UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 2, 2023, Acadia Pharmaceuticals Inc. issued a press release announcing its financial results for the second quarter and six months ended June 30, 2023. A copy of this press release is furnished herewith as Exhibit 99.1. Pursuant to the rules and regulations of the Securities and Exchange Commission, such exhibit and the information set forth therein and in this Item 2.02 have been furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing regardless of any general incorporation language.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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Description |
99.1 |
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104 |
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Cover page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Acadia Pharmaceuticals Inc. |
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Date: |
August 2, 2023 |
By: |
/s/ Austin D. Kim |
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Austin D. Kim |
Exhibit 99.1
Acadia Pharmaceuticals Reports Second Quarter 2023 Financial Results and Operating Overview
- 2Q23 DAYBUE™ (trofinetide) net product sales of $23.2 million
- 2Q23 NUPLAZID® (pimavanserin) net product sales of $142.0 million
- Expanded licensing agreement for trofinetide includes ex-North American rights
SAN DIEGO, CA, August 2, 2023 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the second quarter ended June 30, 2023.
“Our second quarter 2023 results reflect strong performances from both commercial franchises. The DAYBUE launch is off to a highly successful start as evidenced by broad demand across the entire Rett community, and our NUPLAZID franchise is increasingly profitable while continuing to gain market share,” said Steve Davis, President and Chief Executive Officer. “In our late-stage portfolio, we have completed enrollment in our Phase 3 negative symptoms of schizophrenia clinical trial, with results on track for the first quarter of next year. In the fourth quarter of this year, we will initiate a Phase 3 trial of ACP-101 for Prader-Willi syndrome, and commence a seamless Phase 2 and 3 program to study ACP-204 in Alzheimer’s disease psychosis.”
Company Updates
Financial Results
Revenue
Total net product sales, comprised of NUPLAZID and DAYBUE were $165.2 million for the three months ended June 30, 2023, and were $283.7 million for the six months ended June 30, 2023.
Net product sales of NUPLAZID were $142.0 million and $134.6 million for the three months ended June 30, 2023 and 2022, respectively. The increase in net product sales of NUPLAZID was primarily due to an increase in volume due to demand from new patient starts of NUPLAZID and a higher average net selling price. Net product sales of NUPLAZID were $260.5 million and $250.0 million for the six months ended June 30, 2023 and 2022. The increase in net product sales of NUPLAZID was a result of similar demand and price dynamics, partially offset by a moderate reduction of in-channel inventory.
Net product sales of DAYBUE were $23.2 million for the quarter ended June 30, 2023, the first quarter of commercialization of DAYBUE following the launch of DAYBUE on April 17, 2023.
Research and Development
Research and development expenses for the three months ended June 30, 2023 were $58.8 million, compared to $75.6 million for the same period of 2022. The decrease in research and development expenses was mainly due to decreased costs in the prior year associated with pre-approval manufacturing supply expenses for trofinetide. For the six months ended June 30, 2023 and 2022, research and development expenses were $127.9 million and $204.5 million, respectively. The decrease was primarily due to a $60.0 million upfront payment made to Stoke Therapeutics for a license and collaboration agreement in the first quarter of 2022 as well as a reduction in overall program spend.
Selling, General and Administrative
Selling, general and administrative expenses for the three months ended June 30, 2023 were $96.0 million, compared to $89.9 million for the same period of 2022. For the six months ended June 30, 2023 and 2022, selling, general and administrative expenses were $197.2 million and $186.6 million, respectively. The increase in selling, general and administrative expenses in both periods was primarily due to increased commercial costs associated with the DAYBUE launch, partially offset by efficiencies in our commercial support of NUPLAZID.
Net Income
For the three months ended June 30, 2023, Acadia reported net income of $1.1 million, or $0.01 per common share, compared to a net loss of $34.0 million, or $0.21 per common share, for the same period in 2022. The net income and loss for the three months ended June 30, 2023 and 2022 included $15.2 million and $20.5 million, respectively, of non-cash stock-based compensation expense. For the six months ended June 30, 2023, Acadia reported a net loss of $41.9 million, or $0.26 per common share, compared to a net loss of $147.1 million, or $0.91 per common share, for the same period in 2022. The net losses for the six months ended June 30, 2023 and 2022 included $29.9 million and $35.5 million, respectively, of non-cash stock-based compensation expense.
Cash and Investments
At June 30, 2023, Acadia’s cash, cash equivalents and investment securities totaled $375.4 million, compared to $416.8 million at December 31, 2022.
Financial Guidance
Third Quarter 2023
Full Year 2023
Conference Call and Webcast Information
The conference call will be available on Acadia’s website, www.acadia.com, under the investors section and will be archived there until September 1, 2023. The conference call may also be accessed by registering for the call here. Once registered, participants will receive an email with the dial-in number and unique PIN number to use for accessing the call.
About NUPLAZID® (pimavanserin)
Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID. In addition, Acadia is developing pimavanserin as a potential treatment for the negative symptoms of schizophrenia.
About DAYBUE™ (trofinetide)
Trofinetide is a synthetic version of a naturally occurring molecule known as the tripeptide glycine-proline-glutamate (GPE). The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown. In animal studies, trofinetide has been shown to increase branching of dendrites and synaptic plasticity signals.1,2
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapies for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Prader-Willi syndrome, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia.com and follow us on LinkedIn and Twitter.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia’s annual report on Form 10-K for the year ended December 31, 2022, as well as Acadia’s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation
to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
References
1Tropea D, Giacometti E, Wilson NR, et al. Partial reversal of Rett Syndrome-like symptoms in MeCP2 mutant mice. Proc Natl Acad Sci USA. 2009;106(6):2029-2034.
2Acadia Pharmaceuticals Inc., Data on file. Study Report 2566-026. 2010.
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenues |
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Product sales, net |
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$ |
165,235 |
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$ |
134,563 |
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$ |
283,697 |
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$ |
250,031 |
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Total revenues |
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165,235 |
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134,563 |
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283,697 |
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250,031 |
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Operating expenses |
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Cost of product sales (1)(2) |
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7,459 |
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2,667 |
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9,126 |
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5,617 |
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Research and development (2) |
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58,771 |
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75,646 |
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127,915 |
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204,501 |
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Selling, general and administrative (2) |
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95,968 |
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89,901 |
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197,203 |
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186,580 |
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Total operating expenses |
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162,198 |
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168,214 |
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334,244 |
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396,698 |
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Income (loss) from operations |
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3,037 |
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(33,651 |
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(50,547 |
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(146,667 |
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Interest income, net |
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4,550 |
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580 |
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8,350 |
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685 |
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Other (loss) income |
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(1,244 |
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(497 |
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3,601 |
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(157 |
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Income (loss) before income taxes |
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6,343 |
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(33,568 |
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(38,596 |
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(146,139 |
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Income tax (benefit) expense |
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5,229 |
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443 |
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3,311 |
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928 |
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Net income (loss) |
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$ |
1,114 |
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$ |
(34,011 |
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$ |
(41,907 |
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$ |
(147,067 |
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Earnings (net loss) per share: |
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Basic |
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$ |
0.01 |
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$ |
(0.21 |
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$ |
(0.26 |
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$ |
(0.91 |
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Diluted |
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$ |
0.01 |
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$ |
(0.21 |
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$ |
(0.26 |
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$ |
(0.91 |
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Weighted average common shares outstanding: |
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Basic |
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163,458 |
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161,654 |
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163,109 |
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161,443 |
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Diluted |
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165,046 |
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161,654 |
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163,109 |
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161,443 |
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(1) Includes license fees and royalties |
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(2) Includes the following stock-based compensation expense |
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Cost of product sales, license fees and royalties |
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$ |
200 |
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$ |
346 |
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$ |
368 |
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$ |
669 |
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Research and development |
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$ |
3,666 |
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$ |
7,232 |
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$ |
7,638 |
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$ |
12,696 |
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Selling, general and administrative |
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$ |
11,288 |
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$ |
12,934 |
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$ |
21,853 |
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$ |
22,110 |
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ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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June 30, |
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December 31, |
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(unaudited) |
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Assets |
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Cash, cash equivalents and investment securities |
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$ |
375,378 |
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$ |
416,823 |
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Accounts receivable, net |
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81,852 |
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62,195 |
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Interest and other receivables |
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2,304 |
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885 |
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Inventory |
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9,199 |
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6,636 |
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Prepaid expenses |
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23,895 |
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21,398 |
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Total current assets |
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492,628 |
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507,937 |
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Property and equipment, net |
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5,193 |
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6,021 |
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Operating lease right-of-use assets |
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52,382 |
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55,573 |
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Intangible assets, net |
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68,219 |
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— |
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Restricted cash |
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8,120 |
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5,770 |
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Long-term inventory |
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4,924 |
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4,924 |
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Other assets |
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11,303 |
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7,587 |
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Total assets |
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$ |
642,769 |
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$ |
587,812 |
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Liabilities and stockholders’ equity |
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Accounts payable |
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$ |
18,811 |
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$ |
12,746 |
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Accrued liabilities |
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169,131 |
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112,884 |
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Total current liabilities |
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187,942 |
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125,630 |
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Operating lease liabilities |
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49,778 |
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52,695 |
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Other long-term liabilities |
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9,256 |
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9,074 |
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Total liabilities |
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246,976 |
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187,399 |
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Total stockholders’ equity |
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395,793 |
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400,413 |
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Total liabilities and stockholders’ equity |
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$ |
642,769 |
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$ |
587,812 |
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Media Contact:
Acadia Pharmaceuticals Inc.
Deb Kazenelson
(818) 395-3043
media@acadia-pharm.com
Investor Contact:
Acadia Pharmaceuticals Inc.
Jessica Tieszen
(858) 261-2950
ir@acadia-pharm.com