UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): November 5, 2007
ACADIA PHARMACEUTICALS INC.
(Exact Name of Registrant as Specified in Charter)
| DELAWARE | 000-50768 | 06-1376651 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
| 3911 SORRENTO VALLEY BOULEVARD SAN DIEGO, CALIFORNIA |
92121 | |
| (Address of Principal Executive Offices) | (Zip Code) |
(858) 558-2871
(Registrant’s telephone number, including area code)
N/A
(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:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.02. | Results of Operations and Financial Condition. |
On November 5, 2007, ACADIA Pharmaceuticals Inc. issued a press release announcing its financial results for the third quarter and nine months ended September 30, 2007. 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) The following exhibit is furnished herewith:
| 99.1 | Press release dated November 5, 2007 |
2.
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.
| ACADIA Pharmaceuticals Inc. | ||||||||
| Date: November 5, 2007 | By: | /s/ Thomas H. Aasen | ||||||
| Thomas H. Aasen Vice President, Chief Financial Officer, Treasurer, and Secretary | ||||||||
3.
INDEX TO EXHIBITS
| Exhibit Number |
Description | |
| 99.1 | Press release dated November 5, 2007 | |
4.
Exhibit 99.1
Contacts:
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President and Chief Financial Officer
(858) 558-2871
ACADIA PHARMACEUTICALS REPORTS THIRD
QUARTER 2007 FINANCIAL RESULTS
SAN DIEGO, CA November 5, 2007 – ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today reported its unaudited financial results for the third quarter and nine months ended September 30, 2007.
ACADIA reported a net loss of $16.0 million, or $0.43 per common share, for the third quarter of 2007 compared to a net loss of $11.3 million, or $0.38 per common share, for the third quarter of 2006. For the nine months ended September 30, 2007, ACADIA reported a net loss of $39.4 million, or $1.14 per common share, compared to a net loss of $32.6 million, or $1.20 per common share, for the comparable period of 2006.
At September 30, 2007, ACADIA’s cash, cash equivalents, and investment securities totaled $141.0 million compared to $83.3 million at December 31, 2006. The increase in cash was primarily due to $96.1 million in net proceeds raised in a public offering of common stock, partially offset by cash used to fund ACADIA’s operations.
“The third quarter of 2007 was highlighted by continued progress with the ongoing trials in our advanced clinical programs, including the first pivotal trial in our Phase III program with pimavanserin for Parkinson’s disease psychosis and the Phase IIb trial with ACP-104 for schizophrenia,” said Uli Hacksell, Ph.D., ACADIA’s Chief Executive Officer. “Meanwhile, having completed our full analysis of the data from our Phase II schizophrenia co-therapy trial with pimavanserin, we are excited to present these data at the December meeting of the American College of Neuropsychopharmacology. In addition, we will present these data and other information on our programs at ACADIA’s inaugural analyst/investor day, which we have scheduled immediately following this prestigious medical meeting.”
Revenues totaled $2.0 million for the third quarter of 2007 compared to $1.9 million for the third quarter of 2006, and were comprised of revenues earned from ACADIA’s collaborations with Sepracor Inc. and Allergan, Inc. as well as its agreements with other parties.
Research and development expenses totaled $16.9 million for the third quarter of 2007, including $805,000 in stock-based compensation, compared to $15.5 million for the third quarter of 2006, including $550,000 in stock-based compensation. The increase in research and development expenses was primarily due to increased costs associated with ongoing trials in ACADIA’s advanced clinical programs, including $655,000 in increased fees paid to external service providers, which totaled $9.7 million for the third quarter of 2007, and increased costs associated with expansion of ACADIA’s development organization.
General and administrative expenses totaled $2.9 million for the third quarter of 2007, including $441,000 in stock-based compensation, compared to $3.0 million for the third quarter of 2006, including $421,000 in stock-based compensation.
The results for the comparable quarter and nine month periods of 2006 included a gain of $4.0 million and $3.6 million, respectively, related to settlement of a civil action.
Third Quarter 2007 and Recent Highlights
| • |
ACADIA, in collaboration with Herbert Y. Meltzer, M.D., Professor of Psychiatry and Pharmacology and Director of the Psychosis Program at the Vanderbilt School of Medicine, is preparing to present data from its Phase II schizophrenia co-therapy trial with pimavanserin at the 46th Annual Meeting of the American College of Neuropsychopharmacology to be held in Boca Raton, Florida from December 9-13, 2007. Dr. Meltzer’s presentation will reflect data from the full analysis of this Phase II schizophrenia co-therapy trial. This analysis confirmed the robustness of the top-line results reported in March 2007 and provided additional data in support of the benefits of pimavanserin co-therapy when combined with a sub-maximal dose of risperidone. |
| • | ACADIA announced today that it will host an analyst/investor meeting in New York City on Friday, December 14, 2007. The event will feature a presentation of data from ACADIA’s Phase II schizophrenia co-therapy trial with pimavanserin together with presentations of ACADIA’s Phase III program with pimavanserin for Parkinson’s disease psychosis (PDP), its Phase II program with ACP-104 for schizophrenia, and other discovery and development activities. |
| • | ACADIA continues to enroll patients in its Phase IIb clinical trial with ACP-104. This double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of ACP-104 in approximately 250 patients with schizophrenia who are experiencing an acute psychotic episode. ACADIA expects to report top-line results from this trial during the third quarter of 2008. |
| • | ACADIA continues to enroll patients in its first pivotal Phase III trial with pimavanserin as a treatment for PDP. The double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of pimavanserin in approximately 240 patients with PDP. ACADIA expects to report top-line results from this trial during 2009. |
| • | ACADIA announced in July that it earned a milestone payment associated with Allergan’s initiation of an exploratory clinical study with a small molecule drug candidate for the treatment of glaucoma. |
| • | ACADIA was selected to be one of the inaugural companies in the new NASDAQ NeuroInsights Neurotech Index, which was launched on September 25, 2007. |
Conference Call and Webcast Information
ACADIA management will review its third quarter results and development programs via conference call and webcast later today at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 866-203-2528 for participants in the U.S. or Canada and 617-213-8847 for international callers (reference passcode 99836009). A telephone replay of the conference call may be accessed through November 19, 2007 by dialing 888-286-8010 for callers in the U.S. or Canada and 617-801-6888 for international callers (reference passcode 54193185). 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 November 19, 2007.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders. ACADIA currently has five mid-to-late stage clinical programs as well as a portfolio of preclinical and discovery assets directed at diseases with large unmet medical needs, including schizophrenia, Parkinson’s disease psychosis, sleep maintenance insomnia, and neuropathic pain. All of the drug candidates in ACADIA’s product pipeline emanate from discoveries made using its proprietary drug discovery platform. ACADIA’s corporate headquarters is located in San Diego, California and it maintains research and development operations in both San Diego and Malmö, Sweden.
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 ACADIA’s plans to present clinical data, the progress and timing of ACADIA’s drug discovery and development programs, including clinical trials and the results therefrom, and the benefits to be derived from ACADIA’s drug candidates and preclinical programs, including pimavanserin and ACP-104. 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 discovery, development and commercialization, and collaborations with others, and the fact that past results of clinical trials may not be indicative of further 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, 2006 as well as other 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.
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, |
|||||||||||||||
| 2007 | 2006 | 2007 | 2006 | |||||||||||||
| Collaborative revenues |
$ | 1,957 | $ | 1,943 | $ | 5,972 | $ | 6,360 | ||||||||
| Operating expenses |
||||||||||||||||
| Research and development (includes stock-based compensation of $805, $550, $2,414 and $1,417, respectively) |
16,909 | 15,501 | 40,664 | 36,611 | ||||||||||||
| General and administrative (includes stock-based compensation of $441, $421, $1,188 and $1,141, respectively) |
2,941 | 2,962 | 9,257 | 8,813 | ||||||||||||
| Provision for loss from (settlement of) litigation |
— | (3,981 | ) | — | (3,560 | ) | ||||||||||
| Total operating expenses |
19,850 | 14,482 | 49,921 | 41,864 | ||||||||||||
| Loss from operations |
(17,893 | ) | (12,539 | ) | (43,949 | ) | (35,504 | ) | ||||||||
| Interest income (expense), net |
1,848 | 1,276 | 4,598 | 2,855 | ||||||||||||
| Loss before change in accounting principle |
(16,045 | ) | (11,263 | ) | (39,351 | ) | (32,649 | ) | ||||||||
| Cumulative effect of change in accounting principle |
— | — | — | 51 | ||||||||||||
| Net loss |
$ | (16,045 | ) | $ | (11,263 | ) | $ | (39,351 | ) | $ | (32,598 | ) | ||||
| Net loss per common share, basic and diluted |
||||||||||||||||
| Before change in accounting principle |
$ | (0.43 | ) | $ | (0.38 | ) | $ | (1.14 | ) | $ | (1.20 | ) | ||||
| Cumulative effect of change in accounting principle |
— | — | — | — | ||||||||||||
| Net loss per common share, basic and diluted |
$ | (0.43 | ) | $ | (0.38 | ) | $ | (1.14 | ) | $ | (1.20 | ) | ||||
| Weighted average common shares outstanding, basic and diluted |
36,946 | 29,732 | 34,619 | 27,277 | ||||||||||||
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited)
| September 30, 2007 |
December 31, 2006(1) | |||||
| Assets |
||||||
| Cash, cash equivalents, and investment securities |
$ | 140,962 | $ | 83,255 | ||
| Prepaid expenses, receivables and other current assets |
3,989 | 2,528 | ||||
| Total current assets |
144,951 | 85,783 | ||||
| Property and equipment, net |
3,095 | 3,505 | ||||
| Other assets |
300 | 256 | ||||
| Total assets |
$ | 148,346 | $ | 89,544 | ||
| Liabilities and Stockholders’ Equity |
||||||
| Current liabilities |
17,155 | 20,534 | ||||
| Long-term liabilities |
1,457 | 1,851 | ||||
| Stockholders’ equity |
129,734 | 67,159 | ||||
| Total liabilities and stockholders’ equity |
$ | 148,346 | $ | 89,544 | ||
| (1) | The condensed consolidated balance sheet at December 31, 2006 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. |