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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 June 30, 2021
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 001-38080
Biohaven Pharmaceutical Holding Company Ltd.
(Exact Name of Registrant as Specified in its Charter)
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British Virgin Islands |
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Not applicable |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
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c/o Biohaven Pharmaceuticals, Inc. |
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215 Church Street, New Haven, Connecticut
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06510 |
(Address of principal executive offices) |
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(Zip Code) |
(203) 404-0410
(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 Act:
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Title of each class |
Trading Symbol |
Name of each exchange on which registered |
Common Shares, no par value |
BHVN |
New York Stock Exchange |
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.
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Large accelerated filer |
☒ |
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Accelerated filer |
☐ |
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Non-accelerated filer |
☐ |
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Small reporting company |
☐ |
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Emerging growth company |
☐ |
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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 7(a)(2)(B) of the
Securities 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 August 5, 2021, the registrant had 65,401,228 common
shares, without par value per share, outstanding.
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Table of Contents |
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Page |
Part I |
Financial Information |
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Item 1.
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Item 2.
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Item 3.
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Item 4.
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Part II |
Other Information
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Item 1.
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Item 1A.
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Item 2.
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Item 6.
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Part I. Financial Information
Item 1. Condensed Consolidated Financial
Statements (Unaudited)
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Index to Condensed Consolidated Financial Statements
(Unaudited) |
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Page |
Condensed Consolidated Balance Sheets as of June 30, 2021 and
December 31, 2020 |
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Condensed Consolidated Statements of Operations and Comprehensive
Loss for the three and six months ended June 30, 2021 and
2020 |
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Condensed Consolidated Statements of Cash Flows for the six months
ended June 30, 2021 and 2020 |
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Notes to Condensed Consolidated Financial Statements |
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BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share amounts)
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June 30, 2021 |
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December 31, 2020 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
306,267 |
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$ |
132,149 |
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Marketable securities |
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59,840 |
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223,185 |
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Trade receivable, net |
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168,637 |
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120,111 |
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Inventory |
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64,058 |
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39,563 |
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Prepaid expenses |
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48,871 |
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76,682 |
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Other current assets |
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18,907 |
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11,716 |
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Total current assets |
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666,580 |
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603,406 |
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Property and equipment, net |
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10,885 |
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9,340 |
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Equity method investment |
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— |
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1,176 |
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Intangible assets, net |
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57,501 |
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39,087 |
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Other assets |
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110,927 |
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33,966 |
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Total assets |
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$ |
845,893 |
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$ |
686,975 |
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Liabilities and Shareholders’ Deficit |
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Current liabilities: |
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Accounts payable |
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$ |
60,002 |
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$ |
48,476 |
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Accrued expenses and other current liabilities |
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276,630 |
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166,630 |
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Current portion of mandatorily redeemable preferred
shares |
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62,500 |
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62,500 |
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Total current liabilities |
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399,132 |
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277,606 |
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Long-term debt |
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274,138 |
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267,458 |
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Liability related to sale of future royalties, net |
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347,384 |
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328,350 |
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Mandatorily redeemable preferred shares, net |
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133,091 |
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111,591 |
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Derivative liability |
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15,890 |
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14,190 |
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Obligation to perform R&D services |
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55,353 |
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932 |
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Other long-term liabilities |
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17,501 |
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19,037 |
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Total liabilities |
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1,242,489 |
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1,019,164 |
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Commitments and contingencies (Note 15)
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Contingently redeemable non-controlling interests |
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60,000 |
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60,000 |
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Shareholders’ deficit: |
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Common shares, no par value; 200,000,000 shares authorized as of
June 30, 2021 and December 31, 2020; 65,240,458 and 60,436,876
shares issued and outstanding as of June 30, 2021 and December 31,
2020, respectively
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1,618,194 |
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1,249,547 |
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Additional paid-in capital |
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142,405 |
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98,938 |
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Accumulated other comprehensive income |
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280 |
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314 |
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Accumulated deficit |
|
(2,214,756) |
|
|
(1,739,169) |
|
Total shareholders’ deficit attributable to Biohaven Pharmaceutical
Holding Company Ltd. |
|
(453,877) |
|
|
(390,370) |
|
Non-controlling interests in consolidated subsidiaries |
|
(2,719) |
|
|
(1,819) |
|
Total shareholders' deficit |
|
(456,596) |
|
|
(392,189) |
|
Total liabilities and shareholders’ deficit |
|
$ |
845,893 |
|
|
$ |
686,975 |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Product revenue, net |
|
$ |
92,933 |
|
|
$ |
9,698 |
|
|
$ |
136,756 |
|
|
$ |
10,849 |
|
Cost of goods sold |
|
17,339 |
|
|
3,058 |
|
|
30,201 |
|
|
3,482 |
|
Gross profit |
|
75,594 |
|
|
6,640 |
|
|
106,555 |
|
|
7,367 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
77,428 |
|
|
42,425 |
|
|
184,539 |
|
|
98,495 |
|
Selling, general and administrative |
|
170,057 |
|
|
124,802 |
|
|
329,580 |
|
|
220,403 |
|
Total operating expenses |
|
247,485 |
|
|
167,227 |
|
|
514,119 |
|
|
318,898 |
|
Loss from operations |
|
(171,891) |
|
|
(160,587) |
|
|
(407,564) |
|
|
(311,531) |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(7,836) |
|
|
(172) |
|
|
(15,567) |
|
|
(227) |
|
Interest expense on mandatorily redeemable preferred
shares |
|
(8,042) |
|
|
(6,993) |
|
|
(15,985) |
|
|
(12,554) |
|
Interest expense on liability related to sale of future
royalties |
|
(14,499) |
|
|
(11,570) |
|
|
(28,007) |
|
|
(19,995) |
|
|
|
|
|
|
|
|
|
|
Change in fair value of derivatives |
|
(1,490) |
|
|
650 |
|
|
(1,700) |
|
|
(5,131) |
|
Gain (loss) from equity method investment |
|
— |
|
|
(1,485) |
|
|
5,261 |
|
|
(2,865) |
|
Other expense, net |
|
(3,051) |
|
|
(119) |
|
|
(4,751) |
|
|
(216) |
|
Total other income (expense), net |
|
(34,918) |
|
|
(19,689) |
|
|
(60,749) |
|
|
(40,988) |
|
Loss before provision for income taxes |
|
(206,809) |
|
|
(180,276) |
|
|
(468,313) |
|
|
(352,519) |
|
Provision for income taxes |
|
4,350 |
|
|
658 |
|
|
8,174 |
|
|
1,352 |
|
Net loss |
|
(211,159) |
|
|
(180,934) |
|
|
(476,487) |
|
|
(353,871) |
|
Less: Net loss attributable to non-controlling
interests |
|
(540) |
|
|
— |
|
|
(900) |
|
|
— |
|
Net loss attributable to Biohaven Pharmaceutical Holding Company
Ltd. |
|
$ |
(210,619) |
|
|
$ |
(180,934) |
|
|
$ |
(475,587) |
|
|
$ |
(353,871) |
|
Net loss per share attributable to Biohaven Pharmaceutical Holding
Company Ltd. — basic and diluted |
|
$ |
(3.23) |
|
|
$ |
(3.08) |
|
|
$ |
(7.48) |
|
|
$ |
(6.15) |
|
Weighted average common shares outstanding—basic and
diluted |
|
65,112,179 |
|
|
58,742,329 |
|
|
63,584,932 |
|
|
57,577,384 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(211,159) |
|
|
$ |
(180,934) |
|
|
$ |
(476,487) |
|
|
$ |
(353,871) |
|
Other comprehensive loss, net of tax |
|
(129) |
|
|
— |
|
|
(34) |
|
|
— |
|
Comprehensive loss |
|
(211,288) |
|
|
(180,934) |
|
|
(476,521) |
|
|
(353,871) |
|
Less: comprehensive loss attributable to non-controlling
interests |
|
(540) |
|
|
— |
|
|
(900) |
|
|
— |
|
Comprehensive loss attributable to Biohaven Pharmaceutical Holding
Company Ltd. |
|
$ |
(210,748) |
|
|
$ |
(180,934) |
|
|
$ |
(475,621) |
|
|
$ |
(353,871) |
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
Cash flows from operating activities: |
|
|
|
|
Net loss |
|
$ |
(475,587) |
|
|
$ |
(353,871) |
|
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash share-based compensation expense |
|
74,312 |
|
|
28,641 |
|
Interest expense on mandatorily redeemable preferred
shares |
|
15,985 |
|
|
12,554 |
|
Interest expense on liability related to sale of future
royalties |
|
28,007 |
|
|
19,995 |
|
Interest expense paid-in-kind on long-term debt |
|
5,649 |
|
|
— |
|
Issuance of common shares as payment for license and consulting
agreements |
|
4,243 |
|
|
— |
|
|
|
|
|
|
Change in fair value of derivatives |
|
1,700 |
|
|
5,131 |
|
(Gain) loss from equity method investment |
|
(5,261) |
|
|
2,865 |
|
Depreciation and amortization |
|
11,278 |
|
|
1,551 |
|
Change in obligation to perform R&D services |
|
(10,205) |
|
|
— |
|
Other non-cash items |
|
2,093 |
|
|
150 |
|
Changes in operating assets and liabilities: |
|
|
|
|
Trade receivables, net |
|
(48,526) |
|
|
(44,796) |
|
Inventories |
|
(19,046) |
|
|
(6,931) |
|
Prepaid expenses |
|
28,710 |
|
|
(36,626) |
|
Other current assets |
|
(7,051) |
|
|
2,246 |
|
|
|
|
|
|
Other assets |
|
(79,832) |
|
|
17 |
|
Accounts payable |
|
5,085 |
|
|
934 |
|
Accrued expenses and other current liabilities |
|
63,868 |
|
|
41,543 |
|
Other long-term liabilities |
|
(28,138) |
|
|
62 |
|
Net cash used in operating activities |
|
(432,716) |
|
|
(326,535) |
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
Sales and maturities of marketable securities |
|
162,293 |
|
|
— |
|
Purchases of property and equipment |
|
(1,657) |
|
|
(1,381) |
|
|
|
|
|
|
Payments for leasehold improvements |
|
— |
|
|
(1,600) |
|
Payments for intangible assets |
|
— |
|
|
(21,500) |
|
Net cash provided by (used in) investing activities |
|
160,636 |
|
|
(24,481) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common shares |
|
308,743 |
|
|
283,333 |
|
|
|
|
|
|
Proceeds from obligation to perform R&D services |
|
100,000 |
|
|
— |
|
Proceeds from the issuance of series B preferred shares |
|
35,170 |
|
|
— |
|
Proceeds from exercise of share options and employee share purchase
plan |
|
8,643 |
|
|
14,355 |
|
|
|
|
|
|
Payment of term loan commitment fee |
|
(3,750) |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
Payment of principal for finance leases |
|
(2,514) |
|
|
(37) |
|
Payment of term loan |
|
(1,195) |
|
|
— |
|
|
|
|
|
|
Other |
|
1,090 |
|
|
(500) |
|
|
|
|
|
|
Net cash provided by financing activities |
|
446,187 |
|
|
297,151 |
|
Effect of exchange rate changes on cash, cash equivalents and
restricted cash |
|
(189) |
|
|
— |
|
Net increase (decrease) in cash, cash equivalents and restricted
cash |
|
173,918 |
|
|
(53,865) |
|
Cash, cash equivalents and restricted cash at beginning of
period |
|
134,231 |
|
|
317,727 |
|
Cash, cash equivalents and restricted cash at end of
period |
|
$ |
308,149 |
|
|
$ |
263,862 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
1. Nature of the Business
Biohaven Pharmaceutical Holding Company Ltd. (“we,” “us”,
"our," "Biohaven" or the “Company”) was incorporated in Tortola,
British Virgin Islands in September 2013. We are a
biopharmaceutical company with a portfolio of innovative product
candidates targeting neurological diseases, including rare
disorders. The Company's lead product, NURTEC™ ODT (rimegepant),
was approved by the U.S. Food and Drug Administration ("FDA") on
February 27, 2020, which became available by prescription in U.S.
pharmacies on March 12, 2020, and was approved for the preventive
treatment of migraine on May 27, 2021. NURTEC ODT is the first and
only calcitonin gene-related peptide ("CGRP") receptor antagonist
available in a quick-dissolve orally dissolving tablet ("ODT")
formulation that is approved by the FDA for both the acute and
preventive treatment of migraine in adults. Our other late-stage
product candidates are based on multiple mechanisms — CGRP receptor
antagonists, glutamate modulators and myeloperoxidase
inhibition—which we believe have the potential to significantly
alter existing treatment approaches across a diverse set of
neurological indications with high unmet need in both large and
orphan indications.
The Company is subject to risks and uncertainties common to
companies in the biopharmaceutical industry, including, but not
limited to, the risks associated with developing product candidates
at each stage of non-clinical and clinical development; the
challenges associated with gaining regulatory approval of such
product candidates; the risks associated with commercializing
pharmaceutical products for marketing and sale; the potential for
development by third parties of new technological innovations that
may compete with the Company’s products; the dependence on key
personnel; the challenges of protecting proprietary technology; the
need to comply with government regulations; the high costs of drug
development; and the uncertainty of being able to secure additional
capital when needed to fund operations.
Subsequent to its May 2017 initial public offering, the Company has
primarily raised funds through sales of equity in private
placements and public offerings, sale of revenue participation
rights related to future royalties, debt financing and funds
received for a research and development obligation. The Company has
incurred recurring losses since its inception, had an accumulated
deficit as of June 30, 2021, and expects to continue to generate
operating losses during the commercial launch of NURTEC ODT for the
acute and preventive treatment of migraine. To execute its business
plans, the Company will continue to require additional funding to
support its continuing operations and pursue its growth
strategy.
As of August 9, 2021, the issuance date of our condensed
consolidated financial statements, the Company expects that its
cash, cash equivalents and marketable securities as of June 30,
2021, and the funds available from the Sixth Street Financing
Agreement (see Note 14) and Series B Preferred Shares (see Note 8)
will be sufficient to fund its current forecast for operating
expenses, including commercialization of NURTEC ODT, financial
commitments and other cash requirements for more than one year. The
Company may need to raise additional capital until it is
profitable. If no additional capital is raised through either
public or private equity financings, debt financings, strategic
relationships, alliances and licensing agreements, or a combination
thereof, the Company may delay, limit or reduce discretionary
spending in areas related to research and development activities
and other general and administrative expenses in order to fund its
operating costs and working capital needs.
2. Summary of Significant Accounting
Policies
Our significant accounting policies are described in Note 2 of the
notes to the consolidated financial statements included in our
Annual Report on Form 10-K for the year ended December 31, 2020
(the "2020 Form 10-K"). Updates to our accounting policies,
including impacts from the adoption of new accounting standards,
are discussed below in this Note 2.
Basis of Presentation
The accompanying condensed consolidated financial statements have
been prepared in accordance with accounting principles generally
accepted in the United States of America (“GAAP”) and include the
accounts of the Company and its controlled subsidiaries after
elimination of all significant intercompany accounts and
transactions. Investments in companies in which the Company owns
less than a 50% equity interest and where it exercises significant
influence over the operating and financial policies of the investee
are accounted for using the equity method of
accounting.
The financial statements of our subsidiaries with functional
currencies other than the U.S. dollar are translated into U.S.
dollars using period-end exchange rates for assets and liabilities,
historical exchange rates for shareholders' equity (deficit) and
weighted average exchange rates for operating results. Translation
gains and losses are included in accumulated other
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
2. Summary of Significant Accounting Policies
(Continued)
comprehensive income, net of tax, in shareholders' deficit. Foreign
currency transaction gains and losses are included in other income
(expense) in the condensed consolidated statement of operations and
comprehensive loss.
Reclassifications
Certain items in the prior period’s condensed consolidated
financial statements have been reclassified to conform to the
current presentation.
Use of Estimates
The preparation of condensed consolidated financial statements in
conformity with GAAP requires management 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 the condensed consolidated financial statements and the
reported amounts of income and expenses during the reporting
periods. Significant estimates and assumptions reflected in these
condensed consolidated financial statements include, but are not
limited to, revenue recognition, interest expense on liability
related to sale of future royalties, valuation of Series B
preferred shares forward contracts and income taxes. In addition,
management’s assessment of the Company’s ability to continue as a
going concern involves the estimation of the amount and timing of
future cash inflows and outflows. Estimates are periodically
reviewed in light of changes in circumstances, facts and
experience. Changes in estimates are recorded in the period in
which they become known. Actual results could differ from those
estimates.
Inventory
The Company values its inventories at the lower-of-cost or net
realizable value. The Company determines the cost of its
inventories, which includes costs related to products held for sale
in the ordinary course of business, products in process of
production for such sale and items to be currently consumed in the
production of goods to be available for sale, on a first-in,
first-out (FIFO) basis. Due to the nature of the Company’s supply
chain process, inventory that is owned by the Company, is
physically stored at third-party warehouses, logistics providers
and contract manufacturers. The Company classifies inventory costs
as noncurrent when we expect to utilize the inventory beyond our
normal operating cycle and includes these costs in other assets in
our condensed consolidated balance sheets. The Company performs an
assessment of the recoverability of capitalized inventory during
each reporting period, and writes down any excess and obsolete
inventories to their net realizable value in the period in which
the impairment is first identified. If they occur, such impairment
charges are recorded as a component of cost of goods sold in the
consolidated statements of operations.
The Company capitalizes inventory costs associated with products
following regulatory approval when future commercialization is
considered probable and the future economic benefit is expected to
be realized. Products which may be used in clinical development
programs are excluded from inventory and charged to research and
development expense in the consolidated statement of operations as
incurred. Prior to the initial date regulatory approval is
received, costs related to the production of inventory are recorded
as research and development expense on the Company’s consolidated
statements of operations in the period incurred. Following FDA
approval of NURTEC ODT on February 27, 2020, the Company
subsequently began capitalizing costs related to inventory
manufacturing.
Acquisitions
Our condensed consolidated financial statements include the
operations of acquired businesses after the completion of the
acquisitions. We account for acquired businesses using the
acquisition method of accounting, which requires, among other
things, that most assets acquired and liabilities assumed be
recognized at their estimated fair values as of the acquisition
date and that the fair value of acquired In-Process Research and
Development ("IPR&D") be recorded on the balance sheet.
Transaction costs are expensed as incurred. Any excess of the
consideration transferred over the assigned values of the net
assets acquired is recorded as goodwill. Contingent consideration
in a business acquisition is included as part of the consideration
transferred and is recognized at fair value as of the acquisition
date. Fair value is generally estimated by using a
probability-weighted discounted cash flow approach.
Acquired In-Process Research and Development
IPR&D that the Company acquires in conjunction with the
acquisition of a business represents the fair value assigned to
incomplete research projects which, at the time of acquisition,
have not reached technological feasibility. The amounts are
capitalized and are accounted for as indefinite-lived intangible
assets, subject to impairment testing until completion
or
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
2. Summary of Significant Accounting Policies
(Continued)
abandonment of the projects. Upon successful completion of each
project, the Company will make a determination as to the
then-useful life of the intangible asset, generally determined by
the period in which the substantial majority of the cash flows are
expected to be generated, and begin amortization. The Company
evaluates IPR&D for impairment at least annually, or more
frequently if impairment indicators exist, by performing a
quantitative test that compares the fair value of the IPR&D
intangible asset with its carrying value. If the fair value is less
than the carrying amount, an impairment loss is recognized in
operating results.
Obligation to Perform Research and Development
Services
The Company accounts for obligations to perform Research and
Development ("R&D") services by recording the consideration
received as a liability, which then is recognized in the condensed
consolidated statement of operations and comprehensive loss as an
offset to R&D expense using the percentage completion method.
The percentage complete is determined based on incurred R&D
costs as a percent of the total forecasted costs of the contractual
R&D commitment.
Unaudited Interim Condensed Consolidated Financial
Information
The accompanying unaudited condensed consolidated financial
statements have been prepared in accordance with accounting
principles generally accepted in the United States of America for
interim financial information. The accompanying unaudited condensed
consolidated financial statements do not include all of the
information and footnotes required by accounting principles
generally accepted in the United States of America for complete
consolidated financial statements. The accompanying year-end
condensed consolidated balance sheet was derived from audited
financial statements, but does not include all disclosures required
by accounting principles generally accepted in the United States of
America. The unaudited interim condensed consolidated
financial statements have been prepared on the same basis as the
audited annual consolidated financial statements and, in the
opinion of management, reflect all adjustments, which include only
normal recurring adjustments, necessary for the fair statement of
the Company’s financial position as of June 30, 2021 and the
results of its operations for the three and six months ended June
30, 2021 and 2020 and its cash flows for the six months ended June
30, 2021 and 2020. The results for the three and six months ended
June 30, 2021 are not necessarily indicative of results to be
expected for the year ending December 31, 2021, any other interim
periods or any future year or period. The financial
information included herein should be read in conjunction with the
financial statements and notes in the Company's Annual Report on
Form 10-K for the year ended December 31, 2020.
Recently Adopted Accounting Pronouncements
Effective January 1, 2021, the Company adopted ASU No.
2019-12,
Income Taxes (Topic 740): Simplifying the Accounting for Income
Taxes
("ASU 2019-12"). This ASU simplifies the accounting for income
taxes by removing certain exceptions to the general principles in
Topic 740. The amendments also improve consistent application of
and simplify GAAP for other areas of Topic 740 by clarifying and
amending existing guidance. The adoption of ASU 2019-12 did not
have a material impact on the Company's condensed consolidated
financial statements.
Future Adoption of New Accounting Pronouncements
In August 2020 the FASB issued ASU No. 2020-06,
Debt—Debt with Conversion and Other Options (Subtopic 470-20) and
Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic
815-40): Accounting for Convertible Instruments and Contracts in an
Entity’s Own Equity.
The update addresses issues identified as a result of the
complexity associated with applying GAAP for certain financial
instruments with characteristics of liabilities and equity. The
amendments in ASU 2020-06 are effective for fiscal years beginning
after December 15, 2021, with early adoption permitted, but no
earlier than fiscal years beginning after December 15, 2020,
including interim periods within those fiscal years. Adoption of
the standard requires changes to be made through either a modified
retrospective method of transition or a fully retrospective method.
In applying the modified retrospective method, the updated guidance
is applied to transactions outstanding as of the beginning of the
fiscal year in which the amendments are adopted. The Company is
currently evaluating the impact that the adoption of ASU 2020-06
will have on its condensed consolidated financial
statements.
In January 2021 the FASB issued ASU No. 2021-01,
Reference Rate Reform (Topic 848): Facilitation of the Effects of
Reference Rate Reform on Financial Reporting,
providing temporary guidance to ease the burden in accounting for
reference rate reform primarily resulting from the discontinuation
of LIBOR, which is currently expected to occur in mid-2023 for
legacy contracts. The amendments in 2021-01 are elective
immediately and apply to all entities that have contracts,
hedging
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
2. Summary of Significant Accounting Policies
(Continued)
relationships, and other transactions that reference LIBOR or
another reference rate expected to be discontinued.
The Company is currently evaluating the impact that the adoption of
ASU 2021-01 will have on its condensed consolidated financial
statements.
In May 2021 the FASB issued ASU No. 2021-04,
Earnings Per Share (Topic 260), Debt—Modifications and
Extinguishments (Subtopic 470-50), Compensation—Stock Compensation
(Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own
Equity (Subtopic 815-40): Issuer’s Accounting for Certain
Modifications or Exchanges of Freestanding Equity-Classified
Written Call Options (a consensus of the FASB Emerging Issues Task
Force),
which provides guidance on modifications or exchanges of a
freestanding equity-classified written call option that is not
within the scope of another topic. An entity should treat a
modification of the terms or conditions or an exchange of a
freestanding equity-classified written call option that remains
equity classified after modification or exchange as an exchange of
the original instrument for a new instrument, and provides further
guidance on measuring the effect of a modification or an exchange
of a freestanding equity-classified written call option that
remains equity classified after modification or exchange. ASU
2021-04 also provides guidance on the recognition of the effect of
a modification or an exchange of a freestanding equity-classified
written call option that remains equity classified after
modification or exchange on the basis of the substance of the
transaction, in the same manner as if cash had been paid as
consideration. The guidance is applied prospectively and is
effective for all entities for fiscal years beginning after 15
December 2021, and interim periods within those fiscal years. Early
adoption is permitted. The Company is currently evaluating the
impact that the adoption of ASU 2021-04 will have on the condensed
consolidated financial statements. The effect will largely depend
on the terms of written call options or financings issued or
modified in the future.
3. Marketable Securities
The amortized cost, gross unrealized holding gains, gross
unrealized holding losses and fair value of available-for-sale debt
securities by type of security at June 30, 2021 was as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized Cost |
|
Allowance for Credit Losses |
|
Net Amortized Cost |
|
Gross Unrealized Gains |
|
Gross Unrealized Losses |
|
Fair Value |
Corporate bonds |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
$ |
46,172 |
|
|
$ |
— |
|
|
$ |
46,172 |
|
|
$ |
35 |
|
|
$ |
(2) |
|
|
$ |
46,205 |
|
Foreign |
|
13,637 |
|
|
— |
|
|
13,637 |
|
|
— |
|
|
(2) |
|
|
13,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
59,809 |
|
|
$ |
— |
|
|
$ |
59,809 |
|
|
$ |
35 |
|
|
$ |
(4) |
|
|
$ |
59,840 |
|
The amortized cost, gross unrealized holding gains, gross
unrealized holding losses and fair value of available-for-sale debt
securities by type of security at December 31, 2020 was as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized Cost |
|
Allowance for Credit Losses |
|
Net Amortized Cost |
|
Gross Unrealized Gains |
|
Gross Unrealized Losses |
|
Fair Value |
Corporate bonds |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
$ |
185,989 |
|
|
$ |
— |
|
|
$ |
185,989 |
|
|
$ |
1 |
|
|
$ |
(106) |
|
|
$ |
185,884 |
|
Foreign |
|
37,321 |
|
|
— |
|
|
37,321 |
|
|
1 |
|
|
(21) |
|
|
37,301 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
223,310 |
|
|
$ |
— |
|
|
$ |
223,310 |
|
|
$ |
2 |
|
|
$ |
(127) |
|
|
$ |
223,185 |
|
The Company had 9 and 47 available-for-sale debt securities in an
unrealized loss position, with an aggregate fair value of $31,387
and $212,378, as of June 30, 2021 and December 31, 2020,
respectively. As of June 30, 2021, the Company did not intend to
sell these securities, and did not believe it was more likely than
not that it would be required to sell these securities
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
3. Marketable Securities (Continued)
prior to the anticipated recovery of their amortized cost basis. We
did not have any investments in a continuous unrealized loss
position for more than twelve months as of June 30, 2021 and
December 31, 2020.
The fair values of debt securities available-for-sale by
classification in the condensed consolidated balance sheets were as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021 |
|
December 31, 2020 |
|
|
|
|
|
Marketable securities |
|
$ |
59,840 |
|
|
$ |
223,185 |
|
|
|
|
|
|
|
|
|
|
|
The net amortized cost and fair value of debt securities
available-for-sale at June 30, 2021 are shown below by contractual
maturity. Actual maturities may differ from contractual maturities
because securities may be restructured, called or prepaid, or the
Company intends to sell a security prior to maturity.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Amortized Cost |
|
Fair Value |
Due to mature: |
|
|
|
|
Less than one year |
|
$ |
59,809 |
|
|
$ |
59,840 |
|
|
|
|
|
|
|
|
|
|
|
Net Investment Income
Sources of net investment income included in other income (expense)
in the condensed consolidated statements of operations and
comprehensive loss for the three and six months ended June 30, 2021
were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2021 |
|
Six Months Ended June 30, 2021 |
|
|
Gross investment income from debt securities
available-for-sale |
|
$ |
89 |
|
|
$ |
161 |
|
|
|
Investment expenses |
|
(24) |
|
|
(76) |
|
|
|
Net investment income (excluding net realized capital gains or
losses) |
|
65 |
|
|
85 |
|
|
|
Net realized capital gains (losses) |
|
— |
|
|
19 |
|
|
|
Net investment income |
|
$ |
65 |
|
|
$ |
104 |
|
|
|
The Company had no net investment income during the three and six
months ended June 30, 2020.
We utilize the specific identification method in computing realized
gains and losses. The Company had no maturities or sales of
available-for-sale debt securities or resulting realized gains and
losses for the three and six months ended June 30,
2020.
4. Fair Value of Financial Assets and
Liabilities
The preparation of the Company’s condensed consolidated financial
statements in accordance with GAAP requires certain assets and
liabilities to be reflected at their fair value and others to be
reflected on another basis, such as an adjusted historical cost
basis. In this note, the Company provides details on the fair value
of financial assets and liabilities and how it determines those
fair values.
Financial Instruments Measured at Fair Value on the Condensed
Consolidated Balance Sheets
Certain assets of the Company are carried at fair value under GAAP.
Fair value is defined as the exchange price that would be received
for an asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in
an orderly transaction between market participants on the
measurement date. Valuation techniques used to measure fair value
must maximize the use of observable inputs and minimize the use of
unobservable inputs. Financial assets and
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
4. Fair Value of Financial Assets and Liabilities
(Continued)
liabilities carried at fair value are to be classified and
disclosed in one of the following three levels of the fair value
hierarchy, of which the first two are considered observable and the
last is considered unobservable:
•Level
1 — Quoted prices in active markets for identical assets or
liabilities.
•Level
2 — Observable inputs (other than Level 1 quoted prices), such
as quoted prices in active markets for similar assets or
liabilities, quoted prices in markets that are not active for
identical or similar assets or liabilities, 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 that are significant to determining the fair value of the
assets or liabilities, including pricing models, discounted cash
flow methodologies and similar techniques.
For a description of the methods and assumptions that are used to
estimate the fair value and determine the fair value hierarchy
classification of each class of financial instrument, see (Note 4)
“Fair Value of Financial Assets and Liabilities” in the 2020 Form
10-K. Financial assets and liabilities measured at fair value on a
recurring basis on the condensed consolidated balance sheet at June
30, 2021 and December 31, 2020 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement as of June 30, 2021 Using: |
Balance Sheet Classification |
|
Type of Instrument |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Assets: |
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
Money market funds |
|
$ |
145,462 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
145,462 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable securities |
|
U.S. corporate bonds |
|
— |
|
|
46,205 |
|
|
— |
|
|
46,205 |
|
Marketable securities |
|
Foreign corporate bonds |
|
— |
|
|
13,635 |
|
|
— |
|
|
13,635 |
|
Total assets |
|
|
|
$ |
145,462 |
|
|
$ |
59,840 |
|
|
$ |
— |
|
|
$ |
205,302 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
Series B preferred shares forward contracts |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
15,890 |
|
|
$ |
15,890 |
|
Contingent value right liability |
|
— |
|
|
— |
|
|
1,457 |
|
|
1,457 |
|
Total liabilities |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
17,347 |
|
|
$ |
17,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement as of December 31, 2020 Using: |
Balance Sheet Classification |
|
Type of Instrument |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Assets: |
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
Money market funds |
|
$ |
6,858 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
6,858 |
|
Marketable securities |
|
U.S. corporate bonds |
|
— |
|
|
185,884 |
|
|
— |
|
|
185,884 |
|
Marketable securities |
|
Foreign corporate bonds |
|
— |
|
|
37,301 |
|
|
— |
|
|
37,301 |
|
Total assets |
|
|
|
$ |
6,858 |
|
|
$ |
223,185 |
|
|
$ |
— |
|
|
$ |
230,043 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
Series B preferred shares forward contracts |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
14,190 |
|
|
$ |
14,190 |
|
Total liabilities |
|
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
14,190 |
|
|
$ |
14,190 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There were no securities transferred between Level 1, 2 and 3
during the six months ended June 30, 2021 and 2020.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
4. Fair Value of Financial Assets and Liabilities
(Continued)
•Series
B Preferred Shares Forward Contracts
The following table provides a roll forward of the aggregate fair
value of the Company's Series B Preferred Shares Forward Contracts
for which fair value is determined by Level 3 inputs for the
six months ended June 30, 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forward Contracts |
|
|
Balance at December 31, 2020 |
|
|
$ |
14,190 |
|
|
|
Change in fair value |
|
|
1,700 |
|
|
|
Balance at June 30, 2021 |
|
|
$ |
15,890 |
|
|
|
The Company had no Series B Preferred Shares Forward Contracts for
the six months ended June 30, 2020.
•Contingent
Value Right Liability
On January 4, 2021, the Company acquired Kleo Pharmaceuticals, Inc.
(“Kleo”) (see Note 6). Included in the purchase consideration
transferred was a contingent value right to receive one dollar in
cash for each Kleo share if certain specified Kleo
biopharmaceutical products or product candidates receive the
approval of the FDA prior to the expiration of 30 months following
the effective time of the transaction. The maximum amount payable
pursuant to the contingent value right is approximately $17,300,
and the fair value of the contingent value right was $1,457 as of
the acquisition date. The Company recorded the contingent value
right in other long-term liabilities on the condensed consolidated
balance sheets.
The fair value of the contingent value right was determined based
on significant inputs not observable in the market, which
represents a Level 3 measurement within the fair value hierarchy.
The Company used a discounted cash flow approach to value the
contingent value right liability. As inputs into the valuation, the
Company considered the probability of FDA approval within the 30
month period, which we estimated at approximately 10%, the amount
of the payment, and a discount rate of approximately 7% determined
using an implied credit spread adjusted based on companies with
similar credit risk.
There was no material change in fair value of the contingent value
right liability during the three and six months ended June 30,
2021.
•Series
A Preferred Shares Derivative Liability
The Company had no Series A preferred shares derivative liability
for the six months ended June 30, 2021.
The following table provides a roll forward of the aggregate fair
value of the Company’s Series A preferred shares derivative
liability for which fair value is determined by Level 3 inputs
for the six months ended June 30, 2020:
|
|
|
|
|
|
|
|
|
|
|
Series A Derivative
Liability |
Balance at December 31, 2019 |
|
$ |
37,690 |
|
Change in fair value of derivative liability |
|
5,131 |
|
Partial settlement of derivative liability |
|
(42,821) |
|
Balance at June 30, 2020 |
|
$ |
— |
|
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
5. Balance Sheet Components
Restricted Cash
Restricted cash included in other current assets in the condensed
consolidated balance sheets is primarily employee contributions to
the Company's employee share purchase plan held for future
purchases of the Company's outstanding shares.
Restricted cash included in other assets in the condensed
consolidated balance sheets represents collateral held by a bank
for a letter of credit ("LOC") issued in connection with the leased
office space in Yardley, Pennsylvania. The following represents a
reconciliation of cash and cash equivalents in the condensed
consolidated balance sheets to total cash, cash equivalents and
restricted cash as of June 30, 2021 and December 31, 2020,
respectively, in the condensed consolidated statement of cash
flows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021 |
|
December 31, 2020 |
Cash and cash equivalents |
|
$ |
306,267 |
|
|
$ |
132,149 |
|
Restricted cash (included in other current assets) |
|
1,132 |
|
|
1,082 |
|
Restricted cash (included in other assets) |
|
750 |
|
|
1,000 |
|
Cash, cash equivalents and restricted cash in the statement of cash
flows |
|
$ |
308,149 |
|
|
$ |
134,231 |
|
Trade Receivables, Net
The Company’s trade accounts receivable consists of amounts due
from pharmacy wholesalers in the U.S. (collectively, its
"Customers") related to sales of NURTEC ODT and have standard
payment terms. For certain Customers, the trade accounts receivable
for the Customer is net of distribution service fees, prompt pay
discounts and other adjustments. The Company monitors the financial
performance and creditworthiness of its Customers so that it can
properly assess and respond to changes in their credit profile. The
Company reserves against trade accounts receivable for estimated
losses that may arise from a Customer’s inability to pay and any
amounts determined to be uncollectible are written off against the
reserve when it is probable that the receivable will not be
collected. The allowance for doubtful accounts, including reserve
amounts for estimated credit losses, was immaterial as of June 30,
2021 and December 31, 2020.
Inventories
Inventories consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2021 |
|
As of December 31, 2020 |
Raw materials |
|
$ |
— |
|
|
$ |
931 |
|
Work-in-process |
|
94,324 |
|
|
33,266 |
|
Finished goods |
|
3,462 |
|
|
5,366 |
|
Total inventories |
|
$ |
97,786 |
|
|
$ |
39,563 |
|
Less noncurrent inventories(1)
|
|
33,728 |
|
|
— |
|
Total inventories classified as current |
|
$ |
64,058 |
|
|
$ |
39,563 |
|
(1)
Included in other assets on the condensed consolidated balance
sheets. There are no recoverability issues for these
amounts.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
5. Balance Sheet Components (Continued)
Prepaid Expenses
Prepaid expenses consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2021 |
|
As of December 31, 2020 |
|
Prepaid clinical trial costs |
|
$ |
24,108 |
|
|
$ |
21,173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid manufacturing |
|
2,919 |
|
|
36,040 |
|
|
Prepaid commercial costs |
|
19,326 |
|
|
16,448 |
|
|
Other prepaid expenses |
|
2,518 |
|
|
3,021 |
|
|
Prepaid expenses |
|
$ |
48,871 |
|
|
$ |
76,682 |
|
|
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2021 |
|
As of December 31, 2020 |
Accrued development milestones |
|
$ |
500 |
|
|
$ |
667 |
|
Accrued employee compensation and benefits |
|
26,964 |
|
|
29,447 |
|
Accrued clinical trial costs |
|
29,972 |
|
|
19,887 |
|
Accrued commercialization and other professional fees |
|
27,273 |
|
|
6,336 |
|
|
|
|
|
|
|
|
|
|
|
Accrued sales discounts and allowances |
|
104,668 |
|
|
73,155 |
|
Current obligation to perform R&D services |
|
37,466 |
|
|
846 |
|
Other accrued expenses and other current liabilities |
|
49,787 |
|
|
36,292 |
|
Accrued expenses and other current liabilities |
|
$ |
276,630 |
|
|
$ |
166,630 |
|
6. Business Acquisition
On January 4, 2021, the Company acquired Kleo Pharmaceuticals, Inc.
(“Kleo”). Kleo is a development-stage biopharmaceutical company
focused on advancing the field of immunotherapy by developing small
molecules that emulate biologics. The transaction was accounted for
as the acquisition of a business using the acquisition method of
accounting.
The total fair value of the consideration transferred was $20,043
which consisted of the issuance of a total of 115,836 common shares
of the Company to Kleo stockholders and contingent consideration in
the form of a contingent value right to receive one dollar in cash
for each Kleo share if certain specified Kleo biopharmaceutical
products or product candidates receive the approval of the FDA
prior to the expiration of 30 months following the effective time
of the transaction. The maximum amount payable pursuant to the
contingent value right is approximately $17,300, and the fair value
of the contingent value right is $1,457 as of the acquisition date.
The transaction also provides for approximately $950 of cash
holdbacks to provide for potential indemnification claims and other
reserves. Any holdback amounts remaining after the holdback periods
will be released to the Kleo stockholders in the form of cash
consideration.
Prior to the consummation of the transaction, the Company owned
approximately 41.9% of the outstanding shares of Kleo and accounted
for it as an equity method investment. As part of the transaction,
the Company acquired the remainder of the shares of Kleo, and
post-transaction the Company owns 100% of the outstanding shares of
Kleo. The carrying value of the Company’s investment in Kleo was
$1,176 immediately prior to the acquisition date. The Company
determined the fair value of the existing interest was $6,437, and
recognized a gain from our equity method investment of $5,261 for
the six months ended June 30, 2021 on the condensed consolidated
statement of operations and comprehensive loss as a result of
remeasuring to fair value the existing equity interest in
Kleo.
In connection with the transaction, we recorded: net working
capital of $573; property, plant and equipment of $1,257;
intangible assets consisting of in progress research and
development assets of $18,400 which include an oncology therapeutic
candidate entering Phase I clinical trials, and a COVID-19
therapeutic candidate in the planning stage for clinical
development; debt assumed of $1,577; and goodwill of
$1,390.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
6. Business Acquisition (Continued)
Kleo’s employees, other than its President and Chief Financial
Officer, were retained as part of the transaction. In connection
with the transaction agreement, the Company filed a registration
statement permitting Kleo stockholders to offer and sell the common
shares of the Company issued in the transaction.
7. Liability Related to Sale of Future Royalties,
net
2018 RPI Funding Agreement
In June 2018, the Company entered into a funding agreement (the
"2018 RPI Funding Agreement") to sell tiered, sales-based royalty
rights on global net sales of pharmaceutical products containing
the compounds rimegepant or zavegepant (previously known as
BHV-3500 and vazegepant) and certain derivative compounds thereof
("Products") to RPI, a Delaware statutory trust. The Company issued
to RPI the right to receive certain revenue participation payments,
subject to certain reductions, based on the future global net sales
of the Products for each calendar quarter during the royalty term
contemplated by the 2018 RPI Funding Agreement, in exchange for
$100,000 in cash.
Concurrent with the 2018 RPI Funding Agreement, the Company entered
into a common stock purchase agreement (the "Purchase Agreement")
with RPI. Pursuant to the Purchase Agreement, the Company sold
1,111,111 common shares of the Company to RPI at a price of $45.00
per share, for gross proceeds of $50,000.
The Company concluded that there were two units of account for the
consideration received comprised of the liability related to sale
of future royalties and the common shares. The Company allocated
the $100,000 from the 2018 RPI Funding Agreement and $50,000 from
the Purchase Agreement among the two units of account on a relative
fair value basis at the time of the transaction. The Company
allocated $106,047 in transaction consideration to the liability,
and $43,953 to the common shares. The Company determined the fair
value of the common shares based on the closing share price on the
transaction date, adjusted for the trading restrictions. The
transaction costs of $377 were allocated in proportion to the
allocation of total consideration to the two units of account. The
effective interest rate under the 2018 RPI Funding Agreement,
including transaction costs, is approximately 27% as of June 30,
2021.
2020 RPI Funding Agreement
In August 2020, the Company entered into a funding agreement with
RPI 2019 Intermediate Finance Trust (“RPI 2019 IFT”) providing for
up to $250,000 of funding in exchange for rights to participation
payments based on global net sales of products containing
zavegepant and rimegepant and certain payments based on
success-based milestones relating to zavegepant (the "2020 RPI
Funding Agreement"). Under the 2020 RPI Funding Agreement, RPI 2019
IFT will be entitled to receive tiered, sales based participation
rights up to 3.0% of future global net sales of products containing
zavegepant, 0.4% of future global net sales of products containing
rimegepant, and payments tied to success-based milestones as
described below. Pursuant to the 2020 RPI Funding Agreement, the
Company received $150,000 on the transaction date in August 2020
and $100,000 in March 2021 upon the commencement of the oral
zavegepant Phase 3 clinical program.
If at any time during the 180 days following the closing of the
2020 RPI Funding Agreement, the Company enters into a definitive
agreement to consummate a Change of Control (as defined in the
Company's articles and memorandum of association), the Company will
have the option to repurchase the participation rights and
milestone payment rights for a purchase price of 2.0x of the amount
received under the agreement at that date, contingent upon the
closing of a Change of Control (the "Buy-Back
Option").
The success-based milestone payments range from 0.6x to 2.95x of
the funded amount depending on the number of regulatory approvals
achieved for zavegepant (including 1.9x for the first zavegepant
migraine regulatory approval) and would be paid over a 10-year
period. If the Company consummates a Change of Control, and the
Buy-Back Option has not previously been exercised, RPI 2019 IFT has
the option to accelerate each unpaid milestone payment which has or
thereafter occurs.
The Company concluded that there were two units of account for the
$150,000 in initial consideration received, which comprised of a
liability related to sale of future royalties for products
containing rimegepant and a research and development arrangement
with RPI 2019 IFT for zavegepant. The Company allocated the
$150,000 from the 2020 RPI Funding Agreement among the two units of
account based on the present value of probability adjusted net
sales at the time of the transaction. The Company allocated
$147,876 in transaction consideration to the liability related to
sale of future royalties and $2,124 to the
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
7. Liability Related to Sale of Future Royalties, net
(Continued)
obligation to perform contractual services in the condensed
consolidated balance sheets. The transaction costs of $400 were
allocated only to the liability related to sale of future
royalties. The effective interest rate under the 2020 RPI Funding
Agreement, including transaction costs, is approximately 6% as of
June 30, 2021.
In March 2021, the Company received $100,000 from RPI 2019 IFT for
the commencement of the oral zavegepant Phase 3 clinical program.
The Company allocated the proceeds to obligation to perform R&D
services liability in the condensed consolidated balance
sheets.
Since there is a substantive and genuine transfer of risk to RPI
2019 IFT for the development of zavegepant, the $102,124 of
consideration allocated to the development of zavegepant is being
recognized by the Company as an obligation to perform contractual
services and therefore is a reduction of research and development
expenses as incurred. The reduction to research and development
expenses related to the 2020 RPI Funding Agreement for the three
and six months ended June 30, 2021 was $10,016 and
$10,205.
The following table shows the activity within the liability related
to sales of future royalties account for the six months ended June
30, 2021 and 2020, respectively, related to the 2018 and 2020 RPI
Funding Agreements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
Liability related to sale of future royalties - beginning
balance
|
|
$ |
335,282 |
|
|
$ |
144,111 |
|
|
|
|
|
|
Royalty revenues payable to RPI |
|
(3,419) |
|
|
(228) |
|
Interest expense on liability related to sale of future
royalties |
|
28,007 |
|
|
19,995 |
|
Liability related to sale of future royalties - ending
balance
|
|
$ |
359,870 |
|
|
$ |
163,878 |
|
8. Mandatorily Redeemable Preferred Shares,
net
In April 2019, the Company sold 2,495 Series A preferred shares
(the "Series A Preferred Shares") to RPI at a price of $50,100 per
preferred share pursuant to a Series A preferred share purchase
agreement (the "Preferred Share Agreement"). The gross proceeds
from the transaction with RPI were $125,000, with $105,000 of the
proceeds used to purchase a priority review voucher ("PRV") issued
by the United States Secretary of Health and Human Services to
potentially expedite the regulatory review of the new drug
application ("NDA") for the ODT formulation of rimegepant and the
remainder of the proceeds to be used for other general corporate
purposes. Pursuant to the Preferred Share Agreement, the Company
had the option to issue additional Series A Preferred Shares to RPI
in up to three additional closings for an aggregate amount of
$75,000. The Company was not obligated to issue any additional
Series A Preferred Shares, subject to a fee up to $3,000 if not all
of the Series A Preferred Shares were issued. In the third quarter
of 2020, the Company determined it will not exercise the option to
issue additional Series A Preferred Shares and accordingly
recognized the full $3,000 fee in other expense in the condensed
consolidated statements of operations and comprehensive
loss.
The holders of the Company's outstanding Series A Preferred Shares
will have the right to require redemption of the shares in certain
circumstances. If a Change of Control, as defined in the Company's
memorandum and article of association, occurs and the Series A
Preferred Shares have not previously been redeemed, the Company
must redeem the Series A Preferred Shares for two times (2x)
the original purchase price of the Series A Preferred Shares
payable in a lump sum at the closing of the Change of Control or in
equal quarterly installments following the closing of the Change of
Control through December 31, 2024.
The Company may redeem the Series A Preferred Shares at its
option at any time for two times (2x) the original purchase price,
which redemption price may be paid in a lump sum or in equal
quarterly installments through December 31, 2024.
In the event that the Company defaults on any obligation to redeem
Series A Preferred Shares when required, the redemption amount
shall accrue interest at the rate of eighteen percent (18%) per
annum. If any such default continues for at least one year, the
holders of such shares shall be entitled to convert, subject to
certain limitations, such Series A Preferred Shares into
common shares, with no waiver of their redemption
rights.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
8. Mandatorily Redeemable Preferred Shares, net
(Continued)
The Company is required to redeem the Series A Preferred Shares for
two times (2x) the original purchase price, payable beginning March
31, 2021 in equal quarterly installments through December 31, 2024.
Accordingly, the Company has concluded the Series A Preferred
Shares are mandatorily redeemable instruments and classified as a
liability. The Company initially measured the liability at fair
value, and will subsequently accrete the carrying value to the
redemption value through interest expense using the effective
interest rate method. The effective interest rate under the
Preferred Share Agreement, including transaction costs, was
determined to be approximately 20% as of June 30, 2021. The Company
recognized $7,677 and $6,993 in interest expense for the three
months ended June 30, 2021 and June 30, 2020, respectively. The
Company recognized $15,620 and $12,554 in interest expense for the
six months ended June 30, 2021 and June 30, 2020, respectively. The
Company had 2,183 and 2,495 Series A Preferred Shares issued and
outstanding as of June 30, 2021 and December 31, 2020,
respectively.
The following table shows the activity within the Series A
preferred share liability for the six months ended June 30, 2021
and 2020, respectively:
|
|
|
|
|
|
|
|
|
|
|
Carrying Value |
Gross balance at December 31, 2020 |
|
$ |
174,264 |
|
Interest expense recognized, excluding transaction cost
amortization |
|
15,599 |
|
Redemption of Series A preferred shares |
|
(31,250) |
|
Gross balance at June 30, 2021 |
|
$ |
158,613 |
|
Less: unamortized transaction costs |
|
(152) |
|
Net balance at June 30, 2021 |
|
$ |
158,461 |
|
|
|
|
Gross balance at December 31, 2019 |
|
$ |
103,864 |
|
Partial settlement of derivative liability |
|
42,821 |
|
Interest expense recognized, excluding transaction cost
amortization |
|
12,532 |
|
Gross balance at June 30, 2020 |
|
$ |
159,217 |
|
Less: unamortized transaction costs |
|
(196) |
|
Net balance at June 30, 2020 |
|
$ |
159,021 |
|
Certain scenarios as described in the Preferred Share Agreement
were determined by the Company to result in a derivative liability.
The with-and-without valuation method was used to determine the
fair value of the embedded derivatives within the agreement. As
inputs into the valuation, the Company considered the type and
probability of occurrence of certain events, the amount of the
payments, the expected timing of certain events, and a
risk-adjusted discount rate. In accordance with ASC 815,
Derivatives and Hedging, the fair value of the derivative was
recorded on the balance sheet as a Series A preferred shares
derivative liability with changes in fair value recorded in other
income (expense) in the condensed consolidated statements of
operations and comprehensive loss (see Note 4 for details on the
fair value measurement).
Upon the FDA's approval of NURTEC ODT the Company remeasured the
derivative using the inputs noted above. In the first quarter of
2020, the Company partially settled the Series A preferred shares
derivative liability associated with this approval of $42,821,
which modified the timing of the payment obligation related to the
redeemable preferred share liability.
On August 7, 2020, the Company entered into the RPI Series B
Preferred Share Agreement, pursuant to which RPI agreed to invest
in the Company through the purchase of up to 3,992 Series B
Preferred Shares at a price of $50,100 per share. The shares will
be issued in quarterly increments from March 31, 2021 to December
31, 2024. Upon issuance of the Series B Preferred Shares, they will
qualify as mandatorily redeemable instruments and be classified as
a mandatorily redeemable preferred shares liability on the
condensed consolidated balance sheets. The Company will then
measure the liability at fair value, and subsequently accrete the
carrying value to the redemption value through interest expense
using the effective interest rate method. The effective interest
rate under the Series B Preferred Share Agreement was determined to
be approximately 8%,
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
8. Mandatorily Redeemable Preferred Shares, net
(Continued)
and the Company recognized $365 in interest expense for the three
and six months ended June 30, 2021. The Company had 702 and no
Series B preferred shares issued and outstanding, as of June 30,
2021 and December 31, 2020, respectively.
The following table shows the activity within the Series B
preferred share liability for the six months ended June 30,
2021:
|
|
|
|
|
|
|
|
|
|
|
Carrying Value |
Balance at December 31, 2020 |
|
$ |
— |
|
Interest expense recognized |
|
365 |
|
Issuance of Series B preferred shares |
|
36,765 |
|
Balance at June 30, 2021 |
|
$ |
37,130 |
|
9. Shareholders' Equity (Deficit)
Changes in shareholders’ deficit for the three and six months ended
June 30, 2021 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
Amount |
|
Additional Paid-in Capital |
|
Accumulated Deficit |
|
Accumulated Other Comprehensive Income |
|
Biohaven Shareholders' Equity (Deficit) |
|
Non-controlling Interests |
|
Total Shareholders' Equity (Deficit) |
Balances as of December 31, 2020 |
|
60,436,876 |
|
|
$ |
1,249,547 |
|
|
$ |
98,938 |
|
|
$ |
(1,739,169) |
|
|
$ |
314 |
|
|
$ |
(390,370) |
|
|
$ |
(1,819) |
|
|
$ |
(392,189) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares as part of acquisition |
|
115,836 |
|
|
10,673 |
|
|
— |
|
|
— |
|
|
— |
|
|
10,673 |
|
|
— |
|
|
10,673 |
|
Issuance of common shares as payment for license
agreements |
|
110,998 |
|
|
10,243 |
|
|
— |
|
|
— |
|
|
— |
|
|
10,243 |
|
|
— |
|
|
10,243 |
|
Issuance of common shares, net of offering costs |
|
4,037,204 |
|
|
308,243 |
|
|
— |
|
|
— |
|
|
— |
|
|
308,243 |
|
|
— |
|
|
308,243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares under equity incentive plan |
|
365,554 |
|
|
25,315 |
|
|
(23,933) |
|
|
— |
|
|
— |
|
|
1,382 |
|
|
— |
|
|
1,382 |
|
Non-cash share-based compensation expense |
|
— |
|
|
— |
|
|
48,726 |
|
|
— |
|
|
— |
|
|
48,726 |
|
|
— |
|
|
48,726 |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
(264,968) |
|
|
— |
|
|
(264,968) |
|
|
(360) |
|
|
(265,328) |
|
Other comprehensive income |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
95 |
|
|
95 |
|
|
— |
|
|
95 |
|
Balances as of March 31, 2021 |
|
65,066,468 |
|
|
$ |
1,604,021 |
|
|
$ |
123,731 |
|
|
$ |
(2,004,137) |
|
|
$ |
409 |
|
|
$ |
(275,976) |
|
|
$ |
(2,179) |
|
|
$ |
(278,155) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares under equity incentive plan and employee
share purchase plan |
|
173,990 |
|
|
14,173 |
|
|
(6,912) |
|
|
— |
|
|
— |
|
|
7,261 |
|
|
— |
|
|
7,261 |
|
Non-cash share-based compensation expense |
|
— |
|
|
— |
|
|
25,586 |
|
|
— |
|
|
— |
|
|
25,586 |
|
|
— |
|
|
25,586 |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
(210,619) |
|
|
— |
|
|
(210,619) |
|
|
(540) |
|
|
(211,159) |
|
Other comprehensive loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(129) |
|
|
(129) |
|
|
— |
|
|
(129) |
|
Balances as of June 30, 2021 |
|
65,240,458 |
|
|
$ |
1,618,194 |
|
|
$ |
142,405 |
|
|
$ |
(2,214,756) |
|
|
$ |
280 |
|
|
$ |
(453,877) |
|
|
$ |
(2,719) |
|
|
$ |
(456,596) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
9. Shareholders' Equity (Deficit)
(Continued)
Changes in shareholders’ equity (deficit) for the three and six
months ended June 30, 2020 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
Amount |
|
Additional Paid-in Capital |
|
Accumulated Deficit |
|
Accumulated Other Comprehensive Income |
|
Biohaven Shareholders' Equity (Deficit) |
|
Non-controlling Interests |
|
Total Shareholders' Equity (Deficit) |
Balance as of December 31, 2019 |
|
52,385,283 |
|
|
$ |
881,426 |
|
|
$ |
83,523 |
|
|
$ |
(972,373) |
|
|
$ |
— |
|
|
$ |
(7,424) |
|
|
$ |
— |
|
|
$ |
(7,424) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares, net of offering costs |
|
5,555,554 |
|
|
282,833 |
|
|
— |
|
|
— |
|
|
— |
|
|
282,833 |
|
|
— |
|
|
282,833 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares under equity incentive plan |
|
447,111 |
|
|
10,880 |
|
|
(8,273) |
|
|
— |
|
|
— |
|
|
2,607 |
|
|
— |
|
|
2,607 |
|
Non-cash share-based compensation expense |
|
— |
|
|
— |
|
|
16,879 |
|
|
— |
|
|
— |
|
|
16,879 |
|
|
— |
|
|
16,879 |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
(172,937) |
|
|
— |
|
|
(172,937) |
|
|
— |
|
|
(172,937) |
|
Balance as of March 31, 2020 |
|
58,387,948 |
|
|
$ |
1,175,139 |
|
|
$ |
92,129 |
|
|
$ |
(1,145,310) |
|
|
$ |
— |
|
|
$ |
121,958 |
|
|
$ |
— |
|
|
$ |
121,958 |
|
Issuance of common shares under equity incentive plan |
|
1,137,617 |
|
|
23,866 |
|
|
(12,118) |
|
|
— |
|
|
— |
|
|
11,748 |
|
|
— |
|
|
11,748 |
|
Non-cash share-based compensation expense |
|
— |
|
|
— |
|
|
11,762 |
|
|
— |
|
|
— |
|
|
11,762 |
|
|
— |
|
|
11,762 |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
(180,934) |
|
|
— |
|
|
(180,934) |
|
|
— |
|
|
(180,934) |
|
Balance as of June 30, 2020 |
|
59,525,565 |
|
|
$ |
1,199,005 |
|
|
$ |
91,773 |
|
|
$ |
(1,326,244) |
|
|
$ |
— |
|
|
$ |
(35,466) |
|
|
$ |
— |
|
|
$ |
(35,466) |
|
Issuance of Common Shares for the March 2021 Offering
In March 2021, the Company issued and sold 2,686,409 common shares
at a public offering price of $76.00 per share for net proceeds of
approximately $199,500 after deducting underwriting discounts and
commissions of approximately $4,167 and other offering expenses of
approximately $500. In addition, in March 2021, the underwriter of
the March follow-on offering exercised its option to purchase
additional shares, and the Company issued and sold 402,961 common
shares for net proceeds of approximately $30,000 after deducting
underwriting discounts and commissions of approximately $625. Thus,
the aggregate net proceeds to the Company from the follow-on
offering, after deducting underwriting discounts and commissions
and other offering costs, were approximately $229,500.
Acquisition of Kleo Pharmaceuticals, Inc.
On January 4, 2021, the Company acquired Kleo Pharmaceuticals, Inc.
(Note 6). In the merger, each share of Kleo common stock issued and
outstanding immediately prior to the effective time of the merger
was converted into the right to receive approximately 0.007 of a
common share of the Company, rounded up to the nearest whole share.
Prior to the consummation of the merger, the Company owned
approximately 41.9% of the outstanding shares of Kleo through its
subsidiary Therapeutics, resulting in 115,836 common shares of the
Company being issued to Kleo stockholders in the
merger.
Yale MoDE Agreement
On January 1, 2021, the Company entered into a worldwide, exclusive
license agreement for the development and commercialization of a
novel Molecular Degrader of Extracellular Protein (MoDEs) platform
based on ground-breaking research conducted in the laboratory of
Professor David Spiegel at Yale University (Note 13). Under the
agreement, the Company paid Yale University an upfront cash payment
of $1,000 and 11,668 shares valued at $1,000, both of which were
included in research and development expense in the condensed
consolidated statements of operations and comprehensive
loss.
Consulting Agreement with Moda Pharmaceuticals LLC
On January 1, 2021, the Company entered into a consulting services
agreement with Moda Pharmaceuticals LLC to further the scientific
and commercial advancement of technology, drug discovery platforms,
product candidates and related intellectual property owned or
controlled by the Company (Note 13). Under the agreement, the
Company paid Moda an upfront cash payment of $2,700 and 37,836
shares valued at $3,243, both of which were included in research
and development expense in the condensed consolidated statements of
operations and comprehensive loss.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
9. Shareholders' Equity (Deficit)
(Continued)
Equity Distribution Agreement
In December 2020, the Company entered into an equity distribution
agreement with Goldman Sachs & Co. LLC, Piper Sandler &
Co., SVB Leerink LLC, Canaccord Genuity LLC, Mizuho Securities USA
LLC, Wedbush Securities Inc., and William Blair & Company,
L.L.C., as our sales agents (the "Equity Distribution Agreement").
In accordance with the terms of the Equity Distribution Agreement,
we may offer and sell common shares having an aggregate offering
price of up to $400,000 from time to time through or to the sales
agents, acting as our agents or principals. Sales of our common
shares will be made in sales deemed to be “at the market offerings”
as defined in Rule 415 promulgated under the Securities Act of
1933, as amended, or the Securities Act, in ordinary brokers’
transactions, to or through a market maker, on or through the New
York Stock Exchange or any other market venue where the securities
may be traded, in the over-the-counter market, in privately
negotiated transactions, or through a combination of any such
methods of sale. The sales agents may also sell our common shares
by any other method permitted by law. The sales agents are not
required to sell any specific amount of securities but will act as
our sales agents using commercially reasonable efforts consistent
with their normal trading and sales practices, on mutually agreed
terms between the sales agents and us. The Company issued and sold
no shares in the three months ended June 30, 2021, and 939,328
common shares for net proceeds of approximately $78,743 during the
six months ended June 30, 2021.
Issuance of Series A Preferred Shares and Employee Share Options by
Consolidated Subsidiary
In September 2020, the Company's Asia-Pacific Subsidiary, BioShin
Limited, authorized, issued and sold 15,384,613 BioShin Series A
Preferred Shares at a price of $3.90 per share for a total of
$60,000 to a group of investors led by OrbiMed, with participation
from Cormorant Asset Management LLC, HBM Healthcare Investments
Ltd, Surveyor Capital (a Citadel Company), and Suvretta Capital
Management, LLC (the "BioShin Investors"). The BioShin Series A
Preferred Shares contain both a call option by the Company and a
put option held by the BioShin Investors. The call and put options
have mirroring features that allow for the Company to buy, or the
BioShin Investors to sell the preferred shares following a change
of control of the Company at the greater of the fair market value
of the BioShin preferred shares on execution of the options or a
multiple of 2.5x to 3.5x dependent on when the change of control
occurs, prior to an initial public offering of BioShin. Due to the
contingently redeemable features, the Company has classified the
BioShin Series A Preferred Shares in mezzanine equity since the
redemption is out of the Company's control. In the event that a
change of control becomes probable, the Company will accrete the
carrying value of the BioShin Series A Preferred Shares to their
redemption value.
In connection with the BioShin Series A Preferred Shares issuance,
BioShin Limited executed the 2020 Equity Incentive Plan ("BioShin
2020 Equity Incentive Plan") and granted options under the BioShin
2020 Equity Incentive Plan to certain employees. The compensation
expense is measured at the grant date based on the fair value of
the award and is recognized as expense over the requisite service
period of the award (generally three years) using the straight-line
method. The Company is accounting for the expense being recognized
over the requisite service period as non-controlling interest in
shareholder's equity. The Company recognized $540 and $900 in
non-controlling interest relating to the options for the three and
six months ended June 30, 2021, respectively.
Artizan Biosciences Inc.
In December 2020, the Company entered into a Series A-2 Preferred
Stock Purchase Agreement with Artizan Biosciences Inc. ("Artizan")
(Note 13). Under the agreement, the Company paid Artizan 61,494
shares valued at $6,000, which were issued in January 2021. In
exchange, the Company acquired 34,472,031 shares of series A-2
preferred stock of Artizan.
Issuance of Common Shares for the January 2020
Offering
In January 2020, the Company issued and sold 4,830,917 common
shares at a public offering price of $51.75 per share for net
proceeds of approximately $245,877 after deducting underwriting
discounts and commissions of approximately $3,623 and other
offering expenses of approximately $500. In addition, in February
2020, the underwriter of the January follow-on offering exercised
its option to purchase additional shares, and the Company issued
and sold 724,637 common shares for net proceeds of approximately
$36,956 after deducting underwriting discounts and commissions of
approximately $543. Thus, the aggregate net proceeds to the Company
from the follow-on offering, after deducting underwriting discounts
and commissions and other offering costs, were approximately
$282,833.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
10. Accumulated Other Comprehensive Income (Loss)
Shareholders’ deficit included the following activity in
accumulated other comprehensive income for the three and six months
ended June 30, 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2021 |
|
Six Months Ended June 30, 2021 |
|
|
|
|
|
Net unrealized investment gains (losses): |
|
|
|
|
Beginning of period balance |
|
$ |
(43) |
|
|
$ |
(125) |
|
Other comprehensive income(1)
|
|
73 |
|
|
136 |
|
Amounts reclassified from accumulated other comprehensive
income(1)
|
|
— |
|
|
19 |
|
Other comprehensive income |
|
73 |
|
|
155 |
|
End of period balance |
|
30 |
|
|
30 |
|
|
|
|
|
|
Foreign currency translation adjustments: |
|
|
|
|
Beginning of period balance |
|
452 |
|
|
439 |
|
Other comprehensive loss(1)
|
|
(202) |
|
|
(189) |
|
|
|
|
|
|
End of period balance |
|
250 |
|
|
250 |
|
|
|
|
|
|
Total beginning of period accumulated other comprehensive
income |
|
409 |
|
|
314 |
|
Total other comprehensive loss |
|
(129) |
|
|
(34) |
|
Total end of period accumulated other comprehensive
income |
|
$ |
280 |
|
|
$ |
280 |
|
(1)
There was no tax on other comprehensive income (loss) or amounts
reclassified from accumulated other comprehensive income during the
period
The Company had no accumulated other comprehensive income (loss)
included in shareholders' deficit as of June 30, 2020.
11. Share-Based Compensation
Non-Cash Share-Based Compensation Expense
Non-cash share-based compensation is measured at the grant date
based on the fair value of the award and is recognized as expense
over the requisite service period of the award (generally
three to four years) using the straight-line method.
Non-cash share-based compensation expense, consisting of expense
for stock options, Restricted Share Units ("RSUs") and Employee
Share Purchase Plan ("ESPP"), was classified in the condensed
consolidated statements of operations and comprehensive loss as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Research and development expenses |
|
$ |
9,273 |
|
|
$ |
6,426 |
|
|
$ |
29,331 |
|
|
$ |
12,677 |
|
Selling, general and administrative expenses |
|
16,313 |
|
|
5,336 |
|
|
44,981 |
|
|
15,964 |
|
Total non-cash share-based compensation expense |
|
$ |
25,586 |
|
|
$ |
11,762 |
|
|
$ |
74,312 |
|
|
$ |
28,641 |
|
Less: Share-based compensation expense attributable to
non-controlling interests |
|
540 |
|
|
— |
|
|
900 |
|
|
— |
|
Share-based compensation expense attributable to Biohaven
Pharmaceutical Holding Company Ltd. |
|
$ |
25,046 |
|
|
$ |
11,762 |
|
|
$ |
73,412 |
|
|
$ |
28,641 |
|
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
11. Share-Based Compensation (Continued)
Stock Options
All stock option grants are awarded at fair value on the date of
grant. The fair value of stock options is estimated using the
Black-Scholes option pricing model and stock-based compensation is
recognized on a straight-line basis over the requisite service
period. Stock options granted generally become exercisable over a
three-year or
four-year period from the grant date. Stock options
generally expire 10 years after the grant date.
The aggregate intrinsic value of stock options is calculated as the
difference between the exercise price of the stock options and the
fair value of the Company's common shares for those stock options
that had exercise prices lower than the fair value of the Company's
common shares at June 30, 2021.
As of June 30, 2021, the Company's unrecognized compensation
expense related to unvested stock options totaled $76,622, which
the Company expects to be recognized over a weighted-average period
of 1.87 years. The Company expects approximately 3,167,723 of the
unvested stock options to vest over the requisite service
period.
The following table is a summary of the Company's stock option
activity for the six months ended June 30, 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
Weighted Average Exercise Price |
|
Weighted Average Remaining Contractual Term (in years) |
|
Aggregate Intrinsic Value |
Outstanding as of December 31, 2020 |
|
7,545,907 |
|
|
$28.21 |
|
|
|
|
Granted |
|
1,252,530 |
|
|
$82.53 |
|
|
|
|
Exercised |
|
(153,847) |
|
|
$35.05 |
|
|
|
|
Forfeited |
|
(70,790) |
|
|
$55.98 |
|
|
|
|
Outstanding as of June 30, 2021 |
|
8,573,800 |
|
|
$35.78 |
|
6.92 |
|
$ |
525,563 |
|
Options exercisable as of June 30, 2021 |
|
5,406,077 |
|
|
$25.91 |
|
6.17 |
|
$ |
384,734 |
|
Vested and expected to vest as of June 30, 2021 |
|
8,573,800 |
|
|
$35.78 |
|
6.92 |
|
$ |
525,563 |
|
Restricted Share Units
The Company’s RSUs are considered nonvested share awards and
require no payment from the employee. For each RSU, employees
receive one common share at the end of the vesting period. The
employee can elect to receive the one common share net of taxes or
pay for taxes separately and receive the entire share. Compensation
cost is recorded based on the market price of the Company’s common
shares on the grant date and is recognized on a straight-line basis
over the requisite service period.
As of June 30, 2021, there was $74,781 of total unrecognized
compensation cost related to Company RSUs that are expected to
vest. These costs are expected to be recognized over a
weighted-average period of 2.41 years. The total fair value of RSUs
vested during the six months ended June 30, 2021 was
$25,846.
The following table is a summary of the RSU activity for the six
months ended June 30, 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
Weighted Average Grant Date Fair Value |
Unvested outstanding as of December 31, 2020 |
|
467,160 |
|
|
$56.00 |
Granted |
|
1,093,250 |
|
|
$82.86 |
Forfeited |
|
(25,631) |
|
|
$75.23 |
Vested |
|
(355,308) |
|
|
$72.74 |
Unvested outstanding as of June 30, 2021 |
|
1,179,471 |
|
|
$75.43 |
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
12. Net Loss Per Share
Basic and diluted net loss per share attributable to common
shareholders of Biohaven Pharmaceutical Holding Company Ltd.
was calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Numerator: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(211,159) |
|
|
$ |
(180,934) |
|
|
$ |
(476,487) |
|
|
$ |
(353,871) |
|
Net loss attributable to non-controlling interests |
|
(540) |
|
|
— |
|
|
(900) |
|
|
— |
|
Net loss attributable to common shareholders of Biohaven
Pharmaceutical Holding Company Ltd. |
|
$ |
(210,619) |
|
|
$ |
(180,934) |
|
|
$ |
(475,587) |
|
|
$ |
(353,871) |
|
Denominator: |
|
|
|
|
|
|
|
|
Weighted average common shares outstanding—basic and
diluted |
|
65,112,179 |
|
|
58,742,329 |
|
|
63,584,932 |
|
|
57,577,384 |
|
Net loss per share attributable to common shareholders of Biohaven
Pharmaceutical Holding Company Ltd.—basic and diluted |
|
$ |
(3.23) |
|
|
$ |
(3.08) |
|
|
$ |
(7.48) |
|
|
$ |
(6.15) |
|
The Company’s potential dilutive securities, which include stock
options, restricted share units, and warrants to purchase common
shares, have been excluded from the computation of diluted net loss
per share as the effect would be to reduce the net loss per share.
Therefore, the weighted average number of common shares outstanding
used to calculate both basic and diluted net loss per share
attributable to common shareholders of the Company is the
same.
The Company excluded the following potential common shares,
presented based on amounts outstanding at each period end, from the
computation of diluted net loss per share attributable to common
shareholders for the periods indicated because including them would
have had an anti-dilutive effect:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, |
|
|
2021 |
|
2020 |
Options to purchase common shares |
|
8,573,800 |
|
|
8,120,648 |
|
Warrants to purchase common shares |
|
106,751 |
|
|
106,751 |
|
Restricted share units |
|
1,179,471 |
|
|
477,798 |
|
Total |
|
9,860,022 |
|
|
8,705,197 |
|
13. License and Other Agreements
Yale University Agreements
In September 2013, the Company entered into an exclusive license
agreement with Yale University (the "Yale Agreement") to obtain a
license to certain patent rights for the commercial development,
manufacture, distribution, use and sale of products and processes
resulting from the development of those patent rights, related to
the use of riluzole in treating various neurological conditions,
such as general anxiety disorder, post-traumatic stress disorder
and depression. As part of the consideration for this license, the
Company issued Yale 250,000 common shares and granted Yale the
right to purchase up to 10% of the securities issued in specified
future equity offerings by the Company, in addition to the
obligation to issue shares to prevent anti-dilution. The obligation
to contingently issue equity to Yale was no longer outstanding as
of December 31, 2018.
The Yale Agreement was amended and restated in May 2019. As
amended, the Company agreed to pay Yale up to $2,000 upon the
achievement of specified regulatory milestones and annual royalty
payments of a low single-digit percentage based on net sales of
riluzole-based products from the licensed patents or from products
based on troriluzole. Under the amended and restated agreement, the
royalty rates are reduced as compared to the original agreement. In
addition, under the amended and
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
13. License and Other Agreements (Continued)
restated agreement, the Company may develop products based on
riluzole or troriluzole. The amended and restated agreement retains
a minimum annual royalty of up to $1,000 per year, beginning after
the first sale of product under the agreement. If the Company
grants any sublicense rights under the Yale Agreement, it must pay
Yale a low single-digit percentage of sublicense income that it
receives. To date, no milestone or royalty payments have been made
under this agreement.
In January 2021, the Company entered a worldwide, exclusive license
agreement with Yale University for the development and
commercialization of a novel Molecular Degrader of Extracellular
Protein ("MoDE") platform (the "Yale MoDE Agreement"). Under the
license agreement, Biohaven acquired exclusive, worldwide rights to
Yale's intellectual property directed to its MoDE platform. The
platform pertains to the clearance of disease-causing protein and
other biomolecules by targeting them for lysosomal degradation
using multi-functional molecules. As part of consideration for this
license, the Company paid Yale University an upfront cash payment
of $1,000 and 11,668 common shares valued at approximately $1,000.
Under the agreement, the Company may develop products based on the
MoDE platform. The agreement includes an obligation to pay a
minimum annual royalty of up to $1,000 per year, and low single
digit royalties on the net sales of licensed products. If the
Company grants any sublicense rights under the Yale Agreement, it
must pay Yale a low single-digit percentage of sublicense income
that it receives. In addition, Yale University will be eligible to
receive additional development milestone payments of up to $800 and
commercial milestone payments of up to $2,950. The agreement
terminates on the later of twenty years from the effective date,
twenty years from the filing date of the first investigational new
drug application for a licensed product or the last to expire of a
licensed patent.
For the three and six months ended June 30, 2021, excluding the
upfront payments noted above, the Company did not record any
material expense, or make any milestone or royalty payments under
the Yale Agreement or the Yale MoDE Agreement.
ALS Biopharma Agreement
In August 2015, the Company entered into an agreement (the "ALS
Biopharma Agreement") with ALS Biopharma and FCCDC, pursuant to
which ALS Biopharma and FCCDC assigned the Company their worldwide
patent rights to a family of over 300 prodrugs of glutamate
modulating agents, including troriluzole, as well as other
innovative technologies. Under the ALS Biopharma Agreement, the
Company is obligated to use commercially reasonable efforts to
commercialize and develop markets for the patent products. The
Company is obligated to pay $3,000 upon the achievement of
specified regulatory milestones with respect to the first licensed
product and $1,000 upon the achievement of specified regulatory
milestones with respect to subsequently developed products, as well
as royalty payments of a low single-digit percentage based on net
sales of products licensed under the agreement, payable on a
quarterly basis. To date, no milestone or royalty payments have
been made under this agreement.
The ALS Biopharma Agreement terminates on a country-by-country
basis as the last patent rights expire in each such country. If the
Company abandons its development, research, licensing or sale of
all products covered by one or more claims of any patent or patent
application assigned under the ALS Biopharma Agreement, or if the
Company ceases operations, it has agreed to reassign the applicable
patent rights back to ALS Biopharma.
For the three and six months ended June 30, 2021 and 2020, the
Company did not record any expense or make any milestone or royalty
payments under the ALS Biopharma Agreement.
Catalent Agreements for Rimegepant
In January 2018, the Company entered into an exclusive
world-wide license and development agreement with Catalent U.K.
Swindon Zydis Limited, a subsidiary of Catalent, Inc. ("Catalent")
pursuant to which the Company obtained certain license rights to
the Zydis ODT technology for use with NURTEC ODT. Since NURTEC ODT
utilizes the Zydis ODT technology, the agreement permits the
Company to purchase the commercial product from Catalent at a fixed
price, inclusive of a royalty. Under the agreement, Catalent will
not develop or manufacture a formulation of any oral CGRP compound
using Zydis ODT technology for itself or a third party until 2031,
subject to certain minimum commercial revenues.
Under this agreement, the Company is responsible for conducting
clinical trials and preparing and filing regulatory submissions.
The Company has the right to sublicense its rights under the
agreement subject to Catalent’s prior written consent. Catalent has
the right to enforce the patents covering the Zydis technology and
to defend any allegation that a formulation using Zydis technology,
such as NURTEC ODT, infringes a third party’s patent.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
13. License and Other Agreements (Continued)
This agreement terminates on a country-by-country basis upon the
later of (i) 10 years after the launch of the most
recently launched product in such country and (ii) the
expiration of the last valid claim covering each product in such
country, unless earlier voluntarily terminated by the Company or by
Catalent. This agreement automatically extends for one-year terms
unless either party gives advance notice of intent to terminate. In
addition, Catalent may terminate the agreement either in its
entirety or terminate the exclusive nature of the agreement on a
country-by-country basis if, among other things, the Company fails
to meet specified development timelines, which the Company may
extend in certain circumstances.
In connection with the agreement with Catalent, upon FDA approval
of NURTEC ODT on February 27, 2020, the Company became obligated to
pay Catalent up to $1,500 upon the achievement of specified
regulatory and commercial milestones. The Company recorded the
$1,500 in milestone payments as an intangible asset in its
condensed consolidated balance sheets in the first quarter of 2020,
and is amortizing the expense to cost of goods sold on its
condensed consolidated statement of operations and comprehensive
loss over the patent life. The Company paid $750 of the $1,500 in
milestone payments to Catalent in the first quarter of 2020 and
paid the remaining $750 in milestone payments in the second quarter
of 2020.
Rutgers Agreement
In June 2016, the Company entered into an exclusive license
agreement (the "Rutgers Agreement") with Rutgers, The State
University of New Jersey ("Rutgers"), licensing several patents and
patent applications related to the use of riluzole to treat various
cancers. Under the Rutgers Agreement, the Company is required to
pay Rutgers annual license maintenance fees until the first
commercial sale of a licensed product, at which point the Company
will pay Rutgers minimum annual royalties. The Company is also
obligated to pay Rutgers up to $825 in the aggregate upon the
achievement of specified clinical and regulatory milestones. The
Company agreed to pay Rutgers royalties of a low single-digit
percentage of net sales of licensed products sold by the Company,
its affiliates or its sublicensees, subject to a minimum amount of
up to $100 per year. If the Company grants any sublicense rights
under the Rutgers Agreement, the Company must pay Rutgers a low
double-digit percentage of sublicense income it
receives.
Under the Rutgers Agreement, in the event that the Company
experiences a change of control or sale of substantially all of its
assets prior to the initiation of a Phase 3 clinical trial related
to products licensed under the agreement, and such change of
control or sale results in a full liquidation of the Company, the
Company will be obligated to pay Rutgers a change-of-control fee
equal to 0.30% of the total value of the transaction, but not less
than $100. The Company determined that the change-of-control
payment should be accounted for as a liability. The fair value of
the obligation for all periods presented was $0 based on the
Company's assessment that the probability of a change-in-control
event occurring prior to the initiation of a Phase 3 clinical trial
related to products licensed under the agreement was
remote.
The Rutgers Agreement also requires the Company to meet certain due
diligence requirements based upon specified milestones. The Company
can elect to extend the deadline for its compliance with the due
diligence requirements by a maximum of one year upon payments to
Rutgers of up to $500 in the aggregate. Under the Rutgers
Agreement, the Company is required to reimburse Rutgers for any
fees that Rutgers incurs related to the filing, prosecution,
defending, and maintenance of patent rights licensed under the
agreement. The Rutgers Agreement expires upon expiration of the
patent rights under the agreement or ten years from the date of
first commercial sale of a licensed product, whichever is later,
unless terminated by either party.
For the three and six months ended June 30, 2021 and 2020, the
Company did not record any material expense or make any milestone
or royalty payments under the Rutgers Agreement.
BMS Agreement
In July 2016, the Company entered into an exclusive, worldwide
license agreement with BMS (the "BMS Agreement") for the
development and commercialization rights to rimegepant and
zavegepant, as well as other CGRP-related intellectual property. In
exchange for these rights, the Company agreed to pay BMS initial
payments, milestone payments and royalties on net sales of licensed
products under the agreement.
The Company is obligated to make milestone payments to BMS upon the
achievement of specified development and commercialization
milestones. The development milestone payments due under the
agreement depend on the licensed product being developed. With
respect to rimegepant, the Company is obligated to pay up to
$127,500 in the aggregate upon the
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
13. License and Other Agreements (Continued)
achievement of the development milestones. For any product other
than rimegepant, the Company is obligated to pay up to $74,500 in
the aggregate upon the achievement of the development milestones.
In addition, the Company is obligated to pay up to $150,000 for
each licensed product upon the achievement of commercial
milestones. If the Company receives revenue from sublicensing any
of its rights under the agreement, it is also obligated to pay a
portion of that revenue to BMS. The Company is also obligated to
make tiered royalty payments to BMS based on annual worldwide net
sales, with percentages in the low to mid-teens.
Under the BMS Agreement, the Company is obligated to use
commercially reasonable efforts to develop licensed products and to
commercialize at least one licensed product using the patent rights
licensed from BMS and is solely responsible for all development,
regulatory and commercial activities and costs. The Company is also
required to reimburse BMS for any fees that BMS incurs related to
the filing, prosecution, defending, and maintenance of patent
rights licensed under the BMS Agreement. Under the BMS Agreement,
BMS transferred to the Company manufactured licensed products,
including certain materials that will be used by the Company to
conduct clinical trials.
The BMS Agreement will terminate on a licensed product-by-licensed
product and country-by-country basis upon the expiration of the
royalty term with respect to each licensed product in each country
and can also be terminated if certain events occur, e.g., material
breach or insolvency.
In March 2018, the Company entered into an amendment to the BMS
Agreement (the “2018 BMS Amendment”) Under the 2018 BMS Amendment,
the Company paid BMS an upfront payment of $50,000 in return for a
low single-digit reduction in the royalties payable on net sales of
rimegepant and a mid single-digit reduction in the royalties
payable on net sales of zavegepant, recorded in Research and
Development expense in the Condensed Consolidated Statements of
Operations and Comprehensive Loss.
The BMS Amendment also removes BMS’s right of first negotiation to
regain its intellectual property rights or enter into a license
agreement with the Company following the Company’s receipt of
topline data from its Phase 3 clinical trials with rimegepant, and
clarifies that antibodies targeting CGRP are not prohibited as
competitive compounds under the non-competition clause of the
Original License Agreement.
In August 2020, the Company entered into a further amendment of the
BMS Agreement (the “August 2020 BMS Amendment”) Under the August
2020 BMS Amendment, the Company paid BMS an upfront payment of
$5,000 in return for a reduction in the royalties payable on net
sales of rimegepant and zavegepant in China, with percentages in
the low to mid-single digits. In addition, the Company is obligated
to pay up to $22,500 for each licensed product upon the achievement
of commercial milestones in China. The August 2020 BMS Amendment
also amended the BMS Agreement to remove sales in China from the
commercial milestone payment obligations.
In November 2020, the Company entered into a further amendment of
the BMS Agreement (the “November 2020 BMS Amendment”). Under the
November 2020 BMS Amendment, certain exclusivity provisions under
the BMS Agreement are waived which permits the Company to develop
certain CGRP compounds licensed by the Company from Heptares
Therapeutics Limited (“Heptares”). Under the November 2020
Amendment, if the Company initiates clinical development of a
Heptares compound prior to July 8, 2023, the Company is obligated
to pay BMS certain fees based on net sales of the Heptares
compounds from low single percentage to 10% and pay up to $17,500
for each Heptares compound upon the achievement of certain
development milestones and up to $150,000 for each Heptares
compound upon the achievement of certain commercial milestones. No
fees or milestones are due by the Company to BMS for Heptares
compounds that begin clinical trials after July 8,
2023.
The BMS License Agreement continues to provide the Company with
exclusive global development and commercialization rights to
rimegepant, zavegepant and related CGRP molecules, as well as
related know-how and intellectual property. The Company’s
obligations to make development milestone payments to BMS under the
Original License Agreement remain unchanged.
In connection with the BMS Agreement, upon FDA approval of NURTEC
ODT on February 27, 2020, the Company became obligated to pay BMS
$40,000 in milestone payments. The Company recorded the $40,000 in
milestone payments as an intangible asset on its condensed
consolidated balance sheets in the first quarter of 2020, and will
amortize the expense to cost of goods sold on its condensed
consolidated statement of operations and comprehensive loss over
the patent life. The Company
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
13. License and Other Agreements (Continued)
paid $20,000 of the $40,000 in milestone payments to BMS in the
first quarter of 2020 and the remaining $20,000 in milestone
payments in the third quarter of 2020.
In connection with the BMS Agreement, the Company was required to
pay $2,000 to BMS on commencement of a Phase 1 clinical trial,
$4,000 on commencement of a Phase 2 clinical trial, and $6,000 on
commencement of a Phase 3 clinical trial, the occurrence of which
the Company believes is probable, for certain milestones relating
to the development of zavegepant. Accordingly, the Company
recognized these liabilities in accrued expenses within the
condensed consolidated balance sheets in the fourth quarter of
2018, first quarter of 2019, and fourth quarter of 2019,
respectively. Per the BMS Agreement, the $2,000 and $4,000 payment
obligations under the agreement were deferred until the earlier of
FDA approval of rimegepant or the discontinuation of the rimegepant
development program. Upon FDA approval of NURTEC ODT on February
27, 2020, the Company became obligated to pay BMS the $2,000 and
$4,000 milestone payments for the commencement of the Phase 1 and
Phase 2 clinical trials of zavegepant, respectively, and made the
milestone payments in the second quarter of 2020. The Company paid
the $6,000 milestone payment following the commencement of the
Phase 3 clinical trial of zavegepant in the fourth quarter of 2020.
In the first quarter of 2021, the Company accrued a $5,000
development milestone expense following the regulatory filing for
rimegepant in Europe, which was paid in the second quarter of
2021.
For the three and six months ended June 30, 2021, the Company
recorded $9,293 and $13,678, respectively, in royalty expense in
cost of goods sold on the condensed consolidated statements of
operations and comprehensive loss under the BMS agreement. For the
three and six months ended June 30, 2020, the Company recorded $860
and $975, respectively, in royalty expense in cost of goods sold on
the condensed consolidated statements of operations and
comprehensive loss under the BMS agreement.
2016 AstraZeneca Agreement
In October 2016, the Company entered into an exclusive license
agreement (the "2016 AstraZeneca Agreement") with AstraZeneca,
pursuant to which AstraZeneca granted the Company a license to
certain patent rights for the commercial development, manufacture,
distribution and use of any products or processes resulting from
development of those patent rights, including BHV-5000 and
BHV-5500. In exchange for these rights, the Company agreed to pay
AstraZeneca an upfront payment, milestone payments and royalties on
net sales of licensed products under the agreement. The regulatory
milestones due under the agreement depend on the indication of the
licensed product being developed as well as the territory where
regulatory approval is obtained. Development milestones due under
the agreement with respect to Rett syndrome total up to $30,000,
and, for any indication other than Rett syndrome, total up to
$60,000. Commercial milestones are based on net sales of all
products licensed under the agreement and total up to $120,000. The
Company has also agreed to pay tiered royalties based on net sales
of all products licensed under the agreement of mid-single-digit to
low double-digit percentages. If the Company receives revenue from
sublicensing any of its rights under the 2016 AstraZeneca
Agreement, the Company is also obligated to pay a portion of that
revenue to AstraZeneca. To date, no payments have been made related
to these milestones or royalties. The Company is also required to
reimburse AstraZeneca for any fees that AstraZeneca incurs related
to the filing, prosecution, defending, and maintenance of patent
rights licensed under the 2016 AstraZeneca Agreement.
The 2016 AstraZeneca Agreement expires upon the expiration of the
patent rights under the agreement or on a country-by-country basis
ten years after the first commercial sale and can also be
terminated if certain events occur, e.g., material breach or
insolvency.
For the three and six months ended June 30, 2021 and 2020, the
Company did not record any expense or make any milestone or royalty
payments under the 2016 AstraZeneca Agreement.
Revenue Participation Rights
In June 2018, pursuant to the 2018 RPI Funding Agreement entered
into by the Company and RPI (Note 7), the Company granted to RPI
the right to receive certain revenue participation payments,
subject to certain reductions, based on the future global net sales
of the Products, for each calendar quarter during the royalty term
contemplated by the 2018 RPI Funding Agreement, in exchange for
$100,000 in cash. Specifically, the participation rate commences at
2.1 percent on annual global net sales of up to and equal to
$1,500,000, declining to 1.5 percent on annual global net sales
exceeding $1,500,000.
In connection with the 2018 RPI Funding Agreement, the Company
recorded, $12,049 and $23,468 in interest expense on its liability
related to sale of future royalties for the three and six months
ended June 30, 2021, respectively, and $11,570 and
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
13. License and Other Agreements (Continued)
$19,995 in interest expense on its liability related to sale of
future royalties for the three and six months ended June 30, 2020,
respectively, The Company paid $920 and $1,656 under the 2018 RPI
Funding Agreement during the three and six months ended June 30,
2021, respectively and no payments under the 2018 RPI Funding
Agreement during the three and six months ended June 30,
2020.
In August 2020, pursuant to the 2020 RPI Funding Agreement, the
Company sold sales-based participation rights on global net sales
of products containing zavegepant and rimegepant to RPI 2019 IFT
for aggregate funding of $250,000, payable in two tranches. For
further details on the transaction see Note 7 “Liability Related to
Sale of Future Royalties, net.”
In connection with the 2020 RPI Funding Agreement, the Company
recorded $2,450 and $4,539 in interest expense on its liability
related to sale of future royalties for the three and six months
ended June 30, 2021, and no interest expense for the three and six
months ended June 30, 2020 . The Company recorded payments of $175
and $315 during the three and six months ended June 30, 2021, and
no payments under the 2020 RPI Funding Agreement during the three
and six months ended June 30, 2020.
2018 License Agreement with AstraZeneca
In September 2018, the Company entered into an exclusive license
agreement (the "2018 AstraZeneca Agreement") with AstraZeneca,
pursuant to which AstraZeneca granted the Company a license to
certain patent rights for the commercial development, manufacture,
distribution and use of any products or processes resulting from
development of those patent rights, including BHV-3241. Under the
2018 AstraZeneca Agreement, the Company paid AstraZeneca an upfront
cash payment of $3,000 and 109,523 shares valued at $4,080 on the
date of settlement, both of which were included in research and
development expense, and is obligated to pay milestone payments to
AstraZeneca totaling up to $55,000 upon the achievement of
specified regulatory and commercial milestones and up to $50,000
upon the achievement of specified sales-based milestones. In
addition, we will pay AstraZeneca tiered royalties ranging from
high single-digit to low double-digits based on net sales of
specified approved products, subject to specified
reductions.
The Company plans to conduct a Phase 3 clinical trial of this
product candidate, which is now referred to as verdiperstat, for
the treatment of multiple system atrophy (“MSA”), a rare, rapidly
progressive and fatal neurodegenerative disease with no cure or
effective treatments. The Company is solely responsible, and has
agreed to use commercially reasonable efforts, for all development,
regulatory and commercial activities related to verdiperstat. The
Company may sublicense its rights under the agreement and, if it
does so, will be obligated to pay a portion of any milestone
payments received from the sublicense to AstraZeneca in addition to
any milestone payments it would otherwise be obligated to
pay.
The Agreement terminates on a country-by-country basis and
product-by-product basis upon the expiration of the royalty term
for such product in such country and can also be terminated if
certain events occur, e.g., material breach or
insolvency.
For the three and six months ended June 30, 2021 and 2020,
excluding the upfront payments noted above, the Company did not
record any material expense or make any milestone or royalty
payments under the 2018 AstraZeneca Agreement.
Fox Chase Chemical Diversity Center Inc. Agreement
In May 2019, Biohaven entered into the FCCDC Agreement in which the
Company purchased certain intellectual property relating to the
TDP-43 protein from FCCDC. The FCCDC Agreement provides the Company
with a plan and goal to identify one or more new chemical entity
candidates for preclinical development for eventual clinical
evaluation for the treatment of one or more TDP-43 proteinopathies.
As consideration, Biohaven issued 100,000 of its common shares to
FCCDC valued at $5,646. The payment was recorded in research and
development expense in the consolidated statement of operations for
the year ended December 31, 2019.
In addition, Biohaven is obligated to pay FCCDC milestone payments
totaling up to $4,500 with $1,000 for each additional NDA filing.
The Company also issued a warrant to FCCDC, granting FCCDC the
option to purchase up to 100,000 Biohaven common shares, at a
strike price of $56.46 per share, subject to vesting upon
achievement of certain milestones in development of
TD-43.
In connection with the FCCDC Agreement, Biohaven and FCCDC have
established a TDP-43 Research Plan which was amended in November
2020, that provides for certain milestones to be achieved by FCCDC,
and milestone payments to be made by the Company up to
approximately $3,800 over a period of up to 30 months as success
fees for research activities by
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
13. License and Other Agreements (Continued)
FCCDC. In addition to the milestone payments, the Company will pay
FCCDC an earned royalty equal to 0% to 10% of net sales of any
TD-43 patent products with a valid claim as defined in the FCCDC
Agreement. The Company may also license the rights developed under
the FCCDC Agreement and, if it does so, will be obligated to pay a
portion of any payments received from such licensee to FCCDC in
addition to any milestones payments it would otherwise be obligated
to pay. The Company is also responsible for the prosecution and
maintenance of the patents related to the TDP-43
assets.
The FCCDC Agreement terminates on a country-by-country basis and
product-by-product basis upon expiration of the royalty term for
such product in such country and can also be terminated if certain
events occur, e.g., material breach or insolvency.
The Company recorded $509 and $1,321 in research and development
expense in the condensed consolidated statements of operations and
comprehensive loss related to the Research Plan milestones with
FCCDC during the three and six months ended June 30, 2021,
respectively. The Company recorded $450 and $1,405 of expense
related to this agreement during the three and six months ended
June 30, 2020, respectively.
Sosei Heptares
In November 2020, the Company entered into a global collaboration
and license agreement with Heptares Therapeutics Ltd. (the
"Heptares Agreement") to obtain rights to develop, manufacture and
commercialize a portfolio of novel, small-molecule CGRP receptor
antagonists discovered by Sosei Heptares for the treatment of
CGRP-mediated disorders. The portfolio includes the lead candidate
BHV-3100 (also known as "HTL0022562"), which has advanced through
preclinical development demonstrating promising and differentiated
properties for further investigation in human trials. As part of
consideration for this license, the Company paid Sosei Heptares an
upfront cash payment of $5,000 and 54,617 shares valued at $4,858,
both of which were included in research and development expense on
the consolidated statement of operations. In addition, Sosei
Heptares will be eligible to receive additional development,
regulatory and commercialization milestone payments of up to
$370,000, as well as earned royalties equal to zero to ten percent
of net sales of products resulting from the collaboration. The
royalty payments are payable on a country-by-country and licensed
product-by-licensed product basis from the date of commercial
launch of a licensed product by Biohaven until the later of: (a)
the expiration of the last valid claim covering the composition of
matter of such licensed product, or its use or manufacture, in such
country; (b) expiration of the regulatory exclusivity period for
such licensed product in the relevant country; and (c) ten (10)
years following the date of the commercial launch of such licensed
product in the relevant country.
Biohaven has the right to terminate the Heptares Agreement for any
reason or no reason: (a) in its entirety during the research term
on one hundred and eighty (180) days’ written notice to Sosei
Heptares; and (b) following the end of the research term, in its
entirety or on a country-by-country basis, on ninety (90) days’
prior written notice to Sosei Heptares. Biohaven will remain liable
to pay (a) any milestone payments that have become due for payment
and/or (b) royalty payments on net sales by Biohaven, in each case
(a) and (b) on or before the termination date.
Heptares has the right to terminate the Heptares Agreement on
thirty (30) days’ written notice to Biohaven if after the end of
the research term, for a continuous period of not less than three
hundred and sixty five (365) days, no material Development
activities have been undertaken by or on behalf of Biohaven on any
licensed product; provided that, at least three (3) months prior to
exercising such termination right Heptares must notify Biohaven of
its concerns and the parties shall discuss in good faith the
reasons why Biohaven is not undertaking such material development
activities and its plans for recommencing such
activities.
For the three and six months ended June 30, 2021, in addition to
the upfront payments noted above, the Company recorded $2,868 and
$3,485, respectively, in research and development expense related
to the Heptares Agreement.
Artizan Biosciences Inc.
In December 2020, Biohaven entered into an Option and License
Agreement with Artizan Biosciences Inc. (the "Artizan Agreement").
Pursuant to the Artizan Agreement, Biohaven acquired an option
(“Biohaven Option”) to obtain a royalty-based license from Artizan
to manufacture, use and commercialize certain products in the
United States. The Biohaven Option is exercisable throughout the
development phase of the products at an exercise price of
approximately $4,000 to $8,000, which varies based on the market
potential of the products. Biohaven and Artizan have also formed a
JSC to oversee, review and
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
13. License and Other Agreements (Continued)
coordinate the product development activities with regard to all
products for which Biohaven has (or has exercised in the future)
the Biohaven Option.
In December 2020, simultaneously with the Option and License
Agreement, the Company and Artizan entered into a Series A-2
Preferred Stock Purchase Agreement, under which Biohaven acquired
34,472,031 shares of series A-2 preferred stock (the “Series A-2
Preferred Stock”) of Artizan, for a total purchase price of
approximately $6,000. The purchase price was paid in shares of
Biohaven’s common stock in January 2021. The Company recorded the
fair value of the Series A-2 Preferred Stock as an other asset on
its consolidated balance sheets.
For the three and six months ended June 30, 2021, excluding the
upfront payments noted above, the Company did not record any
research and development expense or make any milestone payments
related to the Artizan Agreement.
Moda Pharmaceuticals LLC.
On January 1, 2021, the Company entered into a consulting services
agreement with Moda Pharmaceuticals LLC (the "Moda Agreement") to
further the scientific advancement of technology, drug discovery
platforms (including the technology licensed under the Yale MoDE
Agreement), product candidates and related intellectual property
owned or controlled by the Company.
Under the Moda Agreement, the Company paid Moda an upfront cash
payment of $2,700 and 37,836 shares valued at approximately $3,243.
In addition, Moda will be eligible to receive additional
development milestone payments of up to $81,612 and commercial
milestone payments of up to $30,171. The Moda Agreement has a term
of four years and may be terminated earlier by the Company or Moda
under certain circumstances including, for example, the Company's
discontinuation of research on the MoDE platform or
default.
For the three and six months ended June 30, 2021, excluding the
upfront payments noted above, the Company did not record any
material research and development expense or make any milestone
payments related to the Moda Agreement.
Reliant Glycosciences, LLC
In July 2021, the Company entered into a development and licenses
agreement with Reliant Glycosciences, LLC (the "Reliant
Agreement"). Under the Reliant Agreement, the Company paid Reliant
an upfront share payment valued at approximately $3,686. In
addition, Reliant will be eligible to receive development milestone
payments of up to $36,500, and royalties of a low single-digit
percentage of net sales of licensed products.
14. Debt
In August 2020, the Borrowers, entered into the Sixth Street
Financing Agreement, as amended, pursuant to which the Lenders
agreed to extend a senior secured credit facility to the Company
providing for term loans in an aggregate principal amount up to
$500,000 plus any capitalized interest paid in kind. The facility
consists of an initial term loan of $275,000, which the Borrowers
borrowed at closing, and delayed draw term loans in an aggregate
principal amount not exceeding $225,000, available until August 31,
2021. The facility terminates and the term loans become due and
payable in August 2025. For additional information on the credit
facility and outstanding term loan, see Note 19 “Debt” in the 2020
Form 10-K.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share
amounts)
(Unaudited)
14. Debt (Continued)
The following table is a summary of the Company’s borrowing as of
June 30, 2021:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021 |
Long-term debt |
|
|
Floating rate note due August 2025 (10.00% at June 30,
2021)(1)
|
|
$ |
285,127 |
|
Total debt principal |
|
285,127 |
|
Unamortized debt discount and issuance costs |
|
(10,989) |
|
Less: current portion |
|
— |
|
Long-term debt |
|
$ |
274,138 |
|
(1)
Includes $5,649 of paid in kind interest that was added to the
principal during the six months ended June 30, 2021
15. Commitments and Contingencies
Summarized below are the matters previously described in Note 20 of
the Notes to the Consolidated Financial Statements in the Company's
Form 10-K for the year ended December 31, 2020, updated as
applicable.
Research Commitments
The Company has entered into agreements with several contract
research organizations to provide services in connection with its
preclinical studies and clinical trials. The Company commits to
minimum payments under these arrangements.
Indemnification Agreements
In the ordinary course of business, the Company may provide
indemnification of varying scope and terms to vendors, lessors,
business partners and other parties with respect to certain matters
including, but not limited to, losses arising out of breach of such
agreements or from intellectual property infringement claims made
by third parties. In addition, the Company has entered into
indemnification agreements with certain executive officers and
members of its board of directors that will require the Company,
among other things, to indemnify them against certain liabilities
that may arise by reason of their status or service as directors or
officers. The maximum potential amount of future payments the
Company could be required to make under these indemnification
agreements is, in many cases, unlimited. The Company’s amended and
restated memorandum and articles of association also provide for
indemnification of directors and officers in specified
circumstances. To date, the Company has not incurred any material
costs as a result of such indemnification provisions. The Company
does not believe that the outcome of any claims under
indemnification arrangements will have a material effect on its
financial position, results of operations or cash flows, and it has
not accrued any liabilities related to such obligations in its
condensed consolidated financial statements as of June 30, 2021 or
December 31, 2020.
Legal Proceedings
From time to time, in the ordinary course of business, the Company
is subject to litigation and regulatory examinations as well as
information gathering requests, inquiries and investigations. As of
June 30, 2021, there were no matters which would have a material
impact on the Company’s financial results.
Item 2. Management’s Discussion and Analysis of Financial Condition
and Results of Operations.
The following discussion and analysis of our financial condition
and results of operations should be read in conjunction with our
condensed consolidated financial statements and related notes
appearing elsewhere in this Quarterly Report on Form 10-Q and
our audited consolidated financial statements and related notes
contained in our Annual Report on Form 10-K for the year ended
December 31, 2020 filed with the Securities and Exchange Commission
(“SEC”). Some of the statements contained in this discussion and
analysis or set forth elsewhere in this Quarterly Report on
Form 10-Q, including information with respect to our plans and
strategy for our business, constitute forward looking statements
within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended. We have based these forward-looking
statements on our current expectations and projections about future
events. The following information and any forward-looking
statements should be considered in light of factors discussed
elsewhere in this Quarterly Report on Form 10-Q and our other
filings with the SEC.
Our actual results and timing of certain events may differ
materially from the results discussed, projected, anticipated, or
indicated in any forward-looking statements. We caution you that
forward-looking statements are not guarantees of future performance
and that our actual results of operations, financial condition and
liquidity, and the development of the industry in which we operate
may differ materially from the forward-looking statements contained
in this Quarterly Report on Form 10-Q. Statements made herein
are as of the date of the filing of this Form 10-Q with the
SEC and should not be relied upon as of any subsequent date. Even
if our results of operations, financial condition and liquidity,
and the development of the industry in which we operate are
consistent with the forward-looking statements contained in this
Quarterly Report on Form 10-Q, they may not be predictive of
results or developments in future periods. We disclaim any
obligation, except as specifically required by law and the
rules of the SEC, to publicly update or revise any such
statements to reflect any change in our expectations or in events,
conditions or circumstances on which any such statements may be
based, or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking
statements.
We caution readers not to place undue reliance on any
forward-looking statements made by us, which speak only as of the
date they are made.
Overview
We are a commercial-stage biopharmaceutical company with a marketed
product, NURTEC®
ODT (rimegepant), for the acute and preventive treatment of
migraine and a portfolio of innovative product candidates targeting
neurological diseases, including rare disorders. NURTEC ODT, was
approved by the U.S. Food and Drug Administration ("FDA") for the
acute treatment of migraine on February 27, 2020, which became
available by prescription in U.S. pharmacies on March 12, 2020, and
for the preventive treatment of migraine on May 27, 2021. NURTEC
ODT is the first and only calcitonin gene-related peptide ("CGRP")
receptor antagonist available in a quick-dissolve orally dissolving
tablet ("ODT") formulation that is approved by the FDA for both the
acute and preventive treatment of migraine in adults. Our other
late-stage product candidates are based on multiple mechanisms
—CGRP receptor antagonists, glutamate modulators and
myeloperoxidase inhibition—which we believe have the potential to
significantly alter existing treatment approaches across a diverse
set of neurological indications with high unmet need in both large
and orphan indications.
Our late-stage programs include the following:
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Product |
Platform |
Indication |
Development Stage |
NURTEC ODT |
CGRP |
Acute treatment of migraine |
•Approved
by the FDA on February 27, 2020 and commercialization began in
March 2020.
•Phase
3 trial for China and Korea ongoing.
|
NURTEC ODT |
CGRP |
Prevention of migraine |
Approved by the FDA on May 27, 2021. |
Rimegepant |
CGRP |
Pediatric acute treatment of migraine |
Phase 3 trial ongoing. |
Zavegepant |
CGRP |
Acute treatment of migraine |
Intranasal Phase 3 trial ongoing. Results expected in the second
half of 2021. |
Zavegepant |
CGRP |
Prevention of migraine |
Oral Phase 3 trial ongoing. |
Troriluzole |
Glutamate |
Ataxias |
Phase 2/3 randomization phase in spinocerebellar ataxia ("SCA")
complete and multi-year extension trial ongoing. Global
registrational Phase 3 trial completed enrollment and ongoing in
the U.S. and China. Results expected in the first half of
2022. |
Troriluzole |
Glutamate |
Obsessive Compulsive Disorder (“OCD”) |
Two Phase 3 trials ongoing. Results expected in the second half of
2022. |
Verdiperstat |
MPO |
Multiple System Atrophy ("MSA") |
Phase 3 trial completed enrollment and ongoing. Results expected in
third quarter of 2021. |
Verdiperstat |
MPO |
Amyotrophic Lateral Sclerosis
("ALS") |
Phase 3 HEALEY ALS Platform Trial ongoing. Enrollment expected to
complete in fourth quarter of 2021. |
CGRP Platform
In July 2016, we acquired exclusive, worldwide rights to our CGRP
receptor antagonist platform, including rimegepant and zavegepant
(previously known as BHV-3500 and vazegepant), through a license
agreement, as amended, with Bristol-Myers Squibb Company (“BMS”).
In December 2020, Heptares Therapeutics Ltd. ("Sosei Heptares") and
Biohaven entered a global collaboration and license agreement (the
"Heptares Agreement") under which Biohaven received exclusive
global rights to develop, manufacture and commercialize a portfolio
of novel, small-molecule CGRP receptor antagonists discovered by
Sosei Heptares for the treatment of CGRP-mediated disorders. The
most advanced of these is BHV-3100, previously known as
HTL0022562.
Rimegepant
The most advanced product candidate from our CGRP receptor
antagonist platform is rimegepant, an orally available, potent and
selective small molecule human CGRP receptor antagonist that we
developed for the acute and preventive treatment of migraine.
During the second quarter of 2019, we submitted NDAs for the acute
treatment of migraine to the FDA for the Zydis ODT and tablet
formulations of rimegepant. The NDA submission for the Zydis ODT
formulation of rimegepant was submitted using an FDA priority
review voucher, purchased in March 2019, providing for an expedited
6-month review. The Zydis ODT formulation of rimegepant (NURTEC
ODT) was approved by the FDA for the acute treatment of migraine on
February 27, 2020 and was available by prescription in U.S.
pharmacies on March 12, 2020. During the fourth quarter of 2020, we
submitted an sNDA for the preventive treatment of migraine to the
FDA for NURTEC ODT. The FDA approved NURTEC ODT for the preventive
treatment of migraine on May 27, 2021.
Due to the early success and life-cycle benefits for NURTEC ODT, we
determined that there were no significant added benefits to
patients for the tablet formulation and that it was in the
Company’s best interests not to expend the resources to
commercialize the tablet formulation of rimegepant for the acute
treatment of migraine. In May 2020, we withdrew the rimegepant
tablet NDA that was pending with the FDA.
The Company remains focused on investing in the long-term success
of the launch by driving new-to-brand prescriptions , and
ultimately market share, in this rapidly growing oral CGRP market
and is continuing to observe a positive return on investment with
increasing physician advocacy and attracting a greater pool of
patients. We believe that the rapid adoption of NURTEC ODT is
evidence of significant unmet need among people with migraine and
an associated large acute therapy market opportunity. It is
important to note that the injectable anti-CGRP prevention market
has not been negatively impacted by the oral anti-CGRP (or gepant)
class growth, which signifies two distinct and sizable migraine
market segments. The Company continues to expand commercial payer
coverage, with NURTEC ODT now covered by insurance providers
reflecting 89% of commercial lives.
A summary of key rimegepant studies is described
below.
Study 301/Study 302
In March 2018, we announced positive topline data from our first
two pivotal Phase 3 trials (“Study 301 and Study 302”) for the
acute treatment of migraine. In each trial, treatment with a single
75 mg dose of rimegepant met the co-primary efficacy endpoints of
the trial, which were superior to placebo, at two hours post-dose,
on measures of pain freedom and freedom from the patient’s most
bothersome symptoms ("MBS"). In addition to achieving both
co-primary endpoints in each of the trials, rimegepant also was
observed to be generally safe and well-tolerated in the trials,
with a safety profile similar to placebo. The co-primary endpoints
achieved in the Phase 3 trials were consistent with regulatory
guidance from the FDA and provided the basis for the submission of
a NDA to the FDA.
Study 303
A third Phase 3 clinical trial for the acute treatment of migraine
with a bioequivalent ODT formulation of rimegepant was commenced in
February 2018. On December 3, 2018, we announced positive topline
data from this randomized, controlled Phase 3 clinical trial
(“BHV3000-303” or “Study 303”) evaluating the efficacy and safety
of our Zydis ODT formulation of rimegepant for the acute treatment
of migraine. Rimegepant differentiated from placebo on the two
co-primary endpoints using a single dose, pain freedom and freedom
from the MBS at two hours. In total, rimegepant was significantly
differentiated from the placebo in the first 21 consecutive primary
and secondary outcome measures that were pre-specified. Patients
treated with the rimegepant Zydis ODT formulation began to
numerically separate from placebo on pain relief as early as 15
minutes, and this difference was statistically significant at 60
minutes. Additionally, a significantly greater percentage of
patients treated with rimegepant Zydis ODT returned to normal
functioning by 60 minutes and lasting clinical benefit compared to
placebo was observed through 48 hours after a single dose of
rimegepant on freedom from pain, pain relief, freedom from the MBS,
and freedom from functional disability. The safety and tolerability
observations of rimegepant in Study 303 were consistent with our
previous observations. The overall rates of adverse events were
similar to placebo (13.2% with respect to rimegepant compared to
10.5% with placebo). The co-primary endpoints achieved in the Phase
3 trials were consistent with regulatory guidance from the FDA and
formed the basis of efficacy data required by the FDA for
approval.
Study 305
In November 2018, we initiated a double-blind, placebo-controlled
Phase 3 clinical trial examining regularly scheduled dosing of
rimegepant 75 mg to evaluate its efficacy and safety as a
preventive therapy for migraine (“BHV3000-305” or “Study 305”). In
March 2020, Biohaven announced positive topline results from this
study. Rimegepant 75 mg, dosed every other day, demonstrated
statistically significant superiority, compared to placebo, on the
primary endpoint of reduction in the mean number of migraine days
per month in both episodic and chronic migraine patients. The
safety profile seen in the 370 patients who received rimegepant 75
mg every other day was consistent with prior clinical trial
experience. With this trial, rimegepant has become the only CGRP
targeted therapy to demonstrate efficacy in both the acute and
preventive treatment of migraine. An sNDA for rimegepant for
prevention of migraine was filed with the FDA and accepted for
review in the fourth quarter of 2020. The FDA approved NURTEC ODT
for the preventive treatment of migraine on May 27,
2021.
Pediatric Study Plan
In June 2019, the FDA agreed to our Pediatric Study Plan for the
acute treatment of migraine. The pediatric program was initiated in
the fourth quarter of 2020.
Trigeminal Neuralgia
In the second quarter of 2019, we initiated a Phase 2 proof of
concept trial to evaluate the safety and efficacy of rimegepant in
patients with treatment refractory trigeminal neuralgia. Trigeminal
neuralgia is a chronic facial pain syndrome characterized by
paroxysmal, severe, and lancinating episodes of pain in the
distribution of one or more branches of the trigeminal nerve. The
trigeminal nerve, or fifth cranial nerve, is the largest of the 12
cranial nerves and provides sensory innervation to the head and
neck, as well as motor innervation to the muscles of mastication.
These episodic bouts of severe facial pain can last seconds to
minutes, occur several times per day, and often result in
significant disability. Over the long- term course of the disease,
symptoms often become refractory to medical therapy and current
treatment options remain suboptimal.
Plaque Psoriasis
In the fourth quarter of 2020, we announced a collaboration with
Weill Cornell Medicine's Dr. Richard Granstein, Chairman of
Dermatology, to initiate an investigator-led clinical trial, which
will explore whether treatment with one of Biohaven's CGRP-receptor
antagonists will reduce the severity of disease and percentage of
area affected as measured by patients' Psoriasis Activity Severity
Index (PASI) score after 16 weeks of treatment as compared to
placebo. In addition, the study will assess the potential impact on
itch and patient quality-of-life measures. Psoriasis is a chronic
and painful autoimmune disease characterized by red patches of dry,
cracked skin that may bleed, itch, and burn that affects
approximately 7- 8 million people in the U.S.
International Health Authority Interactions
Scientific advice for rimegepant for acute and preventive migraine
treatment was received from the Committee for Medicinal Products
for Human Use, a committee of the European Medicines Agency, in
June and December 2018, respectively. In the first quarter of 2021,
we submitted the Marketing Authorization Application ("MAA") for
rimegepant dual activity, inclusive of acute and prevention of
migraine. The submission has been validated by the European
Medicines Agency and the European Commission procedure is ongoing.
If approved, Vydura will be the commercial name for rimegepant in
the EU. Filings in Israel and the Middle East began in 2020. In
March 2021, we received approval for rimegepant in Israel and the
UAE, and we anticipate further approvals in 2021 and 2022. In the
second quarter of 2020, we entered into agreements with Genpharm
Services and Medison Pharma to distribute NURTEC ODT in the Middle
East & Gulf Countries and Israel, respectively. With respect to
Japan, we are engaging the Pharmaceuticals and Medical Devices
Agency ("PMDA") on a path forward, and initiation of Phase 2/3
bridging studies are anticipated to begin in the fourth quarter of
2021.
In January 2019, we and our subsidiary, BioShin (Shanghai)
Consulting Services Company Ltd. (“BioShin Shanghai”), a Shanghai
based limited liability company, jointly announced that the
National Medical Products Administration (“NMPA,” formerly, the
China FDA) had accepted the Investigational New Drug (“IND”)
application for rimegepant for the treatment of migraine. As
previously announced, BioShin Shanghai was established to develop
and potentially commercialize our late-stage migraine and neurology
portfolio in China and other Asia-Pacific markets. Following the
results of Study 303, we submitted a second IND application to the
NMPA for the Zydis ODT formulation of rimegepant for the acute
treatment of migraine. The IND application for the Zydis ODT
formulation of rimegepant was accepted by the NMPA in the fourth
quarter of 2019. In September 2020, BioShin Limited ("BioShin"),
our subsidiary and the parent organization of BioShin Shanghai,
raised $60.0 million in series A funding which is being used to
build out BioShin in China and advance the Biohaven clinical
portfolio in the Asia-Pacific region. In November 2020, BioShin
initiated a double-blind, randomized Phase 3 clinical trial
evaluating the safety and efficacy of NURTEC ODT (rimegepant) for
the acute treatment of migraine in China and Korea.
Zavegepant
BHV-3500, formerly "vazegepant", is now referred to as "zavegepant"
(za ve’ je pant). The World Health Organization (WHO)
International Nonproprietary Names (INN) Expert Committee revised
the name to "zavegepant" which was accepted by the United States
Adopted Names Council for use in the U.S. and is pending formal
adoption by the INN for international use.
Administration of intranasal zavegepant in a Phase 1 clinical trial
was initiated in October 2018 and achieved targeted therapeutic
exposures. We advanced zavegepant into a Phase 2/3 trial to
evaluate its efficacy for the acute treatment of migraine in the
first quarter of 2019. We believe that intranasal zavegepant may
provide an ultra-rapid onset of action that could be used in a
complementary fashion with other migraine treatments when the speed
of onset is critical to a patient. In December 2019, we announced
positive topline results from the Phase 2/3 trial. Zavegepant 10
and 20 mg was statistically superior to placebo on the co-primary
endpoints of pain freedom and freedom from the MBS at two hours
using a single dose. A second Phase 3 trial was initiated in fourth
quarter of 2020 with results expected in the second half of
2021.
In April 2020, Biohaven announced its plan to study intranasal
zavegepant in pulmonary complications of COVID-19 disease. The IND
was approved by the Division of Pulmonary, Allergy, and Critical
Care at FDA in April 2020, and a Phase 2 trial began in April 2020
in collaboration with Thomas Jefferson University and other
academic medical institutions. The clinical trial will assess the
potential benefits of CGRP receptor-blockade in mitigating an
excessive immune response which in some cases can be fatal in
COVID-19 patients.
In September 2020, the Company announced that the FDA authorized
the initiation of clinical trials for oral zavegepant and that the
Company has achieved first in human dosing in a Phase 1 trial
designed to assess the safety and pharmacokinetics of oral
formulations of zavegepant. In March 2021, we announced that our
Phase 3 clinical program to assess the efficacy of oral zavegepant
in the preventive treatment of migraine began enrollment.
Additionally, we expect to begin trials in other nonmigraine areas
later this year.
BHV-3100
BHV-3100, previously known as HTL0022562, is the most advanced
clinical candidate being developed through a global collaboration
and license agreement between Biohaven and Sosei Heptares. Under
the agreement, Biohaven received exclusive global rights to
develop, manufacture and commercialize a portfolio of novel,
small-molecule CGRP receptor antagonists discovered by Sosei
Heptares for the treatment of CGRP-mediated disorders.
BHV-3100 was developed successfully through preclinical trials by
Sosei Heptares and demonstrated promising and differentiated
properties in target CGRP-mediated disorders. In June 2021, Sosei
Heptares announced that BHV-3100 had entered a Phase 1 study with
the dosing of a first healthy subject. Future studies are being
planned to target common and rare diseases.
Glutamate Platform
The most advanced product candidate from our glutamate receptor
antagonist platform is troriluzole (previously referred to as
trigriluzole and BHV-4157), which is in multiple Phase 3 trials.
Other product candidates include sublingual riluzole (BHV-0223) and
BHV-5500, an antagonist of the glutamate N-methyl-D-aspartate
(“NMDA”) receptor.
Troriluzole
Ataxias
We are developing troriluzole for the treatment of ataxias; our
initial focus has been spinocerebellar ataxia ("SCA"). We have
received both orphan drug designation and fast track designation
from the FDA for troriluzole for the treatment of SCA. A Phase 2/3
trial began enrollment in March 2019 to evaluate the efficacy of
troriluzole in SCA. We believe that the non-statistically
significant clinical observations from our first Phase 2/3 trial
and open-label extension phase in SCA support our decision to
advance troriluzole into a Phase 3 trial that could provide the
data needed to serve as the basis for an NDA. We completed
enrollment in the Phase 3 trial of troriluzole in SCA in the first
quarter of 2021. Results are expected in the first half of
2022.
Other Indications
A Phase 2/3 double-blind, randomized, controlled trial to assess
the efficacy of troriluzole in OCD commenced in December 2017. The
Phase 2/3 study results were announced in June 2020. Troriluzole
200 mg administered once daily as adjunctive therapy in OCD
patients with inadequate response to standard of care treatment
showed consistent numerical improvement over placebo on the
Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at all study
timepoints (weeks 4 to 12) but did not meet the primary outcome
measure at week 12 (p = 0.22 at week 12) but was significant at
week 8 (p < 0.05). Troriluzole was well tolerated with a safety
profile consistent with past clinical trial experience. Given the
strong signal in the
Phase 2/3 proof of concept study and after receiving feedback from
the FDA in an End of Phase 2 meeting, in December 2020 we initiated
enrollment in the Phase 3 program. Two Phase 3 studies are
currently ongoing with results expected in the second half of
2022.
In addition, a Phase 2/3 double-blind, randomized, controlled trial
of troriluzole in the treatment of mild-to-moderate Alzheimer’s
disease ("AD") was advanced with the Alzheimer’s Disease
Cooperative Study, a consortium of sites funded by the National
Institutes of Health. In the fourth quarter of 2019, we completed
enrollment in the study and announced that the study passed the
interim futility analysis. In order to pass the interim futility
analysis, troriluzole had to demonstrate numerically greater
benefit over placebo on at least one of the two pre-specified
criteria at 26 weeks: either (i) cognitive function as measured by
the Alzheimer’s Disease Assessment Scale-Cognitive Subscale
(“ADAS-cog”) or (ii) hippocampal volume as assessed by magnetic
resonance imaging. In January 2021, topline data from the trial
revealed that troriluzole did not statistically differentiate from
placebo at 48 weeks on the study's prespecified co-primary
endpoints on the Alzheimer's Disease Assessment Scale-Cognitive
Subscale and the Clinical Dementia Rating Scale Sum of Boxes in
study participants with mild-to-moderate AD. Troriluzole also did
not differentiate from placebo on the key secondary measure of
hippocampal volume assessed by magnetic resonance imaging (MRI) in
the overall population. A subgroup analysis consisting only of mild
AD patients did, however, reveal that troriluzole exhibited a
nonsignificant numerical difference of a potential benefit at week
48 on both the ADAS-cog and hippocampal volumetric MRI. Although
the numerical effects on the ADAS-cog and hippocampal MRI measured
in mild AD patients suggests a potential biologic effect of
troriluzole in patients with early stage disease, additional
analyses and biomarker data will be informative and help determine
whether any further study in early AD is warranted. Full study
results, including additional secondary and exploratory outcomes,
biomarker, and subgroup analyses, are expected in the coming months
and will be presented at an upcoming scientific meeting. With
regard to safety and tolerability, treatment with troriluzole at a
dose of 280 mg once daily was relatively well tolerated and
demonstrated a safety profile consistent with previous studies of
troriluzole. Biohaven has amended the ongoing long-term extension
study of troriluzole in AD for mild AD patients to be able to
continue treatment in order to gather additional clinical and
biomarker data.
International Development
In the third quarter of 2020, BioShin raised $60.0 million in
series A funding which will be used to build out BioShin Limited in
China and advance our clinical portfolio in the Asia-Pacific
region, including initiating sites in China to participate in the
global registrational Phase 3 trial of troriluzole in SCA. BioShin
completed enrollment for the trial in China in the first quarter of
2021 with results expected in the first half of 2022.
BHV-5000 and BHV-5500
We are developing BHV-5500, a low-trapping NMDA receptor
antagonist, for the treatment of neuropsychiatric diseases. One
potential target indication includes Complex Regional Pain Syndrome
(“CRPS”). CRPS is a rare, chronic pain condition typically
affecting limbs and triggered by traumatic injury. Accompanying
symptoms also include chronic inflammation and reduced mobility in
the affected areas. Other disorders of interest include
post-herpetic neuralgia and diabetic peripheral neuralgia. We
acquired worldwide rights to BHV-5000 and BHV-5500 under an
exclusive license agreement with AstraZeneca AB in October 2016. We
selected a lead formulation at the end of 2017 and completed single
dosing in a Phase 1 clinical trial of BHV-5000 in January 2018 to
evaluate its pharmacokinetic properties. Results from nonclinical
studies limiting clinical dose of BHV-5000 have led us to focus on
BHV-5500 (lanicemine). Current work is focused on formulation
development.
MPO Platform
Verdiperstat
We are developing verdiperstat (previously BHV-3241), an oral
myeloperoxidase inhibitor for the treatment of neurodegenerative
diseases. One target indication is MSA, a rare, rapidly progressive
and fatal neurodegenerative disease with no cure or effective
treatments. Verdiperstat has received orphan drug designation for
the treatment of MSA from both the FDA and the European Medicines
Agency. In addition, Fast Track status was granted by the FDA in
March 2020 for verdiperstat for the treatment for MSA. A Phase 3
trial began enrollment in July 2019 to evaluate the efficacy of
verdiperstat in MSA. The trial completed enrollment in July 2020.
Results are expected in the third quarter of 2021.
Another potential target indication is ALS. In September 2019, we
announced that verdiperstat was selected to be studied in the Phase
3 HEALEY ALS Platform Trial, which is being conducted by the Sean
M. Healey & AMG Center for ALS at Massachusetts General
Hospital in collaboration with the Northeast ALS Consortium
(“NEALS”) clinical trial network. Promising investigational drugs
were chosen for the HEALEY ALS Platform Trial through a competitive
process, with the Healey Center providing partial financial support
to successful applicants. The Phase 3 HEALEY ALS Platform Trial of
verdiperstat began enrollment in July 2020 and is ongoing.
Enrollment is expected to complete in the fourth quarter of
2021.
Verdiperstat was progressed through Phase 2 clinical trials by
AstraZeneca. Seven clinical studies were completed by AstraZeneca,
including four Phase 1 studies in healthy subjects, two Phase 2a
studies in subjects with Parkinson’s disease, and
one Phase 2b study in subjects with MSA. We have entered into an
exclusive license agreement with AstraZeneca for the product
candidate.
Preclinical
Option and License Agreement with the University of
Connecticut
In October 2018, we entered into an exclusive, worldwide option and
license agreement (the "UConn Agreement") with the University
of Connecticut ("UConn") for the development and
commercialization rights to UC1MT, a therapeutic antibody targeting
extracellular metallothionein. Under this agreement, we have the
option to acquire an exclusive, worldwide license to UC1MT and its
underlying patents to develop and commercialize throughout the
world in all human indications. If we choose to exercise the
option, we would be obligated to pay UConn milestone payments upon
the achievement of specified regulatory and commercial milestones,
and royalties of a low single-digit percentage of net sales of
licensed products.
Fox Chase Chemical Diversity Center, Inc.
In May 2019, we entered into an agreement with Fox Chase Chemical
Diversity Center Inc. (“FCCDC”) for FCCDC’s TDP-43 assets (the
“FCCDC Agreement”). The FCCDC Agreement provides us with a plan and
goal to identify one or more new chemical entity candidates for
preclinical development for eventual clinical evaluation for the
treatment of one or more TDP-43 proteinopathies. In connection with
the FCCDC Agreement, Biohaven and FCCDC have established a TDP-43
Research Plan that provides for certain milestones to be achieved
by FCCDC, and milestone payments to be made by us (See Note
13).
Sosei Heptares
In November 2020, we entered into a global collaboration and
license agreement with Sosei Heptares, an international
biopharmaceutical group focused on the discovery and early
development of new medicines originating from their proprietary
GPCR-targeted StaR technology and structure-based drug design
platform capabilities. Under the agreement, Sosei Heptares will be
eligible to receive development, regulatory and commercialization
milestone payments, as well as tiered royalties on net sales of
products resulting from the collaboration. In return, we will
receive exclusive global rights to develop, manufacture and
commercialize a portfolio of novel, small-molecule CGRP receptor
antagonists discovered by Sosei Heptares for the treatment of
CGRP-mediated disorders. The portfolio includes the lead candidate
HTL0022562 now called BHV-3100, which has advanced through
preclinical development demonstrating promising and differentiated
properties for further investigation in human trials (See Note
13).
Artizan Biosciences, Inc.
In December 2020, we entered into an Option and License Agreement
with Artizan Biosciences Inc. ("Artizan"), a biotechnology company
focused on addressing inflammatory diseases involving the human
intestinal microbiota. Pursuant to the agreement, we acquired an
option to obtain a royalty-based license from Artizan to
manufacture, use and commercialize certain products. Artizan will
use the proceeds to continue advancing the preclinical research and
development of its lead program for inflammatory bowel disease,
which is anticipated to enter the clinic in 2022, as well as to
explore additional disease targets (See Note 13).
Kleo Pharmaceuticals, Inc. and Biohaven Labs
In January 2021, we acquired the remaining approximately 58% of
Kleo that we did not previously own. We have assumed Kleo's
laboratory facilities located in Science Park in New Haven,
Connecticut and formed Biohaven Labs to serve as the integrated
chemistry and discovery research arm of Biohaven. Biohaven Labs
will continue several existing Kleo discovery partnerships,
including with the Bill and Melinda Gates Foundation for the
development of a SARS-CoV-2 neutralizing therapy for COVID-19 and
PeptiDream for the development of immuno-oncology therapeutics (See
Note 6).
Biohaven's proprietary Multimodal Antibody Therapy Enhancer (MATE)
conjugation technology uses a new class of synthetic peptide
binders to target the spike protein of SARS-CoV-2 that are then
selectively conjugated to commercially available intravenous
immunoglobulin. The Biohaven synthetic binders for SARS-CoV2 were
designed to establish a much wider area and number of contacts with
the spike protein that other agents like monoclonal antibodies. In
February 2021, we announced that BHV-1200 developed with Biohaven's
proprietary MATE platform has demonstrated functional binding and
neutralization of the SARS-CoV-2 virus, including the strains known
as the "English" and "South African" variants (also known as
B.1.1.7 and B.1.351, respectively). The preliminary experiments
conducted by Biohaven Labs and an academic collaborator
demonstrated that BHV-1200 substantially reduced viral entry into
cells. The Company intends to advance BHV-1200 into a full clinical
development program. Accelerated development of the COVID-19 MATE
program has been supported by the Bill and Melinda Gates
Foundation. In addition, the in vitro data indicate that BHV-1200
may activate important immune system components including
antibody-dependent cellular phagocytosis and antibody dependent
cellular
cytotoxicity. We believe our proprietary MATE-conjugation
technology could also be used against other infectious diseases by
changing the targeting moiety of its antibody binders.
BHV-1100
In the third quarter of 2021, Biohaven expects to initiate a Phase
1a/1b trial in multiple myeloma patients using its antibody
recruiting molecule (ARM) BHV-1100 in combination with autologous
cytokine induced memory-like (CIML) natural killer (NK) cells and
immune globulin (IG) to target and kill multiple myeloma cells
expressing the cell surface protein CD38. BHV-1100 is the lead
clinical asset from Biohaven’s Antibody Recruiting Molecule (ARM™)
Platform developed from a strategic alliance with PeptiDream Inc.
(TYO: 4587). This clinical trial will assess the safety and
tolerability as well as exploratory efficacy endpoints in newly
diagnosed multiple myeloma patients who have tested positive for
minimal residual disease (MRD+) in first remission prior to
autologous stem cell transplant (ASCT).
Recent Developments
NURTEC ODT (Rimegepant) Patent Issuance
The United States Patent and Trademark Office has awarded a patent
to the Company (US Pat. No. 11,083,724, to be issued on August 10,
2021) that is directed to our drug product, NURTEC ODT
(rimegepant), as well as other CGRP inhibitors in an ODT form. The
patent has a statutory expiration date of March 25, 2039, not
including patent term adjustment or any potential patent term
extension. The patent is also pending in major market countries
throughout the world including Europe, Japan and China. Patent term
extensions, or supplementary protection certificates, of up to five
years can be obtained in the UK, all member states of the EU as
well as Switzerland, Norway, Iceland, Japan, Korea and certain
other countries.
Issuance of Common Shares for the March 2021 Offering
In March 2021, we issued and sold 2,686,409 common shares at a
public offering price of $76.00 per share for net proceeds of
approximately $199,500 after deducting underwriting discounts and
commissions of approximately $4,167 and other offering expenses of
approximately $500. In addition, in March 2021, the underwriter of
the March follow-on offering exercised its option to purchase
additional shares, and we issued and sold 402,961 common shares for
net proceeds of approximately $30,000 after deducting underwriting
discounts and commissions of approximately $625. Thus, the
aggregate net proceeds from the follow-on offering, after deducting
underwriting discounts and commissions and other offering costs,
were approximately $229,500.
First Amendment to Sixth Street Financing Agreement
In August 2020, we and Biohaven Pharmaceuticals, Inc., our
wholly-owned subsidiary (together with us, the "Borrowers"),
entered into a financing agreement (the "Sixth Street Financing
Agreement") with Sixth Street Specialty Lending, Inc. as
administrative agent, various lenders (the "Lenders") and certain
of our subsidiaries, as guarantors. Pursuant to the Sixth Street
Financing Agreement, the Lenders agreed to extend a senior secured
credit facility to the Borrowers providing for term loans in an
aggregate principal amount up to $500.0 million plus any
capitalized interest paid in kind. The credit facility consists of
an initial term loan of $275.0 million, which the Borrowers
borrowed at closing, and delayed draw term loans in an aggregate
principal amount not exceeding $225.0 million, available until
August 31, 2021, with $100.0 million of the delayed draw term loans
currently available at the Borrowers' option. The remaining $125.0
million in delayed draw term loans becomes available if net sales
from NURTEC ODT during the first quarter of 2021 or second quarter
of 2021 equal at least $45.0 million. The facility terminates in
August 2025.
On March 1, 2021, the Borrowers, and certain other of our
subsidiaries entered into the First Sixth Street Financing
Amendment, with Sixth Street Specialty Lending, Inc., as
administrative agent, and the lenders party thereto. Pursuant to
the First Sixth Street Financing Amendment, the parties agreed to,
among other things remove the $45.0 million delayed draw sales
milestone tied to the availability of the $125.0 million tranche of
delayed draw term loans. As of June 30, 2021, the full $225 million
aggregate principal amount of delayed draw term loans is available
to draw at the Borrowers’ option through August 31,
2021.
Acquisition of Kleo Pharmaceuticals, Inc.
On January 1, 2021, we and our subsidiaries Biohaven Therapeutics
Ltd. (“Therapeutics”) and Kleo Acquisition, Inc. (“Merger Sub”)
entered into an Agreement and Plan of Merger (the “Merger
Agreement”) with Kleo Pharmaceuticals, Inc. (“Kleo”) and
Shareholder Representative Services LLC, which contemplates Merger
Sub, subject to the terms and conditions set forth in the Merger
Agreement, merging with and into Kleo, with Kleo surviving the
merger as a wholly-owned subsidiary of the Company. The merger
closed on January 4, 2021.
In the merger, each share of Kleo common stock issued and
outstanding immediately prior to the effective time of the merger
was converted into the right to receive (i) approximately 0.007 of
one of our common shares, rounded up to the nearest whole share,
(ii) one contingent value right, as further described below, and
(iii) certain other amounts to extent released from escrows
established to provide for indemnification claims.
The merger values Kleo at approximately $20.0 million, exclusive of
the value of the contingent value rights, and the Merger Agreement
provides for approximately $1.0 million of holdbacks to provide for
indemnification claims. Prior to the consummation of the merger, we
owned approximately 41.9% of the outstanding shares of Kleo through
our subsidiary Therapeutics, resulting in 115,836 of our common
shares being issued to Kleo stockholders in the
merger.
In the merger, each share of Kleo common stock received one
contingent value right, representing the right to receive one
dollar in cash if certain specified Kleo biopharmaceutical products
or product candidates receive the approval of the FDA prior to the
expiration of 30 months following the effective time of the merger.
The maximum amount payable pursuant to the contingent value rights
is approximately $17.3 million.
The Merger Agreement contains various representations and
warranties, covenants, indemnification obligations and other
provisions customary for transactions of this nature. Kleo’s
employees, other than its President and Chief Financial Officer,
were retained as part of the merger.
Pursuant to the Merger Agreement, in March 2021 we filed a
registration statement permitting Kleo stockholders to offer and
sell the common shares of ours issued in the merger.
Yale MoDE Agreement
On January 1, 2021, we entered into a worldwide, exclusive license
agreement for the development and commercialization of a novel
Molecular Degrader of Extracellular Protein (MoDEs) platform based
on ground-breaking research conducted in the laboratory of
Professor David Spiegel at Yale University. Under the license
agreement, we acquired exclusive, worldwide rights to Yale's
intellectual property directed to its MoDEs platform.
Under the agreement, we paid Yale University an upfront cash
payment of $1.0 million and 11,668 shares valued at $1.0 million.
In addition, Yale University will be eligible to receive additional
development milestone payments of up to $0.8 million and commercial
milestone payments of up to $3.0 million.
Consulting Agreement with Moda Pharmaceuticals LLC
On January 1, 2021, we entered into a consulting services agreement
with Moda Pharmaceuticals LLC to further the scientific and
commercial advancement our technology, drug discovery platforms,
product candidates and related intellectual property.
Under the agreement, we paid Moda an upfront cash payment of $2.7
million and 37,836 shares valued at $3.2 million. In addition, Moda
Pharmaceutical will be eligible to receive additional development
milestone payments of up to $81.6 million and commercial milestone
payments of up to $30.2 million.
COVID-19 Update
We continue to closely monitor the impact of the COVID-19 pandemic
on all aspects of our business.
We have taken numerous steps, and expect to continue to take
further actions, in our approach to addressing the COVID-19
pandemic. For example, we implemented internal controls to effect a
remote work environment and instructed most of our employees to
work from home, and our incident management teams responded to
changes in our work environment quickly and effectively. In April
2020, we announced a collaboration with Cove in order to facilitate
telemedicine evaluation for migraine sufferers while patients are
increasingly looking to remote evaluations during this time of
unprecedented decreased access to routine office visits. We
continue to monitor COVID-19 developments and regulatory and
government actions.
To date, the effects of the COVID-19 pandemic have not had a
material impact on our long-term activity. However, future
developments remain uncertain and the extent to which the COVID-19
pandemic ultimately impacts our business, financial condition or
results of operations will depend on a number of factors, including
the magnitude and duration of the pandemic, the distribution,
acceptance and effectiveness of COVID-19 vaccines and treatments,
the duration of government measures to mitigate the pandemic and
how quickly and to what extent normal economic and operating
conditions can resume, all of which remain uncertain and difficult
to predict. There remains risk that COVID-19 could have material
adverse impacts on future revenue growth as well as overall
profitability.
Components of Our Results of Operations
Product Revenues, Net
We began to recognize revenue from product sales, net of rebates,
chargebacks, discounts and other adjustments, in March 2020 in
conjunction with the launch of our first product, NURTEC ODT. We
will continue to evaluate trends related to revenue momentum for
NURTEC ODT, including any discernible impacts of the COVID-19
pandemic. If our development efforts for our other product
candidates are successful and result in regulatory approval, or
additional license agreements with third parties, we may generate
additional revenue in the future from product sales.
Cost of Goods Sold
Cost of goods sold includes direct and indirect costs related to
the manufacturing and distribution of NURTEC ODT, including
third-party manufacturing costs, packaging services, freight-in,
third-party royalties payable on our net product revenues and
amortization of intangible assets associated with NURTEC
ODT.
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs
incurred in connection with the development of our product
candidates. We expense research and development costs as incurred.
These expenses include:
•expenses
incurred under agreements with contract research organizations
(“CROs”) or contract manufacturing organizations (“CMOs”), as well
as investigative sites and consultants that conduct our clinical
trials, preclinical studies and other scientific development
services;
•manufacturing
scale-up expenses and the cost of acquiring and manufacturing
preclinical and clinical trial materials and commercial materials,
including manufacturing validation batches;
•employee-related
expenses, including salaries, benefits, travel and non-cash
share-based compensation expense for employees engaged in research
and development functions;
•costs
related to compliance with regulatory requirements;
•development
milestone payments incurred prior to regulatory approval of the
product candidate; and
•payments
made in cash, equity securities or other forms of consideration
under third-party licensing agreements.
We recognize external development costs based on an evaluation of
the progress to completion of specific tasks using estimates of our
clinical personnel or information provided to us by our service
providers.
Our external direct research and development expenses are tracked
on a program-by-program basis for our product candidates and
consist primarily of external costs, such as fees paid to outside
consultants, CROs, contract manufacturing organizations, and
central laboratories in connection with our preclinical
development, process development, manufacturing and clinical
development activities. Our direct research and development
expenses by program also include fees and certain development
milestones incurred under license agreements. We do not allocate
employee costs or other indirect costs, to specific programs
because these costs are deployed across multiple programs and, as
such, are not separately classified. We use internal resources
primarily to oversee the research and development as well as for
managing our preclinical development, process development,
manufacturing and clinical development activities. Many employees
work across multiple programs, and we do not track personnel costs
by program.
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. As a result, we expect
that our research and development expenses will remain significant
over the next several years as we increase personnel costs conduct
clinical trials and prepare regulatory filings for our product
candidates. We also expect to incur additional expenses related to
milestone and royalty payments payable to third parties with whom
we have entered into license agreements to acquire the rights to
our product candidates.
The successful development and commercialization of our product
candidates is highly uncertain. At this time, we cannot reasonably
estimate or know the nature, timing and costs of the efforts that
will be necessary to complete the preclinical and clinical
development of any of our product candidates or when, if ever,
material net cash inflows may commence from any of our product
candidates. This uncertainty is due to the numerous risks and
uncertainties associated with product development and
commercialization, including the uncertainty of:
•the
scope, progress, outcome and costs of our preclinical development
activities, clinical trials and other research and development
activities;
•establishment
of an appropriate safety profile with IND-enabling
studies;
•successful
patient enrollment in, and the initiation and completion of,
clinical trials;
•the
timing, receipt and terms of any marketing approvals from
applicable regulatory authorities;
•establishment
of commercial manufacturing capabilities or making arrangements
with third-party manufacturers;
•development
and timely delivery of commercial-grade drug formulations that can
be used in our clinical trials and for commercial
launch;
•acquisition,
maintenance, defense and enforcement of patent claims and other
intellectual property rights;
•significant
and changing government regulation;
•initiation
of commercial sales of our product candidates, if and when
approved, whether alone or in collaboration with others;
and
•maintenance
of a continued acceptable safety profile of the product candidates
following approval.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of
personnel costs, including salaries, benefits and travel expenses
for our executive, commercial, finance, business, commercial,
corporate development and other administrative functions; and
non-cash share-based compensation expense. Selling, general and
administrative expenses also include facilities and other related
expenses, including rent, depreciation, maintenance of facilities,
insurance and supplies; professional fees for expenses incurred
under agreements with third parties relating to the
commercialization of NURTEC ODT; and for public relations, audit,
tax and legal services, including legal expenses to pursue patent
protection of our intellectual property.
We anticipate that our selling, general and administrative
expenses, including payroll and related expenses, will remain
significant in the future as we continue to expand our operations
and organizational capabilities, continue to support our commercial
activities associated with NURTEC ODT, and prepare for potential
commercialization of our product candidates, if successfully
developed and approved. We also anticipate increased expenses
associated with general operations, including costs related to
accounting and legal services, director and officer insurance
premiums, facilities and other corporate infrastructure and
office-related costs, such as information technology
costs.
Other Income (Expense)
Interest Expense
Interest Expense primarily consists of interest on our outstanding
term loan with Sixth Street Specialty Lending, Inc., which includes
interest expense on the outstanding loan balance, accretion of the
debt discount and amortization of issuance costs. Our interest
expense also includes implied interest on our finance leases
associated with our commercial car fleet. We utilize the effective
interest method to determine our interest expense on the term loan
and finance leases and the straight-line method for the
amortization of the debt issuance costs.
Interest Expense on Mandatorily Redeemable Preferred
Shares
Interest expense on mandatorily redeemable preferred shares is
being recognized in connection with the issuance of series A
preferred shares and series B preferred shares pursuant to the
Series A preferred share purchase agreement and Series B preferred
shares forward contracts we entered into with RPI. Since we are
required to redeem the series A preferred shares for two times (2x)
the original purchase price in equal quarterly installments by
December 31, 2024 and the series B preferred shares for one point
seventy seven times (1.77x) the original purchase price in equal
installments beginning on March 31, 2025 and ending December 31,
2030, we concluded that the Series A preferred shares and Series B
preferred shares are mandatorily redeemable instruments and initial
classified the preferred shares at their fair value as a liability.
Interest expense on the mandatorily redeemable preferred shares
represents the accretion of the carrying value of the preferred
shares liability to its redemption value using the effective
interest rate method.
Change in Fair Value of Derivatives
The fair value of the derivative liability recognized in connection
with contingent payments under the Series A Preferred Share
Agreement is determined using the with-and-without valuation
method. As inputs into the valuation, we considered the type and
probability of occurrence of certain events, the amount of the
payments, the expected timing of certain events, and a
risk-adjusted discount rate. In accordance with ASC 815,
Derivatives and Hedging, the fair value of the derivative is
recorded on the condensed consolidated balance sheet as a Series A
preferred derivative liability with changes in fair value recorded
in other income (expense) in the condensed consolidated statements
of operations and comprehensive loss.
The fair value of the derivative liability recognized in connection
with the Series B Preferred Shares Forward Contracts is determined
using discounted cash flow and Monte Carlo valuation methods. As
inputs into the valuation, we considered the probability of
occurrence of certain change of control events, the amount of the
payments, the expected timing of certain events, and a
risk-adjusted discount rate. In accordance with ASC 815,
Derivatives and Hedging, the fair value of the derivative is
recorded on the condensed consolidated balance sheet as a Series B
preferred shares forward contact with changes in fair value
recorded in other income (expense) in the condensed consolidated
statements of operations and comprehensive loss.
Interest Expense on Liability Related to Sale of Future
Royalties
We have accounted for the 2018 RPI Funding Agreement and a unit of
accounting of the 2020 RPI Funding Agreement with RPI Trust both as
liability financings, primarily because they have significant
continuing involvement in generating the future revenue on which
the royalties are based. The liabilities related to sale of future
royalties and the related interest expense are measured based on
the Company's current estimate of the timing and amount of future
royalties expected to be paid over the estimated terms of the 2018
RPI Funding Agreement and 2020 RPI Funding Agreement. The
liabilities are amortized using the effective interest rate method,
resulting in recognition of interest expense over the estimated
term of the agreement. Each reporting period, the Company assesses
the estimated timing and amount of future expected royalty payments
over the estimated terms. If there is a change to one of the
estimates, the Company recognizes the impact to the liability’s
amortization schedule and the related interest expense
prospectively. The Company’s estimate of the amount of expected
future royalties to be paid considers the probability of success of
compounds not yet approved for sale, and market penetration rates,
compliance rate, and net pricing of both NURTEC ODT and compounds
not yet approved for sale. Additionally, the transaction costs
associated with the liabilities will be amortized to interest
expense over the estimated term of the 2018 RPI Funding Agreement
and 2020 RPI Funding Agreement, respectively.
Gain (Loss) from Equity Method Investment
Prior to our acquisition of Kleo in January 2021, we owned
approximately 41.9% of the outstanding shares as of December 31,
2020, and accounted for our investment in Kleo under the equity
method of accounting. As a result, our proportionate share of
Kleo’s net income or loss each reporting period was included in
other income (expense), net, in our condensed consolidated
statement of operations and comprehensive loss and results in a
corresponding adjustment to the carrying value of the equity method
investment on our condensed consolidated balance
sheet.
On January 4, 2021, the Company acquired the rest of the shares of
Kleo, and post-transaction the Company owns 100% of the outstanding
shares of Kleo. The carrying value of the Company’s investment in
Kleo was $1,176 immediately prior to the acquisition date. The
Company determined the fair value of the existing interest was
$6,437, and recognized a gain from our equity method investment of
$5,261 on the condensed consolidated statement of operations and
comprehensive loss as a result of remeasuring to fair value the
existing equity interest in Kleo during the three months ended
March 31,2021.
Provision for Income Taxes
As a company incorporated in the British Virgin Islands (“BVI”), we
are principally subject to taxation in the BVI. Under the current
laws of the BVI, tax on a company’s income is assessed at a zero
percent tax rate. As a result, we have not recorded any income tax
benefits from losses incurred in the BVI during each reporting
period, and no net operating loss carryforwards will be available
to us for those losses. We, and certain of our subsidiaries, have
historically outsourced the research and development for our
programs and commercial activities of NURTEC ODT under master
services agreements with our wholly owned subsidiary, Biohaven
Pharmaceuticals, Inc., a Delaware corporation (“BPI”). As a
result of providing services under these agreements and profit from
US commercial sales of NURTEC ODT, BPI was profitable during the
six months ended June 30, 2021 and 2020, and BPI is subject to
taxation in the United States.
In August 2020, we completed an intra-entity asset transfer of
certain of our intellectual property to our Irish subsidiary. As a
result of the transfer, we recorded a deferred tax asset of $875.0
million for the step up in tax basis received pursuant to Irish tax
law. Based on our analysis of all available objective evidence, we
concluded that it was more likely than not that the deferred tax
asset from the intra-entity transfer will not be realized due to
the lack of net operating income history of our subsidiary.
Therefore, we established a full valuation allowance against our
net deferred tax asset in Ireland.
We continue to maintain a valuation allowance against our US
deferred tax assets. We periodically review our position and have
determined that a full valuation allowance on these assets was
appropriate due to excess research and development ("R&D")
credit carryforwards as of June 30, 2021. We will continue to
evaluate the need for a valuation allowance on our deferred tax
assets until there is sufficient positive evidence to support the
reversal of all or some portion of these allowances. We anticipate
the commercialization of NURTEC ODT will result in future earnings
and believe sufficient positive evidence may become available
within the next 12 months to allow us to reach a conclusion that a
significant portion, or all, of the valuation allowance will no
longer be needed. Release of the valuation allowance would result
in the recognition of certain deferred tax assets and a decrease to
income tax expense for the period the release is recorded. However,
the exact timing and
amount of the valuation allowance release is subject to change on
the basis of the level of profitability that we are able to
actually achieve.
In January 2021, we completed the acquisition of Kleo. The
acquisition and inclusion of Kleo did not result in a material
impact on the provision for income taxes or the effective tax rate
for the three and six months ended June 30, 2021. We recorded a
full valuation allowance against our Kleo US deferred tax assets
and will periodically review our position and have determined that
a full valuation allowance on these assets was appropriate due to
Kleo’s cumulative loss history. We will continue to evaluate the
need for a valuation allowance on our deferred tax assets until
there is sufficient positive evidence to support the reversal of
all or some portion of these allowances.
Results of Operations
Comparison of the Three Months Ended June 30, 2021 and
2020
The following tables summarize our results of operations for the
three months ended June 30, 2021 and 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
|
|
2021 |
|
2020 |
|
Change |
In thousands |
|
|
Product revenue, net |
|
$ |
92,933 |
|
|
$ |
9,698 |
|
|
$ |
83,235 |
|
Cost of goods sold |
|
17,339 |
|
|
3,058 |
|
|
14,281 |
|
Gross profit |
|
75,594 |
|
|
6,640 |
|
|
68,954 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
77,428 |
|
|
42,425 |
|
|
35,003 |
|
Selling, general and administrative |
|
170,057 |
|
|
124,802 |
|
|
45,255 |
|
Total operating expenses |
|
247,485 |
|
|
167,227 |
|
|
80,258 |
|
Loss from operations |
|
(171,891) |
|
|
(160,587) |
|
|
(11,304) |
|
Other income (expense): |
|
|
|
|
|
|
Interest expense |
|
(7,836) |
|
|
(172) |
|
|
(7,664) |
|
Interest expense on mandatorily redeemable preferred
shares |
|
(8,042) |
|
|
(6,993) |
|
|
(1,049) |
|
Interest expense on liability related to sale of future
royalties |
|
(14,499) |
|
|
(11,570) |
|
|
(2,929) |
|
|
|
|
|
|
|
|
Change in fair value of derivatives |
|
(1,490) |
|
|
650 |
|
|
(2,140) |
|
|
|
|
|
|
|
|
Gain (loss) from equity method investment |
|
— |
|
|
(1,485) |
|
|
1,485 |
|
Other expense, net |
|
(3,051) |
|
|
(119) |
|
|
(2,932) |
|
Total other income (expense), net |
|
(34,918) |
|
|
(19,689) |
|
|
(15,229) |
|
Loss before provision for income taxes |
|
(206,809) |
|
|
(180,276) |
|
|
(26,533) |
|
Provision for income taxes |
|
4,350 |
|
|
658 |
|
|
3,692 |
|
Net loss |
|
(211,159) |
|
|
(180,934) |
|
|
(30,225) |
|
Less: Net loss attributable to non-controlling
interests |
|
(540) |
|
|
— |
|
|
(540) |
|
Net loss attributable to Biohaven Pharmaceutical Holding Company
Ltd. |
|
$ |
(210,619) |
|
|
$ |
(180,934) |
|
|
$ |
(29,685) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net
Net product revenue was $92.9 million for the three months ended
June 30, 2021, compared to $9.7 million for the three months ended
June 30, 2020. The increase of $83.2 million in net product
revenues is due to both increased NURTEC ODT sales volume and
improvements in net price realization due to decreases in sales
allowances during the three months ended June 30, 2021, compared to
the three months ended June 30, 2020. The Company began selling
NURTEC ODT in March 2020. Sales allowances and accruals mostly
consisted of patient affordability programs, distribution fees and
rebates.
Cost of Goods Sold
Cost of goods sold was $17.3 million for the three months ended
June 30, 2021, compared to $3.1 million for the three months ended
June 30, 2020. Our cost of goods sold is related to royalties on
net sales payable to BMS under a license agreement (see Note 15
"Commitments and Contingencies" to our condensed consolidated
financial statements), manufacturing costs for NURTEC ODT, certain
distribution costs and amortization of intangible assets related to
milestone payments to BMS
and Catalent, Inc. ("Catalent"). See Note 13 "License and Other
Agreements" to our condensed consolidated financial statements for
more information on the BMS and Catalent agreements. The increase
of 14.3 million in costs of goods sold was primarily due to
increased NURTEC ODT sales during the three months ended June 30,
2021, compared to the three months ended June 30, 2020, which had
no material manufacturing costs included as all of the costs were
incurred prior to FDA approval, and accordingly
expensed.
Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
|
|
2021 |
|
2020 |
|
Change |
In thousands |
|
|
Direct research and development expenses by program: |
|
|
|
|
|
|
Rimegepant |
|
$ |
13,976 |
|
|
$ |
8,090 |
|
|
$ |
5,886 |
|
Troriluzole |
|
13,068 |
|
|
8,293 |
|
|
4,775 |
|
Zavegepant |
|
11,470 |
|
|
6,094 |
|
|
5,376 |
|
Verdiperstat |
|
8,613 |
|
|
5,087 |
|
|
3,526 |
|
BHV-5000 |
|
38 |
|
|
98 |
|
|
(60) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unallocated research and development costs: |
|
|
|
|
|
|
Personnel related (including non-cash share-based
compensation) |
|
19,919 |
|
|
12,868 |
|
|
7,051 |
|
|
|
|
|
|
|
|
Preclinical research programs |
|
4,706 |
|
|
194 |
|
|
4,512 |
|
Other |
|
5,638 |
|
|
1,701 |
|
|
3,937 |
|
Total research and development expenses |
|
$ |
77,428 |
|
|
$ |
42,425 |
|
|
$ |
35,003 |
|
R&D expenses, including non-cash share-based compensation
costs, were $77.4 million for the three months ended June 30, 2021,
compared to $42.4 million for the three months ended June 30, 2020.
The increase of $35.0 million was primarily due to increase in
program expenses of $5.9 million, $4.8 million, $4.5 million, $3.5
million, and $15.4 million for rimegepant, troriluzole,
preclinical research programs, verdiperstat, and zavegepant,
respectively, and an increase of $7.1 million in personnel costs.
The increase in program expenses was partially offset by a
reduction in our obligation to perform R&D services of $10.0
million for zavegepant. Non-cash share-based compensation expense
was $9.3 million for the three months ended June 30, 2021, an
increase of $2.8 million as compared to the same period in
2020.
Selling, General and Administrative Expenses
SG&A expenses, including non-cash share-based compensation
costs, were $170.1 million for the three months ended June 30,
2021, compared to $124.8 million for the three months ended June
30, 2020. The increase of $45.3 million was primarily due to
increases in spending to support increased commercial sales of
NURTEC ODT for the three months ended June 30, 2021, compared to
the three months ended June 30, 2020. Less than half of the
SG&A expense, was for commercial organization personnel costs,
excluding non-cash share-based compensation expense. Non-cash
share-based compensation expense was $16.3 million for the three
months ended June 30, 2021, an increase of $11.0 million as
compared to the same period in 2020. The increase in non-cash
share-based compensation expense was primarily due to the
amortization of the Company's annual equity incentive awards that
were granted in the first quarter of 2021.
Other Income (Expense), Net
Other income (expense), net was a net expense of $34.9 million for
the three months ended June 30, 2021, compared to net expense of
$19.7 million for the three months ended June 30, 2020. The
increase of $15.2 million in net expense was primarily due to the
interest expense on our term loan with Sixth Street, drawn in the
third quarter of 2020, and an increase in the interest expense
recognized on our liability related to sale of future royalties in
the three months ended June 30, 2021.
Provision for Income Taxes
We recorded a provision for income taxes of $4.4 million for the
three months ended June 30, 2021, compared to a provision for
income taxes of $0.7 million for the three months ended June 30,
2020. The increase was primarily attributable to the Company's
profitable operations in the United States in 2021.
Comparison of the Six Months Ended June 30, 2021 and
2020
The following tables summarize our results of operations for the
six months ended June 30, 2021 and 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
|
2021 |
|
2020 |
|
Change |
In thousands |
|
|
Product revenue, net |
|
$ |
136,756 |
|
|
$ |
10,849 |
|
|
$ |
125,907 |
|
Cost of goods sold |
|
30,201 |
|
|
3,482 |
|
|
26,719 |
|
Gross profit |
|
106,555 |
|
|
7,367 |
|
|
99,188 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
184,539 |
|
|
98,495 |
|
|
86,044 |
|
Selling, general and administrative |
|
329,580 |
|
|
220,403 |
|
|
109,177 |
|
Total operating expenses |
|
514,119 |
|
|
318,898 |
|
|
195,221 |
|
Loss from operations |
|
(407,564) |
|
|
(311,531) |
|
|
(96,033) |
|
Other income (expense): |
|
|
|
|
|
|
Interest expense |
|
(15,567) |
|
|
(227) |
|
|
(15,340) |
|
Interest expense on mandatorily redeemable preferred
shares |
|
(15,985) |
|
|
(12,554) |
|
|
(3,431) |
|
Interest expense on liability related to sale of future
royalties |
|
(28,007) |
|
|
(19,995) |
|
|
(8,012) |
|
|
|
|
|
|
|
|
Change in fair value of derivatives |
|
(1,700) |
|
|
(5,131) |
|
|
3,431 |
|
Gain (loss) from equity method investment |
|
5,261 |
|
|
(2,865) |
|
|
8,126 |
|
Other |
|
(4,751) |
|
|
(216) |
|
|
(4,535) |
|
Total other income (expense), net |
|
(60,749) |
|
|
(40,988) |
|
|
(19,761) |
|
Loss before provision for income taxes |
|
(468,313) |
|
|
(352,519) |
|
|
(115,794) |
|
Provision for income taxes |
|
8,174 |
|
|
1,352 |
|
|
6,822 |
|
Net loss |
|
(476,487) |
|
|
|