GTC Biotherapeutics, Inc.’s ("GTC", Nasdaq:
GTCB) total net loss for the second quarter ended June 29, 2008, was
$2.2 million, or $0.02 per share, compared with a net loss of $10.6
million, or $0.14 per share, for the second quarter of 2007. The total
net loss for the first six months of 2008 was $10.4 million, or $0.11
per share, compared to $18.1 million, or $0.23 per share, for the first
six months of 2007.
“We have had an excellent quarter, achieving
strong cash receipts from our partnering activities,”
stated Geoffrey F. Cox, Ph.D., GTC’s Chairman
of the Board and Chief Executive Officer. “In
addition, we have completed preparation of our application to the Food
and Drug Administration for licensure of ATryn®
in the United States and entered into a strategic collaboration
agreement with OVATION Pharmaceuticals for ATryn®’s
further U.S. commercialization and development. In addition, we are
engaged in further partnering discussions for our recombinant plasma
proteins and monoclonal antibodies.”
ATryn®
Update
GTC has completed preparation of the Biologics License Application (BLA)
of ATryn®, a
recombinant form of human antithrombin, for the prophylactic treatment
of hereditary antithrombin deficient patients undergoing surgery or
childbirth. GTC has requested a 6-month Priority Review. If granted, GTC
expects a determination by the FDA on the BLA in the first quarter of
2009. Inspections of GTC’s U.S.-based
production and manufacturing facilities to support this review have
already been completed.
GTC and OVATION Pharmaceuticals have signed a strategic collaboration
agreement with $257 million of potential milestone payments to
commercialize and further develop ATryn®
in the U.S. The agreement includes provisions for OVATION to fund
clinical studies of ATryn®
as a treatment for heparin resistance during cardiopulmonary bypass
surgery, including paying for the product used in the studies. GTC will
receive a $3 million payment associated with the closing of the
agreement and anticipates $2 million of additional milestone payments in
2008.
LEO Pharma A/S, GTC’s partner for ATryn®
in Europe, Canada, and the Middle East, continues recruitment into a
phase II dose ranging study for prophylactic treatment of disseminated
intravascular coagulation associated with severe sepsis. In addition,
LEO continues expanding the number of European countries where pricing
has been set for the approved EU indication of prophylactic treatment of
hereditary antithrombin deficient patients undergoing surgical
procedures. LEO has reported initial sales in the United Kingdom.
Other Partnering Update
In the second quarter, GTC received $3 million of a total $6 million
funding commitment from LFB Biotechnologies for GTC’s
share of the 2008 expenses for the collaboration programs in recombinant
human coagulation factor VIIa, recombinant human alpha-1 antitrypsin,
recombinant human coagulation factor IX, and a monoclonal antibody to
the CD20 human immune receptor. GTC retains the opportunity to reimburse
LFB at a premium for these expenses to restore 50/50 profit sharing
under the terms of the existing collaboration agreement.
Cash and Investment Position
Cash and marketable securities at June 29, 2008 totaled $12.2 million, a
$3.6 million decrease compared to $15.8 million at December 30, 2007 and
a $0.5 million increase from the $11.7 million at March 30, 2008. The
second quarter cash flow reflects in excess of $10 million of cash
receipts from our partnering programs, including $4.2 million from LEO
for the clinical supply of ATryn product, $3 million from LFB to fund GTC’s
portion of the collaboration programs, $1.6 million from PharmAthene for
product development and purification services and $550,000 from Pharming
Group NV, for a license to fibrinogen. We estimate our net cash use for
the remaining six months of 2008 to be approximately $14 million, not
including any payments from potential partnering agreements under
discussion.
Other Financial Results
Revenues for the second quarter of 2008 were $9.1 million, a $6.3
million increase from the $2.8 million recorded in the second quarter of
2007. Revenues totaled $12.7 million for the first six months of 2008
compared to $8.3 million in the first six months of 2007, an increase of
$4.4 million. The revenue increases in 2008 were primarily driven by the
supply of ATryn® to
LEO and our work for PharmAthene.
Costs of revenue and operating expenses totaled $11 million in the
second quarter of 2008, approximately 19% lower than $13.5 million in
the second quarter of 2007. Costs of revenue and operating expenses
totaled $22.7 million for the first half of 2008, approximately 15%
lower than $26.7 million for the first half of 2007. The lower expenses
are primarily due to decreased costs in the ATryn®
program combined with the $3 million received from LFB for funding GTC’s
share of the collaboration programs. The decrease in costs of revenue
and operating expenses compared to the prior periods were offset by a
$2.9 million charge to cost of revenue recorded in the second quarter of
2007 in connection with the write-off of ATryn®
inventory that had been rendered unusable by a contractor. We continue
to pursue recovery of our losses, but we make no assumption of the
recovery, if any, in our financial statements or projections. The lower
expenses in the ATryn®
and LFB programs were partially offset by higher costs supporting
revenues in the PharmAthene program and due to the timing of shipment
for the ATryn®
product sold to LEO.
The per share results were affected by an increase in the weighted
average number of shares outstanding from 77.9 million shares for the
second quarter of 2007 to 102.8 million shares in the second quarter of
2008. The weighted average number of shares outstanding increased from
77.7 million shares for the first six months of 2007 to 93 million
shares in the first six months of 2008. The increases in the weighted
average shares outstanding primarily reflect the conversion by LFB of
most of its preferred stock of GTC into 14,500,000 common shares of
GTCB, which occurred near the end of the first quarter of 2008. GTC had
approximately 102.8 million common shares outstanding as of June 29,
2008.
Conference Call Information
GTC Biotherapeutics will discuss these results and expectations with
financial analysts in a web cast conference call at 10:00 a.m. (Eastern)
today. The dial-in number from inside the United States is 1- 877-391-6849.
The dial-in number from outside the United States is 1-617-597-9298.
The participant passcode is 69521428. The webcast may be found at www.gtc-bio.com.
About GTC Biotherapeutics, Inc.
GTC Biotherapeutics develops, supplies, and commercializes therapeutic
proteins produced through transgenic animal technology. ATryn®,
GTC’s recombinant human antithrombin, has
been approved for use in Europe and has begun the review process in the
United States under a Biologics License Application. In addition to ATryn®,
GTC is developing a portfolio of recombinant human plasma proteins with
known therapeutic properties. These proteins include recombinant forms
of human coagulation factors VIIa and IX, which are used for the
treatment of hemophilia, and alpha-1 antitrypsin. GTC also has a
monoclonal antibody portfolio that includes a monoclonal antibody to
CD20 and a monoclonal antibody to CD137. GTC’s
intellectual property includes a patent in the United States through
2021 for the production of any therapeutic protein in the milk of any
transgenic mammal. GTC’s transgenic
production platform is particularly well suited to enabling cost
effective development of proteins that are difficult to express in
traditional recombinant production systems as well as proteins that are
required in large volumes. Additional information is available on the
GTC web site, http://www.gtc-bio.com.
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, including without
limitation statements regarding the timing and scope of the DIC clinical
program, the anticipated timing of FDA review of ATryn®,
the timing of payments from OVATION and expectations for the development
of the heparin resistance indication, expected funding from LFB for the
collaboration programs, and the expected cash to be used in 2008. Such
forward-looking statements are subject to a number of risks,
uncertainties and other factors that could cause actual results to
differ materially from future results expressed or implied by such
statements. Factors that may cause such differences include, but are not
limited to, the risks and uncertainties discussed in GTC's most recent
Annual Report on Form 10-K and its other periodic reports as filed with
the Securities and Exchange Commission, including the uncertainties
associated with conducting clinical studies, the risks and uncertainties
associated with dependence upon the actions of partners and regulatory
agencies, and the uncertainty that GTC will be able to obtain additional
revenues and financial resources, including through continuing and new
external programs and marketing and strategic partners for some of its
internal programs and additional equity financings. GTC cautions
investors not to place undue reliance on the forward-looking statements
contained in this release. These statements speak only as of the date of
this document, and GTC undertakes no obligation to update or revise the
statements, except as may be required by law.
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GTC BIOTHERAPEUTICS, INC.
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Selected Financial Information
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(Unaudited, in thousands except per share amounts)
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Three months ended
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Six months ended
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June 29,
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July 1,
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June 29,
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July 1,
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2008
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2007
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2008
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2007
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Revenue
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$
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9,139
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$
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2,838
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$
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12,684
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$
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8,267
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Costs of revenue and operating expenses:
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Cost of revenue
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5,592
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4,124
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6,919
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8,288
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Research and development
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2,692
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6,687
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10,396
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13,153
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Selling, general and administrative
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2,680
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2,704
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5,391
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5,261
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10,964
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13,515
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22,706
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26,702
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Loss from operations
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$
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(1,825)
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$
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(10,677)
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$
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(10,022)
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$
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(18,435)
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|
|
|
|
|
|
|
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Other income (expense):
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(388)
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85
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(414)
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334
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Net Loss
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$
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(2,213)
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$
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(10,592)
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$
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(10,436)
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$
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(18,101)
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Net loss per common share (basic and diluted)
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$
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(0.02)
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$
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(0.14)
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$
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(0.11)
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$
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(0.23)
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Weighted average number of shares outstanding (basic and diluted)
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102,794
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77,886
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93,019
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77,677
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June 29,
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December 30,
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2008
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2007
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Cash and marketable securities
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|
$
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12,213
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$
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15,765
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Other current assets
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|
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2,075
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|
1,214
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Property and equipment, (net)
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13,694
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14,449
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Other assets
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8,773
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9,285
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Total assets
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$
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36,755
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$
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40,713
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Current liabilities
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$
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17,767
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$
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15,652
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Short-term deferred contract revenue
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1,675
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3,067
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Long-term deferred contract revenue
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|
|
4,307
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|
|
4,433
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|
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Long-term debt
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|
|
7,798
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9,517
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|
|
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Other liabilities
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|
|
20
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|
|
20
|
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|
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Stockholders' equity
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5,188
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|
|
8,024
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|
|
|
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Total liabilities and stockholders' equity
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|
$
|
36,755
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$
|
40,713
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GTC Biotherapeutics, Inc.
Thomas E. Newberry, 508-370-5374
Vice
President,
Corporate Communications and Government Relations
tom.newberry@gtc-bio.com