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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_________________________________________________________
FORM 10-Q
_________________________________________________________
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2022
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD
FROM TO
Commission file number: 001-38613
_________________________________________________________
Bionano Genomics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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26-1756290 |
(State or Other Jurisdiction of Incorporation or
Organization) |
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(I.R.S. Employer Identification No.) |
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9540 Towne Centre Drive, Suite 100,
San Diego, CA
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92121
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(Address of Principal Executive Offices) |
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(Zip Code) |
(858) 888-7600
(Registrant’s Telephone Number, Including Area Code)
_________________________________________________________
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, $0.0001 par value per share |
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BNGO |
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The Nasdaq Stock Market, LLC |
Warrants to purchase Common Stock |
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BNGOW |
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The Nasdaq Stock Market, LLC |
Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90
days. Yes x
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 x 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 |
☐ |
Non-accelerated filer |
☐ |
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Smaller reporting company |
☒ |
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Emerging growth company |
☐ |
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
☐
Indicate by check mark whether registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No
x
As of July 27, 2022, the registrant had 290,139,940 shares of
Common Stock ($0.0001 par value) outstanding.
BIONANO GENOMICS, INC.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
BIONANO GENOMICS, INC.
Condensed Consolidated Balance Sheets
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(Unaudited) |
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June 30,
2022 |
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December 31,
2021 |
Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
27,159,000 |
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$ |
24,571,000 |
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Investments |
160,178,000 |
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226,041,000 |
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Accounts receivable, net of allowance for doubtful accounts of
$463,000 and $690,000 as of June 30, 2022 and December 31, 2021,
respectively
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4,851,000 |
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4,934,000 |
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Inventory |
20,591,000 |
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12,387,000 |
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Prepaid expenses and other current assets |
3,509,000 |
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4,481,000 |
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Total current assets |
216,288,000 |
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272,414,000 |
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Property and equipment, net |
13,923,000 |
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10,318,000 |
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Operating lease right-of-use assets |
6,431,000 |
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6,691,000 |
|
Finance lease right-of-use assets, related party |
3,810,000 |
|
|
3,926,000 |
|
Intangible assets, net |
24,005,000 |
|
|
26,842,000 |
|
Goodwill |
56,254,000 |
|
|
56,160,000 |
|
Other long-term assets |
841,000 |
|
|
749,000 |
|
Total assets |
$ |
321,552,000 |
|
|
$ |
377,100,000 |
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
7,695,000 |
|
|
$ |
9,696,000 |
|
Accrued expenses |
7,760,000 |
|
|
9,694,000 |
|
Contract liabilities |
1,180,000 |
|
|
684,000 |
|
|
|
|
|
Operating lease liability |
1,757,000 |
|
|
1,467,000 |
|
Finance lease liability, related party |
292,000 |
|
|
299,000 |
|
Contingent consideration |
9,224,000 |
|
|
— |
|
Total current liabilities |
27,908,000 |
|
|
21,840,000 |
|
Operating lease liability, net of current portion |
5,075,000 |
|
|
5,288,000 |
|
Finance lease liability, net of current portion, related
party |
3,632,000 |
|
|
3,642,000 |
|
Contingent consideration |
— |
|
|
9,066,000 |
|
|
|
|
|
Long-term contract liabilities |
203,000 |
|
|
146,000 |
|
|
|
|
|
Total liabilities |
36,818,000 |
|
|
39,982,000 |
|
Commitments and contingencies (Note 7) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized
and no shares issued or outstanding as of June 30, 2022 and
December 31, 2021
|
— |
|
|
— |
|
Common stock, $0.0001 par value, 400,000,000 shares authorized at
June 30, 2022 and December 31, 2021; 290,061,000 and
289,602,000 shares issued and outstanding at June 30, 2022 and
December 31, 2021, respectively
|
29,000 |
|
|
29,000 |
|
Additional paid-in capital |
564,852,000 |
|
|
553,747,000 |
|
Accumulated deficit |
(278,229,000) |
|
|
(216,119,000) |
|
Accumulated other comprehensive loss |
(1,918,000) |
|
|
(539,000) |
|
Total stockholders’ equity |
284,734,000 |
|
|
337,118,000 |
|
Total liabilities and stockholders’ equity |
$ |
321,552,000 |
|
|
$ |
377,100,000 |
|
See accompanying notes to the unaudited condensed consolidated
financial statements
BIONANO GENOMICS, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
|
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
Product revenue |
$ |
3,913,000 |
|
|
$ |
2,496,000 |
|
|
$ |
7,029,000 |
|
|
$ |
4,545,000 |
|
|
|
|
|
Service and other revenue |
2,757,000 |
|
|
1,360,000 |
|
|
5,337,000 |
|
|
2,479,000 |
|
|
|
|
|
Total revenue |
6,670,000 |
|
|
3,856,000 |
|
|
12,366,000 |
|
|
7,024,000 |
|
|
|
|
|
Cost of revenue: |
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue |
3,973,000 |
|
|
1,869,000 |
|
|
7,549,000 |
|
|
3,383,000 |
|
|
|
|
|
Cost of service and other revenue |
1,226,000 |
|
|
548,000 |
|
|
2,485,000 |
|
|
1,159,000 |
|
|
|
|
|
Total cost of revenue |
5,199,000 |
|
|
2,417,000 |
|
|
10,034,000 |
|
|
4,542,000 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
11,767,000 |
|
|
4,086,000 |
|
|
22,296,000 |
|
|
6,765,000 |
|
|
|
|
|
Selling, general and administrative |
21,783,000 |
|
|
13,829,000 |
|
|
42,060,000 |
|
|
23,357,000 |
|
|
|
|
|
Total operating expenses |
33,550,000 |
|
|
17,915,000 |
|
|
64,356,000 |
|
|
30,122,000 |
|
|
|
|
|
Loss from operations |
(32,079,000) |
|
|
(16,476,000) |
|
|
(62,024,000) |
|
|
(27,640,000) |
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
192,000 |
|
|
58,000 |
|
|
301,000 |
|
|
123,000 |
|
|
|
|
|
Interest expense |
(74,000) |
|
|
(268,000) |
|
|
(151,000) |
|
|
(871,000) |
|
|
|
|
|
Gain on forgiveness of Paycheck Protection Program loan |
— |
|
|
— |
|
|
— |
|
|
1,775,000 |
|
|
|
|
|
Loss on debt extinguishment |
— |
|
|
(2,076,000) |
|
|
— |
|
|
(2,076,000) |
|
|
|
|
|
Other income (expense) |
(156,000) |
|
|
(15,000) |
|
|
(188,000) |
|
|
(29,000) |
|
|
|
|
|
Total other income (expense) |
(38,000) |
|
|
(2,301,000) |
|
|
(38,000) |
|
|
(1,078,000) |
|
|
|
|
|
Loss before income taxes |
(32,117,000) |
|
|
(18,777,000) |
|
|
(62,062,000) |
|
|
(28,718,000) |
|
|
|
|
|
Benefit (provision) for income taxes |
(41,000) |
|
|
(9,000) |
|
|
(50,000) |
|
|
(15,000) |
|
|
|
|
|
Net loss |
$ |
(32,158,000) |
|
|
$ |
(18,786,000) |
|
|
$ |
(62,112,000) |
|
|
$ |
(28,733,000) |
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.11) |
|
|
$ |
(0.07) |
|
|
$ |
(0.22) |
|
|
$ |
(0.11) |
|
|
|
|
|
Weighted-average common shares outstanding basic and
diluted |
285,554,000 |
|
|
278,898,000 |
|
|
285,086,000 |
|
|
271,460,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the unaudited condensed consolidated
financial statements.
BIONANO GENOMICS, INC.
Condensed Consolidated Statements of Comprehensive
Loss
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, 2022 |
|
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
Net Loss: |
$ |
(32,158,000) |
|
|
$ |
(18,786,000) |
|
|
$ |
(62,112,000) |
|
|
$ |
(28,733,000) |
|
|
|
|
|
Unrealized (loss) on investment securities
|
(281,000) |
|
|
— |
|
|
(1,379,000) |
|
|
— |
|
|
|
|
|
Comprehensive Loss |
$ |
(32,439,000) |
|
|
$ |
(18,786,000) |
|
|
$ |
(63,491,000) |
|
|
$ |
(28,733,000) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the unaudited condensed consolidated
financial statements.
BIONANO GENOMICS, INC.
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
Additional
Paid-in
Capital |
|
Accumulated
Deficit |
|
Accumulated Other Comprehensive Loss |
|
Total Stockholders’ Equity (Deficit) |
|
|
Shares |
|
Amount |
|
|
|
Balance at January 1, 2021 |
|
189,953,000 |
|
|
$ |
19,000 |
|
|
$ |
178,747,000 |
|
|
$ |
(143,684,000) |
|
|
$ |
— |
|
|
$ |
35,082,000 |
|
Stock option exercises |
|
102,000 |
|
|
— |
|
|
333,000 |
|
|
— |
|
|
— |
|
|
333,000 |
|
Stock-based compensation expense |
|
— |
|
|
— |
|
|
371,000 |
|
|
— |
|
|
— |
|
|
371,000 |
|
Issue common stock, net of issuance costs |
|
78,000,000 |
|
|
8,000 |
|
|
327,478,000 |
|
|
— |
|
|
— |
|
|
327,486,000 |
|
Issue stock for warrant exercises |
|
10,739,000 |
|
|
1,000 |
|
|
9,392,000 |
|
|
— |
|
|
— |
|
|
9,393,000 |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
(9,947,000) |
|
|
— |
|
|
(9,947,000) |
|
Balance at March 31, 2021 |
|
278,794,000 |
|
|
$ |
28,000 |
|
|
$ |
516,321,000 |
|
|
$ |
(153,631,000) |
|
|
$ |
— |
|
|
$ |
362,718,000 |
|
Stock option exercises |
|
60,000 |
|
|
— |
|
|
89,000 |
|
|
— |
|
|
— |
|
|
89,000 |
|
Stock-based compensation expense |
|
— |
|
|
— |
|
|
1,758,000 |
|
|
— |
|
|
— |
|
|
1,758,000 |
|
Issue stock for employee stock purchase plan |
|
150,000 |
|
|
— |
|
|
65,000 |
|
|
— |
|
|
— |
|
|
65,000 |
|
Issue stock for warrant exercises |
|
50,000 |
|
|
— |
|
|
22,000 |
|
|
— |
|
|
— |
|
|
22,000 |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
(18,786,000) |
|
|
— |
|
|
(18,786,000) |
|
Balance at June 30, 2021 |
|
279,054,000 |
|
|
28,000 |
|
|
518,255,000 |
|
|
(172,417,000) |
|
|
— |
|
|
345,866,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2022 |
|
289,602,000 |
|
|
$ |
29,000 |
|
|
$ |
553,747,000 |
|
|
$ |
(216,119,000) |
|
|
$ |
(539,000) |
|
|
$ |
337,118,000 |
|
Stock option exercises |
|
21,000 |
|
|
— |
|
|
15,000 |
|
|
— |
|
|
— |
|
|
15,000 |
|
Stock-based compensation expense |
|
— |
|
|
— |
|
|
5,102,000 |
|
|
— |
|
|
— |
|
|
5,102,000 |
|
Issuance of common stock due to the vesting of restricted stock
units, net of shares withheld to cover taxes |
|
65,000 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
(29,952,000) |
|
|
— |
|
|
(29,952,000) |
|
Other comprehensive loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,098,000) |
|
|
(1,098,000) |
|
Balance at March 31, 2022 |
|
289,688,000 |
|
|
$ |
29,000 |
|
|
$ |
558,864,000 |
|
|
$ |
(246,071,000) |
|
|
$ |
(1,637,000) |
|
|
$ |
311,185,000 |
|
Stock option exercises |
|
249,000 |
|
|
— |
|
|
136,000 |
|
|
— |
|
|
— |
|
|
136,000 |
|
Stock-based compensation expense |
|
— |
|
|
— |
|
|
5,777,000 |
|
|
— |
|
|
— |
|
|
5,777,000 |
|
Issuance of common stock due to the vesting of restricted stock
units, net of shares withheld to cover taxes |
|
(26,000) |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue stock for employee stock purchase plan |
|
150,000 |
|
|
— |
|
|
75,000 |
|
|
— |
|
|
— |
|
|
75,000 |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
(32,158,000) |
|
|
— |
|
|
(32,158,000) |
|
Other comprehensive loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(281,000) |
|
|
(281,000) |
|
Balance at June 30, 2022 |
|
290,061,000 |
|
|
$ |
29,000 |
|
|
$ |
564,852,000 |
|
|
$ |
(278,229,000) |
|
|
$ |
(1,918,000) |
|
|
$ |
284,734,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the unaudited condensed consolidated
financial statements
BIONANO GENOMICS, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
June 30, |
|
2022 |
|
2021 |
Operating activities: |
|
|
|
Net loss |
$ |
(62,112,000) |
|
|
$ |
(28,733,000) |
|
Adjustments to reconcile net loss to net cash used by operating
activities: |
|
|
|
Depreciation and amortization expense |
4,475,000 |
|
|
964,000 |
|
Amortization of financing lease right-of-use asset |
117,000 |
|
|
— |
|
Amortization of interest on securities |
551,000 |
|
|
— |
|
Non-cash lease expense |
337,000 |
|
|
— |
|
Non-cash interest expense |
— |
|
|
383,000 |
|
Stock-based compensation |
10,878,000 |
|
|
2,129,000 |
|
Change in fair value of contingent consideration |
158,000 |
|
|
— |
|
Gain on forgiveness of PPP Loan |
— |
|
|
(1,775,000) |
|
Loss on debt extinguishment |
— |
|
|
2,076,000 |
|
Cost of leased equipment sold to customer |
204,000 |
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
|
Accounts receivable |
24,000 |
|
|
(63,000) |
|
Inventory |
(12,095,000) |
|
|
(3,605,000) |
|
Prepaid expenses and other current assets |
186,000 |
|
|
400,000 |
|
Accounts payable |
(2,072,000) |
|
|
816,000 |
|
Accrued expenses and contract liabilities |
(1,477,000) |
|
|
1,085,000 |
|
Net cash used in operating activities |
(60,826,000) |
|
|
(26,323,000) |
|
Investing Activities: |
|
|
|
|
|
|
|
BioDiscovery acquisition, return of purchase consideration from
escrow |
694,000 |
|
|
— |
|
Purchases of property and equipment |
(371,000) |
|
|
(76,000) |
|
Purchase of available for sale securities |
(29,541,000) |
|
|
— |
|
Sale and maturity of available for sale securities |
93,475,000 |
|
|
— |
|
Construction in progress |
(1,080,000) |
|
|
— |
|
Sale of property and equipment |
27,000 |
|
|
126,000 |
|
Net cash provided by / (used in) investing activities |
63,204,000 |
|
|
50,000 |
|
Financing activities: |
|
|
|
|
|
|
|
Repayment of term-loan debt |
— |
|
|
(17,010,000) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal payments of financing lease liability |
(17,000) |
|
|
— |
|
Proceeds from sale of common stock |
— |
|
|
328,635,000 |
|
Offering expenses on sale of common stock |
— |
|
|
(1,149,000) |
|
Proceeds from sale of common stock under employee stock
purchase plan |
75,000 |
|
|
65,000 |
|
Proceeds from warrant and option exercises |
152,000 |
|
|
9,837,000 |
|
Net cash provided by financing activities |
210,000 |
|
|
320,378,000 |
|
Net increase in cash and cash equivalents |
2,588,000 |
|
|
294,105,000 |
|
Cash and cash equivalents at beginning of period |
24,571,000 |
|
|
38,449,000 |
|
Cash and cash equivalents at end of period |
$ |
27,159,000 |
|
|
$ |
332,554,000 |
|
|
|
|
|
Supplemental cash flow disclosures: |
|
|
|
Cash paid for interest |
$ |
139,000 |
|
|
$ |
487,000 |
|
Cash paid for operating lease liabilities |
$ |
695,000 |
|
|
$ |
422,000 |
|
Supplemental disclosure of non-cash investing and financing
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transfer of instruments and servers from inventory to property and
equipment, net |
$ |
3,890,000 |
|
|
$ |
2,035,000 |
|
Operating lease liabilities resulting from obtaining right-of-use
assets |
$ |
517,000 |
|
|
$ |
2,013,000 |
|
Forgiveness of PPP Loan |
$ |
— |
|
|
$ |
1,775,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise pursuant to cashless exercise |
$ |
— |
|
|
$ |
129,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See
accompanying notes to the unaudited condensed consolidated
financial statements
BIONANO GENOMICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Organization and Basis of Presentation
Description of Business
Bionano Genomics, Inc. (collectively, with its consolidated
subsidiaries, the “Company”) is a provider of genome analysis
solutions that can enable researchers and clinicians to reveal
answers to challenging questions in biology and medicine. The
Company’s mission is to transform the way the world sees the genome
through optical genome mapping (“OGM”) solutions, diagnostic
services and software. The Company offers OGM solutions for
applications across basic, translational and clinical research.
Through its Lineagen, Inc. (“Lineagen”) business, the Company also
provides diagnostic testing for patients with clinical
presentations consistent with autism spectrum disorder and other
neurodevelopmental disabilities. Through its BioDiscovery, LLC
(“BioDiscovery”) business, the Company also offers an
industry-leading, platform-agnostic software solution, which
integrates next-generation sequencing and microarray data designed
to provide analysis, visualization, interpretation and reporting of
copy number variants, single-nucleotide variants and absence of
heterozygosity across the genome in one consolidated
view.
Basis of Presentation
The accompanying financial information has been prepared by the
Company pursuant to the rules and regulations of the Securities and
Exchange Commission (the “SEC”) for interim reporting purposes. The
condensed consolidated financial statements are unaudited. The
unaudited condensed consolidated financial statements reflect, in
the opinion of the Company’s management, all adjustments,
consisting of only normal recurring adjustments, necessary for a
fair presentation of financial position, results of operations,
changes in equity, and comprehensive loss and cash flows for each
period presented in accordance with United States generally
accepted accounting principles (“U.S. GAAP”). All intercompany
transactions and balances have been eliminated. These interim
condensed consolidated financial statements should be read in
conjunction with the audited consolidated financial statements and
related notes thereto included in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2021.
Liquidity
As of June 30, 2022, the Company had approximately
$27.2 million in cash and cash equivalents,
$160.2 million in available for sale investment securities,
and working capital of $188.4 million as a result of common stock
offerings executed in the quarters ended December 31, 2020, March
31, 2021, and September 30, 2021.
The Company believes its available cash, cash equivalents, and
available for sale securities will be sufficient to fund
operations, obligations as they become due and capital investments
for at least the next 12 months. However, the Company expects to
continue to incur net losses for the foreseeable future. The
Company plans to continue to fund its losses from operations and
capital funding needs through a combination of equity offerings,
debt financings or other sources, including potential
collaborations, licenses and other similar arrangements. If the
Company is not able to secure adequate additional funding, the
Company may be forced to make reductions in spending, potentially
harming the Company’s business.
COVID-19 and Other Geopolitical Events
The Company is subject to additional risks and uncertainties as a
result of the continued spread of COVID-19, adverse macroeconomic
events, such as the ongoing conflict between Ukraine and Russia and
related sanctions, and uncertain market conditions, including
higher inflation and supply chain disruptions, which could continue
to have a material impact on the Company’s business and financial
results. The Company closely monitors and complies with various
applicable guidelines and legal requirements in the jurisdictions
in which it operates, which may continue to result in reduced
business operations in response to new or existing stay-at-home
orders, travel restrictions and other social distancing measures.
If restrictions related to COVID-19 persist, the Company could see
additional supply chain disruptions that impact its ability to
produce its products and may cause the Company to make strategic
determinations regarding, among other things, the cost and quality
of the components and supplies it acquires. The Company may also
see negative effects on study enrollment in its ongoing or future
studies. At various times throughout the pandemic, the Company has
been unable to visit certain customer sites to support installation
or service of its OGM systems. The Company’s manufacturing
partners, suppliers, and customers, have implemented similar
operational reductions. Despite reporting an increase in revenue
for the three and six months ended June 30, 2022 when compared
to the same period in 2021, the Company experienced supply chain
constraints that negatively impacted the Company’s first and second
quarter 2021 and 2022 financial results. Given the continued
evolution of the COVID-19 pandemic and the related complexities and
uncertainties associated with the additional variants, the future
effects of COVID-19 are unknown and the Company’s financial results
may continue to be negatively affected in the future. The COVID-19
pandemic may also have long-term effects on the nature of the
office environment and remote working, which may
present strategy, operational, talent recruiting and retention and
workplace culture challenges that may adversely affect its
business.
Following the recent invasion of Ukraine by Russia, the U.S. and
global financial markets experienced volatility, which has led to
disruptions to trade, commerce, pricing stability, credit
availability, supply chain continuity and reduced access to
liquidity globally. In response to the invasion, the United States,
United Kingdom and European Union, along with others, imposed
significant new sanctions and export controls against Russia,
Russian banks and certain Russian individuals and may implement
additional sanctions or take further punitive actions in the
future. The full economic and social impact of the sanctions
imposed on Russia and possible future punitive measures that may be
implemented, as well as the counter measures imposed by Russia, in
addition to the ongoing military conflict between Ukraine and
Russia and related sanctions, which could conceivably expand into
the surrounding region, remains uncertain; however, both the
conflict and related sanctions have resulted and could continue to
result in disruptions to trade, commerce, pricing stability, credit
availability, supply chain continuity and reduced access to
liquidity on acceptable terms, in both Europe and globally, and has
introduced significant uncertainty into global markets. As a
result, our business and results of operations may be adversely
affected by the ongoing military conflict between Ukraine and
Russia and related sanctions, particularly to the extent it
escalates to involve additional countries, further economic
sanctions or wider military conflict.
During the three and six months ended June 30, 2022, the
Company experienced supply chain challenges, which it largely
attributes to the COVID-19 pandemic and the general disruptions
from the ongoing conflict between Ukraine and Russia and related
sanctions. While neither the COVID-19 pandemic nor the
Ukraine-Russia conflict prevented the Company from operating its
business during the three and six months ended June 30, 2022,
it experienced increased cost to secure certain component parts in
its products and to produce its products at its contract
manufacturers. The Company expects these increased costs to remain
high as the COVID-19 pandemic, the Ukraine-Russia conflict and
their respective effects persist.
As global economic conditions recover from the COVID-19 pandemic,
the Ukraine-Russia conflict and the related sanctions, business
activity may not recover as quickly as anticipated, and it is not
possible at this time to estimate the long-term impact that these
and related events could have on the Company’s business, as the
impact will depend on future developments, which are highly
uncertain and cannot be predicted. For instance, product demand may
be reduced due to an economic recession, rising inflation rates,
labor shortages, a decrease in corporate capital expenditures,
prolonged unemployment, reduction in consumer confidence, adverse
macroeconomic events, or any similar negative economic condition.
Further, the travel restrictions on the Company’s business have
limited its ability to support its global and domestic operations,
including providing installation and training and customer service,
which has and may continue to slow the pace of its commercial
strategy, sales and marketing efforts. These negative effects could
have a material impact on the Company’s operations, business,
earnings, and liquidity.
Significant Accounting Policies
During the three and six months ended June 30, 2022, there
were no changes to the Company’s significant accounting policies as
described in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2021.
Recently Issued But Not Yet Adopted Accounting
Pronouncements
In June 2016, the FASB issued ASU No. 2016-13,
Financial Instruments - Credit Losses: Measurement of Credit Losses
on Financial Instruments (ASU 2016-13),
which amends the impairment model by requiring entities to use a
forward looking approach based on expected losses to estimate
credit losses on certain types of financial instruments, including
trade receivables and available for sale debt securities. The
standard is effective for the company beginning in the first
quarter of 2023, with early adoption permitted. The Company is
currently evaluating the expected impact of
ASU 2016-13
on its financial statements.
Recently Adopted Accounting Pronouncements
In February 2016, the Financial Accounting Standards Board issued
Accounting Standards Update 2016-02, “Leases (Topic 842)” (“ASC
842”) which requires lessees to recognize leases on the balance
sheet and disclose key information about leasing arrangements. ASC
842 establishes a right-of-use model that requires a lessee to
recognize a ROU asset and lease liability on the balance sheet for
all leases with a term longer than 12 months. ASC 842 also requires
disclosures to meet the objective of enabling users of financial
statements to assess the amount, timing, and uncertainty of cash
flows arising from leases. The standard was adopted on January 1,
2021, as the Company lost its status as an Emerging Growth Company
effective December 31, 2021, and therefore was required to adopt
the standard for the year ending December 31, 2021, using the
modified retrospective method. Under this transition method, the
Company recognized and measured leases that existed at the adoption
date in the consolidated balance sheet as of January 1, 2021. In
connection with the adoption of ASC 842, the Company elected the
package of practical expedients requiring no reassessment of
whether any expired or existing contracts contain leases, the lease
classification of any expired or existing leases, or initial direct
costs for any existing leases. The Company also made accounting
policy elections not to apply the recognition requirements under
ASC 842 to any short-term leases and to account for each separate
lease and associated non-lease components as a single lease
component for all the Company’s leases. The adoption of this new
accounting standard resulted in increased qualitative and
quantitative disclosures regarding the amount,
timing, and uncertainty of cash flows arising from leases. For
further details, see Note 7, Commitments and Contingencies. The
adoption of the new standard did not materially impact the
Company’s consolidated results of operations.
In May 2021, the FASB issued ASU No. 2021-04, Issuer’s Accounting
for Certain Modifications or Exchanges for Freestanding
Equity-Classified Written Call Options to clarify the accounting
for modifications or exchanges of equity-classified warrants. The
standard is effective for fiscal years beginning after December 15,
2021. Early adoption is permitted. The Company’s adoption of this
accounting standard on January 1, 2022, did not have a material
impact on the Company’s consolidated financial statements and
related disclosures.
2. Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by
the weighted-average number of common shares outstanding for the
period. Diluted net loss per share is computed by dividing the net
loss by the weighted average number of common shares and common
share equivalents outstanding for the period. Common share
equivalents are only included when their effect is dilutive.
Pre-funded warrants from the Company’s follow-on offering have been
treated as if they were common shares outstanding on the date of
issuance. The Company’s potentially dilutive securities which
include outstanding warrants to purchase stock and outstanding
stock options under the Company’s equity incentive plans have been
excluded from the computation of diluted net loss per share as they
would be anti-dilutive to the net loss per share. Restricted stock
is treated as outstanding for accounting purposes. For all periods
presented, there is no difference in the number of shares used to
calculate basic and diluted shares outstanding due to the Company’s
net loss position.
Potentially dilutive securities not included in the calculation of
diluted net loss per share attributable to common stockholders
because to do so would be anti-dilutive are as follows (in common
stock equivalent shares):
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2022 |
|
June 30,
2021 |
Stock options |
23,585,000 |
|
|
9,550,000 |
|
Unvested restricted stock |
3,841,000 |
|
|
— |
|
Warrants |
4,356,000 |
|
|
4,361,000 |
|
RSUs |
230,000 |
|
|
530,000 |
|
PSUs |
290,000 |
|
|
290,000 |
|
Total |
32,302,000 |
|
|
14,731,000 |
|
3. Revenue Recognition
Revenue by Source
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Instruments |
$ |
2,446,000 |
|
|
$ |
1,158,000 |
|
|
$ |
4,042,000 |
|
|
$ |
2,040,000 |
|
Consumables |
1,467,000 |
|
|
1,338,000 |
|
|
2,987,000 |
|
|
2,505,000 |
|
Total product revenue |
3,913,000 |
|
|
2,496,000 |
|
|
7,029,000 |
|
|
4,545,000 |
|
Service and other |
2,757,000 |
|
|
1,360,000 |
|
|
5,337,000 |
|
|
2,479,000 |
|
Total revenue |
$ |
6,670,000 |
|
|
$ |
3,856,000 |
|
|
$ |
12,366,000 |
|
|
$ |
7,024,000 |
|
Revenue by Geographic Location
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
$ |
|
% |
|
$ |
|
% |
|
$ |
|
% |
|
$ |
|
% |
Americas |
$ |
2,611,000 |
|
|
39 |
% |
|
$ |
2,365,000 |
|
|
61 |
% |
|
$ |
5,940,000 |
|
|
48 |
% |
|
$ |
3,872,000 |
|
|
55 |
% |
EMEIA |
2,609,000 |
|
|
39 |
% |
|
940,000 |
|
|
25 |
% |
|
4,348,000 |
|
|
35 |
% |
|
2,518,000 |
|
|
36 |
% |
Asia Pacific |
1,450,000 |
|
|
22 |
% |
|
551,000 |
|
|
14 |
% |
|
2,078,000 |
|
|
17 |
% |
|
634,000 |
|
|
9 |
% |
Total |
$ |
6,670,000 |
|
|
100 |
% |
|
$ |
3,856,000 |
|
|
100 |
% |
|
$ |
12,366,000 |
|
|
100 |
% |
|
$ |
7,024,000 |
|
|
100 |
% |
The table above provides revenue from contracts with customers by
source and geographic region (based on the customer’s billing
address) on a disaggregated basis. Americas consists of North
America and South America. EMEIA consists of Europe, the Middle
East, India and Africa. Asia Pacific includes China, Japan, South
Korea, Singapore and Australia. For the three months ended
June 30, 2022 and 2021, the United States represented 37.4%
and 59.5% of total revenue, respectively. For the
six months ended June 30, 2022 and 2021, the United States
represented 40.9% and 53.1% of total revenue, respectively. For the
three and six months ended June 30, 2022, China represented
19.3% and 12.9% of total revenue, respectively. No other countries
represented greater than 10% of revenue during the three and six
months ended June 30, 2022 and 2021.
Remaining Performance Obligations
As of June 30, 2022, the estimated revenue expected to be
recognized in the future related to performance obligations that
are unsatisfied was approximately $1.4 million. These remaining
performance obligations primarily relate to extended warranty and
support and maintenance obligations. The Company expects to
recognize approximately 59.3% of this amount as revenue during
the remainder of 2022, 32.6% in 2023, and 8.1% in
2024 and thereafter. Warranty revenue is included in service and
other revenue.
The Company recognized revenue of approximately $0.2
million and $0.1 million during the three months ended
June 30, 2022 and 2021, respectively, and revenue of
approximately $0.5 million and $0.2 million during the
six months ended June 30, 2022 and 2021, respectively, which
was included in the contract liability balance at the end of the
previous year.
4. Balance Sheet Account Details
Accounts Receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2022 |
|
|
December 31,
2021 |
Accounts receivable, net: |
|
|
|
|
Accounts receivable, trade |
$ |
5,314,000 |
|
|
|
$ |
5,624,000 |
|
Less allowance for doubtful accounts |
(463,000) |
|
|
|
(690,000) |
|
|
$ |
4,851,000 |
|
|
|
$ |
4,934,000 |
|
Inventory
The components of inventories are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2022 |
|
December 31,
2021 |
Inventory: |
|
|
|
Raw materials |
$ |
837,000 |
|
|
$ |
745,000 |
|
Finished goods |
19,754,000 |
|
|
11,642,000 |
|
|
$ |
20,591,000 |
|
|
$ |
12,387,000 |
|
Intangible Assets
Intangible assets that are subject to amortization consisted of the
following for the periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2022
|
|
December 31, 2021
|
|
|
Gross Carrying Amount |
|
Accumulated Amortization |
|
Net Carrying Amount |
|
Gross Carrying Amount |
|
Accumulated Amortization |
|
Net Carrying Amount |
Trade name |
|
$ |
1,630,000 |
|
|
$ |
(372,000) |
|
|
$ |
1,258,000 |
|
|
$ |
1,630,000 |
|
|
$ |
(210,000) |
|
|
$ |
1,420,000 |
|
Customer relationships |
|
3,950,000 |
|
|
(773,000) |
|
|
3,177,000 |
|
|
3,950,000 |
|
|
(378,000) |
|
|
3,572,000 |
|
Developed technology |
|
22,800,000 |
|
|
(3,230,000) |
|
|
19,570,000 |
|
|
22,800,000 |
|
|
(950,000) |
|
|
21,850,000 |
|
Intangibles, net |
|
$ |
28,380,000 |
|
|
$ |
(4,375,000) |
|
|
$ |
24,005,000 |
|
|
$ |
28,380,000 |
|
|
$ |
(1,538,000) |
|
|
$ |
26,842,000 |
|
Accrued Expenses
Accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2022 |
|
December 31,
2021 |
Compensation expenses |
$ |
4,861,000 |
|
|
$ |
4,529,000 |
|
Goods received not invoiced |
1,238,000 |
|
|
1,073,000 |
|
Customer deposits |
73,000 |
|
|
826,000 |
|
Taxes payable |
722,000 |
|
|
677,000 |
|
Insurance |
— |
|
|
1,011,000 |
|
Professional fees and royalties |
368,000 |
|
|
288,000 |
|
Warranty liabilities |
175,000 |
|
|
175,000 |
|
Accrued clinical study fees |
169,000 |
|
|
1,000 |
|
Other |
154,000 |
|
|
1,114,000 |
|
Total |
$ |
7,760,000 |
|
|
$ |
9,694,000 |
|
5. Debt
Paycheck Protection Program
On April 17, 2020, the Company received the PPP Loan proceeds of
approximately $1.8 million pursuant to the Paycheck Protection
Program under the Coronavirus Aid, Relief, and Economic Security
Act (the “CARES Act”) administered by the U.S. Small Business
Administration (the “SBA”). In February 2021, the Company applied
for forgiveness of the PPP Loan, and in March 2021, the PPP Loan,
including all accrued interest, was forgiven in full. A gain on
forgiveness of Paycheck Protection Program loan of
$1.8 million was recognized during the six months ended
June 30, 2021.
Innovatus Loan and Security Agreement
In May 2021, the outstanding term loan with Innovatus (“Innovatus
LSA”) was paid in full, including all accrued interest, the end of
term fee, and a prepayment fee for a total of approximately
$17.0 million. Interest expense recognized during the three
and six months ended June 30, 2021 totaled approximately $0.3
million and $0.9 million, respectively.
6. Stockholders’ Equity and Stock-Based Compensation
Follow-on Public Offerings
On January 12, 2021 and January 25, 2021, the Company completed an
underwritten public offering of 33.4 million and
38.3 million shares of common stock, respectively. The price
to the public in the offerings on January 12, 2021 and January 15,
2021 was $3.05 and $6.00 per share, respectively. The net proceeds
to the Company from the offerings, after deducting the underwriting
discounts and commissions and other offering expenses, were $101.5
million and $229.6 million, respectively.
Shelf Registration Statements; Ladenburg and Cowen At-the-Market
Facilities
In August 2020, the Company filed a shelf registration statement on
Form S-3 with the SEC covering the offering, issuance and sale of
up to $125 million of the Company’s securities, including up to $40
million of common stock, pursuant to an At Market Issuance Sales
Agreement, with Ladenburg Thalmann & Co. Inc. acting as sales
agent (the “Ladenburg ATM”). During October 2020 through January
2021, the Company sold approximately 27.0 million shares of
common stock under the Ladenburg ATM and received net proceeds of
$38.0 million after deducting aggregate offering costs. The Company
terminated the Ladenburg ATM in March 2021.
On January 19, 2021, the Company filed an automatically effective
shelf registration statement on Form S-3 with the SEC as a
“well-known seasoned issuer,” allowing for the Company to issue an
indeterminate number or amount of its securities from time to time
in one or more offerings. As of June 30, 2022, as a consequence of
the Company’s re-qualification as a “smaller reporting company,”
the Company may lose “well-known seasoned issuer” status at the
time it files its Annual Report on Form 10-K for the fiscal year
ending December 31, 2022 if the worldwide market value of its
voting and non-voting common equity held by its non-affiliates does
not equal $700.0 million or more, calculated as of a date
within 60 days prior to filing such report. If that were to occur
and the Company were no longer considered a well-known seasoned
issuer, the Company anticipates needing to amend its automatically
effective shelf registration statement on Form S-3 prior to its
filing of such annual report (or earlier if required by the
Securities Act or the rules and regulations of the SEC) in order to
sell securities under that Form S-3 on an ongoing
basis.
On March 23, 2021, the Company entered into a Sales Agreement with
Cowen and Company, LLC (“Cowen”) which provides for the sale, in
the Company’s sole discretion, of shares of common stock having an
aggregate offering price of up to
$350.0 million through or to Cowen, acting as sales agent or
principal (the “Cowen ATM”). The Company agreed to pay Cowen a
commission of up to 3.0% of the aggregate gross proceeds from each
sale of shares, reimburse legal fees and disbursements and provide
Cowen with customary indemnification and contribution rights. In
August and September 2021, the Company sold approximately
2.3 million shares of common stock under the Cowen ATM at an
average share price of $6.15 per share, and received gross proceeds
of approximately $13.9 million before deducting offering costs of
$0.6 million. There were no sales of common stock under the Cowen
ATM from January 1, 2022 to June 30, 2022.
Stock Warrants
A summary of the Company’s warrant activity during the six months
ended June 30, 2022 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares of Stock under Warrants |
|
Weighted-
Average
Exercise
Price |
|
Weighted-
Average
Remaining
Contractual
Term |
|
Aggregate
Intrinsic
Value |
Outstanding at January 1, 2022 |
4,356,000 |
|
|
$ |
5.96 |
|
|
1.76 |
|
$ |
785,000 |
|
Granted |
— |
|
|
— |
|
|
— |
|
|
— |
|
Exercised |
— |
|
|
— |
|
|
— |
|
|
— |
|
Canceled |
— |
|
|
— |
|
|
— |
|
|
— |
|
Outstanding at June 30, 2022
|
4,356,000 |
|
|
$ |
5.96 |
|
|
1.27 |
|
$ |
246,000 |
|
Stock Options
A summary of the Company’s stock option activity during the six
months ended June 30, 2022 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares of Stock under Stock Options |
|
Weighted-
Average
Exercise
Price |
|
Weighted-
Average
Remaining
Contractual
Term |
|
Aggregate
Intrinsic
Value |
Outstanding at January 1, 2022 |
12,765,000 |
|
|
$ |
4.97 |
|
|
8.9 |
|
$ |
7,891,000 |
|
Granted |
12,797,000 |
|
|
2.11 |
|
|
— |
|
|
— |
|
Exercised |
(270,000) |
|
|
0.59 |
|
|
— |
|
|
302,000 |
|
Canceled |
(1,708,000) |
|
|
5.00 |
|
|
— |
|
|
— |
|
Outstanding at June 30, 2022
|
23,584,000 |
|
|
$ |
3.47 |
|
|
9.08 |
|
$ |
2,053,000 |
|
Vested and exercisable at June 30, 2022
|
4,976,000 |
|
|
$ |
3.90 |
|
|
7.96 |
|
$ |
1,327,000 |
|
For the three months ended June 30, 2022, the weighted-average
grant date fair value of stock options granted was $1.17 per share.
For the six months ended June 30, 2022, the weighted-average
grant date fair value of stock options granted was $1.33 per
share.
Stock-Based Compensation
The Company recognized stock-based compensation expense for the
periods presented as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
2022 |
|
2021 |
|
2022 |
|
2021 |
Research and development |
$ |
3,468,000 |
|
|
$ |
384,000 |
|
|
$ |
6,795,000 |
|
|
$ |
465,000 |
|
General and administrative |
2,309,000 |
|
|
1,374,000 |
|
|
4,084,000 |
|
|
1,664,000 |
|
Total stock-based compensation expense |
$ |
5,777,000 |
|
|
$ |
1,758,000 |
|
|
$ |
10,879,000 |
|
|
$ |
2,129,000 |
|
The weighted-average assumptions used in the Black-Scholes option
pricing model to determine the fair value of the employee stock
option grants during the periods presented were as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
2022 |
|
2021 |
|
2022 |
|
2021 |
Risk-free interest rate |
2.8 |
% |
|
1.1 |
% |
|
2.1 |
% |
|
1.1 |
% |
Expected volatility |
70.6 |
% |
|
80.4 |
% |
|
70.2 |
% |
|
80.4 |
% |
Expected term (in years) |
5.7 |
|
6.0 |
|
6.0 |
|
6.0 |
Expected dividend yield |
0.0 |
% |
|
0.0 |
% |
|
0.0 |
% |
|
0.0 |
% |
Restricted Stock
Restricted Stock
A restricted stock award in the amount of 5.0 million shares with a
grant date fair value of $5.20 a share was granted as part of the
acquisition of BioDiscovery. One-third of the Restricted Shares
will vest on October 18, 2022 and one-twelfth of the Restricted
Shares shall vest every three months following October 18, 2022,
subject to continuous service of a key employee. The weighted
average remaining contractual term for the restricted stock is 2.3
years as of June 30, 2022. The fair value of the restricted
stock award is based on the market value of common stock as of the
date of grant and is amortized to expense over the respective
vesting period or the service period.
Restricted Stock Units and Performance Stock Units
The following table summarizes restricted share unit (“RSU”)
activity during the six months ended June 30,
2022:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Units |
|
Weighted- Average Grant Date Fair Value per Share |
Outstanding at January 1, 2022 |
361,000 |
|
|
$ |
4.74 |
|
Granted |
— |
|
— |
Released |
(131,000) |
|
4.74 |
Forfeited |
— |
|
|
— |
|
Outstanding at June 30, 2022
|
230,000 |
|
$ |
4.74 |
The total intrinsic value of the RSUs that vested during the six
months ended June 30, 2022 was $0.6 million, determined
as of the date of vesting. The weighted average remaining
contractual term for the RSUs is 0.9 years as of June 30,
2022.
The following table summarizes performance share unit (“PSU”)
activity during the six months ended June 30,
2022:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Units |
|
Weighted- Average Grant Date Fair Value per Share |
Outstanding at January 1, 2021 |
290,000 |
|
$ |
4.74 |
|
Granted |
— |
|
— |
Released |
— |
|
— |
Forfeited |
— |
|
— |
Outstanding at June 30, 2022
|
290,000 |
|
$ |
4.74 |
The weighted average remaining contractual term for the PSUs is 2.9
years as of June 30, 2022.
Executive Option Grants
On February 15, 2022, the compensation committee of the Company’s
board of directors granted various executive officers stock options
to purchase an aggregate of 4.3 million shares of common stock
at an exercise price of $2.18 a share, in each case with an
effective grant date and vesting commencement date of February 15,
2022 (the “Grant Date”). These stock option grants were issued from
the 2018 Stock Plan. The shares subject to the option shall vest
monthly over 48 months beginning on
the one-month anniversary of the Grant Date, such that the option
shall be fully vested and exercisable on the four-year anniversary
of the Grant Date.
7. Commitments and Contingencies
The Company discounts its lease payments using its incremental
borrowing rate as of the commencement of the lease. The Company has
determined a weighted-average discount rate of 7% as of
June 30, 2022 and December 31, 2021.
The operating lease right-of-use asset and operating lease
liability as of June 30, 2022 and December 31, 2021 are
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2022 |
|
December 31, 2021 |
Operating lease right-of-use assets |
$ |
6,431,000 |
|
|
$ |
6,691,000 |
|
|
|
|
|
Operating lease liability |
|
|
|
Current |
1,757,000 |
|
1,467,000 |
Non-current |
5,075,000 |
|
5,288,000 |
Total operating lease liability |
$ |
6,832,000 |
|
|
$ |
6,755,000 |
For the three and six months ended June 30, 2022, the Company
recorded $0.5 million and $1.0 million, respectively, in
expense related to operating leases, including amortized tenant
improvement allowances. For the three and six months ended
June 30, 2021, the Company recorded $0.3 million and
$0.5 million respectively, in expense related to operating
leases, including amortized tenant improvement
allowances.
The finance lease right-of-use asset and finance lease liability as
of June 30, 2022 and December 31, 2021 are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2022 |
|
December 31, 2021 |
Finance lease right-of-use assets |
$ |
3,810,000 |
|
|
$ |
3,926,000 |
|
|
|
|
|
Finance lease liability |
|
|
|
Current |
292,000 |
|
299,000 |
Non-current |
3,632,000 |
|
3,642,000 |
Total finance lease liability |
$ |
3,924,000 |
|
|
$ |
3,941,000 |
For the three and six months ended June 30, 2022, the Company
recorded $0.1 million and $0.3 million, respectively, in
expense related to its finance lease. The Company did not hold a
finance lease as of June 30, 2021.
The future minimum payments under non-cancellable operating and
finance leases as of June 30, 2022, are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Leases |
|
Finance Lease |
Remainder of 2022 |
$ |
1,036,000 |
|
|
$ |
158,000 |
|
2023 |
2,149,000 |
|
|
322,000 |
|
2024 |
2,219,000 |
|
|
330,000 |
|
2025 |
2,305,000 |
|
|
338,000 |
|
2026 |
232,000 |
|
|
347,000 |
|
Thereafter |
— |
|
|
5,949,000 |
|
Total future lease payments |
7,941,000 |
|
|
7,444,000 |
|
Less: imputed interest |
(1,109,000) |
|
|
(3,520,000) |
|
Total lease liabilities |
$ |
6,832,000 |
|
|
$ |
3,924,000 |
|
Litigation
From time to time, the Company may be subject to potential
liabilities under various claims and legal actions that are pending
or may be asserted. These matters arise in the ordinary course and
conduct of the business. The Company regularly assesses
contingencies to determine the degree of probability and range of
possible loss for potential accrual in the financial statements. An
estimated loss contingency is accrued in the financial statements
if it is probable that a liability has been incurred and the amount
of the loss can be reasonably estimated. Based on the Company’s
assessment, it currently does not have any material loss exposure
as it is not a defendant in any claims or legal
actions.
Contingent Consideration
See Note 9 to our condensed consolidated financial statements for a
discussion of the contingent consideration liability.
8. Acquisitions
BioDiscovery Acquisition
In October 2021, the Company completed the acquisition of
BioDiscovery, LLC, for a combination of approximately $52.3 million
in cash, $40.0 million in shares of Company common stock, and $10.0
million in cash payable based on the achievement of certain
milestones. Of the $40.0 million in shares of Company common stock,
approximately $26.0 million is subject to vesting based on
continuous service. See Note 6 to our condensed consolidated
financial statements for a discussion of the restricted stock
vesting terms and accounting treatment.
The purchase price allocation for the acquisition of BioDiscovery
is preliminary and subject to revision as additional information
about the fair value of assets and liabilities becomes available.
As permitted under ASC 805, the Company is allowed a measurement
period, which may not exceed one year, in which to complete its
accounting for the acquisition. During the first quarter of 2022,
the Company recorded an increase to the value of acquired contract
liabilities in the amount of $94,000, with the offset recorded to
goodwill. The purchase price is still subject to adjustment for the
final determination of deferred and current tax assets and
liabilities.
The following is the purchase price for the acquisition of
BioDiscovery:
|
|
|
|
|
|
|
|
|
Cash |
|
$ |
52,291,000 |
|
Estimated fair value of milestone consideration |
|
$ |
9,000,000 |
|
Return of cash to buyer from escrow |
|
$ |
(694,000) |
|
Shares of common stock issued as consideration |
|
2,723,000 |
|
Stock price per share on closing date |
|
$ |
5.20 |
|
Value of estimated common stock consideration |
|
$ |
14,159,000 |
|
Total purchase price |
|
$ |
74,756,000 |
|
The total purchase price was allocated to BioDiscovery’s tangible
and identifiable intangible assets acquired and liabilities assumed
based on their estimated fair values as of the acquisition date,
with the excess recorded as goodwill, as follows:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
3,205,000 |
|
Accounts receivable |
|
1,782,000 |
|
Right-of-use assets |
|
3,987,000 |
|
Other assets |
|
213,000 |
|
Intangible assets |
|
26,800,000 |
|
Goodwill |
|
49,081,000 |
|
Accounts payable and other accrued liabilities |
|
(193,000) |
|
Right-of-use liabilities (short-term and long-term) |
|
(3,987,000) |
|
Deferred tax liability |
|
(5,777,000) |
|
Contract liabilities |
|
(355,000) |
|
Net assets acquired |
|
$ |
74,756,000 |
|
The acquisition date fair values of identifiable intangible assets
acquired are as follows:
|
|
|
|
|
|
|
|
|
Customer relationships |
|
$ |
3,000,000 |
|
Developed technology |
|
22,800,000 |
|
Tradename |
|
1,000,000 |
|
Fair value of identifiable intangible assets |
|
$ |
26,800,000 |
|
The Company uses the income approach to derive the fair value of
the identified intangible assets acquired. This approach calculates
fair value by estimating future cash flows attributable to the
assets and then discounting these cash flows to a present value
using a risk-adjusted discount rate.
The developed technology, customer relationships and trade name
intangibles are both being amortized on a straight-line basis over
their estimated useful lives of five years. Straight-line
amortization was determined to be materially consistent with the
pattern of expected use of the intangible assets.
As the Company began integrating BioDiscovery’s operations with its
existing operations during the fourth quarter of 2021, it is not
practical or meaningful to distinguish BioDiscovery’s expenses or
net income or loss from that of the combined
operations.
Pro forma Financial Information
The unaudited pro forma financial information in the table below
summarizes the combined results of operations for the Company and
BioDiscovery as if the companies had been combined as of the
beginning of the year prior to the acquisition. These amounts have
been calculated after applying the Company’s accounting policies
and adjusting the results of BioDiscovery to reflect the additional
amortization that would have been charged assuming the fair value
adjustments to intangible assets had been applied at the beginning
of the year prior to the acquisition. The following unaudited pro
forma financial information is for informational purposes only and
is not necessarily indicative of the results of operations that
would have been achieved as if the acquisitions had taken place as
of January 1, 2020.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
Three Months Ended June 30, |
|
2021 |
|
2021 |
Revenue |
|
$ |
9,467,000 |
|
|
$ |
5,313,000 |
|
Net loss |
|
(30,479,000) |
|
|
(19,320,000) |
|
Basic and diluted net loss per share
|
|
$ |
(0.11) |
|
|
$ |
(0.07) |
|
9. Investments and Fair Value Measurements
The Company holds investment securities that consist of highly
liquid, investment grade debt securities. The Company determines
the fair value of its investment securities based upon one or more
valuations reported by its investment accounting and reporting
service provider. The investment service provider values the
securities using a hierarchical security pricing model that relies
primarily on valuations provided by an industry-recognized
valuation service. Such valuations may be based on trade prices in
active markets for identical assets or liabilities (Level 1 inputs)
or valuation models using inputs that are observable either
directly or indirectly (Level 2 inputs), such as quoted prices for
similar assets or liabilities, yield curves, volatility factors,
credit spreads, default rates, loss severity, current market and
contractual prices for the underlying instruments or debt, and
broker and dealer quotes, as well as other relevant economic
measures.
The following table presents the Company’s financial assets and
liabilities measured at fair value on a recurring basis as of
June 30, 2022 and December 31, 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2022
|
|
Total Fair Value and Carrying Value on Balance Sheet |
|
Fair Value Measurement Category |
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
Assets: |
|
|
|
|
|
|
|
Commercial Paper |
$ |
56,809,000 |
|
|
$ |
— |
|
|
$ |
56,809,000 |
|
|
$ |
— |
|
Corporate Notes/Bonds |
100,384,000 |
|
|
— |
|
|
100,384,000 |
|
|
— |
|
Securities of Government Sponsored Entities |
2,985,000 |
|
|
$ |
— |
|
|
2,985,000 |
|
|
$ |
— |
|
Total Investments: |
$ |
160,178,000 |
|
|
$ |
— |
|
|
$ |
160,178,000 |
|
|
$ |
— |
|
Money Market Funds |
$ |
15,923,000 |
|
|
$ |
15,923,000 |
|
|
$ |
— |
|
|
$ |
— |
|
Liabilities: |
|
|
|
|
|
|
|
Contingent consideration |
$ |
9,224,000 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
9,224,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2021
|
|
Total Fair Value and Carrying Value on Balance Sheet |
|
Fair Value Measurement Category |
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
Assets: |
|
|
|
|
|
|
|
Commercial Paper |
$ |
100,860,000 |
|
|
$ |
— |
|
|
$ |
100,860,000 |
|
|
$ |
— |
|
Corporate Notes/Bonds |
125,181,000 |
|
|
— |
|
|
125,181,000 |
|
|
— |
|
Total Investments: |
$ |
226,041,000 |
|
|
$ |
— |
|
|
$ |
226,041,000 |
|
|
$ |
— |
|
Money Market Funds |
$ |
11,126,000 |
|
|
$ |
11,126,000 |
|
|
$ |
— |
|
|
$ |
— |
|
Liabilities: |
|
|
|
|
|
|
|
Contingent consideration |
$ |
9,066,000 |
|
|
|
|
|
|
$ |
9,066,000 |
|
Money Market Funds are classified as cash equivalents on the
balance sheet. As of June 30, 2022 and December 31, 2021,
the Company held 47 and 57 securities in an unrealized loss
position, respectively.
As of June 30, 2022 and December 31, 2021, the Company
does not intend to sell these investments and it is not more likely
than not that the Company will be required to sell the investments
before recovery of their amortized cost basis. The Company does not
believe the unrealized losses incurred during the period are due to
credit-related factors. The credit ratings of the securities held
remain of high quality, and the Company continues to receive
payments of interest and principal as they become due, and our
expectation is that those payments will continue to be received
timely. As such, the Company has not recognized any impairment in
its financial statements related to its available for sale
investment securities.
The fair value of the contingent consideration liability is
reassessed on a quarterly basis using the income approach.
Assumptions used to estimate the acquisition date fair value of the
contingent consideration include the probability of achieving
certain milestones and a discount rate of 3%. The fair value
measurement of the contingent consideration is based on significant
inputs not observed in the market (Level 3 inputs). The Company
determined the fair value of the milestone consideration using a
scenario-based technique, as the trigger for payment is event
driven. The outcome of the milestone consideration is binary,
meaning the milestone is either achieved or not achieved, and the
only other variable factor is the timing of when the milestone is
achieved. The Company determined it is highly likely that the
milestone will be achieved and therefore used a 95% probability
factor which is applied to the $10.0 million milestone
consideration. The change in fair value of the contingent
consideration during the three and six month period ended
June 30, 2022 was due to the passage of time. During the three
months ended June 30, 2022, the milestone consideration
liability was reclassified from non-current liabilities to current
liabilities.
Changes in estimated fair value of contingent consideration
liability in the six months ended June 30, 2022 is as
follows:
|
|
|
|
|
|
|
Contingent
Consideration
Liability
(Level 3
Measurement)
|
Balance as of January 1, 2021 |
$ |
9,066,000 |
|
Liability recorded as a result of current period
acquisition |
— |
|
Change in estimated fair value, recorded in selling, general and
administrative expenses |
158,000 |
|
Cash payments |
— |
|
Balance as of June 30, 2022
|
$ |
9,224,000 |
|
|
|
As of June 30, 2022, the following table summarizes the
amortized cost and the unrealized gains (losses) of the available
for sale securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial Paper |
|
Corporate Notes/Bonds |
|
Securities of Government Sponsored Entities |
|
Amortized Cost
|
|
Unrealized gains (losses)
|
|
Amortized Cost
|
|
Unrealized gains (losses)
|
|
Amortized Cost |
|
Unrealized gains (losses) |
Less than 1 year |
$ |
57,070,000 |
|
|
$ |
(261,000) |
|
|
$ |
65,045,000 |
|
|
$ |
(909,000) |
|
|
$ |
2,986,000 |
|
|
$ |
(1,000) |
|
Due after one year through five years |
— |
|
|
— |
|
|
36,997,000 |
|
|
(749,000) |
|
|
— |
|
|
— |
|
Total |
$ |
57,070,000 |
|
|
$ |
(261,000) |
|
|
$ |
102,042,000 |
|
|
$ |
(1,658,000) |
|
|
$ |
2,986,000 |
|
|
$ |
(1,000) |
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2021, the following table summarizes the
amortized cost and the unrealized gains (losses) of the available
for sale securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial Paper |
|
Corporate Notes/Bonds |
|
Securities of Government Sponsored Entities |
|
Amortized Cost
|
|
Unrealized loss
|
|
Amortized Cost
|
|
Unrealized loss
|
|
Amortized Cost |
|
Unrealized gains (losses) |
Less than 1 year |
$ |
100,929,000 |
|
|
$ |
(69,000) |
|
|
$ |
41,173,000 |
|
|
$ |
(61,000) |
|
|
$ |
— |
|
|
$ |
— |
|
Due after one year through five years |
— |
|
|
— |
|
|
84,478,000 |
|
|
(409,000) |
|
|
— |
|
|
— |
|
Total |
$ |
100,929,000 |
|
|
$ |
(69,000) |
|
|
$ |
125,651,000 |
|
|
$ |
(470,000) |
|
|
$ |
— |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in interest income for the three-month period ended
June 30, 2022 was interest income related to the Company’s
available for sale securities of $0.2 million. Included in
interest income for the six-month period ended June 30, 2022
was interest income related to the Company’s available for sale
securities of $0.3 million. All available for sale securities
are classified as current assets, even if the maturity when
acquired by the Company is greater than one year due to the ability
to liquidate within the next 12 months.
10. Related Party Transactions
Through the acquisition of BioDiscovery in October 2021, the
Company inherited a building lease with a landlord owned by
BioDiscovery’s former Director and Chief Executive Officer, who is
now the Company’s Chief Informatics Officer. The Company recorded
$0.1 million in finance lease costs related to this lease for
the three-month period ended June 30, 2022. The Company
recorded $0.3 million in finance lease costs related to this
lease for the six-month period ended June 30,
2022.
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
unaudited consolidated financial statements and related notes
included in this Quarterly Report on Form 10-Q and the audited
consolidated financial statements and notes thereto as of and for
the year ended December 31, 2021 and the related Management’s
Discussion and Analysis of Financial Condition and Results of
Operations, both of which are contained in our Annual Report on
Form 10-K, or our Annual Report, filed with the Securities and
Exchange Commission, or the SEC, on March 1, 2022. Unless the
context requires otherwise, references in this Quarterly Report on
Form 10-Q to “we,” “us,” and “our” refer to Bionano Genomics, Inc.
and its subsidiaries or, as the context may require, Bionano
Genomics, Inc. only.
Forward-Looking Statements
The information in this Quarterly Report on Form 10-Q contains
forward-looking statements and information within the meaning of
Section 27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section 21E of the Securities Exchange Act of
1934, as amended, or the Exchange Act, which are subject to the
“safe harbor” created by those sections. These forward-looking
statements include, but are not limited to any statements
concerning the potential effects of the COVID-19 pandemic on our
business, statements concerning our strategy, future operations,
future financial position, future revenues, projected costs,
prospects and plans and objectives of management. The words
“anticipates,” “believes,” “estimates,” “expects,” “intends,”
“may,” “plans,” “projects,” “will,” “would” and similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words. We
may not actually achieve the plans, intentions, or expectations
disclosed in our forward-looking statements and you should not
place undue reliance on our forward-looking statements. Actual
results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking
statements that we make. These forward-looking statements involve
risks and uncertainties that could cause our actual results to
differ materially from those in the forward-looking statements,
including, without limitation, the risks set forth in our filings
with the SEC. The forward-looking statements are applicable only as
of the date on which they are made, and we do not assume any
obligation to update any forward-looking statements.
Overview
We are a provider of genome analysis solutions that can enable
researchers and clinicians to reveal answers to challenging
questions in biology and medicine. Our mission is to transform the
way the world sees the genome through optical genome mapping, or
OGM, solutions, diagnostic services and software. We offer OGM
solutions for applications across basic, translational and clinical
research. Through our Lineagen, Inc., or Lineagen, business, we
also provide diagnostic testing for patients with clinical
presentations consistent with autism spectrum disorder and other
neurodevelopmental disabilities. Through our BioDiscovery, LLC, or
BioDiscovery, business, we also offer an industry-leading,
platform-agnostic software solution, which integrates
next-generation sequencing and microarray data designed to provide
analysis, visualization, interpretation and reporting of copy
number variants, single-nucleotide variants and absence of
heterozygosity across the genome in one consolidated
view.
We have incurred losses in each year since our inception. Our net
loss was $32.2 million and $62.1 million for the three and six
months ended June 30, 2022, respectively. As of June 30,
2022, we had an accumulated deficit of $278.2 million.
We expect to continue to incur significant expenses and operating
losses as we:
•expand
our sales and marketing efforts to further commercialize our
products;
•continue
research and development efforts to improve our existing
products;
•hire
additional personnel;
•enter
into collaboration arrangements, if any;
•add
operational, financial and management information systems;
and
•incur
increased costs as a result of operating as a public
company.
Recent Highlights
Commercial Adoption of Offerings for Saphyr
In executing on our commercialization strategy, we expanded the
utilization of our Saphyr®
system and:
•Grew
our installed base to 196 as of June 30, 2022, an increase of
approximately 62% from a total installed base of 121 as of
June 30, 2021. Installed base represents the global number of
Saphyr instruments installed at end-customer locations and
therefore having the technology to process OGM.
•Sold
3,394 flowcells in the three-month period ended June 30, 2022,
an increase of approximately 24% over the 2,742 flowcells sold
during the same quarter of 2021. The Saphyr cartridge is the
consumable that packages nanochannel arrays for DNA linearization.
In its current form, the Saphyr cartridge has two configurations -
one with two flowcells per cartridge and the other with three
flowcells per cartridge. Flowcells sold refers to the units of
genome mapping consumables used for analyzing one genome, purchased
by customers to process optical genome mapping.
•We
analyzed 373 samples in our Saphyr service lab during the quarter
ended June 30, 2022, compared to 190 samples analyzed in the
same quarter in 2021.
COVID-19 and Other Geopolitical Events
We are subject to additional risks and uncertainties as a result of
the continued spread of COVID-19, adverse geopolitical and
macroeconomic events, such as the ongoing conflict between Ukraine
and Russia and related sanctions, and uncertain market conditions,
including higher inflation and supply chain disruptions, which
could continue to have a material impact on our business and
financial results.
We closely monitor and comply with various applicable guidelines
and legal requirements in the jurisdictions in which we operate,
which may continue to result in reduced business operations in
response to new or existing stay-at-home orders, travel
restrictions and other social distancing measures. If restrictions
related to COVID-19 persist, we could see additional supply chain
disruptions that impact our ability to produce our products and may
cause us to make strategic determinations regarding, among other
things, the cost and quality of the components and supplies we
acquire. We may also see negative effects on enrollment in our
ongoing or future clinical studies. At various times throughout the
pandemic, we have been unable to visit certain customer sites to
support installation or service our OGM systems. Our manufacturing
partners, suppliers, and customers, have implemented similar
operational reductions. This overall reduction in activity has
contributed to a decrease in sales which negatively impacted the
Company’s financial results in the first and second quarters of
2021 and 2022. Given the continued evolution of the COVID-19
pandemic and the related complexities and uncertainties associated
with the additional variants, the future effects of COVID-19 are
unknown and our financial results may continue to be negatively
affected in the future. The COVID-19 pandemic may also have
long-term effects on the nature of the office environment and
remote working, which may present strategy, operational, talent
recruiting and retention and workplace culture challenges that may
adversely affect our business.
Following the recent invasion of Ukraine by Russia, the U.S. and
global financial markets experienced volatility, which has led to
disruptions to trade, commerce, pricing stability, credit
availability, supply chain continuity and reduced access to
liquidity globally. In response to the invasion, the United States,
United Kingdom and European Union, along with others, imposed
significant new sanctions and export controls against Russia,
Russian banks and certain Russian individuals and may implement
additional sanctions or take further punitive actions in the
future. The full economic and social impact of the sanctions
imposed on Russia and possible future punitive measures that may be
implemented, as well as the counter measures imposed by Russia, in
addition to the ongoing military conflict between Ukraine and
Russia, which could conceivably expand into the surrounding region,
remains uncertain; however, both the conflict and related sanctions
have resulted and could continue to result in disruptions to trade,
commerce, pricing stability, credit availability, supply chain
continuity and reduced access to liquidity on acceptable terms, in
both Europe and globally, and has introduced significant
uncertainty into global markets. As a result, our business and
results of operations may be adversely affected by the ongoing
conflict between Ukraine and Russia and related sanctions,
particularly to the extent it escalates to involve additional
countries, further economic sanctions or wider military
conflict.
During the three and six months ended June 30, 2022, we
experienced supply chain challenges, which we largely attribute to
the COVID-19 pandemic and the general disruptions resulting from
the ongoing conflict between Ukraine and Russia and related
sanctions. While neither the COVID-19 pandemic nor the
Ukraine-Russia conflict prevented us from operating our business
during the three and six months ended June 30, 2022, we
experienced increased cost to secure certain component parts in our
products and to produce our products at our contract manufacturers.
We expect these increased costs to remain high as the COVID-19
pandemic, the Ukraine-Russia conflict and their respective effects
persist. As global economic conditions recover from the COVID-19
pandemic, the Ukraine-Russia conflict and the related sanctions,
business activity may not recover as quickly as anticipated, and it
is not possible at this time to estimate the long-term impact that
these and related events could have on our business, as the impact
will depend on future developments, which are highly uncertain and
cannot be predicted. For instance, product demand may be reduced
due to an economic recession, a decrease in corporate capital
expenditures, prolonged unemployment, rising inflation rates, labor
shortages, reduction in consumer confidence, adverse geopolitical
and macroeconomic events, or any similar negative economic
condition. Further, the travel restrictions on our business have
limited our ability to support our global and domestic operations,
including providing installation and training and customer service,
which has and may continue to slow the pace of our commercial
strategy, sales and marketing efforts. These negative effects could
have a material impact on our operations, business, earnings, and
liquidity.
Financial Overview
Revenue
We generate product revenue from sales of our instruments and
consumables. We currently sell our products for research use only
applications and our customers are primarily laboratories
associated with academic and governmental research institutions,
academic and commercial clinical laboratories, as well as
pharmaceutical, biotechnology and contract research companies. In
addition, we provide instruments to certain customers under our
reagent rental program, under which we provide an instrument to
customers at no cost and the customers agree to purchase minimum
quantities of consumables. Consumable revenue consists of sales of
reagents and chips necessary to process a sample. We generate
service revenue from the sale of diagnostic testing services for
those with autism spectrum disorder and other neurodevelopmental
disabilities through our wholly owned subsidiary Lineagen. We also
generate service and product revenue through BioDiscovery’s
NxClinical™ software, which provides customers with solutions for
analysis, interpretation and reporting of genomics data. Other
revenue consists of warranty and other service-based revenue,
including services performed related to customer sample evaluations
using the Saphyr system, license maintenance agreements, and
support, repair and maintenance services.
The following table presents our revenue for the periods
indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Product revenue |
$ |
3,913,000 |
|
|
$ |
2,496,000 |
|
|
$ |
7,029,000 |
|
|
$ |
4,545,000 |
|
Service and other revenue1
|
2,757,000 |
|
|
1,360,000 |
|
|
5,337,000 |
|
|
2,479,000 |
|
Total |
$ |
6,670,000 |
|
|
$ |
3,856,000 |
|
|
$ |
12,366,000 |
|
|
$ |
7,024,000 |
|
|
|
|
|
|
|
|
|
1
Includes $1.0 million and $2.2 million of revenue
generated from BioDiscovery during the three and six months ended
June 30, 2022, respectively.
The following table reflects total revenue by geography and as a
percentage of total revenue, based on the billing address of our
customers. Americas consists of North America and South America.
EMEIA consists of Europe, Middle East, India and Africa. Asia
Pacific includes China, Japan, South Korea, Singapore and
Australia.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
2022 |
|
2021 |
|
2022 |
|
2021 |
$ |
|
% |
|
$ |
|
% |
|
$ |
|
% |
|
$ |
|
% |
Americas |
$ |
2,611,000 |
|
|
39 |
% |
|
$ |
2,365,000 |
|
|
61 |
% |
|
$ |
5,940,000 |
|
|
48 |
% |
|
$ |
3,872,000 |
|
|
55 |
% |
EMEIA |
2,609,000 |
|
|
39 |
% |
|
940,000 |
|
|
25 |
% |
|
4,348,000 |
|
|
35 |
% |
|
2,518,000 |
|
|
36 |
% |
Asia Pacific |
1,450,000 |
|
|
22 |
% |
|
551,000 |
|
|
14 |
% |
|
2,078,000 |
|
|
17 |
% |
|
634,000 |
|
|
9 |
% |
Total |
$ |
6,670,000 |
|
|
100 |
% |
|
$ |
3,856,000 |
|
|
100 |
% |
|
$ |
12,366,000 |
|
|
100 |
% |
|
$ |
7,024,000 |
|
|
100 |
% |
Cost of Revenue
Cost of product revenue for our instruments and consumables
includes costs from the manufacturer, raw material parts costs and
associated freight, shipping and handling costs, contract
manufacturer costs, salaries and other personnel costs, overhead
and other direct costs related to those sales recognized as product
revenue in the period. Cost of service and other revenue consists
of third-party laboratory costs to process the diagnostic samples,
salaries of our clinical technicians who interpret and deliver the
results to patients, warranty services, and other costs of
servicing equipment at customer sites.
Research and Development Expenses
Research and development expenses consist of salaries and other
personnel costs, stock-based compensation, research supplies,
third-party development costs for new products, materials for
prototypes, and allocated overhead costs that include facility and
other overhead costs. We have made substantial investments in
research and development since our inception, and plan to continue
to make investments in the future. Our research and development
efforts have focused primarily on the tasks required to support
development and commercialization of new and existing products. We
believe that our continued investment in research and development
is essential to our long-term competitive position.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of
salaries and other personnel costs, stock-based compensation for
our sales and marketing, amortization expense related to acquired
intangible assets, finance, legal, human resources and general
management, as well as professional services, such as legal and
accounting services.
Results of Operations
Comparison of the Three Months Ended June 30, 2022 and
2021
The following table sets forth our results of operations for the
three months ended June 30, 2022 and 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Period-to-Period Change |
|
2022
|
|
2021 |
|
$ |
|
% |
Revenues: |
|
|
|
|
|
|
|
Product revenue |
$ |
3,913,000 |
|
|
$ |
2,496,000 |
|
|
$ |
1,417,000 |
|
|
57 |
% |
Service and other revenue |
2,757,000 |
|
|
1,360,000 |
|
|
1,397,000 |
|
|
103 |
% |
Total revenue |
6,670,000 |
|
|
3,856,000 |
|
|
2,814,000 |
|
|
73 |
% |
Cost of revenue: |
|
|
|
|
|
|
|
Cost of product revenue |
3,973,000 |
|
|
1,869,000 |
|
|
2,104,000 |
|
|
113 |
% |
Cost of other revenue |
1,226,000 |
|
|
548,000 |
|
|
678,000 |
|
|
124 |
% |
Total cost of revenue |
5,199,000 |
|
|
2,417,000 |
|
|
2,782,000 |
|
|
115 |
% |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
11,767,000 |
|
|
4,086,000 |
|
|
7,681,000 |
|
|
188 |
% |
Selling, general and administrative |
21,783,000 |
|
|
13,829,000 |
|
|
7,954,000 |
|
|
58 |
% |
Total operating expenses |
33,550,000 |
|
|
17,915,000 |
|
|
15,635,000 |
|
|
87 |
% |
Loss from operations |
(32,079,000) |
|
|
(16,476,000) |
|
|
(15,603,000) |
|
|
95 |
% |
Other income (expenses): |
|
|
|
|
|
|
|
Interest income |
192,000 |
|
|
58,000 |
|
|
134,000 |
|
|
231 |
% |
Interest expense |
(74,000) |
|
|
(268,000) |
|
|
194,000 |
|
|
(72) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on debt extinguishment |
— |
|
|
(2,076,000) |
|
|
2,076,000 |
|
|
(100) |
% |
|
|
|
|
|
|
|
|
Other income (expenses) |
(156,000) |
|
|
(15,000) |
|
|
(141,000) |
|
|
940 |
% |
Total other income (expenses) |
(38,000) |
|
|
(2,301,000) |
|
|
2,263,000 |
|
|
(98) |
% |
Loss before income taxes |
(32,117,000) |
|
|
(18,777,000) |
|
|
(13,340,000) |
|
|
71 |
% |
Provision for income taxes |
(41,000) |
|
|
(9,000) |
|
|
(32,000) |
|
|
356 |
% |
Net loss |
$ |
(32,158,000) |
|
|
$ |
(18,786,000) |
|
|
$ |
(13,372,000) |
|
|
71 |
% |
Revenue
Total revenue increased by $2.8 million, or 73%, to $6.7 million
for the three months ended June 30, 2022 compared to $3.9
million for the same period in 2021. The increase in product sales
was driven by increased demand for our Saphyr OGM solutions,
including an increase in instrument installed base (62%) and
flowcell units sold (24%), when compared to the same period last
year. The increased demand for our reagent rental program continues
to drive a significant portion of the increase in consumable sales.
We believe increased demand for our OGM systems was primarily
driven by increased market awareness and additional published data
demonstrating the utility of OGM. While not immune to the negative
effects caused by COVID-19 and other geopolitical events, we expect
revenue to increase as market awareness and published data of OGM
utility increases. The increase in service and other revenue was
primarily driven by $1.0 million in revenues generated by our
BioDiscovery subsidiary, which was acquired in October
2021.
Cost of Revenue
Cost of revenue increased by $2.8 million, or 115%, to $5.2 million
for the three months ended June 30, 2022 compared to $2.4
million for the same period in 2021. During the three months ended
June 30, 2022, gross margin was 22%, compared to 37% during
the same period in 2021. Gross margin for the three months ended
June 30, 2022 improved compared to gross margin for the first
quarter of 2022, which was 15%. The improvement in gross margin was
primarily due to improvements in chip yield during the second
quarter of 2022. Cost of product revenue increased primarily due to
increased instrument and flowcell sales volume, but was also
negatively impacted by unfavorable flowcell yields in the
production cycle, which is in part attributable to COVID-19. Our
gross margins for the three months ended June 30, 2022 were
affected by the unfavorable flowcell yields in the production cycle
which led to increased scrap and quality control costs during the
second quarter of 2022. If we are unable to solve the unfavorable
flowcell yield issue, it could lead to lower gross margins in
future periods. Cost of service and other revenue increased
primarily due to increased maintenance and service costs on our
increased installed base, as
well as increased service expenses related to our laboratory
services. We expect cost of product and service and other revenue
to continue to increase as we continue to increase our installed
base and the number of customers purchasing laboratory
services
Research and Development Expenses
Research and development, or R&D, expenses increased by $7.7
million, or 188%, to $11.8 million for the three months ended
June 30, 2022 compared to $4.1 million for the same period in
2021. The increase is primarily due to a $5.5 million increase in
compensation expenses, of which $3.1 million relates to stock-based
compensation expense, and an increase of $1.8 million in product
development costs. The increase in compensation expense is
primarily driven by increased headcount. We anticipate future
additions to our development teams as well as continued increases
to our product development costs and, thus, future increases to
R&D expenses.
We expect R&D expenses to increase in the remainder of 2022
relative to 2021 as we have added headcount in order to support our
efforts to develop more scalable and efficient manufacturing
workflows, expand the utility of Saphyr, and develop the next
versions of OGM products – including integration of OGM data into
our NxClinical software. We expect that stock based compensation
will continue to drive a significant portion of the increase in
expense in the remainder of 2022 as a result of the stock issued as
consideration in the BioDiscovery acquisition, which primarily
rolls up into R&D expense.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by $8.0
million, or 58%, to $21.8 million for the three months ended
June 30, 2022 compared to $13.8 million for the same period in
2021. The increase is primarily due to a $4.1 million increase in
compensation expenses, of which $0.9 million relates to stock-based
compensation, a $1.3 million increase in amortization of
intangibles related to the acquisition of BioDiscovery, a $0.6
million increase in marketing expenses, and a $0.4 million increase
in other headcount-related expenses. The increase in compensation
expense is driven primarily by increased headcount. This is due to
growth in our global sales, service, and back-office teams to
facilitate the expanding customer base, as well as headcount
additions attributed to the acquisition of BioDiscovery. We
anticipate headcount additions to our global sales and back-office
teams in the coming 12 months. Other headcount-related expenses
included the cost of recruiting, temporary employment, and
facilities expenses incurred in order to support increased product
demand.
We expect selling, general, and administrative expenses to increase
in the remainder of 2022 due to our continuing investment in
growing and supporting our customer base. We expect stock based
compensation to continue to drive a significant portion of the
increase in expense in the remainder of 2022 due to stock option
awards issued to senior-level fourth quarter 2021 hires as well as
annual refresher grants issued to executives and non-executives in
February 2022.
Interest Expense
Interest expense decreased by $0.2 million, or 72%, to $0.07
million for the three months ended June 30, 2022 compared to
$0.3 million for the same period in 2021, driven by us paying off
the outstanding principal balance of our outstanding term loan with
Innovatus, or the Innovatus LSA, during the three months ended
June 30, 2021.
Interest Income
Interest income was $0.2 million for the three months ended
June 30, 2022, as compared to $58,000 for the same period in
2021 resulting from positive returns on investments. Our total
available for sale securities balance was $160.2 million as of
June 30, 2022.
Loss on debt extinguishment
A loss on debt extinguishment of $2.1 million was recognized during
the three months ended June 30, 2021 in connection with our
payment in full of the term loan under the Innovatus LSA, including
all accrued interest, an end of term fee, a prepayment fee, and
write-off of unamortized debt issuance costs.
Comparison of the Six Months Ended June 30, 2022 and
2021
The following table sets forth our results of operations for the
six months ended June 30, 2022 and 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
Period-to-Period Change |
|
2022
|
|
2021 |
|
$ |
|
% |
Revenues: |
|
|
|
|
|
|
|
Product revenue |
$ |
7,029,000 |
|
|
$ |
4,545,000 |
|
|
$ |
2,484,000 |
|
|
55 |
% |
Service and other revenue |
5,337,000 |
|
|
2,479,000 |
|
|
2,858,000 |
|
|
115 |
% |
Total revenue |
12,366,000 |
|
|
7,024,000 |
|
|
5,342,000 |
|
|
76 |
% |
Cost of revenue: |
|
|
|
|
|
|
|
Cost of product revenue |
7,549,000 |
|
|
3,383,000 |
|
|
4,166,000 |
|
|
123 |
% |
Cost of other revenue |
2,485,000 |
|
|
1,159,000 |
|
|
1,326,000 |
|
|
114 |
% |
Total cost of revenue |
10,034,000 |
|
|
4,542,000 |
|
|
5,492,000 |
|
|
121 |
% |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
22,296,000 |
|
|
6,765,000 |
|
|
15,531,000 |
|
|
230 |
% |
Selling, general and administrative |
42,060,000 |
|
|
23,357,000 |
|
|
18,703,000 |
|
|
80 |
% |
Total operating expenses |
64,356,000 |
|
|
30,122,000 |
|
|
34,234,000 |
|
|
114 |
% |
Loss from operations |
(62,024,000) |
|
|
(27,640,000) |
|
|
(34,384,000) |
|
|
124 |
% |
Other income (expenses): |
|
|
|
|
|
|
|
Interest income |
301,000 |
|
|
123,000 |
|
|
178,000 |
|
|
145 |
% |
Interest expense |
(151,000) |
|
|
(871,000) |
|
|
720,000 |
|
|
(83) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on debt extinguishment |
— |
|
|
(2,076,000) |
|
|
2,076,000 |
|
|
— |
% |
Gain on forgiveness of Paycheck Protection Program Loan |
— |
|
|
1,775,000 |
|
|
(1,775,000) |
|
|
(100) |
% |
Other income (expenses) |
(188,000) |
|
|
(29,000) |
|
|
(159,000) |
|
|
548 |
% |
Total other income (expenses) |
(38,000) |
|
|
(1,078,000) |
|
|
1,040,000 |
|
|
(96) |
% |
Loss before income taxes |
(62,062,000) |
|
|
(28,718,000) |
|
|
(33,344,000) |
|
|
116 |
% |
Provision for income taxes |
(50,000) |
|
|
(15,000) |
|
|
(35,000) |
|
|
233 |
% |
Net loss |
$ |
(62,112,000) |
|
|
$ |
(28,733,000) |
|
|
$ |
(33,379,000) |
|
|
116 |
% |
Revenue
Total revenue increased by $5.3 million, or 76%, to $12.4 million
for the six months ended June 30, 2022 compared to $7.0
million for the same period in 2021. The increase in product sales
was driven by increased demand for our Saphyr OGM solutions,
including an increase in instrument installed base (62%) and
flowcell units sold (24%), when compared to the same period last
year. The increased demand for our reagent rental program continues
to drive a significant portion of the increase in consumable sales.
We believe increased demand for our OGM systems was primarily
driven by increased market awareness and additional published data
demonstrating the utility of OGM. While not immune to the negative
effects caused by COVID-19 and other geopolitical events, we expect
revenue to increase as market awareness and published data of OGM
utility increases. The increase in service and other revenue was
primarily driven by $2.2 million in revenues generated by our
BioDiscovery subsidiary, which was acquired in October
2021.
Cost of Revenue
Cost of revenue increased by $5.5 million, or 121%, to $10.0
million for the six months ended June 30, 2022 compared to
$4.5 million for the same period in 2021. Cost of product revenue
increased primarily due to increased instrument and flowcell sales
volume, but was also negatively impacted by unfavorable flowcell
yields in the production cycle, which is in part attributable to
COVID-19. Our gross margins for the six months ended June 30,
2022 were affected by the unfavorable flowcell yields in the
production cycle which led to increased scrap and quality control
costs during the first half of 2022. If we are unable to solve the
unfavorable flowcell yield issue, it could lead to lower gross
margins in future periods. Cost of service and other revenue
increased primarily due to increased maintenance and service costs
on our increased installed base, as well as increased service
expenses related to our laboratory services. We expect cost of
product and service and other revenue to continue to increase as we
continue to increase our installed base and the number of customers
purchasing laboratory services.
Research and Development Expenses
R&D expenses increased by $15.5 million, or 230%, to $22.3
million for the six months ended June 30, 2022 compared to
$6.8 million for the same period in 2021. The increase is primarily
due to a $11.6 million increase in compensation expenses, of which
$6.3 million relates to stock-based compensation expense, and an
increase of $3.1 million in product development costs. The increase
in compensation expense is primarily driven by increased headcount.
We anticipate future additions to our development teams as well as
continued increases to our product development costs and, thus,
future increases to R&D expenses.
We expect R&D expenses to increase in the remainder of 2022
relative to 2021 as we have added headcount in order to support our
efforts to develop more scalable and efficient manufacturing
workflows, expand the utility of Saphyr, and develop the next
versions of OGM products – including integration of OGM data into
our NxClinical software. We expect that stock based compensation
will continue to drive a significant portion of the increase in
expense in the remainder of 2022 as a result of the stock issued as
consideration in the BioDiscovery acquisition, which primarily
rolls up into R&D expense.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by $18.7
million, or 80%, to $42.1 million for the six months ended
June 30, 2022 compared to $23.4 million for the same period in
2021. The increase is primarily due to a $9.9 million increase in
compensation expenses, of which $2.4 million relates to stock-based
compensation, a $2.7 million increase in amortization of
intangibles related to the acquisition of BioDiscovery, a $1.8
million increase in marketing expenses, and a $1.0 million increase
in other headcount-related expenses. The increase in compensation
expense is driven primarily by increased headcount. This is due to
growth in our global sales, service, and back-office teams to
facilitate the expanding customer base, as well as headcount
additions attributed to the acquisition of BioDiscovery. We
anticipate headcount additions to our global sales and back-office
teams in the coming 12 months. Other headcount-related expenses
included the cost of recruiting, temporary employment, and
facilities expenses incurred in order to support increased product
demand.
We expect selling, general, and administrative expenses to increase
in the remainder of 2022 due to our continuing investment in
growing and supporting our customer base. We expect stock based
compensation to continue to drive a significant portion of the
increase in expense in the remainder of 2022 due to stock option
awards issued to senior-level fourth quarter 2021 hires as well as
annual refresher grants issued to executives and non-executives in
February 2022.
Interest Expense
Interest expense decreased by $0.7 million, or 83%, to $0.2 million
for the six months ended June 30, 2022 compared to $0.9
million for the same period in 2021, driven by us paying off the
outstanding principal balance of our outstanding term loan under
the Innovatus LSA during the six months ended June 30,
2021.
Interest Income
Interest income was $0.3 million for the six months ended
June 30, 2022, as compared to $0.1 million for the same period
in 2021 resulting from positive returns on investments. Our total
available for sale securities balance was $160.2 million as of
June 30, 2022.
Loss on debt extinguishment
A loss on debt extinguishment of $2.1 million was recognized during
the six months ended June 30, 2021 in connection with our
payment in full of the term loan under the Innovatus LSA, including
all accrued interest, an end of term fee, a prepayment fee, and
write-off of unamortized debt issuance costs.
Gain on forgiveness of Paycheck Protection Program
loan
A gain on forgiveness of our Paycheck Protection Program loan, or
PPP Loan, of $1.8 million was recognized during the six months
ended June 30, 2021 in connection with the forgiveness of the
PPP Loan in full, including all accrued interest.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have incurred net losses and negative cash
flows from operations. We have primarily generated cash flows from
sales of equity securities and debt financings. We anticipate that
future sources of liquidity will principally come from sales of
common stock and other equity instruments, borrowings from credit
facilities and revenue from our commercial operations. Revenue from
our commercial operations has increased due to increased demand for
our product offerings and our acquisition of revenue-positive
BioDiscovery. See Note 6 to our condensed consolidated financial
statements for a discussion of our recent equity activity included
elsewhere in this Quarterly Report on Form 10-Q for more
information. We incurred net losses of $62.1 million and $28.7
million for the six months ended June 30, 2022 and 2021,
respectively. As of June 30, 2022, we had an accumulated
deficit of $278.2 million, cash and cash equivalents of $27.2
million, and available for sale investment
securities of $160.2 million. As of December 31, 2021, we had
an accumulated deficit of $216.1 million, cash and cash equivalents
of $24.6 million, and available for sale investment securities of
$226.0 million.
Future Capital Requirements
We expect that our near and longer-term liquidity requirements will
consist of working capital and general corporate expenses
associated with the growth of our business, including, without
limitation, expenses associated with scaling up our operations and
continuing to increase our manufacturing capacity, sales and
marketing expense, increasing market awareness of our products and
services to target customers, instrument placements with customers
via the reagent rental sales strategy, additional research and
development expenses associated with expanding our offerings,
expenses associated with continuing to build out our corporate
infrastructure and expenses associated with being a public company.
Our short-term capital expenditure needs relate primarily to the
ongoing build out of our facilities, service lab and
service-related capabilities, research and development expenses
related to current and future product offerings, and enhancements
to information technology. We expect such expenditures to continue
throughout 2022.
Cash Flows
The following table sets forth the cash flow from operating,
investing and financing activities for the periods
presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in): |
Six Months Ended June 30, |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
Operating activities |
$ |
(60,826,000) |
|
|
$ |
(26,323,000) |
|
|
|
|
Investing activities |
63,204,000 |
|
|
50,000 |
|
|
|
|
Financing activities |
210,000 |
|
|
320,378,000 |
|
|
|
|
Operating Activities
We derive cash flows from operations primarily from the sale of our
products and services. Our cash flows from operating activities are
also significantly influenced by our use of cash for operating
expenses to support the growth of our business. We have
historically experienced negative cash flows from operating
activities as we have developed our technology, expanded our
business and built our infrastructure and this may continue in the
future. We anticipate our use of cash in operating activities to
increase in the next 12 to 24 months due to anticipated increases
in headcount and ongoing support of our growing operations,
including, R&D operations. As discussed below, we anticipate
our available cash balance will be sufficient to fund those
increases in cash used in operating activities for at least the
next 12 months, but we may consider funding those increases or
increases beyond the next 12 months with the methods discussed in
the section below entitled “Capital Resources.”
Net cash used in operating activities was $60.8 million during the
six months ended June 30, 2022 as compared to $26.3 million
during the same period in 2021. The increase in cash used in
operating activities of $34.5 million was primarily attributed to
an incremental headcount growth compared to our headcount as of
June 30, 2021.
Investing Activities
Historically, our primary investing activities have consisted of
capital expenditures for the purchase of capital equipment to
support our expanding infrastructure, the acquisitions of Lineagen
and BioDiscovery to grow our business, and purchases of available
for sale investment securities. We expect to continue to incur
additional costs for capital expenditures related to these efforts
in future periods. During the six months ended June 30, 2022,
cash provided by investing activities was $63.2 million, as
compared to $0.05 million during the same period in 2021. The
increase in cash provided by investing activities of $63.2 million
was primarily attributed to the sale of $93.5 million in available
for sale securities, offset by a purchase of $29.5 million in
available for sale securities.
Financing Activities
Net cash provided by financing activities was $0.2 million during
the six months ended June 30, 2022 as compared to the same
period in 2021 where we had net cash provided by financing
activities of $320.4 million, a decrease of $320.2 million. During
the six months ended June 30, 2021, we raised approximately
$328.6 million in gross proceeds from executing two follow-on
offerings and sales under our at-the-market facilities with
Ladenburg Thalmann & Co. Inc., or Ladenburg, and Cowen and
Company, LLC, or Cowen. We did not have similar fundraising
activity in the six months ended June 30, 2022.
Paycheck Protection Program
In April 2020, we received loan proceeds of approximately $1.8
million, or the PPP Loan, pursuant to the Paycheck Protection
Program under the Coronavirus Aid, Relief, and Economic Security
Act, or the CARES Act, administered by the U.S. Small Business
Administration, or the SBA.
The PPP Loan accrued interest at a rate of 1.00% per annum, and is
subject to the standard terms and conditions applicable to loans
administered by the SBA under the CARES Act. In February 2021, we
applied for forgiveness of the PPP Loan and, in March 2021, the PPP
Loan, including all accrued interest, was forgiven in
full.
The PPP Loan is also described in Note 5 to our condensed
consolidated financial statements included elsewhere in this
Quarterly Report on Form 10-Q.
Capital Resources
As of June 30, 2022, we had approximately $27.2 million in
cash and cash equivalents, available for sale securities of $160.2
million, and working capital of $188.4 million.
In August 2020, we filed a shelf registration statement on Form S-3
with the SEC covering the offering, issuance and sale of up to
$125.0 million of our securities, including up to $40.0 million of
common stock pursuant to an At Market Issuance Sales Agreement,
with Ladenburg acting as sales agent, or the Ladenburg ATM. During
October 2020 through January 2021, we sold 27.0 million shares
of common stock under the Ladenburg ATM and received net proceeds
of $38.0 million after deducting aggregate offering costs. We
terminated the Ladenburg ATM in March 2021.
On January 12, 2021, we completed an underwritten public offering
of 33.4 million shares of our common stock, including
4.4 million shares of our common stock sold pursuant to the
underwriters’ exercise in full of their option to purchase
additional shares. The price to the public in the offering was
$3.05 per share and the underwriters purchased the shares from us
pursuant to the underwriting agreement at a price of $2.87 per
share. The gross proceeds to us were approximately $101.8 million
before deducting underwriting discounts and commissions and other
offering expenses.
On January 19, 2021, we filed an automatically effective shelf
registration statement on Form S-3 (File No. 333-252216) with the
U.S. Securities and Exchange Commission, or SEC, as a “well-known
seasoned issuer.” The registration statement allows us to issue an
indeterminate number or amount of common stock, preferred stock,
debt securities and warrants from time to time in one or more
offerings. However, there can be no assurance that we will complete
any future offerings of securities. Any future offerings under this
registration statement will be dependent upon, among other factors,
market conditions, available pricing, our financial condition,
investor perception of our prospects, our capital needs and our
ability to maintain status as a well-known seasoned issuer.
Further, as of June 30, 2022, as a consequence of our
re-qualification as a “smaller reporting company,” we may lose
“well-known seasoned issuer” status at the time we file our Annual
Report on Form 10-K for the fiscal year ending December 31, 2022 if
the worldwide market value of our voting and non-voting common
equity held by our non-affiliates does not equal $700.0 million or
more, calculated as of a date within 60 days prior to filing such
report. If that were to occur and we were no longer considered a
well-known seasoned issuer, we anticipate needing to amend our
automatically effective shelf registration statement on Form S-3
prior to our filing of such annual report (or earlier if required
by the Securities Act or the rules and regulations of the SEC) in
order to sell securities under that Form S-3 on an ongoing
basis.
On January 25, 2021, we completed an underwritten public offering
pursuant to our shelf registration statement of 38.3 million
shares of our common stock, including 5.0 million shares of
our common stock sold pursuant to the underwriters’ exercise in
full of their option to purchase additional shares. The price to
the public in the offering was $6.00 per share, and the
underwriters purchased the shares from us pursuant to the
underwriting agreement at a price of $5.64 per share. The gross
proceeds to us were approximately $230.0 million before deducting
underwriting discounts and commissions and other offering
expenses.
On March 23, 2021, we entered into a Sales Agreement with Cowen
pursuant to which we may offer and sell, from time to time at our
sole discretion, shares of our common stock having an aggregate
offering price of up to $350.0 million, through or to Cowen, acting
as sales agent or principal, or the Cowen ATM. In August and
September 2021, the Company sold 2.3 million shares of common
stock under the Cowen ATM at an average share price of $6.15 per
share, and received gross proceeds of approximately $13.9 million
before deducting offering
costs of $0.6 million. There were no sales of common stock under
the Cowen ATM from January 1, 2022 to June 30,
2022.
We believe that our cash, cash equivalents, and available for sale
securities will be sufficient to fund our planned operations,
obligations as they become due and capital investments for at least
the next twelve months. This estimate is based on our current
business plan. This estimate does not reflect any additional
expenditures resulting from potential acquisitions or strategic
transactions. We have based these estimates on assumptions that may
prove to be wrong, and we could use our available capital resources
sooner than we currently expect. See Note 1 to our condensed
consolidated financial statements included elsewhere in this
Quarterly Report on Form 10-Q for more information.
Contingent Consideration
As part of the merger agreement related to the acquisition of
BioDiscovery, the Company agreed to pay a milestone payment of
$10.0 million in cash contingent on the achievement of a commercial
milestone within eighteen months of the acquisition date. The
Company determined the fair value of the milestone consideration
using a scenario-based technique, as the trigger for payment is
event driven. The outcome of the milestone consideration is binary,
meaning the milestone is either achieved or not achieved, and the
only other variable factor is the timing of when the milestone is
achieved. The Company determined it is highly likely that the
milestone will be achieved and therefore used a 95% probability
factor which is applied to the $10.0 million milestone
consideration. Based on these valuation assumptions, the fair value
of the milestone consideration was determined to be $9.2 million as
of June 30, 2022. During the three months ended June 30,
2022, the milestone consideration liability was reclassified from
non-current liabilities to current liabilities.
Contractual Obligations
There were no material changes to our contractual obligations from
those disclosed in the Company’s Annual Report on Form 10-K for the
year ended December 31, 2021.
Critical Accounting Policies and Estimates
Our management’s discussion and analysis of our financial condition
and results of operations is based on our consolidated financial
statements, which have been prepared in accordance with generally
accepted accounting principles in the United States. These
accounting principles require us to make certain estimates,
judgments and assumptions that affect the reported amounts of
assets and liabilities as of the date of the financial statements,
as well as the reported amounts of revenues and expenses during the
periods presented. We have discussed the development, selection and
disclosure of the accounting estimates with our audit committee. We
believe that the estimates, judgments and assumptions are
reasonable based upon information available to us at the time that
these estimates, judgments and assumptions are made. To the extent
there are material differences between these estimates, judgments
or assumptions and actual results, our financial statements will be
affected. Historically, revisions to our estimates have not
resulted in a material change to our financial
statements.
During the three and six months ended June 30, 2022, there
have been no changes to our critical accounting policies and
estimates as described in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2021.
Recent Accounting Pronouncements
See Note 1 to our condensed consolidated financial statements
included elsewhere in this Quarterly Report on Form 10-Q for
information concerning recent accounting
pronouncements.
ITEM 3. QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
We have operations both within the United States and
internationally, and we are exposed to market risks in the ordinary
course of business. These risks primarily relate to interest rates,
foreign currency exchange rates and inflation.
Interest Rate Risk
We had approximately $27.2 million in cash and cash equivalents and
$160.2 million in available for sale securities as of June 30,
2022, which include highly liquid, investment grade debt
securities. Such interest-bearing instruments are exposed to a
certain degree of interest rate risk. The primary objective of our
investment activities is to preserve principal while at the same
time maximizing yields without significantly increasing risk. We do
not enter into investments for trading or speculative purposes and
have not used any derivative financial instruments to manage our
interest rate risk exposure. To achieve this objective, we invest
in highly liquid and high-quality government and other debt
securities. To minimize our exposure due to adverse shifts in
interest rates, we invest primarily in short-term
securities.
Although we are seeing, and expect to continue to see, increased
interest rates, due to our investment in highly liquid and high
quality government and other debt securities as well as short-term
securities, as of the date of this Quarterly Report on Form 10-Q,
we do not expect anticipated changes in interest rates to have a
material effect on our interest rate risk in future reporting
periods. Due to the short holding period of our investments and the
nature of our investments, a hypothetical change of 100 basis
points would have approximately a $0.6 million impact on our
investments.
Our liabilities for acquisition-related contingent consideration,
which is adjusted to fair value each reporting period, is also
impacted by changes in interest rates. The risk-free interest rate
used to estimate our weighted average cost of capital is a
component of the discount rate used to calculate the present value
of future cash flows due upon the achievement of certain
milestones. As a result, any changes in the underlying risk-free
interest rate could result in material changes to the fair value of
such liabilities and could materially impact the amount of non-cash
expense (or income) recorded each reporting period. As a
consequence of the U.S. Federal Reserve raising interest rates, the
underlying risk-free interest rate we use for purposes of
calculating fair value of our liabilities for acquisition-related
contingent consideration has increased from our prior
reporting
periods, but such increase did not have a material impact on our
financial statements, and we currently do not expect anticipated
future changes to have a material effect in future reporting
periods.
Foreign Currency Exchange Rate Risk
We conduct a portion of our business in currencies other than our
U.S. dollar functional currency. These transactions give rise to
monetary assets and liabilities that are denominated in currencies
other than the U.S. dollar. The value of these monetary assets and
liabilities are subject to changes in currency exchange rates from
the time the transactions are originated until settlement in cash.
Our foreign currency exposures are primarily concentrated in the
British Pound, Chinese Renminbi, Euro, and Canadian dollar. Both
realized and unrealized gains or losses on the value of these
monetary assets and liabilities are included in the determination
of net income. We do not currently participate in material foreign
exchange hedging activities. As of June 30, 2022 and December
31, 2021, we had minimal assets and liabilities denominated in
foreign currencies and expect similar levels of foreign currency
denomination in the next 12 months. We believe a hypothetical 10%
change in foreign exchange rates as of June 30, 2022 would not
have a material impact on our business, financial condition, or
results of operations.
Inflation
The COVID-19 pandemic and other geopolitical and macroeconomic
events, including the conflict between Ukraine and Russia and
related sanctions, have contributed to supply chain challenges,
which we believe have resulted in inflation headwinds, particularly
increased logistical costs and raw material prices. During the
three and six months ended June 30, 2022, we experienced
increased costs to secure certain component parts in our products
and to produce our products at our contract manufacturers. However
we do not believe that inflation has had a material effect on our
business, financial condition or results of operations, other than
its impact on the general economy, as our cost of revenue for the
three and six months ended June 30, 2022 was not significantly
impacted by the cost increases we experienced. While the effects of
the COVID-19 pandemic and other macroeconomic events as well as
other inflationary pressures, are highly uncertain, as of the date
of this Quarterly Report on Form 10-Q, we do not expect anticipated
changes in inflation to have a material effect on our business,
financial condition or results of operations for future reporting
periods other than the general impacts on companies due to general
economic and market conditions. If our costs were to become subject
to significant inflationary pressures, we may not be able to fully
offset such higher costs through price increases. Our inability or
failure to do so could harm our business, financial condition or
results of operations.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in
Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act.
Disclosure controls and procedures are controls and other
procedures designed to ensure that the information required to be
disclosed by us in the reports that we file or submit under the
Exchange Act is recorded, processed, summarized, and reported
within the time periods specified in the SEC’s rules and forms.
Disclosure controls and procedures include, without limitation,
controls and procedures designed to ensure that information
required to be disclosed by us in the reports that we file or
submit under the Exchange Act is accumulated and communicated to
our management, including our principal executive officer and our
principal financial officer, or persons performing similar
functions, as appropriate to allow timely decisions regarding
required disclosure.
As of June 30, 2022, our management, with the participation of
our principal executive officer and principal financial officer,
evaluated the effectiveness of our disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the
Exchange Act). Our management recognizes that any controls and
procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving their objectives, and
management necessarily applies its judgment in evaluating the
cost-benefit relationship of possible controls and procedures.
Based on this assessment, our management, including our principal
executive officer and principal financial officer, has concluded
that our disclosure controls and procedures were effective as of
the end of the period covered by this Quarterly Report on Form
10-Q.
Changes in Internal Control over Financial Reporting
Under the supervision and with the participation of our management,
including our principal executive officer and our principal
financial officer, we carried out an evaluation of any potential
changes in our internal control over financial reporting during the
fiscal quarter covered by this Quarterly Report on Form 10-Q.
Except as described below, there were no changes in our internal
control over financial reporting during the quarter ended
June 30, 2022 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
In October 2021, we acquired BioDiscovery LLC. We are in the
process of integrating the internal controls of the acquired
business into our overall system of internal control over financial
reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1A. RISK FACTORS
RISK FACTOR SUMMARY
Below is a summary of the principal factors that make an investment
in our securities speculative or risky. This summary does not
address all of the risks that we face. Additional discussion of the
risks and uncertainties summarized in this risk factor summary, and
other risks and uncertainties that we face, are set forth below
under the heading “Risk Factors” and should be carefully
considered, together with other information in this Quarterly
Report and our other filings with the SEC before making investment
decisions regarding our securities.
•We
are an early-commercial-stage company and have a limited commercial
history, which may make it difficult to evaluate our current
business and predict our future performance;
•We
have incurred recurring net losses since we were formed and expect
to incur losses in the future. We cannot be certain that we will
achieve or sustain profitability;
•Our
quarterly and annual operating results and cash flows have
fluctuated in the past and might continue to fluctuate, which makes
our future operating results difficult to predict and could cause
the market price of our securities to decline
substantially;
•Our
future capital needs are uncertain and we may require additional
funding in the future to advance the commercialization of Saphyr
system, NxClinical software and our other products, technologies,
and services, as well as continue our research and development
efforts. If we fail to obtain additional funding, we will be forced
to delay, reduce or eliminate our commercialization and development
efforts;
•Our
business, and that of our customers, has been adversely affected by
the effects of public health crises, including the COVID-19
pandemic. In particular, the COVID-19 pandemic has materially
affected our operations globally, including at our headquarters in
San Diego, California, as well as the business or operations of our
research partners, customers and other third parties with whom we
conduct business;
•Acquisitions,
joint ventures and other strategic transactions could disrupt or
otherwise harm our business and may cause dilution to our
stockholders;
•If
our products or technologies fail to achieve and sustain sufficient
market acceptance, our revenue will be adversely
affected;
•In
the near term, sales of our Saphyr system, the NxClinical software,
our consumables and genome analysis services will depend on levels
of research and development spending by clinical research
laboratories, academic and governmental research institutions and
biopharmaceutical companies, a reduction in which could limit
demand for our technologies and products and adversely affect our
business and operating results;
•If
we do not successfully manage the development and launch of new
products and technologies, our financial results could be adversely
affected;
•Our
future success is dependent upon our ability to further penetrate
our existing customer base and attract new customers;
•We
are currently limited to “research use only” with respect to many
of the materials and components used in our consumable products
including our assays;
•If
the FDA determines that our RUO products are medical devices or if
we seek to market our RUO products for clinical diagnostic or
health screening use, we will be required to obtain regulatory
clearance(s) or approval(s), and may be required to cease or limit
sales of our then marketed products, which could materially and
adversely affect our business, financial condition and results of
operations. Any such regulatory process would be expensive,
time-consuming and uncertain both in timing and in
outcome;
•If
we are unable to protect our intellectual property, it may reduce
our ability to maintain any technological or competitive advantage
over our competitors and potential competitors, and our business
may be harmed; and
•The
price of our securities has been and may in the future be volatile
or may decline regardless of our operating performance, and you
could lose all or part of your investment.
RISK FACTORS
Investing in our common stock involves a high degree of risk. You
should carefully consider the following risk factors, together with
other information in this Quarterly Report on Form 10-Q and our
other filings with the SEC, before making investment decisions
regarding our securities. The occurrence of any of the following
risks could harm our business, financial condition, results of
operations and/or growth prospects or cause our actual results to
differ materially from those contained in forward-looking
statements we have made in this report and those we may make from
time to time. The risks described below are not the only risks
facing our company. Additional risks and uncertainties not
currently known to us or that we currently deem to be immaterial
also may materially adversely affect our business, financial
condition or future results. We have marked with an asterisk (*)
those risk factors that reflect changes from the risk factors
previously disclosed in Item 1A of our Annual Report on Form
10-K.
Risks related to our financial condition and need for additional
capital
We are an early commercial-stage company and have a limited
commercial-history, which may make it difficult to evaluate our
current business and predict our future performance.
We are an early commercial-stage company and have a limited
commercial history. Our limited commercial history may make it
difficult to evaluate our current business and, especially when
combined with the other risk factors listed in this section, makes
predictions about our future success or viability subject to
significant uncertainty. In particular, we have significantly
increased our headcount through recent acquisitions of other
businesses and the expansion of our sales, marketing and research
and development teams, which has increased our operating costs in a
manner not historically reflected in our consolidated financial
statements, and plan to further increase headcount as we expand our
operations. Our business model has evolved over time, and combined
with our recent acquisitions, this has impacted the composition and
concentration of our revenues, which we expect to continue to
change with any future acquisitions and further expansion of our
operations. These changes, among others, may make it difficult to
evaluate our current business, assess our future performance
relative to prior performance and accurately predict our future
performance. We have encountered in the past, and will continue to
encounter in the future, risks and difficulties frequently
experienced by early commercial-stage companies, including those
associated with scaling up our infrastructure, increasing the size
of our organization and integrating acquired businesses. If we do
not address these risks successfully, or if our assumptions
regarding these risks and uncertainties are incorrect or change
over time, our results of operations could differ materially from
our expectations and our business, financial condition and results
of operations could be materially and adversely
affected.
We have incurred recurring net losses since we were formed and
expect to incur losses in the future. We cannot be certain that we
will achieve or sustain profitability.*
Since our inception, we have incurred recurring net losses. We
incurred net losses of $62.1 million and $28.7 million, and used
cash in operations of $60.8 million and $26.3 million for the six
months ended June 30, 2022 and 2021, respectively. As of
June 30, 2022, we had an accumulated deficit of $278.2
million. We cannot predict if we will be profitable in the near
future or at all. We expect that our losses will continue for the
foreseeable future as we plan to invest significant additional
funds toward the expansion of our commercial organization, research
and development efforts and capital expenditures, among other
things. Our recent acquisitions have increased our expenses and we
expect that any future acquisitions of businesses, assets, products
or technologies will further increase our expenses, which may
result in additional losses. We also expect significant increases
in our stock-based compensation expense in future periods,
reflecting higher stock option valuations as a public company and
the issuance of additional equity awards due to increased
headcount. In addition, we incur significant legal, accounting and
other expenses as a result of being a public company, especially as
we no longer qualify as an emerging growth company and are
therefore required to comply with additional disclosure and
compliance requirements. These factors, among others, will make it
hard for us to achieve and sustain profitability. We may also incur
significant losses in the future for a number of other reasons,
many of which are beyond our control, including the level of market
acceptance of our products, the introduction of competitive
products and technologies, our future product development efforts,
our market penetration and our margins, as well as the other risks
described below.
Our quarterly and annual operating results and cash flows have
fluctuated in the past and might continue to fluctuate, which makes
our future operating results difficult to predict and could cause
the market price of our securities to decline
substantially.*
Numerous factors, many of which are outside our control, may cause
or contribute to significant fluctuations in our quarterly and
annual operating results. These fluctuations may make financial
planning and forecasting uncertain and may result in unanticipated
decreases in our available cash, which could negatively affect our
business and prospects. In addition, one or more of such factors
may cause our revenue or operating expenses in one period to be
disproportionately higher or lower relative to the other periods.
As a result, comparing our operating results on a period-to-period
basis might not be meaningful. You should not rely on our past
results as indicative of our future performance. Moreover, our
stock price might be based on
expectations of future performance that are unrealistic or that we
might not meet and, if our revenue or operating results fall below
the expectations of investors or securities analysts, the price of
our securities could decline substantially.
Our operating results have varied in the past. In addition to other
risk factors listed in this section, some of the important factors
that, alone or together, may cause fluctuations in our quarterly
and annual operating results include:
•adoption
of our optical genome mapping solutions on our Saphyr system or
successor systems;
•the
successful integration of our Lineagen and BioDiscovery
businesses;
•execution
on our commercial and reimbursement strategy involving
Lineagen;
•customer
demand for current BioDiscovery software solutions, including
NxClinical software, and future software solutions developed
through BioDiscovery’s platform;
•the
timing of customer orders and payments and our ability to recognize
revenue;
•the
rate of utilization of consumables by our customers;
•reductions
in or other difficulties relating to staffing, capacity, shutdowns
or slowdowns of laboratories and other institutions in our customer
base, as well as other impacts stemming from the COVID-19 pandemic
or other similar factors, such as reduced or delayed investment in
new technologies or spending on products, technologies or
consumables;
•differences
in purchasing patterns across our customer base, including
potential differences in consumables spending between earlier
adopters of our technologies and more recent customers and
variances in rates of increase of consumables spending following
new technology purchases, some of which may be compounded by
impacts of the COVID-19 pandemic;
•geopolitical
events, such as the conflict between Ukraine and Russia and related
sanctions, and macroeconomic conditions, such as inflation,
increased cost of goods, supply chain issues, and global financial
market conditions;
•our
ability to successfully integrate new personnel, technology and
other assets that we may acquire into our company;
•the
timing of the introduction of new systems, products, technologies,
system and product enhancements and services;
•changes
in governmental funding of life sciences research and development
or other changes that impact budgets, budget cycles or seasonal or
other spending patterns of our customers;
•future
accounting pronouncements or changes in our accounting policies;
and
•the
outcome of any current or future litigation or governmental
investigations involving us or other third parties with whom we do
business.
In addition, a significant portion of our operating expenses are
relatively fixed in nature, and planned expenditures are based in
part on expectations regarding future revenue. Accordingly,
unexpected revenue shortfalls could decrease our gross margins and
cause significant changes in our operating results from quarter to
quarter. If this occurs, the trading price of our securities could
fall substantially. This variability and unpredictability caused by
factors such as those described above and elsewhere in this section
could also result in our failing to meet the expectations of
industry or financial analysts or investors for any period. If our
revenue or operating results fall below the expectations of
analysts or investors or below any guidance we may provide, or if
the guidance we provide is below the expectations of analysts or
investors, the price of our securities could decline substantially.
Such a stock price decline could occur even when we have met or
exceeded any previously publicly stated guidance.
If we are unable to maintain adequate revenue growth or do not
successfully manage such growth, our business and growth prospects
will be harmed.
We may not achieve substantial growth rates in future periods.
Investors should not rely on our operating results for any prior
periods as an indication of our future operating performance. To
effectively manage our anticipated future growth, we must continue
to maintain and enhance our financial, accounting, manufacturing,
customer support and sales administration systems, processes and
controls. Failure to effectively manage our anticipated growth
could lead us to over-invest or under-invest in development,
operational and administrative infrastructure; result in weaknesses
in our infrastructure, systems, or controls; give rise to
operational mistakes, losses, loss of customers, productivity or
business opportunities; and result in loss of employees and reduced
productivity of remaining employees.
Our continued growth could require significant capital expenditures
and might divert financial resources from other projects such as
the development of new products, technologies and services. As
additional products and technologies are commercialized, we may
need to incorporate new equipment, implement new technology
systems, or hire new personnel with different qualifications.
Failure to manage this growth or transition could result in
turnaround time delays, higher product costs,
declining product quality, deteriorating customer service, and
slower responses to competitive challenges. A failure in any one of
these areas could make it difficult for us to meet market
expectations for our products and technologies, and could damage
our reputation and the prospects for our business.
If our management is unable to effectively manage our anticipated
growth, our expenses may increase more than expected, our revenue
could decline or grow more slowly than expected and we may be
unable to implement our business strategy. The quality of our
products, technologies and services may suffer, which could
negatively affect our reputation and harm our ability to retain and
attract customers.
Our future capital needs are uncertain and we may require
additional funding in the future to advance the commercialization
of our Saphyr system, NxClinical software, and our other products,
technologies and services, as well as continue our research and
development efforts. If we fail to obtain additional funding, we
will be forced to delay, reduce or eliminate our commercialization
and development efforts.*
Our operations have consumed substantial amounts of cash since our
inception. We expect to continue to spend substantial amounts of
cash in order to continue the commercialization of our products and
technologies, fund our research and development programs, expand
headcount and execute potential strategic transactions. Although we
raised $384.7 million of gross proceeds during 2021, we may need to
raise additional funding, or we may seek additional capital due to
favorable market conditions or strategic considerations, even if we
believe we have sufficient funds for our current or future
operating plans. Such funding may mean the sale of common or
preferred equity or convertible debt securities, entry into one or
more credit facilities or another form of third-party funding, or
seeking other debt financing. We may also consider raising
additional capital in the future to expand our business, to pursue
strategic investments, to take advantage of financing
opportunities, or for other reasons, including to:
•expand
our sales and marketing efforts to further commercialize our
products, technologies and services and address competitive
developments;
•expand
our research and development efforts to improve our existing
products, technologies and services and develop and launch new
products, technologies and services, particularly if any of our
products, technologies and services are deemed by the U.S. Food and
Drug Administration, or FDA, to be medical devices or otherwise
subject to additional regulation by the FDA;
•pursue
a regulatory path with the FDA, or a regulatory body outside the
United States, to market our existing RUO products or new products
utilized for diagnostic purposes;
•lease
additional facilities or build-out existing facilities as we
continue to grow our employee headcount, inventory and research and
development;
•further
expand our operations outside the United States;
•enter
into collaboration arrangements, if any, or in-license products and
technologies;
•acquire
or invest in complimentary businesses or assets;
•add
operational, financial and management information systems;
and
•cover
increased costs incurred as a result of continued operation as a
public company, including costs resulting from our no longer
qualifying as an emerging growth company and a smaller reporting
company and becoming a large accelerated filer.
Our future funding requirements will be influenced by many factors,
including:
•market
acceptance of our products, technologies and services, and the
variability in costs to achieve such acceptance;
•the
cost and timing of establishing additional sales, marketing and
distribution capabilities;
•the
cost of our research and development activities;
•our
ability to satisfy any outstanding or future debt
obligations;
•increasing
interest rates;
•the
success of our existing distribution and marketing arrangements and
our ability to enter into additional arrangements in the
future;
•the
effects of the ongoing military conflict between Russia and Ukraine
and the related sanctions imposed against Russia;
•the
effects of the COVID-19 pandemic; and
•the
effect of competing technological and market
developments.
The various ways we could raise additional capital carry potential
risks. We cannot assure you that we will be able to obtain
additional funds on acceptable terms, or at all. If we raise
additional funds by issuing equity or equity-linked securities, our
stockholders may experience dilution. Any equity or debt securities
we issue could provide for rights, preferences, or privileges
senior to those of holders of our common stock. Future debt
financing, if available, may involve covenants restricting our
operations or our ability to incur additional debt. Any debt or
equity financing may contain terms that are not favorable to us or
our stockholders. If we raise additional funds through
collaboration and licensing arrangements with third parties, it may
be necessary to relinquish some rights to our technologies or our
products, or grant licenses on terms that are not favorable to
us.
However, global economic conditions have been worsening, with
disruptions to, and volatility in, the credit and financial markets
in the U.S. and worldwide resulting from the effects of COVID-19
and otherwise. If these conditions persist and deepen, we could
experience an inability to access additional capital. If we do not
have, or are not able to obtain, sufficient funds, we may have to
delay development or commercialization of our technologies and
products. We also may have to reduce marketing, customer support or
other resources devoted to our products or technologies or cease
operations. Any of these factors could have a material adverse
effect on our financial condition, operating results and business.
Any of the foregoing could significantly harm our business,
prospects, financial condition and results of operation and could
cause the price of our securities to decline.
Our business, and that of our customers, has been adversely
affected by the effects of public health crises, including the
COVID-19 pandemic. In particular, the COVID-19 pandemic has
materially affected our operations globally, including at our
headquarters in San Diego, California, as well as the business or
operations of our research partners, customers and other third
parties with whom we conduct business.*
Our business could be adversely affected by health crises in
regions where we have operations, concentrations of sales and
marketing teams, distributors or other business operations. Such
health crises could also affect the business or operations of our
research partners, customers and other third parties with whom we
conduct business. In particular, the evolving effects of the
COVID-19 pandemic and government measures taken in response have
had significant impacts, both direct and indirect, on businesses
and commerce, as significant reductions in business-related
activities have occurred, supply chains have been disrupted,
manufacturing and clinical development activities have been
curtailed or suspended and enrollment in studies has been limited
or made more difficult. Continued remote work policies,
quarantines, shelter-in-place and similar government orders,
shutdowns or other restrictions on the conduct of business
operations related to the effects of the COVID-19 pandemic have
materially affected and may continue to materially affect how we,
our customers, and our suppliers are operating our
businesses.
In response to public health directives and orders implemented in
response to the COVID-19 pandemic, we have implemented
work-from-home policies for certain employees. We have also
modified certain business practices, including those related to
employee travel and cancellation of physical participation in
meetings, events and conferences, and implemented new protocols to
promote social distancing and enhance sanitary measures in our
offices and facilities. The quarantine of our personnel and the
inability to access our facilities or customer sites has adversely
affected, and is expected to continue adversely affecting, our
operations, namely in sales and marketing and product delivery,
including providing installation and training and customer service,
which has and may continue to slow the pace of our commercial
strategy. For example, we experienced at various times during the
pandemic the inability to visit certain customer sites to support
installation or service our OGM systems. As a result, in the past,
we have had to delay instrument installations or service related
visits. In addition, certain members of our workforce are now
performing their duties remotely and these employees have not been
able to maintain the same level of productivity and efficiency due
a lack of resources that would otherwise be available to them in
our offices and additional demands on their time, such as increased
responsibilities resulting from school closures or the illness of
family members. Furthermore, our remote workforce poses increased
risks to our information technology systems and data as more of our
personnel leverage resources not necessarily within our
control.
The effects of these public health directives and orders and our
related adjustments in our business have negatively impacted
productivity, disrupted our business and delayed our timelines, the
magnitude of which will depend, in part, on the length and severity
of the restrictions and other limitations on our ability to conduct
our business in the ordinary course. The spread of COVID-19 has
resulted in a widespread health crisis that is also adversely
affecting economies and financial markets globally, including
inflation higher than we have seen in decades, which may negatively
affect demand for our products, technologies and services and
materially affect us financially. For example, customers who have
committed to order minimum quantities of consumables or to purchase
our Saphyr instrument have delayed these commitments. Further,
restrictions on our ability to travel, stay-at-home orders and
other similar restrictions on our business have limited our ability
to support our global and domestic operations, including providing
installation and training and customer service, resulting in
disruptions in our sales and marketing efforts and negative impacts
on our commercial strategy. In addition, despite the increased
availability of vaccines, due to the continuing and evolving nature
of the COVID-19 pandemic and the potential for periods of increases
in case numbers and emergence and spread of COVID-19 variants in
markets and communities where we, our customers, and our suppliers
are
operating our businesses, it is not possible for us to accurately
predict the duration or magnitude of the adverse impacts of the
pandemic and its effects on our business, results of operations, or
financial condition. The COVID-19 pandemic may also have long-term
effects on the nature of the office environment and remote working,
which may present strategy, operational, talent recruiting and
retention, and workplace culture challenges that may adversely
affect our business.
As public health directives surrounding the pandemic have relaxed,
our offices have reopened and we have begun permitting travel and
in-person events, taking into consideration government
restrictions, employee safety and health risks. Our approach may
vary among geographies depending on appropriate health protocols,
and may change at any time. Additionally, our efforts to reopen our
offices safely may not be successful, could expose our employees to
health risks, and could involve additional costs or liability. To
the extent our employees are exposed to or become ill with
COVID-19, our ability to conduct our operations may be impaired
from time to time.
In addition, disruption of global financial markets as a result of
COVID-19 may limit our ability to access capital, which could
negatively affect our liquidity. A recession or market correction
resulting from the spread of COVID-19 could also materially affect
our business and the value of our securities even after the
outbreak of COVID-19 has subsided due to, among other things,
unforeseen adverse impacts on us or our third-party manufacturers,
vendors and customers. Such a recession could also cause product
demand to be reduced, a decrease in corporate capital expenditures,
prolonged unemployment, reduction in consumer confidence and
similar negative economic conditions.
Also, in connection with our Lineagen diagnostic services, COVID-19
poses the risk that we or our employees, contractors, suppliers,
courier delivery services and other partners may be prevented from
conducting business activities for an indefinite period of time,
including due to spread of the disease within these groups or due
to shutdowns that may be requested or mandated by governmental
authorities. The continued spread of COVID-19 and the measures
taken by the governments of countries affected could disrupt the
supply chain of materials needed for our diagnostic tests,
interrupt our ability to receive specimens, impair our ability to
perform or deliver the results from our tests, impede patient
movement or interrupt healthcare services causing a decrease in
test volumes, delay coverage decisions from Medicare and
third-party payors, delay ongoing and planned clinical studies
involving our tests, negatively affect enrollment in our ongoing or
future studies, cause us to make strategic determinations
regarding, among other things, the cost and quality of the
components and supplies we acquire, and have a material adverse
effect on our business, financial condition and results of
operations. For example, COVID-19 related disruptions to the global
supply chain created challenges in getting sufficient components
and raw materials for production of our OGM systems and
consumables, as well as resulted, at least in part, in the
unfavorable flowcell yields. If the pandemic persists, these
disruptions could reoccur or persist.
These and similar, and perhaps more severe, disruptions in our
operations could negatively impact our business, operating results
and financial condition. In addition, quarantines, stay-at-home,
executive and similar government orders, or the perception that
such orders, shutdowns or other restrictions on the conduct of
business operations could occur, have disrupted our supply chain
and affected customer decision-making. For example, any actual or
perceived disruption in our product distribution channel could
alter customer buying decisions, prompting customers to delay or
cancel their orders, which would negatively impact our sales
revenue and could harm our reputation. In addition, we anticipate
that ongoing disruptions in our supply chain will cause shortages
in the materials required to operate our instruments, therefore
limiting our ability to process customer samples and the ability of
users of our system to operate our system.
As global economic conditions recover from the COVID-19 pandemic,
the Ukraine-Russia conflict and the related sanctions, business
activity may not recover as quickly as anticipated, and it is not
possible at this time to estimate the long-term impact that
COVID-19 could have on our business, as the impact will depend on
future developments, which are highly uncertain and cannot be
predicted. Conditions will be subject to the effectiveness of
government policies, including vaccine mandates, vaccine shortages
and administration rates, the emergence of new strains or variants
of the virus, and other factors that are not foreseeable. Any of
the foregoing could adversely affect our business, financial
condition and results of operations.
The ultimate impact of the COVID-19 outbreak or a similar health
epidemic is highly uncertain and subject to change. We do not yet
know the full extent of delays or impacts on our business or the
global economy as a whole, and such impacts may not be fully
recoverable. In addition, the current and potential adverse impacts
of the COVID-19 pandemic on our business, financial condition,
results of operations and growth prospects, may also have the
effect of heightening many of the other risks and uncertainties
described in this Quarterly Report on Form 10-Q.
Changes in tax laws or regulations that are applied adversely to us
or our customers may have a material adverse effect on our
business, cash flow, financial condition or results of
operations.*
New income, sales, use or other tax laws, statutes, rules,
regulations or ordinances could be enacted at any time, which could
adversely affect our business operations and financial performance.
Further, existing tax laws, statutes, rules, regulations or
ordinances could be interpreted, changed, modified or applied
adversely to us. For example, legislation enacted in 2017
informally titled the Tax Cuts and Jobs Act, or the Tax Act,
enacted many significant changes to the U.S. tax laws. Future
guidance from the Internal Revenue Service and other tax
authorities with respect to the Tax Act may affect us, and
certain
aspects of the Tax Act could be repealed or modified in future
legislation. For example, the Coronavirus Aid, Relief and Economic
Security Act, or the CARES Act, modified certain provisions of the
Tax Act. In addition, it is uncertain if and to what extent various
states will conform to the Tax Act, the CARES Act or any newly
enacted federal tax legislation. In addition, the Biden
administration and Congress have proposed various changes to the
U.S. federal tax regime. Certain of these proposals include, among
other things, eliminating or modifying some of the provisions
enacted in the Tax Act, a significant increase in the corporate
income tax rate, a new alternative minimum tax on book income and
changes in the taxation of non-U.S. income. While these proposals
have not yet been enacted and it is unclear whether these proposals
or similar changes will ultimately ever be enacted, the passage of
any legislation as a result of these proposals or any other future
changes in U.S. tax laws could have a material impact on the value
of our deferred tax assets, could result in significant one-time
charges, and could increase our future U.S. tax expense. Moreover,
should the scale of our international business activities expand,
any changes in the U.S. taxation of such activities or any other
changes in applicable non-U.S. tax laws could increase our
worldwide effective tax rate and harm our future financial position
and results of operations.
Limitations on the ability of taxpayers to claim and utilize
foreign tax credits and the deferral of certain tax deductions
until earnings outside of the U.S. are repatriated to the U.S., as
well as changes to United States tax laws that may be enacted in
the future, could impact the tax treatment of future foreign
earnings. Should the scale of our international business activities
expand, any changes in the United States taxation of such
activities could increase our worldwide effective tax rate and harm
our future financial position and results of
operations.
Our ability to use net operating losses and certain other tax
attributes to offset future taxable income and taxes may be subject
to limitations.*
As of December 31, 2021, we had federal and state tax net operating
loss carryforwards of $341.1 million and $158.4 million,
respectively. The federal tax loss carryforwards include $176.8
million that do not expire, but utilization of such tax loss
carryforwards is limited to 80% of our taxable income. The
remaining federal tax loss carryforwards of $164.3 million and
state tax loss carryforwards begin to expire in 2027 and 2023,
respectively, unless previously utilized. As of December 31, 2021,
we also had federal and California research credit carryforwards of
$6.7 million and $6.1 million, respectively. The federal research
credit carryforwards begin to expire in 2027 unless previously
utilized. The California research credits carry forward
indefinitely.
In addition, utilization of net operating losses and research and
development credit carryforwards may be subject to limitations due
to ownership changes that have occurred or that could occur in the
future in accordance with applicable provisions of the Internal
Revenue Code of 1986, as amended, and corresponding provisions of
state law. We may have experienced one or more ownership changes in
the past and we may also experience additional ownership changes in
the future as a result of subsequent changes in our stock
ownership, some of which may be outside of our control. If an
ownership change occurs and our ability to use our net operating
loss or research and development credit carryforwards is materially
limited, it would harm our future operating results by increasing
our future tax obligations. In addition, at the state level, there
may be periods during which the use of net operating loss
carryforwards is suspended or otherwise limited, which could
accelerate or permanently increase state taxes owed.
If our estimates or judgments relating to our critical accounting
policies are based on assumptions that change or prove to be
incorrect, our results of operation could fall below our publicly
announced guidance or the expectations of securities analysts and
investors, resulting in a decline in the market price of our
securities.
The preparation of financial statements in conformity with
generally accepted accounting principles in the United States, or
GAAP, requires management to make estimates and assumptions that
affect the amounts reported in our financial statements and
accompanying notes. We base our estimates on historical experience
and on various other assumptions that we believe to be reasonable
under the circumstances, the results of which form the basis for
making judgments about the carrying values of assets, liabilities,
equity, revenue and expenses that are not readily apparent from
other sources. If our assumptions underlying our estimates and
judgements relating to our critical accounting policies change or
if actual circumstances differ from our assumptions, estimates or
judgements, our operating results may be adversely affected and
could fall below our publicly announced guidance or the
expectations of securities analysts and investors, resulting in a
decline in the market price of our securities.
Risks related to our business operations
Acquisitions, joint ventures and other strategic transactions could
disrupt or otherwise harm our business and may cause dilution to
our stockholders.*
As part of our growth strategy, we have acquired and may continue
to acquire other businesses, products or technologies as well as
pursue strategic alliances, joint ventures, technology licenses or
investments in complementary businesses or assets. We may not be
able to locate or make suitable acquisitions on acceptable terms,
and future acquisitions may not be effectively and profitably
integrated into our business. Our failure to successfully complete
the integration of any business or assets that we
acquire could have an adverse effect on our prospects, business
activities, cash flow, financial condition, results of operations
and stock price. Integration challenges may include the
following:
•disruption
in our relationships with customers, distributors or suppliers as a
result of such a transaction;
•unanticipated
expenses and liabilities related to acquired companies or
assets;
•disputes
with the seller(s) of any acquired companies or assets or
litigation resulting from acquired companies or
assets;
•difficulties
integrating acquired personnel, technologies, operations and legal
compliance obligations into our existing business;
•diversion
of management time and focus from operating our business to
acquisition integration challenges;
•increases
in our expenses and reductions in our cash available for operations
and other uses;
•possible
write-offs or impairment charges relating to acquired businesses or
assets;
•difficulties
developing and marketing new products, technologies and
services;
•entering
markets in which we have limited or no prior experience;
and
•coordinating
our efforts throughout various localities and time
zones.
Foreign acquisitions involve unique risks in addition to those
mentioned above, including those related to integration of
operations across different cultures and languages, currency risks
and the particular economic, political and regulatory risks
associated with specific countries.
In addition, in connection with any such transactions, we may also
issue equity securities in a dilutive manner, incur additional
debt, assume contractual obligations or liabilities or expend
significant cash. Such transactions could harm our operating
results and cash position, negatively affect the price of our stock
and cause dilution to our current stockholders. For example, in
connection with our acquisition of Lineagen, Inc., or Lineagen, a
U.S.-based provider of proprietary molecular diagnostics services
for individuals presenting with certain neurodevelopmental
disorders, we issued 6.2 million shares of our common stock, and in
our acquisition of BioDiscovery, LLC, or BioDiscovery, a U.S.-based
software company with solutions for analysis, interpretation and
reporting of genomics data, we paid upfront consideration
consisting of a combination of approximately $52.3 million in cash
and 2.7 million shares of our common stock. In connection with the
acquisition of BioDiscovery, we issued an additional 5.0 million
shares of our common stock subject to vesting based on continued
service of a key employee. The issuances of shares in connection
with the Lineagen and BioDiscovery acquisitions resulted in
dilution to our existing stockholders, the payment of cash in the
BioDiscovery acquisition reduced our cash by approximately $52.3
million and our headcount increased by more than 50 employees as a
result of both acquisitions. Accordingly, in addition to
transaction costs, these acquisitions have increased our operating
expenses, further increasing our net losses. We cannot predict the
number, timing or size of any future strategic transactions, or the
effect that any such transactions might have on our operating
results.
Although we conducted extensive business, financial and legal due
diligence in connection with our evaluation of our recent
acquisitions, our due diligence investigations may not have
identified every matter that could adversely affect our business,
operating results and financial condition, and such investigations
may have identified matters that, in the opinion of our management
based on information available at the time, bore an acceptable
level of risk that they, individually or in the aggregate, might or
might not adversely affect our business, operating results or
financial condition. We may be unable to adequately address the
financial, legal and operational risks introduced by our recent
acquisitions and may have difficulty developing experience with the
industries in which Lineagen and/or BioDiscovery operate.
Accordingly, we cannot guarantee that our recent acquisitions will
yield the results we have anticipated and unforeseen complexities
and expenses may arise. In addition, we may not achieve the
revenues, growth prospects and synergies expected from these recent
acquisitions, and any such benefits we do achieve may not offset
our increased costs, resulting in a potential impairment of
goodwill or other assets that were acquired. For any future
acquisitions, we may similarly be unable to achieve revenue, growth
prospects and synergies in a manner consistent with our
expectations. Our failure to do so could adversely affect our
business, operating results and financial condition.
If our products or technologies fail to achieve and sustain
sufficient market acceptance, our revenue will be adversely
affected.
Our success depends on our ability to develop and market products
and technologies that are recognized and accepted as reliable,
enabling and cost-effective. Most of the potential customers for
our products and technologies already use expensive research
systems in their laboratories that they have used for many years
and may be reluctant to replace those systems with ours. Market
acceptance of our systems will depend on many factors, including
our ability to demonstrate to potential customers that our
technology is an attractive alternative to existing technologies.
Compared to some competing technologies,
our technology is new and complex, and many potential customers
have limited knowledge of, or experience with, our products and
technologies. Prior to adopting our systems, some potential
customers may need to devote time and effort to testing and
validating our systems. Any failure of our systems to meet these
customer benchmarks could result in potential customers choosing to
retain their existing systems or to purchase systems other than
ours. In addition, it is important that our gene mapping systems be
perceived as accurate and reliable by the scientific and medical
research community as a whole. The scientific community is
comprised of a small number of early adopters and key opinion
leaders who significantly influence the rest of the community.
Historically, a significant part of our sales and marketing efforts
has been directed at demonstrating the advantages of our technology
to industry leaders, including those key opinion leaders, and
encouraging such leaders to publish or present the results of their
evaluation of our system. If we are unable to continue to motivate
leading researchers to use our technology, or if such researchers
are unable to achieve or unwilling to publish or present
significant experimental results using our systems, acceptance and
adoption of our systems will be slowed and our ability to increase
our revenue would be adversely affected. We also run the risk that
researchers may produce publications or presentations with findings
that are negative about our technologies or systems, and t