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GTC Biotherapeutics Reports Third Quarter 2006 Financial Results.


FRAMINGHAM, Mass. -- GTC GTC

See: Good 'til cancelled order


GTC

See good-till-canceled order (GTC).
 Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB GTCB Gulf Tax Credit Bond (Alabama, Louisiana, Mississippi, USA) ) reported today its financial results for the third quarter ended October 1, 2006. The total net loss for the current quarter was $10.3 million, or $0.14 per share, compared with $6.7 million, or $0.14 per share, in the third quarter of 2005. The total net loss for the first nine months of 2006 was $27.9 million, or $0.43 per share, compared to $21.8 million, or $0.46 per share, for the first nine months of 2005. The reported total net loss included the impact of deferring $2.6 million of cash receipts as deferred revenue in the third quarter of 2006 and $5 million as deferred revenue for the first nine months of 2006.

"We have had a very strong third quarter for the development of our business, starting with the approval of ATryn([R]) by the European Commission European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community  and finishing with the signing of the strategic collaboration with LFB LFB Legislative Fiscal Bureau
LFB London Fire Brigade
LFB Linear Frame Buffer
LFB Left Fullback (soccer)
LFB Lyman Frank Baum (The Wizard of Oz author)
LFB Liquid Factor Boiling
LFB Low-Frequency Beacon
 Biotechnologies," stated Geoffrey F. Cox, Ph.D., GTC's Chairman and Chief Executive Officer. "We now have the ability to transform GTC's prospects with a healthier balance sheet and a valuable portfolio of proprietary programs focused on recombinant plasma proteins and monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). , greatly expanding our opportunities for growth."

Strategic Elements for Growth

At the end of the third quarter, we entered a strategic collaboration with LFB Biotechnologies to jointly develop products on an anticipated 50/50 basis. The first product in this collaboration, rhFVIIa, is a recombinant form of a human clotting factor clot·ting factor
n.
Any of various plasma components involved in the clotting of blood, including fibrinogen, prothrombin, thromboplastin, and calcium ion. Also called coagulation factor.
 involved in blood coagulation. Recombinant and plasma-derived products are used in treating hemophilia caused by genetic conditions in which a patient's failure to express sufficient clotting factors Clotting factors
Substances in the blood that act in sequence to stop bleeding by forming a clot.

Mentioned in: Partial Thromboplastin Time

clotting factors,
n.
 may lead to excessive bleeding. Factor VIIa is used for those hemophiliacs who have developed inhibitors, or antibodies, to other coagulation factors.

* This is a large market opportunity with reported sales of the currently available recombinant factor VIIa product reported to be $845 million in 2005 and an independent market analysis report estimating that sales will reach $2 billion by 2012.

* The application of transgenic technology may enable the production and pricing of rhFVIIa at appropriate levels for broader utilization, as well as expanding its use to the treatment of the unmet needs of patients in a broader range of countries and to the treatment of other acquired bleeding conditions.

* rhFVIIa will be developed from the milk of transgenic rabbits. Rabbits are anticipated to be capable of supplying the projected needs of the marketplace, currently supplied by approximately 1 kilogram of product. We are planning to perform preclinical studies preclinical studies,
n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research.
 and produce clinical product in 2007 and 2008.

LFB Biotechnologies has also committed to invest a total of $25 million in GTC stock and convertible debt. Of the total, $6 million has been invested in October and $19 million is subject to shareholder approval, which we will seek at a meeting on December 5. The proceeds of this investment by LFB does not obligate obligate /ob·li·gate/ (ob´li-gat) pertaining to or characterized by the ability to survive only in a particular environment or to assume only a particular role, as an obligate anaerobe.  us to any required expenditures.

ATryn([R]), our recombinant form of human antithrombin, was approved by the European Commission for use in preventing deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. , or DVT See deep vein thrombosis. , and thromboembolisms in patients with a hereditary antithrombin deficiency that are undergoing surgical procedures. Antithrombin has both anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting).  and anti-inflammatory properties. In partnership with LEO, we are:

* Producing material for a phase II clinical study of ATryn([R]) in the treatment of disseminated intravascular coagulation disseminated intravascular coagulation
n.
Abbr. DIC A hemorrhagic disorder that occurs following the uncontrolled activation of clotting factors and fibrinolytic enzymes throughout small blood vessels, resulting in tissue necrosis and
, or DIC DIC diffuse intravascular coagulation; disseminated intravascular coagulation.

DIC
abbr.
disseminated intravascular coagulation


Disseminated intravascular coagulation (DIC) 
, associated with severe sepsis severe sepsis A condition defined clinically as 'Sepsis associated with organ dysfunction, hypotension, or hypoperfusion abnormalities (which include) …lactic acidosis, oliguria, or an acute alteration in mental status .
        -- This is a large unmet medical need with 220,000 cases in
           Europe and 250,000 in the US with 50% mortality.

        -- LEO anticipates initiating recruitment into this dose
           ranging study by the end of 2006.


* Transferring the market authorization for ATryn([R]) to LEO to support a planned launch in Europe beginning in the second quarter of 2007.
        -- LEO will establish reimbursement rates and begin commercial
           launch on a country-by-country basis in Europe.


Independently from LEO, ATryn([R]) is also in a phase III study that is anticipated to support a Biologics License Application, or BLA BLA
abbr.
Bachelor of Liberal Arts
, to the US Food and Drug Administration for prevention of DVT and thromboembolisms in hereditary antithrombin deficient patients undergoing high risk procedures. We anticipate completing enrollment in the phase III study in the first half of 2007 and filing the BLA in the second half of 2007.

Financial Position

Cash and marketable securities Marketable Securities

Very liquid securities that can be converted into cash quickly at a reasonable price.

Notes:
Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has
 at October 1, 2006 totaled $29.3 million, a $6.8 million decrease compared to $36.2 million at January 1, 2006. The decrease includes $16.2 million of net proceeds Net Proceeds

The amount received after all costs are deducted from the sale of a piece of property or security.

Notes:
In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions).
 from the July 2006 registered direct placement as well as the final payment of $2.4 million on a promissory note promissory note, unconditional written promise to pay a certain sum of money at a definite time to bearer or to a specified person on his order. Promissory notes are generally used as evidence of debt.  in January 2006. Exclusive of the effects of the registered direct placement and the promissory note repayment, $20.6 million of net cash and marketable securities were used in the first nine months of 2006. Exclusive of the registered direct placement of stock in July 2006, $6.3 million of net cash were used in the third quarter.

Assuming a successful shareholder vote on the completion of the investment by LFB Biotechnologies, we anticipate ending the year with a pro forma As a matter of form or for the sake of form. Used to describe accounting, financial, and other statements or conclusions based upon assumed or anticipated facts.

The phrase pro forma
 $50 - 54 million of cash and marketable securities, consistent with our previous projections for a net cash utilization of $21 - 25 million for 2006 excluding financings and the promissory note repayment. This includes projected fourth quarter 2006 cash receipts from our ongoing product supply commitments for Merrimack Pharmaceuticals and the sale of clinical supplies of ATryn([R]) to LEO Pharma A/S.

Financial Results

Revenues were approximately $0.7 million for the current quarter, a 42% decrease from the approximately $1.2 million in the third quarter 2005. The revenues in the third quarter were primarily from the program with Merrimack Pharmaceuticals for the production of their MM-093 product. Third quarter revenues in 2005 included the completion of the program with Elan Pharmaceuticals as well as the on-going Merrimack program. We deferred $2.6 million of revenues in the third quarter primarily related to cash received from LEO for successful approval of ATryn([R]) in the EU as well as cash received from Merrimack that was not recognized as revenue in the current period. There was no deferral of revenue during the third quarter of 2005. Revenues for the first nine months of 2006 totaled $3.3 million, a 6% decrease compared to the $3.5 million in the first nine months of 2005. The revenues for the nine-month results were primarily due to the program with Merrimack. We deferred $5 million of revenues in the first nine months of 2006 primarily related to cash received from LEO and Merrimack that was not recognized as revenue. Revenues deferred in the first nine months of 2005 totaled approximately $0.7 million.

Costs of revenue and operating expenses Operating expenses

The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted.
 totaled $11.1 million in the current quarter, a 44% increase from the $7.7 million total in the third quarter 2005. Costs of revenue and operating expenses totaled $31.4 million for the first nine months of 2006, a 26% increase from the $24.9 million for the first nine months of 2004. These cost increases were driven primarily by production of supplies for both the Merrimack and ATryn([R]) clinical programs.

The per share results were affected by an increase in the weighted average number of shares outstanding from 49.4 million shares for the third quarter 2005 to 71.7 million shares in the third quarter 2005. The weighted average number of shares outstanding increased from 47 million shares for the first nine months of 2005 to 64.6 million shares in the first nine months of 2006. The increases in the weighted average shares outstanding primarily reflect the issuance of common stock in financing transactions that provided the cash necessary for our operations to reach significant milestones in GTC's product development programs. GTC had approximately 73.6 million shares outstanding as of October 1, 2006.

Other Programs

GTC is also developing a recombinant form of human alpha-1 antitrypsin as a potential chronic treatment for patients with a genetic deficiency of this plasma protein. An hereditary deficiency of this protein can lead to emphysema emphysema (ĕmfĭsē`mə), pathological or physiological enlargement or overdistention of the air sacs of the lungs. A major cause of pulmonary insufficiency in chronic cigarette smokers, emphysema is a progressive disease that commonly . GTC has developed goats that produce this protein at high levels in their milk. Preclinical testing of the product and establishment of partnering arrangements are planned for 2007 and 2008.

CD137 is an agonistic agonistic /ag·o·nis·tic/ (ag?o-nis´tik) pertaining to a struggle or competition; as an agonistic muscle, counteracted by an antagonistic muscle.  antibody to the CD137 receptor in the human immune system immune system

Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders.
. This antibody, which functions as a modulator Modulator

Any device or circuit by means of which a desired signal is impressed upon a higher-frequency periodic wave known as a carrier. The process is called modulation. The modulator may vary the amplitude, frequency, or phase of the carrier.
 of the immune system, has the potential to stimulate the immune response immune response
n.
An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes.
 to solid tumors. GTC has developed goats that express the CD137 antibody in their milk. A Small Business Innovative Research grant was awarded in October 2006 to support preclinical development of CD137 is planned for 2007.

Conference Call Information

GTC Biotherapeutics will discuss these results and its business outlook 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- 866-277-1182. The dial-in number from outside the United States is 1-617-597-5359. The participant passcode is 47892493. The webcast may be found at www.gtc-bio.com.

About GTC Biotherapeutics, Inc.

GTC Biotherapeutics develops, produces, and commercializes therapeutic proteins through transgenic animal Transgenic animal
Animals that have had genes from other species inserted into their genetic code.

Mentioned in: Glycogen Storage Diseases
 technology. GTC obtained the first approval of a transgenically derived therapeutic protein anywhere in the world in August 2006. ATryn([R]), GTC's recombinant form of human antithrombin, was approved by the European Commission for use in patients with a hereditary antithrombin deficiency undergoing surgical procedures. ATryn([R]) is in phase III studies to support a filing in the United States requesting approval in the hereditary deficiency indication. LEO Pharma A/S of Denmark will launch ATryn([R]) commercially in Europe and will work with GTC to develop ATryn([R]) as a potential treatment for disseminated intravascular coagulation (DIC) in conjunction with severe sepsis. LEO plans to commence a phase II study in DIC at the end of 2006. In addition, GTC established a strategic collaboration with LFB Biotechnologies of France in October 2006 to jointly develop recombinant forms of human plasma proteins and monoclonal antibodies. The first program of the collaboration will be to develop recombinant human factor VIIa as a potential treatment for hemophilia in patients with antibodies to other coagulation factors.

GTC has also recently been granted a patent in the United States for the production of any therapeutic protein in the milk of any transgenic mammal through 2021. 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 those 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995, including without limitation statements regarding GTC's expected amount of cash and marketable securities at the end of 2006, the planned completion of the investment by LFB Biotechnologies, the anticipated progress in each of GTC's product development programs, the anticipated timing for a European market launch of ATryn([R]), the projected sales potential for rhFVIIa, the regulatory and clinical strategy for ATryn([R]) in the United States, and the potential for further activities in the Merrimack program. 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 Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 and its other periodic reports as filed with the Securities and Exchange Commission, including the uncertainties associated with developing therapeutics and conducting clinical studies, and the risks and uncertainties associated with dependence upon the actions of partners and regulatory agencies. 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. GTC specifically disclaims responsibility for information describing LEO and its business other than the agreement with GTC.
[TABLE OMITTED]
COPYRIGHT 2006 Business Wire
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Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Nov 2, 2006
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