstein. The Company also has made MAA submissions to the regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore via the Access Consortium framework for which the Company has obtained a four-way sharing agreement by the Medicines and Healthcare product Regulatory Agency, Swissmedic, the Therapeutic Goods Administration and Health Sciences Authority. The Access Consortium is designed to maximize regulatory collaboration across countries and support a timely review process. In January 2025, the Company announced that it submitted a Japanese New Drug Application for sebetralstat to the Japanese Pharmaceuticals and Medical Devices Agency and also that Japan’s Ministry of Health, Labour and Welfare has granted sebetralstat Orphan Drug Designation. If approved, sebetralstat would be the first oral on-demand treatment for HAE in each of these territories.
The Company’s headquarters is currently located in Cambridge, Massachusetts, with additional offices and research activities located in Porton Down, United Kingdom; Salt Lake City, Utah; Zug, Switzerland; and Tokyo, Japan.
Liquidity
The Company has devoted substantially all of its efforts to research and development, including preclinical and clinical trials of sebetralstat. The Company has not completed the development of any product candidates or commenced commercial operations. Pharmaceutical drug product candidates, like those being developed by the Company, require approvals from the FDA or foreign regulatory agencies prior to commercial sales. There can be no assurance that any product candidate will receive the necessary approvals and any failure to receive approval or delay in approval may have a material adverse impact on the Company’s business and financial results. The Company is subject to risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of a late-stage product candidate; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; the challenges of protecting and enhancing intellectual property rights; and complying with applicable regulatory requirements.
In November 2024, the Company entered into an underwriting agreement with Jefferies LLC, BofA Securities, Inc., TD Securities (USA) LLC and Stifel Nicolaus & Company, Incorporated, as the representatives of several underwriters to sell an aggregate of 5,500,000 shares of common stock at an offering price of $10.00 per share (the “November 2024 Offering”). The net proceeds from the November 2024 Offering, after deducting estimated expenses, were approximately $51.3 million.
Also in November 2024, the Company entered into a securities purchase agreement with DRI Healthcare Acquisitions LP to sell an aggregate of 500,000 shares of our common stock at a price of $10.00 per share in a private placement. The net proceeds from the private placement, after deducting placement agent fees and other expenses, were approximately $4.7 million.
To date, the Company has not generated any product sales revenues and does not have any products that have been approved for commercialization. As of January 31, 2025, the Company had an accumulated deficit of $600.9 million and $253.2 million of cash, cash equivalents and marketable securities. The Company does not expect to generate significant revenue unless and until it obtains regulatory approval for, and commercializes, one of its current or future product candidates. The Company anticipates that it will continue to incur losses for the foreseeable future, and it expects those losses to increase as it continues the development of, and seeks regulatory approvals for, product candidates, and begins to commercialize any approved products. The Company is subject to risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, and it may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. The Company currently anticipates that, based upon its operating plans and existing capital resources, it has sufficient funding to operate for at least the next twelve months.
The Company may seek to finance future cash needs through equity offerings, debt financing, corporate partnerships and product sales. In the event of failure to obtain regulatory approval for product candidates, the Company will not be able to generate product sales, which will have a material adverse effect on the business and prospects.
2.Summary of Significant Accounting Policies
Principles of Consolidation: The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. Such financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial position, results of operations, and cash flows. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements. There were no adjustments other than normal recurring adjustments. These unaudited interim condensed consolidated financial results are not necessarily indicative of the results to be expected for the year ending April 30, 2025, or for any other future annual or interim period. The accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements as of and for the year ended April 30, 2024 in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on July 11, 2024.
Segment Reporting: The chief operating decision maker, the CEO, manages the Company’s operations as a single operating segment for the purposes of assessing performance and making operating decisions.
Use of Estimates: The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Accounting estimates and management judgments reflected in the condensed financial statements include: the accrual of research and development expenses, stock-based compensation, operating lease liabilities, interest expense on our deferred royalty obligation, and assumptions used to value the embedded derivative in our deferred royalty obligation. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions.
Recent Accounting Pronouncements: In November 2024, the Financial Accounting Standards Board (“FASB”) issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures, which requires public business entities to disclose, on an annual and interim basis, disaggregated information about certain income statement expense line items. The required information includes purchases of inventory, employee compensation, depreciation, intangible asset amortization and depletion. The standard will be effective for the Company beginning with annual financial statements for the fiscal year ending April 30, 2028. The Company has not yet determined the impact of adopting this guidance on its financial statements.
In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. The Company does not expect the amendments in this ASU to have a material impact on its consolidated financial statements.
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting – Improvements to Reportable Segment Disclosures, which provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant segment expenses and increased interim disclosure requirements, among others. ASU 2023-07 will be effective for the Company beginning with annual financial statements for the fiscal year ending April 30, 2025 and for interim periods starting in the first quarter of fiscal 2026. The Company does not expect the amendments in this ASU to have a material impact on its consolidated financial statements.
Net Loss per Share: Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the sum of the weighted average number of common shares and the number of potential dilutive common share equivalents outstanding during the period. Potential dilutive common share equivalents consist of outstanding options, unvested restricted stock units, unvested performance stock units, and shares committed to be purchased under the employee stock purchase plan.
Potential dilutive common share equivalents consist of:
|
|
|
|
|
|
|
|
|
|
|
January 31, |
|
|
|
2025 |
|
|
2024 |
|
Stock options and awards |
|
|
5,825,195 |
|
|
|
6,229,313 |
|
In computing diluted earnings per share, common share equivalents are not considered in periods in which a net loss is reported, as the inclusion of the common share equivalents would be anti-dilutive. As a result, there is no difference between the Company’s basic and diluted loss per share for the periods presented.
The weighted average number of common shares used in the basic and diluted net loss per common share calculations includes the weighted-average pre-funded warrants outstanding during the period as they are exercisable at any time for nominal cash consideration.
Restricted Cash: Restricted cash consists of deposits held at financial institutions that are used to collateralize irrevocable letters of credit required under the Company’s lease agreements. The following table provides a reconciliation of cash and cash equivalents and restricted cash as reported on the consolidated balance sheets to the total of these amounts as reported at the end of the period in the consolidated statements of cash flows (in thousands):
|
|
|
|
|
|
|
January 31, |
|
January |
|
|
2025 |
|
2024 |
Cash and cash equivalents |
|
$167,288 |
|
$23,056 |
Restricted cash |
|
653 |
|
— |
Total cash and cash equivalents and restricted cash |
|
$167,941 |
|
$23,056 |
Deferred Royalty Obligation: The Company treats the debt obligation to DRI Healthcare Acquisitions LP, an affiliate of DRI Healthcare Trust (“DRI”) discussed further in Note 8, “Purchase and Sale Agreement”, as a deferred royalty obligation, amortized using the effective interest rate method over the estimated life of the revenue stream. The Company periodically assesses its expected revenues using internal projections, imputes interest on the carrying value of the deferred royalty obligation, and records interest expense using the imputed effective interest rate. To the extent its estimates of future revenues are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will account for any such changes by adjusting the effective interest rate on a prospective basis. The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs require that the Company makes estimates that could impact the classification of such costs, as well as the period over which such costs will be amortized.
Embedded Derivative Liability: The Company evaluates all its financial instruments to determine if such instruments contain features that qualify as embedded derivatives per ASC 815, Derivatives and Hedging (“ASC 815”). The Purchase and Sale agreement (“PSA”) with DRI contains certain features that meet the definition of an embedded derivative requiring bifurcation as a separate compound financial instrument (the “Derivative Liability”). The Derivative Liability was recorded at fair value upon entering into the PSA and is subsequently remeasured to fair value at each reporting period with the corresponding change in fair value recognized in Other Income (Expense) in the condensed consolidated statements of operations. The PSA was initially valued and is remeasured using Monte Carlo simulation models to perform the “with-and-without” method, which involves valuing the PSA with the embedded derivative and then valuing it without the embedded derivative. The Monte Carlo simulation model requires the use of Level 3 unobservable inputs, primarily the amount and timing of expected future revenue, the estimated volatility of these revenues, the discount rate corresponding to the risk of revenue, and the probability of a change in control. The difference between values is determined to be the estimated fair value of the derivative liability. Bifurcated embedded derivatives are classified with the related host contract in the Company’s balance sheet. Refer to Note 3, “Fair Value Measurements” for details regarding the fair value.
Fair Value Measurement: The Company classifies fair value measurements using a three-level hierarchy that prioritizes the inputs used to measure fair value. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:
•Level 1 - Quoted market prices in active markets for identical assets or liabilities;
•Level 2 - Observable inputs other than quoted market prices included in Level 1, such as quoted market prices for markets that are not active or other inputs that are observable or can be corroborated by observable market data
•Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, including certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.
The Company’s cash equivalents, marketable securities, and derivative liability as of January 31, 2025 were carried at fair value, determined according to the fair value hierarchy. See Note 3, “Fair Value Measurements” for further discussion.
3.Fair Value Measurements
The following tables present information about financial assets and liability that have been measured at fair value and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
January 31, 2025 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
$ |
30,223 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
30,223 |
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
— |
|
|
|
76,094 |
|
|
|
— |
|
|
|
76,094 |
|
U.S. government agency securities |
|
— |
|
|
|
9,821 |
|
|
|
— |
|
|
|
9,821 |
|
Total financial assets |
$ |
30,223 |
|
|
$ |
85,915 |
|
|
$ |
— |
|
|
$ |
116,138 |
|
Liability: |
|
|
|
|
|
|
|
|
|
|
|
Derivative liability |
$ |
— |
|
|
$ |
— |
|
|
$ |
4,430 |
|
|
$ |
4,430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
April 30, 2024 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
$ |
11,143 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
11,143 |
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
— |
|
|
|
130,423 |
|
|
|
— |
|
|
|
130,423 |
|
U.S. government agency securities |
|
— |
|
|
|
48,189 |
|
|
|
— |
|
|
|
48,189 |
|
Total |
$ |
11,143 |
|
|
$ |
178,612 |
|
|
$ |
— |
|
|
$ |
189,755 |
|
The objectives of the Company’s investment policy are to ensure the safety and preservation of invested funds, as well as to maintain liquidity sufficient to meet cash flow requirements. The Company invests its excess cash in securities issued by financial institutions, commercial companies, and government agencies that management believes to be of high credit quality in order to limit the amount of its credit exposure. The Company has not realized any material losses from its investments.
The Company classifies all of its debt securities as available-for-sale. Unrealized gains and losses on investments are recognized in accumulated comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are included in other income in the consolidated statements of operations and comprehensive loss and are determined using the specific identification method with transactions recorded on a trade date basis.
The estimated fair value of the derivative liability as of January 31, 2025 relates to the PSA and was determined using Level 3 inputs. The fair value measurement of the derivative liability is sensitive to changes in the unobservable inputs used to value the financial instrument. Changes in the inputs could result in changes to the fair value of each financial instrument.
The embedded derivative liability associated with the deferred royalty obligation, as discussed further in Note 8, “Purchase and Sale Agreement,” is measured at fair value using an option pricing Monte Carlo simulation model and is included as a component of the deferred royalty obligation on the condensed consolidated balance sheet. The embedded derivative liability is subject to remeasurement at the end of each reporting period, with changes in fair value recognized as a component of other income (expense), net. The assumptions used in the option pricing Monte Carlo simulation model incorporates certain Level 3 inputs including: (1) estimates of the probability and timing of related events; (2) the probability-weighted global net sales of sebetralstat, including milestones and royalties; (3) the risk-adjusted discount rate; (4) the estimated volatility of expected future revenues; and (5) the probability of a change in control occurring during the term of the instrument.
The Company recorded $4.4 million for the initial fair value of the derivative liability upon the closing of the PSA. The initial fair value allocated to the derivative liability was recorded against the deferred royalty obligation as a debt discount, which is being amortized in interest expense on the condensed consolidated statement of operations over the expected term using the effective interest method. The embedded derivative is subsequently remeasured at fair value each reporting period, with the change in fair value being recorded as a component of other income (expense) on the condensed consolidated statement of operations. During the period from November 4, 2024 through January 31, 2025, the Company recognized $0.2 million as a component of other income (expense), net as the change in fair value for the embedded derivative liability as of January 31, 2025. Refer to Note 8, “Purchase and Sale Agreement” for details regarding the valuation methodology related to the embedded derivative and its related inputs.
Marketable Securities
The following tables summarize the fair values of the Company’s marketable securities by type as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January 31, 2025 |
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Corporate debt securities |
$ |
74,915 |
|
|
$ |
1,184 |
|
|
$ |
(5 |
) |
|
$ |
76,094 |
|
Obligations of the U.S. Government and its agencies |
|
9,734 |
|
|
|
87 |
|
|
|
— |
|
|
|
9,821 |
|
Total |
$ |
84,649 |
|
|
$ |
1,271 |
|
|
$ |
(5 |
) |
|
$ |
85,915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 30, 2024 |
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Corporate debt securities |
$ |
130,099 |
|
|
$ |
600 |
|
|
$ |
(276 |
) |
|
$ |
130,423 |
|
Obligations of the U.S. Government and its agencies |
|
48,228 |
|
|
|
83 |
|
|
|
(122 |
) |
|
|
48,189 |
|
Total |
$ |
178,327 |
|
|
$ |
683 |
|
|
$ |
(398 |
) |
|
$ |
178,612 |
|
The Company has classified all of its available-for-sale investment securities, including those with maturities beyond one year, as current assets on its condensed consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations.
The Company has not recognized an allowance for credit losses on any securities in an unrealized loss position as of January 31, 2025 and April 30, 2024.
The following table summarizes the scheduled maturity for the Company’s marketable securities at January 31, 2025 (in thousands):
|
|
|
|
|
January 31, 2025 |
|
Maturing in one year or less |
$ |
50,247 |
|
Maturing after one year through two years |
|
30,676 |
|
Maturing after two years through four years |
|
4,992 |
|
Total |
$ |
85,915 |
|
4. Accrued Expenses
Accrued expenses consisted of the following as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
January 31, |
|
|
April 30, |
|
|
|
2025 |
|
|
2024 |
|
Accrued compensation |
|
$ |
9,554 |
|
|
$ |
6,687 |
|
Accrued research expense |
|
|
3,781 |
|
|
|
3,416 |
|
Accrued professional fees |
|
|
4,091 |
|
|
|
2,042 |
|
Other accrued expenses |
|
|
889 |
|
|
|
253 |
|
|
|
$ |
18,315 |
|
|
$ |
12,398 |
|
5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
January 31, |
|
|
April 30, |
|
|
|
2025 |
|
|
2024 |
|
Prepaid preclinical and clinical activities |
|
$ |
792 |
|
|
$ |
1,585 |
|
Other prepaid expenses |
|
|
3,962 |
|
|
|
2,833 |
|
Interest and other receivables |
|
|
1,027 |
|
|
|
1,409 |
|
VAT receivable |
|
|
890 |
|
|
|
1,023 |
|
Total prepaid expenses and other current assets |
|
$ |
6,671 |
|
|
$ |
6,850 |
|
6. Commitments and Contingencies
Clinical Studies: The Company enters into contractual agreements with contract research organizations in connection with preclinical and toxicology studies and clinical trials. Amounts due under these agreements are invoiced to the Company on predetermined schedules during the course of the studies and clinical trials and are not refundable regardless of the outcome. The Company has contractual obligations related to the expected future costs to be incurred to complete the ongoing preclinical studies and clinical trials. The remaining clinical commitments, which have cancellation provisions, totals $21.9 million at January 31, 2025.
Indemnification: In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves future claims that may be made against the Company but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. No amounts associated with such indemnifications have been recorded to date.
Contingencies: From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. There were no contingent liabilities requiring accrual at January 31, 2025.
7. Leases
The Company has a lease agreement for approximately 8,300 square feet of space for its headquarters located in Cambridge, Massachusetts that runs through September 2028.
In July 2024, the Company signed a new headquarters lease for approximately 32,110 square feet in Framingham, Massachusetts that is expected to commence in the first half of 2025 and has an expected initial lease term of approximately 10 years. Prior to lease commencement of its new headquarters, the Company is occupying a temporary space in the same building. The Company intends to sublease its office in Cambridge, Massachusetts for occupancy once the Company has moved into its new headquarters space.
The Company has lease agreements for approximately 13,400 square feet of office and research laboratory space located in Porton Down, United Kingdom that run through April 2028.
The Company has a lease agreement for approximately 6,200 square feet of office space in Salt Lake City, Utah that runs through February 2032.
The Company has a lease agreement for approximately 500 square feet of research laboratory space in Cambridge, Massachusetts that commenced in July 2022 with an option to renew annually. As of January 31, 2025, the Company does not intend to renew for 2025.
The Company has a lease agreement for approximately 7,200 square feet of office space in Zug, Switzerland that runs through November 2025.
The Company has a lease agreement for office space in Tokyo, Japan that runs through April 2026.
Pursuant to the new headquarter lease in Framingham, the Company provided a security deposit in the form of a letter of credit in the amount of $0.7 million which is classified in long-term assets on our condensed balance sheet.
Total rent expense was approximately $2.0 million and $1.4 million for the nine months ended January 31, 2025 and 2024, respectively, and is reflected in general and administrative expenses and research and development expenses as determined by the underlying activities.
The following table summarizes the maturity of undiscounted payments due under lease liabilities and the present value of those liabilities as of January 31, 2025 (in thousands):
|
|
|
|
|
Years ending April 30, |
|
Operating Leases |
|
2025 |
|
$ |
524 |
|
2026 |
|
|
1,748 |
|
2027 |
|
|
1,599 |
|
2028 |
|
|
1,596 |
|
2029 |
|
|
769 |
|
Thereafter |
|
|
664 |
|
Total minimum lease payments |
|
|
6,900 |
|
Less amounts representing interest |
|
|
1,118 |
|
Present value of minimum payments |
|
|
5,782 |
|
Current portion |
|
|
1,444 |
|
Long-term portion |
|
$ |
4,338 |
|
Total lease payments in the table above excludes approximately $11.2 million of legally binding minimum lease payments for the signed new headquarter lease that has not yet commenced as of January 31, 2025.
8. Purchase and Sale Agreement
Royalty Liability
On November 4, 2024, the Company, as guarantor, and KalVista Pharmaceuticals Limited, a wholly owned subsidiary of the Company (the “Subsidiary”), entered into a Purchase and Sale Agreement (the “PSA”) with DRI Healthcare Acquisitions LP, an affiliate of DRI Healthcare Trust (“DRI”), for up to $179 million. Under the terms of the synthetic royalty financing agreement, the Subsidiary received an upfront payment of $100.0 million in exchange for tiered royalty payments on worldwide net sales of sebetralstat, as follows: 5.00% on annual net sales up to and including $500.0 million (the “First Tier Royalty Rate”); 1.10% on annual net sales above $500.0 million and up to and including $750.0 million; and 0.25% on annual net sales above $750.0 million.
Beginning in calendar year 2031, the First Tier Royalty Rate for any calendar year will be determined based on annual net sales of sebetralstat for the prior calendar year: 5.00% if the prior year’s annual net sales are at or above $500.0 million or 5.65% if the prior year’s annual net sales are below $500.0 million. Additionally, if sebetralstat achieves annual net sales of at least $550.0 million in any calendar year ending before January 1, 2031, the Subsidiary will earn a sales-based milestone payment of $50.0 million.
If sebetralstat is approved prior to October 1, 2025, the Subsidiary will have the option to receive a one-time cash payment of $22.0 million. If the Subsidiary chooses to receive this optional payment, the royalty rate on net sales up to and including $500.0 million will increase from 5.00% to 6.00%, and the sales-based milestone amount will increase from $50.0 million to $57.0 million.
On receipt of the $100.0 million payment from DRI, the Company recorded a deferred royalty obligation of $93.6 million, net of the initial fair value of the bifurcated embedded derivative liability upon execution of the PSA, and debt issuance costs incurred.
The PSA is considered a sale of future revenues and is accounted for as long-term debt recorded at amortized cost using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. During the three and nine months ended January 31, 2025, the Company recorded $2.8 million of interest expense related to this arrangement on the condensed consolidated statement of operations. The interest rate on this liability may vary during the term of the agreement depending on a number of factors, including the level of forecasted net sales. The company evaluates the interest rate quarterly based on its current net sales forecasts utilizing the prospective method. A significant increase or decrease in actual or forecasted net sales may materially impact the revenue interest liability, interest expense, other income, and the time period for repayment. The deferred royalty obligation, net of the bifurcated embedded derivative liability had a net carrying amount of $96.5 million as of January 31, 2025.
The PSA is denominated in US Dollars and was executed with the Company’s wholly owned U.K. Subsidiary, whose functional currency is the British Pound. As such, the Company will remeasure the liability each reporting period at current exchange rates and recognize unrealized gains and loss in other income (expense).
Embedded Derivative Liability
Under the PSA, the Subsidiary has the option (the “Buy-Back Option”) to repurchase future Revenue Participation Rights at any time until December 31, 2026 either (i) in the event of a change of control of the Subsidiary or (ii) in the event that confirmation that payment of the Revenue Participation Rights will not receive certain tax treatment has not been obtained. Additionally, the Purchaser has an option (the “Put Option”) to require the Subsidiary to repurchase future Revenue Participation Rights in the event of a change of control of the Subsidiary exercisable until December 31, 2026. If the Put Option or the Buy-Back Option is exercised terminating the PSA, the required repurchase price is an amount equal to (a) 1.5 multiplied by (b) the Investment Amount, net of the sum of any payments received by the Purchaser prior to such Put Option or Buy-Back Option repurchase date, as applicable.
The Buy-Back and Put Options are considered embedded derivatives requiring bifurcation as a single compound derivative instrument. The Company estimated the fair value of the derivative liability using a “with-and-without” method. The with-and-without methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the individual embedded derivative. The difference between the entire instrument with the embedded derivative compared to the instrument without the embedded derivative is the fair value of the derivative liability.
The Company recorded $4.4 million for the initial fair value of the derivative liability upon the closing of the PSA. The initial fair value allocated to the derivative liability was recorded against the deferred royalty obligation as a debt discount, which is being amortized in interest expense on the condensed consolidated statement of operations over the expected term using the effective interest method. The embedded derivative is subsequently remeasured at fair value each reporting period, with the change in fair value being recorded as a component of other income (expense) on the condensed consolidated statement of operations. During the period from November 4, 2024 through January 31, 2025, the Company recognized $0.2 million as a component of other income (expense), net as the change in fair value for the embedded derivative liability as of January 31, 2025. This change in fair value consists of foreign currency remeasurement due to the PSA being denominated in US Dollars and executed with the Company’s wholly owned U.K. Subsidiary, whose functional currency is the British Pound. Bifurcated embedded derivatives are classified with the related host contract in the Company’s balance sheet. Of the $100.9 million deferred royalty obligation as of January 31, 2025, the embedded derivative had a fair value of $4.4 million.
The estimated probability and timing of underlying events triggering the exercisability of the Buy-Back and Put Options contained in the PSA, forecasted cash flows and the discount rate are significant unobservable inputs used to determine the estimated fair value of the entire instrument with the embedded derivative. As of January 31, 2025, the discount rate used for valuation of the derivative liability was 9.15%.
9. Income Taxes
As a result of the PSA between the Company, as guarantor, the Subsidiary, and DRI, the $100.0 million up-front payment was treated as income for tax purposes in the UK under the Research and Development Expenditure Credit scheme. After applying the estimated net operating loss carryforwards and research and development tax credits, the Company recorded income tax expense of $4.1 million for the three months ended January 31, 2025 due to an increase in the valuation allowance against its deferred tax assets. The $7.5 million R&D tax credit receivable balance on the consolidated balance sheet as of January 31, 2025 is the amount due to the Company from R&D claims payable to the company from the prior fiscal year plus current year additions, net of the current year payable.
The Company has also recorded income tax expense of $0.1 million for US federal income tax purposes due to the recognition of Global Intangible Low-Taxed Income from the royalty arrangement.
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion in conjunction with our unaudited interim condensed financial statements and related notes included elsewhere in this report. This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential” or “continue” or the negative of these terms or other comparable terminology. These forward-looking statements, include, but are not limited to, statements regarding the success, cost and timing of our product development activities and clinical trials as well as other activities we may undertake, macroeconomic conditions, including rising inflation and changing interest rates, labor shortages, supply chain issues, and global conflicts such as the war in Ukraine and conflicts in the Middle East, our business strategy, our ability to receive, maintain and recognize the benefits of certain designations received by product candidates and the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates. Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or our future financial performance, are based on assumptions, and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” in our Annual Report on Form 10-K or described elsewhere in this Quarterly Report on Form 10-Q. These forward-looking statements speak only as of the date hereof. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. Unless the context indicates otherwise, in this Quarterly Report on Form 10-Q, the terms “KalVista,” “Company,” “we,” “us” and “our” refer to KalVista Pharmaceuticals, Inc. and, where appropriate, its consolidated subsidiaries.
Management Overview
We are a pre-commercial stage pharmaceutical company focused on the discovery, development and commercialization of drug therapies for diseases with significant unmet need. We have used our capabilities to develop sebetralstat, a novel, orally delivered, small molecule plasma kallikrein inhibitor targeting the disease hereditary angioedema (“HAE”).
HAE is a rare and potentially life-threatening, genetically driven disease that features episodes of debilitating and often painful swelling in the skin, gastrointestinal tract or airways. Although multiple therapies have been approved for the disease, we believe people living with HAE are in need of alternatives that better meet their objectives for quality of life and ease of disease control. Other than one oral therapy approved for prophylaxis, currently marketed therapies are all administered by injection, which patients find challenging despite their efficacy because they are painful, time consuming to prepare and administer, and difficult to transfer and store. As a result, many attacks are treated too late to prevent significant symptoms, and a large percentage are not treated at all, leading to needless suffering. We anticipate that there will be strong interest in a safe and effective, orally delivered on-demand treatment, which would provide patients a new and compelling option with which to treat their disease.
We have filed a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) seeking marketing approval of sebetralstat as the first oral, on-demand HAE therapy for adults as well as adolescents ages 12 and above, and have a PDUFA notification date of June 17, 2025. We believe the adolescent population has a particularly high unmet need, as patients in this age group frequently experience attacks yet currently only have approved access to injectable on-demand therapies, which causes them to have particularly long delays in treatment of attacks.
We have submitted a Marketing Authorization Application (“MAA”) for sebetralstat to the European Medicines Agency (“EMA), which currently is being reviewed by the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) under the centralized licensing procedure for all 27 Member States of the European Union, as well as the EEA countries Norway, Iceland and Liechtenstein. We also have made MAA submissions to the regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore via the Access Consortium framework for which we have obtained a four-way sharing agreement by the Medicines and Healthcare product Regulatory Agency, Swissmedic, the Therapeutic Goods Administration and Health Sciences Authority. The Access Consortium is designed to maximize regulatory collaboration across countries and support a timely review process. In January 2025, we announced that we submitted a Japanese New Drug Application for sebetralstat to the Japanese Pharmaceuticals and Medical Devices Agency, and also that the Japanese Ministry of Health, Labour and Welfare has granted sebetralstat Orphan Drug Designation. If approved, sebetralstat would be the first oral on-demand treatment for HAE in all of these territories.
In June 2024, we initiated a pediatric clinical trial (KONFIDENT-KID), using an orally disintegrating tablet (“ODT”) formulation of sebetralstat developed specifically for pediatric use. We intend to submit a supplemental NDA (“sNDA”) filing seeking marketing authorization of sebetralstat for pediatric use in 2026. If approved, sebetralstat ODT would be the first oral therapy for pediatric patients
aged 2 to 11 years old. In the fourth quarter of 2024, we began conversion of adolescent and adult participants in the ongoing KONFIDENT-S open label extension trial to an ODT formulation, enabling a potential 2025 supplemental NDA (“sNDA”) filing with the FDA for adolescent and adult usage of this formulation. If approved, the ODT formulation would provide people living with HAE with an additional novel option for oral on-demand treatment.
Sebetralstat has received Fast Track and Orphan Drug designations from the FDA, as well as Orphan Drug Designation and an approved Pediatric Investigational Plan from the EMA and Orphan Drug Status in Switzerland. The U.K. Medicines and Healthcare products Regulatory Agency (“MHRA”) awarded the Innovation Passport for sebetralstat.
We believe our preclinical oral Factor XIIa inhibitor program has the potential to be the first orally delivered Factor XIIa inhibitor for indications across a wide variety of therapeutic areas. We are undertaking a strategic review of this program, to evaluate the potential for further progress and indications for future development, and we intend to make further decisions on this program following completion of this process.
In November 2024, we, as guarantor, and KalVista Pharmaceuticals Limited, our wholly owned subsidiary (the “Subsidiary), entered into a Purchase and Sale Agreement the (“PSA”) with DRI Healthcare Acquisitions LP (the “Purchaser”), an affiliate of DRI Healthcare Trust, pursuant to which the Subsidiary sold to the Purchaser the right to receive payments from the Subsidiary at a tiered percentage of future worldwide net sales of sebetralstat.
Under the terms of the PSA, the Subsidiary received an upfront payment of $100.0 million in exchange for tiered payments on worldwide net sales of sebetralstat, as follows: 5.00% on annual net sales up to and including $500.0 million; 1.10% on annual net sales above $500.0 million and up to and including $750.0 million; and 0.25% on annual net sales above $750.0 million. The Subsidiary is entitled to a potential one-time sales-based milestone payment of $50.0 million if annual global net sales of sebetralstat meet or exceed $550.0 million in any calendar year before January 1, 2031.
If sebetralstat is approved prior to October 1, 2025, the Subsidiary will have the option to receive a one-time payment of $22.0 million. If the Subsidiary chooses to receive this optional payment, the royalty rate on net sales up to and including $500 million will increase from 5.00% to 6.00%, and the sales-based milestone amount will increase from $50.0 million to $57.0 million.
Also in November 2024, we entered into an underwriting agreement with Jefferies LLC, BofA Securities, Inc., TD Securities (USA) LLC, and Stifel, Nicholas & Company Incorporated (the “Underwriters”) pursuant to which we agreed to issue and sell an aggregate of 5,500,000 shares of our common stock, to the Underwriters at an offering price of $10.00 per share (the “Offering”). The net proceeds from the Offering, after deducting underwriting discounts and commissions and Offering expenses, were approximately $51.3 million.
Further in November 2024, we entered into a securities purchase agreement with the Purchaser pursuant to which we agreed to sell and issue to the Purchaser an aggregate of 500,000 shares of our common stock, at a purchase price of $10.00 per share, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended. The net proceeds from the private placement, after deducting placement agent fees and other expenses, were approximately $4.7 million.
Financial Overview
Research and Development Expenses
Research and development expenses primarily consist of costs associated with our research activities, including the preclinical and clinical development of product candidates. We contract with clinical research organizations to manage our clinical trials under agreed upon budgets for each study, with oversight by our clinical program managers. All research and development costs are expensed as incurred.
Costs for certain research and development activities, such as manufacturing development activities and clinical studies are recognized based on the contracted amounts, as adjusted for the percentage of work completed to date. Payments for these activities are based on the terms of the contractual arrangements, which may differ from the pattern of costs incurred, and are reflected on the consolidated balance sheets as prepaid or accrued expenses. We defer and capitalize non-refundable advance payments made for research and development activities until the related goods are delivered or the related services are performed.
We expect to continue to spend a significant amount of our resources on research and development activities for the foreseeable future as we continue to conduct clinical development, manufacturing, and toxicology studies. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials, additional drug manufacturing requirements, and later stage toxicology studies
such as carcinogenicity studies. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. The probability of success for each product candidate is affected by numerous factors, including preclinical data, clinical data, competition, manufacturing capability and commercial viability. Accordingly, we may never succeed in achieving marketing approval for any of our product candidates.
Completion dates and costs for clinical development programs as well as our research program can vary significantly for each current and future product candidate and are difficult to predict. As a result, we cannot currently estimate with any degree of certainty the costs associated with development of our product candidates. We anticipate making determinations as to which programs and product candidates to pursue and how much funding to direct to each program and product candidate on an ongoing basis in response to the scientific success of early research programs, results of ongoing and future clinical trials, our ability to enter into collaborative agreements with respect to programs or potential product candidates, as well as ongoing assessments as to the commercial potential of each current or future product candidate.
General and Administrative Expenses
General and administrative expenses consist primarily of employee-related expenses, including salaries, benefits and equity-based compensation expenses for personnel in executive, finance, legal, medical affairs, information technology, human resources, investor relations, and commercial functions. Other significant general and administrative expenses include facility costs not otherwise included in research and development expenses, legal fees relating to patent and corporate matters and fees for accounting, consulting services, and corporate expenses. We expect general and administrative expense to increase as we continue to invest in building the infrastructure to support the commercialization of sebetralstat.
Other Income
Other income consists of interest income earned on bank interest and marketable securities, research and development tax credits from the United Kingdom government’s tax incentive programs set up to encourage research and development in the United Kingdom, realized gains and losses from marketable securities and realized and unrealized exchange rate gains and losses on cash held in foreign currencies and transactions settled in foreign currencies.
Deferred Royalty Obligation
We treat the liability related to the sale of future royalties as a debt instrument, amortized under the effective interest rate method over the estimated life of the revenue stream. We recognize interest expense thereon using the effective rate, which is based on our current estimates of future revenues over the life of the arrangement. We periodically assess our expected revenues using internal projections, impute interest on the carrying value of the deferred royalty obligation, and record interest expense using the imputed effective interest rate. To the extent our estimates of future revenues are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, we will account for any such changes by adjusting the effective interest rate on a prospective basis, with a corresponding impact to the reclassification of the deferred royalty obligation. The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs requires that we make estimates that could impact the classification of such costs, as well as the period over which such costs will be amortized.
Income Taxes
We historically have incurred net losses and have had no corporation tax liabilities. We file U.S. Federal tax returns, as well as certain state returns. We also file returns in the United Kingdom. Under the U.K. government’s research and development tax incentive scheme, we have incurred qualifying research and development expenses and filed claims for research and development tax credits in accordance with the relevant tax legislation. The research and development tax credits are paid out to us in cash and reported as other income. As a result of the November 2024 PSA, the $100.0 million up-front payment was treated as income for tax purposes in the UK under the Research and Development Expenditure Credit scheme. After applying the estimated net operating loss carryforwards and research and development tax credits, we recorded income tax expense of $4.1 million for the three months ended January 31, 2025 due to an increase in the valuation allowance against its deferred tax assets. We also recorded income tax expense of $0.1 million for US federal income tax purposes due to the recognition of Global Intangible Low-Taxed Income from the royalty arrangement. Because of the operating losses and the full valuation allowance provided on all deferred tax assets, including the net operating losses, no tax provision had been recognized in the three and nine months ended January 31, 2024.
For tax purposes, pursuant to the Tax Cuts and Jobs Act of 2017, we are required to capitalize and subsequently amortize all R&D expenditures over five years for research activities conducted in the U.S. and over fifteen years for research activities conducted outside of the U.S. We adopted ASU 2019-12 as of January 1, 2022.
Results of Operations
Comparison of the three months ended January 31, 2025 and 2024
The following table sets forth the key components of our results of operations for the three months ended January 31, 2025 and 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
January 31, |
|
|
Increase |
|
|
|
|
2025 |
|
|
2024 |
|
|
(decrease) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
12,594 |
|
|
$ |
22,523 |
|
|
$ |
(9,929 |
) |
|
General and administrative expenses |
|
|
30,346 |
|
|
|
10,628 |
|
|
|
19,718 |
|
|
Other income (expense), net |
|
|
|
|
|
|
|
|
|
|
Interest, exchange rate gain and other income |
|
|
(1,322 |
) |
|
|
4,123 |
|
|
|
(5,445 |
) |
|
Research and Development Expenses. Research and development expenses decreased $9.9 million to $12.6 million for the three months ended January 31, 2025 compared to $22.5 million in the same period in the prior fiscal year due to decreases in spending on sebetralstat of $6.9 million, personnel costs of $1.0 million, and other R&D activities of $2.0 million. The impact of exchange rates on research and development expenses was immaterial for the three months ended January 31, 2025 compared to the same period in the prior fiscal year, which is reflected in the figures above.
Research and development expenses by major programs or categories were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
January 31, |
|
|
Increase |
|
|
|
2025 |
|
|
2024 |
|
|
(decrease) |
|
|
|
|
|
|
|
|
|
|
|
Program-specific costs |
|
|
|
|
|
|
|
Sebetralstat |
|
$ |
3,922 |
|
|
$ |
10,836 |
|
|
$ |
(6,914 |
) |
KVD824 |
|
|
- |
|
|
|
29 |
|
|
|
(29 |
) |
Unallocated costs |
|
|
|
|
|
|
|
|
|
Personnel |
|
|
6,079 |
|
|
|
7,069 |
|
|
|
(990 |
) |
Other R&D |
|
|
2,593 |
|
|
|
4,589 |
|
|
|
(1,996 |
) |
Total |
|
$ |
12,594 |
|
|
$ |
22,523 |
|
|
$ |
(9,929 |
) |
Expenses for the sebetralstat program decreased primarily due to the Phase 3 KONFIDENT trial completing in February 2024. We anticipate that these expenses will remain approximately at current levels as both the KONFIDENT-S and KONFIDENT-KID trials are ongoing and continue to enroll participants.
Personnel expenses will remain at or slightly below current levels as we prioritize commercial launch efforts.
Other costs decreased primarily due to decreased spending on preclinical activities and a transition to recognizing expense associated with sebetralstat pre-commercial awareness within General & Administrative. We anticipate Other Costs to remain at current levels as we continue development of the oral Factor XIIa inhibitor program and other preclinical activities.
General and Administrative Expenses. General and administrative expenses increased by $19.7 million primarily due to increases in personnel costs of $8.6 million, commercial expenses of $5.7 million, sebetralstat awareness of $1.9 million, professional fees of $1.9 million, and other administrative expenses of $1.6 million. We anticipate that expenses will continue at or above current levels as we continue to expand to support the growth of the Company and the planned commercialization of sebetralstat.
Other Income (Expense), net. Other income decreased $5.4 million primarily due to an increase in net interest expense of $2.1 million, a decrease in foreign currency exchange rate gains of $2.1 million, and a decrease of $1.1 million in income from research and development tax credits.
Comparison of the nine months ended January 31, 2025 and 2024
The following table sets forth the key components of our results of operations for the nine months ended January 31, 2025 and 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
January 31, |
|
|
Increase |
|
|
|
2025 |
|
|
2024 |
|
|
(decrease) |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
55,818 |
|
|
$ |
60,919 |
|
|
$ |
(5,101 |
) |
General and administrative expenses |
|
|
77,147 |
|
|
|
31,071 |
|
|
|
46,076 |
|
Other income (expense), net |
|
|
|
|
|
|
|
|
|
Interest, exchange rate gain and other income |
|
|
5,994 |
|
|
|
9,995 |
|
|
|
(4,001 |
) |
Research and Development Expenses. Research and development expenses decreased $5.1 million to $55.8 million for the nine months ended January 31, 2025 due to a decrease in spending on sebetralstat of $3.9 million, a decrease in spending on KVD824 of $0.8 million, and a decrease in other R&D activities of $1.7 million as compared to the same period in the prior fiscal year. These decreases were offset by an increase in personnel costs of $1.3 million. The impact of exchange rates on research and development expenses resulted in an increase to expenses of $0.7 million in the nine months ended January 31, 2025 compared to the same period in the prior fiscal year, which is reflected in the figures above.
Research and development expenses by major programs or categories were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
January 31, |
|
|
Increase |
|
|
|
2025 |
|
|
2024 |
|
|
(decrease) |
|
|
|
|
|
|
|
|
|
|
|
Program-specific costs |
|
|
|
|
|
|
|
|
|
Sebetralstat |
|
$ |
23,869 |
|
|
$ |
27,782 |
|
|
$ |
(3,913 |
) |
KVD824 |
|
|
- |
|
|
|
755 |
|
|
|
(755 |
) |
Unallocated costs |
|
|
|
|
|
|
|
|
|
Personnel |
|
|
22,104 |
|
|
|
20,789 |
|
|
|
1,315 |
|
Other R&D |
|
|
9,845 |
|
|
|
11,593 |
|
|
|
(1,748 |
) |
Total |
|
$ |
55,818 |
|
|
$ |
60,919 |
|
|
$ |
(5,101 |
) |
Expenses for the sebetralstat program decreased primarily due to the Phase 3 KONFIDENT trial completing in February 2024.
Expenses for KVD824 decreased primarily due to the termination of the Phase 2 KOMPLETE clinical trial in October 2022. These expenses have ceased as we do not anticipate any further development of KVD824.
Personnel expenses increased primarily due to higher research and development headcounts compared to the same period in the prior year.
General and Administrative Expenses. General and administrative expenses increased $46.1 million primarily due to increases in personnel costs of $18.1 million, commercial strategy expenses of $16.4 million, sebetralstat awareness of $4.5 million, professional fees of $3.2 million and other administrative expenses of $3.8 million.
Other Income (Expense), net. Other income decreased $4.0 million primarily due to an increase in net interest expense of $0.8 million, a decrease in foreign currency exchange rate gains of $0.7 million, and a decrease of $2.5 million in income from research and development tax credits.
Liquidity and Capital Resources
Since inception, we have not generated any revenue from product sales and have incurred losses since inception and cash outflows from operating activities for the nine months ended January 31, 2025 and 2024. We have funded operations primarily through the issuance of capital stock, pre-funded warrants, and royalty financing. Our working capital, primarily cash and marketable securities, is anticipated to fund our operations for at least the next twelve months from the date these unaudited interim condensed consolidated financial statements are issued.
In February 2024, we entered into an underwriting agreement with Jefferies LLC, Leerink Partners LLC, Stifel, Nicolaus & Company, Incorporated, and Cantor Fitzgerald & Co., as the representatives of several underwriters to sell an aggregate of 7,016,312 shares of our common stock at a price of $15.25 per share and pre-funded warrants to purchase up to 3,483,688 shares of our common stock at a price of $15.249 per pre-funded warrant (the “February 2024 Offering”). The net proceeds from the February 2024 Offering, after deducting expenses, were approximately $150.1 million. As of January 31, 2025, no pre-funded warrants from the February 2024 Offering have been exercised.
In July 2024, we filed the Registration Statement pursuant to which we may offer and sell securities having an aggregate public offering price of up to $300 million. During the three months ended January 31, 2025, we did not offer or sell any shares pursuant to the Registration Statement.
In November 2024, we entered into an underwriting agreement with Jefferies LLC, BofA Securities, Inc., TD Securities (USA) LLC and Stifel Nicolaus & Company, Incorporated, as the representatives of several underwriters to sell an aggregate of 5,500,000 shares of our common stock at an offering price of $10.00 per share (the “November 2024 Offering”). The net proceeds from the November 2024 Offering, after deducting estimated expenses, were approximately $51.3 million.
Also in November 2024, we entered into a securities purchase agreement with DRI Healthcare Acquisitions LP to sell an aggregate of 500,000 shares of our common stock at a price of $10.00 per share in a private placement. The net proceeds from the private placement, after deducting placement agent fees and other expenses, were approximately $4.7 million.
Finally, in November 2024 we entered into a royalty purchase agreement with DRI Healthcare Acquisitions LP, an affiliate of DRI Healthcare Trust Royalty Pharma to monetize a portion of our future sebetralstat worldwide net sales. Under the terms of the agreement, we received an upfront payment of $100.0 million in exchange for tiered royalty payments on worldwide net sales of sebetralstat.
Cash Flows
The following table shows a summary of the net cash flow activity for the nine months ended January 31, 2025 and 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
January 31, |
|
|
|
2025 |
|
|
2024 |
|
|
|
|
|
Cash flows used in operating activities |
|
$ |
(112,543 |
) |
|
$ |
(74,126 |
) |
Cash flows provided by investing activities |
|
|
94,352 |
|
|
|
41,467 |
|
Cash flows provided by financing activities |
|
|
155,068 |
|
|
|
616 |
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
(725 |
) |
|
|
(1,139 |
) |
Net increase (decrease) in cash and cash equivalents |
|
$ |
136,152 |
|
|
$ |
(33,182 |
) |
Net cash used in operating activities
Net cash used in operating activities was $112.5 million for the nine months ended January 31, 2025 and primarily consisted of a net loss of $131.2 million adjusted for stock-based compensation of $8.7 million, interest expense and issuance cost amortization associated with the sale of future royalties of $2.9 million, realized gains from available for sale securities of $1.2 million, and other changes in net working capital. Net cash used in operating activities was $74.1 million for the nine months ended January 31, 2024 and primarily consisted of a net loss of $82.0 million adjusted for stock-based compensation of $9.2 million, an increase in the research and development tax credit receivable of $6.2 million, realized gains from available for sale securities of $1.1 million, a decrease in prepaid expenses and other assets of $0.9 million and other changes in net working capital.
Net cash provided by investing activities
Net cash provided by investing activities for the nine months ended January 31, 2025 was $94.4 million and primarily consisted of the sales and maturities of marketable securities of $102.3 million offset by purchases of marketable securities of $7.5 million, as compared to $41.5 million provided by investing activities during the same period in the prior year primarily due to sales and maturities of marketable securities of $89.5 million offset by purchases of marketable securities of $47.7 million.
Net cash provided by financing activities
Net cash provided by financing activities during the nine months ended January 31, 2025 was $155.1 million and primarily consisted of $98.0 million in net proceeds from the PSA with DRI, $55.9 million in aggregate net proceeds from the November 2024
Offering and private placement, and $4.0 million from the issuance of common stock from equity incentive plans. Net cash provided by financing activities during the same period in the prior year was $0.6 million which consisted of the issuance of common stock from equity incentive plans.
Operating Capital Requirements
To date, we have not generated any revenues from the sale of products, and we do not have any products that have been approved for commercialization. We do not expect to generate product revenue unless and until we obtain regulatory approval for, and commercialize, one of our current or future product candidates. We anticipate that we will continue to incur losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, product candidates, and begin to commercialize any approved products. We are subject to all of the risks inherent in the development of new therapeutic products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We currently anticipate that, based upon our operating plans and existing capital resources, we have sufficient funding to operate for at least the next twelve months. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our preclinical and clinical development efforts, future growth to support commercial sales of any approved products, and other activities we may choose to undertake.
Until such time, if ever, as we can generate substantial revenues, we expect to finance our cash needs through a combination of equity and debt financings, collaborations, strategic partnerships, royalty financings, and licensing arrangements. To the extent that additional capital is raised through the sale of stock or convertible debt securities, the ownership interest of existing stockholders will be diluted, and the terms of these newly issued securities may include liquidation or other preferences that adversely affect the rights of common stockholders. Debt financing, if available, may involve agreements that include increased fixed payment obligations and covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends, selling or licensing intellectual property rights and other operating restrictions that could adversely impact our ability to conduct business. Additional fundraising through collaborations, strategic partnerships or licensing arrangements with third parties may require us to relinquish valuable rights to product candidates, including our other technologies, future revenue streams or research programs, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate product development or future commercialization efforts or grant rights to develop and commercialize other product candidates even if we would otherwise prefer to develop and commercialize such product candidates internally.
Contractual Obligations and Commitments
We enter into contracts in the normal course of business with contract research organizations and clinical trial sites for the conduct of clinical trials, preclinical and clinical studies, professional consultants and other vendors for clinical supply manufacturing or other services. These contracts generally provide for termination on notice, and therefore are cancelable contracts and not included in the table of contractual obligations and commitments in our Annual Report on Form 10-K for the fiscal year ended April 30, 2024, filed with the SEC on July 11, 2024. We are party to several operating leases for office and laboratory space as of January 31, 2025.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with U.S. GAAP. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of our financial statements and the reported revenue and expenses during the reported periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience, known trends and events, contractual milestones and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. See Note 2 to the unaudited interim condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report on Form 10-Q for a description of our significant accounting policies and assumptions used in applying those policies. The accounting policies and estimates that we deem to be critical are discussed in more detail in our Annual Report on Form 10-K for the fiscal year ended April 30, 2024, filed with the SEC on July 11, 2024. There have been no material changes to our critical accounting policies and significant estimates in the nine months ended January 31, 2025 except for the deferred royalty obligation and its embedded derivative liability, as discussed in Note 2.
Recently Issued Accounting Pronouncements
See Note 2 in the Interim Financial Statements for a description of recent accounting pronouncements, including the expected dates of adoption and expected effects on results of operations and financial condition, if known.
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.
Item 4. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15(b) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of January 31, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute assurance of achieving the desired objectives. Also, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer has concluded that our disclosure controls and procedures were effective as of January 31, 2025.
Changes in Internal Controls over Financial Reporting
There have been no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended January 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II
OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
From time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. We are currently not aware of any such legal proceedings or claims that we believe will have a material adverse effect on our business, financial condition or operating results.
Item 1A. RISK FACTORS
There have been no material changes to the risk factors described in the section captioned “Part I, Item 1A, Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2024.
In addition to the other information set forth in this report, you should carefully consider the factors discussed in the section captioned “Part I, Item 1A, Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2024 filed with the SEC on July 11, 2024, which may materially affect our business, financial condition, or future results. The risks described in our Annual Report on Form 10-K and in our Quarterly Reports on Form 10-Q are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may have a material adverse effect on our business, financial condition, or operating results.
Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Sales of Unregistered Securities
Not applicable.
Use of Proceeds
None.
Issuer Purchases of Equity Securities
Not applicable.
Item 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
Item 4. MINE SAFETY DISCLOSURES
Not applicable.
Item 5. OTHER INFORMATION
(c) Insider Trading Arrangements and Policies
In the third quarter of fiscal 2025, no trading plans were adopted, modified or terminated by a director or officer of the Company.
Item 6. EXHIBITS
Registrant has omitted portions of the exhibit as permitted under Item 601(b)(10) of Regulation S-K.
^ Registrant has omitted schedules and exhibits pursuant to Item 601(a)(5) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of the omitted schedules and exhibits to the SEC upon request.
# This certification is deemed not filed for purpose of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
KALVISTA PHARMACEUTICALS, INC. |
|
|
|
Date: March 12, 2025 |
By: |
/s/ Benjamin L. Palleiko |
|
|
Benjamin L. Palleiko Chief Executive Officer (Principal Executive Officer) |
|
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Date: March 12, 2025 |
By: |
/s/ Brian Piekos |
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Brian Piekos Chief Financial Officer (Principal Financial and Accounting Officer) |
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND OF THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE AND CONFIDENTIAL.
Purchase and Sale Agreement
By and Among
KalVista Pharmaceuticals Limited,
DRI Healthcare Acquisitions LP
and, solely for the purposes of the Guarantor Provisions,
KalVista Pharmaceuticals, Inc.
Dated as of November 4, 2024
TABLE OF CONTENTS
Page
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ARTICLE I DEFINITIONS |
1 |
Section 1.1. Definitions |
1 |
Section 1.2. Certain Interpretations |
22 |
ARTICLE II PURCHASE, SALE AND ASSIGNMENT OF THE REVENUE PARTICIPATION RIGHT |
23 |
Section 2.1. Purchase, Sale and Assignment |
23 |
Section 2.2. Purchase Price; Sales-Based Milestone Payment; Optional Payment |
25 |
Section 2.3. No Assumed Obligations, Etc |
25 |
ARTICLE III CLOSING |
26 |
Section 3.1. Closing |
26 |
Section 3.2. Payment of Closing Price |
26 |
Section 3.3. Closing Deliverables of the Seller |
26 |
ARTICLE IV REPRESENTATIONS AND WARRANTIES |
26 |
Section 4.1. Seller’s Representations and Warranties |
26 |
Section 4.2. Buyer’s Representations and Warranties |
33 |
ARTICLE V COVENANTS |
35 |
Section 5.1. Reporting |
35 |
Section 5.2. Royalty Payments; Revenue Participation and Royalty Payment Details; Put Option; Buy-Back Option |
36 |
Section 5.3. Disclosures |
39 |
Section 5.4. Inspections and Audits of the Seller |
39 |
Section 5.5. Intellectual Property and Regulatory Matters |
40 |
Section 5.6. In-Licenses |
42 |
Section 5.7. Permitted Licenses; Sales |
43 |
Section 5.8. Restricted Indebtedness; Secured Indebtedness |
44 |
Section 5.9. Liens |
44 |
Section 5.10. Development, Marketing and Commercialization |
44 |
Section 5.11. Continuing Efforts; Further Assurances |
45 |
Section 5.12. Non-Impairment; Back-Up Security Interest |
45 |
Section 5.13. Certain Tax Matters |
46 |
Section 5.14. Use of Proceeds |
46 |
Section 5.15. Parent Obligations |
48 |
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ARTICLE VI BANKRUPTCY EVENTS |
48 |
ARTICLE VII INDEMNIFICATION |
48 |
Section 7.1. General Indemnity |
48 |
Section 7.2. Notice of Claims |
49 |
Section 7.3. Claim Procedures |
49 |
Section 7.4. Limitations on Liability |
50 |
Section 7.5. Exclusive Remedy |
50 |
Section 7.6. Tax Treatment of Indemnification Payments |
51 |
Section 7.7. Survival of Representations and Warranties |
51 |
ARTICLE VIII CONFIDENTIALITY |
51 |
Section 8.1. Confidentiality |
51 |
Section 8.2. Authorized Disclosure |
52 |
ARTICLE IX TERMINATION |
53 |
Section 9.1. Mutual Termination |
53 |
Section 9.2. Automatic Termination |
53 |
Section 9.3. Survival |
53 |
ARTICLE X MISCELLANEOUS |
53 |
Section 10.1. Headings |
53 |
Section 10.2. Notices |
53 |
Section 10.3. Assignment |
55 |
Section 10.4. Amendment and Waiver |
56 |
Section 10.5. Entire Agreement |
56 |
Section 10.6. No Third Party Beneficiaries |
56 |
Section 10.7. Governing Law |
56 |
Section 10.8. Jurisdiction; Venue |
56 |
Section 10.9. Severability |
57 |
Section 10.10. Specific Performance |
57 |
Section 10.11. Counterparts |
58 |
Section 10.12. Relationship of the Parties |
58 |
Section 10.13. Intercreditor Agreement |
58 |
Section 10.14. Expenses |
58 |
Section 10.15. Parent Guarantee |
58 |
Index of Exhibits
Exhibit A: Description of Sebetralstat
Exhibit B: Form of Intercreditor Agreement
Exhibit C: Bill of Sale
Exhibit D: Form of Royalty Report
PURCHASE AND SALE AGREEMENT
This PURCHASE AND SALE AGREEMENT, dated as of November 4, 2024 (this “Agreement”), is made and entered into by and among DRI Healthcare Acquisitions LP, a Delaware limited partnership (the “Buyer”), and KalVista Pharmaceuticals Limited, a company limited by shares incorporated in England and Wales (the “Seller”) and, solely for the purposes of the Guarantor Provisions, KalVista Pharmaceuticals, Inc., a Delaware corporation (the “Parent”).
RECITALS:
WHEREAS, the Seller is in the business of, among other things, developing and commercializing the chemical compound “Sebetralstat” and Products related thereto; and
WHEREAS, the Buyer desires to purchase the Revenue Participation Right from the Seller in exchange for payment of the Purchase Price, and the Seller desires to sell the Revenue Participation Right to the Buyer in exchange for the Buyer’s payment of the Purchase Price, in each case on the terms and conditions set forth in this Agreement.
NOW THEREFORE, in consideration of the representations, warranties, covenants and agreements set forth herein and for good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Seller and the Buyer hereby agree as follows:
ARTICLE I
DEFINITIONS
Section 1.1. Definitions. The following terms, as used herein, shall have the following meanings:
“Additional Amount” is defined in Section 5.13(b).
“Affiliate” means, with respect to any particular Person, any other Person directly or indirectly controlling, controlled by or under common control with such particular Person. For purposes of the foregoing sentence, the term “control” means direct or indirect ownership of (a) fifty percent (50%) or more, including ownership by trusts with substantially the same beneficial interests, of the voting and equity rights of such Person, firm, trust, corporation, partnership or other entity or combination thereof, or (b) the power to direct the management of such person, firm, trust, corporation, partnership or other entity or combination thereof, by contract or otherwise. For the avoidance of doubt, for the purposes of this Agreement, each of the Parent and its Subsidiaries (including KalVista Pharmaceuticals (Ireland) Limited) are deemed to be an Affiliate of the Seller.
“Aggregate Net Invested Capital” means, if positive, an amount equal to the difference of (a) the Purchase Price actually received by the Seller compounded at a rate per annum equal to Three-Month Term SOFR plus [*], which shall compound annually from the date such Purchase Price is received minus (b) the Cumulative Royalty Payments actually received by the Buyer (and not merely accrued by the Seller).
“Agreement” is defined in the preamble.
“Back-Up Security Interest” is defined in Section 2.1(b).
“Bankruptcy Event” means the occurrence of any of the following in respect of a Person: (a) such Person shall generally not, shall be unable to, or shall admit in writing its inability to, pay its debts as they come due (in the case of the Seller, including an inability to pay its debts as they fall due within the meaning of Section 123 of the UK Insolvency Act 1986) or a general assignment by such Person for the benefit of creditors; (b) the filing of any petition or answer by such Person seeking to adjudicate itself as bankrupt or insolvent, or seeking for itself any liquidation, winding-up, reorganization, arrangement, adjustment, protection, relief or composition of such Person or its debts under any applicable Law relating to bankruptcy, insolvency, receivership, winding-up, liquidation, reorganization, administration, examination, relief of debtors or other similar applicable Law now or hereafter in effect, or seeking, consenting to or acquiescing in the entry of an order for relief in any case under any such applicable Law, or the appointment of or taking possession by an administrative or other receiver, manager, trustee, custodian, liquidator, administrator, examiner, assignee, sequestrator or other similar official for such Person or for any substantial part of its property; (c) corporate or other entity action taken by such Person to authorize any of the actions set forth in clause (a) or clause (b) above; (d) without the consent or acquiescence of such Person, the commencement of an action seeking entry of an order for relief or approval of a petition for relief or reorganization or any other petition seeking any reorganization, arrangement, composition, readjustment, winding-up, liquidation, dissolution or other similar relief under any present or future bankruptcy, insolvency or similar applicable Law, or the filing of any such petition against such Person, or, without the consent or acquiescence of such Person, the commencement of an action seeking entry of an order appointing a trustee, custodian, administrative or other receiver, manager, administrator or liquidator of such Person or of all or any substantial part of the property of such Person, in each case where such petition or order shall remain unstayed or shall not have been stayed or dismissed within [*] from entry thereof; or (e) the making of an application to a court of competent jurisdiction for protection from the creditors of such Person generally other than in connection with any refinancing in the ordinary course of business.
“Bankruptcy Laws” means, collectively, bankruptcy, insolvency, administration, reorganization, moratorium, fraudulent conveyance, fraudulent transfer or other similar Laws affecting the enforcement of creditors’ rights generally.
“Borrower” is defined in Section 5.8(b).
“Business Day” means any day other than (a) a Saturday or Sunday or (b) a day on which banking institutions located in London, England and New York, NY, U.S.A. are permitted or required by applicable Law or regulation to remain closed.
“Buyer” is defined in the preamble.
“Buyer Indemnified Parties” is defined in Section 7.1(a).
“Buy-Back Option” is defined in Section 5.2(e).
“Buy-Back Option Trigger Event” is defined in Section 5.2(e).
“Buy-Back Price” is defined in Section 5.2(e).
“Buy-Back Window” is defined in Section 5.2(e).
“Capital Lease” means, as applied to any Person, any lease of any property by that Person as lessee which, in accordance with GAAP, is required to be accounted for as a capital lease on the balance sheet of that Person. Notwithstanding anything to the contrary herein, all obligations of any Person that are or would have been treated as operating leases for purposes of GAAP prior to the issuance by the Financial Accounting Standards Board on February 25, 2016 of the Accounting Standards Update (“ASU”) shall continue to be accounted for as operating leases for purposes of all financial definitions, calculations and covenants for purpose of this Agreement (whether or not such operating lease obligations were in effect on such date) notwithstanding the fact that such obligations are required in accordance with the ASU (on a prospective or retroactive basis or otherwise) to be treated as capitalized lease obligations in accordance with GAAP.
“Change of Control” means the occurrence of any one or more of the following: (a) the acquisition, whether directly, indirectly, beneficially or of record, whether by merger, consolidation, sale or other transfer of securities in a single transaction or series of related transactions, by any Person of any voting securities of the Seller, or if the percentage ownership of any Person in the voting securities of the Seller is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such Person is, directly or indirectly, the beneficial owner of voting securities representing fifty percent (50%) or more of the total voting power of all of the then outstanding voting securities of the Seller; (b) a merger, consolidation, recapitalization, or reorganization of the Seller is consummated that would result in shareholders or equity holders of the Seller immediately prior to such transaction that did not own more than fifty percent (50%) of the outstanding voting securities of the Seller immediately prior to such transaction, owning more than fifty percent (50%) of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; or (c) the sale, lease, transfer, license or other disposition, in a single transaction or series of related transactions, by the Seller or any Subsidiary of the Seller of (x) all or substantially all rights relating to Sebetralstat, (y) all or substantially all the assets of the Seller and its Subsidiaries taken as a whole or (z) the sale or disposition (whether by merger, consolidation or otherwise) of one or more Subsidiaries of the Seller if substantially all rights relating to Sebetralstat or all of the assets of the Seller and its Subsidiaries taken as a whole are held by such Subsidiary or Subsidiaries, except where such sale, lease, transfer, license or other disposition is to a wholly owned Subsidiary of the Seller.
[*]
“Clinical and Commercial Annual Report” is defined in Section 5.1(b).
“Clinical Trial” means a clinical trial, investigation or study intended to support or maintain Marketing Approval or Commercialization of a Product, including post-approval clinical trials or studies, in each case on-going as of the Closing Date or initiated thereafter.
“Clinical Updates” means (a) a summary of any material updates with respect to the Clinical Trials, including (as applicable) the number of patients currently enrolled in each such Clinical Trial, the number of sites conducting each such Clinical Trial, the material progress of each such Clinical Trial, any material modifications to each such Clinical Trial, any adverse events in the Clinical Trials, and (b) written plans to start new Clinical Trials.
“Closing” means the closing of the sale, transfer, assignment and conveyance of the Revenue Participation Right hereunder.
“Closing Date” means the date on which the Closing occurs pursuant to Section 3.1.
“Closing Price” is defined in Section 2.2(a)(i).
“CMC” means chemistry, manufacturing and controls with respect to a Product.
“Combination Product” means:
(a) a single pharmaceutical formulation (whether co-formulated or administered together via the same administration route) containing as its active ingredients both a Product and one or more other therapeutically or prophylactically active pharmaceutical or biologic ingredients (each an “Other Component”), or
(b) a combination therapy comprised of a Product and one or more Other Component(s), whether priced and sold in a single package containing such multiple products, packaged separately but sold together for a single price, or sold under separate price points but labeled for use together, in each case, including all dosage forms, formulations, presentations, and package configurations. Drug delivery vehicles, adjuvants and excipients will not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant or excipient is recognized by the FDA as an active ingredient in accordance with 21 C.F.R. 210.3(b)(7). All references to Products in this Agreement shall be deemed to include Combination Products.
“Commercial Updates” means (a) a summary of material updates with respect to the Seller’s and its Affiliates’ and any Licensee’s sales and marketing activities, (b) a summary of material business development transaction updates, and, (c) if material, a summary of commercial manufacturing arrangements with respect to a Product.
“Commercialization” means any and all activities directed to the distribution, marketing, detailing, promotion, selling and securing of reimbursement of a Product (including the using, importing, selling and offering for sale of such Product), and shall include post-Marketing Approval studies to the extent required by a Regulatory Authority, post-launch marketing,
promoting, detailing, distributing, selling such Product, importing, exporting or transporting such Product for sale, and regulatory compliance with respect to the foregoing. When used as a verb, “Commercialize” shall mean to engage in Commercialization. Except with respect to post-Marketing Approval studies required by a Regulatory Authority, Commercialization shall not include any activities directed to the research or development (including pre-clinical and clinical development) or manufacture of a Product.
“Commercially Reasonable Efforts” means the level of efforts and resources (measured as of the time that such efforts and resources are required to be used under this Agreement) that are commonly used by a commercial-stage public biotechnology company of similar size and resources to the Seller [*], to develop, manufacture or commercialize, as the case may be, a comparable product for a comparable clinical indication [*] at a similar stage in its development or product life and of a similar market and potential to a Product, but without regard to the Seller’s financial obligations under this Agreement.
“Community Register of Orphan Medicinal Products” means the Community Register of Orphan Medicinal Products maintained pursuant to Article 5(9) of Regulation (EC) No 141/2000, and/or such other official EU register of designated orphan medicinal products that may from time to time replace or supplement the same.
“Conditional Approval” means regulatory authorization for Commercialization of a Product for which continued approval is contingent upon verification and description of clinical benefit in confirmatory clinical trials or other conditions or requirements set forth by the Regulatory Authority issuing the approval.
“Confidential Information” is defined in Section 8.1.
“Cumulative Royalty Payments” means, as of any date, the aggregate amount of all Royalty Payments received by the Buyer from the Seller and the amount of any Royalty Payments due but unpaid to the Buyer as of such date.
“Disclosing Party” is defined in Section 8.1.
“Disclosure Schedule” means the Disclosure Schedule, dated as of the date hereof, delivered to the Buyer by the Seller concurrently with the execution of this Agreement.
“Distributor” means a Third Party that (a) purchases or has the option to purchase any Product in finished form from or at the direction of the Seller or any of its Affiliates, (b) has the right, option or obligation to distribute, market and sell such Product (with or without packaging rights) in one or more regions, and (c) is not a Licensee. The term “packaging rights” in this definition will mean the right for the Distributor to package or have packaged Product supplied in unpackaged bulk form into individual ready-for-sale packs.
“Dollars” or “$” refers to the lawful money of the United States of America.
“Double Tax Convention” is defined in Section 4.2(h)(ii).
“EMA” means the European Medicines Agency, or any successor agency thereto.
“Existing Product Patent Rights” is defined in Section 4.1(k)(i).
“FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act.
“FDA” means the U.S. Food and Drug Administration, or any successor agency thereto.
“First Commercial Sale” means, with respect to a Product, the first sale for use or consumption by an end-user of such Product after Marketing Approval of such Product has been granted, or such marketing and sale is otherwise permitted, by any Regulatory Authority.
“Fiscal Quarter” means, for the first fiscal quarter of the Seller, the period beginning on the Closing Date and ending on the last day of the Seller’s fiscal quarter in which the Closing Date falls, and thereafter each successive period of three (3) consecutive fiscal months ending on January 31, April 30, July 31, or October 31.
“GAAP” means generally accepted accounting principles in the United States in effect from time to time.
“Governmental Entity” means any: (a) nation, principality, republic, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; (c) governmental or quasi-governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or other entity and any court, arbitrator or other tribunal); (d) multi-national organization or body; or (e) individual, body or other entity exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature. For the avoidance of doubt, “Governmental Entities” shall include Regulatory Authorities.
“Gross Sales” is defined in the definition of “Net Sales”.
“Guarantee” means, as to any Person, (a) any obligation, contingent or otherwise, of such Person guaranteeing or having the economic effect of guaranteeing any indebtedness or other obligation payable or performable by another Person (the “primary obligor”) in any manner, whether directly or indirectly, and including any obligation of such Person, direct or indirect, (i) to purchase or pay (or advance or supply funds for the purchase or payment of) such indebtedness or other obligation, (ii) to purchase or lease property, securities or services for the purpose of assuring the obligee in respect of such indebtedness or other obligation of the payment or performance of such indebtedness or other obligation, (iii) to maintain working capital, equity capital or any other financial statement condition or liquidity or level of income or cash flow of the primary obligor so as to enable the primary obligor to pay such indebtedness or
other obligation, or (iv) entered into for the purpose of assuring in any other manner the obligee in respect of such indebtedness or other obligation of the payment or performance thereof or to protect such obligee against loss in respect thereof (in whole or in part), (b) any lien on any assets of such Person securing any indebtedness or other obligation of any other Person, whether or not such indebtedness or other obligation is assumed by such Person (or any right, contingent or otherwise, of any holder of such indebtedness to obtain any such lien) or (c) any direct or indirect liability, contingent or not, of that Person for (i) any obligations for undrawn letters of credit for the account of that Person or (ii) all obligations from any interest rate, currency or commodity swap agreement, interest rate cap or collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices. The amount of any Guarantee shall be deemed to be an amount equal to the stated or determinable amount of the related primary obligation, or portion thereof, in respect of which such Guarantee is made or, if not stated or determinable, the maximum reasonably anticipated liability in respect thereof as determined by the guaranteeing Person in good faith. The term “Guarantee” as a verb has a corresponding meaning.
“Guarantor Provisions” means Section 10.15, including the Parent Guarantee set forth therein, Section 5.8, Section 5.9, Section 5.15, ARTICLE I and ARTICLE X.
[*]
“ICAV” is defined in Section 4.2(h)(i).
“Improvements” means any improvement, invention or discovery relating to a Product (other than with respect to a new composition of matter), including the formulation, or the method of manufacture of a Product.
“In-License” means any license or other agreement or arrangement between the Seller or any of its Affiliates and any Third Party pursuant to which the Seller or any of its Affiliates obtains a license or a covenant not to sue or similar grant of rights to any Intellectual Property rights of such Third Party that is necessary or reasonably useful for the research, development, manufacture, use or Commercialization of a Product.
“Indebtedness” of any Person means any indebtedness for borrowed money, any obligation evidenced by a note, bond, debenture or similar instrument, or any Guarantee of any of the foregoing.
“Indemnified Party” is defined in Section 7.2.
“Indemnifying Party” is defined in Section 7.2.
“Initial Approved Indication” means the treatment of acute hereditary angioedema attacks (on demand treatment) in adolescent and adult patients aged twelve (12) years and older or such other indication that is substantially equivalent.
“Intellectual Property” means, all of the following, in each case in any jurisdiction throughout the world: (a) any patents and patent applications (together with all extensions, adjustments, renewals, divisions, continuations, continuations-in-part, provisional or any substitute applications, any patent issued with respect to any of the foregoing patent applications, any certificate, renewal or patent term extension or adjustment (including any supplementary protection certificate), reissues and re-examinations thereof or other governmental actions which extend any of the subject matter of a patent, and any substitution patent, confirmation patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing) and all proprietary rights associated therewith (collectively, “Patents”), (b) any registered or common law trademarks, trademark registrations and applications therefor, trade dress, trade names, service marks, service mark registrations and applications therefor, logos and the goodwill associated therewith, (c) any copyrightable works, copyright registrations and applications therefor, (d) any proprietary inventions, know-how, trade secrets, discoveries, improvements, designs, processes, formulae, models and techniques and other proprietary or confidential business information, in each case, to the extent qualifying as a trade secret under applicable Law (collectively, “Know-How”), (e) any websites and domain names, (f) any social media handles and other source identifiers and any applications of any of the foregoing, including any and all goodwill associated therewith, (g) any computer source code and object code versions thereof, data databases, programs and other software (including all machine readable code, documentation and related property and information) and (h) any other proprietary intellectual property rights recognized under applicable Law.
“Intellectual Property Updates” means an updated list of the Product Patent Rights in any jurisdiction throughout the Territory, including any new Patents issued or filed, amended or supplemented, relating to a Product or any abandonments or other termination of prosecution with respect to any of the Product Patent Rights, and any other material information or developments with respect to any of the Product Intellectual Property Rights.
“Intercreditor Agreement” means an intercreditor agreement among the Buyer, the Seller, any Borrower and the administrative agent, trustee or representative under any secured Indebtedness incurred by such Borrower or any agent, representative or trustee acting on behalf of the holders of such Indebtedness, in substantially the form attached hereto as Exhibit B, or in such other form as may be agreed by the Buyer, the Seller, such Borrower and any agent, representative or trustee acting on behalf of such holders, in each case, as amended, amended and restated, supplement and otherwise modified from time to time in accordance with the terms thereof.
[*]
“Inventory Updates” means a listing of wholesaler, and/or distributor, inventory levels (on both a dollar basis and unit basis) with respect to any Product.
“Judgment” means any judgment, order, writ, injunction, citation, award or decree of any nature.
“Know-How” is defined in the definition of “Intellectual Property”.
“Knowledge of the Seller” or “the Seller’s Knowledge” means the actual knowledge of the individuals listed on Schedule 1.1 of the Disclosure Schedule, after due inquiry.
“Law” means any law, statute, rule, regulation or ordinance issued or promulgated by a Governmental Entity.
“License Revenue” means any payments or other consideration in any form received by the Seller or any of its Affiliates from a Licensee or any of its Affiliates or sublicensees under or pursuant to an Out-License of any rights relating to Sebetralstat or any sublicense under or other agreement ancillary to such Out-License, or payments received by the Seller or any of its Affiliates from a Third Party in lieu of any of the foregoing payments, in each case, except for:
(a) payments or grants received from a commercial or non-commercial Third Party, specifically to cover future reasonable, documented fully-burdened costs incurred by or on behalf of the Seller or any Affiliate after the execution of such Out-License directly attributable to the performance of research and development (including support of clinical development and preparation of regulatory submissions), and manufacturing services (including supply of clinical material) of Product, which costs are expressly covered by the Licensee (or Licensee’s Affiliates or sublicensees) under such Out-License;
(b) equity investments in the Seller or any Affiliate to the extent priced at or below fair market value; provided that in the case of common stock or its equivalent, fair market value shall be the greater of: (i) the last reported closing price of the Seller’s common stock on NASDAQ, or (ii) the 30-day volume-weighted average price of the Seller’s common stock;
(c) loans received as part of a debt financing for so long as an obligation of repayment exists; provided that if at the time any such debt becomes due, the amount of such debt that is forgiven, and, for accounting or Tax purposes (in accordance with GAAP), is booked as income to the Seller or its Affiliates, then such amount shall be deemed License Revenue hereunder;
(d) Tax credits or Tax refunds; and
(e) sales or supply of Product inventory at or below the Seller’s actual cost of goods sold; provided, however, that any mark-up from, or other amounts in excess of, the Seller’s cost of goods sold for such inventory shall be License Revenue.
Notwithstanding any provision in this Agreement to the contrary, “License Revenue” shall include, without limitation, any upfront payment, license signing fee, license maintenance fee, minimum royalty payment in excess of earned royalties, option fee, lump sum payment, distribution fee, joint marketing fee, profit share, milestone payment, and other payments. In the
event the Seller or its Affiliate(s) receives non-monetary consideration, License Revenue shall be calculated based on the fair market value of such consideration at the time of the transaction (where fair market value shall be determined by agreement of the parties or by an independent appraiser mutually agreeable to the parties), assuming an arm’s length transaction made in the ordinary course of business. To the extent that the Seller makes any offsetting payments to a Licensee (such as a true-up payment) that are specifically permitted pursuant to the Out-License (not entered into in violation of this Agreement) with such Licensee, then the License Revenue under such Out-License shall be calculated net of such payments. Without limiting clauses (a) through (e) above, to the extent that the Seller permits any Licensee to set off any payments payable pursuant to the Out-License with such Licensee against any amounts payable by the Seller to such Licensee, then the License Revenue under such Out-License shall include all such payments payable to the Seller under such Out-License without giving effect to any such setoff.
“Licensee” means, with respect to any Product, a Third Party to whom the Seller or any Affiliate of the Seller has granted a license or sublicense to Commercialize such Product. For clarity, a Distributor shall not be deemed to be a “Licensee.”
“Licensee Reports” is defined in Section 5.7(c).
“Lien” means any mortgage, lien, pledge, participation interest, charge, adverse claim, security interest, encumbrance or restriction of any kind, including any restriction on use, transfer or exercise of any other attribute of ownership of any kind.
“Loss” means any and all Judgments, damages, losses, claims, costs, liabilities (including, in the case of each of the foregoing, in connection with claims of infringement or misappropriation of any Intellectual Property rights of any Third Parties) and expenses, including reasonable fees and out-of-pocket expenses of counsel.
“Major Market Countries” means [*].
“Marketing Approval” means authorization by a Regulatory Authority, including the FDA, the EMA or any equivalent Regulatory Authority in the Territory or any successor agency of the foregoing, to Commercialize a Product based upon a Marketing Approval Application.
“Marketing Approval Application” means (a) a marketing authorization application filed with the FDA, the EMA, any equivalent Regulatory Authority or any successor agency of the foregoing, or (b) any other equivalent or related regulatory submission, in each case to gain approval to Commercialize a Product in any jurisdiction in the Territory, and, in each case, including any amendments and supplemental applications thereto.
“Material Adverse Effect” means (a) a material adverse effect on (i) the timing, duration or amount of the Royalty Payments, (ii) a Product, (iii) any of the Orange Book Patents, including the Seller’s rights in or to any Orange Book Patents, (iv) the legality, validity or enforceability of any provision of this Agreement, (v) the ability of the Seller to perform any of its obligations under this Agreement, (vi) the rights or remedies of the Buyer under this
Agreement, or (vii) the business of the Seller or its Affiliates or (b) an adverse effect in any material respect on the Revenue Participation Right, the Product Collateral, or the Back-Up Security Interest.
“NASDAQ” means The NASDAQ Stock Market LLC.
“NDA” means a New Drug Application submitted to the FDA in the United States in accordance with the FD&C Act with respect to a pharmaceutical product.
[*]
“Net Sales” means, with respect to each Product, the gross amount invoiced, billed or otherwise recorded for worldwide sales of such Product by or on behalf of the Seller, its Affiliates, any Distributor, any Licensee of the Seller or any of the Seller’s Affiliates (each of the foregoing Persons, for purposes of this definition, shall be considered a “Related Party”) to a Third Party in an arms-length transaction (“Gross Sales”), less the following amounts incurred in connection with such worldwide Product sales, to the extent actually incurred or accrued in accordance with GAAP consistently applied, and not reimbursed by such Third Party; provided that any given amount may be taken as a permitted deduction only once:
(A) reasonable and customary rebates, chargebacks, quantity, trade and similar discounts, credits and allowances and other price reductions reasonably granted, allowed, incurred or paid in so far as they are applied to sales of a Product;
(B) discounts (including cash, quantity, trade, governmental, and similar discounts), coupons, retroactive price reductions, charge back payments and rebates granted to managed care organizations or to federal, state and local governments, or to their agencies (including payments made under the “Medicare Part D Coverage Gap Discount Program” and the “Annual Fee for Branded Pharmaceutical Manufacturers” specific to a Product), in each case, as applied to sales of a Product and actually given to customers;
(C) reasonable and customary credits, adjustments, and allowances, including those granted on account of price adjustments, billing errors, and damage, Product otherwise not in saleable condition, and rejection, return or recall of a Product;
(D) reasonable and customary freight and insurance costs incurred with respect to the shipment of a Product to customers, in each case if charged separately and invoiced to the customer;
(E) customs duties, surcharges and other similar governmental charges incurred in connection with the exportation or importation of a Product to the extent included in the gross amount invoiced;
(F) sales, use, value-added, excise, turnover, inventory, and other similar Taxes (excluding income Taxes that are not collected via withholding at source), and that portion of annual fees due under Section 9008 of the United States Patient Protection and Affordable Care Act of 2010 (Pub. L. No. 111-48) and any other fee imposed by any equivalent applicable Law, in each of the foregoing cases, that the Seller (or Related Party) allocates to sales of a Product in accordance with the Seller’s (or Related Party’s) standard policies and procedures consistently applied across its products, as adjusted for rebates and refunds, imposed in connection with the sales of a Product to any Third Party, to the extent such Taxes are not paid by the Third Party;
(G) reasonable, customary and documented out of pocket amounts directly relating to co-pay programs, bridging programs or other similar patient assistance programs which may be implemented from time to time by the Seller (or Related Party);
(H) bad debt actually written off in accordance with GAAP applied to Net Sales in the period in which such receivables are written off; provided that if any such debt is thereafter paid, the corresponding amount shall be added to the Net Sales in the period in which it is paid;
(I) any (i) rebates (or other similar credits, allowances, fees or reimbursements) and (ii) price reductions under drug affordability measures, in each case mandated by a Regulatory Authority or other Governmental Entity solely to the extent (i) attributable to the manufacture or sale of Product and (ii) duly imposed by applicable Law; and
(J) other similar or customary deductions taken in the ordinary course of business as permitted in calculating net sales or net revenue (as applicable) under GAAP consistently applied. For the avoidance of doubt, such deductions shall not include any amount that is treated as an operating expense for U.S. federal income tax purposes.
Notwithstanding anything herein to the contrary, in determining the gross amount invoiced, billed or otherwise recorded for sale of any Product by any Distributor, in no event shall such gross amount exceed the gross amount invoiced, billed or otherwise recorded for sale of such Product by the Seller, its Affiliates or any Licensee of the Seller or any of the Seller’s Affiliates to such Distributor, except to the extent of any such excess that is paid by such Distributor to the Seller, its Affiliates or any Licensee of the Seller or any of the Seller’s Affiliates, which excess shall be included in such gross amount.
“Net Sales” shall also include monetary damages recovered by the Seller from a Third Party in accordance with Section 5.5(e)(ii); provided that in calculating Net Sales for any calendar year for the purpose of contributing towards meeting the Sales-Based Milestone as set forth in Section 2.2(a)(ii), such monetary damages recovered by the Seller from such Third Party shall exclude any enhanced damages, such as treble damages for willful Patent infringement (provided, that any portion of such enhanced damages attributable to lost sales shall be included for purposes of contributing towards meeting the Sales-Based Milestone as set forth in Section
2.2(a)(ii)), and shall be capped in such calendar year by an amount equal to (i) the aggregate amount of such monetary damages divided by (ii) the number of calendar years, rounded up to the nearest whole number, in which the applicable Third Party was infringing on a Product Patent Right.
For clarity, “Net Sales” will not include (i) sales or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, compassionate use, named patient use or indigent or other similar programs, reasonable quantities of Products used as samples, and Products used in the development of Products, (ii) sales or dispositions between any of the Related Parties (unless a Related Party is the final end-user of such Product), but will include subsequent sales or dispositions of Products to a non-Related Party, (iii) License Revenue (other than royalties from the sale of any Product by a Licensee that is required under any Permitted Out-License to be paid to the Buyer as Royalty Payments in accordance with Section 2.1(c) herein, provided, if paid directly to the Buyer in accordance with the terms herein shall not be double-counted as Net Sales under this Agreement), or (iv) any amounts or other consideration received by a Related Party from a Licensee, Distributor, or a non-Related Party in consideration of the grant of a co-promotion or distribution right to such non-Related Party.
With respect to sales of a Product invoiced in Dollars, Net Sales shall be determined in Dollars. With respect to sales of a Product invoiced in a currency other than Dollars, Net Sales shall be determined by converting the currencies at which the sales are made into Dollars, at rates of exchange determined in a manner consistent with the Seller’s or a Licensee’s, as applicable, method for calculating rates of exchange in the preparation of the Seller’s or such Licensee’s annual financial statements in accordance with GAAP consistently applied.
Net Sales for any Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where “A” is the weighted average invoice price of a Product contained in such Combination Product when sold separately during the applicable accounting period in which the sales of the Combination Product were made, and “B” is the combined weighted average invoice prices of all of the Other Components contained in such Combination Product sold separately during such same accounting period. If a Product contained in such Combination Product is not sold separately in finished form, the Seller and the Buyer shall determine Net Sales for such Product by mutual agreement based on the relative contribution of such Product and each Other Component in such Combination Product in accordance with the above formula, and shall take into account in good faith any applicable allocations and calculations that may have been made for the same period.
“Optional Payment” is defined in Section 2.2(b).
“Orange Book” means the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” as may be amended from time to time.
“Orange Book Patents” means the Patents listed in the Orange Book or listed in an NDA and Forms 3542a submitted with the NDA for listing in the Orange Book upon Marketing Approval by the Seller, its Affiliates or Licensees in connection with Sebetralstat.
“Other Component” is defined in the definition of “Combination Products”.
“Other License” is defined in Section 5.7(a).
“Out-License” means each license or other agreement between the Seller or any of its Affiliates and any Third Party (other than Distributors) pursuant to which the Seller or any of its Affiliates grants a license or sublicense of any Product Intellectual Property Right to market, detail, promote, sell or secure reimbursement of a Product.
“Parent” is defined in the preamble.
“Parent Guarantee” is defined in Section 10.15(b).
“Patents” is defined in the definition of “Intellectual Property”.
“Pediatric Investigation Plan” means the Paediatric Investigation Plan EMEA-002723-PIP01-19-M01 as modified or replaced from time to time.
“Permitted License” is defined in Section 5.7(a).
“Permitted Liens” means the following:
(a) Liens for Taxes, assessments or governmental charges or levies not yet due or which are being contested in good faith and by appropriate proceedings diligently conducted, if adequate reserves with respect thereto are maintained on the books of the applicable Person in accordance with GAAP;
(b) statutory Liens of landlords and Liens of carriers, warehousemen, mechanics, materialmen and suppliers and other Liens imposed by Law or pursuant to customary reservations or retentions of title arising in the ordinary course of business; provided that such Liens secure only amounts not yet due and payable or, if due and payable, are being contested in good faith by appropriate proceedings for which adequate reserves determined in accordance with GAAP have been established;
(c) Permitted Licenses, including any interest or title of a licensee under a Permitted License;
(d) licenses, sublicenses, leases or subleases (other than such licenses, sublicenses, leases or subleases expressly permitted under this Agreement) granted to others in the ordinary course of business or otherwise and not interfering in any material respect with the Revenue Participation Right, the Royalty Payments, the Product Rights, the Product Collateral or the Back-Up Security Interest;
(e) Liens created by, or in favor of, the Buyer;
(f) banker’s liens, rights of setoff and Liens in favor of financial institutions incurred in the ordinary course of business arising in connection with Seller’s and its Subsidiaries’ deposit accounts or securities accounts held at such institutions solely to secure payment of fees and similar costs and expenses; and
(g) Liens arising from judgments, decrees or attachments in circumstances not constituting a default.
“Permitted Out-License” means any Out-License relating to the Commercialization of a Product solely with a Permitted Third Party.
“Permitted Third Party” means a Third Party that is (a) among the [*] biopharma companies in a Major Market Country possessing the desirable market position, sales force and track-record to maximize sales of the Product, [*] as of the effective date of the applicable Permitted Out-License, as may be applicable, and, in each case, as compared to similarly situated biopharma companies in the applicable Major Market Country in which such Third Party would obtain rights to a Product pursuant to such Permitted Out-License, or (b) any other biopharma companies in a Major Market Country (other than one within the foregoing (a)) selected based on [*], in each case as reasonably determined by the Seller.
“Person” means any individual, firm, corporation, company, partnership, limited liability company, trust, joint venture, association, estate, trust, Governmental Entity or other entity, enterprise, association or organization.
[*]
“Prime Rate” means the prime rate published by The Wall Street Journal, from time to time, as the prime rate.
“Product” means any and all products of the Seller, its Affiliates or Licensees incorporating Sebetralstat.
“Product Collateral” means the Seller’s rights, title and interests in (a) all Products (including all inventory of all Products), (b) the Product Rights owned, licensed or otherwise held by the Seller, and (c) any proceeds from either (a) or (b) above, including all accounts receivable and general intangibles resulting from the sale, license or other disposition of all Products by the Seller or its Licensees.
“Product Intellectual Property Rights” means any and all Intellectual Property and rights related thereto, including Product Patent Rights, that are necessary or reasonably useful in the development, manufacture, use or Commercialization of a Product.
“Product Patent Rights” means any and all Patents owned or In-Licensed by the Seller or any of its Affiliates or under which the Seller or any of its Affiliates is or may become empowered to grant licenses necessary or reasonably useful in the development, manufacture,
use or Commercialization of a Product, as well as existing or future Patents covering any Improvements.
“Product Rights” means any and all of the following: (a) Product Intellectual Property Rights, (b) regulatory filings, submissions and approvals, including Marketing Approval Applications, with or from any Regulatory Authorities with respect to the Products, (c) In-Licenses and (d) Out-Licenses.
“Purchase Price” means the Closing Price plus (a) to the extent the Sales-Based Milestone Payment is actually paid to the Seller, the Sales-Based Milestone Payment and (b) to the extent the Optional Payment is actually paid to the Seller, the Optional Payment.
“Purchaser” means any Third Party who acquires rights to Sebetralstat in a Sale.
“Put Option” is defined in Section 5.2(d).
“Put Price” is defined in Section 5.2(d).
“Receiving Party” is defined in Section 8.1.
“Regulatory and IP Annual Report” is defined in Section 5.1(c).
“Regulatory Authority” means any national or supranational governmental authority, including the FDA, the EMA or such equivalent regulatory authority anywhere in the Territory, or any successor agency thereto, that has responsibility in granting a Marketing Approval.
“Regulatory Updates” means a summary of any and all material information and developments that materially impact a Product with respect to any regulatory filings or submissions made to any Regulatory Authority.
“Related Party” is defined in the definition of “Net Sales”.
“Reports” is defined in Section 5.1(c).
“Representative” means, with respect to any Person, (a) any direct or indirect member or partner of such Person and (b) any manager, director, trustee, officer, employee, agent, advisor or other representative (including attorneys, accountants, consultants, contractors, actual and potential lenders, investors, co-investors and assignees, bankers and financial advisers) of such Person.
“Restricted Indebtedness” mean any financing, sale, or loan of royalties on the Products, or any Indebtedness, in each case other than the following:
(a) true sales of royalty interests in one or more transactions and in connection with such true sale the Seller or its Affiliates do not grant (or purport to grant) any Lien on the Royalty Payments, the Revenue Participation Right or the Product Collateral;
(b) intercompany Indebtedness between and among the Seller and its Subsidiaries or between and among Subsidiaries of the Seller, in each case incurred in the ordinary course of business;
(c) obligations (contingent or otherwise) of the Seller or any of its Subsidiaries existing or arising under any Swap Contract; provided that such obligations are (or were) entered into by such Person in the ordinary course of business for the purpose of directly mitigating risks associated with liabilities, commitments, investments, assets, or property held or reasonably anticipated by such Person, or changes in the value of securities issued by such Person, and not for purposes of speculation or taking a “market view”;
(d) purchase money Indebtedness (including obligations in respect of Capital Leases or Synthetic Leases) hereafter incurred by the Seller or any of its Subsidiaries in the ordinary course of business to finance the purchase of fixed assets, and renewals, refinancings and extensions thereof; provided that (i) such Indebtedness when incurred shall not exceed the purchase price of the asset(s) financed and (ii) no such Indebtedness shall be refinanced for a principal amount in excess of the principal balance outstanding thereon at the time of such refinancing except by an amount equal to unpaid accrued interest and premium thereon plus other amounts owing or paid related to such Indebtedness, and fees, commissions and expenses (including upfront fees and original issue discount) reasonably incurred, in connection with such refinancing;
(e) Indebtedness that is convertible or exchangeable into equity interests of the Seller or any of its Subsidiaries (other than with respect to any fractional shares, which may be repaid in cash); provided that any Lien on the Revenue Participation Right, the Royalty Payments or the Product Collateral, as applicable, securing such Indebtedness, shall be subordinated to the Buyer’s Liens on the Revenue Participation Right, the Royalty Payments or the Product Collateral, as applicable, securing the Back-Up Security Interest; and
(f) other Indebtedness hereafter incurred by the Seller or any of its Subsidiaries in the ordinary course of business; provided that the Seller or its Subsidiaries do not grant (or purport to grant) any Lien on the Revenue Participation Right, the Royalty Payments, the Product Rights or the Product Collateral.
“Revenue Participation Right” means the right to receive the Royalty Payments.
“Royalty Payments” means, for each Fiscal Quarter, an amount equal to the aggregate Net Sales of Products in the Territory during such Fiscal Quarter multiplied by the applicable Royalty Rate.
“Royalty Rate” means the percentage based on the applicable level of aggregate Net Sales of Products in the Territory in a calendar year as set forth in the chart below:
|
|
|
Payment Tiers based on Annual Net Sales |
Royalty Rate if the Seller Does Not Elect to Receive the Optional Payment |
Royalty Rate if the Seller Elects to Receive the Optional Payment |
A. Annual Net Sales less than or equal to $500,000,000 |
5.00% until December 31, 2030; provided that after such date, the Royalty Rate for any calendar year will be determined based on Net Sales for the prior calendar year, such that (a) if Net Sales for the prior calendar year are less than $500,000,000, then the Royalty Rate for this payment tier will be 5.65% for such calendar year or (b) if Net Sales for the prior year are greater than or equal to $500,000,000, then the Royalty Rate for this payment tier will be 5.00% for such calendar year |
6.00% until December 31, 2030; provided that after such date, the Royalty Rate for any calendar year will be determined based on Net Sales for the prior calendar year, such that (a) if Net Sales for the prior calendar year are less than $500,000,000, then the Royalty Rate for this payment tier will be 6.75% for such calendar year or (b) if Net Sales for the prior year are greater than or equal to $500,000,000, then the Royalty Rate for this payment tier will be 6.00% for such calendar year |
B. Annual Net Sales greater than $500,000,000 and less than or equal to $750,000,000 |
1.10% |
1.10% |
C. Annual Net Sales greater than $750,000,000 |
0.25% |
0.25% |
The Royalty Rates above are incremental rates, which apply only for the respective increment of annual Net Sales described in the “Payment Tiers based on Annual Net Sales” column.
“Royalty Report” is defined in Section 5.2(b).
“Royalty Term” means for each country the period starting on the First Commercial Sale in such country and ending on the later of (a) the date that is [*] after the expiration of the last-to-expire Valid Claim of the Product Patent Rights covering the sale of Product in such country (which, for the avoidance of doubt, includes any Patent Term Extension (PTE), Supplementary Protection Certificate (SPC) and other term extensions (e.g., pediatric, orphan drug, rare disease designations) applied to such Product Patent Rights), and (b) the tenth (10th) anniversary of First Commercial Sale in such country.
“Sale” means any encumbrance, sale, transfer, assignment or other disposition, not constituting an Out-License, of any rights relating to Sebetralstat.
“Sales-Based Milestone” is defined in Section 2.2(a)(ii).
“Sales-Based Milestone Deadline” is defined in Section 2.2(a)(ii).
“Sales-Based Milestone Payment” is defined in Section 2.2(a)(ii).
“Sale Reports” is defined in Section 5.7(c).
“Sebetralstat” means the drug substance sebetralstat, described on Exhibit A hereto, and any formulations thereof.
“SEC” means the Securities and Exchange Commission.
“Seller” is defined in the preamble. References to the Seller herein shall be deemed to include any assignee of the Seller pursuant to Section 10.3.
“Seller Fundamental Representations” means the representations and warranties contained in Sections 4.1(a) (Existence; Good Standing); 4.1(b) (Authorization); 4.1(c) (Enforceability); 4.1(d)(i) (No Conflicts with Organizational Documents); 4.1(h) (Licenses) 4.1(i) (No Liens; Title to Revenue Participation Right); 4.1(k) (Intellectual Property), 4.1(m) (Solvency); 4.1(n) (Lien Related Representations and Warranties), 4.1(o) (Brokers’ Fees) and 4.1(q) (Taxes).
“Seller Indemnified Parties” is defined in Section 7.1(b).
“Seller SEC Documents” is defined in Section 4.1(p).
“SOFR” means the Secured Overnight Financing Rate.
“Subsidiary” means any and all corporations, partnerships, limited liability companies, joint ventures, associations and other entities controlled (by contract or otherwise) by the Parent or the Seller, as applicable, directly or indirectly through one or more intermediaries. For purposes hereof, the Seller shall be deemed to control (a) a corporation if the Parent or the Seller, as applicable, directly or indirectly through one or more intermediaries, owns or controls a majority of the total voting power of shares of stock entitled to vote in the election of directors of such corporation or (b) a partnership, limited liability company, association or other business entity if the Parent or the Seller, as applicable, directly or indirectly through one or more intermediaries, shall be allocated a majority of partnership, limited liability company, association or other business entity gains or losses or shall be or control the managing director or general partner of such partnership, limited liability company, association or other business entity.
“Swap Contract” means (a) any and all rate swap transactions, basis swaps, credit derivative transactions, forward rate transactions, commodity swaps, commodity options, forward commodity contracts, equity or equity index swaps or options, bond or bond price or bond index swaps or options or forward bond or forward bond price or forward bond index transactions, interest rate options, forward foreign exchange transactions, cap transactions, floor
transactions, collar transactions, currency swap transactions, cross-currency rate swap transactions, currency options, spot contracts, or any other similar transactions or any combination of any of the foregoing (including any options to enter into any of the foregoing), whether or not any such transaction is governed by or subject to any master agreement, and (b) any and all transactions of any kind, and the related confirmations, which are subject to the terms and conditions of, or governed by, any form of master agreement published by the International Swaps and Derivatives Association, Inc., any International Foreign Exchange Master Agreement, or any other master agreement, including any such obligations or liabilities under any such master agreement.
“Synthetic Lease” means any synthetic lease, tax retention operating lease, off-balance sheet loan or similar off-balance sheet financing arrangement whereby the arrangement is considered borrowed money indebtedness for tax purposes but is classified as an operating lease or does not otherwise appear on a balance sheet under GAAP.
“Tax” or “Taxes” means any federal, state, local or foreign income, gross receipts, license, payroll, employment, excise, severance, occupation, premium, windfall profits, environmental, customs duties, capital stock, franchise, profits, withholding, social security, unemployment, disability, real property, personal property, abandoned property, value added, alternative or add-on minimum, estimated or other tax of any kind whatsoever, in each case in the nature of a tax, including any interest, penalty or addition thereto, whether disputed or not.
“Term SOFR Administrator” means CME Group Benchmark Administration Limited as administrator of the forward-looking term SOFR (or a successor administrator).
“Territory” means the world.
“Third Party” means any Person that is not the Seller or the Seller’s Affiliates.
“Three-Month Term SOFR” means, as of the date of determination, three-month SOFR published by the Term SOFR Administrator and identified as the forward-looking term rate based on SOFR.
“Transaction Documents” means this Agreement, any Intercreditor Agreement and any other transaction document contemplated by this Agreement.
“UCC” means the Uniform Commercial Code as in effect from time to time in the State of New York; provided that if, with respect to any financing statement or by reason of any provisions of applicable Law, the perfection or the effect of perfection or non-perfection of the Back-Up Security Interest or any portion thereof granted pursuant to Section 2.1(b) is governed by the Uniform Commercial Code as in effect in a jurisdiction of the United States other than the State of New York, then “UCC” means the Uniform Commercial Code as in effect from time to time in such other jurisdiction for purposes of the provisions of this Agreement and any financing statement relating to such perfection or effect of perfection or non-perfection.
“UCC Financing Statements” means the UCC-1 financing statements that shall be filed by the Buyer, with the assistance of the Seller as reasonably requested by the Buyer, at or promptly following the Closing, as well as any additional UCC-1 financing statements or amendments thereto as requested by the Buyer from time to time, to record the purchase and perfect the Buyer’s security interest in the Revenue Participation Right and the Product Collateral.
“USPTO” is defined in Section 2.1(b).
“U.S. Marketing Approval” means Marketing Approval of NDA #219301 from the FDA, based on the active ingredient Sebetralstat, for the Commercialization of a Product in the United States for the Initial Approved Indication; provided that if such Marketing Approval is obtained with Conditional Approval or the FDA requires (a) any black box warning on the label for such Product, (b) any risk evaluation and mitigation strategy (REMS) with respect to such Product or (c) any change to the draft label contained in NDA #219301 that would have a Material Adverse Effect, the Seller shall not be entitled to receive the Optional Payment.
“Valid Claim” shall mean: (a) any claim of an issued and unexpired Patent included within the Product Patent Rights, that: (i) has not been revoked, canceled or held invalid or unenforceable by a court, Governmental Entity, national or regional patent office or other appropriate body that has competent jurisdiction in a decision being final and unappealable or not appealed within the time allowed for appeal; and (ii) has not lapsed or been withdrawn, abandoned, disclaimed, denied or admitted to be invalid or unenforceable; or (b) a claim of a pending Patent application included within the Product Patent Rights that is filed and being prosecuted in good faith and that has not been finally abandoned, finally rejected or finally disallowed and which has been pending for no more than [*] from the date of filing of the earliest Patent application to which such pending Patent application claims priority.
Section 1.2. Certain Interpretations. Except where expressly stated otherwise in this Agreement, the following rules of interpretation apply to this Agreement:
(a) “either” and “or” are not exclusive and “include,” “includes” and “including” are not limiting and shall be deemed to be followed by the words “without limitation”;
(b) “extent” in the phrase “to the extent” means the degree to which a subject or other thing extends, and such phrase does not mean simply “if”;
(c) “hereof,” “hereto,” “herein” and “hereunder” and words of similar import when used in this Agreement refer to this Agreement as a whole and not to any particular provision of this Agreement;
(d) references to a Person are also to its permitted successors and assigns;
(e) definitions are applicable to the singular as well as the plural forms of such terms;
(f) references to an “Article”, “Section” or “Exhibit” refer to an Article or Section of, or an Exhibit to, this Agreement, and references to a “Schedule” refer to the corresponding part of the Disclosure Schedule; and
(g) references to a Law include any amendment or modification to such Law and any rules and regulations issued thereunder, whether such amendment or modification is made, or issuance of such rules and regulations occurs, before or after the date of this Agreement.
ARTICLE II
PURCHASE, SALE AND ASSIGNMENT OF THE REVENUE PARTICIPATION RIGHT
Section 2.1. Purchase, Sale and Assignment.
(a) At the Closing and upon the terms and subject to the conditions of this Agreement, the Seller shall sell, transfer, assign and convey to the Buyer, without recourse (except as expressly provided herein), and the Buyer shall purchase, acquire and accept from the Seller, the Revenue Participation Right, free and clear of all Liens. Immediately upon the sale to the Buyer by the Seller of the Revenue Participation Right pursuant to this Section 2.1, all of the Seller’s right, title and interest in and to the Revenue Participation Right shall terminate, and all such right, title and interest shall vest in the Buyer, free and clear of all Liens.
(b) It is the intention of the parties hereto that the sale, transfer, assignment and conveyance contemplated by this Agreement be, and is, a true, complete, absolute and irrevocable sale, transfer, assignment and conveyance by the Seller to the Buyer of all of the Seller’s right, title and interest in and to the Revenue Participation Right. Neither the Seller nor the Buyer intends the transactions contemplated by this Agreement to be, or for any purpose characterized as, a loan from the Buyer to the Seller or a pledge, a security interest, a financing transaction or a borrowing. It is the intention of the parties hereto that the beneficial interest in and title to the Revenue Participation Right and any “proceeds” (as such term is defined in the UCC) thereof shall not be part of the Seller’s estate in the event of the filing of a petition by or against the Seller under any Bankruptcy Laws. Each of the Seller and the Buyer hereby waives, to the maximum extent permitted by applicable Law, any right to contest or otherwise assert that this Agreement does not constitute a true, complete, absolute and irrevocable sale, transfer, assignment and conveyance by the Seller to the Buyer of all of the Seller’s right, title and interest in and to the Revenue Participation Right under applicable Law. Accordingly, the Seller shall treat the sale, transfer, assignment and conveyance of the Revenue Participation Right as a sale of an “account” or a “payment intangible” (as appropriate) in accordance with the UCC. Not in derogation of the foregoing statement of the intent of the parties hereto in this regard, and for the purposes of providing additional assurance to the Buyer in the event that, despite the intent of the parties hereto, the sale, transfer, assignment and conveyance contemplated hereby is hereafter
held not to be a sale, the Seller does hereby grant to the Buyer, as security for the payment of amounts due to the Buyer hereunder, a first priority security interest in and to all right, title and interest in, to and under the Revenue Participation Right and the Royalty Payments and a security interest in and to all right, title and interest in, to and under the Product Collateral, and this Agreement shall constitute a security agreement for the purposes of the UCC. The Seller does hereby consent and authorize the Buyer, from and after the Closing, to: (i) file UCC Financing Statements, documents required to be recorded to Regulatory Authorities for the relevant Product Rights, including U.S. Patent and Trademark Office (the “USPTO”) filings and short-form sale, security agreement or equivalent filings in any other jurisdictions, and continuation statements or filings with respect to such financing statements, agreements or filings when applicable; (ii) record the security created by this Agreement (whether the security interest itself or this Agreement, as applicable) at UK Companies House and against all relevant registered Product Intellectual Property Rights at the World Intellectual Property Office, the European Patent Office, and all Intellectual Property offices of the Major Market Countries, including the United Kingdom Intellectual Property Office and USPTO (and the Seller shall execute all such documents and do all such acts as required to facilitate such recordals) and (iii) otherwise meet the requirements of applicable Law, in such manner and such jurisdictions as are necessary or appropriate to perfect such security interest (the “Back-Up Security Interest”) and naming the Seller as the debtor and the Buyer as the secured party in respect to the Revenue Participation Right, the Royalty Payments and the Product Collateral.
(c) Notwithstanding any provision in this Agreement to the contrary, as a condition of entering into any agreement or arrangement with any Licensee, Purchaser or other Related Party in respect of any Permitted Out-License or Sale, or any other Out-License made to a Third Party with the consent of the Buyer pursuant to Section 5.7(a), in each case relating to Commercialization of a Product in a Major Market Country in the Territory, the Seller shall (i) cause such Licensee, Purchaser or other Related Party, as may be applicable, to be contractually obligated to pay to the Seller a royalty based on net sales of Products by such Licensee, Purchaser or other Related Party in such Major Market Country that would be equal to or greater than Royalty Payments payable by the Seller to the Buyer on Net Sales under this Agreement, (ii) cause any agreement(s) with such Licensee, Purchaser or other Related Party (A) to provide the Seller with audit rights at least as favorable as the audit rights in favor of the Buyer under this Agreement, (B) to not restrict the Seller from granting security over its rights under such agreement(s), (C) to not contain any provisions that would materially prejudice or encumber the Buyer’s rights in the event of an insolvency of the Seller as set forth in this Agreement, and (D), in the event of such an insolvency of the Seller and to the extent permitted under applicable Law, to not permit such Licensee, Purchaser or other Related Party to terminate its payment obligations under such agreement(s) and (iii) use Commercially Reasonable Efforts to cause any agreement(s) with such Purchaser to provide that the Buyer is an intended third party beneficiary under such agreement with respect to such obligations to pay the Seller on behalf of the Buyer.
Section 2.2. Purchase Price; Sales-Based Milestone Payment; Optional Payment.
(a) Upon the terms and subject to the conditions of this Agreement, the Buyer agrees to pay the purchase price as consideration to the Seller for the sale, transfer, assignment and conveyance of the Revenue Participation Right to the Buyer as follows:
(i) One Hundred Million Dollars ($100,000,000) in cash, payable in accordance with Section 3.2 (the “Closing Price”).
(ii) (x) Fifty Million Dollars ($50,000,000) in cash if the Seller does not receive the Optional Payment set forth in paragraph (b) below or (y) Fifty-Seven Million Dollars ($57,000,000) in cash if the Seller receives the Optional Payment set forth in paragraph (b) below (such payment described in clauses (x) and (y), the “Sales-Based Milestone Payment”), in either case, payable [*] after (1) the Seller’s delivery to the Buyer of written confirmation of achievement of Net Sales of at least Five Hundred Fifty Million Dollars ($550,000,000) (the “Sales-Based Milestone”) for any calendar year ended before January 1, 2031 (the “Sales-Based Milestone Deadline”) and (2) the Seller shall have paid all Royalty Payments then due and payable; provided that in the event that the Sales-Based Milestone shall not have been achieved by the Sales-Based Milestone Deadline, then the Buyer’s obligation to pay the Sales-Based Milestone Payment shall terminate.
(b) If U.S. Marketing Approval is received by September 30, 2025, the Seller may, at its option, elect to receive a payment from the Buyer in the amount of Twenty Two Million Dollars ($22,000,000) in cash (the “Optional Payment”). Within [*] of receipt of such U.S. Marketing Approval, the Seller shall notify the Buyer in writing that it has received U.S. Marketing Approval and whether it elects to receive or forego the Optional Payment. If the Seller elects to receive the Optional Payment, the Optional Payment shall be payable by the Buyer [*] after such written notice of election is received by the Buyer. If U.S. Marketing Approval is not received by September 30, 2025, or the Seller notifies the Buyer of its intention to forego the Optional Payment or fails to deliver such written notice to the Buyer within [*] of receipt of U.S. Marketing Approval, then the Buyer’s obligation to make the Optional Payment shall terminate and the Royalty Rate under the heading “Royalty Rate if the Seller Does Not Elect to Receive the Optional Payment” in the chart set forth in the definition of “Royalty Rate” shall apply.
Section 2.3. No Assumed Obligations, Etc. Notwithstanding any provision in this Agreement to the contrary, the Buyer is only agreeing, on the terms and conditions set forth in this Agreement, to purchase, acquire and accept the Revenue Participation Right and is not assuming any liability or obligation of the Seller of whatever nature, whether presently in existence or arising or asserted hereafter. All such liabilities and obligations are, and from and after the Closing shall be retained by and remain, obligations and liabilities of the Seller or its Affiliates.
ARTICLE III
CLOSING
Section 3.1. Closing. The Closing shall take place remotely via the exchange of documents and signatures on the date hereof.
Section 3.2. Payment of Closing Price. At the Closing, the Buyer shall deliver (or cause to be delivered) payment of the Closing Price to the Seller by electronic funds transfer or wire transfer of immediately available funds to one or more accounts specified by the Seller.
Section 3.3. Closing Deliverables of the Seller. At the Closing, the Seller shall deliver (or cause to be delivered) to the Buyer the following:
(a) a duly executed bill of sale evidencing the sale, transfer, assignment and conveyance of the Revenue Participation Right in form attached hereto as Exhibit C; and
(b) a certificate of an officer or other authorized signatory of the Seller, dated the Closing Date, certifying as to (i) the incumbency of each officer of the Seller executing this Agreement and (ii) the attached thereto copies of (A) the Seller’s organizational documents, and (B) resolutions adopted by the Seller’s Board of Directors authorizing the execution and delivery by the Seller of this Agreement and the consummation by the Seller of the transactions contemplated hereby.
ARTICLE IV
REPRESENTATIONS AND WARRANTIES
Section 4.1. Seller’s Representations and Warranties. Except as set forth on the Disclosure Schedules attached hereto, the Seller represents and warrants to the Buyer that as of the date hereof:
(a) Existence; Good Standing. The Seller is a corporation duly incorporated, validly existing and in good standing under the Laws of England and Wales. The Seller is duly licensed or qualified to do business and is in corporate good standing in each jurisdiction in which the nature of the business conducted by it or the character or location of the properties and assets owned, leased or operated by it makes such licensing or qualification necessary.
(b) Authorization. The Seller has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement. The execution, delivery and performance of this Agreement, and the consummation of the transactions contemplated hereby, have been duly authorized by all necessary corporate action on the part of the Seller.
(c) Enforceability. This Agreement has been duly executed and delivered by an authorized officer of the Seller and constitutes a legal, valid and binding obligation of the
Seller, enforceable against the Seller in accordance with its terms, except as may be limited by applicable Bankruptcy Laws or by general principles of equity (whether considered in a proceeding in equity or at law).
(d) No Conflicts. The execution, delivery and performance by the Seller of this Agreement and the consummation of the transactions contemplated hereby and thereby do not and will not conflict with, result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, or give a right of termination, cancellation or acceleration of any obligation or to a loss of a benefit under, any provision of: (i) any organizational document of the Seller; (ii) any applicable Law or any Judgment to which the Seller or its properties or assets may be subject; (iii) any other agreement (whether written or oral), commitment or instrument to which the Seller is a party or by which the Seller is bound.
(e) Consents. Except for the consents that have been obtained on or prior to the Closing, the UCC financing statements and other filings and recordals contemplated by Section 2.1(b), or any filings required by the federal securities Laws or stock exchange rules, no consent, approval, license, order, authorization, registration, declaration or filing with or of any Governmental Entity or other Person is required to be done or obtained by the Seller in connection with (i) the execution and delivery by the Seller of this Agreement, (ii) the performance by the Seller of its obligations under this Agreement or (iii) the consummation by the Seller of any of the transactions contemplated by this Agreement.
(f) No Litigation. Neither the Seller nor any of its Affiliates is a party to, and has not received any written notice of, any action, suit, investigation or proceeding pending before any Governmental Entity and, to the Knowledge of the Seller, no such action, suit, investigation or proceeding has been threatened against the Seller, that, individually or in the aggregate, has had or would, if determined adversely, reasonably be expected to have a Material Adverse Effect.
(g) Compliance.
(i) The Seller has not violated, is not in violation of, has not been given notice that it has violated, and, to the Knowledge of the Seller, the Seller is not under investigation with respect to its violation of, and has not been threatened to be charged with any violation of, any applicable Law or any Judgment of any Governmental Entity, court or arbitrator, which violation would reasonably be expected to result in a Material Adverse Effect.
(ii) All applications, submissions, information and data related to a Product submitted or utilized as the basis for any request to any Regulatory Authority by or on behalf of the Seller were true and correct in all material respects as of the date of such submission or request, and, to the Knowledge of the Seller any material updates, changes, corrections or modification to such applications, submissions, information or data required under applicable Laws or regulations have been submitted to the necessary Regulatory Authorities.
(iii) Clinical Trials conducted on behalf of the Seller or its Affiliates relating to the Products were conducted in all material respects in compliance with applicable Laws and, in all material respects, in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards. Neither the Seller nor its Affiliates has received any notices or correspondence from any Regulatory Authority or comparable authority requiring the termination, suspension, or material modification or clinical hold of any Clinical Trials conducted by or on behalf of the Seller or its Affiliates with respect to the Products.
(iv) No Governmental Entity has commenced, or threatened to initiate, any action or proceeding to place a clinical hold order on, or otherwise terminate, delay or suspend any proposed or ongoing Clinical Trials, conducted in connection with a Product.
(v) Neither the Seller nor any of its Affiliates has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or EMA or other equivalent Regulatory Authority in the Territory to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, or similar policies, set forth in any applicable Laws or regulations.
(vi) Neither the Seller, its Affiliates, or to the Knowledge of the Seller, any Third Party acting on behalf of the Seller, has used in any capacity the services of a person debarred, excluded or disqualified (or convicted of any crime or engaged in any conduct for which debarment, exclusion or disqualification is mandated) under 21 U.S.C. § 335a.
(vii) The Seller has provided to the Buyer prior to the date hereof in a data room available to the Buyer true and correct copies (other than the NDA for which the Seller has provided the Buyer a materially true and correct summary) of all material written communications sent or received by the Seller and any of its Affiliates to or from any Regulatory Authorities that relate to each Product since January 1, 2022, including but not limited to any written reports or other written communications received from a Governmental Entity that would indicate that any Regulatory Authority (A) is likely to reject, condition, or delay any Marketing Approval Application, or (B) is likely to pursue any material compliance actions against the Seller.
(viii) Sebetralstat has not been the subject of a prior Marketing Approval in the Territory.
(ix) The Seller has received no information or communications and is not aware of any facts that FDA would not grant sebetralstat new chemical entity
exclusivity under 21 CFR 314.108(b)(2) or Orphan Drug exclusivity under 21 CFR 316.31(a) for on demand treatment of hereditary angioedema (HAE) attacks.
(h) Licenses.
(i) In-Licenses. There are no In-Licenses.
(ii) Out-Licenses. There are no Out-Licenses.
(i) No Liens; Title to Revenue Participation Right. None of the property, assets or Product Intellectual Property Rights, in each case, that relate to a Product of the Seller or any of its Affiliates is subject to any Lien, except for Permitted Liens. The Seller has the full right to sell, transfer, convey and assign to the Buyer all of the Seller’s rights and interests in and to the Revenue Participation Right being sold, transferred, conveyed and assigned to the Buyer pursuant to this Agreement without any requirement to obtain the consent of any Person, except for the consents that have been obtained on or prior to the Closing. The claims and rights of the Buyer created by this Agreement in and to the Revenue Participation Right and any other Product Collateral are not subordinated to any creditor of the Seller or any other Person. Upon the Closing, the Buyer will have acquired good and marketable title to the Revenue Participation Right, free and clear of all Liens.
(j) Manufacturing; Supply. To the Seller’s Knowledge, all Products have, since January 1, 2022, been manufactured, transported, stored and handled in all material respects in accordance with applicable Law and applicable good manufacturing practices. Since January 1, 2022, neither the Seller nor any Affiliate of the Seller has experienced any significant failures in the manufacturing or supply of any Product. The Seller has on hand or has made adequate provisions to secure sufficient clinical quantities of all Products to complete all Clinical Trials and all activities required for Marketing Approvals, in each case, that are ongoing or planned as of the date hereof. The Seller has on hand or has made adequate provisions to secure sufficient quantities of the Products to support the commercial launch of Products in the Territory.
(k) Intellectual Property.
(i) Schedule 4.1(k)(i) of the Disclosure Schedule lists all of the currently existing Patents included within the Product Patent Rights owned or exclusively licensed by the Seller or any of its Affiliates throughout the Territory (the “Existing Product Patent Rights”), including, for each item, (A) the name of the applicant/registrant, (B) the application or registration number, (C) the jurisdictions in which it has been issued or registered or in which any application for such issuance and registration has been filed or the jurisdictions in which any other filing or recordation has been made and (D) for Orange Book Patents, the expiration date. The Seller is the sole and exclusive owner of all of the Existing Product Patent Rights. No other Patents owned or licensed by the Seller or any of
its Affiliates are necessary to make, have made, offer to sell, sell, have sold, use, import, distribute, Commercialize or market a Product in the Territory.
(ii) The Seller has listed all of the Existing Product Patent Rights that qualify as Orange Book Patents in its NDA, and has included accurate expiration dates for such Orange Book Patents.
(iii) Neither the Seller nor any of its Affiliates is a party to any pending ongoing, and is not aware of any threatened, litigation, interference, reexamination, reissue, inter partes review, post grant review, opposition or like procedure involving any of the Existing Product Patent Rights in any jurisdiction in the Territory.
(iv) To the Seller’s Knowledge, the Patents included in the Existing Product Patent Rights are valid and enforceable. None of the granted Patents within the Existing Product Patent Rights have lapsed, expired or otherwise been terminated as of the date hereof. Neither the Seller nor any of its Affiliates has received any written notice relating to the lapse, expiration or other termination of any of the issued Patents within the Existing Product Patent Rights, and neither the Seller nor its Affiliates has received any written legal opinion that alleges that, an issued Patent within any of the Existing Product Patent Rights is invalid or unenforceable.
(v) Neither the Seller nor any of its Affiliates has received any written notice that there is any Person, and to the Knowledge of the Seller there is no Person, who is or claims to be an inventor under any of the Existing Product Patent Rights who is not a named inventor thereof.
(vi) Neither the Seller nor its Affiliates has received any written notice of any claim by any Person challenging the ownership of, the rights of the Seller in and to, or the patentability, validity or enforceability of, any of the Existing Product Patent Rights, or asserting that the development, manufacture, importation, sale, offer for sale or use of a Product infringes, misappropriates or otherwise violates, or will infringe, misappropriate or otherwise violate such Person’s Patents or other Intellectual Property rights.
(vii) To the Knowledge of the Seller, the discovery, development manufacture, importation, sale, offer for sale or use of each Product, in each case in the form such Product exists as of the date hereof and as such activity is currently contemplated by the Seller, has not and will not, infringe, misappropriate or otherwise violate (A) any U.S. Patents or other U.S. Intellectual Property rights owned by any Third Party or (B) any valid claim of any non-U.S. Patents or other non-U.S. Intellectual Property rights owned by any Third Party.
(viii) To the Knowledge of the Seller or any of its Affiliates, no Person has infringed, misappropriated or otherwise violated, or is infringing, misappropriating or otherwise violating, any of the Product Intellectual Property Rights.
(ix) The Seller has paid all maintenance fees, annuities and like payments required as of the date hereof with respect to each of the Existing Product Patent Rights.
(x) The Seller has not misrepresented, or failed to disclose, any facts or circumstances in any application for any Product Intellectual Property Rights, or in the prosecution thereof, in a fashion that would constitute fraud or a misrepresentation with respect to such application or, that would otherwise affect the enforceability of any Product Intellectual Property Rights.
(xi) Each of the Seller and its Affiliates has used reasonable efforts and taken commercially reasonable steps designed to maintain, preserve and protect its confidential Know-How and other confidential information acquired, conceived, developed, collected, compiled, generated, reduced to practice or otherwise made or used in connection with or related to the business of the Seller, including through (A) the development of a policy for the protection of Intellectual Property rights, (B) requiring all employees of the Seller and its Affiliates to execute confidentiality agreements with respect to Intellectual Property rights developed for or obtained from the Seller and its Affiliates and (C) entering into licenses and contracts that generally require licensees, contractors and other Third Parties with access to the Know-How or other confidential information to keep such Know-How or other confidential information confidential.
(xii) [*].
(l) Indebtedness; Liabilities. The Seller has (i) no outstanding Indebtedness and (ii) there are no liabilities of the Seller or its Affiliates related to a Product not incurred in the ordinary course and in excess of [*] in the aggregate.
(m) Solvency. The Seller has determined that, and by virtue of its entering into the transactions contemplated by the Transaction Documents to which the Seller is party and its authorization, execution and delivery of the Transaction Documents to which the Seller is party, the Seller’s incurrence of any liability hereunder or thereunder or contemplated hereby or thereby is in its own best interests. Upon consummation of the transactions contemplated by the Transaction Documents and the application of the proceeds therefrom, (a) the fair saleable value of the Seller’s assets will be greater than the sum of its debts, liabilities and other obligations, including known contingent liabilities, (b) the present fair saleable value of the Seller’s assets will be greater than the amount that would be required to pay its liabilities on its existing debts, liabilities and other obligations, including known contingent liabilities, as they become absolute
and matured, (c) the Seller will be able to realize upon its assets and pay its debts, liabilities and other obligations, including known contingent obligations, as they mature, (d) the Seller will not be unable to pay its debts as they mature, (e) the Seller has not incurred and does not have any present plans or intentions to incur debts or other obligations or liabilities beyond its ability to pay such debts or other obligations or liabilities as they become absolute and matured, (f) the Seller will not have become subject to any Bankruptcy Event and (g) the Seller will not have been rendered insolvent within the meaning of any applicable Law. No step has been taken or is intended by the Seller or, to the Knowledge of the Seller, any other Person to make the Seller subject to a Bankruptcy Event.
(n) Lien Related Representation and Warranties. The Seller’s exact legal name is, and for the immediately preceding five (5) years has been, “KalVista Pharmaceuticals Limited” The Seller is, and for the prior five (5) years has been, incorporated in England and Wales . The Seller’s principal place of business is located at Porton Science Park, Bybrook Road, Porton Down, Wiltshire, United Kingdom, SP4 0BF.
(o) Brokers’ Fees. Except for fees payable to Jefferies LLC, which are being paid by the Seller, there is no investment banker, broker, finder, financial advisor or other intermediary who has been retained by or is authorized to act on behalf of the Seller who might be entitled to any fee or commission in connection with the transactions contemplated by this Agreement.
(p) Public Company Reporting Obligations. The Seller has filed or furnished (as applicable) with or to the SEC all registration statements, forms, reports, certifications and other documents required to be filed or furnished by the Seller with or to the SEC since January 1, 2023 (all such registration statements, forms, reports, certifications and other documents (including those that the Seller may file or furnish after the date hereof until the Closing) are referred to herein as the “Seller SEC Documents”). The Seller SEC Documents (i) were filed or furnished on a timely basis, (ii) at the time filed or furnished, were prepared in compliance as to form in all material respects with the applicable requirements of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, as the case may be, and the rules and regulations of the SEC thereunder applicable to such Seller SEC Documents, and (iii) did not at the time they were filed or furnished contain any untrue statement of a material fact or omit to state a material fact required to be stated in such Seller SEC Documents or necessary in order to make the statements in such Seller SEC Documents, in the light of the circumstances under which they were made, not misleading. The Seller’s financial statements included within the Seller SEC Documents have been prepared in accordance with GAAP and such financial statements do not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading at the time made.
(q) Taxes. The Seller has filed (or caused to be filed) all material Tax returns and material Tax reports required to be filed under applicable Law and has paid all material Taxes required to be paid, except for any such Taxes that are being contested in good faith by
appropriate proceedings and for which adequate reserves have been provided in accordance with generally accepted accounting principles applicable to the Seller, as in effect from time to time.
(r) Disclosure. No representation or warranty made by the Seller in this Agreement or in any Transaction Document contains any untrue statement of material fact or omits to state any material fact necessary to make any such representation or warranty not misleading to a prospective buyer of the Revenue Participation Right or the Royalty Payments.
Section 4.2. Buyer’s Representations and Warranties. The Buyer hereby represents and warrants to the Seller that:
(a) Existence; Good Standing. The Buyer is a limited partnership duly organized, validly existing and in good standing under the Laws of the State of Delaware.
(b) Authorization. The Buyer has the requisite right, power and authority to execute, deliver and perform its obligations under this Agreement. The execution, delivery and performance of this Agreement, and the consummation of the transactions contemplated hereby, have been duly authorized by all necessary action on the part of the Buyer.
(c) Enforceability. This Agreement has been duly executed and delivered by the Buyer and constitutes the valid and binding obligation of the Buyer, enforceable against the Buyer in accordance with its terms, except as may be limited by applicable Bankruptcy Laws or by general principles of equity (whether considered in a proceeding in equity or at law).
(d) No Conflicts. The execution, delivery and performance by the Buyer of this Agreement do not and will not conflict with, result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, or give a right of termination, cancellation or acceleration of any obligation or to a loss of a benefit under, any provision of: (i) any organizational document of the Buyer; (ii) any applicable Law or any Judgment to which the Buyer or its properties or assets may be subject; (iii) any other agreement (whether written or oral), commitment or instrument to which the Buyer is a party or by which the Buyer is bound, except, in the case of clauses (ii) and (iii), only for such breaches and defaults that, individually or in the aggregate, would not reasonably be expected to result in a material adverse effect on the ability of the Buyer to consummate the transactions contemplated by the Transaction Documents or perform its obligations under the Transaction Documents.
(e) Consents. Except for any consents that have been obtained on or prior to the Closing and any filings required by the federal securities Laws or stock exchange rules, no consent, approval, license, order, authorization, registration, declaration or filing with or of any Governmental Entity or other Person is required to be done or obtained by the Buyer in connection with (i) the execution and delivery by the Buyer of this Agreement, (ii) the performance by the Buyer of its obligations under this Agreement or (iii) the consummation by the Buyer of any of the transactions contemplated by this Agreement.
(f) No Litigation. There is no action, suit, investigation or proceeding pending or, to the knowledge of the Buyer, threatened before any Governmental Entity to which the Buyer is a party that would, if determined adversely, reasonably be expected to result in a material adverse effect on the ability of the Buyer to consummate the transactions contemplated by the Transaction Documents or perform its obligations under the Transaction Documents.
(g) Financing. The Buyer has sufficient cash to pay the Closing Price at the Closing, and the Buyer will have sufficient cash to pay the Sales-Based Milestone Payment and the Optional Payment when due and payable. The Buyer acknowledges that its obligations under this Agreement are not contingent on obtaining financing.
(h) Tax Status.
(i) The Buyer confirms that (1) it is a Limited Partnership formed in the State of Delaware, United States of America and (2) DRI Healthcare ICAV (“ICAV”) is a company incorporated and resident for tax purposes solely in the Republic of Ireland.
(ii) (1) ICAV is a resident of the Republic of Ireland for the purposes of the double taxation convention between the United Kingdom and the Republic of Ireland (“Double Tax Convention”), as the term “resident of the Republic of Ireland” is defined under Article 4 of the Double Tax Convention and (2) [*].
(i) Brokers’ Fees. There is no investment banker, broker, finder, financial advisor or other intermediary who has been retained by or is authorized to act on behalf of the Buyer who might be entitled to any fee or commission in connection with the transactions contemplated by this Agreement.
ARTICLE V
COVENANTS
Section 5.1. Reporting. From and after the date hereof, the Seller shall provide the Buyer:
(a) promptly following the end of each of the [*] periods in a calendar year, but in any event, in each case, no later than [*] after the end of such [*] period, a reasonably detailed quarterly report setting forth, with respect to such period, the Inventory Updates ([*]);
(b) promptly following the end of each calendar year, but in any event, in each case, no later than [*] after the end of such calendar year, and with respect to such same period, the Clinical Updates, and the Commercial Updates (the “Clinical and Commercial Annual Report”); and
(c) promptly following the end of each calendar year, but in any event, in each case, no later than [*] after the end of such calendar year, a reasonably detailed annual report setting forth, with respect to such same period, (i) the Regulatory Updates, and (ii) the Intellectual Property Updates (the “Regulatory and IP Annual Report”, and, collectively with the [*], the Clinical and Commercial Annual Report and the Royalty Report, the “Reports”).
(d) The Seller shall include in each Report any (i) material CMC updates and (ii) details as to the achievement of any development, sales, regulatory or other milestone event set forth in any Out-License.
(e) The Seller shall promptly notify the Buyer (and in no event more than [*] of the Seller’s Knowledge of the following events) of (i) any action, demand, suit, claim, cause of action, proceeding or investigation pending or, to the Knowledge of the Seller, threatened by or against the Seller or any of its Affiliates, or (ii) proceeding or inquiry of any Regulatory Authority pending or, to the Knowledge of the Seller, threatened against the Seller or any of its Affiliates, in each case, related to any Product, the Product Collateral or any Transaction Document.
(f) During the term of this Agreement, in the event that the Seller or any of its Affiliates enters into any Permitted Out-License, commercialization, co-promotion, collaboration, distribution, marketing or partnering agreement with respect to Sebetralstat or the Product Collateral that grants a license with respect to the Intellectual Property covering a Product with any Affiliate of the Seller, at least [*] prior to the consummation of any such transaction, the Seller shall give the Buyer written notice thereof and will prior to such consummation cause any such Affiliate to execute and deliver to the Buyer a joinder agreement and other documents reasonably requested and satisfactory to the Buyer in order to cause such Affiliate to become a party to the applicable Transaction Documents as if such Affiliate was a party thereto as of the date hereof.
(g) The Seller shall also provide the Buyer with such additional information regarding the updates included in each Report as the Buyer may reasonably request from time to time. The Seller shall prepare and maintain and shall cause its Affiliates and Licensees to prepare and maintain reasonably complete and accurate records of the information to be disclosed in each Report. All Reports, and the Confidential Information contained therein, shall be the Confidential Information of the Seller and subject to the obligations of confidentiality set forth in ARTICLE VIII.
Section 5.2. Royalty Payments; Revenue Participation and Royalty Payment Details; Put Option; Buy-Back Option.
(a) From and after the First Commercial Sale of a Product in any country in the Territory until the expiry of the Royalty Term in such country, the Seller shall pay to the Buyer, without any setoff or offset (subject, in each case, to Section 5.12 and Section 5.13), the Royalty Payment for each Fiscal Quarter promptly, but in any event no later than [*] after the end of each Fiscal Quarter; provided that for any payments received by the Seller after the end
of each Fiscal Quarter, such payment will be paid with the following Fiscal Quarter’s Royalty Payment; provided further that any adjustments to the Royalty Payment for a Fiscal Quarter based on or arising out of any discrepancies with the Seller’s Form 10-Q or Form 10-K filed with the SEC will be paid with or credited against, as applicable, the following Fiscal Quarter’s Royalty Payment. A late fee of [*] over the Prime Rate (calculated on a per annum basis) will accrue on all unpaid amounts with respect to any Royalty Payment from the date such obligation was due. The imposition and payment of a late fee shall not constitute a waiver of the Buyer’s rights with respect to such payment default. If the Buyer has any questions regarding the Royalty Payment, or disagrees with the amount thereof, the Buyer shall contact [*], Chief Financial Officer ([*]).
(b) From and after the First Commercial Sale of a Product in any country in the Territory until the expiry of the Royalty Term in such country, for each Fiscal Quarter promptly, but in any event no later than [*] after the end of each [*], the Seller shall provide to the Buyer a report (a “Royalty Report”), in substantially the form attached to this Agreement as Exhibit D, setting forth in reasonable detail with respect to all Products, (i) Gross Sales and Net Sales (A) for the applicable [*], (B) the most recent period of [*], and (C) the calendar year to date, in each case, on a Product-by-Product basis (including a detailed break-down of all permitted deductions from Gross Sales used to determine Net Sales and any Net Sales described in Section 5.5(e), together with a reasonably detailed explanation of any deviations, deductions or changes to the calculations of Gross Sales and Net Sales as compared to the such calculations for each of the three immediately preceding Fiscal Quarters), (ii) the calculation of the Royalty Payment payable to the Buyer for the applicable [*], identifying, on a Product-by-Product basis, the number of units of each Product sold by the Seller, its Affiliates, Distributors, and each Licensee, together with a reasonably detailed explanation of any deviations, deductions or changes to such Royalty Payment as compared to the Royalty Payment for each of the [*], and (iii) if applicable, foreign currency exchange rates used (which shall be rates of exchange determined in a manner consistent with the Seller’s method for calculating rates of exchange in the preparation of the Seller’s annual financial statements in accordance with GAAP); provided that for any Licensee Reports or Sale Reports received by the Seller after the date that is [*] after the end of each [*], the Seller shall provide to the Buyer the relevant information from such reports in the following [*] report; provided further that any adjustments to the Royalty Payment for a [*] based on or arising out of any discrepancies with the Seller’s Form 10-Q of Form 10-K filed with the SEC will be paid with or credited against, as applicable, the following [*] Royalty Payment.
(c) Any payments required to be made by either party under this Agreement shall be made in Dollars via electronic funds transfer or wire transfer of immediately available funds to such bank account as the other party shall designate in writing prior to the date of such payment.
(d) If the Seller enters into a definitive agreement with a Person that is not an Affiliate of the Seller to consummate a Change of Control, the Buyer shall have the option (the “Put Option”) at any time during the period from the date of the consummation of such Change
of Control until the date that is the earlier of (i) [*] following such Change of Control and (ii) December 31, 2026 to require the Seller to repurchase from the Buyer one hundred percent (100%) of the Revenue Participation Right for a cash purchase price (the “Put Price”), if positive, equal to the result of the product of (A) (x) one and one-half (1.5) multiplied by (y) the Purchase Price actually received by the Seller prior to the payment by the Seller to the Buyer of the Put Price, minus (B) the Cumulative Royalty Payments actually received by the Buyer at the time of payment of the Change of Control. The Buyer may exercise the Put Option by delivering to the Seller written notice thereof. If the Buyer exercises the Put Option, the Seller shall promptly but no later than [*] following the provision of such notice to the Seller, purchase from the Buyer all of the Buyer’s rights to the Revenue Participation Right for the Put Price. The payment of the Put Price shall be made by wire transfer of immediately available funds to one or more accounts specified by the Buyer or, if not timely designated by the Buyer, to the account to which the Royalty Payments were transmitted or are to be transmitted pursuant to Section 5.2. Upon Buyer’s receipt of the Put Price, (1) all rights of the Buyer under Section 5.2 and Section 5.12 shall immediately terminate; (2) except as set forth in Section 9.3, all rights and obligations of the parties hereunder shall automatically without any further action of the parties be deemed to be released and irrevocably terminated; and (3) the Buyer shall take such actions as are reasonably requested by the Seller to evidence the termination of such provisions, including the termination of the Back-Up Security Interest. Notwithstanding any of the foregoing to the contrary, in the event that the Put Option is exercised during any Fiscal Quarter during which the Seller has earned Net Sales and would otherwise be obligated to make a Royalty Payment to the Buyer, the Seller shall be obligated to make all Royalty Payments otherwise due in accordance with Section 5.2 for all such earned Net Sales up to the date the Seller remits the Put Price to the Buyer, and such Put Price shall include the foregoing amount of such final Royalty Payment in the calculation of Cumulative Royalty Payments for the Put Price.
(e) If at any time during the period from the date hereof until December 31, 2026 (the “Buy-Back Window”), (x) the Seller enters into a definitive agreement with a Person that is not an Affiliate of the Seller to consummate a Change of Control, (y) [*] or (z) as of December 31, 2026, [*] (each of clauses (x) through (z), a “Buy-Back Option Trigger Event”), the Seller shall have the option (the “Buy-Back Option”) to repurchase from the Buyer one hundred percent (100%) of the Revenue Participation Right for a cash purchase price (the “Buy-Back Price”) equal to the result of the product of (i) (A) one and one-half (1.5) multiplied by (B) the Purchase Price actually received by the Seller prior to the payment by the Seller to the Buyer of the Buy-Back Price, minus (ii) the Cumulative Royalty Payments actually received by Buyer at the time of payment of the Buy-Back Price. The Seller may exercise the Buy-Back Option solely during the Buy-Back Window, by delivering to the Buyer written notice thereof. In the event of an exercise of the Buy-Back Option pursuant to a “Buy-Back Option Trigger Event” described in clause (x) of such definition, the Seller’s right and obligation to consummate the repurchase of the Revenue Participation Right following the exercise of the Buy-Back Option shall be contingent upon the consummation of such Change of Control during the Buy-Back Window; if such Change of Control is not consummated during the Buy-Back Window, the exercise of such Buy-Back Option shall be void and the Seller’s right to repurchase Buyer’s Revenue Participation Right shall automatically terminate. If the Seller exercises the Buy-Back
Option, the Seller shall promptly but no later than [*] following the consummation of such Change of Control or the Seller’s exercise of the Buy-Back Option pursuant to another Buy-Back Option Trigger Event, as applicable, purchase from the Buyer all of the Buyer’s rights to the Revenue Participation Right for the Buy-Back Price. The payment of the Buy-Back Price shall be made by wire transfer of immediately available funds to one or more accounts specified by the Buyer or, if not timely designated by Buyer, to the account to which the Royalty Payments were transmitted or are to be transmitted pursuant to Section 5.2. Upon Buyer’s receipt of the Buy-Back Price, (a) all rights of the Buyer under Section 5.2 shall immediately terminate; and (b) except as set forth in Section 9.3, all rights and obligations of the parties hereunder shall automatically without any further action of the parties be deemed to be released and irrevocably terminated. Notwithstanding any of the foregoing to the contrary, in the event that the Buy-Back Option is exercised during any Fiscal Quarter during which the Seller has earned Net Sales and would otherwise be obligated to make a Royalty Payment to the Buyer, the Seller shall be obligated to make all Royalty Payments otherwise due in accordance with Section 5.2 for all such earned Net Sales up to the date the Seller remits the Buy-Back Price to the Seller, and such Buy-Back Price shall include the foregoing amount of such final Royalty Payment in the calculation of Cumulative Royalty Payments for the Buy-Back Price.
Section 5.3. Disclosures. Except for a press release previously approved in form and substance by the Seller and the Buyer or any other public announcement using substantially the same text or disclosing substantially the same substance as such press release, neither the Buyer nor the Seller shall, and each party hereto shall cause its respective Representatives, Affiliates and Affiliates’ Representatives not to issue a press release or other public announcement or otherwise make any public disclosure with respect to this Agreement or the subject matter hereof without the prior written consent of the other party hereto (which consent shall not be unreasonably withheld or delayed), except as may be required by applicable Law or stock exchange rule (in which case the party hereto required to make the press release or other public announcement or disclosure shall allow the other party hereto reasonable time to comment on, and, if applicable, reasonably direct the disclosing party to seek confidential treatment in respect of portions of, such press release or other public announcement or disclosure in advance of such issuance, and the disclosing party shall consider any such comments in good faith and use commercially reasonable efforts to seek such confidential treatment, as applicable). Without limiting the foregoing, the Buyer acknowledges that it will be necessary for the Seller to file this Agreement with the SEC regarding the terms of this Agreement in its reports filed with the SEC, and the Seller agrees that it will provide the Buyer a reasonable opportunity to review and comment on any proposed redactions to the copy of this Agreement to be filed with the SEC, which comments the Seller shall consider in good faith.
Section 5.4. Inspections and Audits of the Seller. Following the Closing, upon at least [*] written notice and during normal business hours, no more frequently than [*] per calendar year, the Buyer may cause an inspection and/or audit by an independent public accounting firm reasonably acceptable to the Seller to be made of the Seller’s books of account for the [*] prior to the audit [*]. Upon the Buyer’s reasonable request, no more frequently than [*] per calendar year while any Out-License remains in effect, the Seller shall use Commercially
Reasonable Efforts to exercise any rights it may have under any Out-License relating to a Product to cause an inspection and/or audit by an independent public accounting firm to be made of the books of account of any counterparty thereto [*]. All of the out-of-pocket expenses of any inspection or audit requested by the Buyer hereunder (including the fees and expenses of such independent public accounting firm designated for such purpose) shall be borne solely by the Buyer, unless the independent public accounting firm determines that Royalty Payments previously paid during the period of the audit were underpaid by an amount greater than [*] of the Royalty Payments actually paid during such period, in which case such expenses shall be borne by the Seller. Any such accounting firm shall not disclose the confidential information of the Seller or any such Licensee relating to a Product to the Buyer, except to the extent such disclosure is necessary to determine [*]. All information obtained by the Buyer as a result of any such inspection or audit shall be Confidential Information subject to ARTICLE VIII. If any audit discloses any underpayments by the Seller to the Buyer, then such underpayment, shall be paid by the Seller to the Buyer within [*] of it being so disclosed. If any audit discloses any overpayments by the Seller to the Buyer, then the Seller shall have the right to credit the amount of the overpayment against each subsequent [*] Royalty Payment due to the Buyer until the overpayment has been fully applied. If the overpayment is not fully applied prior to the final [*] Royalty Payment due hereunder, the Buyer shall promptly refund an amount equal to any such remaining overpayment.
Section 5.5. Intellectual Property and Regulatory Matters.
(a) The Seller shall, at its sole expense, either directly or by causing any Licensee to do so, use Commercially Reasonable Efforts to take such actions (including taking legal action to specifically enforce the applicable terms of any In-License or Out-License), and prepare, execute, deliver and file any and all agreements, documents or instruments which are necessary or reasonably useful to diligently prosecute and maintain, and avoid disclaimer or abandonment of, the Product Patent Rights (owned or exclusively licensed by the Seller or any of its Affiliates). The Seller shall use Commercially Reasonable Efforts to ensure that all patent applications corresponding to the Product Patent Rights (owned or exclusively licensed by the Seller or any of its Affiliates) are diligently prosecuted. In connection with any such prosecution of Product Patent Rights that could affect the timing, duration, or amount of the Revenue Participation Right, the Seller shall provide the Buyer with drafts of all substantive submissions and advise the Buyer of all material actions to be taken in advance of making such filings or taking such actions so that the Buyer may provide comments and the Seller shall reasonably consider such comments. After first U.S. Marketing Approval of Sebetralstat, the Seller shall submit for listing in the Orange Book any Patent included in the Product Patent Rights (owned or exclusively licensed by the Seller or any of its Affiliates) that issues and is eligible to be listed in the Orange Book within [*] of the issue date of such Patent. Notwithstanding the foregoing, the Seller shall not select any Patent for term extension, including Patent Term Extension (PTE) and Supplementary Protection Certificate (SPC) or other equivalent process in any jurisdiction in the Territory, without obtaining the prior written approval of the Buyer (not to be unreasonably withheld). The Seller shall use Commercially Reasonable Efforts to diligently file and prosecute applications to extend patent term for the Product upon Marketing Approval, including, for
patent term extension, supplementary certificate protection and the like, within the applicable deadline in the relevant jurisdiction for filing such applications. The Seller shall use Commercially Reasonable Efforts to diligently defend or assert the Product Intellectual Property Rights (owned or exclusively licensed by the Seller or any of its Affiliates) against infringement by any other Persons, and against any claims of invalidity (including any reexamination, inter partes review, post grant review, opposition, or like proceeding) or unenforceability, including, without limitation and where reasonable to do so based on the chances of success and the cost of doing so, by bringing any legal action for infringement or defending any counterclaim of invalidity or action of a Third Party for declaratory judgment of non-infringement or non-interference. Without limiting any other obligation of the Seller under this Section 5.5(a), the Seller shall (i) bring and prosecute infringement actions in response to a notification of certification made under paragraph IV of 21 U.S.C. §355(j)(2)(A)(vii) or §355(b)(2)(A) with respect to any Orange Book Patent and shall bring the action for patent infringement within [*] of receipt of the notification of certification under 21 U.S.C. §355(j)(5)(B)(iii) or §355(c)(3)(C), (ii) defend the Orange Book Patents against any claim of invalidity, unenforceability or non-infringement, and (iii) not disclaim or abandon any Orange Book Patent.
(b) The Seller shall provide to the Buyer a copy of any written notice received by the Seller from a Third Party alleging or claiming that the making, having made, using, importing, offering for sale or selling of a Product infringes or misappropriates any Patents or other Intellectual Property rights of such Third Party, together with copies of material correspondence sent or received by the Seller related thereto, as soon as practicable and in any event not more than [*] following such delivery or receipt.
(c) The Seller shall promptly inform the Buyer of any infringement by a Third Party of any Product Intellectual Property Right (owned or exclusively licensed by the Seller or any of its Affiliates) of which any of the individuals named in the definition of “Knowledge of the Seller” (or the successors of such Person at the Seller) becomes aware. Without limiting the foregoing, the Seller shall provide to the Buyer a copy of any written notice of any infringement or suspected infringement of any Product Patent Rights delivered or received by the Seller, as well as copies of material correspondence related thereto, including any notice of a paragraph IV certification, as soon as practicable and in any event not more than [*] following such delivery or receipt.
(d) Within [*] of initiating, or permitting a Licensee to initiate, an enforcement action regarding any suspected infringement by a Third Party of any Product Intellectual Property Right (owned or exclusively licensed by the Seller or any of its Affiliates), the Seller shall provide the Buyer with written notice of such enforcement action. In connection with any such enforcement action, the Seller shall provide the Buyer with drafts of all substantive submissions and advise the Buyer of all material actions to be taken in advance of making such filings or taking such actions so that the Buyer may provide comments and the Seller shall reasonably consider such comments. Until the date that the Buyer has received from the Seller Royalty Payments that, in the aggregate, are equal to or greater than [*].
(e) If the Seller recovers monetary damages from a Third Party in an action brought for such Third Party’s infringement of any Product Intellectual Property Rights relating to a Product, where such damages, whether in the form of judgment or settlement, are awarded for such infringement of such Product Intellectual Property Rights, (i) such recovery will be allocated first to the reimbursement of any expenses incurred by the Seller (or any party to an In-License or Permitted Out-License of such Product Intellectual Property Rights entitled to such reimbursement under any such In-License or Out-License) in bringing such action (including all reasonable attorney’s fees) and (ii) any residual amount of such damages after application of (i) will be treated as Net Sales; provided that in apportioning the amount of any such residual amount of such damages after application of clause (i) that constitute Net Sales for each calendar year for which the applicable Third Party was infringing on a Product Patent Right, such monetary damages recovered by the Seller from such Third Party shall, in such calendar year, be equal to [*].
(f) The Seller shall ensure that all Orange Book Patents meet the statutory and regulatory criteria for listing in the Orange Book.
(g) At least [*] prior to submission to the EMA of the results of any studies conducted in compliance with the Pediatric Investigation Plan for Sebetralstat in the European Union, the Seller shall consult with the Buyer regarding [*], [*]. [*]:
(i) [*]
(ii) [*]
Section 5.6. In-Licenses.
(a) The Seller shall promptly (and in any event within [*]) provide the Buyer with (i) executed copies of any In-License entered into by the Seller or its Affiliates, and (ii) executed copies of each amendment, supplement, modification or written waiver of any provision of any In-License.
(b) The Seller shall use Commercially Reasonable Efforts to comply in all material respects with its obligations under any In-Licenses it enters into and shall not take any action or forego any action that would reasonably be expected to result in a material breach thereof. Promptly, and in any event within [*], after receipt of any (written or oral) notice from a counterparty to any In-License or its Affiliates of an alleged material breach under any In-License, the Seller shall provide the Buyer a copy thereof. The Seller shall use its Commercially Reasonable Efforts to cure any material breaches by it under any In-License and shall give written notice to the Buyer upon curing any such breach. The Seller shall provide the Buyer with written notice following becoming aware of a counterparty’s material breach of its obligations under any In-License. The Seller shall not terminate any In-License without providing the Buyer prior written notice. Promptly, and in any event within [*] following the Seller’s notice to a counterparty to any In-License of an alleged breach by such counterparty under any such In-License, the Seller shall provide the Buyer a copy thereof.
Section 5.7. Permitted Licenses; Sales.
(a) The Seller may not enter into any Out-License other than a Permitted Out-License without the Buyer’s prior written consent (not to be unreasonably withheld). Subject to compliance with this Section 5.7, the Seller may enter into (i) a Permitted Out-License or (ii) an agreement to research, develop or manufacture any Product in all or any portion of the Territory, in each case without the Buyer’s prior written consent (“Other License”); provided that (A) such Permitted Out-License or Other License, as may be applicable, shall not assign or otherwise convey title to or impose any Lien, other than the grant of the license or sublicense in favor of any Third Party without the Buyer’s prior written consent, and (B) for a Permitted Out-License in respect of the Commercialization of a Product, the Seller shall comply with the requirements set forth in Section 2.1(c) (any such Permitted Out-License or Other License, a “Permitted License”). The Seller may enter into any definitive agreement with respect to any Sale, subject to compliance with the requirements set forth in Section 2.1(c) and Section 5.7(c) with respect to such Sale; provided further that, notwithstanding any provision in this Agreement to the contrary, for any Sale made to a Third Party that constitutes a Change of Control pursuant to clauses (a) or (b) of the definition of “Change of Control”, the Seller shall (i) not be required to obtain the Buyer’s consent or comply with Section 2.1(c) or Section 5.7(c) and (ii) be required to cause the purchaser in such Sale to assume all of the rights and obligations of the Seller under this Agreement and such purchaser shall be deemed an assignee of the Seller under this Agreement.
(b) The Seller shall promptly (and in any event within [*]) provide the Buyer with (i) executed copies of each Sale or definitive agreement (and all ancillary agreements underlying or related to such Sale) with respect to any Sale, as may be applicable, and (ii) executed copies of each amendment, supplement, modification or written waiver of any material provision of a Permitted License or of any definitive agreement (and ancillary and related agreements thereto) with respect to any Permitted License, as may be applicable.
(c) The Seller shall include in all Permitted Out-Licenses, or definitive agreements with respect to any Sale, as may be applicable, provisions (i) requiring the Licensee or Purchaser (as applicable) to provide to the Seller all information that the Seller is required to provide in the Royalty Reports within the same time frame as required under Section 5.2(b), including but not limited to Gross Sales and Net Sales for the applicable [*], on a Product-by-Product basis (including a detailed break-down of all permitted deductions from Gross Sales used to determine Net Sales and any Net Sales described in Section 5.5(e)) (collectively, the “Licensee Reports” (or “Sale Reports” in respect of any Purchaser)), (ii) allowing the Seller to provide such Licensee Reports or Sale Reports (as applicable) to the Buyer (and the Seller hereby covenants to provide such Licensee Reports or Sale Reports (as applicable) promptly to the Buyer but in no event later than delivery of the respective Royalty Report under Section 5.2(b)), and (iii) for inspection and audit rights in favor of the Seller no less favorable in nature and scope as provided to the Buyer pursuant to Section 5.4.
(d) The Seller shall provide the Buyer prompt (and in any event within [*]) written notice of a material breach by a Licensee or Purchaser (as applicable) (or of its
obligations under any Permitted Out-License or definitive agreement with respect to any Sale, as may be applicable), of which any of the individuals named in the definition of “Knowledge of the Seller” (or the successors of such Person at the Seller) becomes aware.
(e) The Seller shall provide the Buyer with written notice promptly (and in any event within [*]) following the termination of any Permitted Out-License or of definitive agreements with respect to any Sale, as may be applicable.
Section 5.8. Restricted Indebtedness; Secured Indebtedness.
(a) [*], the Parent shall not, and shall not permit any of its Subsidiaries to, create, incur, assume or suffer to exist any Restricted Indebtedness.
(b) Prior to the incurrence by the Parent, the Seller or any of their respective Subsidiaries of any Indebtedness for borrowed money secured by a Lien on the assets of the Parent, the Seller or any of their respective Subsidiaries permitted under this Agreement (each such Person, in such capacity, a “Borrower”), the Buyer shall enter, and the Parent shall cause each Borrower to enter and cause the creditor(s), or any agent, representative or trustee acting on behalf of such creditor(s), to enter into an Intercreditor Agreement. Any such Intercreditor Agreement shall be subject to the prior written consent of the Buyer (such consent to not be unreasonably withheld, conditioned or delayed).
Section 5.9. Liens. The Parent and the Seller shall not, and shall not permit any of their respective Subsidiaries to, create, incur, assume or suffer to exist any Lien upon the Royalty Payments, the Revenue Participation Right or the Product Collateral, other than (i) Liens in favor of the Buyer pursuant to the Transaction Documents and (ii) Permitted Liens.
Section 5.10. Development, Marketing and Commercialization.
(a) The Seller shall use Commercially Reasonable Efforts, in each case throughout the Territory, to (i) complete clinical development of Sebetralstat, (ii) obtain and maintain Marketing Approvals for all Products for the Initial Approved Indication, (iii) conduct and complete any post-marketing Clinical Trials required by the FDA, EMA, any equivalent Regulatory Authority or any successor agency of the foregoing as a condition for any Marketing Approval and (iv) Commercialize all Products. In furtherance of the foregoing, the Seller shall use Commercially Reasonable Efforts to prepare, execute, deliver and file any and all agreements, documents or instruments that are necessary or desirable to secure and maintain each such Marketing Approval required to Commercialize all Products throughout the Territory and the Seller shall use Commercially Reasonable Efforts to not withdraw or abandon, or fail to take any action necessary to prevent the withdrawal or abandonment of, any such Marketing Approval in any jurisdiction in the Territory. If the Seller does not obtain U.S. Marketing Approval by [*], the Buyer shall have the right but not the obligation to provide guidance and make strategy recommendations, including through its agents or consultants, regarding the strategy, additional clinical testing, written and oral communications with FDA, including
participating in meetings with FDA, and any other filings necessary to obtain Marketing Approval, and the Seller shall reasonably consider such guidance and strategy recommendations.
Section 5.11. Continuing Efforts; Further Assurances.
(a) After the Closing, the Seller and the Buyer agree to execute and deliver such other documents, certificates, agreements and other writings and to take such other actions as may be reasonably necessary in order to give effect to the transactions contemplated by this Agreement. After the Closing, the Seller shall use its Commercially Reasonable Efforts to obtain and maintain any required consents, acknowledgements, certificates or waivers so that the transactions contemplated by this Agreement or any other Transaction Document may be consummated and shall not result in any default or breach or termination of any material contract in respect of the Revenue Participation Right or the Product Collateral.
(b) The Buyer and the Seller shall cooperate and provide assistance as reasonably requested by the other party, at the expense of such other party (other than expenses that are Losses subject to indemnification in accordance with ARTICLE VII), in connection with any Third Party litigation, arbitration or other Third Party proceeding with respect to the Revenue Participation Right or the Product Collateral (whether threatened, existing, initiated, or contemplated prior to, on or after the date hereof) to which any party hereto or any of its officers, directors, shareholders, agents or employees is or may become a party or is or may become otherwise directly or indirectly affected or as to which any such Persons have a direct or indirect interests, in each case relating to this Agreement, any other Transaction Document, the Revenue Participation Right or the Product Collateral, or the transactions described herein or therein.
Section 5.12. Non-Impairment; Back-Up Security Interest. Notwithstanding any provision in this Agreement to the contrary, the Seller shall not, and the Seller shall use Commercially Reasonable Efforts to reasonably ensure that any Licensee or Purchaser, as may be applicable, shall not (i) enter into any contracts or arrangement or otherwise take any action or fail to act in a manner that would, individually or in the aggregate, reasonably be expected to materially and adversely affect the Buyer’s interest in the Revenue Participation Right or the Back-Up Security Interest, and (ii) take any action or engage in any transaction (or series of actions or transactions), whether by reorganization, transfer of assets, merger, dissolution, amendment of organizational documents or otherwise, the primary purpose or the effect of which is to evade, avoid or seek to avoid the performance or observance of the covenants, agreements or obligations of the Seller under the Transaction Documents (or of a Licensee in any Permitted Out-License or Purchaser in any definitive agreements for a Sale, in each case in respect of the Revenue Participation Right, Royalty Payments or the Product Collateral). During the term of the Agreement, the Seller shall, at all times until its obligations under the Transaction Documents are paid and performed in full, grant in favor of the Buyer, and take such additional actions as reasonably requested by the Buyer to ensure that the Buyer has a valid, continuing, first priority security interest in and to all right, title and interest in, to and under the Revenue Participation Right and the Royalty Payments and a security interest in and to all right, title and interest in, to and under the Product Collateral in accordance with the terms set forth in Section 2.1; provided that the parties agree that the entry into any agreement evidencing any secured Indebtedness
expressly permitted hereunder, which shall be subject to and in compliance with an Intercreditor Agreement, shall be deemed to not materially and adversely affect the Buyer’s interest in the Revenue Participation Right or the Back-Up Security Interest. The Seller shall not, without providing [*] prior written notice to the Buyer and otherwise taking any steps that in the Buyer’s reasonable discretion would be necessary, appropriate or convenient to maintain the recording of the purchase and the perfection of the security interests granted to the Buyer under the Transaction Documents, change its name, address, jurisdiction of organization or form of organization.
Section 5.13. Certain Tax Matters.
(a) The Seller and the Buyer agree that for Tax purposes, (a) the Seller and the Buyer shall treat the transactions contemplated by this Agreement as a sale of the Revenue Participation Right, (b) subject to receipt of a duly executed IRS Form W-8BEN-E certifying the Seller’s entitlement to benefits under the U.S. – U.K. Income Tax Convention, the Closing Price and Sales-Based Milestone Payment will not be subject to U.S. withholding Tax; and (c) any and all amounts remitted by the Seller to the Buyer after the Closing Date pursuant to this Agreement shall be treated as received by the Seller as agent for the Buyer. The Seller shall not, by reason of its duties and functions hereunder, be deemed to be acting as a partner of or to be engaged in a joint venture, association or syndication with, the Buyer for tax purposes. The parties hereto agree not to take any position that is inconsistent with the provisions of this Section 5.13(a) on any Tax return or in any audit or other tax-related administrative or judicial proceeding unless the other party hereto has consented in writing (such consent not to be unreasonably withheld, conditioned or delayed) to such actions. If there is an inquiry by any Governmental Entity of the Buyer or the Seller related to the treatment described in this Section 5.13(a), the parties hereto shall cooperate with each other in responding to such inquiry in a reasonable manner which is consistent with this Section 5.13(a).
(b) Any and all payments by or on account of any obligation of the Seller shall be made free and clear of and without withholding or deduction for any Taxes; provided that if the Seller shall be required by Law to withhold or deduct any Tax from any such payment, then Seller shall withhold or deduct such Taxes as are required by Law and pay over such Taxes to the appropriate Taxing authority; and [*], [*]. [*].
(c) [*].
(d) [*].
Section 5.14. Use of Proceeds. The Seller shall use proceeds received from the Buyer pursuant to this Agreement in support of the development of the Product Intellectual Property Rights and development and Commercialization of all Products.
Section 5.15. Parent Obligations. In the event that (i) the Seller does not have the requisite power, rights or authority to perform any obligation of the Seller under this Agreement and (ii) the Parent or any Subsidiary of the Parent does have the requisite power,
rights or authority to perform such obligation, the Parent shall, or shall cause its applicable Subsidiary or Subsidiaries to, take such actions as are reasonably necessary to perform such obligation.
ARTICLE VI
BANKRUPTCY EVENTS
If the Seller becomes subject to any Bankruptcy Event, the obligation of the Buyer to make payments in accordance with Section 2.2 shall terminate and [*] shall become immediately due and payable by the Seller to the Buyer, in each case without further act of the Buyer. Any payment payable pursuant to this ARTICLE VI shall be presumed to be the liquidated damages sustained by the Buyer, and the parties hereto agree that such payment is reasonable under the circumstances currently existing. TO THE EXTENT PERMITTED BY APPLICABLE LAW, THE SELLER EXPRESSLY WAIVES THE PROVISIONS OF ANY PRESENT OR FUTURE STATUTE OR LAW THAT PROHIBITS OR MAY PROHIBIT THE COLLECTION OF THE PAYMENT SET FORTH IN THIS ARTICLE VI. The parties hereto expressly agree that (i) such payment is reasonable and is the product of an arm’s length transaction between sophisticated business people, ably represented by counsel, (ii) such payment shall be payable notwithstanding the then prevailing market rates at the time such payment is made, (iii) the parties hereto shall be estopped hereafter from claiming differently than as agreed to in this ARTICLE VI and (iv) such payment represents a good faith, reasonable estimate and calculation of the lost profits or damages of the Buyer and that it would be impractical and extremely difficult to ascertain the actual amount of damages to the Buyer or profits lost by the Buyer as a result of a Bankruptcy Event. The parties hereto expressly acknowledge and agree that such payment is a material inducement to the Buyer to enter into this Agreement.
ARTICLE VII
INDEMNIFICATION
Section 7.1. General Indemnity. From and after the Closing:
(a) the Seller hereby agrees to indemnify, defend and hold harmless the Buyer and its Affiliates and its and their directors, managers, members, partners, trustees, officers, agents and employees (the “Buyer Indemnified Parties”) from, against and in respect of all Losses suffered or incurred by the Buyer Indemnified Parties to the extent arising out of or resulting from (i) any breach of any of the representations or warranties of the Seller in this Agreement or the other Transaction Documents, and (ii) any breach of any of the covenants or agreements of the Seller in this Agreement or the other Transaction Documents; and
(b) the Buyer hereby agrees to indemnify, defend and hold harmless the Seller and its Affiliates and its and their directors, officers, agents and employees (the “Seller Indemnified Parties”) from, against and in respect of all Losses suffered or incurred by the Seller
Indemnified Parties to the extent arising out of or resulting from (i) any breach of any of the representations or warranties of the Buyer in this Agreement or the other Transaction Documents, and (ii) any breach of any of the covenants or agreements of the Buyer in this Agreement or the other Transaction Documents.
Section 7.2. Notice of Claims. If either a Buyer Indemnified Party, on the one hand, or a Seller Indemnified Party, on the other hand (such Buyer Indemnified Party on the one hand and such Seller Indemnified Party on the other hand being hereinafter referred to as an “Indemnified Party”), has suffered or incurred any Losses for which indemnification may be sought under this ARTICLE VII, the Indemnified Party shall so notify the other party from whom indemnification is sought under this ARTICLE VII (the “Indemnifying Party”) promptly in writing describing such Loss, the amount or estimated amount thereof, if known or reasonably capable of estimation, and the method of computation of such Loss, all with reasonable particularity and containing a reference to the provisions of this Agreement in respect of which such Loss shall have occurred. If any claim, action, suit or proceeding is asserted or instituted by or against a Third Party with respect to which an Indemnified Party intends to claim any Loss under this ARTICLE VII, such Indemnified Party shall, promptly [*] after it becomes aware of such claim, action, suit or proceeding, notify the Indemnifying Party of such claim, action, suit or proceeding and tender to the Indemnifying Party the defense of such claim, action, suit or proceeding. A failure by an Indemnified Party to give notice and to tender the defense of such claim, action, suit or proceeding in a timely manner pursuant to this Section 7.2 shall not limit the obligation of the Indemnifying Party under this ARTICLE VII, except to the extent such Indemnifying Party is actually prejudiced thereby.
Section 7.3. Claim Procedures. In case any such action is brought against an Indemnified Party and it notifies the Indemnifying Party of the commencement thereof, the Indemnifying Party will be entitled to participate therein and, to the extent that it may wish, jointly with any other Indemnifying Party similarly notified, to assume the defense thereof, with counsel reasonably satisfactory to such Indemnified Party, and after notice from the Indemnifying Party to such Indemnified Party of its election so to assume the defense thereof, the Indemnifying Party will not be liable to such Indemnified Party under this Section 7.3 for any legal or other expenses subsequently incurred by such Indemnified Party in connection with the defense thereof other than reasonable costs of investigation. In any such proceeding, an Indemnified Party shall have the right to retain its own counsel reasonably satisfactory to the Indemnifying Party, but the reasonable fees and expenses of such counsel shall be at the expense of such Indemnified Party unless (i) the Indemnifying Party has assumed the defense of such proceeding and has failed within a reasonable time to retain counsel reasonably satisfactory to such Indemnified Party or (ii) the named parties to any such proceeding (including any impleaded parties) include both the Indemnifying Party and the Indemnified Party and representation of both parties by the same counsel would be inappropriate due to actual or potential conflicts of interests between them based on the advice of such counsel. It is agreed that the Indemnifying Party shall not, in connection with any proceeding or related proceedings in the same jurisdiction, be liable for the reasonable fees and expenses of more than one separate law firm (in addition to local counsel where necessary) for all such Indemnified Parties. The
Indemnifying Party shall not be liable for any settlement of any proceeding effected without its written consent, which shall not be unreasonably withheld, conditioned, or delayed. No Indemnifying Party shall, without the prior written consent of the Indemnified Party, which shall not be unreasonably withheld, conditioned, or delayed, effect any settlement of any pending or threatened proceeding in respect of which any Indemnified Party is or could have been a party and indemnity could have been sought hereunder by such Indemnified Party, unless such settlement includes an unconditional release of such Indemnified Party from all liability on claims that are the subject matter of such proceeding.
Section 7.4. Limitations on Liability. Except for claims arising from a breach of confidentiality obligations under ARTICLE VIII or in cases of fraud, gross negligence, or willful misconduct, no party hereto shall be liable for any consequential, punitive, special or incidental damages under this ARTICLE VII (and no claim for indemnification hereunder shall be asserted) as a result of any breach or violation of any covenant or agreement of such party (including under this ARTICLE VII) in or pursuant to this Agreement. In connection with the foregoing, the parties hereto acknowledge and agree that (a) the Buyer’s damages, if any, for any such action or claim will include Losses for Royalty Payments that the Buyer was entitled to receive in respect of its ownership of the Royalty Payments but did not receive timely or at all due to such indemnifiable event and (b) the Buyer shall be entitled to make claims for all such missing or delayed Royalty Payments as Losses hereunder, and such missing or Royalty Payments shall not be deemed consequential, punitive, special, indirect or incidental damages.
Section 7.5. Exclusive Remedy. Except as set forth in ARTICLE VI and Section 10.10, from and after Closing, the rights of the parties hereto pursuant to (and subject to the conditions of) this ARTICLE VII shall be the sole and exclusive remedy of the parties hereto and their respective Affiliates with respect to any Losses (whether based in contract, tort or otherwise) resulting from or relating to any breach of the representations, warranties covenants and agreements made under this Agreement or any certificate, document or instrument delivered hereunder, and each party hereto hereby waives, to the fullest extent permitted under applicable Law, and agrees not to assert after Closing, any other claim or action in respect of any such breach. Notwithstanding the foregoing, claims for fraud, gross negligence, or willful misconduct shall not be waived or limited in any way by this ARTICLE VII.
Section 7.6. Tax Treatment of Indemnification Payments. For all purposes hereunder, any indemnification payments made pursuant to this ARTICLE VII will be treated as an adjustment to the Purchase Price to the fullest extent permitted by applicable Tax Law.
Section 7.7. Survival of Representations and Warranties. The representations and warranties contained in this Agreement shall survive the Closing and shall terminate on the date that is the [*] anniversary of the Closing Date; provided, however, that the Seller Fundamental Representations shall survive the Closing and shall terminate on the date that is the [*] anniversary of the Closing Date.
ARTICLE VIII
CONFIDENTIALITY
Section 8.1. Confidentiality. Except as provided in this ARTICLE VIII, Section 10.4 or otherwise agreed in writing by the parties, the parties hereto agree that, during the term of this Agreement and for [*] thereafter, each party (the “Receiving Party”) shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder) any information furnished to it by or on behalf of the other party (the “Disclosing Party”) pursuant to this Agreement (such information, “Confidential Information” of the Disclosing Party), except for that portion of such information that:
(a) was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party;
(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;
(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement or any other agreement;
(d) is independently developed by the Receiving Party or any of its Affiliates without the use of or reference of the Confidential Information; or
(e) is subsequently disclosed to the Receiving Party by a Third Party that, to the knowledge of the Receiving Party, is not subject to obligations of confidentiality with respect thereto.
Section 8.2. Authorized Disclosure.
(a) Either party may disclose Confidential Information to the extent such disclosure is reasonably necessary in the following situations:
(i) prosecuting or defending litigation;
(ii) complying with applicable Laws and regulations, including regulations promulgated by securities exchanges;
(iii) complying with a valid order of a court of competent jurisdiction or other Governmental Entity;
(iv) for regulatory, Tax or customs purposes;
(v) for audit purposes; provided that each recipient of Confidential Information must be bound by customary and reasonable obligations of confidentiality and non-use prior to any such disclosure;
(vi) disclosure to its Affiliates and Representatives on a need-to-know basis; provided that each such recipient of Confidential Information must be bound by contractual or professional obligations of confidentiality and non-use at least as stringent as those imposed upon the parties hereunder prior to any such disclosure;
(vii) upon the prior written consent of the Disclosing Party;
(viii) disclosure to its potential investors, and other sources of funding, including debt financing, or potential partners, collaborators or acquirers, and their respective accountants, financial advisors and other professional representatives; provided that such disclosure shall be made only to the extent customarily required to consummate such investment, financing transaction partnership, collaboration or acquisition and that each recipient of Confidential Information must be bound by customary obligations of confidentiality and nonuse prior to any such disclosure;
(ix) as is necessary in connection with an actual or potential permitted assignment pursuant to Section 10.3.
(b) Notwithstanding the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential Information pursuant to Section 8.2(a)(i), (ii), (iii) or (iv), it will, except where impracticable, give reasonable advance notice to the Disclosing Party of such disclosure and use reasonable efforts to secure confidential treatment of such information. In any event, the Buyer shall not file any patent application based upon or using the Confidential Information of the Seller provided hereunder.
ARTICLE IX
TERMINATION
Section 9.1. Mutual Termination. This Agreement may be terminated by mutual written agreement of the Buyer and the Seller.
Section 9.2. Automatic Termination. Unless earlier terminated as provided in this ARTICLE IX, this Agreement shall continue in full force and effect until [*] after such time as the Seller is no longer obligated to make any Royalty Payments under this Agreement, at which point this Agreement shall automatically terminate, except with respect to any rights that shall have accrued prior to such termination.
Section 9.3. Survival. Notwithstanding anything to the contrary in this ARTICLE IX, the following provisions shall survive termination of this Agreement: Section 5.3 (Disclosures), Section 5.4 (Inspections and Audits of the Seller), ARTICLE VII (Indemnification), ARTICLE VIII (Confidentiality), this Section 9.3 (Survival) and ARTICLE X (Miscellaneous). Termination of the Agreement shall not relieve any party of liability in respect of breaches under this Agreement by any party on or prior to termination.
ARTICLE X
MISCELLANEOUS
Section 10.1. Headings. The table of contents and the descriptive headings of the several Articles and Sections of this Agreement and the Exhibits and Schedules are for convenience only, do not constitute a part of this Agreement and shall not control or affect, in any way, the meaning or interpretation of this Agreement.
Section 10.2. Notices. All notices and other communications under this Agreement shall be in writing and shall be by email with PDF attachment, facsimile, courier service or personal delivery to the following addresses, or to such other addresses as shall be designated from time to time by a party hereto in accordance with this Section 10.2:
If to the Seller, to it at:
KalVista Pharmaceuticals, Inc.
55 Cambridge Parkway
Suite 901E
Cambridge, Massachusetts, 02142
Attention: General Counsel
Chief Financial Officer
E-mail: [*]
with a copy to:
Fenwick & West LLP
555 California St, Floor 12
San Francisco, CA 94104
Attention: [*]
E-mail: [*]
If to the Buyer, to it at:
DRI Healthcare Acquisitions LP
c/o DRI Capital Inc.
First Canadian Place
100 King St. West, Suite 7250
P.O. Box 62
Toronto, ON M5X 1B1
Attn: Legal Department
Email: [*]
with a copy to:
Cravath, Swaine & Moore LLP
Two Manhattan West
375 Ninth Avenue
New York, NY 10001
Attention: [*]
Email: [*]
All notices and communications under this Agreement shall be deemed to have been duly given (a) when delivered by hand, if personally delivered, (b) when sent, if by email with PDF attachment, with an acknowledgement of receipt being produced by the recipient’s email account, or (c) one (1) Business Day following sending within the United States by overnight delivery via commercial one-day overnight courier service.
Section 10.3. Assignment. The Seller may not assign in whole or in part this Agreement or any of its rights or obligations hereunder without the Buyer’s prior written consent, in its sole discretion, except for in connection with a Sale or Permitted Out-License, and only if upon closing any such transaction, the Seller causes such Purchaser or Licensee, as applicable, to deliver a writing to the Buyer in which it assumes all of the obligations of the Seller to the Buyer under this Agreement, and such Purchaser or Licensee shall be deemed an assignee of the Seller under this Agreement. Following the Closing, the Buyer may only assign its obligations or rights under this Agreement to an Affiliate and shall not be entitled to assign any of its obligations and rights under this Agreement to a Third Party without prior written consent of the Seller, in its sole and absolute discretion; provided, however, that the Buyer may assign, delegate or otherwise transfer, in whole or in part, its obligations or rights under this Agreement in connection with an acquisition, merger or change of control of the Buyer without the consent of the Seller; provided further that following the earlier of the date (i) the Buyer has made the Sales-Based Milestone Payment and the Optional Payment to the Seller, in each case, to the extent required under Section 2.2 or (ii) the obligation of the Buyer to make the Sales-Based Milestone Payment and/or the Optional Payment, has terminated, each, as may be applicable, in accordance with Section 2.2 hereof, the Buyer may assign, without the consent of
the Seller, its obligations and rights under this Agreement to any Person, including to any Third Party or to one or more of its Affiliates. This Agreement shall be binding upon, inure to the benefit of and be enforceable by, the parties hereto and their respective permitted successors and assigns. Without limiting the foregoing, in the event of any assignment by the Buyer, the assignee shall comply with the covenants, and be bound by the provisions, set forth in Section 5.13. Any purported assignment in violation of this Section 10.3 shall be null and void.
Section 10.4. Amendment and Waiver.
(a) This Agreement may be amended, modified or supplemented only in a writing signed by each of the parties hereto. Any provision of this Agreement may be waived only in a writing signed by the party hereto granting such waiver.
(b) No failure or delay on the part of any party hereto in exercising any right, power or remedy hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power or remedy preclude any other or further exercise thereof or the exercise of any other right, power or remedy. No course of dealing between the parties hereto shall be effective to amend, modify, supplement or waive any provision of this Agreement.
Section 10.5. Entire Agreement. This Agreement, the Exhibits annexed hereto and the Disclosure Schedule constitute the entire understanding between the parties hereto with respect to the subject matter hereof and supersede all other understandings and negotiations with respect thereto. As of the date hereof, that certain Non-Disclosure Agreement between the Buyer and the Seller, dated as of June 26, 2024 is hereby terminated without further force and effect, superseded by ARTICLE VIII of this Agreement and all obligations between the parties relating to confidentiality shall be governed by ARTICLE VIII of this Agreement.
Section 10.6. No Third Party Beneficiaries. This Agreement is for the sole benefit of the Seller and the Buyer and their permitted successors and assigns and nothing herein expressed or implied shall give or be construed to give to any Person, other than the parties hereto and such successors and assigns, any legal or equitable rights hereunder, except that the Indemnified Parties shall be third party beneficiaries of the benefits provided for in Section 7.1.
Section 10.7. Governing Law. This Agreement shall be governed by, and construed in accordance with, the Laws of the State of New York without giving effect to any choice or conflict of Law provision or rule that would cause the application of the Laws of any other jurisdiction.
Section 10.8. Jurisdiction; Venue.
(a) EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY AND UNCONDITIONALLY SUBMITS, FOR ITSELF AND ITS RESPECTIVE PROPERTY AND ASSETS, TO THE EXCLUSIVE JURISDICTION OF ANY NEW YORK STATE COURT OR FEDERAL COURT OF THE UNITED STATES OF AMERICA SITTING IN NEW YORK COUNTY, NEW YORK, AND ANY APPELLATE COURT THEREOF, IN ANY ACTION OR
PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT, OR FOR RECOGNITION OR ENFORCEMENT OF ANY JUDGMENT IN RESPECT THEREOF, AND THE BUYER AND THE SELLER HEREBY IRREVOCABLY AND UNCONDITIONALLY AGREE THAT ALL CLAIMS IN RESPECT OF ANY SUCH ACTION OR PROCEEDING MAY BE HEARD AND DETERMINED IN ANY SUCH NEW YORK STATE COURT OR, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN SUCH FEDERAL COURT. THE BUYER AND THE SELLER HEREBY AGREE THAT A FINAL JUDGMENT IN ANY SUCH ACTION OR PROCEEDING SHALL BE CONCLUSIVE AND MAY BE ENFORCED IN OTHER JURISDICTIONS BY SUIT ON THE JUDGMENT OR IN ANY OTHER MANNER PROVIDED BY APPLICABLE LAW. EACH OF THE BUYER AND THE SELLER HEREBY SUBMITS TO THE EXCLUSIVE PERSONAL JURISDICTION AND VENUE OF SUCH NEW YORK STATE AND FEDERAL COURTS. THE BUYER AND THE SELLER AGREE, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, THAT PROCESS MAY BE SERVED ON THE BUYER OR THE SELLER IN THE SAME MANNER THAT NOTICES MAY BE GIVEN PURSUANT TO SECTION 10.2.
(b) EACH OF THE PARTIES HERETO HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES, TO THE FULLEST EXTENT IT MAY LEGALLY AND EFFECTIVELY DO SO, ANY OBJECTION THAT IT MAY NOW OR HEREAFTER HAVE TO THE LAYING OF VENUE OF ANY ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT IN ANY NEW YORK STATE OR FEDERAL COURT. EACH OF THE BUYER AND THE SELLER HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, THE DEFENSE OF AN INCONVENIENT FORUM TO THE MAINTENANCE OF SUCH ACTION OR PROCEEDING IN ANY SUCH COURT.
(c) EACH PARTY HEREBY JOINTLY AND SEVERALLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY ACTION OR PROCEEDING RELATING TO THIS AGREEMENT OR ANY OTHER DOCUMENT DELIVERED HEREUNDER OR IN CONNECTION HEREWITH, OR ANY TRANSACTION ARISING FROM OR CONNECTED TO ANY OF THE FOREGOING. EACH OF THE PARTIES REPRESENTS THAT THIS WAIVER IS KNOWINGLY, WILLINGLY, AND VOLUNTARILY GIVEN.
Section 10.9. Severability. If any term or provision of this Agreement shall for any reason be held to be invalid, illegal or unenforceable in any situation in any jurisdiction, then, to the extent that the economic and legal substance of the transactions contemplated hereby is not affected in a manner that is materially adverse to either party hereto, all other terms and provisions of this Agreement shall nevertheless remain in full force and effect and the enforceability and validity of the offending term or provision shall not be affected in any other situation or jurisdiction.
Section 10.10. Specific Performance. Each of the parties acknowledges and agrees that the other party would be damaged irreparably in the event any of the provisions of this Agreement are not performed in accordance with their specific terms or otherwise are breached or violated. Accordingly, each of the parties agrees that, without posting bond or other
undertaking, the other party will be entitled to seek an injunction or injunctions to prevent breaches or violations of the provisions of this Agreement and to seek to enforce specifically this Agreement and the terms and provisions hereof in any action, suit or other proceeding instituted in any court of the United States or any state thereof having jurisdiction over the parties and the matter in addition to any other remedy to which it may be entitled, at law or in equity. Each of the parties further agrees that, in the event of any action for specific performance in respect of such breach of violation, it will not assert the defense that a remedy at law would be adequate.
Section 10.11. Counterparts. This Agreement may be executed in any number of counterparts and by the parties hereto in separate counterparts, each of which when so executed shall be deemed to be an original and all of which taken together shall constitute one and the same agreement. Copies of executed counterparts transmitted by telecopy, facsimile or other similar means of electronic transmission, including “PDF,” shall be considered original executed counterparts, provided receipt of such counterparts is confirmed.
Section 10.12. Relationship of the Parties. The relationship between the Buyer and the Seller is solely that of purchaser and seller, and neither the Buyer nor the Seller has any fiduciary or other special relationship with the other party or any of its Affiliates. This Agreement is not a partnership or similar agreement, and nothing contained herein shall be deemed to constitute the Buyer and the Seller as a partnership, an association, a joint venture or any other kind of entity or legal form for any purposes, including any Tax purposes. The Buyer and the Seller agree that they shall not take any inconsistent position with respect to such treatment in a filing with any Governmental Entity.
Section 10.13. Intercreditor Agreement. Notwithstanding any provision in this Agreement to the contrary, the Liens and Back-Up Security Interest granted to the Buyer and its successors and assigns pursuant to this Agreement and the exercise of any right or remedy by the Buyer and its successors and assigns hereunder shall be subject to the provisions of any Intercreditor Agreement. If there is conflict between the terms of an Intercreditor Agreement and the terms of this Agreement with respect to the Liens, security interests or the exercise of any right or remedy of the Buyer or any holder of any Indebtedness that is a party to an Intercreditor Agreement, then the terms of such Intercreditor Agreement will control.
Section 10.14. Expenses. All fees, costs and expenses (including any legal, accounting, financial advisory and banking fees) incurred in connection with the preparation, negotiation, execution and delivery of the Transaction Documents and to consummate the transactions contemplated thereby shall be paid by the party hereto incurring such fees, costs and expenses.
Section 10.15. Parent Guarantee.
(a) The Parent represents and warrants that: (i) the Parent is a corporation duly incorporated, validly existing and in good standing under the Laws of the State of Delaware; (ii) the Parent has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement; (iii) the execution, delivery and performance of
this Agreement, and the consummation of the transactions contemplated hereby, have been duly authorized by all necessary corporate action on the part of the Parent; (iv) this Agreement has been duly executed and delivered by an authorized officer of the Parent and constitutes a legal, valid and binding obligation of the Parent, enforceable against the Parent in accordance with its terms, except as may be limited by applicable Bankruptcy Laws or by general principles of equity (whether considered in a proceeding in equity or at law); (v) the execution, delivery and performance by the Parent of this Agreement and the consummation of the transactions contemplated hereby and thereby do not and will not conflict with, result in a breach or violation of, constitute a default (with or without notice or lapse of time, or both) under, or give a right of termination, cancellation or acceleration of any obligation or to a loss of a benefit under, any provision of: (A) any organizational document of the Parent; (B) any applicable Law or any Judgment to which the Parent or its properties or assets may be subject; (C) any other agreement (whether written or oral), commitment or instrument to which the Parent is a party or by which the Parent is bound; (vi) no consent, approval, license order, authorization, registration, declaration or filing with or of any Governmental Entity or other Person is required to be done or obtained by the Parent in connection with the execution, delivery and performance by the Parent of this Agreement, and (vii) the Parent has the financial capacity to pay and perform its obligations pursuant to the Parent Guarantee, and all funds necessary for the Parent to pay and perform its obligations pursuant to the Parent Guarantee shall be available to the Parent for so long as the Parent Guarantee shall remain in effect.
(b) As a material inducement to the Buyer’s willingness to enter into this Agreement and perform its obligations hereunder, the Parent (i) hereby unconditionally guarantees the due and punctual payment and performance of all of the Seller’s obligations and commitments under this Agreement and any related documents, and (ii) hereby further covenants to procure and cause the Seller to take such actions necessary to support and duly complete the due and punctual payment and performance of the Seller’s obligations and commitments under this Agreement and any related documents in relation to the Buyer’s exercise of its rights and remedies under this Agreement and any related documents (collectively, (i) and (ii) this “Parent Guarantee”). This Parent Guarantee is an irrevocable guarantee of payment and performance (and not just of collection) and shall continue in effect notwithstanding any extension or modification of the terms of this Agreement or any other Transaction Document, any assumption of any such guaranteed obligations by any other party or Person or any other act or event that might otherwise operate as a legal or equitable discharge of the Parent. The Parent hereby waives all its rights to subrogation arising out of any payment or performance by the Parent under this Parent Guarantee. The obligations of the Parent hereunder shall be absolute and unconditional, and shall not be affected by or contingent upon (a) the merger or consolidation of the Seller with or into any corporation or other Person, or any sale or transfer by the Seller of all or any part of its or their property or assets, (b) a Bankruptcy Event affecting the Seller, or (c) any modification, alteration, amendment, supplement, waiver or addition of or to this Agreement or any related document. The Parent hereby waives all suretyship defenses and protest, notice of protest, demand for performance, diligence, notice of any other action at any time taken or omitted by the Buyer and, generally, all demands and notices of every kind in connection with this Parent Guarantee, and the Seller’s obligations in this Agreement and any related documents
hereby guaranteed, and which the Parent may otherwise assert against the Buyer. This Parent Guarantee shall continue to be effective or shall be reinstated, as the case may be, if at any time payment or performance of any of the obligations of the Seller under this Agreement or any related document is rescinded or must otherwise be restored or returned by the Seller upon a Bankruptcy Event of the Seller or otherwise. The Parent acknowledges that each of the waivers set forth in this Parent Guarantee is made with full knowledge of its significance and consequences and under the circumstances the waivers are reasonable and not contrary to public policy. If any of said waivers is determined to be contrary to any applicable law or public policy, such waivers shall be effective only to the extent permitted and required by applicable law.
[Signature Page Follows]
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed and delivered by their respective representatives thereunto duly authorized as of the date first above written.
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SELLER KALVISTA PHARMACEUTICALS LIMITED |
By |
/s/ Benjamin Palleiko |
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Name: Benjamin Palleiko |
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Title: Director |
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BUYER DRI HEALTHCARE ACQUISITIONS LP |
By: DRC Management III LLC 2 Its: General Partner |
By |
/s/ Grant Cellier |
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Name: Grant Cellier |
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Title: Manager |
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Solely for the purposes of the Guarantor Provisions, KALVISTA PHARMACEUTICALS INC. |
By |
/s/ Benjamin Palleiko |
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Name: Benjamin Palleiko |
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Title: Chief Executive Officer |
[Signature Page to Purchase and Sale Agreement]
Exhibit A
Description of Sebetralstat
[*]
Exhibit B
Form of Intercreditor Agreement
[*]
Exhibit C
Bill of Sale
[*]
[Signature Page to Bill of Sale]
Exhibit D
Form of [*] Royalty Report
[*]
Dated 4 November 2024
KalVista Pharmaceuticals Limited
as Company
and
DRI Healthcare Acquisitions LP
as Purchaser
___________________________________________________
DEBENTURE CREATING
FIXED AND FLOATING CHARGES
___________________________________________________
Slaughter and May
One Bunhill Row
London EC1Y 8YY
CONTENTS
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|
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1. |
DEFINITIONS AND INTERPRETATION |
1 |
2. |
PAYMENT OF SECURED OBLIGATIONS |
8 |
3. |
FIXED CHARGES, ASSIGNMENTS, FLOATING CHARGE AND US SECURITY INTEREST |
8 |
4. |
CRYSTALLISATION OF FLOATING CHARGE |
9 |
5. |
GENERAL UNDERTAKINGS |
10 |
6. |
RECEIVABLES |
10 |
7. |
PRODUCTS AND PRODUCT RIGHTS |
10 |
8. |
ASSIGNED LICENSES |
11 |
9. |
FURTHER ASSURANCE |
11 |
10. |
POWER OF ATTORNEY |
12 |
11. |
EFFECTIVENESS OF SECURITY |
12 |
12. |
RELEASE OF SECURITY |
15 |
13. |
ENFORCEMENT |
16 |
14. |
EXTENSION AND VARIATION OF POWERS CONFERRED BY LAW |
16 |
15. |
APPOINTMENT OF RECEIVERS |
16 |
16. |
DISCRETION AND DELEGATION |
18 |
17. |
APPLICATION OF MONEYS |
18 |
18. |
SUSPENSE ACCOUNT |
19 |
19. |
PROTECTION OF THIRD PARTIES |
19 |
20. |
NO LIABILITY |
19 |
21. |
COSTS AND EXPENSES |
20 |
22. |
STAMP TAXES |
20 |
23. |
PAYMENTS FREE OF DEDUCTION |
20 |
|
|
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24. |
CURRENCY |
21 |
25. |
CERTIFICATES AND DETERMINATIONS |
21 |
26. |
ASSIGNMENT |
21 |
27. |
AMENDMENTS |
22 |
28. |
NOTICES |
22 |
29. |
REMEDIES AND WAIVERS |
22 |
30. |
PARTIAL INVALIDITY |
23 |
31. |
TRUSTS |
23 |
32. |
EXECUTION AS A DEED |
23 |
33. |
COUNTERPARTS |
23 |
34. |
JURISDICTION |
23 |
35. |
GOVERNING LAW |
24 |
Schedule 1 Patents |
25 |
Schedule 2 Trade Marks and design rights |
26 |
Schedule 3 US Security Interest 29
THIS DEBENTURE is made on 4 November 2024
PARTIES:
(1) KALVISTA PHARMACEUTICALS LIMITED incorporated in England and Wales with company number 07543947 whose registered office is at Porton Science Park, Bybrook Road, Porton Down, Wiltshire, United Kingdom, SP4 0BF (the “Company”); and
(2) DRI HEALTHCARE ACQUISITIONS LP as Purchaser (the “Purchaser”).
IT IS AGREED as follows:
1. DEFINITIONS AND INTERPRETATION
1.1 Definitions
Terms defined in the Purchase Agreement shall, unless otherwise defined in this Deed, have the same meaning when used in this Deed and in addition:
“Affiliate” means with respect to any particular Person, any other Person directly or indirectly controlling, controlled by or under common control with such particular Person. For purposes of the foregoing sentence, the term “control” means direct or indirect ownership of (a) fifty percent (50%) or more, including ownership by trusts with substantially the same beneficial interests, of the voting and equity rights of such Person, firm, trust, corporation, partnership or other entity or combination thereof, or (b) the power to direct the management of such person, firm, trust, corporation, partnership or other entity or combination thereof, by contract or otherwise.
“Assigned Licenses” means the In-Licenses and the Out-Licenses.
“Bankruptcy Event” means the occurrence of any of the following in respect of a Person: (a) such Person shall generally not, shall be unable to, or shall admit in writing its inability to, pay its debts as they come due or a general assignment by such Person for the benefit of creditors; (b) the filing of any petition or answer by such Person seeking to adjudicate itself as bankrupt or insolvent, or seeking for itself any liquidation, winding-up, reorganization, administration, arrangement, adjustment, protection, relief or composition of such Person or its debts under any applicable Law relating to bankruptcy, insolvency, receivership, winding-up, liquidation, reorganization, examination, relief of debtors or other similar applicable Law now or hereafter in effect, or seeking, consenting to or acquiescing in the entry of an order for relief in any case under any such applicable Law, or the appointment of or taking possession by an administrative or other receiver, manager, trustee, custodian, liquidator, administrator, examiner, assignee, sequestrator or other similar official for such Person or for any substantial part of its property; (c) corporate or other entity action taken by such Person to authorize any of the actions set forth in clause (a) or clause (b) above; (d) without the consent or acquiescence of such Person, the commencement of an action seeking entry of an order for relief or approval of a petition for relief or reorganization or any other petition seeking any reorganization, arrangement, composition, readjustment, winding-up, liquidation, dissolution or other similar relief under any present or future bankruptcy, insolvency or similar applicable Law, or the filing of any such petition against such Person, or, without the consent or acquiescence of such Person, the commencement of an action seeking entry of an order appointing a trustee, custodian, administrative or other receiver, manager, administrator or liquidator of such Person or of all or any substantial part of the property of such
Person, in each case where such petition or order shall remain unstayed or shall not have been stayed or dismissed within ninety (90) days from entry thereof; or (e) the making of an application to a court of competent jurisdiction for protection from the creditors of such Person generally other than in connection with any refinancing in the ordinary course of business.
“Commercialization” means any and all activities directed to the distribution, marketing, detailing, promotion, selling and securing of reimbursement of a Product (including the using, importing, selling and offering for sale of such Product), and shall include post-Marketing Approval studies to the extent required by a Regulatory Authority, post-launch marketing, promoting, detailing, distributing, selling such Product, importing, exporting or transporting such Product for sale, and regulatory compliance with respect to the foregoing. When used as a verb, “Commercialize” shall mean to engage in Commercialization. Except with respect to post-Marketing Approval studies required by a Regulatory Authority, Commercialization shall not include any activities directed to the research or development (including pre-clinical and clinical development) or manufacture of a Product.
“Costs and Expenses” means all out-of-pocket costs, charges, losses, liabilities, expenses and other sums (including legal, accountants’ and other professional fees) reasonably incurred and any Value-Added Taxes thereon (but only to the extent such Value-Added Taxes are not recoverable by the paying party or any Affiliate thereof).
“Default Rate” means the default interest rate determined in accordance with Section 5.2(a) (Royalty Payments; Revenue Participation and Royalty Payment Details; Put Option; Buy-Back Option) of the Purchase Agreement.
“Delegate” means a delegate or sub-delegate appointed pursuant to Clause 16.2 (Delegation).
“Dissolution” includes, in relation to any Person, any corporate action, legal proceedings or other procedure or step taken in relation to:
(a) the suspension of payments, a moratorium of any indebtedness, winding up, dissolution, administration or reorganisation (by way of voluntary arrangement, scheme of arrangement or otherwise);
(b) a composition, compromise, assignment or arrangement with any of its creditors;
(c) the appointment of any liquidator, receiver, administrative receiver, compulsory manager or other similar officer in respect of it or any of its assets; or
(d) the enforcement of any security interest over any of its assets,
or any analogous procedure or step taken in any jurisdiction save that the foregoing shall not apply to any winding-up petition which is frivolous or vexatious and is discharged, stayed or dismissed within 21 days of commencement.
“Distributor” means a Third Party that (a) purchases or has the option to purchase any Product in finished form from or at the direction of the Company or any of its Affiliates, (b) has the right, option or obligation to distribute, market and sell such Product (with or without packaging rights) in one or more regions, and (c) is not a Licensee. The term “packaging rights” in this definition will mean the right for the Distributor to package or have packaged Product supplied in unpackaged bulk form into individual ready-for-sale packs.
“Event of Default” means:
(a) subject to the Legal Reservations and Perfection Requirements, this Deed ceasing to be a first charge;
(b) the Company being in material breach of this Deed;
(c) the Company becoming subject to a Bankruptcy Event; or
(d) the Company becoming subject to a Dissolution.
“Group” means the Company and its Subsidiaries for the time being.
“In-License” means any license or other agreement or arrangement between the Company or any of its Affiliates and any Third Party pursuant to which the Company or any of its Affiliates obtains a license or a covenant not to sue or similar grant of rights to any Intellectual Property rights of such Third Party that is necessary or reasonably useful for the research, development, manufacture, use or Commercialization of a Product.
“Intellectual Property” means, all of the following, in each case in any jurisdiction throughout the world: (a) any patents and patent applications (together with all extensions, adjustments, renewals, divisions, continuations, continuations-in-part, provisional or any substitute applications, any patent issued with respect to any of the foregoing patent applications, any certificate, renewal or patent term extension or adjustment (including any supplementary protection certificate), reissues and re-examinations thereof or other governmental actions which extend any of the subject matter of a patent, and any substitution patent, confirmation patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing) and all proprietary rights associated therewith (collectively, “Patents”), (b) any registered or common law trademarks, trademark registrations and applications therefor, trade dress, trade names, service marks, service mark registrations and applications therefor, logos and the goodwill associated therewith, (c) any copyrightable works, copyright registrations and applications therefor, (d) any proprietary inventions, know-how, trade secrets, discoveries, improvements, designs, processes, formulae, models and techniques and other proprietary or confidential business information, in each case, to the extent qualifying as a trade secret under applicable Law (collectively, “Know-How”), (e) any websites and domain names, (f) any social media handles and other source identifiers and any applications of any of the foregoing, including any and all goodwill associated therewith, (g) any computer source code and object code versions thereof, data databases, programs and other software (including all machine readable code,
documentation and related property and information) and (h) any other proprietary intellectual property rights recognized under applicable Law.
“Legal Reservations” means:
(a) the principle that equitable remedies are remedies which may be granted or refused at the discretion of the court and principles of good faith and fair dealing;
(b) the time barring of claims under applicable limitation laws and defences of acquiescence, set‑off or counterclaims (including the Limitation Acts) and the possibility that an undertaking to assume liability for or indemnify a person against non‑payment of UK stamp duty may be void;
(c) the principle that in certain circumstances, security granted by way of a fixed charge may be re‑characterised by a court as a floating charge or that security purported to be constituted as an assignment may be re‑characterised as a charge;
(d) the principle that additional interest imposed pursuant to any relevant agreement may be held to be unenforceable on the grounds that it is a penalty and thus void;
(e) the principle that a court may not give effect to an indemnity for legal costs incurred by an unsuccessful litigant or the court itself has made an order for costs;
(f) principle that the creation or purported creation of collateral over any claim, other right, contract or agreement which is subject to a prohibition on transfer, assignment or charging may be void, ineffective or invalid and may give rise to a breach of the contract or agreement (or contract or agreement relating to or governing the claim or other right) over which security has purportedly been created;
(g) the principles of private and procedural laws which affect the enforcement of a foreign court judgment;
(h) similar principles, rights and defences under the laws of any relevant jurisdiction; and
(i) any other matters which are set out as qualifications or reservations (however described) in any legal opinion delivered pursuant to the Purchase Agreement;
“Licensee” means, with respect to any Product, a Third Party to whom the Company or any Affiliate of the Company has granted a license or sublicense to Commercialize such Product. For clarity, a Distributor shall not be deemed to be a “Licensee.”
“Limitation Acts" means the Limitation Act 1980 and the Foreign Limitation Periods Act 1984.
“LPA 1925” means the Law of Property Act 1925.
“Marketing Approval” means authorization by a Regulatory Authority, including the U.S. Food and Drug Administration (or any successor agency thereto), the European Medicines Agency (or any successor agency thereto) or any equivalent Regulatory Authority in the Territory or any successor agency of the foregoing, to Commercialize a Product based upon a Marketing Approval Application.
“Marketing Approval Application” means (a) a marketing authorization application filed with the U.S. Food and Drug Administration (or any successor agency thereto), the European Medicines Agency (or any successor agency thereto), any equivalent Regulatory Authority or any successor agency of the foregoing, or (b) any other equivalent or related regulatory submission, in each case to gain approval to Commercialize a Product in any jurisdiction in the Territory, and in each case, including any amendments and supplemental applications thereto.
“Out-License” means each license or other agreement between the Company or any of its Affiliates and any Third Party (other than Distributors) pursuant to which the Company or any of its Affiliates grants a license or sublicense of any Intellectual Property Product Right to market, detail, promote, sell or secure reimbursement of a Product.
“Patents” is defined in the definition of “Intellectual Property”.
“Perfection Requirement” means the making or procuring of the appropriate registrations, filings, endorsements, acknowledgements, notarisations, stampings and/or notifications of this Deed and any other Purchase Document which creates or purports to create a Lien and/or any Lien created (or expressed to be created) thereunder.
“Permitted Disposals” means:
(a) the Permitted Licenses;
(b) the Permitted Sales;
(c) the Permitted Out-License;
(d) any sale, lease, licence, transfer or other disposal which, except in the case of paragraph (ii), is on arm's length terms:
(i) of cash made by any member of the Group in the ordinary course of trading of the disposing entity, other than any cash held which is required to be held on trust for the Purchaser pursuant to this Deed or which is required to be paid to the Purchaser under the Purchase Agreement; or
(ii) of any asset by a member of the Group (the "Disposing Company") to another member of the Group (the "Acquiring Company"), but if the Disposing Company had given Security over the asset, the Acquiring
Company must give equivalent Security over that asset to the Purchaser in form and substance satisfactory to the Purchaser.
“Permitted Security” has the meaning given to the term “Permitted Liens” in the Purchase Agreement.
“Person” means any individual, firm, corporation, company, partnership, limited liability company, trust, joint venture, association, estate, trust, Governmental Entity or other entity, enterprise, association or organization.
“Product” means any and all products of the Company, its Affiliates or Licensees incorporating Sebetralstat.
“Product Intellectual Property Rights” means any and all Intellectual Property and rights related thereto, including Product Patent Rights and the Intellectual Property listed in Schedule 2 (Trade Marks and design rights), that are necessary or reasonably useful in the development, manufacture, use or Commercialization of a Product.
“Product Patent Rights” means any and all Patents owned or In-Licensed by the Company or any of its Affiliates or under which the Company or any of its Affiliates is or may become empowered to grant licenses necessary or reasonably useful in the development, manufacture, use or Commercialization of a Product, including the Intellectual Property listed in Schedule 1 (Patents) (which shall include, for the avoidance of doubt, all Patents granted pursuant to any World Intellectual Property Organization or European Patent Office application listed therein), as well as existing or future Patents covering any Improvements.
“Product Rights” means any and all of the following: (a) Product Intellectual Property Rights, (b) regulatory filings, submissions and approvals, including Marketing Approval Applications, with or from any Regulatory Authorities with respect to the Products, (c) In-Licenses and (d) Out-Licenses.
“Purchase Document” means the Purchase Agreement, this Deed and any other Transaction Documents.
“Purchase Agreement” means the Purchase and Sale Agreement dated on or about the date of this Deed and entered into between the Company and the Purchaser and, solely for the purposes of the Guarantor Provisions, KalVista Pharmaceuticals, Inc., a Delaware corporation.
"Receiver" means a receiver or receiver and manager or administrative receiver of the whole or any part of the Security Assets.
“Regulatory Authority” means any national or supranational governmental authority, including the U.S. Food and Drug Administration (or any successor agency thereto), the European Medicines Agency (or any successor agency thereto) or such equivalent regulatory authority anywhere in the Territory, or any successor agency thereto, that has responsibility in granting a Marketing Approval.
"Related Rights" means, in relation to any asset:
(a) the proceeds of sale or other disposal of any part of that asset;
(b) all rights under any agreement for sale in respect of that asset;
(c) all other assets and rights at any time receivable or distributable in respect of, or in exchange for, that asset;
(d) the benefit of all rights in respect of or appurtenant to that asset (including, the benefit of all claims, distributions, covenants for title, warranties, guarantees, indemnities and security interests); and
(e) any moneys and proceeds paid or payable in respect of that asset.
“Sebetralstat” means the drug substance sebetralstat, described in Exhibit A to the Purchase Agreement, and any formulations thereof.
“Secured Obligations” means all present and future obligations and liabilities of the Company (whether actual or contingent and whether owed jointly or severally or in any other capacity whatever) which are, or are expressed to be, or may become, due, owing or payable to the Purchaser (or any Person to which the Purchaser assigns or transfers its rights under the Purchase Agreement in accordance with the terms of the Purchase Agreement) under or in connection with the Purchase Documents or this Deed (as such may be varied, amended, waived, released, novated, supplemented, extended, restated or replaced from time to time, in each case, however fundamentally), together with all costs, charges and expenses incurred by the Purchaser (or any person to which the Purchaser assigns or transfers its rights under the Purchase Agreement in accordance with the terms of the Purchase Agreement) which are, or are expressed to be, or may become due, owing or payable by the Company under or in connection with the Purchase Documents or this Deed.
“Security” means the security interests constituted or expressed to be constituted in favour of the Purchaser by or pursuant to this Deed, including, for the avoidance of doubt, the US Security Interest.
“Security Assets” means all the assets which from time to time are the subject of the Security.
“Security Rights” means all rights of the Purchaser or any Receiver or Delegate provided by or pursuant to this Deed or by law in respect of the subject matter of this Deed.
“Subsidiary” means a subsidiary undertaking within the meaning of section 1159 of the Companies Act 2006.
“Tax” includes any present or future tax, levy, impost, duty or other charge or withholding of a similar nature (including any penalty or interest in connection with any failure to pay or delay in paying any of the same).
“Territory” means the world.
“UCC” means the Uniform Commercial Code as in effect from time to time in the State of New York; provided, that, if, with respect to any financing statement or by reason of any provisions of applicable Law, the perfection or the effect of perfection or non-perfection of the US Security Interest or any portion thereof set forth in Clause 3.4 (US Security Interest) is governed by the Uniform Commercial Code as in effect in a jurisdiction of the United States other than the State of New York, then “UCC” means the Uniform Commercial Code as in effect from time to time in such other jurisdiction for purposes of the provisions of this Agreement and any financing statement relating to such perfection or effect of perfection or non-perfection.
“UCC Financing Statements” means the UCC-1 financing statements that shall be filed by the Purchaser, with the assistance of the Company as reasonably requested by the Purchaser, at or promptly following the Closing, as well as any additional UCC-1 financing statements or amendments thereto as requested by the Purchaser from time to time, to record the purchase and perfect the Purchaser’s security interest in the Revenue Participation Right and the Product Collateral.
“US Security Interest” is defined in Clause 3.4.
“Value-Added Tax” means:
(a) any value added tax imposed by Value Added Tax Act 1994;
(b) any Tax imposed in compliance with the council directive of 28 November 2006 on the common system of value added tax (EC Directive 2006/112); and
(c) any other Tax of a similar nature to the Taxes referred to in (a) or (b) above, whether imposed in the UK or a member state of the EU in substitution for, or levied in addition to, the Taxes referred to in (a) or (b) above or imposed elsewhere.
1.2 Construction of Particular Terms
Unless a contrary intention appears, in this Deed the provisions of Section 1.2 (Certain Interpretations) of the Purchase Agreement shall apply as if set out in full in this Deed, save that references to the Purchase Agreement shall be construed as references to this Deed and:
(a) “assets” includes properties, revenues and rights of every kind, present, future and contingent and whether tangible or intangible;
(b) “authorisation” or “consent” shall be construed as including any authorisation, consent, approval, resolution, licence, exemption, filing, notarisation or registration;
(c) a “company” includes any company, corporation or other body corporate, wherever and however incorporated or established;
(d) “this Deed” or any other agreement or instrument is a reference to this Deed or other agreement or instrument as it may have been amended, supplemented, replaced or novated from time to time and includes a reference to any document which amends, supplements, replaces, novates or is entered into, made or given pursuant to or in accordance with any of the terms of this Deed or, as the case may be, the relevant deed, agreement or instrument;
(e) “indebtedness” includes any obligation (whether incurred as principal or as surety) for the payment or repayment of money, whether present or future, actual or contingent;
(f) “law” includes any present or future common or customary law, principles of equity and any constitution, decree, judgment, decision, legislation, statute, order, ordinance, regulation, bye-law or other legislative measure in any jurisdiction or any present or future official directive, regulation, guideline, request, rule, code of practice, treaty or requirement (in each case, whether or not having the force of law but, if not having the force of law, the compliance with which is in accordance with the general practice of a person to whom the directive, regulation, guideline, request, rule, code of practice, treaty or requirement is intended to apply) of any governmental, intergovernmental or supranational body, agency, department or regulatory, self-regulatory or other authority or organisation;
(g) “qualified person” means a person who, under the Insolvency Act 1986, is qualified to act as a receiver of the property of any company with respect to which he is appointed or an administrative receiver of any such company;
(h) “rights” includes all rights, title, benefits, powers, privileges, interests, claims, authorities, discretions, remedies, liberties, easements, quasi easements and appurtenances (in each case, of every kind, present, future and contingent); and
(i) “security” includes any mortgage, charge, pledge, lien, security assignment, hypothecation or trust arrangement for the purpose of providing security and any other encumbrance or security interest of any kind having the effect of securing any obligation of any person (including the deposit of moneys or property with a person with the intention of affording such person a right of lien, set-off, combination or counter-claim) and any other agreement or any other type of arrangement having a similar effect (including any “flawed-asset” or “hold back” arrangement) and “security interest” shall be construed accordingly.
1.3 Interpretation of this Deed
(a) Unless a contrary indication appears, a reference to any party or person shall be construed as including its and any subsequent successors in title, permitted
transferees and permitted assigns, in each case in accordance with their respective interests.
(b) Unless a contrary indication appears, a reference to a time of day shall be construed as referring to London time.
(c) The terms “include”, “includes” and “including” shall be construed without limitation.
(d) References in this Deed to any Clause or Schedule shall be to a clause or schedule contained in this Deed.
(e) Clause and Schedule headings are for ease of reference only and shall be ignored in construing this Deed.
(f) Unless a contrary indication appears, references to any provision of any law are to be construed as referring to that provision as it may have been, or may from time to time be, amended or re enacted, and as referring to all bye laws, instruments, orders, decrees, ordinances and regulations for the time being made under or deriving validity from that provision.
(g) An Event of Default is "continuing" if it has not been waived.
1.4 Third Party Rights
(a) Save as otherwise provided in this Deed, a person who is not a party to this Deed has no right under the Contracts (Rights of Third Parties) Act 1999 to enforce or enjoy the benefit of any term of this Deed.
(b) Notwithstanding any term of this Deed, the consent of any person who is not a party is not required to rescind or vary this Deed at any time.
(c) Any Receiver or Delegate may, subject to this Clause 1.4 and the Contracts (Rights of Third Parties) Act 1999, rely on any Clause of this Deed which expressly confers rights on it.
2. PAYMENT OF SECURED OBLIGATIONS
2.1 Covenant to Pay
The Company shall pay and discharge the Secured Obligations in accordance with the Purchase Documents.
2.2 Interest on Demands
If the Company fails to pay any sum payable by it pursuant to this Deed on its due date, interest shall accrue on the overdue amount from the due date until the date of actual payment (both before and after judgment) calculated on a daily basis at the rate and in the manner agreed in the Purchase Agreement and, in the absence of such agreement, at the Default Rate from time to time.
3. FIXED CHARGES, ASSIGNMENTS, FLOATING CHARGE AND US SECURITY INTEREST
3.1 Fixed Charges
As continuing security for the full and punctual payment, performance and discharge of the Secured Obligations, with full title guarantee and free of any security interest, the Company charges all its right, title and interest from time to time in and to each of the following assets (other than Assigned Licenses and Related Rights in respect of Assigned Licenses to the extent constituting contractual claims) in favour of the Purchaser:
(a) all Products (including all inventory of all the Products) by way of first fixed charge;
(b) the Product Rights owned, licensed or otherwise held by the Company, by way of first fixed charge; and
(c) any proceeds from Products and Product Rights, including all account receivables and general intangibles resulting from the sale, license or other disposition of all Products by the Company or its Licensees (“Receivables”), by way of first fixed charge.
3.2 Assignment
As continuing security for the full and punctual payment, performance and discharge of the Secured Obligations, with full title guarantee and free from any security interest, the Company assigns absolutely (subject to (i) a proviso for reassignment on redemption and to the required consent of any third party being obtained, and (ii) any right, title and interest being capable of being assigned in accordance with its applicable terms) all its rights, title and interest from time to time in and to the Assigned Licenses and the Related Rights to the extent they constitute contractual claims in favour of the Purchaser.
3.3 Floating Charge
(a) As continuing security for the full and punctual payment, performance and discharge of the Secured Obligations, with full title guarantee and free of any security interest, the Company charges by way of first floating charge all its rights, title and interest from time to time in and to each of the assets listed in Clauses
3.1(a) to 3.1(c) and 3.2 which are not effectively charged by virtue of Clauses 3.1 and 3.2, respectively, in favour of the Purchaser.
(b) This floating charge shall be without prejudice to and shall rank behind all fixed Security but shall rank in priority to any other security interest created by the Company after the date of this Deed.
3.4 US Security Interest
(a) As continuing security for the full and punctual payment, performance and discharge of the Secured Obligations, with full title guarantee and free of any security interest, the Company grants to the Purchaser a first priority security interest in and to all right, title and interest in, to and under the Revenue Participation Right, the Royalty Payments and the Product Collateral (collectively, (the “US Security Interest”), as set forth in Schedule [3] hereto, and this Agreement shall constitute a security agreement for the purposes of the UCC.
(b) The Company consents and authorizes the Purchaser, from and after the Closing, to: (i) file UCC Financing Statements, documents required to be recorded to Regulatory Authorities for the relevant Product Rights, including U.S. Patent and Trademark office filings and short-form sale, or security agreement, and continuation statements or filings with respect to such financing statements, agreements or filings when applicable; (ii) record the security created by this Agreement (whether the security interest itself or this Agreement, as applicable) against all relevant registered Intellectual Property Rights at the United Kingdom Intellectual Property Office (and the Company shall execute all such documents and do all such acts as required to facilitate such recordals) and (iii) otherwise meet the requirements of applicable Law, in such manner and such jurisdictions as are necessary or appropriate to perfect such security interest and naming the Company as the debtor and the Purchaser as the secured party in respect to the Revenue Participation Right, the Royalty Payments and the Product Collateral.
4. CRYSTALLISATION OF FLOATING CHARGE
4.1 Crystallisation by Notice
Subject to Clause 11.8 (Part A1 of the Insolvency Act 1986), the Purchaser may at any time by notice in writing to the Company convert the floating charge created by Clause 3.3 (Floating Charge) with immediate effect into a fixed charge as regards any property or assets specified in the notice if:
(a) Event of Default has occurred; or
(b) the Purchaser reasonably considers that any of the Security Assets may be in danger of being seized or sold pursuant to any form of legal process or otherwise in jeopardy; or
(c) the Purchaser reasonably considers that it is necessary or prudent in order to protect the priority of the Security.
4.2 Automatic Crystallisation
Notwithstanding Clause 4.1 (Crystallisation by Notice), without prejudice to any law which may have a similar effect, and subject to Clause 11.8 (Part A1 of the Insolvency Act 1986), the floating charge will automatically and immediately be converted into a fixed charge as regards all the Security Assets subject to the floating charge if:
(a) the Company creates or attempts to create or permits to subsist any security interest (other than Permitted Security or as expressly permitted by the terms of the Purchase Documents) affecting any of the Security Assets; or
(b) any person:
(i) levies any distress, attachment, execution or other process against any of the Security Assets; or
(ii) attempts to levy any distress, attachment, execution or other process against any of the Security Assets other than in circumstances where such attempt is (A) frivolous or vexatious or (B) dismissed within 21 days of commencement; or
(c) Dissolution occurs in relation to the Company.
5. GENERAL UNDERTAKINGS
5.1 Negative Pledge
The Company shall not (and the Company shall ensure that no other member of the Group will), create or permit to subsist any security interest over all or any part of the Security Assets other than Permitted Security or as otherwise expressly permitted under the Purchase Documents.
5.2 No Disposal
The Company shall not enter into a single transaction or series of transactions (whether related or not) and whether voluntary or involuntary to sell, transfer, assign, lease, licence or otherwise dispose of any interest in a Security Asset other than (a) a Permitted Disposal, or (b) as expressly permitted under the Purchase Documents.
5.3 Preservation of Security Assets
(a) The Company shall not take or permit any action which is reasonably likely to materially adversely affect the value or otherwise depreciate, impair or prejudice any Security Asset or the Security Rights or result in an Event of Default.
(b) The Company shall keep or cause to be kept all of the Security Assets in good and substantial repair and condition (ordinary wear and tear permitted).
(c) The Company shall punctually pay, as they become due, all debts and liabilities which by law would have priority over all or any part of the Secured Obligations unless such debts and liabilities are being contested in good faith and adequate reserves are being maintained by the Company in respect of such debts and liabilities.
6. RECEIVABLES
The Company shall not at any time deal or factor or discount any of the Receivables (or enter into any agreement to do so) save that the Company shall get in and realise the Receivables in the ordinary course of its business and, following the Event of Default that is continuing, shall pay the proceeds of those Receivables in such an account as the Purchaser may require. The proceeds of the Receivables shall, following an Event of Default that has occurred and is continuing, be held upon trust by the Company for the Purchaser prior to such payment in.
7. PRODUCTS AND PRODUCT RIGHTS
7.1 Perfection: Product and Product Rights
(a) The Company shall deliver to the Purchaser on the date of this Deed (and, if any change occurs thereafter, on the date of such change), details of all Products and Product Rights.
(b) The Company shall execute all such documents and do all acts as reasonably required to record the interest of the Purchaser in any registers relating to any registered Products and Product Rights.
7.2 Undertakings: Product and Product Rights
The Company shall take all such steps and do all such acts as may be necessary to preserve and maintain the subsistence and the validity of any Products and Product Rights and shall not use or permit the use of any such Products and Product Rights in any way which could either (a) reasonably be expected to materially adversely to affect the value of such Products and Product Rights, or (b) reasonably be expected to result in an Event of Default.
8. ASSIGNED LICENSES
8.1 Perfection: Assigned Licenses
(a) The Company shall deliver to the Purchaser on the date of this Deed (and, if any change occurs thereafter, on the date of such change), details of each Assigned License, including date, licensees, nature and key terms.
(b) The Company and / or the Purchaser shall not give notice of any assignment effected by virtue of Clause 3.2 (Assignment) to any relevant licensee before the Security is properly enforceable in accordance with Clause 13.1 (Timing of Enforcement).
8.2 Undertakings: Assigned Licenses
(a) If Security under this Deed becomes enforceable in accordance with the terms of this Deed, then the Company shall pay all moneys received under any Assigned License into such an account as the Purchaser may require. Such moneys shall, following the occurrence of an Event of Default that is continuing, be held upon trust by the Company for the Purchaser prior to payment in such account.
9. FURTHER ASSURANCE
9.1 General
The Company shall (at its own reasonable cost), promptly take all action necessary to:
(a) ensure that the Security is and remains, subject to the Legal Reservations and Perfection Requirements, valid, legally binding and enforceable;
(b) perfect, preserve or protect the Security and its priority; and/or
(c) following the occurrence of an Event of Default that is continuing, facilitate the exercise of any and all of the Security Rights and the realisation of the Security Assets,
including the execution of all such charges, assignments and other documents, the giving of all such notices, orders, instructions and directions and the making of all such registrations and filings as the Purchaser or any Receiver or Delegate may consider necessary from time to time.
9.2 Consents
Subject to Clause 8.1(b), the Company shall use Commercially Reasonable Efforts to obtain as soon as possible (in a form satisfactory to the Purchaser (acting reasonably)) any consents and/or waivers necessary to enable each asset of the Company to be the subject of the security interest expressed to be created in respect of that asset pursuant to Clause 3 (Fixed Charges, Assignments, Floating Charge and US Security Interest). Immediately upon obtaining any such consent and/or waiver, the relevant asset shall become subject to such security interest and the Company shall, upon written request, promptly deliver a copy of each consent and/or waiver to the Purchaser.
10. POWER OF ATTORNEY
10.1 Appointment
The Company appoints as its attorney, irrevocably (within the meaning of section 4 of the Powers of Attorney Act 1971) and by way of security for the performance of its obligations under this Deed, the Purchaser and any person nominated in writing by the Purchaser, severally (with full powers of substitution and delegation), on its behalf and in its name or otherwise and as its act and deed, at such time and in such manner as the attorney may think fit:
(a) to take any action which it is obliged to take under this Deed but has not taken; and
(b) to take any action required to enable the Purchaser to exercise all or any of the Security Rights,
and the taking of action by the attorney or attorneys shall (as between the attorney and any third party) be conclusive evidence to any third party of its right to take such action.
10.2 Ratification
The Company undertakes to ratify and confirm everything that any attorney does or purports to do in the exercise or purported exercise of the power of attorney in Clause 10.1 (Appointment).
11. EFFECTIVENESS OF SECURITY
11.1 Continuing Security
(a) The Security shall remain in full force and effect as continuing security for the Secured Obligations unless and until discharged by the Purchaser in accordance with Clause 12 (Release of Security).
(b) No part of the Security will be considered satisfied or discharged by any intermediate payment, discharge or satisfaction of the whole or any part of the Secured Obligations.
11.2 Additional Security
The Security and the Security Rights shall be cumulative, in addition to and independent of every other security which the Purchaser may at any time hold for the Secured Obligations or any other rights provided by law. No prior security held by the Purchaser (whether in its capacity as Purchaser or otherwise) over the whole or any part of the Security Assets shall merge into the Security.
11.3 No Prejudice
Without prejudice to any other provision of this Deed, none of the Security, its priority, the Security Rights nor the liability of the Company or any other person for the Secured Obligations shall be prejudiced, reduced, released or otherwise adversely affected by any act, omission, fact or any other thing which but for this Clause 11.3 would or may do so, including:
(a) any time, waiver or consent granted, or any other indulgence or concession granted to the Company or any other person;
(b) the release of the Company or any other person under the terms of any composition or arrangement with any creditor;
(c) the taking, holding, variation, compromise, exchange, renewal, realisation or release by any person of any rights under or in connection with any security, guarantee, indemnity or any other document including any arrangement or compromise entered into by the Purchaser with the Company or any other person;
(d) the refusal or failure to take up, hold, perfect or enforce by any person any rights under or in connection with any security, guarantee, indemnity or other document (including, any failure to comply with any formality or other requirement or any failure to realise the full value of any security);
(e) the existence of any claim, set-off or other right which the Company may have at any time against the Purchaser or any other person;
(f) the making or absence of any demand for payment or discharge of any Secured Obligations;
(g) any amalgamation, merger or reconstruction that may be effected by the Purchaser with any other person, including any reconstruction by the Purchaser involving the formation of a new company and the transfer of all or any of its assets to that company, or any sale or transfer of the whole or any part of the undertaking and assets of the to any other person;
(h) any incapacity, lack of power, authority or legal personality of or Dissolution or change in the members or status of the Company or any other person;
(i) any variation, amendment, waiver, release, novation, supplement, extension or restatement or replacement of any Purchase Document, or any other security, guarantee, indemnity or other document, in each case however fundamental and of whatsoever nature;
(j) any change in the identity of the Purchaser; or
(k) any unenforceability, illegality or invalidity of any obligation of any person under any Purchase Document or any other security, guarantee, indemnity or other document.
11.4 Details of Security Assets
The fact that no or incomplete details of any Security Asset are inserted in the Schedules to this Deed shall not affect the validity or enforceability of the Security.
11.5 Immediate recourse
The Company waives any right it may have of first requiring the Purchaser to proceed against or enforce any other rights or security or claim payment from any person before claiming from the Company under this Deed. The waiver applies irrespective of any law or any provision of this Deed to the contrary.
11.6 Deferral of Rights
(a) Until such time as the Security has been released in accordance with Clause 12 (Release of Security), the Company will not exercise any rights which it may have:
(i) to claim, rank, prove or vote as a creditor of any other party to any of the Purchase Documents; or
(ii) to receive, claim or have the benefit of any payment, guarantee, indemnity, contribution or security from or on account of any such party (in whole or in part or whether by way of subrogation or otherwise); and/or
(iii) of set-off, combination or counter-claim or in relation to any “flawed-asset” or “hold back” arrangement as against any such party.
(b) The Company shall hold on trust for, and immediately pay or transfer to, the Purchaser an amount equal to any payment or benefit received by it contrary to paragraphs (a)(i) or (ii) above.
(c) If the Company exercises any right of set-off, combination or counter-claim or any rights in relation to any “flawed asset” or “hold back arrangement” contrary to (a)(iii) above, it will immediately pay or transfer to the Purchaser an amount equal to the amount set-off, combined or counterclaimed.
(d) The Purchaser shall apply all amounts received pursuant to (b) and (c) above in accordance with Clause 17 (Application of Moneys).
11.7 New Account
At any time after:
(a) the Purchaser (acting in its capacity as Purchaser or otherwise) receives or is deemed to have received notice of any subsequent security interest affecting all or any part of the Security Assets or any assignment or transfer of the Security Assets which is prohibited by the terms of this Deed or the Purchase Agreement; or
(b) the commencement of the Dissolution of the Company,
all payments by or on behalf of the Company to the Purchaser (whether in its capacity as Purchaser or otherwise) shall be treated as having been credited to a new account of the Company and not, upon the occurrence of any of the circumstances specified in paragraphs (a) or (b) above, as having been applied in reduction of the Secured Obligations.
11.8 Part A1 of the Insolvency Act 1986
(a) Subject to paragraph (b) below, but notwithstanding the other provisions of this Deed, the obtaining of a moratorium, or anything done with a view to obtaining a moratorium, under Part A1 of the Insolvency Act 1986 for the Company, will not, by itself:
(i) cause any floating charge granted by the Company under this Deed to crystallise; nor
(ii) cause restrictions in this Deed which would not otherwise apply to be imposed on the disposal of property by the Company; nor
(iii) be a ground for the appointment of a Receiver of the Company.
(b) Paragraph (a) above shall not apply to any floating charge of a type referred to in section A52(4) of Part A1 of the Insolvency Act 1986.
(c) The Purchaser may not, for the duration of a moratorium under Part A1 of the Insolvency Act 1986, give any notice which would have the effect of causing any floating charge granted by the Company under this Deed to crystallise or cause restrictions would not otherwise apply to be imposed on the disposal of property by the Company.
12. RELEASE OF SECURITY
12.1 Release of Security Assets
If the Purchaser is satisfied (acting reasonably and in good faith) that:
(a) all Secured Obligations have been unconditionally and irrevocably paid or discharged in full; or
(b) security or a guarantee for the Secured Obligations, in either case, acceptable to the Purchaser, has been provided in substitution for this Deed; or
(c) the Company is unconditionally entitled pursuant to any provision of the Purchase Documents to have any Security Asset released from the Security,
then, subject to Clause 12.2 (Reinstatement), the Purchaser shall, at the request and cost of the Company, take all necessary action to release the Security Assets (or, in the case of (c) above, the relevant Security Assets), from the Security.
12.2 Reinstatement
If the Purchaser reasonably considers and acting in good faith that any payment to, or security or guarantee provided to it is capable of being avoided, reduced or invalidated by virtue of applicable law the liability of the Company under this Deed and the Security shall continue as if such amounts had not been paid or as if any such security or guarantee had not been provided.
13. ENFORCEMENT
13.1 Timing of Enforcement
The Security shall be enforceable immediately upon and at any time after the occurrence of an Event of Default that is continuing.
13.2 Enforcement Rights
Upon or after the Security becoming enforceable the Purchaser may, without notice to the Company or prior authorisation from any court enforce all or any part of that Security and exercise all or any of the powers, authorities and discretions conferred by this Deed or otherwise by law on chargees and Receivers (whether or not it has appointed a Receiver), in each case at the times, in the manner and on the terms it thinks fit.
14. EXTENSION AND VARIATION OF POWERS CONFERRED BY LAW
14.1 Extension of Powers
The powers conferred by section 101 of the LPA as varied and extended by this Deed shall be deemed to arise (and the Secured Obligations shall be deemed due and payable for that purpose) immediately on execution of this Deed. Section 109(1) of the LPA 1925 shall not apply to this Deed.
14.2 Restrictions
The restrictions contained in Section 98 and 103 of the LPA 1925 shall not apply to this Deed or to the exercise by the Purchaser or any Receiver or Delegate of its right to consolidate all or any of the Security with any other security in existence at any time or to its power of sale.
15. APPOINTMENT OF RECEIVERS
15.1 Appointment
Subject to Clause 11.8 (Part A1 of the Insolvency Act 1986), at any time:
(a) on or after any of the Security becoming enforceable (whether or not the Purchaser shall have taken possession of the Security Assets); or
(b) at the written request of the Company,
the Purchaser may, without notice to the Company, appoint, one or more qualified persons to be Receiver or Receivers. If the Purchaser appoints more than one person as Receiver, the Purchaser may give the relevant persons power to exercise all or any of the powers conferred on Receivers individually as well as jointly and to the exclusion of the other or others of them.
15.2 Scope of appointment
Any Receiver may be appointed either Receiver of all the Security Assets or of such part of the Security Assets as may be specified in the appointment. In the latter case, the rights conferred by Clause 15.4 (Powers of Receivers) shall take effect as though every reference in that clause to “rights” were a reference to rights in respect of the specified part of the Security Assets.
15.3 Removal
The Purchaser may, by deed or by instrument in writing signed by any officer or other person authorised for such purpose by it (so far as it is lawfully able and subject to any requirement of the court in the case of an administrative receiver), remove any Receiver appointed by it and may, whenever it deems expedient, appoint any one or more other qualified persons in place of or to act jointly with any other Receiver.
15.4 Powers of Receivers
Any Receiver appointed under this Deed will (subject to any contrary provision specified in his appointment but notwithstanding the Dissolution of the Company) have:
(a) all the rights of an administrative receiver set out in Schedule 1 to the Insolvency Act 1986 as in force at the date of this Deed (whether or not in force at the date of exercise) and all rights of an administrative receiver as may be added to Schedule 1 of the Insolvency Act 1986 after the date of this Deed, in either case, whether or not the Receiver is an administrative receiver;
(b) the right to manage, use and apply all or any of the Security Assets and to exercise (or permit the Company or its nominee to exercise) all other rights of an absolute beneficial owner of the Security Assets;
(c) the right to dispose of or otherwise realise all or any part of the Security Assets in any manner whatsoever;
(d) the right to redeem or transfer to the Purchaser any prior security interest over the Security Assets
(e) all the rights expressed to be conferred upon the Purchaser in this Deed; and
(f) the right to do all lawful things which in the opinion of the Receiver seem to be incidental or conducive to any of the functions, powers, authorities or discretions conferred on or vested in him, the exercise of the Security Rights or bringing into his hands any assets forming part of, or which when got in would form part of, the Security Assets.
15.5 Agent
Any Receiver shall for all purposes be the agent of the Company and therefore deemed to be in the same position as a Receiver duly appointed by a mortgagee under the LPA 1925. The Company shall be solely responsible for his contracts, engagements, acts, omissions, defaults and losses and for all liabilities incurred by him and for the payment of his remuneration. No Receiver shall at any time act as, or be deemed to be, agent of the Purchaser.
15.6 Remuneration
Subject to section 36 of the Insolvency Act 1986, the Purchaser may from time to time fix the remuneration of any Receiver appointed by it (without being limited to the maximum rate specified in section 109(6) of the LPA 1925) and may direct payment of such remuneration out of moneys accruing to him as Receiver, but the Company alone shall be liable for the payment of such remuneration and for all other costs, charges and expenses of the Receiver.
16. DISCRETION AND DELEGATION
16.1 Discretion
Any liberty or power which may be exercised or any determination which may be made under this Deed by the Purchaser or any Receiver may, subject to the terms and conditions of the Purchase Agreement, be exercised or made from time to time in its absolute and unfettered discretion without any obligation to give reasons.
16.2 Delegation
(a) Each of the Purchaser and any Receiver may at any time delegate all or any of the rights conferred on it by this Deed.
(b) The delegation may be made upon any terms and conditions (including the power to sub-delegate) and subject to any restrictions as the Purchaser may think fit.
(c) Such delegation shall not preclude either the subsequent exercise of such power, authority or discretion by the Purchaser or the Receiver itself or any subsequent delegation or revocation.
(d) Under no circumstances shall the Purchaser nor any Receiver or Delegate nor any officer, agent or employee of any of them be liable to the Company or any other person as a result of or in connection with any act, default, omission or misconduct on the part of any Delegate.
17. APPLICATION OF MONEYS
All moneys arising from the exercise of the powers of enforcement under this Deed shall (except as may be otherwise required by applicable law) be held by the Purchaser and any Receiver and (subject to Clause 18 (Suspense Account)), applied in the following order of priority (but without prejudice to the right of the Purchaser to recover any shortfall from the Company):
(a) in satisfaction of, or provision for, all costs, charges and expenses incurred and incidental to the appointment of any Receiver and the exercise of any of his rights including his remuneration and all outgoings paid by him;
(b) in or towards the payment or discharge of such of the Secured Obligations in such order as the Purchaser in its absolute discretion may from time to time determine; and
(c) after all of the Security Assets have been released from the Security in accordance with paragraph (a) of Clause 12 (Release of Security), in payment of any surplus to the Company or other person entitled to it,
and section 109(8) of the LPA 1925 shall be deemed varied and extended in such respect.
18. SUSPENSE ACCOUNT
At any time following the occurrence of an Event of Default, the Purchaser may place and retain on a suspense account, for as long as it considers fit, any moneys received, recovered or realised under or in connection with this Deed to the extent of the Secured Obligations, without any obligation on the part of the Purchaser to apply such moneys in or towards the discharge of such Secured Obligations.
19. PROTECTION OF THIRD PARTIES
19.1 Consideration
The receipt of the Purchaser or any Receiver or Delegate shall be conclusive discharge to a purchaser and any sale or disposal of any of the Security Assets or any acquisition by the Purchaser or any Receiver or Delegate shall be for such consideration, and made in such manner and on such terms as it thinks fit.
19.2 Protection of Purchasers
(a) No purchaser or other person dealing with the Purchaser, any Receiver or any Delegate shall be bound to inquire whether the right of the Purchaser or such Receiver or Delegate to exercise any of its powers has arisen or become exercisable or be concerned with any propriety or regularity on the part of the Purchaser or such Receiver or Delegate in such dealings.
(b) All the protections given to persons dealing with a receiver in section 42(3) of the Insolvency Act 1986, shall apply equally to any person purchasing from or dealing with the Purchaser any Receiver or any Delegate.
20. NO LIABILITY
Neither the Purchaser nor any Receiver or Delegate nor any officer, agent or employee of any of them will in any circumstances (whether by reason of taking possession of the Security Assets or for any other reason whatsoever):
(a) be liable to account to the Company or any other person for anything; or
(b) be liable to the Company or any other person as a result of or in connection with:
(i) taking any action permitted by this Deed;
(ii) any neglect, default or omission in relation to the Security Assets; or
(iii) taking possession of or realising all or any part of the Security Assets,
except in each case, to the extent directly caused by fraud or wilful default or gross negligence on its part.
21. COSTS AND EXPENSES
21.1 Transaction and administration expenses
All fees, costs and expenses (including any legal, accounting, financial advisory and banking fees) incurred in connection with the preparation, negotiation, execution and delivery of this Deed shall be paid by the party hereto incurring such fees, costs and expenses.
21.2 Enforcement costs
The Company shall, within three Business Days of demand, pay to the Purchaser and every Receiver or Delegate the amount of all costs and expenses (including legal fees and together with any applicable Value-Added Taxes thereon, but only to the extent such Value-Added Taxes are not recoverable by the Purchaser, Receiver or Delegate (or any of their Affiliates)) expended, paid, incurred or debited on account by it in connection with enforcing, protecting, preserving or realising, or attempting to enforce, protect, preserve or realise, the rights vested in it by this Deed or by law.
22. STAMP TAXES
The Company shall pay promptly, and in any event before any penalty or interest becomes payable, all stamp, registration, documentary and similar Taxes, if any, payable in connection with the entry into, performance, enforcement or admissibility in evidence of this Deed.
23. PAYMENTS FREE OF DEDUCTION
All payments to be made to the Purchaser under this Deed shall be made free and clear of and without deduction for or on account of Tax unless the Company is required by Law to make such payment subject to the deduction or withholding of Tax, in which case the sum payable by the Company shall be increased to the extent necessary to ensure that, after the making of such deduction or withholding, the Purchaser receives a net sum equal to the sum which it would have received and so retained had no such deduction or withholding been made or required to be made; provided that, if and to the extent there is any conflict between the provisions of this Clause 23 and Section 5.13(b) of the Purchase Agreement, then the relevant provision of Purchase Agreement shall prevail.
24. CURRENCY
24.1 Currency indemnity
(a) If, under any applicable law, whether pursuant to a judgment against the Company or the Dissolution of the Company or for any other reason, any payment
under or in connection with this Deed is made or falls to be satisfied in a currency (the “Other Currency”) other than the currency in which the relevant payment is expressed to be payable (the “Required Currency”), then, to the extent that the payment actually received by the Purchaser (when converted into the Required Currency at the rate of exchange on the date of payment or, if it is not practicable to make the conversion on that date, at the rate of exchange as soon afterwards as it is practicable for the Purchaser to do so or, in the case of a Dissolution, at the rate of exchange on the latest date permitted by applicable law for the determination of liabilities in such Dissolution) falls short of the amount expressed to be due or payable under or in connection with this Deed, the Company shall, as an original and independent obligation under this Deed, indemnify and hold the Purchaser harmless against the amount of such shortfall.
(b) The Company waives any right it may have in any jurisdiction to pay any amount under or in connection with this Deed in a currency or currency unit other than that in which it is expressed to be payable.
24.2 Rate of exchange
For the purpose of Clause 24.1 (Currency indemnity), “rate of exchange” means the rate at which the Purchaser is able on the relevant date to purchase the Required Currency with the Other Currency and shall take into account any commission, premium and other costs of exchange and Taxes payable in connection with such purchase.
25. CERTIFICATES AND DETERMINATIONS
For all purposes, including any legal proceedings, a determination by the Purchaser or a copy of a certificate signed by an officer of the Purchaser, of the amount of any indebtedness comprised in the Secured Obligations shall, in the absence of manifest error, be conclusive evidence against the Company as to such amount.
26. ASSIGNMENT
26.1 Assignment by the Purchaser
(a) The Purchaser may at any time, without the consent of the Company, assign or transfer any of its rights and obligations under this Deed to any person to whom its rights and obligations under the Purchase Agreement may be assigned or transferred, provided that in the event of any such assignment or transfer, the liability of the Company under this Deed shall be no greater than it would have been if such assignment or transfer had not occurred.
(b) On the occurrence of an assignment or transfer in accordance with Clause 26.1(a), the Company shall grant a new debenture executed as a deed and on equivalent terms to this Deed to the relevant assignee or transferee, if required,
and shall register or cooperate in the registration in the United Kingdom of that new debenture.
26.2 Assignment by the Company
The Company shall not assign or transfer, or attempt to assign or transfer, any of its rights or obligations under this Deed.
27. AMENDMENTS
This Deed may not be amended, modified or waived in any respect without the prior written consent of the Purchaser given with express reference to this Clause 27.
28. NOTICES
28.1 Communications in writing
Any communication to be made under or in connection with this Deed shall be in writing and, unless otherwise stated, may be made by email or letter.
28.2 Addresses
The address and email (and the department or officer, if any, for whose attention the communication is to be made) of each party to this Deed for any communication or document to be made or delivered under or in connection with this Deed is that specified in Section 10.2 of the Purchase Agreement or any substitute address, email address or department or officer as the party may notify to the other parties by not less than five Business Days’ notice.
28.3 Delivery
(a) Any communication or document made or delivered by one person to another under or in connection with this Deed will only be effective:
(i) if by way of email, with an acknowledgment of receipt being produced by the recipient’s email account; or
(ii) if by way of letter, when it has been left at the relevant address or five Business Days after being deposited in the post, postage prepaid in an envelope addressed to it at that address,
and, if a particular department or officer is specified as part of its address details provided under Clause 28.2 (Addresses), if addressed to that department or officer.
(b) Any communication or document to be made or delivered to the Purchaser will be effective only when actually received by the Purchaser and then only if it is expressly marked for the attention of the department or officer specified in Section
10.2 of the Purchase Agreement (or any substitute department or officer as the Purchaser shall specify for this purpose).
29. REMEDIES AND WAIVERS
No failure to exercise, nor any delay or omission in exercising, on the part of the Purchaser, any right provided by law or under this Deed shall impair, affect or operate as a waiver of that or any other right or constitute an election to affirm this Deed. No election to affirm this Deed on the part of the Purchaser shall be effective unless it is in writing. No single or partial exercise of any right shall prevent any further or other exercise or the exercise of any other right. The rights provided in this Deed are cumulative and not exclusive of any rights provided by law.
30. PARTIAL INVALIDITY
(a) If at any time any provision of this Deed is or becomes illegal, invalid or unenforceable in any respect under the law of any jurisdiction, neither:
(i) the legality, validity or enforceability of the remaining provisions under the law of that jurisdiction or any other jurisdiction; nor
(ii) the legality, validity or enforceability of such provision under the law of any other jurisdiction,
will in any way be affected or impaired.
(b) The parties shall enter into good faith negotiations, but without any liability whatsoever in the event of no agreement being reached, to replace any illegal, invalid or unenforceable provision with a view to obtaining the same commercial effect as this Deed would have had if such provision had been legal, valid and enforceable.
31. TRUSTS
If any trust intended to arise pursuant to any provision of this Deed fails or for any reason (including the laws of any jurisdiction in which any assets, moneys, payments or distributions may be situated) cannot be given effect to, the Company will pay to the Purchaser for application in accordance with Clause 17 (Application of Moneys) an amount equal to the amount (or the value of the relevant assets) intended to be so held on trust for the Purchaser.
32. EXECUTION AS A DEED
Each of the parties intends this Deed to be a deed and confirms that it is executed and delivered as a deed, notwithstanding the fact that any one or more of the parties may only execute it under hand.
33. COUNTERPARTS
This Deed may be executed in any number of counterparts, and by the parties to this Deed on separate counterparts, but will not be effective until each such party has executed at least one counterpart. Each counterpart shall constitute an original of this Deed, but all the counterparts will together constitute one and the same instrument.
34. JURISDICTION
(a) The courts of England have exclusive jurisdiction to settle any dispute arising out of or in connection with this Deed (including a dispute regarding the existence, validity or termination of this Deed) or any non-contractual obligation arising out of or in connection with this Deed (a "Dispute").
(b) The parties agree that the courts of England are the most appropriate and convenient courts to settle Disputes and accordingly no party will argue to the contrary.
(c) This Clause 34 is for the benefit of only the Purchaser. As a result, the Purchaser shall not be prevented from taking proceedings relating to a Dispute in any other courts with jurisdiction. To the extent allowed by law, the Purchaser may take concurrent proceedings in any number of jurisdictions.
35. GOVERNING LAW
(a) Subject to paragraph (b) below, this Deed is governed by and is to be construed in accordance with English law. Except as otherwise agreed in the Purchase Agreement, any matter, claim or dispute arising out of or in connection with this Deed, whether contractual or non-contractual, is to be governed by and determined in accordance with English law.
(b) Clause 3.4 (US Security Interest) and any terms in this Deed relating to the US Security Interest are governed by, and are to be construed in accordance with, the Laws of the State of New York without giving effect to any choice or conflict of Law provision or rule that would cause the application of the Laws of any other jurisdiction.
Schedule 1
Patents
Schedule 2
Trade Marks AND DESIGN RIGHTS
Schedule 3
US Security Interest
[Note to draft: UCC-1 Filing against the Company to be inserted]
IN WITNESS of which this document has been signed on behalf of the Purchaser and executed as a deed by the Company and is delivered on the date stated at the beginning of this Deed.
The Company
EXECUTED as a DEED
by KALVISTA PHARMACEUTICALS LIMITED
/s/ Benjamin Palleiko__________ Director
In the presence of:
Witness’s signature: /s/ Brian Piekos
Name: Brian Piekos
Address: 55 Cambridge Parkway Cambridge, MA 02142
The Purchaser
DRI HEALTHCARE ACQUISITIONS LP
By: /s/ Grant Cellier
Name: Grant Cellier
Title: Manager
[Signature Page to Debenture]
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Exhibit 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) OR 15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Benjamin L. Palleiko, certify that:
1.I have reviewed this quarterly report on Form 10-Q of KalVista Pharmaceuticals, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: March 12, 2025 |
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/s/ Benjamin L. Palleiko |
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Benjamin L. Palleiko Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) OR 15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Brian Piekos, certify that:
1.I have reviewed this quarterly report on Form 10-Q of KalVista Pharmaceuticals, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
|
Date: March 12, 2025 |
|
/s/ Brian Piekos |
|
|
Brian Piekos Chief Financial Officer (Principal Financial and Accounting Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF
THE SARBANES-OXLEY ACT OF 2002
In connection with the accompanying Quarterly Report of KalVista Pharmaceuticals Inc. (the “Company”) on Form 10-Q for the fiscal quarter ended January 31, 2025 (the “Report”), I, Benjamin L. Palleiko, as Chief Executive Officer and Principal Executive Officer of the Company, and Brian Piekos, as Chief Financial Officer and Principal Accounting Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
(1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the periods presented therein.
|
|
Date: March 12, 2025 |
/s/ Benjamin L. Palleiko |
|
Benjamin L. Palleiko |
|
Chief Executive Officer |
|
(Principal Executive Officer) |
|
|
Date: March 12, 2025 |
/s/ Brian Piekos |
|
Brian Piekos |
|
Chief Financial Officer |
|
(Principal Financial and Accounting Officer) |
v3.25.0.1
Document and Entity Information - shares
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9 Months Ended |
|
Jan. 31, 2025 |
Mar. 07, 2025 |
Cover [Abstract] |
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Document Fiscal Year Focus |
2025
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Document Fiscal Period Focus |
Q3
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Trading Symbol |
KALV
|
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Entity Registrant Name |
KALVISTA PHARMACEUTICALS, INC.
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Entity Central Index Key |
0001348911
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Current Fiscal Year End Date |
--04-30
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Entity Filer Category |
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Entity Small Business |
true
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Entity File Number |
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Entity Incorporation, State or Country Code |
DE
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Entity Tax Identification Number |
20-0915291
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Entity Address, Address Line One |
55 Cambridge Parkway
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Entity Address, Address Line Two |
Suite 901E
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Entity Address, City or Town |
Cambridge
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Entity Address, State or Province |
MA
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02142
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v3.25.0.1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Jan. 31, 2025 |
Apr. 30, 2024 |
Current assets: |
|
|
Cash and cash equivalents |
$ 167,288
|
$ 31,789
|
Marketable securities |
85,915
|
178,612
|
Research and development tax credit receivable |
7,485
|
8,439
|
Prepaid expenses and other current assets |
6,671
|
6,850
|
Total current assets |
267,359
|
225,690
|
Property and equipment, net |
1,807
|
2,227
|
Right of use assets |
5,440
|
6,920
|
Other assets |
1,387
|
567
|
Total assets |
275,993
|
235,404
|
Current liabilities: |
|
|
Accounts payable |
5,856
|
9,107
|
Accrued expenses |
18,315
|
12,398
|
Lease liability - current portion |
1,444
|
1,302
|
Total current liabilities |
25,615
|
22,807
|
Long-term liabilities: |
|
|
Lease liability - net of current portion |
4,338
|
6,015
|
Deferred royalty obligation |
100,914
|
|
Total long-term liabilities |
105,252
|
6,015
|
Commitments and contingencies (Note 6) |
|
|
Stockholders’ equity |
|
|
Common stock, $0.001 par value, 100,000,000 authorized Shares issued and outstanding: 49,493,210 at January 31, 2025 and 42,521,975 at April 30, 2024 |
49
|
42
|
Additional paid-in capital |
748,231
|
679,754
|
Accumulated deficit |
(600,946)
|
(469,726)
|
Accumulated other comprehensive loss |
(2,208)
|
(3,488)
|
Total stockholders’ equity |
145,126
|
206,582
|
Total liabilities and stockholders’ equity |
$ 275,993
|
$ 235,404
|
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v3.25.0.1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jan. 31, 2025 |
Apr. 30, 2024 |
Statement of Financial Position [Abstract] |
|
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
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49,493,210
|
42,521,975
|
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49,493,210
|
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v3.25.0.1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Jan. 31, 2025 |
Jan. 31, 2024 |
Jan. 31, 2025 |
Jan. 31, 2024 |
Operating expenses: |
|
|
|
|
Research and development |
$ 12,594
|
$ 22,523
|
$ 55,818
|
$ 60,919
|
General and administrative |
30,346
|
10,628
|
77,147
|
31,071
|
Total operating expenses |
42,940
|
33,151
|
132,965
|
91,990
|
Operating loss |
(42,940)
|
(33,151)
|
(132,965)
|
(91,990)
|
Other income (expense), net |
|
|
|
|
Interest income |
1,394
|
684
|
4,443
|
2,383
|
Interest expense related to the sale of future royalties |
(2,842)
|
|
(2,842)
|
|
Foreign currency exchange (loss) gain |
(983)
|
1,120
|
(401)
|
277
|
Other income |
1,109
|
2,319
|
4,794
|
7,335
|
Total other income (expense), net |
(1,322)
|
4,123
|
5,994
|
9,995
|
Net loss before income taxes |
(44,262)
|
(29,028)
|
(126,971)
|
(81,995)
|
Provision for income taxes |
4,247
|
|
4,247
|
|
Net loss |
(48,509)
|
(29,028)
|
(131,218)
|
(81,995)
|
Other comprehensive (loss) income: |
|
|
|
|
Foreign currency translation gain (loss) |
352
|
(46)
|
390
|
(373)
|
Unrealized holding gain on marketable securities |
367
|
438
|
2,082
|
1,270
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
(226)
|
(221)
|
(1,192)
|
(1,130)
|
Other comprehensive income (loss) |
493
|
171
|
1,280
|
(233)
|
Comprehensive loss |
$ (48,016)
|
$ (28,857)
|
$ (129,938)
|
$ (82,228)
|
Net loss per share to common stockholders, basic |
$ (0.92)
|
$ (0.84)
|
$ (2.7)
|
$ (2.37)
|
Net loss per share to common stockholders, diluted |
$ (0.92)
|
$ (0.84)
|
$ (2.7)
|
$ (2.37)
|
Weighted average common shares outstanding, basic |
52,638,888
|
34,723,379
|
48,522,362
|
34,567,853
|
Weighted average common shares outstanding, diluted |
52,638,888
|
34,723,379
|
48,522,362
|
34,567,853
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.25.0.1
Condensed Consolidated Statement of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Total |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Accumulated Deficit [Member] |
Accumulated Other Comprehensive Loss [Member] |
Balance at Apr. 30, 2023 |
$ 161,025
|
$ 34
|
$ 507,133
|
$ (343,082)
|
$ (3,060)
|
Balance, shares at Apr. 30, 2023 |
|
34,171,138
|
|
|
|
Issuance of common stock from equity incentive plans |
204
|
|
204
|
|
|
Issuance of common stock from equity incentive plans, shares |
|
35,313
|
|
|
|
Release of restricted stock units, shares |
|
60,144
|
|
|
|
Stock-based compensation expense |
3,254
|
|
3,254
|
|
|
Net loss |
(25,317)
|
|
|
(25,317)
|
|
Foreign currency translation gain (loss) |
91
|
|
|
|
91
|
Unrealized holding gain from marketable securities |
392
|
|
|
|
392
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
(314)
|
|
|
|
(314)
|
Balance at Jul. 31, 2023 |
139,335
|
$ 34
|
510,591
|
(368,399)
|
(2,891)
|
Balance, shares at Jul. 31, 2023 |
|
34,266,595
|
|
|
|
Balance at Apr. 30, 2023 |
161,025
|
$ 34
|
507,133
|
(343,082)
|
(3,060)
|
Balance, shares at Apr. 30, 2023 |
|
34,171,138
|
|
|
|
Net loss |
(81,995)
|
|
|
|
|
Foreign currency translation gain (loss) |
(373)
|
|
|
|
|
Unrealized holding gain from marketable securities |
1,270
|
|
|
|
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
(1,130)
|
|
|
|
|
Balance at Jan. 31, 2024 |
88,583
|
$ 34
|
516,920
|
(425,077)
|
(3,294)
|
Balance, shares at Jan. 31, 2024 |
|
34,595,623
|
|
|
|
Balance at Jul. 31, 2023 |
139,335
|
$ 34
|
510,591
|
(368,399)
|
(2,891)
|
Balance, shares at Jul. 31, 2023 |
|
34,266,595
|
|
|
|
Issuance of common stock from equity incentive plans |
128
|
|
128
|
|
|
Issuance of common stock from equity incentive plans, shares |
|
18,000
|
|
|
|
Release of restricted stock units, shares |
|
136,863
|
|
|
|
Stock-based compensation expense |
3,207
|
|
3,207
|
|
|
Net loss |
(27,650)
|
|
|
(27,650)
|
|
Foreign currency translation gain (loss) |
(419)
|
|
|
|
(419)
|
Unrealized holding gain from marketable securities |
440
|
|
|
|
440
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
(595)
|
|
|
|
(595)
|
Balance at Oct. 31, 2023 |
114,446
|
$ 34
|
513,926
|
(396,049)
|
(3,465)
|
Balance, shares at Oct. 31, 2023 |
|
34,421,458
|
|
|
|
Issuance of common stock from equity incentive plans |
283
|
|
283
|
|
|
Issuance of common stock from equity incentive plans, shares |
|
36,914
|
|
|
|
Release of restricted stock units, shares |
|
137,251
|
|
|
|
Stock-based compensation expense |
2,711
|
|
2,711
|
|
|
Net loss |
(29,028)
|
|
|
(29,028)
|
|
Foreign currency translation gain (loss) |
(46)
|
|
|
|
(46)
|
Unrealized holding gain from marketable securities |
438
|
|
|
|
438
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
(221)
|
|
|
|
(221)
|
Balance at Jan. 31, 2024 |
88,583
|
$ 34
|
516,920
|
(425,077)
|
(3,294)
|
Balance, shares at Jan. 31, 2024 |
|
34,595,623
|
|
|
|
Balance at Apr. 30, 2024 |
206,582
|
$ 42
|
679,754
|
(469,726)
|
(3,488)
|
Balance, shares at Apr. 30, 2024 |
|
42,521,975
|
|
|
|
Issuance of common stock from equity incentive plans |
3,001
|
$ 1
|
3,000
|
|
|
Issuance of common stock from equity incentive plans, shares |
|
385,234
|
|
|
|
Release of restricted stock units, shares |
|
174,713
|
|
|
|
Stock-based compensation expense |
3,040
|
|
3,040
|
|
|
Net loss |
(40,443)
|
|
|
(40,443)
|
|
Foreign currency translation gain (loss) |
(128)
|
|
|
|
(128)
|
Unrealized holding gain from marketable securities |
1,064
|
|
|
|
1,064
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
(317)
|
|
|
|
(317)
|
Balance at Jul. 31, 2024 |
172,799
|
$ 43
|
685,794
|
(510,169)
|
(2,869)
|
Balance, shares at Jul. 31, 2024 |
|
43,081,922
|
|
|
|
Balance at Apr. 30, 2024 |
206,582
|
$ 42
|
679,754
|
(469,726)
|
(3,488)
|
Balance, shares at Apr. 30, 2024 |
|
42,521,975
|
|
|
|
Net loss |
(131,218)
|
|
|
|
|
Foreign currency translation gain (loss) |
390
|
|
|
|
|
Unrealized holding gain from marketable securities |
2,082
|
|
|
|
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
(1,192)
|
|
|
|
|
Balance at Jan. 31, 2025 |
145,126
|
$ 49
|
748,231
|
(600,946)
|
(2,208)
|
Balance, shares at Jan. 31, 2025 |
|
49,493,210
|
|
|
|
Balance at Jul. 31, 2024 |
172,799
|
$ 43
|
685,794
|
(510,169)
|
(2,869)
|
Balance, shares at Jul. 31, 2024 |
|
43,081,922
|
|
|
|
Issuance of common stock from equity incentive plans |
294
|
|
294
|
|
|
Issuance of common stock from equity incentive plans, shares |
|
36,738
|
|
|
|
Release of restricted stock units, shares |
|
152,841
|
|
|
|
Stock-based compensation expense |
2,999
|
|
2,999
|
|
|
Net loss |
(42,268)
|
|
|
(42,268)
|
|
Foreign currency translation gain (loss) |
166
|
|
|
|
166
|
Unrealized holding gain from marketable securities |
651
|
|
|
|
651
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
(649)
|
|
|
|
(649)
|
Balance at Oct. 31, 2024 |
133,992
|
$ 43
|
689,087
|
(552,437)
|
(2,701)
|
Balance, shares at Oct. 31, 2024 |
|
43,271,501
|
|
|
|
Issuance of common stock from equity incentive plans |
632
|
|
632
|
|
|
Issuance of common stock from equity incentive plans, shares |
|
88,017
|
|
|
|
Release of restricted stock units, shares |
|
133,692
|
|
|
|
Issuance of common stock, net of issuance costs of $0.3 million |
55,911
|
$ 6
|
55,905
|
|
|
Issuance of common stock, net of issuance costs of $0.3 million, shares |
|
6,000,000
|
|
|
|
Stock-based compensation expense |
2,607
|
|
2,607
|
|
|
Net loss |
(48,509)
|
|
|
(48,509)
|
|
Foreign currency translation gain (loss) |
352
|
|
|
|
352
|
Unrealized holding gain from marketable securities |
367
|
|
|
|
367
|
Reclassification adjustment for realized (gain) on marketable securities included in net loss |
(226)
|
|
|
|
(226)
|
Balance at Jan. 31, 2025 |
$ 145,126
|
$ 49
|
$ 748,231
|
$ (600,946)
|
$ (2,208)
|
Balance, shares at Jan. 31, 2025 |
|
49,493,210
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.25.0.1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Jan. 31, 2025 |
Jan. 31, 2024 |
Cash flows from operating activities |
|
|
Net loss |
$ (131,218)
|
$ (81,995)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
680
|
597
|
Stock-based compensation expense |
8,649
|
9,172
|
Realized gain from sale of marketable securities |
(1,192)
|
(1,130)
|
Non-cash operating lease benefit |
(58)
|
(11)
|
Amortization of premium on marketable securities |
11
|
88
|
Foreign currency exchange loss |
4,015
|
596
|
Non-cash interest expense and amortization of issuance costs |
2,924
|
|
Fair value adjustment to derivative liability |
150
|
|
Changes in operating assets and liabilities: |
|
|
Research and development tax credit, net |
838
|
(6,215)
|
Prepaid expenses and other assets |
(77)
|
906
|
Accounts payable |
(3,579)
|
(1,778)
|
Accrued expenses |
6,314
|
5,644
|
Net cash used in operating activities |
(112,543)
|
(74,126)
|
Cash flows from investing activities |
|
|
Purchases of marketable securities |
(7,547)
|
(47,687)
|
Sales and maturities of marketable securities |
102,313
|
89,475
|
Acquisition of property and equipment |
(153)
|
(27)
|
Capitalized website development costs |
(261)
|
(294)
|
Net cash provided by investing activities |
94,352
|
41,467
|
Cash flows from financing activities |
|
|
Proceeds from royalty agreement |
97,190
|
|
Issuance costs associated with royalty agreement |
(1,960)
|
|
Issuance of common stock, net of offering expenses |
55,911
|
|
Issuance of common stock from equity incentive plans |
3,927
|
616
|
Net cash provided by financing activities |
155,068
|
616
|
Effect of exchange rate changes on cash and cash equivalents |
(725)
|
(1,139)
|
Net increase in cash and cash equivalents |
136,152
|
(33,182)
|
Cash, cash equivalents and restricted cash at beginning of period |
31,789
|
56,238
|
Cash, cash equivalents and restricted cash at end of period |
167,941
|
$ 23,056
|
Supplemental disclosures of non-cash activities: |
|
|
Right of use assets obtained in exchange for operating lease liabilities |
$ 267
|
|
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v3.25.0.1
Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Jan. 31, 2025 |
Oct. 31, 2024 |
Jul. 31, 2024 |
Jan. 31, 2024 |
Oct. 31, 2023 |
Jul. 31, 2023 |
Jan. 31, 2025 |
Jan. 31, 2024 |
Pay vs Performance Disclosure |
|
|
|
|
|
|
|
|
Net Income (Loss) |
$ (48,509)
|
$ (42,268)
|
$ (40,443)
|
$ (29,028)
|
$ (27,650)
|
$ (25,317)
|
$ (131,218)
|
$ (81,995)
|
X |
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- DefinitionThe portion of profit or loss for the period, net of income taxes, which is attributable to the parent.
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v3.25.0.1
The Company
|
9 Months Ended |
Jan. 31, 2025 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
The Company |
Company Background KalVista Pharmaceuticals, Inc. (“KalVista” or the “Company”) is a pre-commercial stage pharmaceutical company focused on the discovery, development and commercialization of drug therapies for diseases with significant unmet need. The Company has used its capabilities to develop sebetralstat, a novel, orally delivered, small molecule plasma kallikrein inhibitor targeting the disease hereditary angioedema (“HAE”). The Company has filed a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) seeking marketing approval of sebetralstat as the first oral, on-demand therapy for HAE, with a Prescription Drug User Fee Act (“PDUFA”) notification date of June 17, 2025. The Company has submitted a Marketing Authorization Application (“MAA”) for sebetralstat to the European Medicines Agency (“EMA”), which currently is being reviewed by the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) under the centralized licensing procedure for all 27 Member States of the European Union, as well as the EEA countries Norway, Iceland and Liechtenstein. The Company also has made MAA submissions to the regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore via the Access Consortium framework for which the Company has obtained a four-way sharing agreement by the Medicines and Healthcare product Regulatory Agency, Swissmedic, the Therapeutic Goods Administration and Health Sciences Authority. The Access Consortium is designed to maximize regulatory collaboration across countries and support a timely review process. In January 2025, the Company announced that it submitted a Japanese New Drug Application for sebetralstat to the Japanese Pharmaceuticals and Medical Devices Agency and also that Japan’s Ministry of Health, Labour and Welfare has granted sebetralstat Orphan Drug Designation. If approved, sebetralstat would be the first oral on-demand treatment for HAE in each of these territories. The Company’s headquarters is currently located in Cambridge, Massachusetts, with additional offices and research activities located in Porton Down, United Kingdom; Salt Lake City, Utah; Zug, Switzerland; and Tokyo, Japan. Liquidity The Company has devoted substantially all of its efforts to research and development, including preclinical and clinical trials of sebetralstat. The Company has not completed the development of any product candidates or commenced commercial operations. Pharmaceutical drug product candidates, like those being developed by the Company, require approvals from the FDA or foreign regulatory agencies prior to commercial sales. There can be no assurance that any product candidate will receive the necessary approvals and any failure to receive approval or delay in approval may have a material adverse impact on the Company’s business and financial results. The Company is subject to risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of a late-stage product candidate; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; the challenges of protecting and enhancing intellectual property rights; and complying with applicable regulatory requirements. In November 2024, the Company entered into an underwriting agreement with Jefferies LLC, BofA Securities, Inc., TD Securities (USA) LLC and Stifel Nicolaus & Company, Incorporated, as the representatives of several underwriters to sell an aggregate of 5,500,000 shares of common stock at an offering price of $10.00 per share (the “November 2024 Offering”). The net proceeds from the November 2024 Offering, after deducting estimated expenses, were approximately $51.3 million. Also in November 2024, the Company entered into a securities purchase agreement with DRI Healthcare Acquisitions LP to sell an aggregate of 500,000 shares of our common stock at a price of $10.00 per share in a private placement. The net proceeds from the private placement, after deducting placement agent fees and other expenses, were approximately $4.7 million. To date, the Company has not generated any product sales revenues and does not have any products that have been approved for commercialization. As of January 31, 2025, the Company had an accumulated deficit of $600.9 million and $253.2 million of cash, cash equivalents and marketable securities. The Company does not expect to generate significant revenue unless and until it obtains regulatory approval for, and commercializes, one of its current or future product candidates. The Company anticipates that it will continue to incur losses for the foreseeable future, and it expects those losses to increase as it continues the development of, and seeks regulatory approvals for, product candidates, and begins to commercialize any approved products. The Company is subject to risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, and it may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. The Company currently anticipates that, based upon its operating plans and existing capital resources, it has sufficient funding to operate for at least the next twelve months. The Company may seek to finance future cash needs through equity offerings, debt financing, corporate partnerships and product sales. In the event of failure to obtain regulatory approval for product candidates, the Company will not be able to generate product sales, which will have a material adverse effect on the business and prospects.
|
X |
- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.25.0.1
Summary of Significant Accounting Policies
|
9 Months Ended |
Jan. 31, 2025 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2.Summary of Significant Accounting Policies Principles of Consolidation: The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. Such financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial position, results of operations, and cash flows. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements. There were no adjustments other than normal recurring adjustments. These unaudited interim condensed consolidated financial results are not necessarily indicative of the results to be expected for the year ending April 30, 2025, or for any other future annual or interim period. The accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements as of and for the year ended April 30, 2024 in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on July 11, 2024. Segment Reporting: The chief operating decision maker, the CEO, manages the Company’s operations as a single operating segment for the purposes of assessing performance and making operating decisions. Use of Estimates: The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Accounting estimates and management judgments reflected in the condensed financial statements include: the accrual of research and development expenses, stock-based compensation, operating lease liabilities, interest expense on our deferred royalty obligation, and assumptions used to value the embedded derivative in our deferred royalty obligation. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions. Recent Accounting Pronouncements: In November 2024, the Financial Accounting Standards Board (“FASB”) issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures, which requires public business entities to disclose, on an annual and interim basis, disaggregated information about certain income statement expense line items. The required information includes purchases of inventory, employee compensation, depreciation, intangible asset amortization and depletion. The standard will be effective for the Company beginning with annual financial statements for the fiscal year ending April 30, 2028. The Company has not yet determined the impact of adopting this guidance on its financial statements. In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. The Company does not expect the amendments in this ASU to have a material impact on its consolidated financial statements. In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting – Improvements to Reportable Segment Disclosures, which provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant segment expenses and increased interim disclosure requirements, among others. ASU 2023-07 will be effective for the Company beginning with annual financial statements for the fiscal year ending April 30, 2025 and for interim periods starting in the first quarter of fiscal 2026. The Company does not expect the amendments in this ASU to have a material impact on its consolidated financial statements. Net Loss per Share: Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the sum of the weighted average number of common shares and the number of potential dilutive common share equivalents outstanding during the period. Potential dilutive common share equivalents consist of outstanding options, unvested restricted stock units, unvested performance stock units, and shares committed to be purchased under the employee stock purchase plan. Potential dilutive common share equivalents consist of:
|
|
|
|
|
|
|
|
|
|
|
January 31, |
|
|
|
2025 |
|
|
2024 |
|
Stock options and awards |
|
|
5,825,195 |
|
|
|
6,229,313 |
|
In computing diluted earnings per share, common share equivalents are not considered in periods in which a net loss is reported, as the inclusion of the common share equivalents would be anti-dilutive. As a result, there is no difference between the Company’s basic and diluted loss per share for the periods presented. The weighted average number of common shares used in the basic and diluted net loss per common share calculations includes the weighted-average pre-funded warrants outstanding during the period as they are exercisable at any time for nominal cash consideration. Restricted Cash: Restricted cash consists of deposits held at financial institutions that are used to collateralize irrevocable letters of credit required under the Company’s lease agreements. The following table provides a reconciliation of cash and cash equivalents and restricted cash as reported on the consolidated balance sheets to the total of these amounts as reported at the end of the period in the consolidated statements of cash flows (in thousands):
|
|
|
|
|
|
|
January 31, |
|
January |
|
|
2025 |
|
2024 |
Cash and cash equivalents |
|
$167,288 |
|
$23,056 |
Restricted cash |
|
653 |
|
— |
Total cash and cash equivalents and restricted cash |
|
$167,941 |
|
$23,056 |
Deferred Royalty Obligation: The Company treats the debt obligation to DRI Healthcare Acquisitions LP, an affiliate of DRI Healthcare Trust (“DRI”) discussed further in Note 8, “Purchase and Sale Agreement”, as a deferred royalty obligation, amortized using the effective interest rate method over the estimated life of the revenue stream. The Company periodically assesses its expected revenues using internal projections, imputes interest on the carrying value of the deferred royalty obligation, and records interest expense using the imputed effective interest rate. To the extent its estimates of future revenues are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will account for any such changes by adjusting the effective interest rate on a prospective basis. The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs require that the Company makes estimates that could impact the classification of such costs, as well as the period over which such costs will be amortized. Embedded Derivative Liability: The Company evaluates all its financial instruments to determine if such instruments contain features that qualify as embedded derivatives per ASC 815, Derivatives and Hedging (“ASC 815”). The Purchase and Sale agreement (“PSA”) with DRI contains certain features that meet the definition of an embedded derivative requiring bifurcation as a separate compound financial instrument (the “Derivative Liability”). The Derivative Liability was recorded at fair value upon entering into the PSA and is subsequently remeasured to fair value at each reporting period with the corresponding change in fair value recognized in Other Income (Expense) in the condensed consolidated statements of operations. The PSA was initially valued and is remeasured using Monte Carlo simulation models to perform the “with-and-without” method, which involves valuing the PSA with the embedded derivative and then valuing it without the embedded derivative. The Monte Carlo simulation model requires the use of Level 3 unobservable inputs, primarily the amount and timing of expected future revenue, the estimated volatility of these revenues, the discount rate corresponding to the risk of revenue, and the probability of a change in control. The difference between values is determined to be the estimated fair value of the derivative liability. Bifurcated embedded derivatives are classified with the related host contract in the Company’s balance sheet. Refer to Note 3, “Fair Value Measurements” for details regarding the fair value. Fair Value Measurement: The Company classifies fair value measurements using a three-level hierarchy that prioritizes the inputs used to measure fair value. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: •Level 1 - Quoted market prices in active markets for identical assets or liabilities; •Level 2 - Observable inputs other than quoted market prices included in Level 1, such as quoted market prices for markets that are not active or other inputs that are observable or can be corroborated by observable market data •Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, including certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs. The Company’s cash equivalents, marketable securities, and derivative liability as of January 31, 2025 were carried at fair value, determined according to the fair value hierarchy. See Note 3, “Fair Value Measurements” for further discussion.
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v3.25.0.1
Fair Value Measurements
|
9 Months Ended |
Jan. 31, 2025 |
Fair Value Disclosures [Abstract] |
|
Fair Value Disclosures [Text Block] |
3.Fair Value Measurements The following tables present information about financial assets and liability that have been measured at fair value and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
January 31, 2025 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
$ |
30,223 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
30,223 |
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
— |
|
|
|
76,094 |
|
|
|
— |
|
|
|
76,094 |
|
U.S. government agency securities |
|
— |
|
|
|
9,821 |
|
|
|
— |
|
|
|
9,821 |
|
Total financial assets |
$ |
30,223 |
|
|
$ |
85,915 |
|
|
$ |
— |
|
|
$ |
116,138 |
|
Liability: |
|
|
|
|
|
|
|
|
|
|
|
Derivative liability |
$ |
— |
|
|
$ |
— |
|
|
$ |
4,430 |
|
|
$ |
4,430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
April 30, 2024 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
$ |
11,143 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
11,143 |
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
— |
|
|
|
130,423 |
|
|
|
— |
|
|
|
130,423 |
|
U.S. government agency securities |
|
— |
|
|
|
48,189 |
|
|
|
— |
|
|
|
48,189 |
|
Total |
$ |
11,143 |
|
|
$ |
178,612 |
|
|
$ |
— |
|
|
$ |
189,755 |
|
The objectives of the Company’s investment policy are to ensure the safety and preservation of invested funds, as well as to maintain liquidity sufficient to meet cash flow requirements. The Company invests its excess cash in securities issued by financial institutions, commercial companies, and government agencies that management believes to be of high credit quality in order to limit the amount of its credit exposure. The Company has not realized any material losses from its investments. The Company classifies all of its debt securities as available-for-sale. Unrealized gains and losses on investments are recognized in accumulated comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are included in other income in the consolidated statements of operations and comprehensive loss and are determined using the specific identification method with transactions recorded on a trade date basis. The estimated fair value of the derivative liability as of January 31, 2025 relates to the PSA and was determined using Level 3 inputs. The fair value measurement of the derivative liability is sensitive to changes in the unobservable inputs used to value the financial instrument. Changes in the inputs could result in changes to the fair value of each financial instrument. The embedded derivative liability associated with the deferred royalty obligation, as discussed further in Note 8, “Purchase and Sale Agreement,” is measured at fair value using an option pricing Monte Carlo simulation model and is included as a component of the deferred royalty obligation on the condensed consolidated balance sheet. The embedded derivative liability is subject to remeasurement at the end of each reporting period, with changes in fair value recognized as a component of other income (expense), net. The assumptions used in the option pricing Monte Carlo simulation model incorporates certain Level 3 inputs including: (1) estimates of the probability and timing of related events; (2) the probability-weighted global net sales of sebetralstat, including milestones and royalties; (3) the risk-adjusted discount rate; (4) the estimated volatility of expected future revenues; and (5) the probability of a change in control occurring during the term of the instrument. The Company recorded $4.4 million for the initial fair value of the derivative liability upon the closing of the PSA. The initial fair value allocated to the derivative liability was recorded against the deferred royalty obligation as a debt discount, which is being amortized in interest expense on the condensed consolidated statement of operations over the expected term using the effective interest method. The embedded derivative is subsequently remeasured at fair value each reporting period, with the change in fair value being recorded as a component of other income (expense) on the condensed consolidated statement of operations. During the period from November 4, 2024 through January 31, 2025, the Company recognized $0.2 million as a component of other income (expense), net as the change in fair value for the embedded derivative liability as of January 31, 2025. Refer to Note 8, “Purchase and Sale Agreement” for details regarding the valuation methodology related to the embedded derivative and its related inputs. Marketable Securities The following tables summarize the fair values of the Company’s marketable securities by type as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January 31, 2025 |
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Corporate debt securities |
$ |
74,915 |
|
|
$ |
1,184 |
|
|
$ |
(5 |
) |
|
$ |
76,094 |
|
Obligations of the U.S. Government and its agencies |
|
9,734 |
|
|
|
87 |
|
|
|
— |
|
|
|
9,821 |
|
Total |
$ |
84,649 |
|
|
$ |
1,271 |
|
|
$ |
(5 |
) |
|
$ |
85,915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 30, 2024 |
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Corporate debt securities |
$ |
130,099 |
|
|
$ |
600 |
|
|
$ |
(276 |
) |
|
$ |
130,423 |
|
Obligations of the U.S. Government and its agencies |
|
48,228 |
|
|
|
83 |
|
|
|
(122 |
) |
|
|
48,189 |
|
Total |
$ |
178,327 |
|
|
$ |
683 |
|
|
$ |
(398 |
) |
|
$ |
178,612 |
|
The Company has classified all of its available-for-sale investment securities, including those with maturities beyond one year, as current assets on its condensed consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. The Company has not recognized an allowance for credit losses on any securities in an unrealized loss position as of January 31, 2025 and April 30, 2024. The following table summarizes the scheduled maturity for the Company’s marketable securities at January 31, 2025 (in thousands):
|
|
|
|
|
January 31, 2025 |
|
Maturing in one year or less |
$ |
50,247 |
|
Maturing after one year through two years |
|
30,676 |
|
Maturing after two years through four years |
|
4,992 |
|
Total |
$ |
85,915 |
|
|
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v3.25.0.1
Accrued Expenses
|
9 Months Ended |
Jan. 31, 2025 |
Payables and Accruals [Abstract] |
|
Accrued Expenses |
4. Accrued Expenses Accrued expenses consisted of the following as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
January 31, |
|
|
April 30, |
|
|
|
2025 |
|
|
2024 |
|
Accrued compensation |
|
$ |
9,554 |
|
|
$ |
6,687 |
|
Accrued research expense |
|
|
3,781 |
|
|
|
3,416 |
|
Accrued professional fees |
|
|
4,091 |
|
|
|
2,042 |
|
Other accrued expenses |
|
|
889 |
|
|
|
253 |
|
|
|
$ |
18,315 |
|
|
$ |
12,398 |
|
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.25.0.1
Prepaid Expenses and Other Current Assets
|
9 Months Ended |
Jan. 31, 2025 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
Prepaid Expenses and Other Current Assets |
5. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
January 31, |
|
|
April 30, |
|
|
|
2025 |
|
|
2024 |
|
Prepaid preclinical and clinical activities |
|
$ |
792 |
|
|
$ |
1,585 |
|
Other prepaid expenses |
|
|
3,962 |
|
|
|
2,833 |
|
Interest and other receivables |
|
|
1,027 |
|
|
|
1,409 |
|
VAT receivable |
|
|
890 |
|
|
|
1,023 |
|
Total prepaid expenses and other current assets |
|
$ |
6,671 |
|
|
$ |
6,850 |
|
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v3.25.0.1
Commitments and Contingencies
|
9 Months Ended |
Jan. 31, 2025 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
6. Commitments and Contingencies Clinical Studies: The Company enters into contractual agreements with contract research organizations in connection with preclinical and toxicology studies and clinical trials. Amounts due under these agreements are invoiced to the Company on predetermined schedules during the course of the studies and clinical trials and are not refundable regardless of the outcome. The Company has contractual obligations related to the expected future costs to be incurred to complete the ongoing preclinical studies and clinical trials. The remaining clinical commitments, which have cancellation provisions, totals $21.9 million at January 31, 2025. Indemnification: In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves future claims that may be made against the Company but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. No amounts associated with such indemnifications have been recorded to date. Contingencies: From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. There were no contingent liabilities requiring accrual at January 31, 2025.
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v3.25.0.1
Leases
|
9 Months Ended |
Jan. 31, 2025 |
Leases [Abstract] |
|
Leases |
7. Leases The Company has a lease agreement for approximately 8,300 square feet of space for its headquarters located in Cambridge, Massachusetts that runs through September 2028. In July 2024, the Company signed a new headquarters lease for approximately 32,110 square feet in Framingham, Massachusetts that is expected to commence in the first half of 2025 and has an expected initial lease term of approximately 10 years. Prior to lease commencement of its new headquarters, the Company is occupying a temporary space in the same building. The Company intends to sublease its office in Cambridge, Massachusetts for occupancy once the Company has moved into its new headquarters space. The Company has lease agreements for approximately 13,400 square feet of office and research laboratory space located in Porton Down, United Kingdom that run through April 2028. The Company has a lease agreement for approximately 6,200 square feet of office space in Salt Lake City, Utah that runs through February 2032. The Company has a lease agreement for approximately 500 square feet of research laboratory space in Cambridge, Massachusetts that commenced in July 2022 with an option to renew annually. As of January 31, 2025, the Company does not intend to renew for 2025. The Company has a lease agreement for approximately 7,200 square feet of office space in Zug, Switzerland that runs through November 2025. The Company has a lease agreement for office space in Tokyo, Japan that runs through April 2026. Pursuant to the new headquarter lease in Framingham, the Company provided a security deposit in the form of a letter of credit in the amount of $0.7 million which is classified in long-term assets on our condensed balance sheet. Total rent expense was approximately $2.0 million and $1.4 million for the nine months ended January 31, 2025 and 2024, respectively, and is reflected in general and administrative expenses and research and development expenses as determined by the underlying activities. The following table summarizes the maturity of undiscounted payments due under lease liabilities and the present value of those liabilities as of January 31, 2025 (in thousands):
|
|
|
|
|
Years ending April 30, |
|
Operating Leases |
|
2025 |
|
$ |
524 |
|
2026 |
|
|
1,748 |
|
2027 |
|
|
1,599 |
|
2028 |
|
|
1,596 |
|
2029 |
|
|
769 |
|
Thereafter |
|
|
664 |
|
Total minimum lease payments |
|
|
6,900 |
|
Less amounts representing interest |
|
|
1,118 |
|
Present value of minimum payments |
|
|
5,782 |
|
Current portion |
|
|
1,444 |
|
Long-term portion |
|
$ |
4,338 |
|
Total lease payments in the table above excludes approximately $11.2 million of legally binding minimum lease payments for the signed new headquarter lease that has not yet commenced as of January 31, 2025.
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v3.25.0.1
Purchase and Sale Agreement
|
9 Months Ended |
Jan. 31, 2025 |
Purchase And Sales Agreement [Abstract] |
|
Purchase and Sale Agreement |
8. Purchase and Sale Agreement Royalty Liability On November 4, 2024, the Company, as guarantor, and KalVista Pharmaceuticals Limited, a wholly owned subsidiary of the Company (the “Subsidiary”), entered into a Purchase and Sale Agreement (the “PSA”) with DRI Healthcare Acquisitions LP, an affiliate of DRI Healthcare Trust (“DRI”), for up to $179 million. Under the terms of the synthetic royalty financing agreement, the Subsidiary received an upfront payment of $100.0 million in exchange for tiered royalty payments on worldwide net sales of sebetralstat, as follows: 5.00% on annual net sales up to and including $500.0 million (the “First Tier Royalty Rate”); 1.10% on annual net sales above $500.0 million and up to and including $750.0 million; and 0.25% on annual net sales above $750.0 million. Beginning in calendar year 2031, the First Tier Royalty Rate for any calendar year will be determined based on annual net sales of sebetralstat for the prior calendar year: 5.00% if the prior year’s annual net sales are at or above $500.0 million or 5.65% if the prior year’s annual net sales are below $500.0 million. Additionally, if sebetralstat achieves annual net sales of at least $550.0 million in any calendar year ending before January 1, 2031, the Subsidiary will earn a sales-based milestone payment of $50.0 million. If sebetralstat is approved prior to October 1, 2025, the Subsidiary will have the option to receive a one-time cash payment of $22.0 million. If the Subsidiary chooses to receive this optional payment, the royalty rate on net sales up to and including $500.0 million will increase from 5.00% to 6.00%, and the sales-based milestone amount will increase from $50.0 million to $57.0 million. On receipt of the $100.0 million payment from DRI, the Company recorded a deferred royalty obligation of $93.6 million, net of the initial fair value of the bifurcated embedded derivative liability upon execution of the PSA, and debt issuance costs incurred. The PSA is considered a sale of future revenues and is accounted for as long-term debt recorded at amortized cost using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. During the three and nine months ended January 31, 2025, the Company recorded $2.8 million of interest expense related to this arrangement on the condensed consolidated statement of operations. The interest rate on this liability may vary during the term of the agreement depending on a number of factors, including the level of forecasted net sales. The company evaluates the interest rate quarterly based on its current net sales forecasts utilizing the prospective method. A significant increase or decrease in actual or forecasted net sales may materially impact the revenue interest liability, interest expense, other income, and the time period for repayment. The deferred royalty obligation, net of the bifurcated embedded derivative liability had a net carrying amount of $96.5 million as of January 31, 2025. The PSA is denominated in US Dollars and was executed with the Company’s wholly owned U.K. Subsidiary, whose functional currency is the British Pound. As such, the Company will remeasure the liability each reporting period at current exchange rates and recognize unrealized gains and loss in other income (expense). Embedded Derivative Liability Under the PSA, the Subsidiary has the option (the “Buy-Back Option”) to repurchase future Revenue Participation Rights at any time until December 31, 2026 either (i) in the event of a change of control of the Subsidiary or (ii) in the event that confirmation that payment of the Revenue Participation Rights will not receive certain tax treatment has not been obtained. Additionally, the Purchaser has an option (the “Put Option”) to require the Subsidiary to repurchase future Revenue Participation Rights in the event of a change of control of the Subsidiary exercisable until December 31, 2026. If the Put Option or the Buy-Back Option is exercised terminating the PSA, the required repurchase price is an amount equal to (a) 1.5 multiplied by (b) the Investment Amount, net of the sum of any payments received by the Purchaser prior to such Put Option or Buy-Back Option repurchase date, as applicable. The Buy-Back and Put Options are considered embedded derivatives requiring bifurcation as a single compound derivative instrument. The Company estimated the fair value of the derivative liability using a “with-and-without” method. The with-and-without methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the individual embedded derivative. The difference between the entire instrument with the embedded derivative compared to the instrument without the embedded derivative is the fair value of the derivative liability. The Company recorded $4.4 million for the initial fair value of the derivative liability upon the closing of the PSA. The initial fair value allocated to the derivative liability was recorded against the deferred royalty obligation as a debt discount, which is being amortized in interest expense on the condensed consolidated statement of operations over the expected term using the effective interest method. The embedded derivative is subsequently remeasured at fair value each reporting period, with the change in fair value being recorded as a component of other income (expense) on the condensed consolidated statement of operations. During the period from November 4, 2024 through January 31, 2025, the Company recognized $0.2 million as a component of other income (expense), net as the change in fair value for the embedded derivative liability as of January 31, 2025. This change in fair value consists of foreign currency remeasurement due to the PSA being denominated in US Dollars and executed with the Company’s wholly owned U.K. Subsidiary, whose functional currency is the British Pound. Bifurcated embedded derivatives are classified with the related host contract in the Company’s balance sheet. Of the $100.9 million deferred royalty obligation as of January 31, 2025, the embedded derivative had a fair value of $4.4 million. The estimated probability and timing of underlying events triggering the exercisability of the Buy-Back and Put Options contained in the PSA, forecasted cash flows and the discount rate are significant unobservable inputs used to determine the estimated fair value of the entire instrument with the embedded derivative. As of January 31, 2025, the discount rate used for valuation of the derivative liability was 9.15%.
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v3.25.0.1
Income Taxes
|
9 Months Ended |
Jan. 31, 2025 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
9. Income Taxes As a result of the PSA between the Company, as guarantor, the Subsidiary, and DRI, the $100.0 million up-front payment was treated as income for tax purposes in the UK under the Research and Development Expenditure Credit scheme. After applying the estimated net operating loss carryforwards and research and development tax credits, the Company recorded income tax expense of $4.1 million for the three months ended January 31, 2025 due to an increase in the valuation allowance against its deferred tax assets. The $7.5 million R&D tax credit receivable balance on the consolidated balance sheet as of January 31, 2025 is the amount due to the Company from R&D claims payable to the company from the prior fiscal year plus current year additions, net of the current year payable. The Company has also recorded income tax expense of $0.1 million for US federal income tax purposes due to the recognition of Global Intangible Low-Taxed Income from the royalty arrangement.
|
X |
- DefinitionThe entire disclosure for income tax.
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v3.25.0.1
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Jan. 31, 2025 |
Accounting Policies [Abstract] |
|
Principles of Consolidation |
Principles of Consolidation: The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. Such financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial position, results of operations, and cash flows. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements. There were no adjustments other than normal recurring adjustments. These unaudited interim condensed consolidated financial results are not necessarily indicative of the results to be expected for the year ending April 30, 2025, or for any other future annual or interim period. The accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements as of and for the year ended April 30, 2024 in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on July 11, 2024.
|
Segment Reporting |
Segment Reporting: The chief operating decision maker, the CEO, manages the Company’s operations as a single operating segment for the purposes of assessing performance and making operating decisions.
|
Use of Estimates |
Use of Estimates: The preparation of condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the reporting period. Accounting estimates and management judgments reflected in the condensed financial statements include: the accrual of research and development expenses, stock-based compensation, operating lease liabilities, interest expense on our deferred royalty obligation, and assumptions used to value the embedded derivative in our deferred royalty obligation. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions.
|
Recent Accounting Pronouncements |
Recent Accounting Pronouncements: In November 2024, the Financial Accounting Standards Board (“FASB”) issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures, which requires public business entities to disclose, on an annual and interim basis, disaggregated information about certain income statement expense line items. The required information includes purchases of inventory, employee compensation, depreciation, intangible asset amortization and depletion. The standard will be effective for the Company beginning with annual financial statements for the fiscal year ending April 30, 2028. The Company has not yet determined the impact of adopting this guidance on its financial statements. In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures, which requires disclosure of disaggregated income taxes paid, prescribes standard categories for the components of the effective tax rate reconciliation, and modifies other income tax-related disclosures. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024 and allows for adoption on a prospective basis, with a retrospective option. Early adoption is permitted. The Company does not expect the amendments in this ASU to have a material impact on its consolidated financial statements. In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting – Improvements to Reportable Segment Disclosures, which provides updates to qualitative and quantitative reportable segment disclosure requirements, including enhanced disclosures about significant segment expenses and increased interim disclosure requirements, among others. ASU 2023-07 will be effective for the Company beginning with annual financial statements for the fiscal year ending April 30, 2025 and for interim periods starting in the first quarter of fiscal 2026. The Company does not expect the amendments in this ASU to have a material impact on its consolidated financial statements.
|
Net Loss per Share |
Net Loss per Share: Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the sum of the weighted average number of common shares and the number of potential dilutive common share equivalents outstanding during the period. Potential dilutive common share equivalents consist of outstanding options, unvested restricted stock units, unvested performance stock units, and shares committed to be purchased under the employee stock purchase plan. Potential dilutive common share equivalents consist of:
|
|
|
|
|
|
|
|
|
|
|
January 31, |
|
|
|
2025 |
|
|
2024 |
|
Stock options and awards |
|
|
5,825,195 |
|
|
|
6,229,313 |
|
In computing diluted earnings per share, common share equivalents are not considered in periods in which a net loss is reported, as the inclusion of the common share equivalents would be anti-dilutive. As a result, there is no difference between the Company’s basic and diluted loss per share for the periods presented. The weighted average number of common shares used in the basic and diluted net loss per common share calculations includes the weighted-average pre-funded warrants outstanding during the period as they are exercisable at any time for nominal cash consideration.
|
Restricted Cash |
Restricted Cash: Restricted cash consists of deposits held at financial institutions that are used to collateralize irrevocable letters of credit required under the Company’s lease agreements. The following table provides a reconciliation of cash and cash equivalents and restricted cash as reported on the consolidated balance sheets to the total of these amounts as reported at the end of the period in the consolidated statements of cash flows (in thousands):
|
|
|
|
|
|
|
January 31, |
|
January |
|
|
2025 |
|
2024 |
Cash and cash equivalents |
|
$167,288 |
|
$23,056 |
Restricted cash |
|
653 |
|
— |
Total cash and cash equivalents and restricted cash |
|
$167,941 |
|
$23,056 |
|
Deferred Royalty Obligation |
Deferred Royalty Obligation: The Company treats the debt obligation to DRI Healthcare Acquisitions LP, an affiliate of DRI Healthcare Trust (“DRI”) discussed further in Note 8, “Purchase and Sale Agreement”, as a deferred royalty obligation, amortized using the effective interest rate method over the estimated life of the revenue stream. The Company periodically assesses its expected revenues using internal projections, imputes interest on the carrying value of the deferred royalty obligation, and records interest expense using the imputed effective interest rate. To the extent its estimates of future revenues are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, the Company will account for any such changes by adjusting the effective interest rate on a prospective basis. The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs require that the Company makes estimates that could impact the classification of such costs, as well as the period over which such costs will be amortized.
|
Embedded Derivative Liability |
Embedded Derivative Liability: The Company evaluates all its financial instruments to determine if such instruments contain features that qualify as embedded derivatives per ASC 815, Derivatives and Hedging (“ASC 815”). The Purchase and Sale agreement (“PSA”) with DRI contains certain features that meet the definition of an embedded derivative requiring bifurcation as a separate compound financial instrument (the “Derivative Liability”). The Derivative Liability was recorded at fair value upon entering into the PSA and is subsequently remeasured to fair value at each reporting period with the corresponding change in fair value recognized in Other Income (Expense) in the condensed consolidated statements of operations. The PSA was initially valued and is remeasured using Monte Carlo simulation models to perform the “with-and-without” method, which involves valuing the PSA with the embedded derivative and then valuing it without the embedded derivative. The Monte Carlo simulation model requires the use of Level 3 unobservable inputs, primarily the amount and timing of expected future revenue, the estimated volatility of these revenues, the discount rate corresponding to the risk of revenue, and the probability of a change in control. The difference between values is determined to be the estimated fair value of the derivative liability. Bifurcated embedded derivatives are classified with the related host contract in the Company’s balance sheet. Refer to Note 3, “Fair Value Measurements” for details regarding the fair value.
|
Fair Value Measurement |
Fair Value Measurement: The Company classifies fair value measurements using a three-level hierarchy that prioritizes the inputs used to measure fair value. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: •Level 1 - Quoted market prices in active markets for identical assets or liabilities; •Level 2 - Observable inputs other than quoted market prices included in Level 1, such as quoted market prices for markets that are not active or other inputs that are observable or can be corroborated by observable market data •Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities, including certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs. The Company’s cash equivalents, marketable securities, and derivative liability as of January 31, 2025 were carried at fair value, determined according to the fair value hierarchy. See Note 3, “Fair Value Measurements” for further discussion.
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v3.25.0.1
Summary of Significant Accounting Policies (Tables)
|
9 Months Ended |
Jan. 31, 2025 |
Accounting Policies [Abstract] |
|
Schedule of Potential Dilutive Common Share Equivalents |
Potential dilutive common share equivalents consist of:
|
|
|
|
|
|
|
|
|
|
|
January 31, |
|
|
|
2025 |
|
|
2024 |
|
Stock options and awards |
|
|
5,825,195 |
|
|
|
6,229,313 |
|
|
Schedule of Cash and Cash Equivalents and Restricted Cash |
The following table provides a reconciliation of cash and cash equivalents and restricted cash as reported on the consolidated balance sheets to the total of these amounts as reported at the end of the period in the consolidated statements of cash flows (in thousands):
|
|
|
|
|
|
|
January 31, |
|
January |
|
|
2025 |
|
2024 |
Cash and cash equivalents |
|
$167,288 |
|
$23,056 |
Restricted cash |
|
653 |
|
— |
Total cash and cash equivalents and restricted cash |
|
$167,941 |
|
$23,056 |
|
X |
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v3.25.0.1
Fair Value Measurements (Tables)
|
9 Months Ended |
Jan. 31, 2025 |
Fair Value Disclosures [Abstract] |
|
Schedule of Financial Assets and Liability Measured at Fair Value |
The following tables present information about financial assets and liability that have been measured at fair value and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
January 31, 2025 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
$ |
30,223 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
30,223 |
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
— |
|
|
|
76,094 |
|
|
|
— |
|
|
|
76,094 |
|
U.S. government agency securities |
|
— |
|
|
|
9,821 |
|
|
|
— |
|
|
|
9,821 |
|
Total financial assets |
$ |
30,223 |
|
|
$ |
85,915 |
|
|
$ |
— |
|
|
$ |
116,138 |
|
Liability: |
|
|
|
|
|
|
|
|
|
|
|
Derivative liability |
$ |
— |
|
|
$ |
— |
|
|
$ |
4,430 |
|
|
$ |
4,430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
April 30, 2024 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
$ |
11,143 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
11,143 |
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
— |
|
|
|
130,423 |
|
|
|
— |
|
|
|
130,423 |
|
U.S. government agency securities |
|
— |
|
|
|
48,189 |
|
|
|
— |
|
|
|
48,189 |
|
Total |
$ |
11,143 |
|
|
$ |
178,612 |
|
|
$ |
— |
|
|
$ |
189,755 |
|
|
Summary of Fair Values of Company's Marketable Securities By Type |
The following tables summarize the fair values of the Company’s marketable securities by type as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January 31, 2025 |
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Corporate debt securities |
$ |
74,915 |
|
|
$ |
1,184 |
|
|
$ |
(5 |
) |
|
$ |
76,094 |
|
Obligations of the U.S. Government and its agencies |
|
9,734 |
|
|
|
87 |
|
|
|
— |
|
|
|
9,821 |
|
Total |
$ |
84,649 |
|
|
$ |
1,271 |
|
|
$ |
(5 |
) |
|
$ |
85,915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
April 30, 2024 |
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Corporate debt securities |
$ |
130,099 |
|
|
$ |
600 |
|
|
$ |
(276 |
) |
|
$ |
130,423 |
|
Obligations of the U.S. Government and its agencies |
|
48,228 |
|
|
|
83 |
|
|
|
(122 |
) |
|
|
48,189 |
|
Total |
$ |
178,327 |
|
|
$ |
683 |
|
|
$ |
(398 |
) |
|
$ |
178,612 |
|
|
Summary of Scheduled Maturity for Marketable Securities |
The following table summarizes the scheduled maturity for the Company’s marketable securities at January 31, 2025 (in thousands):
|
|
|
|
|
January 31, 2025 |
|
Maturing in one year or less |
$ |
50,247 |
|
Maturing after one year through two years |
|
30,676 |
|
Maturing after two years through four years |
|
4,992 |
|
Total |
$ |
85,915 |
|
|
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v3.25.0.1
Accrued Expenses (Tables)
|
9 Months Ended |
Jan. 31, 2025 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses |
Accrued expenses consisted of the following as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
January 31, |
|
|
April 30, |
|
|
|
2025 |
|
|
2024 |
|
Accrued compensation |
|
$ |
9,554 |
|
|
$ |
6,687 |
|
Accrued research expense |
|
|
3,781 |
|
|
|
3,416 |
|
Accrued professional fees |
|
|
4,091 |
|
|
|
2,042 |
|
Other accrued expenses |
|
|
889 |
|
|
|
253 |
|
|
|
$ |
18,315 |
|
|
$ |
12,398 |
|
|
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v3.25.0.1
Prepaid Expenses and Other Current Assets (Tables)
|
9 Months Ended |
Jan. 31, 2025 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
Schedule of Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets consisted of the following as of January 31, 2025 and April 30, 2024 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
January 31, |
|
|
April 30, |
|
|
|
2025 |
|
|
2024 |
|
Prepaid preclinical and clinical activities |
|
$ |
792 |
|
|
$ |
1,585 |
|
Other prepaid expenses |
|
|
3,962 |
|
|
|
2,833 |
|
Interest and other receivables |
|
|
1,027 |
|
|
|
1,409 |
|
VAT receivable |
|
|
890 |
|
|
|
1,023 |
|
Total prepaid expenses and other current assets |
|
$ |
6,671 |
|
|
$ |
6,850 |
|
|
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v3.25.0.1
Leases (Tables)
|
9 Months Ended |
Jan. 31, 2025 |
Leases [Abstract] |
|
Summary of Maturity of Undiscounted Payments and Future Minimum Payments Due Under Lease Liabilities and Present Value of Liabilities |
The following table summarizes the maturity of undiscounted payments due under lease liabilities and the present value of those liabilities as of January 31, 2025 (in thousands):
|
|
|
|
|
Years ending April 30, |
|
Operating Leases |
|
2025 |
|
$ |
524 |
|
2026 |
|
|
1,748 |
|
2027 |
|
|
1,599 |
|
2028 |
|
|
1,596 |
|
2029 |
|
|
769 |
|
Thereafter |
|
|
664 |
|
Total minimum lease payments |
|
|
6,900 |
|
Less amounts representing interest |
|
|
1,118 |
|
Present value of minimum payments |
|
|
5,782 |
|
Current portion |
|
|
1,444 |
|
Long-term portion |
|
$ |
4,338 |
|
|
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v3.25.0.1
The Company - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands |
1 Months Ended |
9 Months Ended |
|
Nov. 30, 2024 |
Jan. 31, 2025 |
Apr. 30, 2024 |
Common stock, shares issued |
|
49,493,210
|
42,521,975
|
Proceeds from issuance of common stock |
|
$ 55,911
|
|
Accumulated deficit |
|
600,946
|
$ 469,726
|
Cash, cash equivalents and marketable securities |
|
$ 253,200
|
|
Underwriting Agreement [Member] | Underwriters [Member] |
|
|
|
Common stock, shares issued |
5,500,000
|
|
|
Price per share under agreements |
$ 10
|
|
|
Proceeds from issuance of common stock |
$ 51,300
|
|
|
Securities Purchase Agreement [Member] | DRI Healthcare Trust [Member] |
|
|
|
Common stock, shares issued |
500,000
|
|
|
Price per share under agreements |
$ 10
|
|
|
Proceeds from issuance of common stock |
$ 4,700
|
|
|
X |
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v3.25.0.1
Fair Value Measurements - Schedule of Financial Assets and Liability Measured at Fair Value (Detail) - USD ($) $ in Thousands |
Jan. 31, 2025 |
Apr. 30, 2024 |
Assets: |
|
|
Cash equivalents |
$ 30,223
|
$ 11,143
|
Marketable securities |
85,915
|
178,612
|
Cash equivalents and marketable securities |
116,138
|
189,755
|
Liabilities: |
|
|
Derivative Liability |
4,430
|
|
Level 1 [Member] |
|
|
Assets: |
|
|
Cash equivalents |
30,223
|
11,143
|
Cash equivalents and marketable securities |
30,223
|
11,143
|
Level 2 [Member] |
|
|
Assets: |
|
|
Cash equivalents and marketable securities |
85,915
|
178,612
|
Level 3 [Member] |
|
|
Liabilities: |
|
|
Derivative Liability |
4,430
|
|
Corporate Debt Securities [Member] |
|
|
Assets: |
|
|
Marketable securities |
76,094
|
130,423
|
Corporate Debt Securities [Member] | Level 2 [Member] |
|
|
Assets: |
|
|
Marketable securities |
76,094
|
130,423
|
U.S. Government Agency Securities [Member] |
|
|
Assets: |
|
|
Marketable securities |
9,821
|
48,189
|
U.S. Government Agency Securities [Member] | Level 2 [Member] |
|
|
Assets: |
|
|
Marketable securities |
$ 9,821
|
$ 48,189
|
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v3.25.0.1
Fair Value Measurements - Summary of Fair Values of Company's Marketable Securities By Type (Detail) - USD ($) $ in Thousands |
Jan. 31, 2025 |
Apr. 30, 2024 |
Marketable Securities [Line Items] |
|
|
Amortized Cost |
$ 84,649
|
$ 178,327
|
Unrealized Gains |
1,271
|
683
|
Unrealized Losses |
(5)
|
(398)
|
Estimated Fair Value |
85,915
|
178,612
|
Corporate Debt Securities [Member] |
|
|
Marketable Securities [Line Items] |
|
|
Amortized Cost |
74,915
|
130,099
|
Unrealized Gains |
1,184
|
600
|
Unrealized Losses |
(5)
|
(276)
|
Estimated Fair Value |
76,094
|
130,423
|
Obligations of U.S. Government and Its Agencies [Member] |
|
|
Marketable Securities [Line Items] |
|
|
Amortized Cost |
9,734
|
48,228
|
Unrealized Gains |
87
|
83
|
Unrealized Losses |
|
(122)
|
Estimated Fair Value |
$ 9,821
|
$ 48,189
|
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v3.25.0.1
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands |
Jan. 31, 2025 |
Apr. 30, 2024 |
Payables and Accruals [Abstract] |
|
|
Accrued compensation |
$ 9,554
|
$ 6,687
|
Accrued research expense |
3,781
|
3,416
|
Accrued professional fees |
4,091
|
2,042
|
Other accrued expenses |
889
|
253
|
Total accrued expenses |
$ 18,315
|
$ 12,398
|
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v3.25.0.1
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands |
Jan. 31, 2025 |
Apr. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
Prepaid preclinical and clinical activities |
$ 792
|
$ 1,585
|
Other prepaid expenses |
3,962
|
2,833
|
Interest and other receivables |
1,027
|
1,409
|
VAT receivable |
890
|
1,023
|
Total prepaid expenses and other current assets |
$ 6,671
|
$ 6,850
|
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v3.25.0.1
Leases - Summary of Maturity of Undiscounted Payments Due Under Lease Liabilities and Present Value of Liabilities (Detail) - USD ($) $ in Thousands |
Jan. 31, 2025 |
Oct. 31, 2024 |
Apr. 30, 2024 |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] |
|
|
|
2025 |
|
$ 524
|
|
2026 |
|
1,748
|
|
2027 |
|
1,599
|
|
2028 |
|
1,596
|
|
2029 |
|
769
|
|
Thereafter |
|
664
|
|
Total minimum lease payments |
|
6,900
|
|
Less amounts representing interest |
|
1,118
|
|
Present value of minimum payments |
|
5,782
|
|
Current portion |
$ 1,444
|
1,444
|
$ 1,302
|
Long-term portion |
$ 4,338
|
$ 4,338
|
$ 6,015
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v3.25.0.1
Purchase and Sale Agreement - Additional Information (Detail) - USD ($)
|
|
3 Months Ended |
9 Months Ended |
12 Months Ended |
Nov. 04, 2024 |
Jan. 31, 2025 |
Jan. 31, 2025 |
Apr. 30, 2024 |
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Annual net sales on royalty payments |
|
|
|
$ 550,000,000
|
Sales-based milestone payment |
|
|
|
$ 50,000,000
|
Deferred royalty obligation |
|
$ 100,914,000
|
$ 100,914,000
|
|
Embedded derivative liability net carrying amount |
|
96,500,000
|
96,500,000
|
|
Fair value of embedded derivative |
|
4,400,000
|
4,400,000
|
|
Interest expense related to the sale of future royalties |
|
2,842,000
|
2,842,000
|
|
Fair value of the derivative liability |
|
4,400,000
|
4,400,000
|
|
Fair value of derivative liability |
|
$ 200,000
|
$ 200,000
|
|
Percentage of discount rate used for valuation of derivative liability |
|
9.15%
|
9.15%
|
|
Royalty Financing [Member] | Annual Net Sales Above 500.0 Million [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Royalty percentage on annual net sales |
|
|
|
5.00%
|
Maximum [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Sales-based milestone payment |
|
|
|
$ 57,000,000
|
Minimum [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Sales-based milestone payment |
|
|
|
$ 50,000,000
|
DRI Healthcare Trust [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Upfront payment received |
|
|
$ 100,000,000
|
|
Royalty agreement amount funded |
$ 100,000,000
|
|
|
|
Deferred royalty obligation |
93,600,000
|
|
|
|
DRI Healthcare Trust [Member] | Royalty Financing [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Upfront payment received |
$ 100,000,000
|
|
|
|
Royalty percentage on annual net sales |
5.00%
|
|
|
|
Annual net sales on royalty payments |
$ 500,000,000
|
|
|
|
Option to receive one time cash payment |
$ 22,000,000
|
|
|
|
DRI Healthcare Trust [Member] | Royalty Financing [Member] | Annual Net Sales Above 500.0 Million [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Royalty percentage on annual net sales |
1.10%
|
|
|
|
DRI Healthcare Trust [Member] | Royalty Financing [Member] | Annual Net Sales Above 750.0 Million [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Royalty percentage on annual net sales |
0.25%
|
|
|
|
DRI Healthcare Trust [Member] | Royalty Financing [Member] | Annual Net Sales Below 500.0 Million [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Royalty percentage on annual net sales |
|
|
|
5.65%
|
DRI Healthcare Trust [Member] | Maximum [Member] | Royalty Financing [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Transaction amount |
$ 179,000,000
|
|
|
|
Royalty percentage on annual net sales |
6.00%
|
|
|
|
Annual net sales on royalty payments |
|
|
|
$ 500,000,000
|
DRI Healthcare Trust [Member] | Maximum [Member] | Royalty Financing [Member] | Annual Net Sales Above 500.0 Million [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Annual net sales on royalty payments |
$ 750,000,000
|
|
|
|
DRI Healthcare Trust [Member] | Maximum [Member] | Royalty Financing [Member] | Annual Net Sales Above 750.0 Million [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Annual net sales on royalty payments |
$ 750,000,000
|
|
|
|
DRI Healthcare Trust [Member] | Minimum [Member] | Royalty Financing [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Royalty percentage on annual net sales |
5.00%
|
|
|
|
Annual net sales on royalty payments |
|
|
|
$ 500,000,000
|
DRI Healthcare Trust [Member] | Minimum [Member] | Royalty Financing [Member] | Annual Net Sales Above 500.0 Million [Member] |
|
|
|
|
Purchase and Sale Agreement [Line Items] |
|
|
|
|
Annual net sales on royalty payments |
$ 500,000,000
|
|
|
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Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
Jan. 31, 2025 |
Jan. 31, 2025 |
Apr. 30, 2024 |
Income Tax Contingency [Line Items] |
|
|
|
Income tax expense |
$ 4,247
|
$ 4,247
|
|
Research and development tax credit receivable |
7,485
|
7,485
|
$ 8,439
|
US federal income tax expense |
|
100
|
|
Valuation Allowance [Member] |
|
|
|
Income Tax Contingency [Line Items] |
|
|
|
Income tax expense |
$ 4,100
|
|
|
DRI Healthcare Trust [Member] |
|
|
|
Income Tax Contingency [Line Items] |
|
|
|
Upfront payment received |
|
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