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Acusphere, Inc. Reports Q4 2008 Recent Business Highlights, Business Priorities and Financial Results
Tuesday, March 31, 2009 4:19 PM


Acusphere, Inc. (ACUS:PK) today reported financial results for the fourth quarter and year ended December 31, 2008, and commented on its business and progress to date. The Company continues to discuss its New Drug Application (NDA) with the U.S. Food & Drug Administration (FDA) for its lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension following the receipt of FDA’s complete response letter in late February. Imagify is a Perfusion Stress Echo imaging agent targeted for use in detecting coronary artery disease.

Recent Business Highlights

  • Signed an agreement to terminate and transition the Company’s Collaboration, License and Supply Agreement for Imagify with Nycomed Danmark ApS thereby regaining the global rights to Imagify
  • Completed a successful Pre-Approval Inspection (PAI) by FDA
  • Announced a planned reduction in force of 40 people, or about two-thirds of the Company’s employees by April 2009
  • Deregistered the Company’s shares and suspended the Company’s SEC reporting obligations to reduce cash costs and enable management to focus more of its efforts on operating the business and enhancing shareholder value
  • Signed an agreement to terminate the lease of the Company’s current headquarters in Watertown, Massachusetts and relocate all Company personnel to its facility in Tewksbury, Massachusetts
  • Renegotiated payment terms under certain intellectual property agreements with payments totaling approximately $6.7 million due in 2009 reduced to $350,000 immediately, with another $350,000 payable upon a financing of the Company, and the remainder due in 2013

Sherri C. Oberg, President and CEO of Acusphere, said, “We have made progress in reducing expenses while we continue our discussions with FDA. While we were disappointed by the results of the FDA Advisory Committee meeting, we are encouraged by the FDA’s willingness to engage in further discussions which we are hopeful will result in a clearly defined path forward for Imagify.”

Business Priorities

Acusphere’s key current priorities are:

  • Working with FDA to determine the most appropriate path forward for Imagify
  • Continuing potential partnership discussions for Imagify and other drug delivery technologies with a wide range of parties
  • Continuing our efforts to reduce fixed costs and overall cash burn

The Company previously announced that it had received a complete response from the FDA for Imagify. The response was largely consistent with the feedback received at the Advisory Committee meeting on December 10, 2008, and discussions that continued with FDA in January 2009. In general, their response suggested that additional clinical work would be required to support the original broad claim. The Company was also invited by FDA to schedule a meeting to discuss alternatives for moving forward.

The Company announced today that it has signed an agreement to terminate and transition its Collaboration, License and Supply Agreement dated as of July 6, 2004, as subsequently amended, with Nycomed Danmark ApS. Under the Termination and Transition Agreement (the “Agreement”), Acusphere reacquires the rights previously granted to Nycomed to develop, promote, market and distribute ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension in the European Union, Turkey, Russia and the other members of the Commonwealth of Independent States. Imagify is designed for the detection of coronary artery disease, the leading cause of death in the United States. Both parties have agreed to an orderly transition of all records and other documents related to regulatory filings and the product from Nycomed to Acusphere. Each party to the Agreement shall incur their own expenses and there shall be no further payments to either party.

Ms. Oberg added, "We have been very pleased with our long-standing and beneficial arrangement with Nycomed. We also recognize that priorities change over time and wish to thank Nycomed for the great progress made in compiling the MAA for filing in Europe which we or another partner will move forward on as we now have the global rights to Imagify.”

Financial Results

The Company's financial results for the quarter and year ended December 31, 2008, are summarized in the accompanying table.

The Company recognized $0.8 million in collaboration revenue during the fourth quarter of 2008. These revenues were recognized in connection with its agreement with Nycomed for European marketing rights for the Company's lead product candidate, Imagify, and for the collaboration agreement associated with the licensing of its HDDS technology for oncology purposes to Cephalon in the first quarter of 2008. As of December 31, 2008, the Company had $17.7 million in deferred revenue.

Operating expenses for the fourth quarter of 2008 were $18.5 million, versus $13.2 million in the prior year period. In the fourth quarter of 2008, the company recorded a non-cash $9.2 million impairment charge against fixed assets. Operating expenses, before the impairment charge, were $9.4 million versus $13.2 million in the prior year. The decrease primarily reflects reduced expenses for salaries and contract services and lower research and development costs. Operating expenses in the fourth quarter of 2008 and 2007 include non-cash expenses of $2.7 million and $3.1 million, respectively, for depreciation, amortization and stock options.

The net loss after dividends for the fourth quarter of 2008 was $33.2 million, or $0.67 per common share, versus a net loss of $13.1 million, or $0.27 per common share, in the prior year period. In the fourth quarter of 2008, in addition to the aforementioned impairment charge of $9.2 million, the company recognized a one-time non cash interest charge of $14.7 million as a result of the beneficial conversion feature related to the Cephalon note.

As of December 31, 2008, the Company's balance sheet included approximately $23.1 million in total assets, comprised primarily of $16.5 million in cash and short-term investments and $4.1 million in property and equipment, net of accumulated depreciation. As of March 31, our unaudited cash balance is $5.7 million.

Total annualized cash savings from the previously announced reductions in staff are estimated to be approximately $3.9 million. The Company estimates it will take a one-time charge in the first quarter of 2009 of approximately $0.3 million associated with these reductions. Total annualized cash savings from the termination of the Watertown headquarters lease are estimated to be approximately $3.6 million with total savings, net of the one-time payment and deposit forfeiture, of an estimated $10.6 million through 2012, the original term of the lease. The Company expects to save approximately $800,000 in 2009 as a result of filing the Form 15 to deregister its shares. These actions, in combination with the previously announced deferral of intellectual property payments, are expected to extend the Company’s cash into the third quarter 2009 and provide additional time to explore strategic partnerships and financing alternatives as we continue to interact with the FDA.

Acusphere also noted today that its financial statements which will be posted on its web site at www.acusphere.com for the fiscal year ended December 31, 2008, contain a going concern qualification to the audit opinion from its independent accounting firm, Deloitte & Touche LLP. The going concern qualification is based upon the Company’s current financial resources. The Company will require significant additional monies to fund operations through and beyond the third quarter of 2009.

About Acusphere, Inc.

Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site (www.acusphere.com).

Forward-looking Statements

The above press release contains forward-looking statements, including statements regarding, the NDA submission for Imagify and likelihood of regulatory approval and the commercial opportunity for Imagify. There can be no assurance that Imagify will be approved for the indication the Company is seeking, or at all. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding regulatory evaluation of the Company's statistical analysis plan and clinical trial results and uncertainties regarding the potential effects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company's commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. The Company notes that effective as of March 3, 2009, pursuant to a Form 15 filing made with the SEC, it is not currently required to file periodic reports with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.

ACUSPHERE, INC.
FINANCIAL HIGHLIGHTS
— In Thousands (except per share data) —

CONDENSED CONSOLIDATED OPERATING RESULTS

 
(Unaudited)
Three Months Ended
Twelve Months Ended
December 31,
2008
December 31,
2007
December 31,
2008
December 31,
2007
Revenue $ 824 $ 667 $ 2,684 $ 2,667
Operating expenses:
Research and development 7,241 10,604 34,452 43,175
General and administrative 2,109 2,550 10,704 12,219
Impairment 9,161 9,161
Total operating expenses 18,511 13,154 54,317 55,394
Interest and other income/(expense), net (15,219 ) (62) (15,977 ) (886)
Change in valuation of derivative – income/(expense) (9 ) (12) (124 ) (117)
Net loss $ (32,915 ) $ (12,562 ) $ (67,734 ) $ (53,730 )
Dividends on preferred stock (241 ) (561 ) (1,687 ) (2,275 )
Net loss available to common stockholders $ (33,156 ) $ (13,123 ) $ (69,421 ) $ (56,005 )
 
Net loss per common share — basic and diluted $ (0.67 ) $ (0.27 ) $ (1.46 ) $ (1.31 )
Weighted-average shares outstanding — basic and diluted 49,275 46,274 47,412 42,627

CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION

   
December 31,
2008
December 31,
2007
 
Cash and short-term investments $ 16,450 $ 26,102
Current assets 17,703 27,367
Total assets 23,113 52,020
Current portion of deferred revenue 3,295 4,667
Other current liabilities 10,633 14,159
Long-term portion of deferred revenue 14,438
Long-term obligations, net of current portion 23,250 8,206
Stockholders’ (deficit)/equity (28,503) 23,740

Acusphere, Inc.
Lawrence A. Gyenes, 617-925-3444
IR@acusphere.com

(Source: Business Wire )


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