ACAD Acadia Pharmaceuticals Inc

- 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

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

• Acquired global rights to trofinetide (DAYBUE) through an expanded agreement with Neuren Pharmaceuticals. The expanded agreement follows the company’s April 2023 U.S. launch of DAYBUE as the first and only drug approved for the treatment of Rett syndrome.
• Completed enrollment in ADVANCE-2, a Phase 3 study evaluating pimavanserin for the treatment of the negative symptoms of schizophrenia, with top-line results expected in the first quarter of 2024.
• Announced the addition of ACP-101, a Phase 3 development candidate to its rare disease portfolio for the treatment of hyperphagia in Prader-Willi syndrome (PWS). The Company recently aligned on plans with the FDA to initiate a Phase 3 study in the fourth quarter of 2023.
• Completed Phase 1 development of ACP-204 which demonstrated a favorable safety and tolerability profile, and supports Acadia's target product profile as a potential treatment for Alzheimer’s disease psychosis. Acadia met with the FDA and aligned on dosing and plans to initiate a Phase 2/3 program in the fourth quarter of 2023.
• Pivotal results from the Phase 3 LAVENDER™ study evaluating DAYBUE (trofinetide) efficacy and safety in patients with Rett syndrome were published in Nature Medicine, demonstrating DAYBUE’s ability to modify the core symptoms of Rett syndrome, which provided the basis for its FDA approval.
• Initiated patient enrollment in the real world evidence Lotus study, a two-year, prospective, online observational study of participants prescribed DAYBUE.
• Announced the appointment of Dr. Kevin R. Oliver as Senior Vice President, Chief Business Officer to oversee all business development functions and partnering activities.

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

• DAYBUE third quarter net sales in the range of $45 to $55 million.

Full Year 2023

• NUPLAZID full year net sales in the range of $530 to $545 million.
• R&D expense in the range of $335 to $355 million, which has been adjusted for the $100.0 million upfront payment to Neuren in July for the expanded licensing agreement.
• SG&A expense range increased to $380 to $400 million due to higher operating costs as a result of favorable business performance, including employee retention costs as well as DAYBUE incentive compensation and investments in patient support services.

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)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Product sales, net

 

$

165,235

 

 

$

134,563

 

 

$

283,697

 

 

$

250,031

 

Total revenues

 

 

165,235

 

 

 

134,563

 

 

 

283,697

 

 

 

250,031

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales (1)(2)

 

 

7,459

 

 

 

2,667

 

 

 

9,126

 

 

 

5,617

 

Research and development (2)

 

 

58,771

 

 

 

75,646

 

 

 

127,915

 

 

 

204,501

 

Selling, general and administrative (2)

 

 

95,968

 

 

 

89,901

 

 

 

197,203

 

 

 

186,580

 

Total operating expenses

 

 

162,198

 

 

 

168,214

 

 

 

334,244

 

 

 

396,698

 

Income (loss) from operations

 

 

3,037

 

 

 

(33,651

)

 

 

(50,547

)

 

 

(146,667

)

Interest income, net

 

 

4,550

 

 

 

580

 

 

 

8,350

 

 

 

685

 

Other (loss) income

 

 

(1,244

)

 

 

(497

)

 

 

3,601

 

 

 

(157

)

Income (loss) before income taxes

 

 

6,343

 

 

 

(33,568

)

 

 

(38,596

)

 

 

(146,139

)

Income tax (benefit) expense

 

 

5,229

 

 

 

443

 

 

 

3,311

 

 

 

928

 

Net income (loss)

 

$

1,114

 

 

$

(34,011

)

 

$

(41,907

)

 

$

(147,067

)

Earnings (net loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.01

 

 

$

(0.21

)

 

$

(0.26

)

 

$

(0.91

)

Diluted

 

$

0.01

 

 

$

(0.21

)

 

$

(0.26

)

 

$

(0.91

)

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

163,458

 

 

 

161,654

 

 

 

163,109

 

 

 

161,443

 

Diluted

 

 

165,046

 

 

 

161,654

 

 

 

163,109

 

 

 

161,443

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) Includes license fees and royalties

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2) Includes the following stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product sales, license fees and royalties

 

$

200

 

 

$

346

 

 

$

368

 

 

$

669

 

Research and development

 

$

3,666

 

 

$

7,232

 

 

$

7,638

 

 

$

12,696

 

Selling, general and administrative

 

$

11,288

 

 

$

12,934

 

 

$

21,853

 

 

$

22,110

 

ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

 

 

June 30, 2023

 

 

December 31, 2022

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Cash, cash equivalents and investment securities

 

$

375,378

 

 

$

416,823

 

Accounts receivable, net

 

 

81,852

 

 

 

62,195

 

Interest and other receivables

 

 

2,304

 

 

 

885

 

Inventory

 

 

9,199

 

 

 

6,636

 

Prepaid expenses

 

 

23,895

 

 

 

21,398

 

Total current assets

 

 

492,628

 

 

 

507,937

 

Property and equipment, net

 

 

5,193

 

 

 

6,021

 

Operating lease right-of-use assets

 

 

52,382

 

 

 

55,573

 

Intangible assets, net

 

 

68,219

 

 

 

—

 

Restricted cash

 

 

8,120

 

 

 

5,770

 

Long-term inventory

 

 

4,924

 

 

 

4,924

 

Other assets

 

 

11,303

 

 

 

7,587

 

Total assets

 

$

642,769

 

 

$

587,812

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Accounts payable

 

$

18,811

 

 

$

12,746

 

Accrued liabilities

 

 

169,131

 

 

 

112,884

 

Total current liabilities

 

 

187,942

 

 

 

125,630

 

Operating lease liabilities

 

 

49,778

 

 

 

52,695

 

Other long-term liabilities

 

 

9,256

 

 

 

9,074

 

Total liabilities

 

 

246,976

 

 

 

187,399

 

Total stockholders’ equity

 

 

395,793

 

 

 

400,413

 

Total liabilities and stockholders’ equity

 

$

642,769

 

 

$

587,812

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20230802606003/en/

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