Human Genome Sciences Inc. (HGSI, Financial) filed Annual Report for the period ended 2011-12-31.
Human Genome has a market cap of $1.68 billion; its shares were traded at around $8.01 with and P/S ratio of 10.7.
Albiglutide is a biological product that is generated from the fusion of human albumin and modified human GLP-1 peptide. GSKs Phase 3 program for albiglutide includes eight trials to evaluate the long-term efficacy, safety and tolerability of albiglutide as monotherapy and add-on therapy for patients with type 2 diabetes mellitus. GSK announced topline results of the first of eight Phase 3 trials in November 2011. The study, known as Harmony 7, was designed to compare once-weekly albiglutide to once-a-day liraglutide. Results showed a reduction in HbA1c from baseline of 0.78% for patients receiving albiglutide compared to a reduction of 0.99% for liraglutide. Although the pre-specified margin of non-inferiority to liraglutide was not met, albiglutide did show a statistically significant reduction in HbA1c from baseline (p<0.001). The most common adverse events observed during this study were nausea (9.9% for albiglutide versus 29.2% for liraglutide) and vomiting (5% for albiglutide versus 9.3% for liraglutide). GSKs conclusion after review is that the data support continued progress toward registration as a possible once-weekly treatment for type 2 diabetes. GSK expects initial results from the remaining studies over the course of the next several months, and has stated that it expects to provide an update on albiglutide once a more complete view of the data is available in mid-2012. We created albiglutide using our proprietary albumin-fusion technology, and licensed it to GSK in 2004. We are entitled to fees and milestone payments that could amount to as much as $183.0 million including $33.0 million received to date in addition to single-digit royalties on worldwide sales if albiglutide is commercialized.
Raxibacumab. In September 2005, we entered into a two-phase contract with BARDA to supply raxibacumab for inhalation anthrax. HHS is the lead agency for public health and medical response to man-made or natural disasters, including acts of bioterrorism. Under the first phase of the contract, we supplied 10 grams of raxibacumab to HHS for comparative in vitro and in vivo testing. In June 2006, under the second phase of the contract, the USG exercised its option to purchase raxibacumab and we agreed to manufacture and deliver 20,001 doses to the SNS. In 2009, we achieved our companys first product sales by completing these deliveries and recognized $162.5 million in product sales and manufacturing and development services revenue. In July 2009, the USG exercised its option to purchase 45,000 additional doses of raxibacumab for the SNS for emergency use in treating inhalation anthrax, with delivery to be completed over a three-year period. HGS expects to receive approximately $142.0 million from this second order as deliveries are completed, including approximately $52.5 million and $47.2 million recognized as product sales revenue in 2011 and 2010, respectively. Also under our contract, HGS submitted a BLA to the FDA for raxibacumab for the treatment of inhalation anthrax in May 2009. We received a Complete Response Letter in November 2009, and we continue to work closely with the FDA to obtain approval. HGS will receive approximately $20.0 million from the USG if raxibacumab is licensed by the FDA. Our raxibacumab agreement can be terminated by the USG if it determines that a termination is in its interest.
Revenues. We had revenues of $131.0 million and $157.4 million for 2011 and 2010, respectively. Revenues for 2011 primarily included $52.3 million in BENLYSTA product sales ($59.2 million in gross sales before sales deductions and returns), as well as $52.5 million in raxibacumab product sales and $24.8 million in manufacturing and development services revenue. Revenues for 2010 consisted primarily of $82.8 million recognized from Novartis with respect to ZALBIN, as well as $47.2 million in raxibacumab product sales and $22.7 million from manufacturing and development services revenue. No revenue with respect to ZALBIN has been recognized beyond September 2010 due to our decision to end further development of ZALBIN based on regulatory feedback. BENLYSTA revenue in future periods is expected to increase as BENLYSTA sales progress. In addition, product sales in 2012 are expected to include approximately $25.0 million of raxibacumab sales related to the second USG order.
Revenues. We had revenues of $157.4 million and $275.7 million for 2010 and 2009, respectively. Revenues for 2010 consisted primarily of $82.8 million recognized from Novartis primarily relating to recognition of all remaining unrecognized up-front license fees and milestones due to the decision to end further development of ZALBIN, as well as $47.2 million in raxibacumab product sales and $21.3 million from contract manufacturing services. Revenues for 2009 consisted primarily of $154.1 million in raxibacumab product sales, $54.2 million recognized from Novartis related to straight-line recognition of up-front license fees and milestones reached for ZALBIN, $26.1 million related to raxibacumab development services and $24.4 million from contract manufacturing services.
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Human Genome has a market cap of $1.68 billion; its shares were traded at around $8.01 with and P/S ratio of 10.7.
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We are developing raxibacumab under a contract entered into in 2006 with BARDA. The U.S. Government is currently our only customer for raxibacumab and has the right to terminate our contract at any time. In 2011, HGS continued delivery 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 of raxibacumab for the Stockpile for emergency use in treating inhalation anthrax, with delivery to be completed over a three-year period. HGS expects to receive approximately $142.0 million from this second order as deliveries are completed. In 2011, we recognized $52.5 million in raxibacumab product sales revenue. Also under our contract, HGS submitted a BLA to the FDA for raxibacumab for the treatment of inhalation anthrax in May 2009. We received a Complete Response Letter in November 2009, and we continue to work closely with the FDA to obtain approval. HGS will receive approximately $20.0 million from the U.S. Government if raxibacumab is licensed by the FDA. Raxibacumab revenue accounted for 42% and 31% of our total revenue for 2011 and 2010, respectively.Albiglutide is a biological product that is generated from the fusion of human albumin and modified human GLP-1 peptide. GSKs Phase 3 program for albiglutide includes eight trials to evaluate the long-term efficacy, safety and tolerability of albiglutide as monotherapy and add-on therapy for patients with type 2 diabetes mellitus. GSK announced topline results of the first of eight Phase 3 trials in November 2011. The study, known as Harmony 7, was designed to compare once-weekly albiglutide to once-a-day liraglutide. Results showed a reduction in HbA1c from baseline of 0.78% for patients receiving albiglutide compared to a reduction of 0.99% for liraglutide. Although the pre-specified margin of non-inferiority to liraglutide was not met, albiglutide did show a statistically significant reduction in HbA1c from baseline (p<0.001). The most common adverse events observed during this study were nausea (9.9% for albiglutide versus 29.2% for liraglutide) and vomiting (5% for albiglutide versus 9.3% for liraglutide). GSKs conclusion after review is that the data support continued progress toward registration as a possible once-weekly treatment for type 2 diabetes. GSK expects initial results from the remaining studies over the course of the next several months, and has stated that it expects to provide an update on albiglutide once a more complete view of the data is available in mid-2012. We created albiglutide using our proprietary albumin-fusion technology, and licensed it to GSK in 2004. We are entitled to fees and milestone payments that could amount to as much as $183.0 million including $33.0 million received to date in addition to single-digit royalties on worldwide sales if albiglutide is commercialized.
Raxibacumab. In September 2005, we entered into a two-phase contract with BARDA to supply raxibacumab for inhalation anthrax. HHS is the lead agency for public health and medical response to man-made or natural disasters, including acts of bioterrorism. Under the first phase of the contract, we supplied 10 grams of raxibacumab to HHS for comparative in vitro and in vivo testing. In June 2006, under the second phase of the contract, the USG exercised its option to purchase raxibacumab and we agreed to manufacture and deliver 20,001 doses to the SNS. In 2009, we achieved our companys first product sales by completing these deliveries and recognized $162.5 million in product sales and manufacturing and development services revenue. In July 2009, the USG exercised its option to purchase 45,000 additional doses of raxibacumab for the SNS for emergency use in treating inhalation anthrax, with delivery to be completed over a three-year period. HGS expects to receive approximately $142.0 million from this second order as deliveries are completed, including approximately $52.5 million and $47.2 million recognized as product sales revenue in 2011 and 2010, respectively. Also under our contract, HGS submitted a BLA to the FDA for raxibacumab for the treatment of inhalation anthrax in May 2009. We received a Complete Response Letter in November 2009, and we continue to work closely with the FDA to obtain approval. HGS will receive approximately $20.0 million from the USG if raxibacumab is licensed by the FDA. Our raxibacumab agreement can be terminated by the USG if it determines that a termination is in its interest.
Revenues. We had revenues of $131.0 million and $157.4 million for 2011 and 2010, respectively. Revenues for 2011 primarily included $52.3 million in BENLYSTA product sales ($59.2 million in gross sales before sales deductions and returns), as well as $52.5 million in raxibacumab product sales and $24.8 million in manufacturing and development services revenue. Revenues for 2010 consisted primarily of $82.8 million recognized from Novartis with respect to ZALBIN, as well as $47.2 million in raxibacumab product sales and $22.7 million from manufacturing and development services revenue. No revenue with respect to ZALBIN has been recognized beyond September 2010 due to our decision to end further development of ZALBIN based on regulatory feedback. BENLYSTA revenue in future periods is expected to increase as BENLYSTA sales progress. In addition, product sales in 2012 are expected to include approximately $25.0 million of raxibacumab sales related to the second USG order.
Revenues. We had revenues of $157.4 million and $275.7 million for 2010 and 2009, respectively. Revenues for 2010 consisted primarily of $82.8 million recognized from Novartis primarily relating to recognition of all remaining unrecognized up-front license fees and milestones due to the decision to end further development of ZALBIN, as well as $47.2 million in raxibacumab product sales and $21.3 million from contract manufacturing services. Revenues for 2009 consisted primarily of $154.1 million in raxibacumab product sales, $54.2 million recognized from Novartis related to straight-line recognition of up-front license fees and milestones reached for ZALBIN, $26.1 million related to raxibacumab development services and $24.4 million from contract manufacturing services.
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