HERON THERAPEUTICS, INC. /DE/ - Quarter Report: 2007 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
[X] Quarterly
Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934
For
the quarterly period ended June 30, 2007
OR
[ ]
|
Transition
Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934
|
For
the transition period
from
to
Commission
File Number 0-16109
A.P.
PHARMA, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
94-2875566
|
(State
or other jurisdiction
|
(I.R.S.
Employer
|
of
incorporation)
|
Identification
No.)
|
123
Saginaw Drive
|
|
Redwood
City CA
|
94063
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(650)
366-2626
(Registrant's
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days.
Yes
[X] No
[ ]
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of
“accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange
Act.
Large
accelerated filer
|
[ ]
|
Accelerated
filer
|
[ ]
|
Non-accelerated
filer
|
[X]
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act.)
Yes
[ ] No
[X]
At
July
31, 2007, the number of outstanding shares of the Company's common stock, par
value $.01, was 30,779,798.
Table
of Contents
A.P.
Pharma, Inc
INDEX
Page
No.
|
||
PART
I.
|
FINANCIAL
INFORMATION
|
|
Item
1.
|
Financial
Statements (unaudited):
|
|
Condensed
Balance Sheets as of June 30, 2007 and December 31, 2006
|
3
|
|
Condensed
Statements of Operations for the three and six months ended June
30, 2007
and 2006
|
4
|
|
Condensed
Statements of Cash Flows for the six months ended June 30, 2007 and
2006
|
5
|
|
Notes
to Condensed Financial Statements
|
6
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
12
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
14
|
Item
4.
|
Controls
and Procedures
|
14
|
PART
II.
|
OTHER
INFORMATION
|
|
Item
1A.
|
RISK
FACTORS
|
15
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
15
|
Item
6.
|
Exhibits
|
16
|
Signatures
|
17
|
Part
I. Financial
Information
Item
1: Financial
Statements:
A.P.
Pharma, Inc.
Condensed
Balance Sheets
(in
thousands)
June
30, 2007
|
December
31, 2006
|
|||
(unaudited)
|
(Note
1)
|
|||
Assets
|
||||
Current
assets:
|
||||
Cash
and cash equivalents
|
$ 40,710
|
$ 2,333
|
||
Marketable
securities
|
4,364
|
13,189
|
||
Accounts
receivable
|
139
|
75
|
||
Prepaid
expenses and other current assets
|
624
|
609
|
||
Total
current assets
|
45,837
|
16,206
|
||
Property
and equipment, net
|
800
|
958
|
||
Other
long-term assets
|
75
|
87
|
||
Total
assets
|
$ 46,712
|
$ 17,251
|
||
Liabilities
and Stockholders' Equity
|
||||
Current
liabilities:
|
||||
Accounts
payable
|
$ 717
|
$ 772
|
||
Accrued
expenses
|
2,570
|
3,085
|
||
Accrued
disposition costs
|
266
|
335
|
||
Total
current liabilities
|
3,553
|
4,192
|
||
Deferred
revenue
|
1,000
|
1,000
|
||
Total
liabilities
|
4,553
|
5,192
|
||
Stockholders'
equity:
|
||||
Common
stock
|
137,700
|
99,835
|
||
Accumulated
deficit
|
(95,540)
|
(87,763)
|
||
Accumulated
other comprehensive loss
|
(1)
|
(13)
|
||
Total
stockholders' equity
|
42,159
|
12,059
|
||
Total
liabilities and stockholders' equity
|
$ 46,712
|
$ 17,251
|
||
See
accompanying notes to condensed financial statements.
|
3
A.P.
Pharma, Inc.
Condensed
Statements of Operations (unaudited)
(in
thousands, except per share amounts)
Three
Months Ended June 30,
|
Six
Months Ended June 30,
|
||||||
2007
|
2006
|
2007
|
2006
|
||||
Contract
revenue
|
$ 160
|
$ -
|
$ 160
|
$ -
|
|||
Operating
expenses:
|
|||||||
Research
and development
|
3,763
|
3,856
|
8,749
|
7,325
|
|||
General
and administrative
|
872
|
933
|
1,991
|
1,865
|
|||
Total
operating expenses
|
4,635
|
4,789
|
10,740
|
9,190
|
|||
Operating
loss
|
(4,475)
|
(4,789)
|
(10,580)
|
(9,190)
|
|||
Interest
income, net
|
156
|
280
|
304
|
542
|
|||
Gain
on sale of interest in royalties
|
2,500
|
8
|
2,500
|
23,429
|
|||
Other
income (expense), net
|
3
|
(15)
|
3
|
(5)
|
|||
Income
(loss) from continuing operations
|
(1,816)
|
(4,516)
|
(7,773)
|
14,776
|
|||
Income
(loss) from discontinued operations
|
40
|
(34)
|
32
|
(27)
|
|||
Income
(loss) before income taxes
|
(1,776)
|
(4,550)
|
(7,741)
|
14,749
|
|||
Tax
provision
|
-
|
-
|
(36)
|
-
|
|||
Net
income (loss)
|
$ (1,776)
|
$ (4,550)
|
$ (7,777)
|
$ 14,749
|
|||
Basic
income (loss) per share:
|
|||||||
Income
(loss) from continuing operations
|
$ (0.19)
|
$ (0.72)
|
$ (0.98)
|
$ 2.34
|
|||
Net
income (loss)
|
$ (0.19)
|
$ (0.72)
|
$ (0.98)
|
$ 2.34
|
|||
Diluted
income (loss) per share:
|
|||||||
Income
(loss) from continuing operations
|
$ (0.19)
|
$ (0.72)
|
$ (0.98)
|
$ 2.33
|
|||
Net
income (loss)
|
$ (0.19)
|
$ (0.72)
|
$ (0.98)
|
$ 2.32
|
|||
Weighted
average common shares
|
|||||||
outstanding-basic
|
9,591
|
6,314
|
7,961
|
6,308
|
|||
Weighted
average common shares
|
|||||||
outstanding-diluted
|
9,591
|
6,314
|
7,961
|
6,345
|
|||
See
accompanying notes to condensed financial statements.
|
4
A.P.
Pharma, Inc.
Condensed
Statements of Cash Flows (unaudited)
(in
thousands)
Six
Months Ended June 30,
|
||||
2007
|
2006
|
|||
Cash
flows from operating activities:
|
||||
Net
income (loss)
|
$ (7,777)
|
$ 14,749
|
||
Adjustments
to reconcile net income (loss) to net
|
||||
cash
provided by (used in) operating activities:
|
||||
Loss
(gain) from discontinued operations
|
(32)
|
27
|
||
Loss
on sale of marketable securities
|
-
|
1
|
||
Depreciation
and amortization
|
189
|
200
|
||
Stock-based
compensation expense
|
276
|
246
|
||
Amortization
of discount and accretion of premium
|
||||
on
marketable securities
|
334
|
(10)
|
||
Changes
in operating assets and liabilities:
|
||||
Accounts
receivable
|
(99)
|
1,407
|
||
Prepaid
expenses and other current assets
|
(15)
|
(287)
|
||
Other
long-term assets
|
15
|
37
|
||
Accounts
payable
|
(55)
|
(467)
|
||
Accrued
expenses
|
(515)
|
55
|
||
Net
cash provided by (used in) continuing operating activities
|
(7,679)
|
15,958
|
||
Net
cash used in discontinued operations
|
(4)
|
(45)
|
||
Cash
flows from investing activities:
|
||||
Purchases
of property and equipment
|
(31)
|
(55)
|
||
Purchases
of marketable securities
|
-
|
(14,701)
|
||
Maturities
of marketable securities
|
2,825
|
1,800
|
||
Sales
of marketable securities
|
5,678
|
2,158
|
||
Net
cash provided by (used in) investing activities
|
8,472
|
(10,798)
|
||
Cash
flows from financing activities:
|
||||
Proceeds
from issuance of common stock, net of issuance cost
|
37,550
|
-
|
||
Proceeds
from the exercise of stock options
|
-
|
4
|
||
Proceeds
from issuance of shares under
|
||||
Employee
Stock Purchase Plan
|
38
|
34
|
||
Net
cash provided by financing activities
|
37,588
|
38
|
||
Net
increase in cash and cash equivalents
|
38,377
|
5,153
|
||
Cash
and cash equivalents, beginning of the period
|
2,333
|
790
|
||
Cash
and cash equivalents, end of the period
|
$ 40,710
|
$ 5,943
|
||
See
accompanying notes to condensed financial statements.
|
5
A.P.
Pharma, Inc.
Notes
to Condensed Financial Statements
June
30, 2007 and 2006 (unaudited)
(1) BUSINESS
AND BASIS OF PRESENTATION
A.P.
Pharma, Inc. (the “Company”, “we”, “our”, or “us”) is a specialty pharmaceutical
company focused on developing pharmaceutical products using our proprietary
Biochronomer polymer-based drug delivery technology. Our product development
philosophy is based on incorporating approved therapeutics into our proprietary
bioerodible drug delivery technology to create controlled release
pharmaceuticals to improve treatments for diseases or conditions. Our
lead product candidate, APF530, is currently in a pivotal Phase III clinical
trial for the prevention of acute and delayed onset chemotherapy-induced nausea
and vomiting, or CINV.
Our
primary focus is to advance our proprietary Biochronomer technology, consisting
of bioerodible polymers designed to release drugs over a defined period. We
have
completed over 100 in vivo and in vitro studies demonstrating that our
Biochronomer technology is potentially applicable to a range of therapeutic
areas, including prevention of nausea and vomiting, pain management, control
of
inflammation and treatment of ophthalmic diseases. We have also completed
comprehensive animal and human toxicology studies that have established that
our
Biochronomer polymers are safe and well tolerated. Furthermore, our Biochronomer
technology can be designed to deliver drugs over periods varying from days
to
several months.
The
accompanying unaudited condensed financial statements have been prepared in
accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for
interim financial information and with the instructions to Form 10-Q and Article
10 of Regulation S-X. Accordingly, they do not include all of the information
and footnotes required by U.S. GAAP for complete financial
statements. All adjustments (all of which are of a normal recurring
nature) considered necessary for a fair presentation have been
included. Operating results for the three and six months ended June
30, 2007 are not indicative of the results that may be expected for the year
ended December 31, 2007 or for any other period. The condensed
balance sheet as of December 31, 2006 has been derived from the audited
financial statements as of that date but it does not include all of the
information and notes required by U.S. GAAP. These condensed
financial statements and the notes thereto should be read in conjunction with
the audited financial statements and notes thereto included in our Annual Report
on Form 10-K for the year ended December 31, 2006 filed with the Securities
and
Exchange Commission (the “SEC”) on March 30, 2007 (our “2006
10-K”).
Summary
of Significant Accounting Policies
Use
of Estimates
The
preparation of our financial statements in conformity with U.S. GAAP requires
management to make estimates and assumptions that affect the amounts reported
in
our financial statements and accompanying notes. Estimates were made
relating to useful lives of fixed assets, valuation allowances, impairment
of
assets, accrued clinical and preclinical expenses, and assumptions for valuing
options and other stock-based compensation. Actual results could
differ materially from those estimates.
Revenue
Recognition
Our
revenue arrangements with multiple deliverables are divided into separate units
of accounting if certain criteria are met, including whether the delivered
element has stand-alone value to the customer and whether there is objective
and
reliable evidence of the fair value of the undelivered elements. The
consideration we receive is allocated among the separate units based on their
respective fair values, and the applicable revenue recognition criteria are
considered separately for each of the separate units. Advance
payments received in excess of amounts earned are classified as deferred revenue
until earned.
Royalties
Royalties
from licensees are based on third-party sales of licensed products or
technologies and recorded as earned in accordance with contract terms when
third-party results can be reliably determined and collectibility is reasonably
assured.
Generally,
contractually required minimum royalties are recorded ratably throughout the
contractual period. Royalties in excess of minimum royalties are
recognized as earned when the related product is shipped to the end customer
by
our licensees based on information provided to us by our
licensees. No such royalties were recorded in any period
presented.
6
License
Fees
Licensing
agreements generally provide for periodic minimum payments, royalties, and/or
non-refundable license fees. These licensing agreements typically
require a non-refundable license fee and allow partners to sell our proprietary
products in a defined field or territory for a defined
period. License agreements provide for the Company to earn future
revenue through royalty payments. These non-refundable license fees
are initially reported as deferred revenue and recognized as revenue over the
estimated life of the product to which they relate as we have continuing
involvement with licensees until the related product is discontinued or the
related patents expire, whichever is earlier. Revenue recognized from
deferred license fees is classified as license fees in the accompanying
statements of operations. License fees received in connection with
arrangements where we have no continuing involvement are recognized as license
fees when the amounts are received or when collectibility is reasonably assured,
whichever is earlier. No such fees were recorded in any period
presented.
A
milestone payment is a payment made by a third party or corporate partner to
us
upon the achievement of a predetermined milestone as defined in a legally
binding contract. Milestone payments relating to licensing agreements
are recognized as license fees when the milestone event has occurred and we
have
completed all milestone related services such that the milestone payment is
currently due and is non-refundable.
Contract
Revenue
Contract
revenue relates to research and development arrangements that generally provide
for the Company to invoice research and development fees based on full-time
equivalent hours for each project. Revenue from these arrangements are
recognized as the related development services are rendered. This
revenue approximates the costs incurred. For the three and six months
ended June 30, 2007, we recorded contract revenue of $160,000. There
were no contract revenue recorded for the three and six months ended June 30,
2006.
Sale
of Royalty Revenue
In
January 2006, we completed the sale of our rights to royalties on sales of
Retin-A Micro® and Carac® for up to $30 million. We received proceeds of $25
million upon the closing of the transaction and received a $2.5 million
milestone payment in June 2007. We may receive up to an additional $2.5 million
based on the satisfaction of certain predetermined milestones. The royalty
interest agreement was entered into by the parties in January 2006, but the
effective date of the sale of the royalty interest was October 1, 2005. The
royalties recognized by the Company from October 1, 2005 through December 31,
2005 were accounted for as an offset against the $25 million gain.
Cash
Equivalents and Short-term Investments
We
consider all short-term investments in debt securities which have original
maturities of less than three months at date of purchase to be cash
equivalents. Investments which have original maturities of three
months or longer are classified as marketable securities in the accompanying
condensed balance sheets. Marketable securities are classified as
available for sale at the time of purchase and carried at fair
value. Unrealized gains or losses, if any, are recorded as other
comprehensive income or loss in stockholders’ equity. Our marketable
securities at June 30, 2007 include certain debt securities with remaining
maturities of less than 6 months.
We
invest
excess cash in a variety of high grade short-term, interest-bearing
securities. The fair value of these investments approximate their
cost at June 30, 2007.
Segment
and Geographic Information
Our
operations are confined to a single business segment, the design and
commercialization of polymer technologies for pharmaceutical and other
applications. Substantially all of our revenue have been derived from
domestic customers.
Stock-Based
Compensation
On
January 1, 2006, we adopted the provisions of Statement of Financial Accounting
Standards No. 123R, “Share-Based Payment” (SFAS 123R). Under SFAS
123R we measure and recognize compensation expense for all employee and
non-employee share-based payments at fair value over the service period
underlying the arrangement. The fair value of options was estimated
at the date of grant using the Black-Scholes option pricing model. The
assumptions used for the three and six months ended June 30, 2007 and 2006
are
as follows:
7
Three
Months
|
Six
Months
|
|||||||||||||||
Ended
June 30,
|
Ended
June 30,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Employee
Stock Options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividend
yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Volatility
factor
|
|
|
240
|
%
|
|
|
240
|
%
|
|
|
240
|
%
|
|
|
240
|
%
|
Risk-free
interest rate
|
|
|
4.8
|
%
|
|
|
5.1
|
%
|
|
|
4.8
|
%
|
|
|
4.8
|
%
|
Expected
life (years)
|
|
|
6.25
|
|
|
|
6.25
|
|
|
|
6.25
|
|
|
|
6.25
|
|
Forfeiture
|
|
3.6
|
|
|
3.3
|
|
|
3.4
|
|
|
3.2
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee
Stock Purchase Plan
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividend
yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Volatility
factor
|
|
|
67
|
%
|
|
|
71
|
%
|
|
|
75
|
%
|
|
|
89
|
%
|
Risk-free
interest rate
|
|
|
4.8
|
%
|
|
|
5.0
|
%
|
|
|
4.9
|
%
|
|
|
4.2
|
%
|
Expected
life (years)
|
|
|
1.25
|
|
|
|
1.25
|
|
|
|
1.25
|
|
|
|
1.25
|
|
The
following table shows the stock-based compensation expense for all awards
(in
thousands except per share amount):
Three
Months
|
Six
Months
|
|||||||||||||||
Ended
June 30,
|
Ended
June 30,
|
|||||||||||||||
2007
|
2006
|
2007
|
2006
|
|||||||||||||
Operating
expenses:
|
|
|
|
|
|
|
|
|||||||||
Research
and development
|
$
|
48
|
|
$
|
21
|
|
$
|
104
|
|
$
|
78
|
|
||||
General
and administrative
|
65
|
|
|
|
44
|
|
|
172
|
|
|
168
|
|
||||
Total
stock-based compensation expense
|
$
|
113
|
|
|
$
|
65
|
|
$
|
276
|
|
$
|
246
|
|
|||
Impact
on basic and diluted net income (loss) per common share
|
$
|
0.01
|
|
$
|
0.01
|
$
|
0.03
|
$
|
0.03
|
There
was
no capitalized stock-based employee compensation cost as of June 30, 2007.
Since the Company had cumulative net losses as of June 30, 2007, there was
no recognized tax benefit associated with stock-based compensation
expense.
During
the three months ended June 30, 2007 we granted 12,500 options to directors
to
purchase our common stock. The following table summarizes option
activity for the six months ended June 30, 2007:
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
|
||||
Outstanding
at January 1, 2007
|
547,305
|
$ 10.68
|
|||||
Granted
|
46,250
|
$ 5.12
|
|||||
Expired
and Forfeited
|
(3,356)
|
$ 6.68
|
|||||
Outstanding
at March 31, 2007
|
590,199
|
$ 10.28
|
5.79
|
$ 5,133
|
|||
Granted
|
12,500
|
$ 3.00
|
|||||
Expired
and Forfeited
|
(60,610)
|
$ 16.06
|
|||||
Outstanding
at June 30, 2007
|
542,089
|
$ 9.26
|
5.85
|
$ -
|
|||
Options
exercisable at June 30, 2007
|
413,722
|
$ 10.50
|
4.90
|
$ -
|
As
of
June 30, 2007 there was approximately $703,000 of total unrecognized
compensation expense for all awards. This expense is expected to be
recognized over a weighted-average period of 1.35 years.
8
Recent
Accounting Pronouncements
In
June
2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48, Accounting for Uncertainty in Income Taxes—an
Interpretation of FASB Statement No. 109 (“FIN 48”), which provides
clarification related to the process associated with accounting for uncertain
tax positions recognized in consolidated financial statements. FIN 48
prescribes a more-likely-than-not threshold for financial statement recognition
and measurement of a tax position taken, or expected to be taken, in a tax
return. FIN 48 also provides guidance related to, among other things,
classification, accounting for interest and penalties associated with tax
positions, and disclosure requirements. We adopted FIN 48 on January
1, 2007 and the impact on our financial statements was not
material.
In
September 2006, the FASB issued FASB Statement (“SFAS”) No. 157, Fair Value
Measurement, (“SFAS 157”). SFAS 157 provides enhanced guidance for using
fair value to measure assets and liabilities. The guidance clarifies
the principle for assessing fair value based on the assumptions market
participants would use when pricing the asset or liability. In
support of this principle, the guidance establishes a fair value hierarchy
that
prioritizes the information used to develop those assumptions. The fair value
hierarchy gives the highest priority to quoted prices in active markets and
the
lowest priority to unobservable data such as companies’ own
data. Under this guidance, fair value measurements would be
separately disclosed by level within the fair value hierarchy. SFAS
157 is effective for financial statements issued for fiscal years beginning
after November 15, 2007 and interim periods within those fiscal
years. The Company is currently evaluating SFAS 157 and expects to
adopt this guidance beginning on January 1, 2008.
In
February 2007, the FASB issued SFAS No. 159, The Fair Value Option for
Financial Assets and Financial Liabilities (“SFAS No.
159”). SFAS No. 159 expands opportunities to use fair value
measurement in financial reporting and permits entities to choose to measure
many financial instruments and certain other items at fair
value. SFAS No. 159 is effective for fiscal years beginning after
November 15, 2007. We have not decided if we will choose to measure
any eligible financial assets and liabilities at fair value.
In
June 2007, the FASB ratified EITF 07-03, “Accounting for Nonrefundable
Advance Payments for Goods or Services to Be Used in Future Research and
Development Activities,” which requires nonrefundable advance payments for
future R&D activities to be capitalized and recognized as an expense as the
goods are delivered or services are performed. Entities should report
the effects of applying the consensus in this issue as a change in accounting
principle through a cumulative-effect adjustment to retained earnings or to
other components of equity or net assets in the statement of financial position
as of the beginning of the year of adoption. An entity should
disclose the cumulative effect of the change on retained earnings or on other
components of equity or net assets in the statement of financial
position. Earlier application is not permitted. EITF 07-03
is effective for fiscal years beginning after December 15, 2007, and interim
periods within those fiscal years. We are currently evaluating the
effect, if any, that the adoption of EITF 07-03 will have on our financial
position and results of operations.
(2) INCOME
(LOSS) PER SHARE INFORMATION
Basic
income (loss) per share is computed by dividing net income (loss) by the
weighted average number of common shares outstanding. Because the
Company is in a net loss position for the three months ended June 30, 2007
and
2006 and six months ended June 30, 2007, diluted earnings per share is also
calculated using the weighted average number of common shares outstanding
excluding the effect of potentially dilutive securities because they are
antidilutive. Such potentially dilutive securities at June 30, 2007
include outstanding stock options for 542,089 common shares and unearned
restricted stock awards for 33,750 common shares. For the six months
ended June 30, 2006, diluted earnings per share is calculated using the weighted
average number of common shares outstanding and other dilutive
securities.
The
following is a reconciliation of the numerators and denominators of the basic
and diluted earnings per share computations for the six months ended June 30,
2006 (in thousands):
Numerator:
|
|
Net
income
|
$ 14,749
|
Denominator:
|
|
Weighted
average shares outstanding used to compute
|
|
basic
earnings per share
|
6,308
|
Effect
of dilutive stock options and restricted stock awards
|
37
|
Weighted
average shares outstanding and dilutive
|
|
securities
used to compute diluted earnings per share
|
6,345
|
9
(3) COMPREHENSIVE
INCOME (LOSS)
Comprehensive
income (loss) for the three and six months ended June 30, 2007 and 2006 consists
of the following (in thousands):
Three
Months Ended
June
30,
|
Six
Months Ended
June
30,
|
||||||
2007
|
2006
|
2007
|
2006
|
||||
Net
income (loss)
|
$ (1,776)
|
$
(4,550)
|
$(7,777)
|
$ 14,749
|
|||
Unrealized
gains (losses) on available-for-sale
|
|||||||
marketable
securities
|
5
|
(13)
|
12
|
(42)
|
|||
Comprehensive
income (loss)
|
$ (1,771)
|
$
(4,563)
|
$(7,765)
|
$ 14,707
|
(4) INCOME
TAXES
We
adopted the provisions of FASB Interpretation No. 48, Accounting for
Uncertainty in Income Taxes – an Interpretation of FASB Statement No. 109,
or FIN 48, on January 1, 2007. Upon adoption of FIN 48, we commenced
a review of our tax positions taken in our tax returns that remain subject
to
examination. Based upon our review, we do not believe we have any
unrecognized tax benefits or that there is material impact on our financial
condition or results of operations as a result of implementing FIN
48.
We
file
income tax returns in the U.S. federal jurisdiction and various state
jurisdictions. We are subject to U.S. federal or state income tax
examinations by tax authorities for all years in which we reported net operating
loss carry forwards. We do not believe there will be any material
changes in our unrecognized tax positions over the next 12 months.
We
recognize interest and penalties accrued on any unrecognized tax benefits as
a
component of income tax expense. As of the date of adoption of FIN
48, we did not have any accrued interest or penalties associated with any
unrecognized tax benefits, nor was any related interest expense recognized
for
the period ended June 30, 2007.
(5) STOCKHOLDERS’
EQUITY
On
May
25, 2007, we effected a one-for-four reverse stock split based on our
stockholders’ approval of such action at the annual stockholder meeting held on
May 23, 2007. All share and per share amounts for all periods presented have
been retroactively adjusted to reflect the reverse stock split.
On
June
19, 2007, we sold 24,393,939 shares of common stock at a price of $1.65 per
share, for net proceeds of approximately $37.5 million after deducting placement
agent fees and costs associated with the offering. The shares were offered
under
our registration statement on Form S-1, as amended (Registration No.
333-14-1918).
During
the six months ended June 30, 2007, 11,254 shares of common stock were issued
to
employees under the employee stock purchase plan and 15,000 shares of restricted
common stock were awarded to directors.
10
(6) DISCONTINUED
OPERATIONS
We
completed the sale of certain assets of our Analytical Standards division as
well as certain technology rights for our topical pharmaceutical and
cosmeceutical product lines and other assets ("cosmeceutical and toiletry
business") in February 2003 and July 2000, respectively.
The
Analytical Standards division and cosmeceutical and toiletry business are
reported as discontinued operations for all periods presented in the
accompanying Condensed Statements of Operations.
Income
(loss) from discontinued operations represents the income (loss) attributable
to
our Analytical Standards division that was sold to GFS Chemicals on February
13,
2003, and changes in estimates for our cosmeceutical and toiletry business
that
was sold to RP Scherer on July 25, 2000, as follows (in thousands):
Three
Months Ended
June
30,
|
Six
Months Ended
June
30,
|
||||||
2007
|
2006
|
2007
|
2006
|
||||
Analytical
Standards Division
|
|||||||
Royalties
earned in excess of minimum amount recorded
|
$ 1
|
$ 16
|
$ 17
|
$ 23
|
|||
Cosmeceutical
and Toiletry Business
|
|||||||
Change
in estimates for gross profit guarantees
|
39
|
(50)
|
15
|
(50)
|
|||
Total
income (loss) from discontinued operations
|
$ 40
|
$ (34)
|
$ 32
|
$ (27)
|
Basic
and
diluted income (loss) per common share from discontinued operations were less
than $0.01 per share for the three and six months ended June 30, 2007 and 2006,
respectively.
Liabilities
related to the discontinued operations at June 30, 2007 in the amount of
$266,000 include severance costs and accruals for gross profit
guarantees. These liabilities are reported as accrued disposition
costs in the accompanying condensed balance sheets.
Under
the
terms of the agreement with RP Scherer, we guaranteed a minimum gross profit
percentage on RP Scherer's combined sales of products to Ortho Neutrogena and
Dermik ("Gross Profit Guaranty"). The guaranty period commenced on
July 1, 2000 and ends on the earlier of July 1, 2010 or the end of two
consecutive guaranty periods where the combined gross profit on sales to Ortho
and Dermik equals or exceeds the guaranteed gross profit. Effective
March of 2007, in conjunction with a sale of assets by RP Scherer’s successor
company to an Amcol International subsidiary (“Amcol”), a new agreement was
signed between us and Amcol to provide continuity of product supply to Ortho
and
Dermik. This new agreement potentially extends the gross profit
guaranty period an additional three years to July 1, 2013 unless it is
terminated earlier via the two period test. We expect the annual
Gross Profit Guaranty payments to range from approximately $100,000 to $150,000
for the remainder of the guaranty period. As the minimum amount of
Gross Profit Guaranty due is based on sales by RP Scherer and cannot be
estimated, no accrual has been recorded relating to sales in future
periods.
Cash
used
in discontinued operations primarily relates to royalty payments received
from
GFS Chemicals for the sale of certain products offset by a payment of $52,000
relating to the Gross Profit Guaranty.
Below
is
a summary of activity for liabilities related to the discontinued operations
for
the six months ended June 30, 2007 (in thousands):
Accrual
at December 31, 2006
|
$
335
|
Adjustment
for gross profit guaranty accrual
|
(14)
|
Payment
for gross profit guaranty
|
(52)
|
Payment
under severance agreement
|
(3)
|
Accrual
at June 30, 2007
|
$
266
|
11
ITEM
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
Forward-looking
Statements
This
Form
10-Q contains "forward-looking statements" as defined by the Private Securities
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.
Critical
Accounting Policies and Estimates
We
believe that there have been no significant changes in our critical accounting
policies during the six months ended June 30, 2007 as compared to those
disclosed in our Annual Report on Form 10-K for the year ended December 31,
2006.
Results
of Operations for the Three and Six Months Ended June 30, 2007 and 2006 (in
thousands unless otherwise indicated)
Our
revenue has been derived principally from contract revenue. In
January 2006, we completed the sale of our rights to royalties on sales of
Retin-A Micro® and Carac® for up to $30 million. We received proceeds of $25
million upon the closing of the transaction and received a $2.5 million
milestone payment in June 2007. We may receive up to an additional $2.5 million
based on the satisfaction of certain predetermined milestones. The royalty
interest agreement was entered into by the parties in January 2006, but the
effective date of the sale of the royalty interest was October 1, 2005. The
royalties recognized by the Company from October 1, 2005 through December 31,
2005 were accounted for as an offset against the $25 million gain. As a result
of this transaction, there were no royalties for the second quarter of 2007
and
2006. We will not record additional royalty revenue on sales of
Retin-A Micro® and Carac® in future periods.
Contract
revenue, which is derived from work performed under collaborative research
and
development arrangements, increased from $0 to $160 in the three and six months
ending June 30, 2007. The amount of contract revenue varies from
period to period depending on the level of activity requested of us by our
collaborators. Therefore we can not predict the amount of contract
revenue in future periods.
Research
and development expense for the three months ended June 30, 2007, decreased
by
$93 from $3,856 for the three months ended June 30, 2006, as a result of
an
increase in the APF530 Phase 3 clinical trial costs of $296 offset by a
reduction in other product development costs. Research and development expense
for the first six months ended June 30, 2007, increased by $1,424 from $7,325
for the six months ended June 30, 2006, to $8,749 due mainly to
increased expenditures on our Phase 3 study for APF530, our product candidate
for the prevention of chemotherapy-induced nausea and vomiting. We
expect research and development expense to increase in the second half of
2007
reflecting the increased number of patients enrolled in our Phase 3 study
for
APF530.
General
and administrative expense decreased for the three months ended June 30, 2007,
by $61 from $933 for the three months ended June 30, 2006, to $872 due primarily
to decreased outside consultant fees. General and administrative
expense for the first six months ended June 30, 2007, increased by $126 from
$1,865 for the six months ended June 30, 2006, to $1,991 due mainly to increased
legal fees. We expect general and administrative expense in the second half
of
2007 to remain relatively constant with the first half of the year.
We
expect
our non-cash operating expenses for employee share-based compensation for the
second half of 2007 to remain relatively constant with the first half of the
year.
Interest
income, net, decreased for the three months ended June 30, 2007 by $124 to
$156
from $280 and for the first six months ended June 30, 2007, by $238 from $542
to
$304 due to lower average cash, cash equivalents and marketable securities
balances.
Income/loss
from discontinued operations represents the net income/loss attributable to
the
Analytical Standards division which was sold to GFS Chemicals, Inc. in February
2003 and the cosmeceutical and toiletries business which was sold to RP Scherer
Corporation in July 2000. Net income from discontinued operations
totaled $40 for the three months ended June 30, 2007, compared with a net loss
of $34 in the three months ended June 30, 2006. For the six months ended June
30, 2007, net income from discontinued operations totaled $32 compared with
a
net loss of $27 in the six months ended June 30, 2006.
12
Capital
Resources and Liquidity
Cash,
cash equivalents and marketable securities increased by $30 million to $45
million at June 30, 2007 from $15 million at December 31, 2006 due primarily
to
the sale of 24,393,939 shares of common stock in an underwritten public offering
in June 2007 at a price of $1.65 per share for net proceeds of approximately
$37.5 million.
Net
cash
used in continuing operating activities for the six months ended June 30, 2007
was $8 million, compared to net cash of $16 million provided by continuing
operating activities for the six months ended June 30, 2006. The
decrease in net cash provided by operating activities from 2006 to 2007 was
mainly due to proceeds from the sale of our interest in royalties in January
2006.
Net
cash
provided by investing activities for the six months ended June 30, 2007 was
$8
million, compared to net cash of $11 million used in investing activities for
the six months ended June 30, 2006. The decrease in the cash used in investing
activities was primarily due to the purchases of $15 million of marketable
securities in the six months ended June 30, 2006.
To
date,
we have financed our operations including technology and product research and
development through the sale of common stock in June 2004 and 2007, royalties
received on sales of Retin-A Micro® and Carac®, income from collaborative
research and development fees, the proceeds received from the sales of our
Analytical Standards division and our cosmeceutical and toiletry business,
interest earned on short-term investments and the sale of our interest in the
royalty income from Retin-A Micro® and Carac®. Our existing cash, cash
equivalents and marketable securities, together with interest income will be
sufficient to meet our cash needs for at least one year.
Our
future capital requirements will depend on numerous factors including, among
others, our ability to enter into collaborative research and development and
licensing agreements; progress of product candidates in preclinical and clinical
trials; investment in new research and development programs; time required
to
gain regulatory approvals; resources that we devote to self-funded products;
potential acquisitions of technology, product candidates or businesses; and
the
costs of defending or prosecuting any patent opposition or litigation necessary
to protect our proprietary technology.
Below
is
a summary of fixed payments related to certain contractual obligations (in
thousands). This table excludes amounts already recorded on our
condensed balance sheet as current liabilities at June 30, 2007.
Total
|
Less
than
1
year
|
2
to 3
years
|
4
to 5
years
|
More
than
5
years
|
|||||
Operating
Leases
|
$ 2,019
|
$ 524
|
$ 1,089
|
$ 406
|
$ -
|
13
ITEM
3. Quantitative and Qualitative Disclosure about Market
Risk
Since
December 31, 2006, there have been no material changes in the Company's market
risk exposure.
ITEM
4. Controls and Procedures
Evaluation
of disclosure controls and procedures: We carried out an evaluation,
under the supervision and with the participation of our management, including
the Chief Executive Officer and Chief Financial Officer, of the effectiveness
of
the design and operations of our disclosure controls and procedures pursuant
to
Rule 13a-15(e) and 15(d)-15(e) of the Exchange Act. Based upon that
evaluation, the Chief Executive Officer and Chief Financial Officer concluded
that as of June 30, 2007, the end of period covered by this report, our
disclosure controls and procedures were effective at the reasonable assurance
level to alert them in a timely manner to material information relating to
the
Company required to be included in our Exchange Act filings.
Changes
in internal controls: During the three months ended June 30, 2007,
there have been no significant changes in our internal control over financial
reporting that materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
14
PART
II. OTHER
INFORMATION
ITEM
1A. Risk
Factors
There
have been no material changes to the risk factors set forth in the "RISK
FACTORS" section of our Annual Report on Form 10-K for the fiscal year ended
December 31, 2006.
ITEM
4. Submission
of Matters to a Vote of Security Holders
The
company’s annual shareholders’ meeting was held on May 23, 2007, at which the
following proposals were approved.
Proposal
I: Election
of the following directors:
Votes
For
|
Votes
Withheld
|
||
Paul
Goddard
|
21,611,641
|
2,334,592
|
|
Chairman
of the Board
|
|||
Michael
O'Connell
|
21,440,808
|
2,505,425
|
|
Peter
Riepenhausen
|
21,375,611
|
2,570,622
|
|
Toby
Rosenblatt
|
21,475,839
|
2,470,394
|
|
Arthur
Taylor
|
21,597,436
|
2,348,797
|
|
Gregory
Turnbull
|
21,512,444
|
2,433,789
|
|
Robert
Zerbe
|
21,611,441
|
2,334,792
|
Proposal
II: To
approve an amendment to the Certificate of Incorporation to effect a reverse
stock split of the Company’s outstanding common stock.
Votes
For
|
Votes
Against
|
Abstain
|
Votes
Withheld
|
|||
21,724,950
|
2,171,069
|
50,214
|
-
|
Proposal
III: To
ratify the appointment of Odenberg, Ullakko, Muranishi & Co. LLP as the
Company’s independent registered public accounting firm for the year ending
December 31, 2007.
Votes
For
|
Votes
Against
|
Abstain
|
Votes
Withheld
|
|||
21,879,622
|
146,587
|
1,920,024
|
-
|
Proposal
IV: To
consider and vote upon an adjournment of the Annual Meeting, if necessary,
to
solicit additional proxies, if there are not sufficient votes in favor of
Proposal No. 2.
Votes
For
|
Votes
Against
|
Abstain
|
Non
Votes
|
|||
22,188,906
|
1,705,893
|
50,394
|
1,040
|
15
ITEM
6. Exhibits
Exhibit
31.1 Certification of Chief Executive Officer pursuant to Rules 13A-15(e)
Promulgated under the Securities Exchange Act of 1934 as amended.
Exhibit
31.2 Certification of Chief Financial Officer pursuant to Rules 13A-15(e)
Promulgated under the Securities Exchange Act of 1934 as amended.
Exhibit
32 Certifications of Chief Executive Officer and Chief Financial Officer
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
16
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 thereunto
duly authorized.
A.P.
PHARMA, INC.
|
||
Date:
August 13, 2007
|
/S/
Gregory Turnbull
|
|
Gregory
Turnbull
|
||
President
and Chief Executive Officer
|
||
Date:
August 13, 2007
|
/S/
Michael O’Connell
|
|
Michael
O’Connell
|
||
Chief
Operating Officer and Chief Financial
Officer
|
17