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 4, 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 94063
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(Address
of principal executive offices)
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(650) 366-2626
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 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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Item 2.02
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Results
of Operations and Financial
Condition
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On August
4, 2009, the Company issued a press release announcing its financial results for
the quarter ended June 30, 2009. A copy of this press release is
furnished as Exhibit 99.1 to this Current Report on Form 8-K (the
“Report”). 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 of this Report and the information contained in
Exhibit 99.1 to this Report 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 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, whether made before or after the date of this Report, regardless of any
general incorporation language in the filing, 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
99.1 Press
Release of A.P. Pharma, Inc. dated August 4, 2009
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.
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A.P.
Pharma, Inc.
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Date:
August 5, 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
For
Immediate Release
A.P.
Pharma Reports Second Quarter 2009 Financial Results
REDWOOD
CITY, Calif. – August 4, 2009 – A.P. Pharma, Inc. (Nasdaq: APPA), a
specialty pharmaceutical company, today reported financial results for its
second quarter ended June 30, 2009.
Results
of Operations
A.P.
Pharma’s net loss for the second quarter was $3.9 million, or $0.13 per share,
compared with a $6.1 million net loss, or $0.20 per share, for the second
quarter of 2008. The decreased net loss for the second quarter of 2009, as
compared to the same period in 2008, was primarily due to lower research and
development expenses related to APF530, largely reflecting the completion of its
Phase 3 trial, net of the U.S. Food and Drug Administration’s (FDA) filing fee
for its New Drug Application (NDA). Additionally, expenses decreased
in the second quarter of 2009 as compared to the same period in 2008, as a
result of A.P. Pharma’s earlier decision to suspend, for the time being,
development of its other product candidates in order to focus its financial and
managerial resources on the NDA submission for APF530.
Cash,
cash equivalents and marketable securities as of June 30, 2009 were $3.8
million, compared with $10.5 million at December 31, 2008. As
previously disclosed, the Company believes its cash, cash equivalents and
marketable securities as of June 30, 2009 will enable the Company to fund its
operations into the fourth quarter of 2009, based on expected spending levels
and certain anticipated positive cash inflows.
The
Company intends to seek additional capital to support its operations, which may
include a collaborative arrangement, an equity offering, or other
alternatives. Based on multiple factors, including market conditions,
the Company may not be able to obtain adequate financing.
Recent
Developments
On July
20, 2009, the Company announced the acceptance of its NDA for APF530 for the
potential treatment of chemotherapy-induced nausea and vomiting (CINV) by the
FDA. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has
issued an action date of March 18, 2010.
In the
second quarter, the Company presented additional data from its Phase 3 study of
APF530 for the prevention of CINV during the 45th Annual Meeting of the American
Society of Clinical Oncology (ASCO).
The new
data presented in the ASCO poster session included observations
that:
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·
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Complete
response (CR) rates for APF530 10 mg dose were generally higher in
treatment experienced patients when compared to treatment naïve
patients.
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·
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The
CR rates for patients receiving cisplatin based regimens were numerically
higher for APF530 10 mg when compared to palonosetron (Aloxi®) in both
acute and delayed CINV.
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·
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A
pharmacokinetic analysis, conducted in a sub-group of patients, confirmed
that a single APF530 10 mg dose successfully maintained blood levels of
granisetron for the entire five day study
period.
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Other
Corporate Developments
In May,
the Company implemented a reduction of its staff representing approximately 34%
of its work force. The actions were taken to allow the Company to conserve the
resources needed to continue advancing its lead program, APF530, towards
regulatory approval and commercialization.
The
Listing Qualifications Staff of the Nasdaq Stock Market (Nasdaq) granted A.P.
Pharma an extension to regain compliance with the minimum $10 million
stockholders' equity requirement for continued listing on The Nasdaq Global
Market under Nasdaq Marketplace Rule 5450(b)(1)(A).
On July
17, 2009, the Company received a notice from the Listing Qualifications Staff
that it has not regained compliance with the listing requirements for the Nasdaq
Global Market. The Company has requested a hearing before a Nasdaq
Listing Qualifications Panel (Panel) at which it will present its plan for
regaining compliance with all applicable listing requirements. The Company’s
shares will remain listed on the Nasdaq Global Market at least until such time
as the Panel renders its decision following the hearing.
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 the Company’s
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. The NDA for APF530 was submitted in May 2009 and accepted
for review in July 2009, at which time the FDA set a Prescription Drug User Fee
Act (PDUFA) date of March 18, 2010. 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 its
proprietary Biochronomer™ polymer-based drug delivery technology. The Company’s
primary focus is on its lead product candidate, APF530, for the prevention of
CINV. The NDA for APF530 was submitted in May 2009 and accepted for review in
July 2009, at which time the FDA set a Prescription Drug User Fee Act (PDUFA)
date of March 18, 2010. 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)
| A.P. PHARMA, INC. | ||||||||||
| Results of Operations Highlights | ||||||||||
| (in thousands, except per share data) | ||||||||||
| (Unaudited) | ||||||||||
| Three Months Ended | Six Months Ended | |||||||||
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June
30,
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June
30,
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June
30,
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June
30,
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2009
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2008
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2009
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2008
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Contract
Revenues
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14
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152
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22
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284
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Operating
Expenses:
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Research
& Development
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2,908
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5,538
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4,958
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11,678
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General
& Administrative
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1,066
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863
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1,993
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1,943
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Total
Operating Expenses
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3,974
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6,401
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6,951
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13,621
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Operating
Loss
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(3,960)
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(6,249)
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(6,929)
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(13,337)
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Interest
Income, Net
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19
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155
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27
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436
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Other
Income , Net
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-
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4
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1
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7
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Loss
from Continuing Operations
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(3,941)
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(6,090)
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(6,901)
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(12,894)
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Loss
from Discontinued Operations
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-
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(40)
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-
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(80)
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Net
Loss
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($3,941)
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($6,130)
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($6,901)
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($12,974)
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Basic
and Diluted Net Loss Per Common Share:
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Loss
from Continuing Operations
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($0.13)
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($0.20)
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($0.22)
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($0.42)
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Net
Loss
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($0.13)
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($0.20)
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($0.22)
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($0.42)
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Shares
Used in Calculating Net Loss Per Share
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31,016
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30,800
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30,943
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30,786
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AP
PHARMA, INC.
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Balance
Sheet Highlights
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(in
thousands)
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|||||||
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June
30, 2009
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December
31, 2008
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(Unaudited)
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(1)
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Assets
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Cash,
Cash Equivalents and Marketable Securities
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$3,804
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$10,538
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Accounts
Receivable, Net
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11
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32
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Other
Current Assets
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165
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246
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Total
Current Assets
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3,980
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10,816
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Property
and Equipment, Net
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684
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881
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Other
Non-Current Assets
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128
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103
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Total
Assets
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$4,792
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$11,800
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Liabilities
and Stockholders' Equity
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Total
Liabilities
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$3,414
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$4,202
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Stockholders'
Equity
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1,378
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7,598
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Total
Liabilities and Stockholders' Equity
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$4,792
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$11,800
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(1)
Derived from our audited financial statements for the year ended December
31, 2008 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 capital
resources and liquidity, timely development and regulatory approval of product
candidates, satisfactory completion of clinical studies, establishment of new
corporate alliances, progress in research and development programs, launch and
acceptance of new products 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
209-814-9564