SEATTLE, Aug. 16 /PRNewswire-FirstCall/ -- Trubion
Pharmaceuticals Inc. (Nasdaq: TRBN) today announced financial
results for its second quarter and six months ended June 30, 2010.
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Second-Quarter and First-Half 2010 Financial Results
Revenue for the second quarter and six months ended June 30, 2010, increased to $5.7 million and $11.2
million, respectively, compared with $4.1 million and $8.3
million, respectively, in 2009. Revenue was primarily earned
through the company's strategic collaborations with Pfizer, for the
development of CD20-directed candidates, including SBI-087, and
Abbott, for the development of CD37-directed targets, including
TRU-016.
During the second quarter and first half of 2010, Trubion
recognized $3.8 million in revenue
from its Abbott collaboration. The $3.8
million includes recognition of $1.1
million from the $20 million
upfront fee and $1.4 million equity
premium received from Abbott, as well as $2.7 million earned through collaborative
research.
The increase in revenue from the Abbott partnership was
partially offset by lower revenue generated by Trubion's
collaboration with Pfizer. The decrease in revenue was attributed
to lower costs related to the retreatment studies of TRU-015 for
rheumatoid arthritis (RA) as well as a decrease in the amount of
reimbursable legal fees. Revenue earned from Trubion's partnership
with Pfizer during the first half of the year was $7.4 million, which included $2.4 million for recognition of the $40 million upfront fee received in January 2006 and $5.0
million earned through collaborative research. This is
compared with $8.3 million earned in
revenue during the first half of 2009, which was composed of
$2.4 million for the recognition of
the $40 million upfront fee and
$5.9 million in revenue earned
through collaborative research.
Total operating expenses for the second quarter and first half
of 2010 were $11.3 million and
$22.8 million, respectively, compared
with $10.7 million and $25.9 million in 2009. The increase in operating
expenses during the second quarter was due to increased clinical
development costs related to the initiation of the Phase 1/2
clinical trial of TRU-016 (16201) and increased TRU-016
manufacturing costs. These increases were partially offset by lower
personnel costs.
Net loss for the second quarter and six months ended
June 30, 2010, decreased to
$5.7 million, or $0.28 per diluted common share, and $11.8 million, or $0.58 per diluted common share, respectively.
This is compared with a net loss of $6.7
million, or $0.37 per diluted
common share, and $17.7 million, or
$0.99 per diluted common share, in
2009.
Trubion had $42.1 million in cash,
cash equivalents and investments as of June
30, 2010, compared with $54.8
million as of Dec. 31,
2009.
"During the course of the past year we've trimmed expenses and
have worked with our partners to prioritize product candidates that
demonstrate the potential for safer, more effective and more
convenient treatments," said Steve
Gillis, Ph.D., executive chairman and acting president of
Trubion. "In the coming months, we will work diligently with
Emergent in an effort to finalize our recently announced merger in
a timely manner, and we will continue to pursue our corporate
objectives and product and collaboration milestones."
Recent milestones
- On Aug. 12, 2010, Trubion
announced the signing of a definitive merger agreement with
Emergent BioSolutions Inc. (NYSE: EBS), in which Emergent has
agreed to acquire Trubion. Under the terms of the agreement, each
share of Trubion common stock will be converted into the right to
receive an upfront payment of $1.365
per share in cash and 0.1641 shares of Emergent BioSolutions common
stock. The upfront payment represents a value of $4.55 per share, or approximately $96.8 million, based on Trubion's total common
shares outstanding, the net value of dilutive stock options, and
the trading average of Emergent BioSolutions common stock for the
five days prior to the signing of the definitive agreement. Trubion
Pharmaceuticals stockholders will also receive one Contingent Value
Right (CVR) per share, which will entitle the holder to receive
cash payments based upon achievement of predefined milestones. The
total potential aggregate value of the CVRs is $38.7 million over a 36-month period,
post-closing. The transaction has been approved by the boards of
directors of both companies and is subject to customary closing
conditions, including the approval of the acquisition by
stockholders of Trubion, and the expiration or termination of the
applicable waiting period under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976. The acquisition is expected to close in
the fourth quarter of 2010.
- In June, the Board of Appeal for the European Patent Office
(EPO) ruled in Trubion's favor to uphold an earlier ruling to
revoke European Patent 1176981. This patent is owned by Genentech
and Biogen Idec and is generally directed to the use of an
anti-CD20 antibody for the treatment of RA. Trubion filed its
opposition to the patent in August
2006 and subsequently announced in September 2008 that the Opposition Division of
the EPO had revoked the European patent in its entirety. Genentech
and Biogen Idec appealed the decision in February 2009. With the EPO's June 2010 ruling, no further appeals can be made
with regard to revoked claims, but Genentech and Biogen Idec can
pursue a claim limited to the use of rituximab in combination with
methotrexate to treat RA. The EPO's decision opens the door for the
development of safer, more effective and more convenient treatment
options for patients.
- Also in June, Trubion presented positive data from a Phase 1
study of SBI-087 for RA and a Phase 1 study of SBI-087 for systemic
lupus erythematosus (SLE) at the 2010 annual congress of the
European League Against Rheumatism (EULAR). Data from both studies
demonstrated that SBI-087 is generally well-tolerated and results
in potent B-cell depletion when given as a subcutaneous dose and
with a day-of-treatment oral steroid regimen. SBI-087 is being
developed in collaboration with Pfizer. Studies are ongoing and
data will be submitted for presentation at future medical
congresses.
- Lastly, Trubion announced Pfizer's decision to discontinue
development of TRU-015 (PF-05212374), an investigational drug in
Phase 2 evaluation for the treatment of rheumatoid arthritis (RA)
developed under the companies' CD20 collaboration. However, Pfizer
also confirmed that it will continue to develop SBI-087
(PF-05230895), Trubion's next-generation, humanized, subcutaneous
CD20 RA product candidate also in Phase 2 clinical evaluation.
2010 Outlook
Trubion has revised its 2010 guidance based on a change in
timing of the anticipated milestone of $6
million from Abbott for the initiation of the Phase 2
portion of the TRU-016 study in chronic lymphocytic leukemia (CLL)
patients, as well as changes to its CD20 partnership with
Pfizer.
Achievement of the Abbott milestone is now expected during the
first half of 2011 as a result of protocol modifications that are
designed to optimize the dose level and regimen. The maximum
tolerated dose has not been reached.
In addition, Trubion has decreased its anticipated annual
operating cash requirements from $33
million–$38 million to $29
million–$34 million. The revised guidance, which does not include
any additional cash receipts associated with potential new
partnerships, is as follows:
- Trubion anticipates 2010 revenues to be approximately
$19 million to $24 million earned
through the company's Pfizer and Abbott collaborations.
- Operating cash requirements in 2010 are expected to be
approximately $29 million to $34
million.
Based on its current forecast, and excluding any proceeds from
potential new partnerships or financings, Trubion expects that its
existing capital resources will support the company's operations
into the second half of 2011.
Conference Call Details
Trubion will host a conference call and webcast to discuss its
second-quarter- and six-months-ended 2010 financial results and
provide an update on business activities. The call will be held
Aug. 16 at 2
p.m. Pacific Time, 5 p.m. Eastern
Time. The live event will be available from Trubion's
website at http://investors.trubion.com, or by calling (877)
564-1186 or (973) 409-9686. A replay of the discussion will be
available beginning 8 p.m. Eastern
Time from Trubion's website or by calling (800) 642-1687 or
(706) 645-9291 and entering 93177343. The telephone replay will be
available until midnight, Aug. 30,
2010.
About Trubion
Trubion is a biopharmaceutical company that is creating a
pipeline of novel protein therapeutic product candidates to treat
autoimmune and inflammatory diseases and cancer. The Company's
mission is to develop a variety of first-in-class and best-in-class
product candidates, customized for optimal safety, efficacy and
convenience that it believes may offer improved patient
experiences. Trubion's current product candidates are novel
single-chain protein, or SMIP, therapeutics, and are designed using
its custom drug assembly technology. Trubion's product pipeline
includes CD20-directed SMIP therapeutics such as SBI-087 for
autoimmune and inflammatory diseases, developed under the Company's
Pfizer collaboration. Trubion's product pipeline also includes
TRU-016, a novel CD37-targeted therapy for the treatment of B-cell
malignancies developed under the Company's Abbott collaboration. In
addition to Trubion's current clinical stage product pipeline, the
Company is also developing its multi-specific SCORPION technology,
both for targeting cell-surface molecules as well as simultaneously
neutralizing soluble ligands. More information is available in the
investors section of Trubion's website:
http://investors.trubion.com/index.cfm.
Forward-Looking Statements
Certain statements in this release may constitute
"forward-looking statements" within the meaning of Section 21E of
the Securities Exchange Act of 1934 and Section 27A of the
Securities Act of 1933. These statements include, but are not
limited to, those related to the pending acquisition of Trubion by
Emergent and those related to the future clinical development of
the Company's programs that are the subject of the Pfizer and
Abbott collaborations and Pfizer's and Abbott's intentions
regarding these programs. These statements are based on current
expectations and assumptions regarding future events and business
performance and involve certain risks and uncertainties that could
cause actual results to differ materially. These risks include, but
are not limited to, the risk that the acquisition of Trubion by
Emergent may not be consummated for reasons including that the
conditions precedent to the completion of the acquisition may not
be satisfied; the risk that one or more of the milestones that
would give rise to CVR payments is not achieved; the possibility
that the expected benefits from the proposed merger will not be
realized, or will not be realized within the anticipated time
period; the risk that Emergent and Trubion's businesses will not be
integrated successfully; the possibility of disruption from the
merger making it more difficult to maintain business and
operational relationships; any actions taken by either of the
companies, including but not limited to, restructuring or strategic
initiatives (including capital investments or asset acquisitions or
dispositions), risks associated with the Company's Pfizer
collaboration, including Pfizer's control over development
timelines and over decisions regarding the advancement of SBI-087,
risks associated with the Company's Abbott collaboration, including
the risk that the Abbott milestone is not achieved in the first
half of 2011, the risks that data resulting from our clinical
development programs are unfavorable or uncertain and such other
risks as identified in the Company's report on Form 10-Q for the
quarter ended June 30, 2010, and from
time to time in other reports filed by Trubion with the U.S.
Securities and Exchange Commission. These reports are available on
the Investors page of the Company's corporate website at
http://www.trubion.com. Trubion undertakes no duty to update any
forward-looking statement to conform the statement to actual
results or changes in the Company's expectations.
TRBN-E
Contact:
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Jim DeNike
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Senior Director, Corporate and
Marketing Communications
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Trubion Pharmaceuticals
Inc.
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(206) 838-0500
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jdenike@trubion.com
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http://www.trubion.com
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Waggener Edstrom Worldwide
Healthcare
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Jenny Moede
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Executive Vice
President
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(503) 443-7507
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jmoede@waggeneredstrom.com
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(Tables Follow)
TRUBION PHARMACEUTICALS
INC.
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STATEMENTS OF
OPERATIONS
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(In thousands, except per share
data)
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(unaudited)
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Three months ended June
30,
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Six months ended June
30,
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2010
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2009
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2010
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2009
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Revenue
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$
5,697
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$
4,119
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$ 11,209
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$
8,331
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Operating expenses:
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Research and
development
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9,031
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8,098
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18,047
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20,177
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General and
administrative
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2,246
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2,621
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4,767
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5,731
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Total operating
expenses
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11,277
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10,719
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22,814
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25,908
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Loss from operations
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(5,580)
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(6,600)
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(11,605)
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(17,577)
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Interest income
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15
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36
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30
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154
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Interest
expense
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(118)
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(138)
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(237)
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(278)
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Other income
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20
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-
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20
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-
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Net loss
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$
(5,663)
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$
(6,702)
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$ (11,792)
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$ (17,701)
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Basic and diluted net loss per
share
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$
(0.28)
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$
(0.37)
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$
(0.58)
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$
(0.99)
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Shares used in computation of
basic and diluted net loss per share
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20,419
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18,023
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20,403
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17,961
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June 30,
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December 31,
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2010
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2009
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Balance Sheet Data:
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Cash and cash
equivalents
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$ 15,600
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$ 22,304
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Investments
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26,521
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32,542
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Total assets
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51,986
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65,380
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Deferred revenue
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31,679
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35,262
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Total stockholders'
equity
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4,542
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15,094
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SOURCE Trubion Pharmaceuticals Inc.
Copyright . 16 PR Newswire