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Form 8-K ACADIA PHARMACEUTICALS For: Feb 28

February 28, 2022 4:24 PM EST

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Exhibit 99.1

 

Acadia Pharmaceuticals Reports

Fourth Quarter and Full Year 2021 Financial Results

 

- Full year 2021 net sales grew to $484.1 million, a 10% increase over 2020

 

- Resubmitted sNDA for pimavanserin

for the treatment of Alzheimer's disease psychosis

 

- Delivered positive top-line results from the pivotal Phase 3 Lavender trial evaluating

trofinetide for the treatment of Rett syndrome

 

SAN DIEGO, CA, February 28, 2022 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2021.

 

“Acadia delivered strong fourth quarter and full year results with an increase in net sales of 10 percent year over year, driven by growth in both NUPLAZID prescriptions and market share,” said Steve Davis, Chief Executive Officer. “We recently resubmitted our sNDA for pimavanserin for Alzheimer’s disease psychosis to the FDA. In addition, this year we plan to submit an NDA for trofinetide for the treatment of Rett syndrome, complete enrollment in our pivotal ADVANCE-2 study for pimavanserin for the negative symptoms of schizophrenia, and deliver results from two Phase 2 studies for ACP-044 in postoperative and osteoarthritis pain.”

 

Company Highlights

 

Grew NUPLAZID® (pimavanserin) total prescriptions and market share, and outperformed other branded drugs in neurology, the Parkinson’s market, and long-term care facilities.

 

Resubmitted supplemental New Drug Application (sNDA) of NUPLAZID (pimavanserin) for the treatment of the hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) to the U.S. Food and Drug Administration (FDA).

 

Delivered positive top-line results from the pivotal Phase 3 Lavender study of trofinetide in Rett syndrome and plan to submit an NDA to the FDA around mid-year 2022.

 

Announced collaboration with Stoke Therapeutics to pursue multiple RNA-based treatments for severe and rare genetic neurodevelopmental diseases for SYNGAP1 syndrome, Rett syndrome (MECP2), and an undisclosed neurodevelopmental target of mutual interest.

 

Expect top-line results from a Phase 2 study evaluating ACP-044 for the treatment of postoperative pain following bunionectomy surgery around the end of the first quarter of 2022.

 

 


 

Published results from the ADVANCE study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia in The Lancet Psychiatry.

 

Financial Results

 

Revenue

Net sales of NUPLAZID (pimavanserin) were $130.8 million for the fourth quarter of 2021, an increase of 8% as compared to $121.0 million reported for the fourth quarter of 2020. For the years ended December 31, 2021 and 2020, Acadia reported net product sales of $484.1 million and $441.8 million, respectively, an increase of 10% year-over-year.

 

Research and Development

Research and development expenses for the fourth quarter of 2021 were $67.1 million, compared to $62.1 million for the same period of 2020. For the years ended December 31, 2021 and 2020, research and development expenses were $239.4 million and $319.1 million, respectively. The decrease was primarily due to the $52.8 million in upfront consideration and transaction costs paid for the acquisition of CerSci and $10.0 million upfront payment to Vanderbilt University for the M1 PAM program in 2020, partially offset by an increase in costs related to trofinetide.

 

Selling, General and Administrative

Selling, general and administrative expenses for the fourth quarter of 2021 were $105.8 million, compared to $120.8 million for the same period of 2020. For the years ended December 31, 2021 and 2020, selling, general and administrative expenses were $396.0 million and $388.7 million, respectively.

 

Net Loss

For the fourth quarter of 2021, Acadia reported a net loss of $43.1 million, or $0.27 per common share, compared to a net loss of $66.8 million, or $0.42 per common share, for the same period in 2020. The net losses for the fourth quarters of 2021 and 2020 included $12.9 million and $21.2 million, respectively, of non-cash stock-based compensation expense. For the year ended December 31, 2021, Acadia reported a net loss of $167.9 million, or $1.05 per common share, compared to a net loss of $281.6 million, or $1.79 per common share, for the same period in 2020. The net losses for the years ended December 31, 2021 and 2020 included $63.6 million and $84.4 million, respectively, of non-cash stock-based compensation expense.

 

Cash and Investments

At December 31, 2021, Acadia’s cash, cash equivalents, and investment securities totaled $520.7 million, compared to $632.0 million at December 31, 2020.

 

2022 Financial Guidance

 

NUPLAZID net sales guidance in Parkinson’s disease psychosis is $510 to $560 million.
GAAP R&D guidance is $355 to $375 million and includes approximately $25 million of stock-based compensation expense.

 


 

GAAP SG&A guidance is $360 to $380 million and includes approximately $45 million of stock-based compensation expense.

 

Conference Call and Webcast Information

Acadia management will review its fourth quarter and full year 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 6887457). A telephone replay of the conference call may be accessed through March 14, 2022 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 6887457). 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 March 28, 2022.

 

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 Alzheimer’s disease 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. Trofinetide is thought to stimulate synaptic maturation and overcome the synaptic and neuronal immaturities that are characteristic of Rett syndrome pathophysiology. 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 shown to inhibit the production of inflammatory cytokines, inhibit the overactivation of microglia and astrocytes, and increase the amount of available IGF-1 that can bind to IGF-1 receptors. Trofinetide has been granted Fast Track Status and Orphan Drug Designation for Rett syndrome and has also been granted Rare Pediatric Disease (RPD) designation by the FDA.

 

About Acadia Pharmaceuticals

Acadia is advancing 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 treating psychosis in patients with dementia, the negative symptoms of schizophrenia and Rett syndrome. Our early-stage development efforts are focused on novel approaches to pain management, 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 2022 NUPLAZID net sales for Parkinson’s disease psychosis only 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 2022, 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 December 31,

 

 

Years Ended December 31,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

130,758

 

 

$

121,007

 

 

$

484,145

 

 

$

441,755

 

Total revenues

 

 

130,758

 

 

 

121,007

 

 

 

484,145

 

 

 

441,755

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales, license fees and royalties (1)

 

 

2,561

 

 

 

5,301

 

 

 

19,141

 

 

 

20,550

 

Research and development (1)

 

 

67,084

 

 

 

62,116

 

 

 

239,415

 

 

 

319,130

 

Selling, general and administrative (1)

 

 

105,770

 

 

 

120,752

 

 

 

396,028

 

 

 

388,661

 

Total operating expenses

 

 

175,415

 

 

 

188,169

 

 

 

654,584

 

 

 

728,341

 

Loss from operations

 

 

(44,657

)

 

 

(67,162

)

 

 

(170,439

)

 

 

(286,586

)

Interest income, net

 

 

129

 

 

 

554

 

 

 

591

 

 

 

6,610

 

Other income (expense)

 

 

1,623

 

 

 

265

 

 

 

2,329

 

 

 

(997

)

Loss before income taxes

 

 

(42,905

)

 

 

(66,343

)

 

 

(167,519

)

 

 

(280,973

)

Income tax (benefit) expense

 

 

189

 

 

 

417

 

 

 

351

 

 

 

611

 

Net loss

 

$

(43,094

)

 

$

(66,760

)

 

$

(167,870

)

 

$

(281,584

)

Net loss per common share, basic and diluted

 

$

(0.27

)

 

$

(0.42

)

 

$

(1.05

)

 

$

(1.79

)

Weighted average common shares outstanding, basic and diluted

 

 

160,866

 

 

 

159,263

 

 

 

160,493

 

 

 

157,331

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) Includes the following share-based compensation expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales, license fees and royalties

 

$

261

 

 

$

545

 

 

$

1,286

 

 

$

2,632

 

Research and development

 

$

4,644

 

 

$

7,669

 

 

$

21,969

 

 

$

31,314

 

Selling, general and administrative

 

$

7,975

 

 

$

12,981

 

 

$

40,360

 

 

$

50,476

 

 

 


 

 

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

 

 

December 31,
2021

 

 

December 31,
2020

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Cash, cash equivalents and investment securities

 

$

520,706

 

 

$

631,958

 

Accounts receivable, net

 

 

64,366

 

 

 

48,247

 

Interest and other receivables

 

 

978

 

 

 

2,035

 

Inventory

 

 

7,881

 

 

 

9,682

 

Prepaid expenses

 

 

23,892

 

 

 

25,694

 

Total current assets

 

 

617,823

 

 

 

717,616

 

Property and equipment, net

 

 

8,047

 

 

 

9,161

 

Operating lease right-of-use assets

 

 

58,268

 

 

 

47,283

 

Intangible assets, net

 

 

 

 

 

1,108

 

Restricted cash

 

 

5,770

 

 

 

5,770

 

Long-term inventory

 

 

6,217

 

 

 

 

Other assets

 

 

3,997

 

 

 

1,678

 

Total assets

 

$

700,122

 

 

$

782,616

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Accounts payable

 

$

6,876

 

 

$

8,493

 

Accrued liabilities

 

 

89,192

 

 

 

97,474

 

Total current liabilities

 

 

96,068

 

 

 

105,967

 

Operating lease liabilities

 

 

56,126

 

 

 

44,460

 

Long-term liabilities

 

 

7,034

 

 

 

5,180

 

Total liabilities

 

 

159,228

 

 

 

155,607

 

Total stockholders’ equity

 

 

540,894

 

 

 

627,009

 

Total liabilities and stockholders’ equity

 

$

700,122

 

 

$

782,616

 

 

 


 

 

Media Contact:

Acadia Pharmaceuticals Inc.

Deb Kazenelson

(818) 395-3043

[email protected]

 

Investor Contact:

Acadia Pharmaceuticals Inc.

Mark Johnson, CFA

(858) 261-2771

[email protected]

 

 

 

 




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