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| AVRX > SEC Filings for AVRX > Form 10-Q on 13-May-2009 | All Recent SEC Filings |
13-May-2009
Quarterly Report
Recent Developments
Effective May 1, 2009, Avalon and Merck & Co., Inc., or Merck, agreed to
terminate the Exclusive License and Research Collaboration Agreement between the
parties (referred to as the "Merck Agreement") pursuant to the terms of the
Merck Agreement. As part of the termination of the Merck Agreement, Merck agreed
to pay Avalon a termination payment of $4 million. The $4 million termination
payment was paid by Merck to Avalon on May 7, 2009. Avalon will recognize the
termination payment as revenue in the second quarter of 2009.
Under the terms of the merger agreement with Clinical Data, the $4 million
payment received by Avalon from Merck was required to be used to pay down the
outstanding balance, including interest, of our secured loan with Clinical Data.
See "-Liquidity and Capital Resources-Clinical Data Secured Loan" below. As of
April 30, 2009, a total of approximately $4.1 million in principal and accrued
interest remained outstanding under this secured loan. On May 8, 2009, Avalon
paid Clinical Data a total of $4 million in respect of the secured loan,
reducing the outstanding balance of the secured loan by that amount.
Financial Operations Overview
Revenue
We have not generated any revenue from sales of commercial products and do
not expect to generate any product revenue for the foreseeable future. To date,
our revenue has consisted of collaboration revenue.
Collaboration Revenue. Since inception, we have generated revenue solely
in connection with our collaboration and pilot study agreements. Our
collaborations with Merck, AstraZeneca and Novartis include upfront payments,
research funding, and/or payments for the achievement of certain discovery and
development related milestones. During the first three months of 2009, we
recognized no revenue from any of our collaborations.
Research and Development Expense
Research and development expense consists of expenses incurred in
connection with developing and advancing our drug discovery technology and
identifying and developing our drug candidates and supporting our collaborative
relationships. These expenses consist primarily of salaries and related
expenses, the purchase of laboratory supplies, access to data sources, facility
costs, costs for preclinical development and expenses related to our in-license
and clinical trials of AVN944. Other than for advance payments for research and
development costs, subject to the provisions of EITF 07-03, we charge all
research and development expenses to operations as incurred.
We expect our research and development costs to be substantial as we
advance our drug candidates into preclinical testing and clinical trials. Based
on the results of our preclinical studies, we expect to selectively advance some
drug candidates into clinical trials. We anticipate that we will select drug
candidates and research projects for further development on an ongoing basis in
response to their preclinical and clinical success and commercial potential. We
are currently conducting Phase I clinical trials for AVN944 in patients with
hematological cancer and Phase IIa clinical trials for patients with pancreatic
cancer. In August 2008, we announced that we had reached a likely maximum
tolerated dose of AVN944 in both the ongoing Phase I clinical trial and in the
Phase IIa trial. We are currently assessing various alternatives regarding the
internal or external development of AVN944.
General and Administrative
General and administrative expense consists primarily of salaries and
related expenses for personnel in administrative, finance, business development
and human resource functions. Other costs include legal costs of pursuing patent
protection of our intellectual property and other fees for legal services.
Results of Operations
Three Months Ended March 31, 2009 and 2008
Revenue. There were no revenues for the three months ended March 31, 2009,
compared with $50,000 in the same period of the prior year. The reported
revenues in 2008 were attributable to our collaboration agreement with Novartis.
Research and Development. Research and development expenses decreased by
$1.7 million, or 39%, to $2.7 million for the three months ended March 31, 2009
from $4.4 million for the same period in 2007. The decrease in research and
development expenses was primarily attributable to lower personnel and lab
supplies costs due to the reduction in force in August 2008 as well as lower
cost for clinical trials in the 2009 period.
General and Administrative. General and administrative expenses decreased
by $1.2 million or 57% when comparing the three months ended March 31, 2009 with
the three months ended March 31, 2008. The decrease is due primarily to lower
personnel costs due to the reduction in force in August 2008 as well as lower
stock compensation expense in 2009.
Interest Income. There was no interest income for the three months ended
March 31, 2009, compared with $307,000 for the three months ended March 31,
2008. The decrease in interest income is due to lower balances of cash and
investments and lower average interest rates.
Interest Expense. Interest expense decreased by $63,000, or 55%, to
$52,000 for the three months ended March 31, 2009, compared to $115,000 for the
three months ended March 31, 2008. The decrease in interest expense was due to
lower debt balances in the 2009 period, principally related to paying off our
loan the Maryland Industrial Development Financing Authority in October 2008.
Other Income. Other income was $80,000 for the three months ended
March 31, 2009, compared with $2,000 for the three months ended March 31, 2008.
The increase in other income was primarily related to income from subletting
part of our facility and the provision of shared services to subtenants.
Liquidity and Capital Resources
Our primary cash requirements are to:
• fund our research and development and clinical programs;
• obtain regulatory approvals;
• prosecute, defend and enforce any patent claims and other intellectual property rights;
• fund general corporate overhead; and
• support our debt service requirements and contractual obligations.
Our cash requirements could change materially as a result of the progress
of our research and development and clinical programs, licensing activities,
acquisitions, divestitures or other corporate developments.
We have incurred operating losses since our inception and historically
have financed our operations principally through public stock offerings, debt
financings, private placements of equity securities, strategic collaborative
agreements that include research and development funding and development
milestones, and investment income.
In evaluating alternative sources of financing we consider, among other
things, the dilutive impact, if any, on our stockholders, the ability to
leverage stockholder returns through debt financing, the particular terms and
conditions of each alternative financing arrangement and our ability to service
our obligations under such financing arrangements.
As of March 31, 2009, we had cash, cash equivalents and marketable
securities of approximately $3.5 million.
Clinical Data Secured Loan
As a part of the proposed merger, we entered into a note purchase
agreement with Clinical Data pursuant to which Clinical Data made a series of
loans to us evidenced by term notes in the aggregate principal amount of
$4 million. The term notes bear interest at a fixed rate of 7% per annum and
mature on May 31, 2009 unless accelerated pursuant to their terms. The original
amount of the loan from Clinical Data under the note purchase agreement was
$3 million and matured on March 31, 2009. On January 12, 2009, Clinical Data
extended the maturity of the original $3 million term note evidencing the loan
until April 30, 2009. On March 30, 2009, Avalon and Clinical Data amended the
note purchase agreement and the original $3 million term note to further extend
the $3 million term note's maturity date to May 31, 2009 and Clinical Data and
Avalon also increased the amount borrowed by Avalon under the note purchase
agreement from $3 million to $4 million through the issuance by Avalon of an
additional $1 million term note. We have the right to prepay the term notes,
together with any accrued interest, at any time without penalty. The maturity of
the term notes accelerates if there is a default under the terms of the note
purchase agreement or related documents, including any default, breach or
termination of Clinical Data's license agreement with us relating to AvalonRx®
or of the merger agreement (other than a termination of the merger agreement as
a result of a failure to obtain the approval by our stockholders of the merger).
The term notes are secured by collateral consisting of certain of our
intellectual property rights.
Sources and Uses of Cash
Operating Activities. Net cash used in operating activities for the three
months ended March 31, 2009 was $3.3 million, compared to $4.8 million for the
same period in fiscal 2008. During the first three months of fiscal year 2009,
our net loss of $3.6 million was reduced by non-cash charges of $430,000,
primarily for stock compensation, depreciation and amortization, offset by
changes in our net operating assets and liabilities.
Investing Activities. Net cash provided by investing activities for the
three months ended March 31, 2009 was $894,000, compared to net cash used in
investing activities of $4.2 million for the same period in 2008. Proceeds from
the sale and maturity of marketable securities were the primary source of cash
from investing activities, providing $899,000 in the first three months of 2009
and $9.2 million in the comparable period of 2008. Cash used in investing
activities principally represents the amount used to purchase marketable
securities, net of proceeds from the sale and maturity of marketable securities.
Financing Activities. Net cash provided by financing activities for the
three months ended March 31, 2009 was $1.0 million, compared to $43,000 of net
cash used in financing activities for the same period in 2008. In March 2009, we
borrowed an additional $1.0 million from Clinical Data under a secured loan to
fund our short-term operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not applicable pursuant to the rules of the Securities and Exchange
Commission relating to the disclosure requirements for a "smaller reporting
company."
Item 4T. Controls and Procedures
Disclosure Controls and Procedures: Under the supervision and with the
participation of our management, including our Chief Executive Officer and our
Chief Financial Officer, we have evaluated the effectiveness of our disclosure
controls and procedures, as of March 31, 2009 (the "Evaluation Date"). Based on
that evaluation, our Chief Executive Officer and Chief Financial Officer have
concluded that, as of the Evaluation Date, our disclosure controls and
procedures were effective.
Changes in Internal Control over Financial Reporting: There have been no
changes in our internal control over financial reporting during the quarter
ended on the Evaluation Date that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
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