HERON THERAPEUTICS, INC. /DE/ - Quarter Report: 2007 March (Form 10-Q)
UNITED
STATES
U.S.
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 March 31, 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
April
30, 2007, the number of outstanding shares of the Company's common stock, par
value $.01, was 25,438,662.
Table
of Contents
A.P.
Pharma, Inc
INDEX
Page
No.
|
||
PART
I.
|
FINANCIAL
INFORMATION
|
|
Item
1.
|
Financial
Statements (unaudited):
|
|
Condensed
Balance Sheets as of March 31, 2007 and December 31, 2006
|
3
|
|
Condensed
Statements of Operations for the three months ended March 31, 2007
and
2006
|
4
|
|
Condensed
Statements of Cash Flows for the three months ended March 31, 2007
and
2006
|
5
|
|
Notes
to Condensed Financial Statements
|
6
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
13
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
15
|
Item
4.
|
Controls
and Procedures
|
15
|
PART
II.
|
OTHER
INFORMATION
|
|
Item
1A.
|
RISK
FACTORS
|
16
|
Item
6.
|
Exhibits
|
16
|
Signatures
|
17
|
Part
I. Financial
Information
Item
1: Financial
Statements:
A.P.
Pharma, Inc.
|
||||
Condensed
Balance Sheets
|
||||
(in
thousands)
|
||||
March
31, 2007
|
December
31, 2006
|
|||
(unaudited)
|
(Note
1)
|
|||
Assets
|
||||
Current
assets:
|
||||
Cash
and cash equivalents
|
$ 1,005
|
$ 2,333
|
||
Marketable
securities
|
8,357
|
13,189
|
||
Accounts
receivable
|
125
|
75
|
||
Prepaid
expenses and other current assets
|
522
|
609
|
||
Total
current assets
|
10,009
|
16,206
|
||
Property
and equipment, net
|
883
|
958
|
||
Other
long-term assets
|
70
|
87
|
||
Total
assets
|
$ 10,962
|
$ 17,251
|
||
Liabilities
and Stockholders' Equity
|
||||
Current
liabilities:
|
||||
Accounts
payable
|
$ 577
|
$ 772
|
||
Accrued
expenses
|
2,853
|
3,085
|
||
Accrued
disposition costs
|
305
|
335
|
||
Total
current liabilities
|
3,735
|
4,192
|
||
Deferred
revenue
|
1,000
|
1,000
|
||
Total
liabilities
|
4,735
|
5,192
|
||
Stockholders'
equity:
|
||||
Common
stock
|
99,998
|
99,835
|
||
Accumulated
deficit
|
(93,765)
|
(87,763)
|
||
Accumulated
other comprehensive loss
|
(6)
|
(13)
|
||
Total
stockholders' equity
|
6,227
|
12,059
|
||
Total
liabilities and stockholders' equity
|
$ 10,962
|
$ 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 March 31,
|
||||
2007
|
2006
|
|||
Revenue
|
$ -
|
$ -
|
||
Operating
expenses:
|
||||
Research
and development
|
4,987
|
3,469
|
||
General
and administrative
|
1,118
|
932
|
||
Total
operating expenses
|
6,105
|
4,401
|
||
Operating
loss
|
(6,105)
|
(4,401)
|
||
Interest
income, net
|
148
|
262
|
||
Gain
on sale of interest in royalties
|
-
|
23,421
|
||
Other
income, net
|
-
|
10
|
||
Income
(loss) from continuing operations
|
(5,957)
|
19,292
|
||
Income
(loss) from discontinued operations
|
(8)
|
7
|
||
Income
(loss) before income taxes
|
(5,965)
|
19,299
|
||
Tax
provision
|
(36)
|
-
|
||
Net
income (loss)
|
$ (6,001)
|
$ 19,299
|
||
Basic
income (loss) per share:
|
||||
Income
(loss) from continuing operations
|
$ (0.24)
|
$ 0.77
|
||
Net
income (loss)
|
$ (0.24)
|
$ 0.77
|
||
Diluted
income (loss) per share:
|
||||
Income
(loss) from continuing operations
|
$ (0.24)
|
$ 0.76
|
||
Net
income (loss)
|
$ (0.24)
|
$ 0.76
|
||
Weighted
average common shares
|
||||
outstanding-basic
|
25,324
|
25,207
|
||
Weighted
average common shares
|
||||
outstanding-diluted
|
25,324
|
25,483
|
||
See
accompanying notes to condensed financial statements
|
4
A.P.
Pharma, Inc.
|
||||
Condensed
Statements of Cash Flows (unaudited)
|
||||
(in
thousands)
|
||||
Three
Months Ended March 31,
|
||||
2007
|
2006
|
|||
Cash
flows from operating activities:
|
||||
Net
income (loss)
|
$ (6,001)
|
|
$ 19,299
|
|
Adjustments
to reconcile net income (loss) to net
|
||||
cash
provided by (used in) operating activities:
|
||||
Loss
(gain) from discontinued operations
|
8
|
|
(7)
|
|
Loss
on sale of marketable securities
|
-
|
1
|
||
Depreciation
and amortization
|
95
|
99
|
||
Stock-based
compensation expense
|
163
|
153
|
||
Amortization
of premium/discount and accretion
|
||||
of
marketable securities
|
(22)
|
(2)
|
||
Changes
in operating assets and liabilities:
|
||||
Accounts
receivable
|
(69)
|
1,426
|
||
Prepaid
expenses and other current assets
|
87
|
(46)
|
||
Other
long-term assets
|
19
|
19
|
||
Accounts
payable
|
(195)
|
(226)
|
||
Accrued
expenses
|
(232)
|
(319)
|
||
Net
cash provided by (used in) continuing operating activities
|
(6,147)
|
20,397
|
||
Net
cash provided by (used in) discontinued operations
|
(21)
|
21
|
||
Cash
flows from investing activities:
|
||||
Purchases
of property and equipment
|
(21)
|
(29)
|
||
Purchases
of marketable securities
|
-
|
(12,363)
|
||
Maturities
of marketable securities
|
1,500
|
500
|
||
Sales
of marketable securities
|
3,361
|
1,651
|
||
Net
cash provided by (used in) investing activities
|
4,840
|
(10,241)
|
||
Cash
flows from financing activities:
|
||||
Proceeds
from the exercise of stock options
|
-
|
3
|
||
Net
cash provided by financing activities
|
-
|
3
|
||
Net
increase (decrease) in cash and cash equivalents
|
(1,328)
|
10,180
|
||
Cash
and cash equivalents, beginning of the period
|
2,333
|
790
|
||
Cash
and cash equivalents, end of the period
|
$ 1,005
|
$ 10,970
|
||
See
accompanying notes to condensed financial statements.
|
5
A.P.
Pharma, Inc.
Notes
to Condensed Financial Statements
March
31, 2007 and 2006 (unaudited)
(1) 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. We expect to complete enrollment of our pivotal Phase III
clinical trial in the first half of 2008 and to announce results of that trial
in the third quarter of 2008. We expect to file our new drug application, or
NDA, for approval of APF530 in the fourth quarter of 2008.
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.
Our
lead
product candidate, which utilizes our proprietary Biochronomer technology,
is
APF530. APF530 is designed to prevent CINV for at least five days and contains
granisetron, a drug approved for the prevention of CINV. In September 2005,
we
completed a Phase II human clinical trial of APF530 that achieved all of its
primary and secondary endpoints. In May 2006, we initiated our pivotal Phase
III
clinical trial of AFP530. We believe that this clinical trial will lead to
regulatory approval of APF530 for the prevention of acute and delayed onset
CINV
for patients undergoing both moderately and highly emetogenic, or
vomit-inducing, chemotherapy.
The
accompanying unaudited condensed financial statements have been prepared in
accordance with accounting principles generally accepted in the United States
of
America ("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 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 months ended March 31, 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 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").
Going
Concern
The
accompanying condensed financial statements have been prepared assuming we
will
continue as a going concern. We have suffered recurring losses and had an
accumulated deficit of $93.8 million as of March 31, 2007.
At
March
31, 2007, we had $9.4 million cash, cash equivalents and marketable securities
that we believe will not enable us to fund our operations through fiscal year
2007. We are seeking additional financing to continue our research and
activities. We anticipate that our cash expenditures during fiscal year 2007
will be approximately $30 million. We expect to meet our cash needs and fund
our
working capital requirements from additional capital sources, which may include
an equity offering. If we are unable to complete an equity offering,
or otherwise obtain sufficient financing, we may be required to reduce, defer,
or discontinue our research and development activities or may not be able to
continue as a going concern entity.
6
Summary
of Significant Accounting Policies
Use
of Estimates
The
preparation of our financial statements in conformity with 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, valuation of stock-based
compensation and contingencies. 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.
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 either period
presented here.
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 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. No such fees were recorded in either period presented
here.
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 may receive up to an additional
$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.
7
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.
Concentrations
of Credit Risk
Financial
instruments that potentially subject us to concentrations of credit risk consist
primarily of cash equivalents and marketable securities. We invest
excess cash in a variety of high grade short-term, interest-bearing
securities. The fair value of these investments approximated their
cost at March 31, 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 has 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 share-based
payments at fair value over the service period underlying the
arrangement. The fair value of each employee and director grant of
options to purchase common stock is estimated on the date of the grant using
the
Black-Scholes option-pricing model with the following weighted-average
assumptions for the three months ended March 31, 2007: 1) risk-free interest
rate of 4.8% for stock options and 4.9% for employee stock purchase plan; 2)
expected dividend yield of 0% for both stock options and employee stock purchase
plan; 3) expected holding period of 6.25 years based on the simplified method
provided in Staff Accounting Bulletin No. 107 for "plain vanilla options" and
expected term of 1.25 years for employee stock purchase plan based on
weighted-average purchase period of the plan; 4) expected volatility of 240%
for
stock options and 82% for employee stock purchase plan based on the Company's
historical stock prices; and 5) an estimated forfeiture rate of 3.2% of the
options granted based on historical data.
The
SFAS
123R share-based compensation expenses recorded for awards granted under the
stock option plans and employee stock purchase plan were approximately $143,000
and $114,000, net of estimated forfeitures, for the three months ended March
31,
2007 and 2006, respectively. The share-based compensation expense of
$54,000 and $53,000 was recorded in research and development expense for the
three months ended March 31, 2007 and 2006, respectively. The
share-based compensation expense of $89,000 and $61,000 was recorded in general
and administrative expense for the three months ended March 31, 2007 and 2006,
respectively. No tax benefit was recognized related to share-based
compensation expense since we have incurred operating losses and we have
established a full valuation allowance to offset all the potential tax benefits
associated with our deferred tax assets.
During
the three months ended March 31, 2007 we did not grant any restricted stock
awards. As of March 31, 2007, we had a total of 100,000 unvested
shares of restricted stock awards granted to employees and
directors. The compensation costs charged as operating expenses for
restricted stock awards were $20,000 and $8,000 for the three months ended
March
31, 2007 and 2006, respectively.
8
During
the three months ended March 31, 2007 we granted 185,000 options to employees
to
purchase common stocks. The following table summarizes option
activity for the three months ended March 31, 2007:
|
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic
Value
|
|||
Outstanding
at January 1, 2007
|
2,189,221
|
|
$ 2.67
|
|
|||
Granted
|
185,000
|
$ 1.28
|
|||||
Forfeited
|
(13,426)
|
$ 1.67
|
|||||
Outstanding
at March 31, 2007
|
2,360,795
|
$ 2.57
|
5.79
|
$ 5,133
|
|||
Options
exercisable at March 31, 2007
|
1,707,090
|
$ 3.01
|
4.53
|
$ 1,433
|
As
of
March 31, 2007 there was approximately $670,000 of total unrecognized
compensation expense related to nonvested stock options. This expense
is expected to be recognized over a weighted-average period of 1.27
years.
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.
9
(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 March 31, 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 include outstanding stock options for 2,360,795 common shares and
unearned restricted stock awards for 100,000 common shares. For the
three months ended March 31, 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 three months ended March
31,
2006 (in thousands):
Numerator:
|
|
Net
income
|
$ 19,299
|
Denominator:
|
|
Weighted
average shares outstanding used to compute
|
|
basic
earnings per share
|
25,207
|
Effect
of dilutive stock options and restricted stock awards
|
276
|
Weighted
average shares outstanding and dilutive
|
|
securities
used to compute diluted earnings per share
|
25,483
|
(3) COMPREHENSIVE
INCOME (LOSS)
Comprehensive
income (loss) for the three months ended March 31, 2007 and 2006 consists of
the
following (in thousands):
Three
Months Ended
March
31,
|
|||
2007
|
2006
|
||
Net
income (loss)
|
$ (6,001)
|
$ 19,299
|
|
Unrealized
gains (losses) on available-for-sale
|
|||
marketable
securities
|
7
|
(29)
|
|
Comprehensive
income (loss)
|
(5,994)
|
19,270
|
(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 carryforwards. We do not believe there will be any material
changes in our unrecognized tax positions over the next 12 months.
10
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 interest expense recognized for the
period ended March 31, 2007.
(5) STOCKHOLDERS’
EQUITY
During
the three months ended March 31, 2007, no shares of common stock were issued
through the exercise of stock options, employee stock purchases or issuance
of
restricted stock awards.
(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
March
31,
|
|||
2007
|
2006
|
||
Analytical
Standards Division
|
|||
Royalties
earned in excess of minimum amount recorded
|
$ 16
|
$ 7
|
|
Cosmeceutical
and Toiletry Business
|
|||
Change
in estimates for gross profit guarantees
|
(24)
|
-
|
|
Total
income (loss) from discontinued operations
|
$ (8)
|
$ 7
|
Basic
and
diluted income (loss) per common share from discontinued operations were less
than $0.01 per share for the three months ended March 31, 2007 and 2006,
respectively.
Liabilities
related to the discontinued operations at March 31, 2007 in the amount of
$305,000 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. 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 can
not
be estimated, no accrual has been recorded relating to sales in future
periods.
11
Cash
provided by (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 three months ended March 31, 2007 (in thousands):
Accrual
at December 31, 2006
|
$ 335
|
Additional
accrual for gross profit guaranty
|
25
|
Payment
for gross profit guaranty
|
(52)
|
Payment
under severance agreement
|
(3)
|
Accrual
at March 31, 2007
|
$ 305
|
12
ITEM
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
(in
thousands unless otherwise indicated)
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 three months ended March 31, 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 Months Ended March 31, 2007 and
2006
Our
revenue has been derived principally from royalties and contract
revenue. Under strategic alliance arrangements entered into with
certain companies, we received non-refundable upfront fees, milestone payments
and royalties based on third party product sales.
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 may receive up to an additional
$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 first 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 is derived from work performed under collaborative research and
development arrangements. There was no contract revenue in the first
quarter of 2007 and 2006. 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 first quarter of 2007 increased by $1.5 million
from $3.5 million to $5 million due mainly to expenditures in the first quarter
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 quarter of 2007 reflecting the
increased number of patients enrolled in our Phase 3 study for
APF530.
General
and administrative expense increased for the first quarter of 2007 by $186
from
$932 to $1,118 due primarily to increased legal fees. We expect
general and administrative expense in the second quarter of 2007 to remain
relatively constant with the first quarter of 2007.
We
expect
our non-cash operating expenses for employee share-based compensation for the
second quarter of 2007 to remain relatively constant with the first quarter
of
2007.
Interest
income, net, decreased for the first quarter of 2007 by $114 to $148 from $262
due to lower average cash, cash equivalents and marketable securities
balances.
13
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 loss from discontinued operations
totaled $8,000 for the three months ended March 31, 2007, compared with net
income of $7,000 in the three months ended March 31, 2006.
Capital
Resources and Liquidity
Cash,
cash equivalents and marketable securities decreased by $6 million to $9 million
at March 31, 2007 from $15 million at December 31, 2006 due to cash used in
operating activities.
Net
cash
used in continuing operating activities for the three months ended March 31,
2007 was $6 million, compared to net cash of $20 million provided by continuing
operating activities for the three months ended March 31, 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 three months ended March 31, 2007
was
$5 million, compared to net cash of $10 million used in investing activities
for
the three months ended March 31, 2006. The decrease in the cash used in
investing activities was primarily due to the purchases of $12 million of
marketable securities in the first quarter of 2006.
To
date,
we have financed our operations including technology and product research and
development, primarily through 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, the sale of common stock in June 2004,
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
not be sufficient to meet our cash needs for the year ended December 31,
2007. We are currently seeking additional financing within this
timeline through an equity financing.
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.
There
can
be no assurance that we will be able to raise sufficient additional capital
when
we need it or to raise capital on favorable terms. The sale of equity
or convertible debt securities in the future may be dilutive to our
stockholders, and debt financing arrangements may require us to pledge certain
assets and enter into covenants that could restrict certain business activities
or our ability to incur further indebtedness and may contain other terms that
are not favorable to us or our stockholders. If we are unable to
obtain adequate funds on reasonable terms, we may be required to curtail
operations significantly or to obtain funds by entering into financing, supply
or collaboration agreements on unattractive terms.
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 March 31, 2007.
Total
|
Less
than
1
year
|
2
to 3
years
|
4
to 5
years
|
More
than
5
years
|
|||||
Operating
Leases
|
$ 2,149
|
$ 521
|
$ 1,082
|
$ 546
|
$ -
|
14
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 March 31, 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 March 31, 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.
15
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
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:
May 8, 2007
|
/S/
Gregory Turnbull
|
|
Gregory
Turnbull
|
||
Vice
President, Finance and Chief Financial Officer
|
||
Date:
May 8, 2007
|
/S/
Stephen C. Whiteford
|
|
Stephen
C. Whiteford
|
||
Vice
President, Finance and Chief Financial
Officer
|
17