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