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Acadia Pharmaceuticals Reports Third Quarter 2021 Financial Results

- 3Q21 net sales of $131.6 million, a 9% increase over 3Q20

- FDA meeting scheduled to discuss next steps towards a resubmission of the pimavanserin sNDA

SAN DIEGO--(BUSINESS WIRE)--Nov. 8, 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® (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® (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 September 30,

 

Nine Months Ended September 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 product sales, license fees and royalties (1)

 

 

6,682

 

 

 

4,801

 

 

 

16,580

 

 

 

15,249

 

Research and development (1)

 

 

58,565

 

 

 

120,083

 

 

 

172,473

 

 

 

257,014

 

Selling, general and administrative (1)

 

 

81,666

 

 

 

81,592

 

 

 

290,116

 

 

 

267,909

 

Total operating expenses

 

 

146,913

 

 

 

206,476

 

 

 

479,169

 

 

 

540,172

 

Loss from operations

 

 

(15,301

)

 

 

(85,899

)

 

 

(125,782

)

 

 

(219,424

)

Interest income, net

 

 

129

 

 

 

1,242

 

 

 

462

 

 

 

6,056

 

Other income (expense)

 

 

383

 

 

 

(202

)

 

 

706

 

 

 

(1,262

)

Loss before income taxes

 

 

(14,789

)

 

 

(84,859

)

 

 

(124,614

)

 

 

(214,630

)

Income tax expense

 

 

(332

)

 

 

(199

)

 

 

162

 

 

 

194

 

Net loss

 

$

(14,457

)

 

$

(84,660

)

 

$

(124,776

)

 

$

(214,824

)

Net loss per common share, basic and diluted

 

$

(0.09

)

 

$

(0.54

)

 

$

(0.78

)

 

$

(1.37

)

Weighted average common shares outstanding, basic and diluted

 

 

160,663

 

 

 

158,129

 

 

 

159,651

 

 

 

156,683

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) Includes the following stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales, license fees and royalties

 

$

439

 

 

$

495

 

 

$

1,025

 

 

$

2,087

 

Research and development

 

$

5,176

 

 

$

7,953

 

 

$

17,325

 

 

$

23,645

 

Selling, general and administrative

 

$

9,931

 

 

$

12,924

 

 

$

32,385

 

 

$

37,495

 

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

 

 

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

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

Source: Acadia Pharmaceuticals Inc.