Emergent BioSolutions Inc. (NYSE: EBS) announced its financial results for the full year ended December 31, 2009.

For the full year 2009, total revenues were $234.8 million as compared to $178.6 million in 2008, and net income was $31.1 million, or $1.02 per share, as compared to $20.7 million, or $0.69 per share, in 2008. The 2009 performance was primarily driven by sales of BioThrax (Anthrax Vaccine Adsorbed), the company’s FDA licensed vaccine for the prevention of anthrax disease, including $34.0 million related to the approval of four-year expiry dating for BioThrax.

For the fourth quarter 2009, total revenues were $53.8 million as compared to $35.8 million in 2008, and net income was $4.2 million, or $0.14 per share, as compared to net income of $1.5 million, or $0.05 per share in 2008.

2009 Key Operational Accomplishments

* Received FDA approval extending shelf life of BioThrax to 4 years, triggering a $34.0 million payment from HHS;
* Received FDA approval to amend the BioThrax license, providing for an intramuscular route of administration and a reduction in the dosing schedule to five doses over 18 months—an initiative supported and funded by the U.S. Centers for Disease Control and Prevention (CDC);
* Received market authorization for BioThrax in India;
* Commenced what we expect will be the only clinical trial of the company’s polyclonal anthrax immune globulin (AIG) candidate for treating anthrax disease;
* Obtained Fast Track designation and Orphan Drug status from FDA and Orphan Drug status from EMEA for the company’s AIG candidate;
* Secured a NIAID grant to fund development of a third-generation anthrax vaccine candidate, valued at $4.9 million over a two-year period;
* Initiated a Phase IIb field efficacy trial in South Africa for the Company’s advanced TB vaccine candidate, largely funded by The Aeras Global TB Vaccine Foundation and the Wellcome Trust;
* Completed a Phase IIb clinical trial of TyphellaTM which demonstrated additional safety and immunogenicity of this typhoid vaccine product candidate in healthy subjects in the U.S.;
* Purchased a 56,000 square foot manufacturing facility in Baltimore, MD., which houses five independent manufacturing suites flexibly designed to support the production of both clinical and commercial materials for the Company’s growing product pipeline, for a total purchase price of $8.2 million;
* Purchased a 48,000 square foot product development facility in Gaithersburg, MD., that the Company previously leased, for a total purchase price of $6.4 million;
* Resumed scale-up of BioThrax in the Company’s large-scale manufacturing facility (Building 55) in Lansing, MI.; and
* Submitted a proposal to HHS, in response to a request, for funding the completion of the manufacturing scale-up of BioThrax in Building 55.

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For the fourth quarter ended December 31, 2009, Natus reported revenue of $51.6 million, compared to $43.4 million reported in the comparable quarter of the previous year. Net income was $4.3 million, or $0.15 per diluted share, for the fourth quarter of 2009, compared with net income of $6.3 million, or $0.22 per diluted share, for the fourth quarter of 2008.

For the year ended December 31, 2009, Natus reported revenue of $166.5 million, compared to $161.8 million reported in 2008. Net income was $11.1 million, or $0.39 per diluted share for the year ended December 31, 2009, compared to net income of $17.5 million, or $0.66 per diluted share in 2008.

The results for the full year 2009 include $550,000 of direct acquisition costs associated with the Company’s acquisitions of Hawaii Medical and Alpine Biomed in July and September 2009, respectively. Excluding these direct costs, which were reported as a component of general and administrative expense, non-GAAP earnings were $11.5 million, or $0.40 per diluted share.

As of December 31, 2009 the Company had cash, cash equivalents, and short-term investments of $33.5 million, stockholders’ equity of approximately $243 million, and working capital of approximately $76 million.

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Operating expenses for the year ended December 31, 2008 include a $1.2 million non-cash charge resulting from the modification of equity awards and $2.5 million of expenses related to the spin-off from Bentley Pharmaceuticals on June 30, 2008.

Fourth-Quarter Highlights

For the fourth quarter of 2009 compared to the fourth quarter of 2008:

* Revenues increased 23% to $5.2 million from $4.2 million.
* Operating expenses increased 45% to $5.8 million from $4.0 million.
* Net loss was $498,000, or $0.20 per share, compared to net income of $292,000, or $0.12 per share.

The growth in revenues for the fourth quarter of 2009 was due to increased royalties on sales of Testim. This growth is due to a reported 13.2% increase in prescriptions for Testim during the fourth quarter of 2009 compared to the same period in 2008.

General and administrative expenses for the fourth quarter of 2009 increased $1.1 million compared to the fourth quarter of 2008 due to $1.2 million in costs relating to the Upsher-Smith litigation. Research and development expenses for the fourth quarter of 2009 increased $627,000 compared to the fourth quarter of 2008 largely due to a $489,000 increase in expenses related to the Nasulin clinical program. Research and development expenses are expected to vary from period to period, primarily due to the number, size and recruitment levels of clinical trials in any given reporting period.

Year-to-Date Highlights

For the year ended December 31, 2009 compared to the comparable period in 2008:

* Revenues increased 20% to $18.7 million from $15.6 million.
* Operating expenses increased 16% to $21.9 million from $18.8 million.
* Net loss increased to $3.0 million, or $1.21 per share, from $2.9 million, or $1.25 per share.

The increase in revenues for the twelve months ended December 31, 2009 was due to increased royalties on sales of Testim. For the year ended December 31, 2009, Testim prescriptions were reported to have grown 14.9% compared to the same period in 2008. General and administrative expenses increased $2.4 million in the year ended December 31, 2009 compared to the same period in 2008. The increase was primarily due to increased litigation costs of $2.8 million partially offset by a $674,000 decrease in non-cash share-based compensation expense. Research and development expenses increased $3.2 million during the year ended December 31, 2009 compared to 2008 due to a $3.7 million increase in clinical trial expenses, primarily related to the Nasulin clinical program, which were partially offset by lower non-cash share-based compensation expense of $494,000.

On June 30, 2008, CPEX had approximately 2,274,000 common shares outstanding after the spin-off. The same number of shares is being used for the basic and diluted loss per share computation for all periods presented prior to June 30, 2008 because no CPEX equity awards were outstanding prior to the spin-off.

As of December 31, 2009, CPEX had unrestricted cash of approximately $13.7 million, working capital of $16.6 million and no debt.

Business Update

Ongoing Clinical Trials: CPEX’s intranasal insulin product candidate for the treatment of hyperglycemia in patients with Type 1 and Type 2 diabetes, Nasulin, is continuing in clinical trials evaluating the efficacy and safety profile of the product. CPEX has completed enrollment in its Phase 2a study designed to assess the efficacy and safety of Nasulin versus placebo over a 6-week treatment period. This study was conducted at multiple sites in the U.S. and randomized 94 patients. Data analysis is ongoing and preliminary results are expected this month. Earlier clinical studies of Nasulin indicated that CPEX’s intranasal insulin candidate achieved a faster time to peak plasma insulin levels when compared to other approved rapid-acting insulin therapies, thereby more closely mimicking the natural response of the pancreas to meals.

Patent Infringement Lawsuit Update: CPEX and Auxilium Pharmaceuticals, Inc. continue to vigorously pursue their lawsuit against Upsher-Smith for infringement of CPEX’s patent that covers Testim. In August 2009, the U.S. Food and Drug Administration (FDA) responded to a Citizen Petition filed by Auxilium. The FDA agreed with some of the statements made in the Citizen Petition regarding the testing required for generic versions of Testim, while disagreeing with other statements. While the FDA did not comment upon any particular filing, the agency stated that: “The practical effect of this determination is that any application for a testosterone gel product that has different penetration enhancers than the reference listed drug cannot be submitted as an ANDA [(i.e., an abbreviated new drug application)] and, instead, will have to be submitted as an NDA under section 505(b) of the Act.” (FDA’s August 26, 2009, Response to Auxilium’s Citizen Petition)

Partnering Update: Serenity Pharmaceuticals, CPEX’s licensing and development partner, continues to recruit patients in multiple Phase 3 clinical trials of their undisclosed urology drug, which is delivered using CPEX’s intranasal technology for the treatment of nocturia. These randomized, double blind, placebo controlled studies are being conducted at multiple sites in the United States.

New Chief Scientific Officer: On February 1, 2010, CPEX announced the appointment of Nils Bergenhem, Ph.D. as its Chief Scientific Officer. Prior to joining CPEX, Dr. Bergenhem served as Chief Scientific Officer at Escoublac, Inc., the first biotechnology company in the Biogen Idec Innovations Incubator, where he was responsible for development and execution of the research plan for human osteocalcin in metabolic disease, Type 2 diabetes and obesity. Dr. Bergenhem succeeds Fred Feldman, Ph.D., who is retiring after a 35 year career in research and drug development.

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Human Genome Sciences, Inc. (Nasdaq: HGSI) announced financial results for the quarter and full year ended December 31, 2009, and provided highlights of recent key developments.

FINANCIAL RESULTS

HGS reported increased revenues of $275.7 million for the year ended December 31, 2009, compared with revenues of $48.4 million for 2008. Revenues for 2009 included $180.2 million recognized from sales and deliveries to the U.S. Strategic National Stockpile under the raxibacumab contract with the U.S. Government, $54.2 million recognized from the ZALBIN agreement with Novartis, $24.4 million recognized from manufacturing and development services other than raxibacumab, and $4.7 million recognized from the BENLYSTA agreement with GSK.

The Company reported net income for 2009 of $5.7 million ($0.04 per share), compared with a net loss of $268.9 million ($1.99 per share) for 2008. The improvement in net income for 2009 was due primarily to increased revenues, lower research and development and general and administrative expenses, and a gain on extinguishment of debt.

Cash increased by $818.7 million during 2009 primarily as a result of the successful public offerings of HGSI common stock completed in August and December 2009. As of December 31, 2009, cash and investments totaled $1.2 billion, of which $1.1 billion was unrestricted and available for operations. This compares with cash and investments totaling $372.9 million as of December 31, 2008, of which $303.6 million was unrestricted and available for operations.

Net cash flow for 2009 totaled $29.7 million, compared with net cash burn of $244.8 million for 2008; this does not include the effect of the public offerings of HGSI common stock and the repurchase of $106.2 million principal amount of outstanding long-term debt. The improvement primarily reflected increased revenues and lower research and development and general and administrative expenses.

For the fourth quarter ended December 31, 2009, HGS reported revenues of $53.0 million, compared with revenues of $12.9 million for the same period in 2008. Fourth quarter 2009 revenues included $27.6 million recognized from the ZALBIN agreement with Novartis, $17.7 million recognized from sales and deliveries of raxibacumab to the U.S. Strategic National Stockpile, $5.3 million recognized from manufacturing and development services other than raxibacumab, and $1.0 million recognized from the BENLYSTA agreement with GSK.

The Company’s net loss for the quarter ended December 31, 2009 decreased to $9.7 million ($0.06 per share), compared with a net loss of $61.9 million ($0.46 per share) for the fourth quarter of 2008. The decrease in net loss was due primarily to higher revenues and lower research and development and general and administrative expenses.

HIGHLIGHTS OF RECENT PROGRESS

BENLYSTA: On Track for Second Quarter 2010 Submission of U.S. and European Marketing Applications; Potential U.S. Approval Fourth Quarter 2010

BENLYSTA (belimumab) met the primary efficacy endpoints in BLISS-52 and BLISS-76, the largest late-stage clinical trials ever conducted in lupus patients. The results of these pivotal Phase 3 studies were reported in July and November 2009. HGS and GSK expect to submit marketing applications for BENLYSTA to regulatory authorities in the United States and Europe in the second quarter of 2010, and it has the potential to receive regulatory approval in the U.S. in the fourth quarter of 2010. BENLYSTA is being developed by HGS and GSK under a co-development and commercialization agreement entered into in 2006.

The Phase 3 data showed that BENLYSTA plus standard of care achieved a clinically and statistically significant improvement in patient response rate, compared with placebo plus standard of care. BLISS study results also showed that belimumab was generally well tolerated, with rates of overall adverse events and discontinuations due to adverse events comparable between belimumab and placebo treatment groups.

ZALBIN: Marketing Applications Filed in United States and Europe in Fourth Quarter 2009; Potential U.S. Approval Fourth Quarter 2010

In the fourth quarter of 2009, HGS submitted a Biologics License Application (BLA) to FDA for ZALBIN (albinterferon alfa-2b) in the United States, and Novartis submitted a Marketing Authorization Application (MAA) under the brand name JOULFERON to the EMEA in Europe. In February 2010, HGS received confirmation that the BLA submission was accepted by the FDA for filing with a Prescription Drug User Fee Act (PDUFA) target date of October 4, 2010. Albinterferon alfa-2b is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006.

The regulatory submissions include the results of two pivotal Phase 3 clinical trials, known as ACHIEVE 1 and ACHIEVE 2/3, showing that 900-mcg ZALBIN dosed every two weeks met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a) dosed once each week. Patients also received oral ribavirin. In both studies, ZALBIN, with half the injections, achieved sustained virologic response comparable to that achieved by Pegasys. The rates of serious and/or severe adverse events were also comparable in these studies. ACHIEVE 1 was conducted in patients infected with genotype 1 virus, and ACHIEVE 2/3 was conducted in patients with genotypes 2 or 3 virus. The two studies treated a total of 2,255 patients.

Raxibacumab: $180 Million in Revenue Recognized in 2009 from Deliveries to U.S. Strategic National Stockpile; First Delivery under Second Order Completed November 2009; Approximately 15,000 Doses to Be Delivered to Stockpile in 2010

In the first half of 2009, HGS achieved its first product sales and recognized $162.5 million in revenue by delivering 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile. In July 2009, the U.S. Government exercised its option to purchase 45,000 additional doses to be delivered over a three-year period. HGS expects to receive approximately $142 million from the second award as deliveries are completed, including $17.7 million recognized as revenue from delivery of approximately 5,600 doses in fourth quarter 2009. The Company expects to deliver approximately 15,000 doses to the Stockpile in 2010.

HGS submitted a BLA to FDA for raxibacumab for the treatment of inhalation anthrax in May 2009, received a Complete Response Letter in November 2009, and is working closely with the FDA to obtain approval. HGS will receive $20 million from the U.S. Government upon FDA licensure of raxibacumab. Raxibacumab is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS).

GSK Pipeline: Phase 3 Trials Ongoing for Darapladib in Cardiovascular Disease and Syncria in Type 2 Diabetes

In December 2009, GSK announced the initiation of its second pivotal Phase 3 trial to evaluate whether darapladib can reduce the risk of adverse cardiovascular events such as a heart attack or stroke. During the year, GSK completed enrollment of its first Phase 3 trial of darapladib ahead of schedule. With more than 27,000 patients enrolled in the two trials, the Phase 3 clinical program for darapladib is among the largest ever conducted to evaluate the safety and efficacy of any cardiovascular medication. Darapladib was discovered by GSK based on HGS technology. HGS will receive 10% royalties on worldwide sales if darapladib is commercialized, and has a 20% co-promotion option in North America and Europe.

HGS received a $9.0 million milestone payment during the first quarter of 2009, following GSK’s initiation of a Phase 3 program to evaluate the efficacy, safety and tolerability of Syncria (albiglutide) in the long-term treatment of type 2 diabetes mellitus. Six Phase 3 trials of Syncria are currently ongoing. Syncria was created by HGS using its proprietary albumin-fusion technology, and the product was licensed to GSK in 2004. HGS is entitled to fees and milestone payments that could amount to as much as $183 million – including $33 million received to date – in addition to single-digit royalties on worldwide sales if Syncria is commercialized.

Oncology Program: Therapeutic Opportunities across Broad Range of Cancers

Three randomized Phase 2 chemotherapy combination trials are currently underway to evaluate the potential of mapatumumab (HGS-ETR1) in the treatment of advanced multiple myeloma, non-small cell lung cancer, and hepatocellular cancer. Results are expected in first quarter 2010 for non-small cell lung cancer and mid-2010 for multiple myeloma. Mapatumumab, a human monoclonal antibody to TRAIL receptor 1, is the most advanced of any product in development that targets the TRAIL apoptosis pathway.

In November 2009, HGS and Aegera Therapeutics announced the initiation of a Phase 1 trial of the Company’s lead IAP inhibitor, HGS1029, as monotherapy in patients with advanced lymphoid tumors. HGS1029 as monotherapy is also being studied in an ongoing Phase 1 study initiated in 2008 in patients with advanced solid tumors. HGS plans to continue the study of HGS1029 both alone and in combination with other anti-cancer agents, including mapatumumab.

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Business Highlights

* AMAG reported fourth quarter 2009 Feraheme net product revenues of $12.8 million, including $1.3 million of the $11.5 million in previously deferred product revenues.
* To date, more than 1,300 providers have purchased Feraheme (ferumoxytol) Injection; collectively, these providers purchased approximately 240,000 grams of all forms of IV iron over the past 52 weeks1.
* Of the providers that have purchased Feraheme to date, more than 1,100 are treating non-dialysis dependent chronic kidney disease patients and more than 60 percent have purchased on a repeat basis.
* AMAG estimates that more than half of Feraheme provider demand in 2009 was outside of the dialysis setting.

As of December 31, 2009, the Company’s cash, cash equivalents, investments and settlement rights associated with certain auction rate securities totaled $129.5 million. In January 2010, AMAG successfully completed a follow-on offering of 3.6 million shares of common stock, with net proceeds to the Company of approximately $165.6 million. Revenues for the quarter ended December 31, 2009 were $13.1 million as compared to revenues of $0.6 million for the same period in 2008. Revenues for the year ended December 31, 2009 were $17.2 million as compared to $1.9 million for the same period in 2008. The increases in revenues in 2009 over the comparable 2008 periods were attributable to Feraheme product sales following its approval and subsequent launch in July 2009.

Total operating costs and expenses for the quarter ended December 31, 2009 were $33.3 million as compared to $23.8 million for the same period in 2008. Total operating costs and expenses for the year ended December 31, 2009 were $115.1 million as compared to $81.5 million for the same period in 2008. The increases in operating costs and expenses in 2009 over the comparable 2008 periods were primarily due to increased selling, general and administrative expenses associated with the commercialization of Feraheme.

The Company reported a net loss of $18.4 million, or a loss of $1.07 per basic and diluted share, for the quarter ended December 31, 2009, as compared to a net loss of $21.8 million, or a loss of $1.28 per basic and diluted share, for the same period in 2008. Net loss for the year ended December 31, 2009 was $93.4 million, or a loss of $5.46 per basic and diluted share, as compared to a net loss of $71.6 million, or a loss of $4.22 per basic and diluted share for the same period in 2008.

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Cash, Cash Equivalents and Total Marketable Securities
At December 31, 2009, Alnylam had cash, cash equivalents and total marketable securities of $435.3 million, as compared to $512.7 million at December 31, 2008.

Net Loss
The net loss according to accounting principles generally accepted in the U.S. (GAAP) for the fourth quarter of 2009 was $7.8 million, or $0.19 per share on both a basic and diluted basis (including $3.9 million, or $0.09 per share of non-cash stock-based compensation expense), as compared to a net loss of $9.4 million, or $0.23 per share on both a basic and diluted basis (including $3.4 million, or $0.08 per share of non-cash stock-based compensation expense), for the same period in the previous year. For the year ended December 31, 2009, the net loss was $47.6 million, or $1.14 per share (including $19.7 million, or $0.47 per share of non-cash stock-based compensation expense), as compared to a net loss of $26.2 million, or $0.64 per share (including $16.4 million, or $0.40 per share of non-cash stock-based compensation expense), for the prior year.

Revenues
Revenues were $26.6 million for the fourth quarter of 2009, as compared to $24.4 million for the same period last year. Revenues for the fourth quarter of 2009 included $15.2 million of collaboration revenues related to the company’s alliance with Roche, $5.5 million of revenues from the company’s alliance with Takeda Pharmaceuticals Company Limited, which began in the second quarter of 2008, and $5.9 million of expense reimbursement and amortization revenues from Novartis, the National Institutes of Health (NIH), Cubist Pharmaceuticals, Inc., Biogen Idec Inc., InterfeRx™, research reagent and services licenses, and other sources. Revenues were $100.5 million for the year ended December 31, 2009, as compared to $96.2 million for the prior year. Revenues increased for the year ended December 31, 2009 as compared to the year ended December 31, 2008 primarily as a result of a full year of GAAP revenues earned from the company’s May 2008 alliance with Takeda. Revenues for the year ended December 31, 2009 included $56.9 million of collaboration revenues related to the company’s alliance with Roche, $21.7 million of revenues related to the company’s collaboration with Takeda, and $21.9 million of revenues related to the company’s collaborations with Novartis, the NIH, Cubist, Biogen Idec, InterfeRx, research reagent and services licenses, and other sources.

Research and Development Expenses
Research and development (R&D) expenses were $21.6 million in the fourth quarter of 2009, which included $2.0 million of non-cash stock-based compensation, as compared to $24.9 million in the fourth quarter of 2008, which included $1.5 million of non-cash stock-based compensation. The decrease in R&D expenses in the fourth quarter of 2009 as compared to the prior year period was due primarily to license fees incurred in the prior year period related to various intellectual property assets, partially offset by an increase in clinical trial and manufacturing expenses. R&D expenses were $108.7 million for the year ended December 31, 2009, which included $11.4 million of non-cash stock-based compensation, as compared to $96.9 million for the prior year, which included $9.6 million of non-cash stock-based compensation. R&D expenses for the year ended December 31, 2009 increased as compared to the year ended December 31, 2008 primarily as a result of increased clinical trial and manufacturing expenses. Also contributing to the increase in R&D expenses for the year ended December 31, 2009 was an increase in compensation and related expenses, non-cash stock-based compensation, and facilities-related expenses due primarily to additional R&D headcount to support the company’s alliances and expanding product pipeline.

Product Pipeline and Scientific Leadership Highlights

* Expanded Development of ALN-RSV for Treatment of Respiratory Syncytial Virus (RSV) Infection. Alnylam and Cubist presented complete data from a Phase IIa randomized, double-blind study of inhaled ALN-RSV01 or placebo in RSV-infected lung transplant patients. This study achieved its primary objective of demonstrating safety and tolerability for ALN-RSV01. Based on the results of this study, Alnylam has recently initiated a double-blind, placebo-controlled, randomized Phase IIb study of ALN-RSV01 in RSV-infected adult lung transplant patients. The study will be performed in over 30 sites worldwide and aims to enroll up to 76 patients. The primary study endpoint is the incidence of new or progressive bronchiolitis obliterans syndrome (BOS), a life threatening complication of RSV infection and an irreversible disease of the transplanted lung, resulting in approximately 50% mortality within three to five years of onset.
* Continued Clinical Development of ALN-VSP for Treatment of Liver Cancers. Alnylam initiated a Phase I multi-center, open label, dose escalation trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALN-VSP in patients with advanced solid tumors with liver involvement, including hepatocellular carcinoma (HCC). ALN-VSP is the company’s first systemic RNAi program and represents Alnylam’s first clinical program in oncology. A significant number of patients have been enrolled across multiple dose cohorts, and Alnylam expects to present preliminary data from the initial dose cohorts of the Phase I trial in mid-2010.
* Advanced ALN-TTR Program for Transthyretin-Mediated Amyloidosis (ATTR) Toward the Clinic. Alnylam is on track to initiate a Phase I trial in ATTR patients in the first half of 2010. ALN-TTR01 is a systemically delivered RNAi therapeutic that employs first generation lipid nanoparticles (LNPs). Pre-clinical studies have demonstrated potent and durable silencing of both the normal and mutated transthyretin (TTR) gene in rodents and non-human primates. Further, administration of the RNAi therapeutic has been shown to reduce the pathogenic accumulation of mutant TTR in peripheral tissues in studies performed in a transgenic mouse model of ATTR. In parallel, Alnylam is also advancing ALN-TTR02 utilizing second generation LNPs.
* Continued to Advance Additional Development and Pre-Clinical Programs. Alnylam continued to advance its additional development programs including ALN-PCS, an RNAi therapeutic targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) for the treatment of hypercholesterolemia, and, in collaboration with Medtronic, Inc., ALN-HTT, an RNAi therapeutic targeting the huntingtin gene for the treatment of Huntington’s disease. Alnylam expects to advance its ALN-PCS program toward the clinic with a goal of initiating a Phase I clinical trial in 2011. Further, Alnylam is advancing a number of additional pre-clinical RNAi therapeutic programs. In addition, Alnylam is advancing its microRNA-based therapeutic programs through its co-ownership of Regulus. Regulus’ lead program, which was recently partnered with GlaxoSmithKline (GSK), is an anti-miR targeting miR-122 for the treatment of hepatitis C virus (HCV) infection. Regulus plans to advance this program toward the clinic in 2011.
* Achieved Major Advances in Delivery of RNAi Therapeutics. In collaboration with scientists at the Massachusetts Institute of Technology (MIT) and, separately, in collaboration with scientists at AlCana Technologies, Inc., Tekmira Pharmaceuticals Corporation, and The University of British Columbia (UBC), Alnylam published on the discovery of novel lipids that enable formulation of second generation LNPs with markedly enhanced gene silencing potency, with in vivo effects achieved at doses as low as 0.01 mg/kg in rodents and non-human primates (Love et al., Proc. Natl Acad. Sci. USA, 107(5):1864-9, 2010 and Semple et al., Nature Biotechnology, 28: 172-178, 2010). Further, Alnylam presented new pre-clinical data at the “Advances in Biopharmaceuticals” Keystone Symposium showing:

— the in vivo mechanism for systemic delivery of LNP-encapsulated siRNAs, demonstrating that endogenous apolipoprotein E (ApoE) mediates hepatocyte delivery of LNPs via ApoE receptors such as the LDL receptor;

— the ability to achieve targeted delivery of engineered LNPs via the asialoglycoprotein receptor (ASGR); and,

— delivery of RNAi therapeutics with novel LNPs to immune cells, including macrophages and dendritic cells.
* Formed New Collaborations Focused on Delivery of RNAi Therapeutics. Alnylam formed a new research collaboration with scientists at UBC and AlCana, in addition to Tekmira, focused on the discovery of novel cationic lipids for use in LNPs for the systemic delivery of RNAi therapeutics. Alnylam also formed a new collaboration with Isis focused on the development of single-stranded RNAi (ssRNAi) technology.
* Launched Alnylam Biotherapeutics. Alnylam presented data at the company’s 2009 R&D Day regarding the application of RNAi technology to improve the manufacturing processes for biologics, an approach the company is advancing in an internal effort called “Alnylam Biotherapeutics.” In particular, Alnylam Biotherapeutics is advancing RNAi technologies to improve the quantity and quality of biologics manufacturing processes using mammalian cell culture, such as Chinese hamster ovary (CHO) cells. RNAi technology can be applied to the improvement of manufacturing processes for existing marketed drugs, new drugs in development, and for the emerging biosimilars market.
* Continued Scientific Leadership. During 2009, scientists from Alnylam and Regulus demonstrated continued scientific leadership with the publication of 25 peer-reviewed scientific papers in some of the world’s top journals. A list and description of Alnylam’s and Regulus’ peer-reviewed publications in the fourth quarter of 2009 and to date in 2010 is provided at the end of this press release.

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Revenues for the fourth quarter were $6.2 million, compared to $7.0 million for the same period in 2008. Net loss for the quarter was $65,000, reduced from $12.5 million in 2008. Full year 2009 revenues were $27.2 million, compared to $27.7 million for the same period last year. Net loss for the year was $1.7 million in 2009 compared to $15.8 million in 2008.

Recent Highlights

* SDIX Collaborates with Fred Hutchinson Cancer Research Center to Discover Biomarkers for Use in Early Detection of Cancer – The objective of the collaboration, which is initially focused on pancreatic cancer, is to identify potential cancer biomarkers to advance the prognostic and diagnostic potential for these challenging diseases.
* SDIX Selected For Third Time to Produce Monoclonal Antibodies for SAIC-F to Advance Cancer Research – SDIX is the only company to be a repeat recipient of this award, underscoring our expertise, quality, and infrastructure as a premier supplier of comprehensive immuno-solutions.
* Newly improved RapidChek E. coli O157 System Awarded AOAC Research Institute Certification for Composite Testing of Raw Beef Products – The AOAC-certified RapidChek E. coli O157 test system, which includes improved materials and reagents, is designed to offer several advantages over competitive testing methods, including greater accuracy, faster results, reduced testing costs, and increased confidence in test results.
* Dr. Klaus Lindpaintner Joins as Vice President of R&D / Chief Scientific Officer – Dr. Lindpaintner served most recently as Director of the “Roche Molecular Medicine Laboratories” and as Roche’s Global Head, Molecular Medicines Policy and External Affairs, coordinating Roche’s efforts in implementing biomarker research based on genetics, genomics, proteomics, and associated disciplines from early discovery to late-stage clinical trials.
* Strategic Diagnostics Inc. Becomes SDIX – The new SDIX branding initiative better reflects the Company’s evolution to a biotechnology company, with all of its core capabilities and expanded expertise in developing and delivering a full suite of innovative immuno-solutions.

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The Company’s segment profit, representing income from continuing operations before stock compensation expense, depreciation and amortization, interest expense, interest income, gain on sale of assets, special charges or benefits, and income taxes, increased $7.6 million over the segment profit of $219.6 million in the prior year. For the year ended December 31, 2008, net revenue was $2.63 billion and net income was $86.2 million, or $2.16 per diluted common share.

For the fourth quarter of 2009, the Company reported net revenue of $718.9 million, compared with $661.8 million in the prior year fourth quarter. Net income in the quarter was $43.7 million, or $1.25 per diluted common share, compared with $23.6 million, or $0.61 per diluted common share, in the fourth quarter of 2008. Segment profit for the fourth quarter was $76.9 million, compared with $55.0 million in the prior year quarter.

The Company ended the quarter with unrestricted cash and investments of $263.8 million, after the impact of stock repurchases for the year of $89.7 million and the purchase of First Health Services for $115.4 million. Cash flow from operations for 2009 was $218.6 million compared with $268.3 million for the prior year.

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For the year ended December 31, 2009, the Company reported revenues of $1.3 billion and net income of $54.1 million, or $1.36 per diluted share, which includes the reversal of the Company’s deferred tax valuation allowance. This compares to revenues of $1.4 billion and a net loss of $74.0 million, or $1.93 diluted per share, and includes the $93.9 million impairment charge. EBITDAO for 2009 was $23.9 million compared to $20.5 million in 2008. Excluding the CHS acquisition expenses discussed above, adjusted EBITDAO would have been $25.7 million for 2009, an increase of 25%.

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The Company reported net income from continuing operations of $76 million (or $1.29 per share) in 2009, compared to $437 million (or $6.93 per share) in 2008. In 2008, a $319 million (or $4.77 per share) non-cash gain was recorded in the fourth quarter, related to the recognition of certain deferred tax assets and based primarily on the expected utilization of the Company’s net operating loss carryforwards (NOL’s). 2009 is the first full year of financial reporting in which OSI has shown a full tax provision on its earnings. Adjusting for non-cash tax expense (to reflect OSI’s actual cash tax rate of approximately 3%), restructuring and other charges related to our consolidation of U.S. operations, expense related to equity-based compensation, non-cash interest expense on our convertible notes, and certain other items detailed in the attached reconciliation of GAAP to non-GAAP financial measures, the Company reported that non-GAAP net income from continuing operations increased to $181 million (or $2.89 per share) in 2009, compared to $157 million (or $2.56 per share) in 2008, an increase of 15% over the prior year. For the fourth quarter of 2009, non-GAAP net income from continuing operations increased to $57 million (or $0.90 per share), compared to $38 million (or $0.62 per share) in the fourth quarter of 2008, an increase of 50% over the prior year.

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