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) May 14, 2009
A.P. Pharma, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-33221
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94-2875566
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(State
or other jurisdiction
of
incorporation)
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(Commission
File Number)
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(I.R.S.
Employer
Identification
No.)
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123
Saginaw Drive
Redwood
City CA
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94063
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code (650) 366-2626
N/A
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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INFORMATION
TO BE INCLUDED IN THE REPORT
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ITEM 2.02
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Results
of Operations and Financial
Condition
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The
Company issued a press release dated May 14, 2009, announcing its
financial results for the quarter ended March 31, 2009. The full text
of the press release is set forth in Exhibit 99.1 attached
hereto. The press release should be read in conjunction with the note
regarding forward-looking statements, which is included in the text of the press
release.
The
information in this Item 2.02 and attached as Exhibit 99.1 to this Report will
not be treated as “filed” for the purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to
the liabilities of that section. This information will not be
incorporated by reference into any filing under the Securities Act of 1933, as
amended, or into another filing under the Exchange Act, unless that filing
expressly incorporates this information by reference.
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ITEM 9.01
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Financial
Statements and Exhibits.
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(d)
Exhibits
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99.1
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Press
Release of A. P. Pharma, Inc., dated May 14,
2009
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SIGNATURE
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.
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A.P.
Pharma, Inc.
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Date:
May 14, 2009
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/s/
Ronald J. Prentki
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Ronald
J. Prentki
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President,
Chief Executive Officer and
Director
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Exhibit
99.1
New
Release
A.P.
Pharma Reports First Quarter 2009 Financial Results
REDWOOD CITY, Calif. – May 14,
2009 – A.P. Pharma, Inc. (Nasdaq: APPA), a specialty pharmaceutical company,
today reported financial results for its first quarter ended March 31,
2009.
Operational
Highlights
A.P.
Pharma continued to make significant progress towards filing a New Drug
Application (NDA) for its lead program, APF530. The Company expects to file the
NDA with the U.S. Food and Drug Administration (FDA) during the second quarter
of 2009. APF530 is being developed for the prevention of chemotherapy-induced
nausea and vomiting (CINV) and is a long-acting formulation of granisetron that
utilizes the Company’s proprietary Biochronomer™ drug delivery
system.
During
the first quarter of 2009, the Company announced the appointment of John B.
Whelan as Vice President, Finance and Chief Financial Officer and the
appointment of Kevin C. Tang to the Board of Directors.
Results
of Operations
A.P.
Pharma’s net loss for the first quarter of 2009 was $3.0 million, or $0.10 per
share, compared with a $6.8 million net loss, or $0.22 per share, for the first
quarter of 2008. The Company’s decreased net loss for the first quarter of 2009,
as compared to the same period in 2008, was principally due to decreased
research and development costs, resulting primarily from decreased expenditures
on APF530, the Company’s lead program. Expenses associated with APF530 decreased
primarily as a result of the completion of the Company’s Phase 3 trials for
APF530 in the third quarter of 2008. Additionally, expenses decreased in the
first quarter of 2009 as compared to the same period of 2008, as a result of
placing A.P. Pharma’s other products “on hold” to focus its financial and
managerial resources on APF530.
Cash,
cash equivalents and marketable securities as of March 31, 2009 were $7.5
million, compared with $10.5 million at December 31, 2008. As previously
disclosed, the Company’s auditors had expressed a “going concern” opinion in the
2008 audited financials. The Company believes its cash, cash equivalents and
marketable securities as of March 31, 2009 will enable the Company to fund its
operations into the fourth quarter of 2009, based on anticipated spending levels
and certain expected positive cash inflows.
The
Company intends to seek additional capital through a corporate partnership or
other alternatives and to pursue further reductions in expenses to ensure its
ongoing financial viability. Based on multiple factors, including market
conditions, the Company may not be able to obtain adequate
financing.
Other
Developments
As
previously disclosed, the Company received notice from the Listing
Qualifications Department of the Nasdaq Stock Market (Nasdaq) that it is not in
compliance with the listing requirements for the Nasdaq Global Market. The
Company has submitted a plan to Nasdaq addressing the listing
requirements.
About APF530
A.P.
Pharma's lead product candidate, APF530, is being developed for the prevention
of both acute and delayed onset chemotherapy-induced nausea and vomiting
(CINV). APF530 contains the 5-HT3 antagonist, granisetron, formulated
in our proprietary Biochronomer™ drug delivery system, which allows therapeutic
drug levels to be maintained for five days with a single subcutaneous
injection. Injections and oral tablets containing granisetron are
approved for the prevention of acute onset CINV, but not for delayed onset
CINV. Granisetron was selected because it is widely prescribed by
physicians based on a well-established record of safety and
efficacy. In September 2008, A.P. Pharma reported positive top-line
results from its pivotal Phase 3 study. In this multi-center,
randomized trial that enrolled 1,395 cancer patients, APF530 was shown to be
equally as effective as (statistically non-inferior to) palonosetron (Aloxi®) in
the prevention of both acute onset and delayed onset
CINV. Palonosetron is the only injectable 5-HT3
antagonist FDA-approved for the prevention of delayed onset
CINV. APF530 was also generally well-tolerated in this
study.
About A.P. Pharma
A.P.
Pharma is a specialty pharmaceutical company developing products using our
proprietary Biochronomer™ polymer-based drug delivery technology. Our primary
focus is on our lead product candidate, APF530, for the prevention of CINV. The
Company has additional clinical and preclinical stage programs in the area of
pain management, all of which utilize its bioerodible injectable and implantable
delivery systems. For further information, visit the Company's web site at www.appharma.com.
(Financial
tables follow)
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A.P.
PHARMA, INC.
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Statement
of Operations Highlights
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(in
thousands, except per share data)
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(Unaudited)
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Three
Months Ended March 31
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2009
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2008
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Contract
revenue
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$ | 8 | $ | 133 | ||||
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Operating
expenses:
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Research
and development
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2,050 | 6,140 | ||||||
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General
and administrative
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927 | 1,080 | ||||||
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Total
operating expenses
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2,977 | 7,220 | ||||||
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Operating
loss
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(2,969 | ) | (7,087 | ) | ||||
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Other
income, net
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9 | 283 | ||||||
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Loss
from continuing operations
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(2,960 | ) | (6,804 | ) | ||||
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Loss
from discontinued operations
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- | (40 | ) | |||||
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Loss
before income taxes
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(2,960 | ) | (6,844 | ) | ||||
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Provision
for income taxes
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- | - | ||||||
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Net
loss
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$ | (2,960 | ) | $ | (6,844 | ) | ||
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Basic
and diluted net loss per common share:
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Loss
from continuing operations
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$ | (0.10 | ) | $ | (0.22 | ) | ||
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Net
loss
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$ | (0.10 | ) | $ | (0.22 | ) | ||
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Shares
used to compute basic and diluted loss per
share
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30,868 | 30,773 | ||||||
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AP
PHARMA, INC.
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Balance
Sheet Highlights
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(in
thousands)
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March
31, 2009
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December
31, 2008(1)
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(Unaudited)
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Assets
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Cash,
cash equivalents and marketable securities
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$ | 7,484 | $ | 10,538 | ||||
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Accounts
receivable, net
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8 | 32 | ||||||
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Other
current assets
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254 | 246 | ||||||
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Total
current assets
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7,746 | 10,816 | ||||||
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Property
and equipment, net
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788 | 881 | ||||||
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Other
non-current assets
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103 | 103 | ||||||
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Total
assets
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$ | 8,637 | $ | 11,800 | ||||
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Liabilities
and stockholders' equity
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Total
liabilities
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$ | 3,764 | $ | 4,202 | ||||
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Stockholders'
equity
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4,873 | 7,598 | ||||||
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Total
liabilities and stockholders' equity
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$ | 8,637 | $ | 11,800 | ||||
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(1) Derived
from the Company's audited financial statements for the year ended
December 31, 2008 included in included in the Company's 2008 Annual
Report on Form 10-K filed with the Securities and Exchange
Commission.
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Forward-looking
Statements
This news
release contains "forward-looking statements" as defined by the Private
Securities Litigation Reform Act of 1995. These forward-looking statements
involve risks and uncertainties, including uncertainties associated with timely
development, approval, launch and acceptance of new products, satisfactory
completion of clinical studies, establishment of new corporate alliances,
progress in research and development programs and other risks and uncertainties
identified in the Company's filings with the Securities and Exchange Commission.
We caution investors that forward-looking statements reflect our analysis only
on their stated date. We do not intend to update them except as required by
law.
Contacts
Corporate
Contact:
A.P.
Pharma, Inc.
John B.
Whelan, Vice President, Finance and Chief Financial Officer
650-366-2626
and
Investor
and Media Relations:
Corporate
Communications Alliance, LLC
Edie
DeVine, President
209-814-9564
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