EX-99.1 2 b66372aiexv99w1.htm EX-99.1 PRESS RELEASE ISSUED BY ALKERMES, INC. ON AUGUST 2, 2007 exv99w1
 

Exhibit 99.1
Contacts:
James Frates
Chief Financial Officer
Alkermes, Inc.
(617) 494-0171
Rebecca Peterson
Vice President, Corporate
Communications
Alkermes, Inc.
(617) 583-6378
ALKERMES ANNOUNCES FIRST QUARTER FISCAL 2008 RESULTS
— Company Reports Record Quarterly Revenues, with 34% Increase in Total Revenues
Compared to First Quarter Fiscal 2007 —
Cambridge, MA, August 2, 2007 — Alkermes, Inc. (Nasdaq: ALKS) today announced financial results for its first quarter of fiscal 2008. Financial highlights for the quarter ended June 30, 2007 include:
  §   Fourth consecutive profitable quarter on a GAAP basis, with net income of $8.7 million.
 
  §   Record quarterly revenues of $68.9 million. Worldwide sales of RISPERDAL® CONSTA® by Janssen-Cilag (Janssen) were $278.7 million.
 
  §   Strong balance sheet, with cash and total investments of $330.9 million.
Key operating results for the first quarter of fiscal 2008 include the following:
  §   Net income was $8.7 million or a basic earnings per share of $0.09 and a diluted earnings per share of $0.08, including $5.7 million in share-based compensation expense, compared to a net loss of $0.7 million or a basic and diluted loss per share of $0.01, which included $8.3 million in share-based compensation expense, for the same period in 2006.

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  §   Pro forma net income was $14.3 million or a basic and diluted earnings per share of $0.14, compared to a net income of $6.8 million or a basic and diluted earnings per share of $0.07, for the same period in 2006.
Alkermes is providing pro forma results as a complement to GAAP results. The pro forma net income excludes certain noncash or nonrecurring items, and Alkermes’ management believes these pro forma measures help to indicate underlying trends in the company’s ongoing operations. The reconciliation between pro forma and reported diluted earnings or loss per share for the first quarters of fiscal 2008 and 2007 is provided in the following table:
                                 
            Share-Based   Net Change in   Reported GAAP
    Pro Forma   Compensation   Fair Value of   Diluted Earnings
    Diluted Earnings   Expense   Warrants   or Loss
Q1 FY 2008
  $ 0.14       ($0.06 )         $ 0.08  
Q1 FY 2007
  $ 0.07       ($0.08 )   $ 0.01     ($ 0.01 )
Note: Amounts may not sum due to rounding.
“Our financial results this quarter were strong, reflecting the continued success of RISPERDAL CONSTA in the marketplace and increased research and development revenues from our partnered programs,” stated James Frates, chief financial officer of Alkermes.
The following financial results are reported on a GAAP basis and include share-based compensation expense:
Revenues
  §   Total revenues for the quarter ended June 30, 2007 were $68.9 million, compared to $51.5 million for the same period in 2006.
 
  §   Total manufacturing revenues for the quarter ended June 30, 2007 were $31.5 million, consisting of $30.2 million for RISPERDAL CONSTA and $1.3 million for VIVITROL®, compared to $22.2 million for the same period in 2006, consisting of $19.1 million for RISPERDAL CONSTA and $3.1 million for VIVITROL.

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  §   Royalty revenues for the quarter ended June 30, 2007 were $7.0 million based on RISPERDAL CONSTA sales of $278.7 million, compared to $5.1 million based on RISPERDAL CONSTA sales of $205.2 million for the same period in 2006.
 
  §   Research and development (R&D) revenue under collaborative arrangements for the quarter ended June 30, 2007 was $23.4 million, compared to $14.5 million for the same period in 2006.
 
  §   Net collaborative profit for the quarter ended June 30, 2007 was $7.0 million, compared to $9.7 million for the same period in 2006.
Costs and Expenses
  §   Cost of goods manufactured for the quarter ended June 30, 2007 was $10.1 million, of which $9.0 million related to RISPERDAL CONSTA and $1.1 million related to VIVITROL, compared to $9.3 million for the same period in 2006, of which $6.5 million related to RISPERDAL CONSTA and $2.8 million related to VIVITROL.
 
  §   R&D expenses for the quarter ended June 30, 2007 were $32.6 million compared to $25.9 million for the same period in 2006.
 
  §   Selling, general and administrative (SG&A) expenses for the quarter ended June 30, 2007 were $15.4 million compared to $16.5 million for the same period in 2006.
 
  §   Interest income for the quarter ended June 30, 2007 was $4.4 million compared to $4.3 million for the same period in 2006. Interest expense for the quarter ended June 30, 2007 was $4.1 million compared to $5.5 million for the same period in 2006.
 
  §   Share-based compensation expense (included in the expenses above) for the quarter ended June 30, 2007 was $5.7 million, of which $0.6 million related to cost of goods manufactured, $1.8 million related to R&D expenses, and $3.3 million related to SG&A expenses. Share-based compensation expense for the quarter ended June 30, 2006 was $8.3 million, of which $0.3 million related to cost of goods manufactured, $2.8 million related to R&D expenses, and $5.2 million related to SG&A expenses.

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  §   Income tax expense for the quarter ended June 30, 2007 was $2.4 million, compared to $0.2 million for the same period in 2006.
At June 30, 2007, Alkermes had cash and total investments of $330.9 million, compared to $356.7 million at March 31, 2007.
Recent Highlights
  §   Positive results from phase 1/2 study of ALKS 29: Alkermes announced positive preliminary results from a phase 1/2 clinical trial of ALKS 29 in alcohol dependent patients. In the study, ALKS 29 was generally well tolerated and led to a statistically significant improvement compared to placebo in terms of percent of days abstinent, percent of heavy drinking days and average number of drinks per day. ALKS 29 is a combination of two agents with distinct pharmacologic properties designed to provide advantages over current oral medications for the treatment of alcohol dependence.
 
  §   Initiation of a phase 1 study of AIR® PTH: Alkermes and its partner Eli Lilly and Company (Lilly) initiated a phase 1 clinical study of AIR® parathyroid hormone (AIR PTH [1-34]) in healthy volunteers. The phase 1 study will assess the safety, tolerability and pharmacokinetics of AIR PTH in healthy postmenopausal women. Alkermes and Lilly expect to report top-line results from the study by early 2008.
Conference Call
Alkermes will host a conference call at 4:30 p.m. EDT on Thursday, August 2, 2007 to discuss these financial results and provide an update on the company. The conference call may be accessed by dialing 1-866-835-8825 for domestic callers and 1-703-639-1407 for international callers. The conference call ID number is 1119053. In addition, a replay of the conference call will be available from 7:30 p.m. EDT on Thursday, August 2, 2007 through 5:00 p.m. EDT on Tuesday, August 7, 2007, and may be accessed by visiting Alkermes’ website or by dialing 1-888-266-2081 for domestic callers and 1-703-925-2533 for international callers. The replay access code is 1119053. Alkermes is also providing a podcast MP3 file available for download on the Alkermes website, which

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will be available shortly following the conference call and will be available until Tuesday, August 7, 2007.
About Alkermes
Alkermes, Inc. is a biotechnology company that develops innovative medicines designed to yield better therapeutic outcomes and improve the lives of patients with serious disease. Alkermes currently has two commercial products: RISPERDAL® CONSTA® [(risperidone) long-acting injection], the first and only long-acting atypical antipsychotic medication approved for use in schizophrenia, and marketed worldwide by Janssen-Cilag (Janssen), a wholly owned division of Johnson & Johnson; and VIVITROL® (naltrexone for extended-release injectable suspension) the first and only once-monthly injectable medication approved for the treatment of alcohol dependence and marketed in the U.S. primarily by Cephalon, Inc. Alkermes’ pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases such as central nervous system disorders, addiction and diabetes. Alkermes’ headquarters are in Cambridge, Massachusetts, and it operates research and manufacturing facilities in Massachusetts and Ohio.
Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to: statements concerning future business and operating results and profitability; the therapeutic value of the company’s product candidates to patients; plans for clinical trials; expectations concerning the commercialization of RISPERDAL CONSTA and VIVITROL; the successful supply of RISPERDAL CONSTA and VIVITROL; and the successful continuation of development activities for proprietary and partnered programs, including ALKS 29 and AIR PTH. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and the company’s business is subject to significant risk and uncertainties and there can be no assurance that its actual results will not differ materially from its expectations. These risks and uncertainties include, among others: whether the company can continue to

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successfully manufacture RISPERDAL CONSTA and VIVITROL at a commercial scale or economically or in sufficient quantities to supply the market; whether RISPERDAL CONSTA will continue to be commercialized successfully by its partner Janssen and whether VIVITROL will be commercialized successfully by Alkermes and its partner Cephalon; whether ALKS 29 will provide advantages over existing oral medications; whether Alkermes and Lilly will report top-line results from the study of AIR PTH by early 2008; whether advancement of the company’s proprietary and partnered product candidates, including ALKS 29 and AIR PTH, will be delayed due to actions or decisions by its partners with regard to development and regulatory strategy, timing and funding which are out of its control, and the outcome of clinical and preclinical work the company is pursuing, both on its own and with partners; decisions by the FDA or foreign regulatory authorities regarding the company’s product candidates; potential changes in cost, scope and duration of clinical trials; and whether RISPERDAL CONSTA, VIVITROL and the company’s product candidates, in commercial use, have unintended side effects, adverse reactions or incidents of misuse that could cause the FDA or other health authorities to require post approval studies or require removal of its products from the market. For further information with respect to factors that could cause the company’s actual results to differ materially from expectations, reference is made to the reports the company filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and the company disclaims any intention or responsibility for updating predictions or financial expectations contained in this release.
AIR® is a registered trademark of Alkermes, Inc.; VIVITROL® is a registered trademark of Cephalon, Inc.; RISPERDAL® CONSTA® is a registered trademark of Janssen-Cilag.
Tables to Follow

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Alkermes, Inc. and Subsidiaries
Selected Financial Information (Unaudited)
                 
    Three Months   Three Months
    Ended   Ended
Condensed Consolidated Statements of Operations   June 30,   June 30,
(In thousands, except per share data)   2007   2006
 
Revenues:
               
Manufacturing revenues
  $ 31,517     $ 22,193  
Royalty revenues
    6,982       5,139  
Research and development revenue under collaborative arrangements
    23,450       14,464  
Net collaborative profit
    6,989       9,742  
 
Total Revenues
    68,938       51,538  
 
Expenses:
               
Cost of goods manufactured
    10,145       9,338  
Research and development
    32,619       25,863  
Selling, general and administrative
    15,400       16,530  
 
Total Expenses
    58,164       51,731  
 
Operating Income (Loss)
    10,774       (193 )
 
Other Income (Expense):
               
Interest income
    4,402       4,335  
Interest expense
    (4,073 )     (5,473 )
Other income (expense), net
    26       787  
 
Total Other Income (Expense)
    355       (351 )
 
Income (Loss) before Income Taxes
    11,129       (544 )
 
Income taxes
    2,382       171  
 
Net Income (Loss)
  $ 8,747     $ (715 )
 
 
               
Earnings (Loss) per Common Share:
               
Basic
  $ 0.09     $ (0.01 )
 
Diluted
  $ 0.08     $ (0.01 )
 
 
               
Weighted Average Number of Common Shares Outstanding (GAAP and Pro Forma):
               
Basic
    101,324       93,784  
 
Diluted
    104,191       99,754  
 
 
               
Pro Forma Reconciliation:
               
Net Income — GAAP
  $ 8,747     $ (715 )
Share-based compensation expense
    5,747       8,347  
Net increase in the fair value of warrants
    (196 )     (846 )
 
Net Income — Pro Forma
  $ 14,298     $ 6,786  
 
 
               
Pro Forma Earnings per Common Share:
               
Basic
  $ 0.14     $ 0.07  
 
Diluted
  $ 0.14     $ 0.07  
 
 
Condensed Consolidated Balance Sheets   June 30,   March 31,
(In thousands)   2007   2007
 
Cash, cash equivalents and total investments
  $ 330,896     $ 356,726  
Receivables
    66,782       56,049  
Prepaid expenses and other current assets
    9,063       7,054  
Inventory
    20,218       18,190  
Property, plant and equipment, net
    130,263       123,595  
Other assets
    7,036       7,007  
 
Total Assets
  $ 564,258     $ 568,621  
 
Unearned milestone revenue — current portion
  $ 6,333     $ 11,450  
Other current liabilities
    31,177       50,610  
Non-recourse RISPERDAL CONSTA secured 7% notes
    157,694       156,851  
Unearned milestone revenue — long-term portion
    115,738       117,300  
Deferred revenue — long-term portion
    23,747       22,153  
Other long-term liabilities
    6,650       6,796  
Total shareholders’ equity
    222,919       203,461  
 
Total Liabilities and Shareholders’ Equity
  $ 564,258     $ 568,621  
 
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in the company’s Annual Report on Form 10-K for the year ended March 31, 2007, and the company’s report on Form 10-Q for the three months ended June 30, 2007, which the company intends to file in August 2007.

 


 

VIVITROL® Selected Financial Information
                 
    Three Months        
    Ended        
    June 30,     Cumulative  
(Unaudited, in thousands)   2007     Collaboration  
VIVITROL Income Statement
               
Alkermes’ expenses
  $ 5,680     $ 56,901  
Cephalon’s net losses
    19,083       87,207  
 
               
 
           
VIVITROL net losses
  $ 24,763     $ 144,108  
 
           
 
               
Flow of funds
               
Alkermes paid Cephalon: net losses up to the $124.6M net loss cap (1)
  $ (5,223 )   $ (73,347 )
Cephalon paid Alkermes: Alkermes’ expenses in excess of the net loss cap
    5,647       5,647  
 
               
 
           
Net flow of funds from (to) Cephalon (3)
  $ 424     $ (67,700 )
 
           
 
               
Net Collaborative Profit
               
Milestone revenue recognized to offset losses up to the net loss cap (1)
  $ 5,256     $ 144,493  
Milestone revenue recognized with respect to the license (2)
    1,309       6,396  
Net flow of funds from (to) Cephalon (3)
    424       (67,700 )
 
               
 
           
Net collaborative profit
  $ 6,989     $ 83,189  
 
           
 
Notes 
 
(1)   Expenses incurred on behalf of the collaboration by Alkermes, Inc. (“Alkermes”) and net losses incurred on behalf of the collaboration by Cephalon, Inc. (“Cephalon”) contribute to the cumulative net product losses incurred on VIVITROL.
 
    Alkermes was responsible for the first $124.6 million of these cumulative net product losses (the “net loss cap”).
 
    Alkermes recognized milestone revenue to offset the net product losses incurred up to the net loss cap.
 
    The collaboration reached the net loss cap in April 2007, at which point the recognition of milestone revenue related to this accounting unit stopped.
 
    In addition, in prior periods, Alkermes recognized $19.9 million of milestone revenue to offset expenses it incurred for which it was solely responsible, related to the successful FDA approval of VIVITROL and the successful completion of the first VIVITROL manufacturing line. These $19.9 million of expenses did not contribute to the cumulative net product losses.
 
(2)   Milestone revenue related to the license commenced upon approval of VIVITROL, by the FDA, on April 13, 2006 and is being recognized on a straight line basis over 10 years, at the rate of approximately $1.3 million per quarter.
 
(3)   Alkermes was responsible for net losses up to the net loss cap and reimbursed Cephalon for their net losses during this period. Once the net loss cap was reached in April 2007, Cephalon started to reimburse Alkermes for its VIVITROL expenses. This will continue through December 31, 2007, after which the two companies will share any net profits or losses.
 
 
    Through June 30, 2007, Alkermes has recognized $152.5 million of milestone revenue out of the $274.6 million received from Cephalon. In addition to (1) and (2) above, this recognition includes $1.6 million of milestone revenue related to a 10% mark-up on manufacturing revenue, which is reported by Alkermes within manufacturing revenues in the unaudited condensed consolidated statement of operations.