Business Wire | Nov 8, 2021 04:06PM EST

Acadia Pharmaceuticals Reports Third Quarter 2021 Financial Results

Nov. 08, 2021

SAN DIEGO--(BUSINESS WIRE)--Nov. 08, 2021--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the third quarter ended September 30, 2021.

"Our third-quarter results reflect volume growth across all channels and our strong relative performance underscores our commercial team's ability to drive sales of NUPLAZID in a challenging environment," said Steve Davis, Chief Executive Officer. "As we close out the year, we will meet with the FDA to discuss additional analyses supporting a potential resubmission of our sNDA for pimavanserin focused on specific subgroups of dementia. In addition, we look forward to announcing results from our ongoing Phase 3 LAVENDER study of trofinetide for the treatment of Rett syndrome."

Company Updates

* Scheduled meeting with the FDA to discuss additional analyses supporting a potential resubmission of the pimavanserin sNDA focused on specific subgroups of dementia. Acadia plans to provide an update following this meeting around year-end.

* Top-line results from the Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome are expected in the fourth quarter of 2021.

* Top-line results from the Phase 2 study of ACP-044 for the treatment of postoperative pain following bunionectomy surgery are expected in the first quarter of 2022.

* Three data presentations featuring new analyses of Medicare claims data on dementia-related psychosis outcomes were presented at the Psych Congress 2021 demonstrating the high unmet need in dementia-related psychosis and providing further evidence of the sub-optimal outcomes associated with the use of dopaminergic atypical antipsychotic treatments in managing dementia-related hallucinations and delusions, along with the related cost burdens.

* A scientific presentation on pimavanserin for the treatment of hallucinations and delusions in patients with Parkinson's disease dementia will be shared at the 14th Clinical Trials on Alzheimer's Disease (CTAD) conference.

* Brendan Teehan has been promoted to Executive Vice President, Chief Operating Officer, Head of Commercial.

* Julie Fisher has been promoted to Senior Vice President, Marketing & Commercial Strategy. Ms. Fisher will report to Mr. Teehan and join the company's Executive Management Committee.

Financial Results

Revenue

Net sales of NUPLAZID(r) (pimavanserin) were $131.6 million for the three months ended September 30, 2021, an increase of 9% as compared to $120.6 million reported for the three months ended September 30, 2020. For the nine months ended September 30, 2021 and 2020, Acadia reported net product sales of $353.4 million and $320.7 million, respectively.

Research and Development

Research and development expenses for the three months ended September 30, 2021 were $58.6 million, compared to $120.1 million for the same period of 2020. The decrease was largely due to decreased costs associated with the upfront consideration and transaction costs related to the acquisition of CerSci Therapeutics. For the nine months ended September 30, 2021 and 2020, research and development expenses were $172.5 million and $257.0 million. The decrease was largely due to the acquisition of CerSci Therapeutics and reduced development costs for trofinetide and the cessation of development of pimavanserin for major depressive disorder, partially offset by increased costs of our development activities for ACP-044.

Selling, General and Administrative

Selling, general and administrative expenses for the three months ended September 30, 2021 were $81.7 million, compared to $81.6 million for the same period of 2020. For the nine months ended September 30, 2021 and 2020, selling, general and administrative expenses were $290.1 million and $267.9 million, respectively. The increase was primarily due to increased advertising and promotional costs as well as an increase in personnel and related costs.

Net Loss

For the three months ended September 30, 2021, Acadia reported a net loss of $14.5 million, or $0.09 per common share, compared to a net loss of $84.7 million, or $0.54 per common share, for the same period in 2020. The net losses for the three months ended September 30, 2021 and 2020 included $15.5 million and $21.4 million, respectively, of non-cash stock-based compensation expense. For the nine months ended September 30, 2021, Acadia reported a net loss of $124.8 million, or $0.78 per common share, compared to a net loss of $214.8 million, or $1.37 per common share, for the same period in 2020. The net losses for the nine months ended September 30, 2021 and 2020 included $50.7 million and $63.2 million, respectively, of non-cash stock-based compensation expense.

Cash and Investments

At September 30, 2021, Acadia's cash, cash equivalents, and investment securities totaled $540.3 million, compared to $632.0 million at December 31, 2020.

2021 Financial Guidance

* NUPLAZID net sales guidance is narrowed to $480 to $500 million from the previous range of $480 to $515 million. * GAAP R&D is decreased to $230 to $245 million from the previous range of $250 to $270 million. Current R&D guidance includes approximately $25 million of stock-based compensation expense. * GAAP SG&A guidance is narrowed to $385 to $405 million from the previous range of $385 to $415 million. Current SG&A guidance includes approximately $45 million of stock-based compensation expense.

Conference Call and Webcast Information

Acadia management will review its third quarter financial results and operations via conference call and webcast today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 9213599). A telephone replay of the conference call may be accessed through November 22, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 9213599). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there until December 6, 2021.

About NUPLAZID(r) (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. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

About Trofinetide

Trofinetide is an investigational drug. It is a novel synthetic analog of the amino?terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells - neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted Fast Track Status and Orphan Drug Designation in the U.S. and Orphan Drug Designation in Europe for both Rett syndrome and Fragile X syndrome.

About Acadia Pharmaceuticals

Acadia is trailblazing breakthroughs in neuroscience to elevate life. For more than 25 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 therapy for hallucinations and delusions associated with Parkinson's disease psychosis. Our late-stage development efforts are focused on dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.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 related to: the potential opportunity for future growth in sales of NUPLAZID; the timing of ongoing and future clinical studies for pimavanserin; the development and commercialization of trofinetide; and guidance for full-year 2021 NUPLAZID net sales for Parkinson's disease psychosis and certain expense line items. 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 uncertainty of future commercial sales and related items that would impact net sales during 2021, the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. 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, 2020 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.

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(Unaudited)



Three Months Ended Nine Months Ended September September 30, 30,

2021 2020 2021 2020

Revenues

Product sales, net $ 131,612 $ 120,577 $ 353,387 $ 320,748

Total revenues 131,612 120,577 353,387 320,748

Operating expenses

Cost of productsales, license fees 6,682 4,801 16,580 15,249 and royalties ^(1)

Research and 58,565 120,083 172,473 257,014 development ^(1)

Selling, general and 81,666 81,592 290,116 267,909 administrative ^(1)

Total operating 146,913 206,476 479,169 540,172 expenses

Loss from operations (15,301 ) (85,899 ) (125,782 ) (219,424 )

Interest income, net 129 1,242 462 6,056

Other income 383 (202 ) 706 (1,262 )(expense)

Loss before income (14,789 ) (84,859 ) (124,614 ) (214,630 )taxes

Income tax expense (332 ) (199 ) 162 194

Net loss $ (14,457 ) $ (84,660 ) $ (124,776 ) $ (214,824 )

Net loss per commonshare, basic and $ (0.09 ) $ (0.54 ) $ (0.78 ) $ (1.37 )diluted

Weighted averagecommon shares 160,663 158,129 159,651 156,683 outstanding, basicand diluted





^(1) Includes thefollowing stock-based compensation expense



Cost of productsales, license fees $ 439 $ 495 $ 1,025 $ 2,087 and royalties

Research and $ 5,176 $ 7,953 $ 17,325 $ 23,645 development

Selling, general and $ 9,931 $ 12,924 $ 32,385 $ 37,495 administrative

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

September 30,

2021

December 31,

2020

(unaudited)

Assets

Cash, cash equivalents and investment securities

$

540,291

$

631,958

Accounts receivable, net

60,696

48,247

Interest and other receivables

972

2,035

Inventory

14,336

9,682

Prepaid expenses

24,622

25,694

Total current assets

640,917

717,616

Property and equipment, net

8,581

9,161

Operating lease right-of-use assets

60,032

47,283

Restricted cash

5,770

5,770

Other assets

2,373

2,786

Total assets

$

717,673

$

782,616

Liabilities and stockholders' equity

Accounts payable

$

7,722

$

8,493

Accrued liabilities

80,496

97,474

Total current liabilities

88,218

105,967

Operating lease liabilities

57,677

44,460

Other long-term liabilities

4,823

5,180

Total liabilities

150,718

155,607

Total stockholders' equity

566,955

627,009

Total liabilities and stockholders' equity

$

717,673

$

782,616

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CONTACT: Media Contact: Acadia Pharmaceuticals Inc. Stephanie Fagan (858) 212-0534 media@acadia-pharm.com

CONTACT: Investor Contact: Acadia Pharmaceuticals Inc. Mark Johnson, CFA (858) 261-2771 ir@acadia-pharm.com