UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_________________
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT PURSUANT SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the Quarterly Period ended MARCH 31, 2009
[ ] TRANSITION REPORT PURSUANT SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____ to _____
Commission file number 000-12950
_________________
ALLIANCE PHARMACEUTICAL CORP.
(Exact Name of Registrant as Specified in Its Charter)
New York 14-1644018
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
7590 Fay Avenue, Suite 404 92037
La Jolla, California
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including are code: (858) 779-1458
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, a non-accelerated filer or a smaller reporting
company. See the definition of "large accelerated filer," "accelerated file" and
"smaller reporting company" in rule 12b-2 of the Exchange Act.
Large accelerated filer |_| Accelerated filer |_| Non-accelerated filer |_|
Smaller reporting company |X| (Do not check if a smaller
reporting company)
Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act). Yes |_| No |X|
Common Stock, $0.01 par value per share, 150,000,000 shares authorized,
67,316,592 shares issued and outstanding at May 13, 2009.
ALLIANCE PHARMACEUTICAL CORP.
- -----------------------------
INDEX
- -----
Page No.
--------
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Condensed Consolidated Balance Sheets at March 31, 2009 (unaudited)
and June 30, 2008 3
Condensed Consolidated Statements of Operations (unaudited) 4
Condensed Consolidated Statements of Cash Flows (unaudited) 5
Notes to Unaudited Condensed Consolidated Financial Statements 6
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations 14
Item 4T. Controls and Procedures 18
PART II - OTHER INFORMATION
Item 1. Legal Proceedings 19
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 19
Item 3. Defaults Upon Senior Securities 19
Item 4. Submission of Matters to a Vote of Security Holders 19
Item 5 Other Information 19
Item 6. Exhibits 19
2
PART I FINANCIAL INFORMATION:
Item 1. Financial Statements
ALLIANCE PHARMACEUTICAL CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
- --------------------------------------------------------------------------------------------------------------------------------
MARCH 31, 2009 JUNE 30, 2008
----------------------- -----------------------
ASSETS (UNAUDITED) (AUDITED)
------
CURRENT ASSETS:
Cash $ 92,000 $ 6,000
Restricted cash - 16,000
Other current assets 13,000 39,000
-------------------- -------------------
Total current assets 105,000 61,000
PROPERTY AND EQUIPMENT - NET 41,000 87,000
-------------------- -------------------
$ 146,000 $ 148,000
==================== ===================
LIABILITIES AND STOCKHOLDERS' DEFICIT
CURRENT LIABILITIES:
Accounts payable $ 260,000 $ 252,000
Accrued expenses 474,000 212,000
Deferred revenue 100,000 100,000
Senior notes payable and accrued interest 11,151,000 11,065,000
-------------------- -------------------
Total current liabilities 11,985,000 11,629,000
OTHER LIABILITIES 750,000 750,000
-------------------- -------------------
Total liabilities 12,735,000 12,379,000
-------------------- -------------------
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' DEFICIT:
Common stock - $0.01 par value; 150,000,000 shares authorized;
63,216,247 and 60,216,247 shares issued and outstanding, respectively 632,000 602,000
Additional paid-in capital 487,260,000 486,760,000
Accumulated deficit (500,481,000) (499,593,000)
-------------------- -------------------
Total stockholders' deficit (12,589,000) (12,231,000)
-------------------- -------------------
$ 146,000 $ 148,000
==================== ===================
SEE ACCOMPANYING NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS.
3
ALLIANCE PHARMACEUTICAL CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
--------------------------------------------------------------------------------------------------------------------------------
THREE MONTHS ENDED NINE MONTHS ENDED
MARCH 31, MARCH 31,
2009 2008 2009 2008
------------------- ------------------- ------------------- -------------------
(UNAUDITED) (UNAUDITED)
REVENUES:
Royalty, license and research $ 79,000 $ 26,000 $ 79,000 $ 83,000
------------------- ------------------- ------------------- -------------------
OPERATING EXPENSES:
Research and development 4,000 72,000 96,000 332,000
General and administrative 167,000 181,000 533,000 672,000
------------------- ------------------- ------------------- -------------------
171,000 253,000 629,000 1,004,000
------------------- ------------------- ------------------- -------------------
LOSS FROM OPERATIONS (92,000) (227,000) (550,000) (921,000)
INVESTMENT INCOME 1,000 1,000 2,000 15,000
OTHER INCOME 226,000 25,000 251,000 188,000
INTEREST EXPENSE (199,000) (196,000) (596,000) (661,000)
LOSS ON MODIFICATION OF DEBT - - - (14,000)
LOSS ON DISPOSITION OF EQUIPMENT - - (20,000) -
GAIN ON DISPOSITION OF ASSETS - - 25,000 -
--------------------- ---------------- ----------------- -------------------
NET LOSS $ (64,000) $ (397,000) $ (888,000) $ (1,393,000)
=================== =================== =================== ===================
NET LOSS PER COMMON SHARE,
BASIC AND DILUTED $ - $ (0.01) $ (0.01) $ (0.03)
=================== =================== =================== ===================
WEIGHTED AVERAGE SHARES OUTSTANDING,
BASIC AND DILUTED 63,216,000 60,077,000 61,984,000 55,282,000
=================== =================== =================== ===================
SEE ACCOMPANYING NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS.
4
ALLIANCE PHARMACEUTICAL CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
- -------------------------------------------------------------------------------------------------------------------
Nine Months Ended March 31,
2009 2008
------------------ -----------------
(UNAUDITED)
OPERATING ACTIVITIES:
Net loss $ (888,000) $ (1,393,000)
Adjustments to reconcile net loss to net cash
provided by (used in) operating activities:
Depreciation and amortization 26,000 29,000
Loss on modification of debt - 14,000
Accrued interest on senior notes 596,000 661,000
Stock-based compensation 20,000 31,000
Loss on disposal of equipment 20,000 -
Changes in operating assets and liabilities:
Other assets 58,000 (3,000)
Accounts payable, accrued expenses and other 254,000 (152,000)
------------------ -----------------
Net cash provided by (used in) operating activities 86,000 (813,000)
------------------ -----------------
FINANCING ACTIVITIES:
Advances from related party 100,000 -
Payment of related party advances (100,000) -
------------------ -----------------
Net cash provided by financing activities - -
------------------ -----------------
INCREASE (DECREASE) IN CASH 86,000 (813,000)
CASH AT BEGINNING OF PERIOD 6,000 873,000
------------------ -----------------
CASH AT END OF PERIOD $ 92,000 $ 60,000
================== =================
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES:
Issuance of common stock upon conversion of senior notes and
interest $ 510,000 $ 2,173,000
================== =================
Conversion of preferred stock to common stock $ - $ 635,000
================== =================
Financing of Directors & Officers insurance $ 13,000 $ -
================== =================
SEE ACCOMPANYING NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS.
5
ALLIANCE PHARMACEUTICAL CORP.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
- --------------------------------------------------------------------------------
THREE AND NINE MONTHS ENDED MARCH 31, 2009
1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization
- ------------
Alliance Pharmaceutical Corp. and its subsidiaries (collectively, the
"Company," "Alliance," "we" or "us") are engaged in identifying, designing and
developing novel medical products. Currently, the Company is focused on
developing its lead product, Oxygent(TM), an intravascular oxygen carrier
designed to augment oxygen delivery in surgical patients.
Liquidity and Basis of Presentation
- -----------------------------------
The accompanying condensed consolidated financial statements have been
prepared assuming the Company will continue as a going concern, which
contemplates, among other things, the realization of assets and satisfaction of
liabilities in the ordinary course of business. The Company has incurred
operating losses through March 31, 2009 and has negative working capital at that
date of approximately $11.9 million. These factors, among others, raise
substantial doubt about the Company's ability to continue as a going concern.
As discussed in Note 3, in June 2004, the Company completed a private
placement financing with net proceeds to the Company of approximately $10
million from the sale of common stock (the "June 2004 Private Placement"). In
September 2004, the terms of the June 2004 Private Placement were renegotiated
by mutual agreement of the Company and investors holding approximately $10.7
million of the original $11 million invested by the various investors in the
June 2004 Private Placement. Concurrently, the investors who elected to rescind
the June 2004 Private Placement were issued senior convertible promissory notes
in like investment amounts (the "Senior Notes"), which, unless previously
converted, were to mature and the unpaid principal, together with accrued
interest, was to become due and payable on April 1, 2007. The Company requested
that each holder of a Senior Note execute an amendment to extend the maturity
date of the Senior Note from April 1, 2007 to June 30, 2008 under certain
conditions, which we did not meet in a timely manner. This amendment was
approved by substantially all of the Senior Note holders. The Company is now in
default under the Senior Notes. The Company is continuing to seek additional
financing of approximately $3 million to fund its continuing operations through
June 2011 (see Note 5). We have not yet identified a source of the funds and it
is uncertain if we will be able to do so. Failure to obtain such financing would
likely result in the liquidation of our Company. It is unlikely that our
shareholders would receive any of the proceeds from such liquidation. Because
adequate funds have not been available to the Company in the past, the Company
has already delayed its Oxygent development efforts and has delayed, scaled
back, and/or eliminated one or more of its other product development programs.
The accompanying unaudited condensed consolidated financial statements do not
include any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amount and classification of
liabilities that may result from the outcome of this uncertainty.
Principles of Consolidation
- ---------------------------
The accompanying unaudited condensed consolidated financial statements
include the accounts of Alliance Pharmaceutical Corp., the accounts of its
wholly owned subsidiary, Molecular Biosystems, Inc. ("MBI"), and its
majority-owned subsidiaries, Talco Pharmaceutical, Inc. and PFC Therapeutics,
LLC ("PFC Therapeutics"). All significant intercompany accounts and transactions
have been eliminated.
Interim Unaudited Condensed Consolidated Financial Statements
- -------------------------------------------------------------
The accompanying unaudited condensed consolidated financial statements
have been prepared by the Company in accordance with accounting principles
generally accepted in the United States of America for interim financial
information. These principles are consistent in all material respects with those
applied in the Company's consolidated financial statements contained in the
Company's annual report on Form 10-KSB for the fiscal year ended June 30, 2008,
and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X
promulgated by the Securities and Exchange Commission (the "SEC"). Interim
financial statements do not include all of the information and footnotes
required by accounting principles generally accepted in the United States of
America for complete financial statements. In the opinion of management, the
accompanying unaudited condensed consolidated financial statements contain all
6
adjustments (all of which are of a normal recurring nature, including the
elimination of intercompany accounts) necessary to present fairly the financial
position, results of operations and cash flows of the Company for the periods
indicated. Interim results of operations are not necessarily indicative of the
results to be expected for the full year or any other interim periods. These
unaudited condensed consolidated financial statements should be read in
conjunction with the consolidated financial statements and footnotes thereto
contained in the Company's annual report on Form 10-KSB for the year ended June
30, 2008.
Use of Estimates
- ----------------
The preparation of financial statements in conformity with accounting
principles generally accepted in the U.S. requires management to make estimates
and assumptions that affect the amounts reported in the financial statements and
disclosures made in the accompanying notes to the condensed consolidated
financial statements. Significant estimates made by management include, among
others, recoverability of property and equipment and the valuation of deferred
tax assets and stock options. Actual results could differ from these estimates.
Property and Equipment
- ----------------------
Property and equipment are stated at cost and depreciated using the
straight-line method over the estimated useful lives of the assets, ranging from
three to five years. Major betterments and renewals are capitalized, while
routine repairs and maintenance are charged to expense when incurred.
The Company assesses the recoverability of property and equipment by
determining whether such assets can be recovered through projected undiscounted
cash flows. The amount of impairment if any, is measured based on fair value and
is charged to operations in the period in which impairment is determined by
management. At March 31, 2009, management has determined that there is no
impairment of property and equipment. There can be no assurance, however, that
market conditions will not change, which could result in future property and
equipment impairment.
Revenue Recognition
- -------------------
The Company recognizes revenue in accordance with Staff Accounting
Bulletin ("SAB") No. 101, "Revenue Recognition in Financial Statements," as
revised by SAB No. 104. As such, the Company recognizes revenue when persuasive
evidence of an arrangement exists, title transfer has occurred, or services have
been performed, the price is fixed or readily determinable and collectibility is
probable.
Revenue is deferred until all contractual obligations have been
satisfied.
Research and Development Revenues Under Collaborative Agreements
----------------------------------------------------------------
Research and development revenues under collaborative agreements are
recognized as the related expenses are incurred, up to contractual limits.
Payments received under these agreements that are related to future performance
are deferred and recorded as revenue as they are earned over the specified
future performance period. Revenue related to nonrefundable, upfront fees are
recognized over the period of the contractual arrangements as performance
obligations related to the services to be provided have been satisfied. Revenue
related to milestones is recognized upon completion of each milestone's
performance requirement.
Licensing and Royalty Revenues
------------------------------
Licensing and royalty revenues for which no services are required to be
performed in the future are recognized immediately, if collectibility is
reasonably assured.
Raw Material Revenues
---------------------
The Company recognizes revenues from the sales of raw material upon
shipment, at which time title transfers and the Company has no further
obligation. Such sales in the amount of $251,000 and $183,000 were recorded
during the nine months ended March 31, 2009 and March 31, 2008, respectively, in
connection with raw material that the Company does not market. Inventory
associated with the sales of these raw materials is carried at zero value. The
amounts earned for these sales were recorded as other income in the accompanying
condensed consolidated statements of operations.
Research and Development Expenses
- ---------------------------------
Research and development expenditures are charged to expense as
incurred. Research and development expenditures include the cost of salaries and
benefits for clinical, scientific, manufacturing, engineering and operations
personnel, payments to outside researchers for preclinical and clinical trials
and other product development work, payments related to facility lease and
utility expenses, depreciation and amortization, patent costs, as well as other
expenditures. During the nine-month periods ended March 31, 2009 and 2008, the
Company incurred research and development expenses of approximately $96,000 and
$332,000, respectively. The research and development costs for the current
period are primarily costs associated with filing a new patent in certain
countries, and archiving and storage costs.
7
Fair Value of Financial Instruments
- -----------------------------------
The carrying amount of certain of the Company's financial instruments
as of March 31, 2009 approximates their respective fair values because of the
short-term nature of these instruments. Such instruments consist of cash,
accounts payable, accrued expenses and other liabilities. The carrying value of
debt approximates fair value as the related interest rate approximates a rate
currently available to the Company.
Computation of Net Income (Loss) Per Common Share
- -------------------------------------------------
Basic loss per share was computed by dividing the net loss by the
weighted average number of common shares outstanding during the period. All
potential dilutive common shares have been excluded from the calculation of
diluted loss per share for the nine months ended March 31, 2009 and 2008, as
their inclusion would be anti-dilutive. The outstanding potentially dilutive
common shares totaled approximately 65,593,000 and 63,835,000 at March 31, 2009
and 2008, respectively.
Accounting for Stock-Based Compensation
- ---------------------------------------
At March 31, 2009, the Company has two stock-based employee
compensation plans.
Statement of Financial Accounting Standards ("SFAS") No. 123 (revised
2004), "Share-Based Payment" ("SFAS No. 123(R)") requires companies to estimate
the fair value of share-based payment awards on the date of grant using an
option-pricing model. The value of the portion of the award that is ultimately
expected to vest is recognized as expense over the requisite service periods in
the Company's consolidated statement of operations.
Stock-based compensation expense recognized during the period is based
on the value of the portion of share-based payment awards that is ultimately
expected to vest during the period. As stock-based compensation expense
recognized in the condensed consolidated statement of operations for the nine
months ended March 31, 2009 is based on awards ultimately expected to vest, it
has been reduced for estimated forfeitures. SFAS No. 123(R) requires forfeitures
to be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. The estimated average
forfeiture rate was based on historical forfeiture experience and estimated
future employee forfeitures.
SFAS No. 123(R) requires cash flows resulting from the tax benefits
resulting from tax deductions in excess of the compensation cost recognized for
those options to be classified as financing cash flows. Due to the Company's
loss position, there were no such tax benefits during the nine months ended
March 31, 2009.
Description of Plans
- --------------------
The Company's stock option plans provide for grants of options to
employees and directors of the Company to purchase the Company's shares, as
determined by management and the board of directors, at the fair value of such
shares on the grant date. The options generally vest over a four- to five-year
period beginning on the date of grant or up to one year after the date of grant
and have a ten-year term. As of March 31, 2009, the Company is authorized to
issue up to 8,100,000 shares under these plans and has 4,102,110 shares
available for future issuance.
Summary of Assumptions and Activity
- -----------------------------------
The fair value of stock-based awards to employees and directors is
calculated using the Black-Scholes option pricing model, even though the model
was developed to estimate the fair value of freely tradable, fully transferable
options without vesting restriction, which differ significantly from the
Company's stock options. The Black-Scholes model also requires subjective
assumptions regarding future stock price volatility and expected time to
exercise, which greatly affect the calculated values. The expected term of
options granted is derived from historical data on employee exercises and
post-vesting employment termination behavior. The risk-free rate selected to
value any particular grant is based on the U.S. Treasury rate that corresponds
to the pricing term of the grant effective as of the date of the grant. The
expected volatility is based on the historical volatility of our common stock.
These factors could change in the future, affecting the determination of
stock-based compensation expense in future periods.
8
A summary of option activity as of March 31, 2009 and changes during
the nine months then ended is presented below:
MARCH 31, 2009
-------------------------------------------------------------
WEIGHTED-AVERAGE
-------------------------------
SHARES EXERCISE REMAINING AGGREGATE
PRICE CONTRACTUAL INTRINSIC
TERM (Years) VALUE
---------------------------------------------------------------
Options outstanding at July 1, 2008 2,703,800 $ 3.49 5.84
Options granted -
Options forfeited/expired (58,100)
Options exercised -
---------------------------
Options outstanding at March 31, 2009 2,645,700 $ 3.03 5.21 $ -
-------------------------------------------------------------
Unvested options expected to vest at March 31, 2009 465,500 $ 0.23 6.08 $ -
-------------------------------------------------------------
Options exercisable at March 31, 2009 2,170,700 $ 3.64 5.02 $ -
=============================================================
Upon the exercise of options, the Company issues new shares from its
authorized shares.
As of March 31, 2009, there was approximately $19,000 of total
unrecognized compensation costs related to employee and director stock option
compensation arrangements. That cost is expected to be recognized on a
straight-line basis over the next four years on average. The total fair value of
shares vested during the nine months ended March 31, 2009 related to employee
and director options and options issued to consultants was approximately $19,000
and $1,000 respectively, net of estimated forfeitures.
The Company allocated $19,000 of the stock-based compensation expense
related to employee and director stock options to general and administrative
expenses and $1,000 of the stock-based compensation expense related to
consultant stock options to research and development expenses.
Recently Issued Accounting Pronouncements
- -----------------------------------------
In September 2006, the FASB issued SFAS No. 157, "Fair Value
Measurements." SFAS No. 157 defines fair value, establishes a framework for
measuring fair value in accounting principals generally accepted in the U.S. and
expands disclosures about fair value measurements. The statement does not
require new fair value measurements, but is applied to the extent that other
accounting pronouncements require or permit fair value measurements. SFAS No.
157 emphasizes that fair value is a market-based measurement that should be
determined based on the assumptions that market participants would use in
pricing an asset or liability. Companies that have assets and liabilities
measured at fair value will be required to disclose information that enables the
users of its financial statements to access the inputs used to develop those
measurements. The reporting entity is encouraged, but not required, to combine
the fair value information disclosed under this statement with the fair value
information disclosed under other accounting pronouncements. SFAS No. 157 was
effective for fiscal years beginning after November 15, 2007. In February 2008,
the FASB issued FSP 157-2, "Effective Date of FASB Statement No. 157", which
delays the effective date of SFAS No. 157 for non-financial assets and
liabilities to fiscal years beginning after November 15, 2008. On July 1, 2008,
the Company adopted SFAS No. 157 for financial assets and liabilities. The
adoption did not have a material effect on the Company's results of operations
and financial position. The Company is in the process of evaluating the impact
of adoption of SFAS No. 157 for non-financial assets and liabilities, but does
not anticipate that the adoption will have a material impact on its consolidated
financial statements.
In December 2007, the FASB issued SFAS No. 141(R), "Business
Combinations" ("SFAS No. 141(R)"). SFAS No. 141(R) requires acquiring entities
in a business combination to recognize the assets acquired and liabilities
assumed in the transaction; establishes the acquisition-date fair value as the
measurement objective for all assets acquired and liabilities assumed; and
requires the acquirer to disclose to investors the information they need to
evaluate and understand the nature and financial effect of the business
combination. SFAS No. 141(R) is effective in fiscal years beginning after
December 15, 2008. The Company expects to adopt SFAS No. 141(R) on July 1, 2009.
The Company is currently assessing the impact the adoption of SFAS No. 141(R)
will have on its consolidated financial statements.
In December 2007, the FASB issued SFAS No. 160, "Noncontrolling
Interests in Consolidated Financial Statements" ("SFAS No. 160"). SFAS No. 160
requires entities to report noncontrolling (minority) interests in subsidiaries
as equity in the consolidated financial statements. SFAS No. 160 is effective in
fiscal years beginning after December 15, 2008. The Company expects to adopt
SFAS No. 160 on July 1, 2009. The Company is currently assessing the impact the
adoption of SFAS No. 160 will have on its consolidated financial statements.
9
In June 2008, the FASB ratified EITF No. 07-5, "Determining Whether an
Instrument (or Embedded Feature) Is Indexed to an Entity's Own Stock," ("EITF
07-5"). EITF 07-5 provides guidance for determining whether an equity-linked
financial instrument, or embedded feature, is indexed to an entity's own stock.
EITF 07-5 is effective for fiscal years beginning after December 15, 2008, and
interim periods within those fiscal years, and will be adopted by the Company in
the first quarter of fiscal year 2010. The Company is currently assessing the
potential impact, if any, of the adoption of EITF 07-5 on its consolidated
results of operations and financial condition.
2. PFC THERAPEUTICS, LLC
On December 22, 2004, PFC Therapeutics and LEO Pharma A/S ("LEO"), one
of the leading Danish research-based pharmaceutical companies that markets
significant products within the fields of dermatology, metabolic and
cardiovascular diseases and ophthalmology and antibiotics, signed an exclusivity
agreement to enter into a license agreement, subject to continued due diligence
by LEO, to develop and commercialize Oxygent in Europe (EU member countries, EU
membership applicants, Norway and Switzerland) and Canada (the "LEO Exclusivity
Agreement"). The terms of the license agreement, if entered into, will include
certain initial and future payments to PFC Therapeutics upon the completion of
various regulatory and commercial milestones for Oxygent development in Europe
and royalties on commercial sales of Oxygent in Europe and Canada. On January 5,
2005, the Company received the non-refundable portion of an exclusivity fee of
$100,000 per the terms of the LEO Exclusivity Agreement. Because the amendment
discussed below extends LEO's due diligence time-period, this amount has been
deferred and is included in current liabilities in the accompanying consolidated
balance sheets at June 30, 2008 and March 31, 2009.
On February 25, 2005, PFC Therapeutics and LEO agreed to amend the LEO
Exclusivity Agreement. The amendment extends the period of time in which LEO may
undertake its due diligence investigation from March 1, 2005 to a date that is
sixty (60) days after submission by us to LEO of the results of a Phase 2b
postoperative ileus study. The postoperative ileus endpoints will be
incorporated in the Phase 2 clinical study described below. The remaining terms
of the LEO Exclusivity Agreement remain in full force and effect.
On May 13, 2005, PFC Therapeutics and Beijing Double-Crane
Pharmaceutical Co., Ltd. ("Double-Crane"), the market leader for IV solutions
and one of the largest pharmaceutical companies in the People's Republic of
China (the "PRC"), entered into a development, license and supply agreement
("Double-Crane Agreement") for the development of Oxygent in the PRC. Pursuant
to the Double-Crane Agreement, Double-Crane made an upfront license fee payment
and will make certain milestone and royalty payments to the Company. The upfront
license fee of $500,000 was deferred until the Company's obligations to perform
were satisfied. These obligations included the transfer and translation of all
intellectual property, preclinical, clinical and regulatory data necessary for
Double-Crane's clinical development and Investigational New Drug ("IND")
application to the State Food and Drug Administration PRC (the "SFDA"). This
transfer and all other corresponding obligations were completed and such amount
was recognized as license revenue at June 30, 2007.
Double-Crane intends to pursue an intraoperative and postoperative
transfusion avoidance endpoint. Double-Crane's clinical development plan
incorporates a new protocol design that is intended to build on the previously
conducted Alliance Phase 2 and Phase 3 clinical trials. In these studies, the
efficacy of Oxygent in terms of drug activity (i.e., its ability to deliver
oxygen) enabled patients to remain physiologically stable at lower
intraoperative hemoglobin ("Hb") levels. Oxygent was shown to be statistically
better than blood in reversing, as well as maintaining reversal of,
physiological transfusion triggers. Importantly, the Double-Crane study will not
employ any blood harvesting techniques (i.e., acute normovolemic hemodilution or
intraoperative autologous donation), which were implicated in safety issues in a
previous Alliance Phase 3 clinical trial.
Double-Crane is obligated pursuant to its agreement with Alliance to
conduct clinical trials in the PRC in accordance with the International
Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use (the "ICH") Guidelines, which would allow Alliance
to use any data derived from the clinical trials in other countries.
Double-Crane will manufacture Oxygent in the PRC after obtaining
approval from the regulatory authorities in the PRC and they will also have a
right of first refusal to add specific additional countries to the Double-Crane
Agreement upon further negotiation with the Company.
3. DEBT OBLIGATIONS
Senior Notes Payable
- --------------------
On July 2, 2004, Nycomed Denmark ApS ("Nycomed") notified the Company
that it was unilaterally terminating its Development, Assignment and Supply
Agreement (the "Nycomed Agreement") effective August 16, 2004. Subsequently, a
dispute arose between the Company and some of its investors who participated in
10
the June 2004 Private Placement. After considering all of the facts and
circumstances relevant to the dispute, the Company's Board of Directors
determined that it was in the Company's and the Company's shareholders' best
interests to offer, as a settlement of the dispute, to rescind the June 2004
Private Placement.
On September 24, 2004, investors holding 30,546,423 shares of common
stock and warrants to purchase 22,909,821 shares of common stock representing
approximately $10.7 million of the $11 million invested in the June 2004 Private
Placement elected to rescind the June 2004 Private Placement. In doing so, each
of these investors returned to the Company its stock certificate representing
the number of shares and the warrant that it received in the June 2004 Private
Placement for cancellation. Immediately thereafter, these same investors entered
into the Senior Note Purchase Agreement whereby the Company issued to such
investors Senior Notes convertible into common stock at $0.25 per share, which
was subsequently amended (see below), in principal amounts equal to the amounts
such investors invested in the June 2004 Private Placement.
After giving effect to both transactions, the Company issued 880,714
shares of common stock and warrants to purchase 660,536 shares of common stock
in the June 2004 Private Placement, and the Company issued Senior Notes in an
aggregate principal amount of approximately $10.7 million.
The Senior Notes were due March 24, 2006, and bore interest at 6% per
annum. In April 2006, the Company entered into the 2006 Amendment with each of
the existing holders of Alliance's Senior Notes. Pursuant to the 2006 Amendment,
the maturity date of each outstanding Senior Note was extended from March 24,
2006 to April 1, 2007. The conversion price of each Senior Note was reduced from
$0.25 to $0.17, and the interest that accrued on each Senior Note from March 25,
2006 through April 1, 2007 was increased from 6% to 10% per annum. In addition
to the amounts due under the Senior Notes, the holders of the Senior Notes were
entitled to receive up to an aggregate of $11.4 million in payments based on
future royalties from Oxygent product sales (or under certain conditions from
milestone payments) payable at a rate equal to 50% of such payments Alliance
actually receives.
On May 15, 2007, Alliance entered into an amendment (the "2007
Amendment") of its Senior Convertible Promissory Note Purchase Agreement and
Registration Rights Agreement (as amended by the 2006 Amendment) with
essentially all of the existing holders of the Senior Notes. Pursuant to the
2007 Amendment, the maturity date of each outstanding Senior Note was extended
as follows:
(a) The maturity date was extended from April 1, 2007 to the date
ninety (90) days after the date of the 2007 Amendment. If the Company received
more than $1.5 million but less than $3 million in connection with a Qualified
Financing (as defined in the 2007 Amendment) prior to the expiration of the
ninety (90) days (which the Company did not receive), the maturity date would
have been automatically extended to the date that is one hundred eighty (180)
days after the date of the 2007 Amendment; and
(b) If the Company received at least $3 million in connection with a
Qualified Financing prior to the extended maturity date, the maturity date would
automatically become June 30, 2008.
The holders of the Senior Notes also agreed to subordinate their rights
to any debt that is issued in a Qualified Financing. Further, any financing that
qualified as a Qualified Financing would not require additional approval from
the Senior Note holders.
Alliance also agreed to issue to each current holder of a Senior Note
an additional note with principal amount equal to 20% of the outstanding
principal amount of such Senior Note on the date of the 2007 Amendment, which
resulted in Alliance issuing new promissory notes in the aggregate principal
amount of approximately $1.8 million. These new notes bear interest at the rate
of 10% per annum, matured on June 30, 2008 and are convertible into common stock
of Alliance on the same terms as the Senior Notes at such time as Alliance has a
sufficient number of authorized and unreserved shares of common stock to
accommodate such conversion.
The Company further agreed to an increase of 20% to the current
royalty/milestone payment participation amounts set forth in the 2006 Amendment.
Under the 2006 Amendment, Senior Note holders receive 50% of the total amounts
of royalties and milestones received by the Company from third parties until
100% of the payment participation amounts have been received. The Senior Note
holders who held their Senior Notes through June 30, 2008 will now receive
payment sharing until 120% of the payment participation amounts have been
received.
The Company was unable to complete a Qualified Financing by the
requisite dates. As a result, the Company is in default under the Senior Notes
in the aggregate principal and interest amount of approximately $11.2 million.
Alliance is continuing to seek additional financing that would qualify as a
Qualified Financing for the purpose of funding its support of Double-Crane's
development of Oxygent in the PRC.
11
The Senior Notes can be converted anytime prior to the maturity date.
During the nine months ended March 31, 2009, holders of certain Senior Notes
converted an aggregate of approximately $266,000 in principal and approximately
$244,000 in accrued interest into an aggregate of 3,000,000 shares of our common
stock at a conversion price of $0.17 per share. During the nine months ended
March 31, 2008, holders of certain Senior Notes converted an aggregate of
approximately $2.1 million in principal and approximately $108,000 in accrued
interest into an aggregate of 12,780,018 shares of our common stock at a
conversion price of $0.17 per share. Also during the nine months ended March 31,
2008, we recorded a loss on modification of debt of $14,000 resulting from the
issuance of an additional note in connection with the 2007 Amendment. At March
31, 2009, the principal and accrued interest balances approximate $8 million and
$3.2 million, respectively.
The discussion included in this report assumes that we will continue as
a going concern, which contemplates, among other things, the realization of
assets and satisfaction of liabilities in the ordinary course of business. As
discussed in Note 1 to the condensed consolidated financial statements, we may
lack sufficient working capital to service our debts and to fund our continuing
operations through the fiscal year ending June 30, 2009, which raises
substantial doubt about our ability to continue as a going concern. As of March
31, 2009, we are in default under the terms of the 2007 Amendment and we owe the
holders of our Senior Notes approximately $11.2 million in principal and accrued
interest. We currently do not have the resources to repay the Senior Notes. If
the holders of our Senior Notes demand repayment, and we are unable to do so,
the holders of our Senior Notes may be able to force our liquidation. In the
event of our liquidation, it is highly unlikely the holders of our equity
securities will receive any of the proceeds of such liquidation.
Indemnification Obligations
- ---------------------------
The Company has undertaken certain indemnification obligations pursuant
to which it may be required to make payments to an indemnified party in relation
to certain transactions. The Company has agreed to indemnify its directors,
officers, employees and agents to the maximum extent permitted under the laws of
the State of New York. In connection with its facility leases, the Company has
agreed to indemnify its lessors for certain claims arising from the use of the
facilities. In connection with certain of its debt, stock purchase and other
agreements, the Company has agreed to indemnify lenders, sellers and various
other parties for certain claims arising from the Company's breach of
representations, warranties and other provisions contained in the agreements.
The duration of certain of these indemnification obligations does not provide
for any limitation of the maximum potential future payments the Company could be
obligated to make. Historically, the Company has not been obligated to make any
payments for these obligations and no liabilities have been recorded for these
indemnities in the accompanying unaudited condensed consolidated balance sheets.
4. RELATED PARTY TRANSACTION
During the period ended March 31, 2009, the Company's Chief Executive
Officer advanced $100,000 to the Company (the "Advances"). The Advances were
repaid during the period upon receipt of proceeds from the sale of raw material.
No interest was accrued or repaid in connection with the Advances.
5. EQUITY
Reverse Stock Split
- -------------------
On April 3, 2008, the Board adopted, and our shareholders approved at
the 2007 Annual Meeting on May 30, 2008, an amendment to our Certificate of
Incorporation, as amended (the "Certificate Amendment"), to effect a reverse
stock split (the "Reverse Stock Split"). The Certificate Amendment does not
reduce the authorized number of shares of common stock so that we will continue
to have an adequate number of shares available for future issuance, as discussed
below. The Certificate of Amendment will, subject to the discretion of the
Board, be filed with the Secretary of State of the State of New York as promptly
as practicable, provided that the Board does not anticipate directing the
Company to file the Certificate Amendment until such time as a Qualified
Financing takes place. The amendment and the proposed Reverse Stock Split will
become effective as of the date of such filing (the "Effective Date").
General
- -------
The Company is presently authorized to issue 150,000,000 shares of
common stock, of which 63,216,247 shares are outstanding, no shares are held in
treasury and 74,572,596 shares are reserved for issuance at March 31, 2009. Upon
the effectiveness of the Reverse Stock Split, the Company will have 150,000,000
shares of common stock authorized, of which, as of the Effective Date,
approximately 6,321,625 shares will be outstanding, and 7,457,260 shares will be
reserved for issuance.
12
Reasons for and Consequences of the Reverse Stock Split
- -------------------------------------------------------
The Company requires additional funding to continue its operations and
desires to issue new securities in a future private placement; however, it has
become clear to management that investors are unwilling to invest any new money
into the Company so long as its existing Senior Notes are outstanding.
The Company has reached an agreement with substantially all of the
holders of the Senior Notes to convert the outstanding principal amount and
accrued but unpaid interest under the Senior Notes into common stock of the
Company in accordance with the terms of the Senior Notes if certain conditions
are met.
To induce the holders of the Senior Notes to convert their Senior Notes
into common stock of the Company, the Company agreed to modify the existing
royalty and milestone sharing arrangements with the holders of the Senior Notes
as follows:
o The holders of the Senior Notes will be given the pro rata right
to receive 100% of all royalties received by the Company from
the sale of Oxygent products up to the maximum total payment
sharing amount of $11.4 million (currently, under our agreement
with the holders of the Senior Notes, the holders of the Senior
Notes have the right to only receive 50% of such royalties up to
the maximum payment amount); and
o The holders of the Senior Notes will also be given the pro rata
right to receive: (i) 100% of the milestone payment to be paid
to the Company by Double-Crane upon SFDA approval of Oxygent in
the PRC (currently, under the Note Purchase Agreement, the
holders of the Senior Notes have the contractual right to only
receive 50% of such milestone payment), and (ii) 50% of any
other milestone payment received from a third party based on the
development of an Oxygent product, in each case subject to the
total maximum amount of payments of $11.4 million.
At March 31, 2009, prior to the Reverse Stock Split taking effect, the
Senior Notes and accrued interest were convertible into 65,592,893 shares of
common stock at $0.17 per share.
In order to allow for the conversion of all of the Senior Notes, and
the subsequent issuance of shares of common stock in connection with a potential
private placement (as discussed below), the Company must effect the Reverse
Stock Split for the purpose of increasing the authorized but unissued and
unreserved shares of common stock.
The conversion of the Senior Notes is conditioned on the following: (i)
100% of the Senior Notes being received in escrow by the Company for conversion
and cancellation (unless this condition is waived by the Company); (ii) approval
of the Reverse Stock Split by the Company's shareholders (which was accomplished
at the 2007 Annual Meeting on May 30, 2008); (iii) filing of the Certificate
Amendment and acceptance of the same with the Secretary of State of the State of
New York; and (iv) receipt by the Company of at least $3 million in new
financing from investors (a "Qualified Financing"). We have not yet identified a
possible source of funds for a Qualified Financing. The Company has no
additional plan, commitment, arrangement, understanding or agreement, either
written or oral, to issue additional shares of common stock upon the
effectiveness of the Reverse Stock Split, other than for the conversion of the
existing Senior Notes and for the potential financing described above.
The Reverse Stock Split may also result in an increase in the trading
price of our common stock and could therefore create greater investor interest
in our common stock and possibly enhance the marketability of our common stock
to the financial market. However, although the Reverse Stock Split may increase
the market price of our common stock, the actual effect of the Reverse Stock
Split on our market price cannot be predicted. The market price of our common
stock may not rise in proportion to the reduction in the number of shares
outstanding as a result of the Reverse Stock Split. Further, the Company does
not know if the Reverse Stock Split will lead to a sustained increase in the
market price of our common stock. The market price of our common stock could
also change as a result of other unrelated factors, including our operating
performance and other factors related to our business as well as general market
conditions.
Principal Effects of the Reverse Stock Split
- --------------------------------------------
The following describes the effects of the Reverse Stock Split assuming
the Board directs management to complete the Reverse Stock Split.
Based upon the 63,216,247 shares of common stock outstanding on March
31, 2009, the proposed Reverse Stock Split would decrease the outstanding shares
of Common Stock by 90%, and thereafter 6,321,625 shares of common stock would be
outstanding. The proposed Reverse Stock Split will not affect any common
shareholder's proportionate equity interest in the Company, subject to the
provisions relating to the elimination of fractional shares as described below.
13
At March 31, 2009, there were outstanding options to purchase an
aggregate of 2,645,700 shares of common stock under the Company's stock option
plans (the "Plans") and an aggregate of 4,102,110 shares were available for
grant under two of the Plans. The Company has reserved 6,747,810 shares for
issuance upon the exercise of the granted options and upon exercise of options
that may be granted in the future. The Plans provide for automatic adjustment in
the event of a reverse stock split so that the amount of shares issuable upon
exercise of outstanding options, the number of shares available for grant and
the number of shares reserved for issuance will be reduced to one-tenth of the
amount issuable prior to the Effective Date, and the exercise prices of the
granted options would become ten times the present exercise prices.
At March 31, 2009, there were outstanding warrants to purchase an
aggregate of 2,231,893 shares of common stock and 2,231,893 shares of common
stock reserved for issuance at such date for the warrants. The provisions of the
relevant instrument pursuant to which the warrants were issued provide for
automatic adjustment in the event of a reverse stock split so that the amount of
shares issuable upon exercise of the warrants will be reduced to one-tenth of
the amount issuable prior to the Effective Date, and the exercise price would
become ten times the present exercise price. Accordingly, 223,189 shares of
common stock will be reserved for issuance on the Effective Date for the
warrants.
At March 31, 2009, the Company, in addition to options and warrants,
had outstanding $8 million principal amount of the Senior Notes and accrued
interest of $3.2 million on said notes. The Senior Notes and accrued interest
are convertible at any time, at the respective holders' option, into shares of
common stock at $0.17 per share, subject to adjustment in the case of a reverse
stock split. In accordance with the provisions of the relevant instruments
pursuant to which the Senior Notes were issued, the number of shares of common
stock into which they may be converted is 65,592,893, which amount will be
reduced to 6,559,289 shares of common stock as a result of the Reverse Stock
Split.
The foregoing may be summarized as follows:
If Reverse Stock Split
Number of Shares of Common Stock As of March 31, 2009 is Effected *
- -------------------------------- -------------------- -------------
Authorized 150,000,000 150,000,000
Issued and Outstanding** 63,216,247 6,321,625
Reserved for Issuance*** 74,572,596 7,457,260
Available for Future Issuance 12,211,157 136,221,116
Par Value Per Share $0.01 $0.01
- ----------------
* Without giving effect to fractional shares.
** Includes 635,000 shares of common stock deemed outstanding due to
the automatic conversion of the Company's Series F Preferred Stock that occurred
in March 2004. The stock certificate representing these shares of common stock
has not yet been issued.
*** Number of shares reserved for estimated issuance upon exercise of
options, warrants and debt.
6. SUBSEQUENT EVENTS
Subsequent to March 31, 2009, holders of certain Senior Notes converted
an aggregate of $380,000 in principal and approximately $317,000 in accrued
interest into an aggregate of 4,100,345 shares of our common stock at a
conversion price of $0.17 per share.
Item 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations
(References to years are to our fiscal years ended June 30.)
PLAN OF OPERATION
Since our inception in 1983, we have financed our operations primarily
through the sale of equity and debt securities, and we have applied
substantially all of our resources to research and development programs and to
clinical trials. We have incurred operating losses since inception and, as of
March 31, 2009, have an accumulated deficit of $500.5 million. We expect to
incur significant operating losses over at least the next few years as we
continue our research and product development efforts and attempt to
commercialize our products.
The Company is continuing to seek additional financing of approximately $3
million to fund its continuing operations through June 2011. Because adequate
funds have not been available to the Company in the past, the Company has
already delayed its Oxygent development efforts and has delayed, scaled back,
and/or eliminated one or more of its other product development programs (see
Note 1 to the accompanying unaudited condensed consolidated financial statements
and the "Liquidity and Capital Resources" section below).
Our revenues from operations have come primarily from collaborations
with corporate partners, including research and development, milestone and
royalty payments. Our expenses have consisted primarily of research and
development costs and administrative costs. To date, our revenues from the sale
of products have not been significant. We believe our future operating results
14
may be subject to quarterly fluctuations due to a variety of factors, including
the timing of future collaborations and the achievement of milestones under
collaborative agreements, whether and when new products are successfully
developed and introduced by us or our competitors, and market acceptance of
products under development.
The discussion included in this report assumes that we will continue as
a going concern, which contemplates, among other things, the realization of
assets and satisfaction of liabilities in the ordinary course of business. As
discussed in Note 1 to the condensed consolidated financial statements, we may
lack sufficient working capital to service our debts and to fund our continuing
operations through the fiscal year ending June 30, 2009, which raises
substantial doubt about our ability to continue as a going concern. As of March
31, 2009, we are in default under the terms of the 2007 Amendment and we owe the
holders of our Senior Notes approximately $11.2 million in principal and accrued
interest. We currently do not have the resources to repay the Senior Notes. If
the holders of our Senior Notes demand repayment, and we are unable to do so,
the holders of our Senior Notes may be able to force our liquidation. In the
event of our liquidation, it is highly unlikely the holders of our equity
securities will receive any of the proceeds of such liquidation.
FORWARD-LOOKING INFORMATION
Except for historical information, the statements made herein and
elsewhere are forward-looking. The Company wishes to caution readers that these
statements are only predictions and that the Company's business is subject to
significant risks. The factors discussed herein and other important factors, in
some cases have affected, and in the future could affect, the Company's actual
results and could cause the Company's actual consolidated results for 2009, and
beyond, to differ materially from those expressed in any forward-looking
statements made by, or on behalf of, the Company. These risks include, but are
not limited to, the inability to obtain adequate financing for the Company's
development efforts; the likelihood that our creditors will force our
liquidation; the inability to enter into collaborative relationships to further
develop, manufacture and commercialize the Company's products; changes in any
such relationships, or the inability of any collaborative partner to adequately
commercialize any of the Company's products; the uncertainties associated with
the lengthy regulatory approval process, including uncertainties associated with
FDA decisions and timing on product development or approval; and the
uncertainties associated with obtaining and enforcing patents important to the
Company's business; and possible competition from other products. Furthermore,
even if the Company's products appear promising at an early stage of
development, they may not reach the market for a number of important reasons.
Such reasons include, but are not limited to, the possibilities that the
potential products will be found ineffective during clinical trials; failure to
receive necessary regulatory approvals; difficulties in manufacturing on a large
scale; failure to obtain market acceptance; and the inability to commercialize
because of proprietary rights of third parties. The research, development and
market introduction of new products will require the application of considerable
technical and financial resources, while revenues generated from such products,
assuming they are developed successfully, may not be realized for several years.
Other material and unpredictable factors which could affect operating results
include, without limitation, the uncertainty of the timing of product approvals
and introductions and of sales growth; the ability to obtain necessary raw
materials at cost-effective prices or at all; the effect of possible technology
and/or other business acquisitions or transactions; and the increasing emphasis
on controlling healthcare costs and potential legislation or regulation of
healthcare pricing. Further cautionary information is contained in documents the
Company files with the SEC from time to time, and you are encouraged to read the
section entitled "Risk Factors" included in the Company's most recently filed
Annual Report on Form 10-KSB filed with the SEC on October 2, 2008.
RESEARCH AND DEVELOPMENT
For the nine months ended March 31, 2009 and 2008, we incurred research
and development expenses of $96,000 and $332,000, respectively, for Oxygent, an
intravascular oxygen carrier that we are developing to augment oxygen delivery
in surgical patients at risk of acute oxygen deficit. Research and development
costs to date for our oxygen-therapeutic product candidates, including Oxygent,
total approximately $161 million. While difficult to predict, we estimate that
the completion of clinical trials for Oxygent will cost at least an additional
$70 million. We do not anticipate that Oxygent will reach the market for at
least a few years, if at all, and, because of the numerous risks and
uncertainties associated with product development efforts, we are unable to
predict the extent of any future expenditures or when material net cash inflows
from Oxygent may commence, if at all.
In January 2007, the French Ethics Committee (IRB) and the French
Competent Authority (regulatory agency) granted approval to start the Phase 2b
clinical trial for Oxygent to prevent postoperative ileus resulting from hypoxia
during major surgery trial. Subsequently in November 2007, Alliance suspended
the clinical trial due to lack of adequate funding.
On February 6, 2007, we announced the manufacture and release for
shipment of Oxygent for the clinical trials planned in France and the PRC.
Alliance successfully completed the contract manufacture of Oxygent clinical
trial material. However, on March 15, 2007, we announced that, in accordance
with the current regulations of the SFDA, the supplies for an IND application
and clinical development must be manufactured in a facility in the PRC to
15
include the active pharmaceutical ingredient (the "API"). This includes the
perfluorochemical components of Oxygent. As a result, Alliance agreed to
accelerate the manufacturing technology transfer to Double-Crane, which
originally was planned to occur when Phase 3 trials were initiated in the PRC.
This technology transfer is underway with Double-Crane building the
manufacturing facility and purchasing the required equipment for emulsion
manufacture. Double-Crane has successfully made pilot scale API quantities and
is in the process of scale-up activities. Once clinical supplies are
manufactured by Double-Crane, Double-Crane has indicated that it will submit its
IND application for initiation of the agreed upon clinical development plan.
Double-Crane will start a Phase 1 safety trial in Chinese nationals immediately
after the SFDA approves the IND application.
Double-Crane has considerable experience in manufacturing large-volume
parenteral and IV solutions and has expressed a desire to supply Alliance with
clinical and commercial supplies of Oxygent from its facilities in the PRC.
Supply of Oxygent to the U.S. would be contingent on Double-Crane's compliance
to cGMP and registration with the U.S. FDA.
RESULTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2009 AS COMPARED WITH THREE MONTHS ENDED MARCH 31,
2008
We recorded $79,000 in revenue for the three months ended March 31,
2009, compared to $26,000 for the three months ended March 31, 2008. The revenue
for both years' quarters consisted of royalties from certain products. The
revenue for the current period consists of a buy-out of the remaining royalty
stream from these products, which was due to expire in 2013-2014; therefore, we
expect no royalty revenue from these products in the future.
Research and development expenses decreased by $68,000, or 94%, to
$4,000 for the three months ended March 31, 2009, compared to $72,000 for the
three months ended March 31, 2008. The decrease in research and development
expenses was primarily the result of a decrease in clinical and regulatory
activities of $14,000, engineering activities of $27,000, patent costs of
$18,000, and archiving and storage expenses of $9,000.
General and administrative expenses decreased by $14,000, or 8%, to
$167,000 for the three months ended March 31, 2009, compared to $181,000 for the
three months ended March 31, 2008. The decrease in general and administrative
expenses was primarily the result of a decrease in legal and accounting fees of
$9,000, personnel costs of $7,000, partially offset by an increase in computer
expenses.
Investment income for the three months ended March 31, 2009 was $1,000,
compared to $1,000 for the three months ended March 31, 2008.
Other income was $226,000 for the three months ended March 31, 2009,
compared to $25,000 for the three months ended March 31, 2008, both of which
were the result of proceeds recorded from the sale of raw material inventory
(which was previously written off).
Interest expense was $199,000 for the three months ended March 31,
2009, compared to $196,000 for the three months ended March 31, 2008.
NINE MONTHS ENDED MARCH 31, 2009 AS COMPARED WITH NINE MONTHS ENDED MARCH 31,
2008
Our revenue decreased to $79,000 for the nine months ended March 31,
2009, compared to $83,000 for the nine months ended March 31, 2008. The revenue
for the both periods was composed of royalties received from sales of certain
products. The revenue for the current period consists of a buy-out of the
remaining royalty stream from these products, which was due to expire in
2013-2014; therefore, we expect no royalty revenue from these products in the
future.
Research and development expenses decreased by $236,000, or 71%, to
$96,000 for the nine months ended March 31, 2009, compared to $332,000 for the
nine months ended March 31, 2008. The decrease in research and development
expenses was primarily due to a decrease of $112,000 because of the discontinued
clinical trial in France, a refund of $18,000 in clinical trial insurance during
the current period, a decrease in contract manufacturing of Oxygent clinical
trial material of $63,000, a decrease of $28,000 in research and development
personnel costs, a decrease in preclinical costs of $8,000 and a decrease of
$16,000 in archiving and storage costs, partially offset by an increase in
patent expenses of $10,000 related to a new patent.
General and administrative expenses decreased by $139,000, or 21%, to
$533,000 for the nine months ended March 31, 2009, compared to $672,000 for the
nine months ended March 31, 2008. The decrease in general and administrative
expenses was primarily a decrease of $78,000 in legal and accounting fees, a
decrease of $26,000 in rent and other office-related expenses, a decrease of
$19,000 in personnel costs and a decrease of $13,000 in travel expenses.
For the nine months ended March 31, 2009, we recorded a gain on the
disposition of an asset of $25,000, which was primarily due to the agreement to
terminate all on-going obligations under previous agreements between the Company
and Imcor Pharmaceutical Inc. ("Imcor") whereby both companies agreed that the
continuing rights and obligations of each company under the terms of their
previous agreements were terminated and were of no further force or effect.
Imcor paid $25,000 to Alliance in satisfaction of all of Imcor's obligations and
liabilities under the terms of the previous agreements. In return, Alliance
released Imcor from all liabilities, including future royalty payments, if any.
16
For the nine months ended March 31, 2009, we recorded a loss on
disposition of equipment of $20,000, which was primarily the transfer of $31,000
of equipment, less $11,000 of depreciation, to Double-Crane.
For the nine months ended March 31, 2008, we recorded a loss on
modification of debt of $14,000 resulting from the issuance of an additional
note in connection with the 2007 Amendment (see Note 3).
Investment income decreased by $13,000 to $2,000 for the nine months
ended March 31, 2009, compared to $15,000 for the nine months ended March 31,
2008. The decrease was primarily a result of lower cash balances during the
current period.
Other income was $251,000 for the nine months ended March 31, 2009,
compared to $188,000 for the nine months ended March 31, 2008, which were both
the result of proceeds recorded from the sale of raw material inventory (which
was previously written off).
Interest expense was $596,000 for the nine months ended March 31, 2009,
compared to $661,000 for the nine months ended March 31, 2008. The decreased
interest expense for the current period was the result of lower Senior Note
principal balances due to the conversion of certain principal amounts into
common stock.
LIQUIDITY AND CAPITAL RESOURCES
Since inception, we have funded our operations primarily through the
sale of equity securities, payments under our collaboration agreements and debt
financing. From inception to March 31, 2009, we had received $243 million in net
proceeds from sales of our equity securities, $260.8 million in payments from
collaboration agreements and $74.3 million in debt financing of which $41
million of such debt has been converted into equity and $25.9 million of such
debt has been retired through the restructuring of various agreements and the
issuance of warrants to purchase our common stock.
At March 31, 2009, we had approximately $92,000 in cash compared to
$6,000 at June 30, 2008. The increase resulted primarily from the net cash
provided by operations of $86,000. At March 31, 2009, we had a working capital
deficit of $11.9 million, compared to a working capital deficit of $11.6 million
at June 30, 2008. The deficit increase was principally due to a net decrease in
prepaid expenses and other current assets of $39,000, a net increase in accounts
payable and accrued expenses of $7,000, an increase in deferred compensation of
$250,000, an increase in the Senior Note accrued interest of $596,000, partially
offset by conversion of a Senior Note and accrued interest of $510,000 and an
increase in cash of $86,000. Our operations to date have consumed substantial
amounts of cash and are expected to continue to do so for the foreseeable
future.
Net cash provided by operating activities totaled $86,000 for the nine
months ended March 31, 2009, compared to net cash used of $813,000 for the nine
months ended March 31, 2008. The net cash provided by operating activities
during the nine months ended March 31, 2009 was primarily due to a decrease in
payments for research and development and general and administrative activities,
an increase in deferred compensation, an increase in revenues from the sale of
raw material and proceeds from the royalty stream buy-out
At March 31, 2009, the following approximate debt obligations were
outstanding:
(a) $260,000 owed to various vendors;
(b) $474,000 in accrued expenses, including $390,000 in deferred
compensation;
(c) $100,000 in deferred revenue;
(d) $11.2 million in Senior Notes, including $3.2 million in accrued
interest;
(e) $750,000 in deferred royalty payments to be paid through future
Imagent earn-out payments, if any. In the event there are no future Imagent
earn-out payments, the deferred royalties will not be paid.
Until we can generate significant continuing revenues, we expect to
satisfy our future cash needs through strategic collaborations, private or
public sales of our securities, debt financings or by licensing all or a portion
of our product candidates or technology. We cannot be certain that additional
funding will be available to us on acceptable terms, or at all.
We no longer have working capital to fund our operations; therefore, in
addition to seeking to complete a Qualified Financing, we are seeking additional
collaborative research and development relationships with suitable corporate
partners for our products. Because adequate funds have not been available to us
in the past, we have already delayed our Oxygent development efforts and have
delayed, scaled back, and/or eliminated one or more of our other product
development programs.
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The accompanying unaudited condensed consolidated financial statements
have been prepared assuming the Company will continue as a going concern, which
contemplates, among other things, the realization of assets and satisfaction of
liabilities in the ordinary course of business. We have incurred operating
losses through March 31, 2009. These factors, among others, raise substantial
doubt about the Company's ability to continue as a going concern. As of March
31, 2009, we are in default under the terms of the 2007 Amendment and we owe the
holders of our Senior Notes approximately $11.2 million in principal and accrued
interest. We currently do not have the resources to repay the Senior Notes. If
the holders of our Senior Notes demand repayment, and we are unable to do so,
the holders of our Senior Notes may be able to force our liquidation. In the
event of our liquidation, it is highly unlikely the holders of our equity
securities will receive any of the proceeds of such liquidation. The
accompanying unaudited condensed consolidated financial statements do not
include any adjustment to reflect the possible future effects on the
recoverability and classification of assets or the amount and classification of
liabilities that may result from the outcome of this uncertainty.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements of the Securities
Exchange Act of 1934, as amended, and must file reports, proxy statements and
other information with the SEC. The reports, information statements and other
information we file with the Commission can be inspected and copied at the
Commission Public Reference Room, 100 F Street, N.E. Washington, D.C. 20549. You
may obtain information on the operation of the Public Reference Room by calling
the SEC at (800) SEC-0330. The Commission also maintains a Web site
(http://www.sec.gov) that contains reports, proxy, information statements and
other information regarding registrants, like us, which file electronically with
the Commission.
We were incorporated in New York in 1983. Our principal executive
offices are located at 7590 Fay Avenue, Suite 404, La Jolla, California 92037,
and our telephone number is (858) 779-1458.
Our common stock is traded on the OTCBB under the symbol "ALLP.OB."
CRITICAL ACCOUNTING POLICIES
There were no significant changes in critical accounting policies or
estimates from those at June 30, 2008.
OFF-BALANCE SHEET FINANCING ARRANGEMENTS
As of March 31, 2009, we did not have any off-balance sheet financing
arrangements or any equity ownership interests in any variable interest entity
or other minority-owned ventures.
ITEM 4T. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures. The Company
carried out an evaluation, under the supervision and with the participation of
the Company's management, including the Company's Chief Executive Officer
("CEO") and Chief Financial Officer ("CFO"), of the effectiveness of the
Company's disclosure controls and procedures. Based upon that evaluation, our
CEO and CFO concluded that as of March 31, 2009 our disclosure controls and
procedures were effective at the reasonable assurance level in timely alerting
them to the material information relating to the Company (or the Company's
consolidated subsidiaries) required to be included in the Company's periodic
filings with the SEC, subject to the various limitations on effectiveness set
forth below under the heading, "Limitations on the Effectiveness of Internal
Controls," such that the information relating to the Company, required to be
disclosed in SEC reports (i) is recorded, processed, summarized and reported
within the time periods specified in SEC rules and forms, and (ii) is
accumulated and communicated to the Company's management, including our CEO and
CFO, as appropriate to allow timely decisions regarding required disclosure.
(b) Changes in internal control over financial reporting. There has
been no change in the Company's internal control over financial reporting that
occurred during the three-month period ended March 31, 2009 that has materially
affected, or is reasonably likely to materially affect, the Company's internal
control over financial reporting.
LIMITATIONS ON THE EFFECTIVENESS OF INTERNAL CONTROLS
The Company's management, including our CEO and CFO, does not expect
that our disclosure controls and procedures or our internal control over
financial reporting will necessarily prevent all fraud and material error. An
internal control system, no matter how well conceived and operated, can provide
only reasonable, not absolute, assurance that the objectives of the control
system are met. Further, the design of a control system must reflect the fact
that there are resource constraints, and the benefits of controls must be
considered relative to their costs. Because of the inherent limitations in all
control systems, no evaluation of controls can provide absolute assurance that
all control issues and instances of fraud, if any, within the Company have been
detected. These inherent limitations include the realities that judgments in
decision-making can be faulty, and that breakdowns can occur because of simple
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error or mistake. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by management
override of the internal control. The design of any system of controls also is
based in part upon certain assumptions about the likelihood of future events,
and there can be no assurance that any design will succeed in achieving its
stated goals under all potential future conditions. Over time, control may
become inadequate because of changes in conditions, and/or the degree of
compliance with the policies or procedures may deteriorate.
Part II OTHER INFORMATION:
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Subsequent to the quarter ended March 31, 2009, holders of certain
Senior Notes converted an aggregate of $380,000 in principal and approximately
$317,000 in accrued interest into an aggregate of 4,100,345 shares of our common
stock at a conversion price of $0.17 per share.
The offers and sales of these securities were deemed to be exempt from
registration under the Securities Act of 1933, as amended, (the "Securities
Act") in reliance on Section 4(2) of the Securities Act and/or Regulation D
promulgated thereunder as transactions by us not involving a public offering.
The recipients of the securities in each such transaction represented their
intention to acquire the securities for investment only and not with a view to
or for sale in connection with any distribution thereof and appropriate legends
were affixed to share certificates issued in such transactions. All recipients
had adequate access to information about us.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
The Company is currently in default with respect to the repayment of
all outstanding principal under the Senior Notes, totaling $8 million, and
accrued interest under the Senior Notes, totaling $3.2 million, at March 31,
2009.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS
(a) Index to Exhibits
Exhibit Description
- ------- -----------
31.1 Certification of our Chief Executive Officer, pursuant to
Securities Exchange Act Rule 13a-14(a) and 15d-14(a) as
adopted pursuant to Section 302 of the Sarbanes Oxley Act of
2002. *
31.2 Certification of our Chief Financial Officer, pursuant to
Securities Exchange Act Rule 13a-14(a) and 15d-14(a) as
adopted pursuant to Section 302 of the Sarbanes Oxley Act of
2002. *
32.1 Certification of our Chief Executive Officer under Section 906
of the Sarbanes Oxley Act of 2002. (18 U.S.C. Section 1350). *
32.2 Certification of our Chief Financial Officer under Section 906
of the Sarbanes Oxley Act of 2002. (18 U.S.C. Section 1350). *
__________________
* Filed Herewith.
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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.
ALLIANCE PHARMACEUTICAL CORP.
(Registrant)
Date: May 15, 2009 By: /s/ Duane J. Roth
-------------------------------------
Duane J. Roth
Chairman and Chief Executive
Officer
By: /s/ Jack DeFranco
-------------------------------------
Jack DeFranco
Chief Operating Officer and
Chief Financial Officer
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