- Company reports record revenues resulting from strong DAYBUE launch and growth in NUPLAZID franchise

- 3Q23 DAYBUE™ (trofinetide) net product sales of $66.9 million

- 3Q23 NUPLAZID® (pimavanserin) net product sales of $144.8 million

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced its financial results for the third quarter ended September 30, 2023.

“In the third quarter, Acadia delivered record product revenue, underscoring the continued strong launch of DAYBUE for the treatment of Rett syndrome, and market share growth for the very successful NUPLAZID franchise,” said Steve Davis, President and Chief Executive Officer. “In addition to our strong commercial performance, we continue to add to our late stage pipeline with the planned initiations in the fourth quarter of a Phase 3 study of ACP-101 for Prader-Willi syndrome and a Phase 2 / Phase 3 program of ACP-204 for the treatment of Alzheimer’s disease psychosis.”

Company Highlights

  • Acquired global rights to trofinetide (DAYBUE) through an expanded agreement with Neuren Pharmaceuticals.
  • The Company expects to report top-line results from ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia in the first quarter of 2024.
  • The Company plans to initiate a Phase 3 placebo-controlled study of ACP-101 for the treatment of hyperphagia in Prader-Willi syndrome in the fourth quarter of 2023.
  • The Company plans to initiate a Phase 2 study of ACP-204 as a potential treatment for Alzheimer’s disease psychosis in the fourth quarter of 2023.
  • Appointed Albert Kildani as Senior Vice President, Investor Relations and Corporate Communications, and Stephanie Kim as Senior Vice President, Regulatory Affairs. Albert and Stephanie both join Acadia’s Executive Management Committee.

Financial Results

Revenues

Total revenues, comprised of net product sales from NUPLAZID and DAYBUE were $211.7 million for the three months ended September 30, 2023, and were $495.4 million for the nine months ended September 30, 2023.

Net product sales of NUPLAZID were $144.8 million and $130.7 million for the three months ended September 30, 2023 and 2022, respectively. The approximately $14 million dollar increase year over year is comprised of a $7 million in-channel inventory reduction in the prior year that did not recur this year, $4 million attributable to lower 340B volumes, and $3 million as a result of 2% demand bottle growth. Net product sales of NUPLAZID were $405.3 million and $380.7 million for the nine months ended September 30, 2023 and 2022, respectively.

Net product sales of DAYBUE were $66.9 million for the quarter ended September 30, 2023, the first full quarter of commercialization of DAYBUE following the April 17, 2023 launch.

Research and Development

Research and development expenses for the three months ended September 30, 2023 were $157.0 million, compared to $81.3 million for the same period of 2022. The increase in research and development expenses was mainly due to the July 2023 agreement with Neuren to expand Acadia’s license to trofinetide (DAYBUE) from North American to worldwide rights, offset in part by other reductions in research and development. For the nine months ended September 30, 2023 and 2022, research and development expenses were $284.9 million and $285.8 million, respectively.

Selling, General and Administrative

Selling, general and administrative expenses for the three months ended September 30, 2023 were $97.9 million, compared to $78.1 million for the same period of 2022. For the nine months ended September 30, 2023 and 2022, selling, general and administrative expenses were $295.1 million and $264.7 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 reductions in expenses associated with NUPLAZID.

Net Loss

For the three months ended September 30, 2023, Acadia reported a net loss of $65.2 million, or $0.40 per common share, compared to a net loss of $27.2 million, or $0.17 per common share, for the same period in 2022. Net loss for the three months ended September 30, 2023 included the $100 million upfront payment to expand Acadia's license to trofinetide (DAYBUE) from North American to worldwide rights. Net loss for the three months ended September 30, 2023 and 2022 included $18.5 million and $18.3 million, respectively, of non-cash stock-based compensation expense. For the nine months ended September 30, 2023, Acadia reported a net loss of $107.1 million, or $0.65 per common share, compared to a net loss of $174.3 million, or $1.08 per common share, for the same period in 2022. The net losses for the nine months ended September 30, 2023 and 2022 included $48.4 million and $53.8 million, respectively, of non-cash stock-based compensation expense.

Cash and Investments

At September 30, 2023, Acadia’s cash, cash equivalents and investment securities totaled $345.9 million, compared to $416.8 million at December 31, 2022. The change in these balances is primarily due to the July 2023 $100 million upfront payment for worldwide rights to trofinetide (DAYBUE) referenced above.

Financial Guidance

Fourth Quarter 2023

  • DAYBUE net sales in the range of $80 to $87.5 million.

Full Year 2023

  • NUPLAZID net sales in the range of $537.5 to $545 million.
  • R&D expense in the range of $340 to $350 million.
  • SG&A expense in the range of $390 to $400 million.

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 December 4, 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)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

211,699

 

 

$

130,714

 

 

$

495,396

 

 

$

380,745

 

Total revenues

 

 

211,699

 

 

 

130,714

 

 

 

495,396

 

 

 

380,745

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales (1)(2)

 

 

14,622

 

 

 

2,136

 

 

 

23,747

 

 

 

7,753

 

Research and development (2)

 

 

156,963

 

 

 

81,336

 

 

 

284,878

 

 

 

285,837

 

Selling, general and administrative (2)

 

 

97,890

 

 

 

78,108

 

 

 

295,094

 

 

 

264,688

 

Total operating expenses

 

 

269,475

 

 

 

161,580

 

 

 

603,719

 

 

 

558,278

 

Loss from operations

 

 

(57,776

)

 

 

(30,866

)

 

 

(108,323

)

 

 

(177,533

)

Interest income, net

 

 

4,125

 

 

 

2,295

 

 

 

12,475

 

 

 

2,980

 

Other income

 

 

1,508

 

 

 

2,156

 

 

 

5,109

 

 

 

1,999

 

Loss before income taxes

 

 

(52,143

)

 

 

(26,415

)

 

 

(90,739

)

 

 

(172,554

)

Income tax expense

 

 

13,033

 

 

 

768

 

 

 

16,344

 

 

 

1,696

 

Net loss

 

$

(65,176

)

 

$

(27,183

)

 

$

(107,083

)

 

$

(174,250

)

Net loss per common share, basic and diluted

 

$

(0.40

)

 

$

(0.17

)

 

$

(0.65

)

 

$

(1.08

)

Weighted average common shares outstanding, basic and diluted

 

 

164,234

 

 

 

161,852

 

 

 

163,488

 

 

 

161,580

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) Includes license fees and royalties

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2) Includes the following stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales, license fees and royalties

 

$

276

 

 

$

344

 

 

$

644

 

 

$

1,013

 

Research and development

 

$

5,063

 

 

$

6,452

 

 

$

12,701

 

 

$

19,148

 

Selling, general and administrative

 

$

13,200

 

 

$

11,516

 

 

$

35,053

 

 

$

33,626

 

 

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

 

 

September 30, 2023

 

 

December 31, 2022

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Cash, cash equivalents and investment securities

 

$

345,920

 

 

$

416,823

 

Accounts receivable, net

 

 

92,802

 

 

 

62,195

 

Interest and other receivables

 

 

1,730

 

 

 

885

 

Inventory

 

 

20,768

 

 

 

6,636

 

Prepaid expenses

 

 

37,950

 

 

 

21,398

 

Total current assets

 

 

499,170

 

 

 

507,937

 

Property and equipment, net

 

 

4,884

 

 

 

6,021

 

Operating lease right-of-use assets

 

 

50,758

 

 

 

55,573

 

Intangible assets, net

 

 

66,855

 

 

 

 

Restricted cash

 

 

5,770

 

 

 

5,770

 

Long-term inventory

 

 

4,628

 

 

 

4,924

 

Other assets

 

 

475

 

 

 

7,587

 

Total assets

 

$

632,540

 

 

$

587,812

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Accounts payable

 

$

12,310

 

 

$

12,746

 

Accrued liabilities

 

 

197,293

 

 

 

112,884

 

Total current liabilities

 

 

209,603

 

 

 

125,630

 

Operating lease liabilities

 

 

48,103

 

 

 

52,695

 

Other long-term liabilities

 

 

12,660

 

 

 

9,074

 

Total liabilities

 

 

270,366

 

 

 

187,399

 

Total stockholders’ equity

 

 

362,174

 

 

 

400,413

 

Total liabilities and stockholders’ equity

 

$

632,540

 

 

$

587,812

 

 

Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818) 395-3043 media@acadia-pharm.com

Investor Contact: Acadia Pharmaceuticals Inc. Al Kildani (858) 261-2872 ir@acadia-pharm.com

Acadia Pharmaceuticals Inc. Jessica Tieszen (858) 261-2950 ir@acadia-pharm.com

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