Hemispherx Biopharma Inc (HEB, Financial) filed Quarterly Report for the period ended 2012-09-30.
Hemispherx Biopharma, Inc. has a market cap of $89.3 million; its shares were traded at around $0.7711 with and P/S ratio of 555.1.
Upon the completion of the fill, finish and packaging protocol, Process Validation of Alferon® Work-In-Process lots need to be completed. A minimum of three months of stability tests is required in a Pre-Approval Supplement (“PAS”). Upon receipt of the PAS, the FDA could take up to six months to render an opinion. When the finished product lots obtain approval from the FDA, we will be able to commercially sell Alferon N Injection® in the United States. If we receive a lot release approval from the FDA as to quality and consistency of these materials, and approval for Althea regarding the fill and finish process, we will then be able to utilize the approved lots for commercial sales of Alferon N Injection®. At the completion of the Company’s redirection of many of its resources to the Ampligen® NDA submission and preparedness for the FDA pre-approval inspections, it is projected that an additional six to nine months may be necessary to determine the status of our existing inventory of Alferon N Injection® for commercial sales.
Revenues from our Ampligen® Cost Recovery Program decreased $6,000 or 13% for the third quarter of 2012 as compared to the same time period of 2011. The number of patients increased 14% in the three months ended September 30, 2012, but as there were some shipments to compassionate care patients in this period, the actual amounts collected dropped resulting in lower revenues. As of September 30, 2012, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study.
Revenues from our Ampligen® Cost Recovery Program increased $37,000 or 30% for the first nine months of 2012 as compared to the same time period of 2011. The number of patients increased 23% in the nine months ended September 30, 2012. As previously stated, we have no Alferon N Injection® product to commercially sell at this time and all revenue was generated from the FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study.
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Hemispherx Biopharma, Inc. has a market cap of $89.3 million; its shares were traded at around $0.7711 with and P/S ratio of 555.1.
Highlight of Business Operations:
Commercial sales of Alferon N Injection® were halted in March 2008 when our finished goods inventory expired. The production of Alferon N Injection® from the Work-In-Process Inventory was restarted in May 2010, continued into January 2011 with its conversion into API and is completed for the related Final Lot Release Test. To formulate, fill, finish and package (“fill and finish”) Alferon N Injection® Drug Product, we require a FDA approved third party Contract Manufacturing Organization (“CMO”). While the Work-In-Process Inventory had expiration dates of September 30, 2012 through March 10, 2013, upon the completion of each inventory lot in the fill, finish and packaging process it is projected that those lots of Alferon N Injection® will then have an expected shelf life of 42 months. In April 2012, FDA reviewers raised certain questions about the status of our existing lots of older Work-In-Process Alferon® materials and API, which would need to be released by FDA before those materials could be used in commercial product. The production of new Alferon® drug product inventory will not commence until the capital improvements and related validation phases at our New Brunswick manufacturing facility are complete.Upon the completion of the fill, finish and packaging protocol, Process Validation of Alferon® Work-In-Process lots need to be completed. A minimum of three months of stability tests is required in a Pre-Approval Supplement (“PAS”). Upon receipt of the PAS, the FDA could take up to six months to render an opinion. When the finished product lots obtain approval from the FDA, we will be able to commercially sell Alferon N Injection® in the United States. If we receive a lot release approval from the FDA as to quality and consistency of these materials, and approval for Althea regarding the fill and finish process, we will then be able to utilize the approved lots for commercial sales of Alferon N Injection®. At the completion of the Company’s redirection of many of its resources to the Ampligen® NDA submission and preparedness for the FDA pre-approval inspections, it is projected that an additional six to nine months may be necessary to determine the status of our existing inventory of Alferon N Injection® for commercial sales.
Revenues from our Ampligen® Cost Recovery Program decreased $6,000 or 13% for the third quarter of 2012 as compared to the same time period of 2011. The number of patients increased 14% in the three months ended September 30, 2012, but as there were some shipments to compassionate care patients in this period, the actual amounts collected dropped resulting in lower revenues. As of September 30, 2012, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study.
Revenues from our Ampligen® Cost Recovery Program increased $37,000 or 30% for the first nine months of 2012 as compared to the same time period of 2011. The number of patients increased 23% in the nine months ended September 30, 2012. As previously stated, we have no Alferon N Injection® product to commercially sell at this time and all revenue was generated from the FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study.
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