Form 8-K

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): August 10, 2005

 


 

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 (see General Instruction A.2. below):

 

¨ 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 August 10, 2005, ACADIA Pharmaceuticals Inc. issued a press release announcing its financial results for the three and six months ended June 30, 2005. 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 herein has been furnished under Item 12 of this Report 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 it 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

 

(c) The following exhibit is furnished herewith:

 

99.1   Press release dated August 10, 2005

 

 

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.
   

By:

 

/s/ Thomas H. Aasen


Date: August 10, 2005

      Thomas H. Aasen
        Vice President, Chief Financial Officer, Treasurer, and Secretary

 

 

3.


INDEX TO EXHIBITS

 

Exhibit

Number


 

Description


99.1   Press release dated August 10, 2005

 

 

4.

Press Release

Exhibit 99.1

 

Contacts:

ACADIA Pharmaceuticals Inc.

Lisa Barthelemy, Director, Investor Relations

Thomas H. Aasen, Vice President and Chief Financial Officer

+1 858-558-2871

 

ACADIA PHARMACEUTICALS REPORTS SECOND QUARTER

2005 FINANCIAL RESULTS

 

SAN DIEGO, CA August 10, 2005 – 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 second quarter and six months ended June 30, 2005.

 

ACADIA reported a net loss of $6.0 million for the second quarter of 2005, compared to a net loss of $5.9 million for the second quarter of 2004. For the six months ended June 30, 2005, ACADIA reported a net loss of $11.6 million, compared to a net loss of $12.4 million for the comparable period of 2004.

 

At June 30, 2005, ACADIA’s cash, cash equivalents, and investment securities totaled $69.0 million, compared to $35.9 million at December 31, 2004. The increase in cash was primarily due to net proceeds from sales of equity securities, including $34 million raised in a private placement in April 2005 and $10 million received from the sale of common stock to Sepracor Inc. in January 2005 in connection with a new collaboration agreement, partially offset by cash used to fund ACADIA’s operations in 2005.

 

“The second quarter of 2005 was an important period for ACADIA, highlighted by the completion of our financing and considerable progress in our lead clinical programs,” said Uli Hacksell, Ph.D., ACADIA’s Chief Executive Officer. “We believe that we are now well positioned to deliver a series of clinical milestones throughout the remainder of 2005 and into 2006 as we continue to advance our pipeline of innovative drugs to treat central nervous system disorders and other areas of unmet medical need.”


Collaborative revenues increased to $2.5 million for the second quarter of 2005, compared to $1.0 million for the second quarter of 2004. This increase was primarily due to $923,000 in revenues recognized under ACADIA’s collaboration with Sepracor, which commenced in January 2005, and $500,000 in revenues earned pursuant to ACADIA’s 2004 development agreement with the Stanley Medical Research Institute. Revenues from ACADIA’s collaborations with Allergan totaled $1.1 million and $1.0 million for the three months ended June 30, 2005 and 2004, respectively.

 

Research and development expenses increased to $6.6 million for the second quarter of 2005 from $5.4 million for the second quarter of 2004. The increase in expenses largely reflected increased clinical development costs associated with ACADIA’s proprietary Phase II programs and costs associated with expansion of ACADIA’s research and development organization.

 

General and administrative expenses increased to $2.1 million for the second quarter of 2005 from $880,000 for the comparable quarter of 2004. The increase in general and administrative expenses was due primarily to increased professional fees, insurance costs and personnel expenses associated with ACADIA operating as a publicly traded company.

 

Non-cash, stock-based compensation expenses decreased to $395,000 for the second quarter of 2005 from $615,000 for the second quarter of 2004.

 

Second Quarter 2005 Highlights

 

    ACADIA significantly strengthened its balance sheet raising net proceeds of $34 million from the sale of shares of common stock and warrants to purchase common stock in a private placement.

 

    ACADIA reported encouraging results from a planned interim trend analysis of its ongoing multi-center Phase II clinical trial of ACP-103 for treatment-induced psychosis in patients with Parkinson’s disease. The interim trend analysis, which was based on data from the first 30 patients to complete the study, showed a greater reduction in psychotic symptoms in the ACP-103 treatment group relative to the placebo group. ACADIA anticipates reporting results from the complete trial encompassing 60 patients in late-2005 or early-2006.


    ACADIA continued to advance its proprietary Phase II schizophrenia programs: ACP-103 as an adjunctive therapy for schizophrenia and ACP-104 as a stand-alone treatment for schizophrenia. ACADIA anticipates reporting initial Phase II results in each of these programs during 2005.

 

    ACADIA enhanced its drug discovery and development capabilities through the consolidation of its chemistry operations in a new custom-built chemistry research and development facility located in Malmo, Sweden.

 

Conference Call and Webcast Information

 

Uli Hacksell, Ph.D., Chief Executive Officer, and Thomas H. Aasen, Vice President and Chief Financial Officer, will review second quarter results and the Company’s development programs via conference call and webcast later today at 4:30 p.m. Eastern Time. The conference call may be accessed by dialing 866-700-7477 for participants from the U.S. or Canada and 617-213-8840 for international callers (reference participant passcode 70881736). 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 August 24, 2005. A telephone replay of the conference call may be accessed through August 24, 2005 by dialing 888-286-8010 for callers in the U.S. or Canada and 617-801-6888 for international callers (reference passcode 28397094).

 

About ACADIA Pharmaceuticals

 

ACADIA Pharmaceuticals 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 four drug programs in clinical development as well as a portfolio of preclinical and discovery assets directed at large unmet medical needs, including schizophrenia, Parkinson’s disease, neuropathic pain, and glaucoma. Using its proprietary drug discovery platform, ACADIA has discovered all of the drug candidates in its product pipeline. ACADIA’s corporate headquarters is located in San Diego, California and it maintains research and development operations in both San Diego and Scandinavia.


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 progress and timing of our drug development programs and related trials and the safety and efficacy of our drug candidates. 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 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, 2004 filed with the United States Securities and Exchange Commission 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
June 30,


    Six Months Ended
June 30,


 
     2005

    2004

    2005

    2004

 

Collaborative revenues

   $ 2,514     $ 1,016     $ 4,840     $ 1,940  

Operating expenses

                                

Research and development

     6,563       5,407       12,679       11,156  

General and administrative

     2,050       880       3,689       1,791  

Stock-based compensation

     395       614       766       1,310  
    


 


 


 


Total operating expenses

     9,008       6,901       17,134       14,257  
    


 


 


 


Loss from operations

     (6,494 )     (5,885 )     (12,294 )     (12,317 )

Interest income (expense)

     457       (1 )     668       (51 )
    


 


 


 


Net loss

     (6,037 )     (5,886 )     (11,626 )     (12,368 )

Participation of preferred stock

     —         (3,110 )     —         (8,587 )
    


 


 


 


Net loss available to common stockholders

     (6,037 )     (2,776 )     (11,626 )     (3,781 )
    


 


 


 


Net loss per common share, basic and diluted

   $ (0.26 )   $ (0.42 )   $ (0.56 )   $ (0.94 )
    


 


 


 


Weighted average common shares outstanding, basic and diluted

     23,274       6,552       20,589       4,024  
    


 


 


 


Net loss available to participating preferred stockholders

   $ —       $ (3,110 )   $ —       $ (8,587 )
    


 


 


 


Net loss per participating preferred share, basic and diluted

   $ —       $ (0.31 )   $ —       $ (0.87 )
    


 


 


 


Weighted average participating preferred shares outstanding, basic and diluted

     —         9,901       —         9,901  
    


 


 


 


 

ACADIA’s preferred stock was reclassified or converted into 9,900,913 shares of common stock upon the closing of its initial public offering on June 2, 2004.


ACADIA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(Unaudited)

 

    

June 30,

2005


  

December 31,

2004(1)


Assets

             

Cash, cash equivalents and investment securities, available-for-sale

   $ 68,961    $ 35,927

Prepaid expenses and other current assets

     2,437      1,891
    

  

Total current assets

     71,398      37,818

Property and equipment, net

     2,233      2,547
    

  

Total assets

   $ 73,631    $ 40,365
    

  

Liabilities and Stockholders’ Equity

             

Current liabilities

     11,078      8,641
    

  

Long-term liabilities

     1,403      1,044
    

  

Stockholders’ equity

     61,150      30,680
    

  

Total liabilities and stockholders’ equity

   $ 73,631    $ 40,365
    

  

 

(1) The condensed consolidated balance sheet at December 31, 2004 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.