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Michael Sweeney is the Editor of Daily Dose Equities, which is focused on Wall Street style research in the Healthcare sector with an emphasis on Biotechnology market analysis. We provide a "Daily Dose" of insights, observations, and fundamental research with a focus on emerging... More
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  • Unilife Corporation Announces Financial Results For Fiscal Year 2012 Third Quarter

    Unilife Corporation (NASDAQ: UNIS; ASX: UNS) announced financial results for the quarter ended March 31, 2012 (the third quarter of Fiscal Year 2012).

    Recent Highlights:

    • Supplying pharmaceutical companies with shipments of the Unifill ready-to-fill (prefilled) syringe.
    • Further expansion of the Unilife AutoInfusor platform of wearable, disposable pumps for the self-administration of large-volume dose. Supplied devices to multiple pharmaceutical companies for evaluation and user studies during the March Quarter, with favorable results.
    • Successful development of Unilife's first specialized device for targeted organ delivery, which is ready for supply to a global pharmaceutical customer for use in human clinical drug trials scheduled to occur later this year. Unilife recognized revenue of $566,000 during the March Quarter as part of the initial stage of this program.
    • Continuing positive developments with pharmaceutical customers for other proprietary devices including the EZMix dual chamber prefilled syringe and Rita Auto-Injector.
    • Sponsorship of Safe in Common's Needlestick Safety Advocacy Tour.
    • Successful Analyst and Shareholder Day held in New York in March 2012.
    • Unilife CEO Alan Shortall completed open market purchases of the Company's common stock totaling approximately $1.0 million from January to February of 2012.

    Unilife CEO Alan Shortall commented, "Unilife remains fully on track to deliver upon several key business milestones this year. We look forward to driving future shareholder value by building partnerships with our expanding network of pharmaceutical customers, accelerating the commercialization of our diversified portfolio of advanced drug delivery systems, and expanding our production capabilities.

    "Unilife continues to supply the Unifill prefilled syringe to current and new pharmaceutical customers. We look forward to the signing of commercial supply contracts for Unifill, which we anticipate throughout the second half of 2012.

    "We have aggressively increased our investment in R&D, as well as existing production capacities in anticipation of several new development and supply agreements that we expect to secure starting in the second half of 2012. Our increase in R&D has already generated many positive developments.

    "For example, I am pleased to advise that the first GMP-compliant batch of our specialized device for targeted organ delivery is now ready to be shipped to a global pharmaceutical company for use in human clinical drug trials scheduled to occur later this year. To date, we have recognized revenue of approximately $800,000 for this program and expect to recognize the balance of this $1.4M initial stage in the next quarter. We further expect to generate additional revenues as this program continues to move forward.

    "In addition, our platform of wearable, disposable AutoInfusors for the subcutaneous self-administration of large volume doses is expanding rapidly in response to accelerating customer demands. Variants of our AutoInfusor technologies were supplied to several pharmaceutical companies during the March Quarter for market evaluations and user studies, with favorable outcomes, resulting in advancing our relationships to the next stages toward human clinical trials.

    "We also continue to generate positive developments regarding other proprietary devices within our expanding proprietary portfolio, such as the EZMix dual chamber prefilled syringe and the Rita Auto-Injector. These investments in R&D reflect strong commercial interest from multiple pharmaceutical customers regarding the Unifill syringe and all other technology platforms within our rapidly expanding device portfolio.

    "Given our confidence in our commercial pipeline to generate additional revenues from a number of sources, we are comfortable with the Company's cash position and ability to support current fixed costs for at least the next year," concluded Mr. Shortall.

    Financial Results for Three Months Ended March 31, 2012

    Revenues for the three months ended March 31, 2012 were $1.3 million compared to $0.7 million for the same period in 2011. During the three months ended March 31, 2012, the Company recognized revenue of $0.6 million related to the clinical development and supply of a novel device for targeted organ delivery.

    The Company's net loss for the three months ended March 31, 2012 was $14.9 million, or $0.21 per diluted share, compared to a net loss of $12.5 million, or $0.20 per diluted share, for the same period in 2011. The increase in the net loss was primarily attributable to an increase in research and development expenses related to the development of additional advanced drug delivery devices. These amounts were partially offset by a reduction of $1.4 million in selling, general and administrative expenses.

    Adjusted net loss for the three months ended March 31, 2012 was $10.7 million, or $0.15 per diluted share, compared to $9.3 million, or $0.15 per diluted share, for the same period in 2011. Adjusted net loss excludes non-cash share-based compensation expense, depreciation and amortization and interest expense.

    As of March 31, 2012, the Company's cash position was $27.2 million.

    Conference Call Information

    Management has scheduled a conference call for 4:30 p.m. U.S. Eastern Daylight Time on April 26, 2012, to review the Company's financial results, market trends and future outlook. The conference call and accompanying slide presentation will be broadcast over the Internet as a "live" listen only Webcast. An archive of the presentation and webcast will be available for 30 days after the call. To listen, please go to: http://ir.unilife.com/events.cfm.

    About Unilife Corporation

    Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of advanced drug delivery systems. Unilife collaborates with pharmaceutical and biotechnology companies seeking innovative, differentiated devices that can enable or enhance the delivery of injectable drugs and vaccines supplied in either a liquid stable or lyophilized form. The Unifill syringe, the world's first and only prefilled syringe with fully integrated safety features, sits at the leading edge of this diversified portfolio. In addition to prefilled and hypodermic safety syringes with automatic, user-controlled needle retraction, Unilife has other proprietary technology platforms including drug reconstitution delivery systems, auto-injectors, auto-infusion pump systems and specialized devices for targeted organ delivery. Unilife's global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information on Unilife, please visit www.unilife.com

    Tags: UNIS
    Apr 27 9:02 AM | Link | Comment!
  • Human Genome ($HGSI) Announces Rejection Of Unsolicited Offer From Glaxo (GSK) To Acquire HGSI For $13/sh Cash

    Human Genome Sciences (NASDAQ: HGSI) exists to place new therapies into the hands of those battling serious disease.

    • HGSI announced that it has received an unsolicited proposal from GSK to acquire HGSI for $13.00 per share in cash.
    • The New York Times Deal Book is now saying it has been rejected - SEE NY TIMES DEAL BOOK
    • The HGSI board, in consultation with independent financial and legal advisors, has carefully reviewed and considered the GSK offer and has determined that the offer does not reflect the value inherent in HGSI
    • HGSI also announced that its board has authorized the exploration of strategic alternatives in the best interests of shareholders, including, but not limited to, a potential sale of the company.
    • HGSI has retained Goldman, Sachs & Co. and Credit Suisse Securities (USA) LLC to assist in this process, with Skadden, Arps, Slate, Meagher & Flom LLP and DLA Piper LLP (US) serving as legal counsel.
    • GSK has been invited to participate in this process and HGSI has requested additional information regarding investigational products in GSK's clinical pipeline to which HGS has substantial financial rights, including darapladib, currently in Phase 3 development for the treatment of cardiovascular disease, and albiglutide, currently in Phase 3 development for the treatment of type 2 diabetes.
    • There can be no assurance that any transaction will occur or if so on what terms.
    • HGSI does not intend to discuss the status of its evaluation unless and until a specific transaction has been approved
    • StreetAccount notes there have been a number of rumors over a period of time regarding a potential bid by GSK for HGSI as the two companies are commercialization and development partners in Benlysta

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Tags: HGSI
    Apr 19 8:53 AM | Link | Comment!
  • MesoBlast ($MSB): FDA Green Lights PII Trial For Type 2 Diabetes

    Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY) is the world's leading developer of innovative biological products for the broad field of regenerative medicine. Mesoblast's commercial strategy is based on its unique proprietary adult mesenchymal precursor cells. The company's lead products will target cardiovascular conditions, diabetes, inflammatory conditions of lungs and joints, eye diseases, bone marrow cancers, bone fractures, cartilage degeneration and musculoskeletal conditions. Mesoblast and Teva Pharmaceutical Industries Ltd. have established a strategic alliance to commercialize adult stem cell products for degenerative conditions of the cardiovascular and central nervous systems. The alliance also extends to products for augmenting bone marrow transplantation in cancer patients.

    Mesoblast announced that its Phase 2 clinical trial of allogeneic (off-the-shelf) Mesenchymal Precursor Cells has now enrolled 50% of the total study patients. This trial will investigate non-surgical treatment of lower back pain due to degenerated intervertebral discs. The rapid enrollment of this study indicated the Phase 2 trail will reach full capcity for its study by the third quarter. The pace in which this study has enrolled participants bespeaks of the great need back patients have for non-surgical treatments.

    The Company commented,

    "Up to 15 per cent of people in industrialized countries have chronic low back pain lasting more than six months. For those with progressive, severe and debilitating pain due to degenerating intervertebral discs, the only current option is major back surgery involving spinal fusion, artificial disc replacement, or other surgical procedures. Avoidance of surgery and its complications is a major objective of any new treatment for degenerative disease of the spine."

    Mesoblast published the results of its previous successful study in the March 2012 issue of the Journal of Neurosurgery.

    Read the full press release here.

    Apr 18 8:24 AM | Link | Comment!
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