UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
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Registrant’s Telephone Number, Including Area Code: (
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. of Form 8-K):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Name of each exchange on which registered |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On February 26, 2020, ACADIA Pharmaceuticals Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2019. A copy of this press release is furnished herewith as Exhibit 99.1. Pursuant to the rules and regulations of the Securities and Exchange Commission, such exhibit and the information set forth therein and in this Item 2.02 have been furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing regardless of any general incorporation language.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit |
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Description |
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99.1 |
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104 |
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Cover page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ACADIA Pharmaceuticals Inc. |
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Dated: February 26, 2020 |
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By: |
/s/ Austin D. Kim |
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Austin D. Kim |
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Executive Vice President, General Counsel & Secretary |
ACADIA Pharmaceuticals Reports
Fourth Quarter and Full Year 2019 Financial Results
- Full Year 2019 Net Sales Grew to $339.1 Million, a 52% Increase over Full Year 2018
- 2020 Net Sales Guidance of $440 to $470 Million
- On-Track to Submit Supplemental New Drug Application for Dementia-Related Psychosis in Summer 2020
SAN DIEGO, CA, February 26, 2020 – ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced financial results for the fourth quarter and full year ended December 31, 2019.
“In 2019 ACADIA demonstrated strong execution from our commercial and R&D teams, driving the continued growth of NUPLAZID and advancing our late-stage pipeline,” said Steve Davis, Chief Executive Officer. “2020 will be a transformational year for ACADIA highlighted by a potential approval in dementia-related psychosis, additional pivotal study results in major depressive disorder, commencement of a second pivotal study for the negative symptoms of schizophrenia and the continued enrollment of the Phase 3 trofinetide study for Rett syndrome. This exciting momentum has created a multi-year cadence of pivotal study readouts and potential regulatory approvals that position the company for long-term growth.”
Company Highlights
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Presented positive top-line results from the Phase 3 HARMONY study of pimavanserin for the treatment of dementia-related psychosis at the Clinical Trials on Alzheimer's Disease (CTAD) meeting on December 4, 2019. |
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The Company plans to submit a supplemental NDA for pimavanserin for the treatment of dementia-related psychosis in the summer of 2020. Pimavanserin previously received Breakthrough Therapy Designation for this indication. |
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Announced positive top-line results from the pivotal Phase 2 ADVANCE study of pimavanserin for the negative symptoms of schizophrenia in November 2019. |
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The Company plans to initiate a second pivotal study, ADVANCE-2, of pimavanserin for the negative symptoms of schizophrenia during the summer of 2020. |
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The Company expects to announce top-line results from its Phase 3 CLARITY-2 study of pimavanserin as an adjunctive treatment for major depressive disorder in the fourth quarter of 2020. |
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Appointed Ponni Subbiah, M.D., M.P.H., as Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer and Stephanie Fagan as Senior Vice President, Corporate Affairs and Chief Communications Officer. |
Revenue
Net sales of NUPLAZID® (pimavanserin) were $98.3 million for the fourth quarter of 2019, an increase of 65% as compared to $59.6 million reported for the fourth quarter of 2018. End of fourth quarter days-on-hand channel inventory increased relative to the third quarter 2019, which resulted in approximately $2.5 million increase in fourth quarter 2019 net sales. For the years ended December 31, 2019 and 2018, ACADIA reported net product sales of $339.1 million and $223.8 million, respectively, an increase of 52% year-over-year.
Research and Development
Research and development expenses for the fourth quarter of 2019 were $57.5 million, compared to $48.2 million for the same period of 2018. For the years ended December 31, 2019 and 2018, research and development expenses were $240.4 million and $187.2 million, respectively. The increase during the 2019 periods as compared to 2018 was primarily due to development costs associated with trofinetide and additional clinical study costs for pimavanserin.
Selling, General and Administrative
Selling, general and administrative expenses for the fourth quarter of 2019 were $91.9 million, compared to $74.3 million for the same period of 2018. For the years ended December 31, 2019 and 2018, selling, general and administrative expenses were $325.6 million and $265.8 million, respectively. This increase during the 2019 periods as compared to 2018 was primarily due to increased general and administrative expenses including charitable contributions and personnel costs.
Net Loss
For the fourth quarter of 2019, ACADIA reported a net loss of $53.0 million, or $0.34 per common share, compared to a net loss of $65.5 million, or $0.50 per common share, for the same period in 2018. The net losses for the fourth quarters of 2019 and 2018 included $19.8 million and $20.4 million, respectively, of non-cash stock-based compensation expense. For the years ended December 31, 2019, ACADIA reported a net loss of $235.3 million, or $1.60 per common share, compared to a net loss of $245.2 million, or $1.94 per common share, for the same period in 2018. The net losses for the years ended December 31, 2019 and 2018 included $82.2 million and $81.6 million, respectively, of non-cash stock-based compensation expense.
Cash and Investments
At December 31, 2019, ACADIA’s cash, cash equivalents, and investment securities totaled $697.4 million, compared to $473.5 million at December 31, 2018. The increase was primarily due to net proceeds of $271.5 million from ACADIA’s September 2019 public offering of common stock as well as additional cash proceeds from employee option exercises of $91.6 million.
2020 Financial Guidance
ACADIA’s 2020 net sales guidance reflects annual revenue growth of approximately 34% for NUPLAZID, at the mid-point of the range. 2020 GAAP R&D guidance reflects the progression
of four phase 3 studies this year. 2020 GAAP SG&A guidance reflects a similar level of investment to 2019 in PDP with new investments in preparing for a launch in DRP including disease-state educational initiatives and plans for the expansion of our commercial and medical affairs functions.
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NUPLAZID net sales are expected to be between $440 and $470 million. |
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GAAP R&D is expected to be between $270 and $285 million. |
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GAAP SG&A is expected to be between $440 and $460 million. |
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Non-cash stock-based compensation expense is expected to be between $90 and $100 million. |
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2020 year-end cash, cash equivalents, and investment securities are expected to be between $470 and $500 million. |
Conference Call and Webcast Information
ACADIA management will review its fourth quarter and full year 2019 financial results and operations via conference call and webcast today at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the U.S. or Canada and 443-877-4067 for international callers (reference passcode 6692587). A telephone replay of the conference call may be accessed through March 11, 2020 by dialing 855-859-2056 for callers in the U.S. or Canada and 404-537-3406 for international callers (reference passcode 6692587). 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 through March 26, 2020.
About NUPLAZID® (pimavanserin)
NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. NUPLAZID is a selective serotonin inverse agonist/antagonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson’s disease psychosis. NUPLAZID is an oral medicine taken once a day with a recommended dose of 34 mg. NUPLAZID is not FDA-approved for dementia-related psychosis, schizophrenia, major depressive disorder, or depressive symptoms in patients with Parkinson’s disease. ACADIA discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize NUPLAZID.
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 a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the
treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, the negative symptoms of schizophrenia, major depressive disorder, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.
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 2020 NUPLAZID net sales 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 2020, 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, 2018 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
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Three Months Ended December 31, |
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Years Ended December 31, |
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2019 |
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2018 |
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2019 |
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2018 |
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Revenues |
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Product sales, net |
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$ |
98,326 |
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$ |
59,571 |
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$ |
339,076 |
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$ |
223,807 |
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Total revenues |
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98,326 |
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59,571 |
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339,076 |
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223,807 |
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Operating expenses |
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Cost of product sales, license fees and royalties (1) |
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5,334 |
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4,392 |
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19,598 |
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18,330 |
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Research and development (1) |
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57,520 |
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48,183 |
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240,385 |
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187,163 |
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Selling, general and administrative (1) |
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91,871 |
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74,271 |
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325,638 |
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265,758 |
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Total operating expenses |
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154,725 |
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126,846 |
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585,621 |
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471,251 |
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Loss from operations |
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(56,399 |
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(67,275 |
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(246,545 |
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(247,444 |
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Interest income, net |
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3,272 |
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1,670 |
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11,165 |
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5,348 |
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Other expense |
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491 |
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127 |
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997 |
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(1,840 |
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Loss before income taxes |
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(52,636 |
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(65,478 |
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(234,383 |
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(243,936 |
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Income tax expense |
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400 |
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14 |
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876 |
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1,256 |
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Net loss |
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$ |
(53,036 |
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$ |
(65,492 |
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$ |
(235,259 |
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$ |
(245,192 |
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Net loss per common share, basic and diluted |
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$ |
(0.34 |
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$ |
(0.50 |
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$ |
(1.60 |
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$ |
(1.94 |
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Weighted average common shares outstanding, basic and diluted |
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154,492 |
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131,627 |
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147,199 |
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126,583 |
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(1) Includes the following share-based compensation expenses |
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Cost of product sales, license fees and royalties |
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$ |
592 |
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$ |
838 |
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$ |
2,936 |
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$ |
3,863 |
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Research and development |
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$ |
8,072 |
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$ |
8,421 |
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$ |
32,533 |
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$ |
32,038 |
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Selling, general and administrative |
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$ |
11,099 |
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$ |
11,142 |
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$ |
46,796 |
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$ |
45,663 |
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CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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December 31, 2019 |
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December 31, 2018 |
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(unaudited) |
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Assets |
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Cash, cash equivalents and investment securities |
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$ |
697,429 |
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$ |
473,520 |
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Accounts receivable, net |
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35,781 |
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26,090 |
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Interest and other receivables |
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2,093 |
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1,699 |
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Inventory |
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6,341 |
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4,070 |
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Prepaid expenses |
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18,606 |
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20,727 |
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Total current assets |
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760,250 |
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526,106 |
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Property and equipment, net |
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3,180 |
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3,309 |
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Operating lease right-of-use assets |
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9,524 |
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— |
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Intangible assets, net |
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2,585 |
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4,062 |
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Restricted cash |
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4,787 |
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4,826 |
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Other assets |
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2,857 |
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1,899 |
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Total assets |
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$ |
783,183 |
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$ |
540,202 |
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Liabilities and stockholders’ equity |
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Accounts payable |
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$ |
7,222 |
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$ |
3,167 |
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Accrued liabilities |
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67,604 |
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56,398 |
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Total current liabilities |
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74,826 |
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59,565 |
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Operating lease liabilities |
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6,361 |
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— |
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Long-term liabilities |
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2,861 |
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1,558 |
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Total liabilities |
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84,048 |
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61,123 |
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Total stockholders’ equity |
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699,135 |
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479,079 |
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Total liabilities and stockholders’ equity |
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$ |
783,183 |
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$ |
540,202 |
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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