REDWOOD CITY, CA, Nov. 3, 2009 (Marketwire) --
REDWOOD CITY, CA -- (Marketwire) -- 11/03/09 -- Facet Biotech Corporation (NASDAQ: FACT) today reported financial results for the third quarter ended September 30, 2009.
"We are executing on our development programs while remaining vigilant on cost containment and expense management," said Faheem Hasnain, president and chief executive officer of Facet Biotech. "We expect our lead program, daclizumab in multiple sclerosis, to enter a second registration-enabling study in the first half of 2010, triggering a $30 million milestone payment to us from Biogen Idec. Our four development-stage oncology programs continue to progress, and for our elotuzumab and TRU-016 oncology programs, we remain on track toward achieving important development milestones in the coming year. Our strong balance sheet enables us to support our programs through these and other future critical milestones to the end of 2012. We possess a focused and promising pipeline and have never been more confident in the future growth prospects for Facet Biotech."
Summary of Financial Results
The financial results for the quarter ended September 30, 2009 represent the third full quarter of operations for Facet as an independent company since its spin-off from PDL BioPharma, Inc. (PDL) on December 18, 2008. The results for the quarter and nine months ended September 30, 2008 are comprised of the results of PDL's former biotechnology operations, which were derived from PDL's historical consolidated financial statements, prior to the spin-off.
-- Total revenues for the third quarter of 2009 were $10.8 million
compared to $5.0 million in the same period of 2008. This increase
was primarily due to an additional $4.6 million in revenues recognized
under the company's collaboration with Bristol-Myers Squibb Company
(BMS). The increase in revenues under the BMS collaboration was driven
by the timing of the effectiveness of the collaboration agreement in
September 2008, resulting in a full quarter of revenue in the 2009
period as compared to approximately one month of revenue in the 2008
period.
-- Total costs and expenses for the third quarter of 2009 were $53.1
million compared to $53.5 million reported for the comparable 2008
period. In the third quarter of 2009, total costs and expenses included
$21.9 million in research and development (R&D) expenses related to the
company's collaboration with Trubion Pharmaceuticals, Inc., which was
entered into in August 2009, and $2.5 million of general and
administrative (G&A) expenses related to Biogen Idec Inc.'s unsolicited
offers to acquire the outstanding shares of common stock of the
company. These costs, for which there were no corresponding expenses in
the third quarter of 2008, were offset by lower personnel and overhead
expenses resulting from the company's restructuring activities in 2009.
-- R&D expenses were $45.1 million for the third quarter of 2009
compared to $41.2 million for the same period of 2008. The increase
was due primarily to costs related to the Trubion collaboration
that was entered into during the 2009 period, including the $20.0
million upfront license payment made to Trubion in September 2009.
These increases were offset by lower employee-related and overhead
expenses in 2009 resulting from the impact of the sale of the
manufacturing assets during the first quarter of 2008 and
restructuring activities, as well as a decrease in volociximab
development costs.
-- G&A expenses in the third quarter of 2009 decreased to $9.5 million
from $11.3 million for the prior year comparable period. This
decrease was primarily due to reduced personnel-related expenses as
a result of prior period restructuring activities and was partially
offset by higher legal and financial expenses incurred in the third
quarter of 2009 in relation to the unsolicited offers to acquire
the company made by Biogen Idec.
-- Restructuring charges in the third quarter of 2009 included a $1.7
million credit resulting from a change in estimate that reduced
lease-related restructuring liabilities. The $1.0 million in
restructuring charges in the comparable 2008 period were the result
of employee-related restructuring activities in 2008.
-- Net loss for the third quarter of 2009 was $40.9 million, or $1.70 per
basic and diluted share, compared to a net loss of $49.0 million, or
$2.05 per basic and diluted share, for the third quarter of 2008.
-- Cash, cash equivalents, marketable securities and restricted cash
totaled $331.9 million at September 30, 2009, a decrease from $403.4
million at December 31, 2008. In the three and nine months ended
September 30, 2009, cash utilization was $39.2 million and $71.5
million, respectively. The cash utilization amounts include the $20.0
million collaboration upfront license payment made to Trubion in
September 2009.
Recent Developments
-- In August, Facet Biotech announced, with its partner Biogen Idec, the
decision to initiate the DECIDE phase 3 study for daclizumab in
multiple sclerosis (MS), which is the second and final required
registration-enabling study. In late July, a futility analysis was
performed with respect to the ongoing SELECT trial, the first
registration-enabling study. An independent statistician analyzed
clinical data from approximately 150 trial subjects that had completed
at least six months of treatment. An independent safety monitoring
committee reviewed the interim data and recommended to both companies
the continuation of the SELECT study for both daclizumab arms. In
addition, to determine whether the collaboration should trigger the
DECIDE phase 3 trial and to inform the design of this phase 3 trial,
certain prearranged employees of both companies, who are not involved
in the management of the SELECT study, reviewed summary data tables
prepared by the independent statistician from the interim analysis.
Based on this review and data from prior studies, the prearranged
employees recommended that the collaboration should initiate the
DECIDE phase 3 study.
