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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
10-Q
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|
|
☒
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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
September 30,
2022
or
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|
|
☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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Commission File Number:
000-50768
ACADIA PHARMACEUTICALS INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
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06-1376651
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(State of Incorporation)
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(I.R.S. Employer Identification No.)
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12830 El Camino Real, Suite 400
San Diego,
California
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92130
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(Address of Principal Executive Offices)
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(Zip Code)
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(858)
558-2871
(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
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Name of Each Exchange on Which Registered
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Common Stock, par value $0.0001 per share
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ACAD
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The Nasdaq Stock Market LLC
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Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90 days.
Yes
☒ No ☐
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
registrant was required to submit such files).
Yes
☒ No ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
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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☒
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Accelerated filer
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☐
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Non-accelerated filer
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☐
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Smaller reporting company
|
☐
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|
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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 the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
☒
Total shares of common stock outstanding as of the close of
business on October 21, 2022:
|
|
|
|
Class
|
|
Number of Shares Outstanding
|
|
Common Stock, $0.0001 par value
|
|
161,930,994
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ACADIA PHARMACEUTICALS INC.
FORM 10-Q
TABLE OF
CONTENTS
i
PART I. FINANCIAL
INFORMATION
ITEM 1.
FINANCIAL
STATEMENTS
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED
BALANCE SHEETS
(in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2022
|
|
|
December 31,
2021
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
154,842
|
|
|
$
|
147,435
|
|
|
Investment securities, available-for-sale
|
|
|
281,737
|
|
|
|
373,271
|
|
|
Accounts receivable, net
|
|
|
55,733
|
|
|
|
64,366
|
|
|
Interest and other receivables
|
|
|
403
|
|
|
|
978
|
|
|
Inventory
|
|
|
5,844
|
|
|
|
7,881
|
|
|
Prepaid expenses
|
|
|
22,993
|
|
|
|
23,892
|
|
|
Total current assets
|
|
|
521,552
|
|
|
|
617,823
|
|
|
Property and equipment, net
|
|
|
6,510
|
|
|
|
8,047
|
|
|
Operating lease right-of-use assets
|
|
|
56,624
|
|
|
|
58,268
|
|
|
Restricted cash
|
|
|
5,770
|
|
|
|
5,770
|
|
|
Long-term inventory
|
|
|
5,992
|
|
|
|
6,217
|
|
|
Other assets
|
|
|
6,043
|
|
|
|
3,997
|
|
|
Total assets
|
|
$
|
602,491
|
|
|
$
|
700,122
|
|
|
Liabilities and stockholders’ equity
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
10,008
|
|
|
$
|
6,876
|
|
|
Accrued liabilities
|
|
|
106,562
|
|
|
|
89,192
|
|
|
Total current liabilities
|
|
|
116,570
|
|
|
|
96,068
|
|
|
Operating lease liabilities
|
|
|
53,769
|
|
|
|
56,126
|
|
|
Other long-term liabilities
|
|
|
6,466
|
|
|
|
7,034
|
|
|
Total liabilities
|
|
|
176,805
|
|
|
|
159,228
|
|
|
Commitments and contingencies (Note
9)
|
|
|
|
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par
value;
5,000,000 shares
authorized at September 30, 2022
and December 31, 2021;
no shares
issued and outstanding at September 30, 2022 and
December 31, 2021
|
|
|
—
|
|
|
|
—
|
|
|
Common stock, $0.0001 par
value;
225,000,000 shares
authorized at September 30, 2022
and December 31, 2021;
161,871,806 shares
and
161,012,695 shares
issued and
outstanding at September 30, 2022 and December
31, 2021, respectively
|
|
|
16
|
|
|
|
16
|
|
|
Additional paid-in capital
|
|
|
2,754,861
|
|
|
|
2,694,646
|
|
|
Accumulated deficit
|
|
|
(2,327,826
|
)
|
|
|
(2,153,576
|
)
|
|
Accumulated other comprehensive loss
|
|
|
(1,365
|
)
|
|
|
(192
|
)
|
|
Total stockholders’ equity
|
|
|
425,686
|
|
|
|
540,894
|
|
|
Total liabilities and stockholders’ equity
|
|
$
|
602,491
|
|
|
$
|
700,122
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
1
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net
|
|
$
|
130,714
|
|
|
$
|
131,612
|
|
|
$
|
380,745
|
|
|
$
|
353,387
|
|
|
Total revenues
|
|
|
130,714
|
|
|
|
131,612
|
|
|
|
380,745
|
|
|
|
353,387
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales
|
|
|
2,136
|
|
|
|
3,688
|
|
|
|
7,753
|
|
|
|
8,399
|
|
|
License fees and royalties
|
|
|
—
|
|
|
|
2,994
|
|
|
|
—
|
|
|
|
8,181
|
|
|
Research and development
|
|
|
81,336
|
|
|
|
58,565
|
|
|
|
285,837
|
|
|
|
172,473
|
|
|
Selling, general and administrative
|
|
|
78,108
|
|
|
|
81,666
|
|
|
|
264,688
|
|
|
|
290,116
|
|
|
Total operating expenses
|
|
|
161,580
|
|
|
|
146,913
|
|
|
|
558,278
|
|
|
|
479,169
|
|
|
Loss from operations
|
|
|
(30,866
|
)
|
|
|
(15,301
|
)
|
|
|
(177,533
|
)
|
|
|
(125,782
|
)
|
|
Interest income, net
|
|
|
2,295
|
|
|
|
129
|
|
|
|
2,980
|
|
|
|
462
|
|
|
Other income
|
|
|
2,156
|
|
|
|
383
|
|
|
|
1,999
|
|
|
|
706
|
|
|
Loss before income taxes
|
|
|
(26,415
|
)
|
|
|
(14,789
|
)
|
|
|
(172,554
|
)
|
|
|
(124,614
|
)
|
|
Income tax expense (benefit)
|
|
|
768
|
|
|
|
(332
|
)
|
|
|
1,696
|
|
|
|
162
|
|
|
Net loss
|
|
$
|
(27,183
|
)
|
|
$
|
(14,457
|
)
|
|
$
|
(174,250
|
)
|
|
$
|
(124,776
|
)
|
|
Net loss per common share, basic and diluted
|
|
$
|
(0.17
|
)
|
|
$
|
(0.09
|
)
|
|
$
|
(1.08
|
)
|
|
$
|
(0.78
|
)
|
|
Weighted average common shares outstanding, basic and
diluted
|
|
|
161,852
|
|
|
|
160,663
|
|
|
|
161,580
|
|
|
|
159,651
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
2
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS
OF COMPREHENSIVE LOSS
(in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
Net loss
|
|
$
|
(27,183
|
)
|
|
$
|
(14,457
|
)
|
|
$
|
(174,250
|
)
|
|
$
|
(124,776
|
)
|
|
Other comprehensive (loss) income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on investment securities
|
|
|
(527
|
)
|
|
|
(41
|
)
|
|
|
(1,187
|
)
|
|
|
(43
|
)
|
|
Foreign currency translation adjustments
|
|
|
6
|
|
|
|
3
|
|
|
|
14
|
|
|
|
6
|
|
|
Comprehensive loss
|
|
$
|
(27,704
|
)
|
|
$
|
(14,495
|
)
|
|
$
|
(175,423
|
)
|
|
$
|
(124,813
|
)
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
3
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS
(in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
|
|
2022
|
|
|
2021
|
|
|
Cash flows from operating activities
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(174,250
|
)
|
|
$
|
(124,776
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
53,787
|
|
|
|
50,735
|
|
|
Amortization of premiums and accretion of discounts on investment
securities
|
|
|
(642
|
)
|
|
|
1,766
|
|
|
Amortization of intangible assets
|
|
|
—
|
|
|
|
1,108
|
|
|
Gain on strategic investment
|
|
|
(1,998
|
)
|
|
|
(706
|
)
|
|
Depreciation
|
|
|
1,537
|
|
|
|
1,701
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
8,633
|
|
|
|
(12,449
|
)
|
|
Interest and other receivables
|
|
|
575
|
|
|
|
1,063
|
|
|
Inventory
|
|
|
2,105
|
|
|
|
(4,427
|
)
|
|
Prepaid expenses
|
|
|
899
|
|
|
|
1,072
|
|
|
Operating lease right-of-use assets
|
|
|
4,845
|
|
|
|
4,794
|
|
|
Other assets
|
|
|
(48
|
)
|
|
|
11
|
|
|
Accounts payable
|
|
|
3,132
|
|
|
|
(771
|
)
|
|
Accrued liabilities
|
|
|
17,771
|
|
|
|
(17,260
|
)
|
|
Operating lease liabilities
|
|
|
(5,959
|
)
|
|
|
(4,044
|
)
|
|
Long-term liabilities
|
|
|
(568
|
)
|
|
|
(357
|
)
|
|
Net cash used in operating activities
|
|
|
(90,181
|
)
|
|
|
(102,540
|
)
|
|
Cash flows from investing activities
|
|
|
|
|
|
|
|
Purchases of investment securities
|
|
|
(269,626
|
)
|
|
|
(453,847
|
)
|
|
Maturities of investment securities
|
|
|
360,615
|
|
|
|
312,317
|
|
|
Purchases of property and equipment
|
|
|
—
|
|
|
|
(1,121
|
)
|
|
Net cash provided by (used in) investing activities
|
|
|
90,989
|
|
|
|
(142,651
|
)
|
|
Cash flows from financing activities
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance
costs
|
|
|
6,585
|
|
|
|
13,797
|
|
|
Net cash provided by financing activities
|
|
|
6,585
|
|
|
|
13,797
|
|
|
Effect of exchange rate changes on cash
|
|
|
14
|
|
|
|
6
|
|
|
Net increase (decrease) in cash, cash equivalents and restricted
cash
|
|
|
7,407
|
|
|
|
(231,388
|
)
|
|
Cash, cash equivalents and restricted cash
|
|
|
|
|
|
|
|
Beginning of period
|
|
|
153,205
|
|
|
|
331,798
|
|
|
End of period
|
|
$
|
160,612
|
|
|
$
|
100,410
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
4
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS
OF STOCKHOLDERS’ EQUITY
(in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
Total stockholders’ equity, beginning balances
|
|
$
|
434,848
|
|
|
$
|
564,838
|
|
|
$
|
540,894
|
|
|
$
|
627,009
|
|
|
Common stock:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beginning balance
|
|
|
16
|
|
|
|
16
|
|
|
|
16
|
|
|
|
16
|
|
|
Ending balance
|
|
|
16
|
|
|
|
16
|
|
|
|
16
|
|
|
|
16
|
|
|
Additional paid-in capital:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beginning balance
|
|
|
2,736,318
|
|
|
|
2,660,809
|
|
|
|
2,694,646
|
|
|
|
2,612,663
|
|
|
Issuance of common stock from exercise of stock options
and units
|
|
|
287
|
|
|
|
1,066
|
|
|
|
3,560
|
|
|
|
10,060
|
|
|
Issuance of common stock pursuant to employee stock
purchase plan
|
|
|
—
|
|
|
|
—
|
|
|
|
3,025
|
|
|
|
3,737
|
|
|
Stock-based compensation
|
|
|
18,256
|
|
|
|
15,547
|
|
|
|
53,630
|
|
|
|
50,962
|
|
|
Ending balance
|
|
|
2,754,861
|
|
|
|
2,677,422
|
|
|
|
2,754,861
|
|
|
|
2,677,422
|
|
|
Accumulated deficit:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beginning balance
|
|
|
(2,300,643
|
)
|
|
|
(2,096,025
|
)
|
|
|
(2,153,576
|
)
|
|
|
(1,985,706
|
)
|
|
Net loss
|
|
|
(27,183
|
)
|
|
|
(14,457
|
)
|
|
|
(174,250
|
)
|
|
|
(124,776
|
)
|
|
Ending balance
|
|
|
(2,327,826
|
)
|
|
|
(2,110,482
|
)
|
|
|
(2,327,826
|
)
|
|
|
(2,110,482
|
)
|
|
Other comprehensive (loss) income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beginning balance
|
|
|
(843
|
)
|
|
|
38
|
|
|
|
(192
|
)
|
|
|
36
|
|
|
Other comprehensive loss
|
|
|
(522
|
)
|
|
|
(39
|
)
|
|
|
(1,173
|
)
|
|
|
(37
|
)
|
|
Ending balance
|
|
|
(1,365
|
)
|
|
|
(1
|
)
|
|
|
(1,365
|
)
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity, ending balances
|
|
$
|
425,686
|
|
|
$
|
566,955
|
|
|
$
|
425,686
|
|
|
$
|
566,955
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
5
ACADIA PHARMACEUTICALS INC.
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
(Unaudited)
1. Organization and Business
Acadia Pharmaceuticals Inc. (the Company), based in San Diego,
California, is a biopharmaceutical company focused on the
development and commercialization of innovative medicines to
address unmet medical needs in central nervous system disorders.
The Company was originally incorporated in Vermont in 1993 as
Receptor Technologies, Inc. and reincorporated in Delaware in
1997.
In April 2016, the U.S. Food and Drug Administration (FDA) approved
the Company’s first drug, NUPLAZID®
(pimavanserin), for the treatment of hallucinations and delusions
associated with Parkinson’s disease psychosis (PDP). NUPLAZID
became available for prescription in the United States in May
2016.
2. Basis of Presentation and Significant Accounting
Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial
statements of the Company should be read in conjunction with the
audited financial statements and notes thereto as of and for the
year ended December 31, 2021 included in the Company’s Annual
Report on Form 10-K (Annual Report) filed with the Securities and
Exchange Commission (the SEC). The accompanying financial
statements have been prepared in accordance with accounting
principles generally accepted in the United States (GAAP) for
interim financial information and in accordance with the
instructions to Form 10-Q and Article 10 of Regulation S-X.
Accordingly, since they are interim statements, the accompanying
financial statements do not include all of the information and
notes required by GAAP for complete financial statements. In the
opinion of management, the accompanying financial statements
reflect all adjustments (consisting of normal recurring
adjustments) that are necessary for a fair statement of the
financial position, results of operations, cash flows, and
stockholders’ equity for the interim periods presented. Interim
results are not necessarily indicative of results for a full year.
The preparation of financial statements in conformity with GAAP
requires management to make estimates and assumptions that affect
the amounts reported in the financial statements and the
accompanying notes. Actual results could differ materially from
those estimates.
Risk and Uncertainties
The global pandemic resulting from the disease known as COVID-19,
caused by a novel strain of coronavirus, SARS-CoV-2, has caused
national and global economic and financial market disruptions and
has adversely impacted the Company’s business. Since the beginning
of the pandemic, the growth of sales of NUPLAZID have been
negatively impacted by ongoing conditions related to the pandemic.
At this time the Company cannot predict the magnitude of the
pandemic or the full impact that it may have on the Company’s
financial condition, operations, suppliers, and
workforce.
In addition to the ongoing COVID-19 pandemic, global economic and
business activities continue to face widespread macroeconomic
uncertainties, including labor shortages, inflation and monetary
supply shifts, recession risks and potential disruptions from the
Russia-Ukraine conflict. The Company continues to actively monitor
the impact of these macroeconomic factors on its financial
condition, liquidity, operations and workforce. The extent of the
impact of these factors on the Company’s operational and financial
performance, including its ability to execute its business
strategies and initiatives in the expected time frame, will depend
on future developments, which are uncertain and cannot be
predicted; however, any continued or renewed disruption resulting
from these factors could negatively impact the Company’s
business.
6
Cash, Cash Equivalents and Restricted Cash
The following table provides a reconciliation of cash, cash
equivalents and restricted cash reported within the statements of
cash flows that sum to the total of the same such amounts shown in
the statements of cash flows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2022
|
|
|
Nine Months Ended September 30, 2021
|
|
|
|
|
Beginning of
period
|
|
|
End of
period
|
|
|
Beginning of
period
|
|
|
End of
period
|
|
|
Cash and cash equivalents
|
|
$
|
147,435
|
|
|
$
|
154,842
|
|
|
$
|
326,028
|
|
|
$
|
94,640
|
|
|
Restricted cash
|
|
|
5,770
|
|
|
|
5,770
|
|
|
|
5,770
|
|
|
|
5,770
|
|
|
Total cash, cash equivalents and restricted cash shown in
the statements of cash flows
|
|
$
|
153,205
|
|
|
$
|
160,612
|
|
|
$
|
331,798
|
|
|
$
|
100,410
|
|
Accounts Receivable
Accounts receivable are recorded net of customer allowances for
distribution fees, prompt payment discounts, chargebacks, and
credit losses. Allowances for distribution fees, prompt payment
discounts and chargebacks are based on contractual terms. The
Company estimated the current expected credit losses of its
accounts receivable by assessing the risk of loss and available
relevant information about collectability, including historical
credit losses, existing contractual payment terms, actual payment
patterns of its customers, individual customer circumstances, and
reasonable and supportable forecast of economic conditions expected
to exist throughout the contractual life of the receivable. The
Company has not historically experienced significant credit losses.
Based on its assessment, as of September 30, 2022
the Company determined that an allowance for credit loss was not
required.
License Fees and Royalties
The Company expenses amounts paid to acquire licenses associated
with products under development when the ultimate recoverability of
the amounts paid is uncertain and the technology has no alternative
future use when acquired. Acquisitions of technology licenses are
charged to expense or capitalized based upon management’s
assessment regarding the ultimate recoverability of the amounts
paid and the potential for alternative future use. The Company has
determined that technological feasibility for its product
candidates is reached when the requisite regulatory approvals are
obtained to make the product available for sale.
The Company accounts for acquisitions of an asset or group of
similar identifiable assets that do not meet the definition of a
business as an asset acquisition using the cost accumulation
method, whereby the cost of the acquisition, including certain
transaction costs, is allocated to the assets acquired on the basis
of their relative fair values. No goodwill is recognized in an
asset acquisition. Intangible assets acquired in an asset
acquisition for use in research and development activities which
have no alternative future use are expensed as in-process research
and development on the acquisition date. Intangible assets acquired
for use in research and development activities which have an
alternative future use are capitalized as in-process research and
development. Future costs to develop these assets are recorded to
research and development expense as they are incurred. Contingent
milestone payments associated with asset acquisitions are
recognized when probable and estimable. These amounts are expensed
if there is no alternative future use associated with the asset, or
capitalized as an intangible asset if alternative future use of the
asset exists. The Company includes the costs of asset acquisitions
as component of cash flows from operations on the condensed
consolidated statements of cash flows.
3. 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, without consideration for common stock equivalents. Diluted
net loss per share is computed by dividing the net loss by the
weighted average number of common shares and common stock
equivalents outstanding for the period determined using the
treasury stock method. For purposes of this calculation, stock
options, employee stock purchase plan rights, restricted stock
units, and warrants are considered to be common stock equivalents
but are not included in the calculations of diluted net loss per
share for the periods presented as their effect would be
anti-dilutive. The Company incurred net losses for all periods
presented and there were no reconciling items for potentially
dilutive securities. More specifically, at September 30, 2022 and
2021, stock options, employee stock purchase plan rights,
restricted stock units, and warrants totaling approximately
21,652,000
shares and
18,569,000
shares, respectively, were excluded from the calculation of diluted
net loss per share as their effect would have been
anti-dilutive.
7
4. Stock-Based Compensation
The following table summarizes the total stock-based compensation
expense included in the Company’s statements of operations for the
periods presented (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
Cost of product sales
|
|
$
|
344
|
|
|
$
|
439
|
|
|
$
|
1,013
|
|
|
$
|
1,025
|
|
|
Research and development
|
|
|
6,452
|
|
|
|
5,176
|
|
|
|
19,148
|
|
|
|
17,325
|
|
|
Selling, general and administrative
|
|
|
11,516
|
|
|
|
9,931
|
|
|
|
33,626
|
|
|
|
32,385
|
|
|
|
|
$
|
18,312
|
|
|
$
|
15,546
|
|
|
$
|
53,787
|
|
|
$
|
50,735
|
|
The fair value of each employee stock option and each employee
stock purchase plan right granted is estimated on the grant date
under the fair value method using the Black-Scholes valuation
model, which requires the Company to make a number of assumptions
including the estimated expected life of the award and related
volatility. The fair value of restricted stock units is estimated
based on the market price of the Company’s common stock on the date
of grant. The estimated fair values of stock options, purchase plan
rights, and restricted stock units are then expensed over the
requisite service period, which is generally the vesting period.
For restricted stock units requiring satisfaction of both market
and service conditions, the estimated fair values are generally
expensed over the longest of the explicit, implicit and derived
service periods.
Performance-based stock awards vest upon the achievement of certain
pre-defined company-specific performance-based criteria. Expense
related to these performance-based stock awards is generally
recognized ratably over the expected performance period once the
pre-defined performance-based criteria for vesting becomes
probable.
5. Balance Sheet Details
Inventory consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2022
|
|
|
December 31,
2021
|
|
|
Finished goods
|
|
$
|
1,610
|
|
|
$
|
1,114
|
|
|
Work in process
|
|
|
4,234
|
|
|
|
6,767
|
|
|
Raw material
|
|
|
5,992
|
|
|
|
6,217
|
|
|
|
|
$
|
11,836
|
|
|
$
|
14,098
|
|
|
Reported as:
|
|
|
|
|
|
|
|
Inventory
|
|
$
|
5,844
|
|
|
$
|
7,881
|
|
|
Long-term inventory
|
|
|
5,992
|
|
|
|
6,217
|
|
|
Total
|
|
$
|
11,836
|
|
|
$
|
14,098
|
|
Amount reported as long-term inventory consisted of raw materials
as of September 30, 2022 and December 31, 2021. The Company has raw
materials beyond a one year production plan that help limit the
exposures from potential supply interruption. Those raw materials
beyond the one year production plan were classified as long-term
inventory.
Accrued liabilities consisted of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2022
|
|
|
December 31,
2021
|
|
|
Accrued research and development services
|
|
$
|
43,490
|
|
|
$
|
27,270
|
|
|
Accrued compensation and benefits
|
|
|
28,794
|
|
|
|
25,896
|
|
|
Accrued sales allowances
|
|
|
11,601
|
|
|
|
15,717
|
|
|
Accrued consulting and professional fees
|
|
|
10,926
|
|
|
|
9,319
|
|
|
Current portion of lease liabilities
|
|
|
9,231
|
|
|
|
8,304
|
|
|
Other
|
|
|
2,520
|
|
|
|
2,686
|
|
|
|
|
$
|
106,562
|
|
|
$
|
89,192
|
|
8
6. Investments
The carrying value and amortized cost of the Company’s investments,
summarized by major security type, consisted of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2022
|
|
|
|
|
Amortized
Cost
|
|
|
Unrealized
Gains
|
|
|
Unrealized
Losses
|
|
|
Estimated
Fair
Value
|
|
|
U.S. Treasury notes
|
|
$
|
23,324
|
|
|
$
|
—
|
|
|
$
|
(42
|
)
|
|
$
|
23,282
|
|
|
Government sponsored enterprise securities
|
|
|
47,327
|
|
|
|
29
|
|
|
|
(225
|
)
|
|
|
47,131
|
|
|
Municipal bonds
|
|
|
22,196
|
|
|
|
—
|
|
|
|
(157
|
)
|
|
|
22,039
|
|
|
Commercial paper
|
|
|
190,281
|
|
|
|
—
|
|
*
|
|
(996
|
)
|
|
|
189,285
|
|
|
|
|
$
|
283,128
|
|
|
$
|
29
|
|
|
$
|
(1,420
|
)
|
|
$
|
281,737
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2021
|
|
|
|
|
Amortized
Cost
|
|
|
Unrealized
Gains
|
|
|
Unrealized
Losses
|
|
|
Estimated
Fair
Value
|
|
|
U.S. Treasury notes
|
|
$
|
140,287
|
|
|
$
|
—
|
|
|
$
|
(100
|
)
|
|
$
|
140,187
|
|
|
Government sponsored enterprise securities
|
|
|
49,512
|
|
|
|
—
|
|
|
|
(38
|
)
|
|
|
49,474
|
|
|
Corporate debt securities
|
|
|
26,006
|
|
|
|
—
|
|
|
|
(22
|
)
|
|
|
25,984
|
|
|
Commercial paper
|
|
|
157,670
|
|
|
|
9
|
|
|
|
(53
|
)
|
|
|
157,626
|
|
|
|
|
$
|
373,475
|
|
|
$
|
9
|
|
|
$
|
(213
|
)
|
|
$
|
373,271
|
|
_______________________
* Unrealized gain was less than $500.
The Company has classified all of its available-for-sale investment
securities as current assets on its condensed consolidated balance
sheets based on the highly liquid nature of the investment
securities and because these investment securities are considered
available for use in current operations. The Company has classified
all equity securities as other assets on its condensed consolidated
balance sheets.
At September 30, 2022
and December 31, 2021, the Company had
47
and
39
available-for-sale investment securities, respectively, in an
unrealized loss position.
The following table presents gross unrealized losses and fair value
for those available-for-sale investment securities that were in an
unrealized loss position as of
September 30, 2022 and December 31, 2021, aggregated by investment
category and length of time that the individual securities have
been in a continuous loss position (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than 12 Months
|
|
|
12 Months or Greater
|
|
|
Total
|
|
|
|
|
|
Estimated
Fair Value
|
|
|
Unrealized
Losses
|
|
|
Estimated
Fair Value
|
|
|
Unrealized
Losses
|
|
|
Estimated
Fair Value
|
|
|
Unrealized
Losses
|
|
|
|
September 30, 2022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury notes
|
|
$
|
23,282
|
|
|
$
|
(42
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
23,282
|
|
|
$
|
(42
|
)
|
|
|
Government sponsored enterprise securities
|
|
|
39,916
|
|
|
|
(225
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
39,916
|
|
|
|
(225
|
)
|
|
|
Municipal bonds
|
|
|
20,739
|
|
|
|
(157
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
20,739
|
|
|
|
(157
|
)
|
|
|
Commercial paper
|
|
|
174,313
|
|
|
|
(996
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
174,313
|
|
|
|
(996
|
)
|
|
|
Total
|
|
$
|
258,250
|
|
|
$
|
(1,420
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
258,250
|
|
|
$
|
(1,420
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than 12 Months
|
|
|
12 Months or Greater
|
|
|
Total
|
|
|
|
|
|
Estimated
Fair Value
|
|
|
Unrealized
Losses
|
|
|
Estimated
Fair Value
|
|
|
Unrealized
Losses
|
|
|
Estimated
Fair Value
|
|
|
Unrealized
Losses
|
|
|
|
December 31, 2021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury notes
|
|
$
|
140,287
|
|
|
$
|
(100
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
140,287
|
|
|
$
|
(100
|
)
|
|
|
Government sponsored enterprise securities
|
|
|
49,512
|
|
|
|
(38
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
49,512
|
|
|
|
(38
|
)
|
|
|
Corporate debt securities
|
|
|
|