GTC Biotherapeutics, Inc. ("GTC", NASDAQ: GTCB) today reported its
financial results for the fourth quarter and fiscal year ended January
3, 2010. The total net loss for the fourth quarter was $1.7 million, or
$0.09 per share, compared with $6.2 million, or $0.60 per share, for the
fourth quarter of 2008. The total net loss for 2009 was $27.9 million,
or $2.18 per share, compared to $22.7 million, or $2.31 per share, for
2008.
“We are now on the
threshold of bringing two additional programs into clinical development,
rhFVIIa and rhAFP, both of which address large market opportunities”
“GTC has maintained strong progress in its core programs in recombinant
plasma proteins and follow on biologics”, stated Geoffrey Cox, Ph.D.,
Chairman, President and CEO of GTC Biotherapeutics. “We are now on the
threshold of bringing two additional programs into clinical development,
rhFVIIa and rhAFP, both of which address large market opportunities”.
Cash Position
Cash at January 3, 2010 totaled $3.8 million, a $7.8 million decrease
compared to $11.6 million at December 28, 2008. Last month, GTC obtained
an aggregate of $7 million of new funding from LFB Biotechnologies (LFB)
in the form of a 4%, 36-month term loan with a single payment of
principal and interest at maturity. With this new funding from LFB and
anticipated receipts from existing partnering agreements, GTC projects
that its cash resources will be sufficient to support its operations to
the end of the second quarter of 2010, exclusive of future cash proceeds
from potential new partnering agreements.
Significant product development events
for 2009 and outlook for 2010
Factor VIIa
GTC, together with its collaboration partner LFB, has established the
transgenic rabbit production system for its rhFVIIa program and
initiated the production of clinical lots to support the IND filing and
subsequent clinical program. Following discussions with the FDA, GTC
plans to file an IND in April, with the objective of initiating a Phase
I study in the 2nd quarter of 2010. This is planned to be a
safety, pharmacokinetic and pharmacodynamic study in comparison with
NovoSeven®, in normal healthy volunteers. On the basis of
current plans, GTC expects to have results from this study in the fourth
quarter of 2010.
Alpha-Fetoprotein (AFP)
GTC in-licensed the AFP program in the middle of 2009. GTC has
established a herd of transgenic goats that produce this product in
significant quantities. Animal model tests are currently being conducted
that are considered to be predictive for efficacy in autoimmune diseases
such as myasthenia gravis and multiple sclerosis. GTC’s plan is to
initiate a Phase II study in myasthenia gravis in the second half of
2010 once a partnering arrangement has been obtained.
ATryn®
Following approval of ATryn® by the FDA, Lundbeck, Inc.
(Lundbeck), formerly Ovation Pharmaceuticals, Inc., launched ATryn®
in the USA in May 2009. Lundbeck continues its commercialization of ATryn®
in the hereditary deficiency indication. In addition, GTC is
collaborating with Lundbeck to develop a protocol for a pivotal study of
patients with acquired antithrombin deficiency who are undergoing
cardiac surgery. GTC aims to initiate a clinical trial in this
indication in the second half of 2010.
In Europe, GTC is seeking to establish an alternative partnering
arrangement for the commercialization and further development of ATryn®
following the termination of GTC’s contract with LEO Pharma (LEO). At
this time there is no final decision in the LEO arbitration proceedings
which GTC initiated with the International Chamber of Commerce.
Monoclonal Antibodies and Follow-on
Biologics
GTC, together with its collaboration partner LFB, has established
transgenic goat production systems for the production of TG20, a
monoclonal antibody that targets CD20. TG20, which is not identical to
Rituximab (Rituxan®), has demonstrated in in-vitro studies
that it has an approximately 10-fold greater antibody dependent
cell-mediated cytotoxicity (ADCC) than Rituximab. This may translate
into improved efficacy or reduced dosage in hematologic malignancies.
GTC is seeking a partner to support its share of the commercialization
and clinical development of TG20.
GTC has established production animals which express Trastuzumab
(Herceptin®) in their milk, and this protein is currently
being characterized. GTC is also developing transgenic animals for the
production of Adalimumab (Humira®), and, together with our
collaboration partner AgResearch in New Zealand, transgenic animals for
the production of Cetuximab (Erbitux®). For each of these
products we will be seeking partners to support further clinical
development and commercialization.
This portfolio of product candidates addresses markets with total annual
sales currently in excess of $16 billion. For our product candidates
addressing oncology indications, the natural glycosylation of the
transgenic production system may provide advantages in ADCC. GTC plans
to characterize each of these proteins as they become available and to
initiate non-clinical studies in support of future partnering activities.
Other Financial Results
Revenues were approximately $1.2 million for the current quarter,
compared to approximately $1.0 million for the fourth quarter of 2008.
Fourth quarter revenues for 2009 were primarily from the sale of ATryn®
product to Lundbeck. The revenues for the fourth quarter 2008 were
primarily from GTC’s program with PharmAthene for services provided for
their Protexia® program. Revenues for the year 2009 totaled
$2.8 million compared to $16.7 million for 2008. The 2009 revenues were
primarily due to the sale of ATryn® product to Lundbeck and
services provided to PharmAthene for their Protexia® program.
Revenues for 2008 were primarily due to the sale of ATryn®
product to LEO, our former marketing partner in the EU, as well as
revenue derived from the PharmAthene program and from the completion of
GTC’s production program for Merrimack Pharmaceuticals for their MM-093
product (AFP).
Costs of revenue and operating expenses were $8.7 million for the
current quarter, compared to $8.4 million for the fourth quarter 2008.
For the year, costs of revenue and operating expenses were $39.1 million
for 2009, compared to $39.9 million for 2008. The reduction in headcount
that GTC implemented in the fourth quarter of 2009, together with other
expense reductions, is expected to produce approximately $6 million in
expense savings for 2010.