Synageva BioPharma Reports First Quarter 2012 Financial Results
LEXINGTON, Mass.--(BUSINESS WIRE)-- Synageva BioPharma Corp. (Synageva) (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, today reported first quarter 2012 financial results, and provided data from a natural history study of infants with early onset LAL Deficiency that were recently presented at the 3rdInternational Congress for Lysosomal Diseases held in North Cyprus, Turkey.
Early Onset Natural History Study Data Recently Presented
Data from a natural history study of infants with early onset LAL Deficiency, also known as Wolman Disease, were presented April 28th at the 3rdInternational Congress for Lysosomal Diseases. An investigator of the study, Dr. Christian J. Hendriksz (Consultant in Transitional Metabolic Medicine at the Adult Inherited Metabolic Disorders Referral Unit, Salford, U.K.) presented data demonstrating that infants diagnosed with the early onset form of LAL Deficiency suffer from rapid disease progression and often die prior to, or very shortly after, diagnosis.
Our review of the disease course in these infants indicates a very rapid disease progression which makes the interval between diagnosis and death very short, said Dr. Hendriksz. Testing for early onset LAL Deficiency when infants present with gastrointestinal symptoms and evidence of failure to thrive is imperative if we are going to close the gap between onset of symptoms and diagnosis for these babies.
About the Early Onset LAL Deficiency Natural History Study
The early onset natural history study represents a retrospective, observational study based on the compilation of patient records from 19 infants diagnosed with LAL Deficiency and growth failure by 6 months of age. In these patients, the median age at first symptom, diagnosis and death were 1.0 month, 2.2 months and 3.4 months, respectively. Of the six of 19 infants who underwent liver, bone marrow or umbilical cord transplants, five died before 9 months of age.
First Quarter 2012 Financial Results
For the quarter ended March 31, 2012, Synageva reported a net loss of $7.4 million compared to a net loss of $5.4 million for the corresponding quarter of the prior year. Results for the quarter ended March 31, 2011 refer to the results for Synageva BioPharma Corp. (GEVA), the private predecessor to the company resulting from the combination of private Synageva and Trimeris.
Revenue for the quarter ended March 31, 2012 of $2.4 million consists of $1.4 million of Fuzeon royalties from Roche, as well as revenue from Synagevas collaboration agreements and payments from an NIH grant. Total operating expenses for the quarter ended March 31, 2012, including R&D and G&A expenses, totaled $9.8 million compared to total operating expenses of $5.5 million for the corresponding quarter of the prior year. As of March 31, 2012, Synageva had a cash balance of $138.9 million with no outstanding debt.
2012 Financial Outlook
Synageva reiterates its previous net operating loss guidance of between $40 and $45 million for 2012. The anticipated increase in net loss from 2011 is expected to be primarily due to higher spending to support our global development for our lead program SBC-102 and our preclinical programs.
About Synagevas Lead Program
SBC-102 is being developed as an enzyme replacement therapy for Lysosomal Acid Lipase (LAL) Deficiency, a lysosomal storage disorder (LSD), and is a recombinant form of the human LAL enzyme. SBC-102 is currently being evaluated in global clinical trials and has been granted orphan designations by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Additionally, SBC-102 received fast track designation by the FDA.
About LAL Deficiency
Lysosomal Acid Lipase Deficiency is a rare, autosomal recessive lysosomal storage disorder (LSD) that is caused by a marked decrease in LAL enzyme activity. Late onset LAL Deficiency, sometimes called Cholesteryl Ester Storage Disease (CESD), affects both children and adults. In these patients, the buildup of fatty material in the liver, spleen and blood vessel walls leads to complications resulting in significant morbidity and mortality. Early onset LAL Deficiency, sometimes called Wolman Disease, affects infants in the first year of life and is characterized by growth failure, malabsorption, steatorrhea and hepatomegaly and is rapidly fatal, usually within the first year of life.
About Synageva BioPharma Corp.
Synageva is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of therapeutic products for patients with life-threatening rare diseases and unmet medical need. Synageva has several protein therapeutics in its pipeline. The company has assembled a team with a proven record of bringing orphan therapies to patients.
Further information regarding Synageva BioPharma Corp. is available at www.synageva.com.
This news release and oral statements made from time to time by Synageva representatives in respect of the same subject matter may contain forward-looking statements under the provisions of the Private Securities Litigation Reform Act of 1995. Such statements can be identified by introductory words such as expects, plans, intends, believes, will, estimates, forecasts, projects, or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Many factors may cause actual results to differ materially from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known, including those identified under the heading Risk Factors in Synagevas Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 22, 2012 and other filings Synageva periodically makes with the SEC, and others of which are not. Synageva cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials or how quickly patient enrollment in clinical trials will occur. In addition, early clinical results are not necessary predictive of results that may be achieved from subsequent clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Synageva will obtain regulatory approval for any phase of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Our future financial results may differ from those currently anticipated due to a number of factors, including unanticipated costs in our research and development programs, fluctuations in royalty revenues and unplanned costs associated with maintaining and enforcing patents and other patent-related costs. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Synageva undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Synageva BioPharma Corp.
Statement of Operations
(Unaudited and in thousands, except per share amounts)
|Three Months Ended|
|Collaboration and license revenue||892||-|
|Research and development||6,832||4,203|
|General and administrative||2,920||1,271|
|Total operating expenses||9,752||5,474|
|Loss from operations||(7,355||)||(5,412||)|
|Other expense, net||-||(34||)|
|Basic and diluted net income per common share (1)||$||(0.35||)||$||(95.77||)|
|Weighted average shares used in basic and diluted|
|per common share computations (1)||20,744||57|
(1) Per share computations for the three months ended March 31, 2011 are based on Private Synagevas historic common stock balance, which excludes preferred stock.
Synageva BioPharma Corp.
Consolidated Balance Sheet Data
|March 31,||December 31,|
|Cash and cash equivalents||$||138,918||$||60,232|
|Total stockholders' equity||$||152,179||$||74,048|
Matthew Osborne, 781-357-9947
Source: Synageva BioPharma Corp.Copyright Business Wire 2012