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Antares Pharma Inc. Message Board

  • mdr0418 mdr0418 May 17, 2012 12:25 PM Flag

    Analyst Covering AIS

    Recent analyst comments on AIS with a strong buy recommendation.


    Highlights



    Second internal Vibex development program, Vibex QST, announced. Antares identified its second Vibex internal development program, Vibex QST. Vibex QST is a testosterone autoinjector which is on-track to enter the clinic in 2013. The testosterone market represents a significant opportunity, with the US testosterone replacement market in 2011 being roughly$1.64 billion (largely based on sales of the topical gels, Androgel and Testim, while the injectable testosterones represent approximately 6% of the market (Wolters Kluwer)). We are encouraged by this announcement as the Vibex injector could offer some advantages over the gels (including lack of transference concerns and no Black Box warning in the label) and over the current injectables (including ease of use and convenience as there would be no need to visit a physician to receive an injection).



    Filing of Vibex MTX NDA expected by 1Q 2013. We expect the Vibex MTX NDA filing to occur by 1Q 2013 and believe the US program will encompass EU requirements to also facilitate a filing for approval in the EU shortly after the US filing. AIS will dose Vibex MTX from 7.5-30mg (in 2.5mg increments). The program encompasses a 1 to 2 month user/usability study and we anticipate an NDA filing in by 1Q 2013 once these usability studies and CMC work are complete (data expected 4Q12). In August 2011, AIS reported positive results from the BE study evaluating MTX in four doses ranging from 10-25mg with doses demonstrating bioequivalence (similar PK profile) to that of intramuscular and subcutaneous injections of MTX. We believe the Vibex MTX program is AIS's first step towards increasing organic, top-line growth. Potential out-licensing of EU rights to Vibex MTX would also add to AIS cash position.



    Watson launched Gelnique 3%TM in April 2012; Top-line revenue contribution expected to begin 3Q12. We are encouraged by Watson's (WPI, not rated, $74.73) branding of Anturol as Genique 3% as we believe this will allow them to leverage brand awareness and more importantly reimbursement status and the established formulary presence for the launch of the product. Additionally, we expect Watson will attempt to differentiate Gelnique 3% from the existing line by emphasizing safety (potentially improved side effect profile), efficacy and the fast-acting nature of the product. Antares will receive regulatory and sales based milestones (which we expect to approximate $10-15 million) and escalating royalties into double-digits on U.S. and Canada product sales. AIS receives royalty revenues from this product franchise (Gelnique 3%+Gelnique) on a one-quarter lag; but we remind investors Watson is present in the overactive bladder (OAB) space and upon launch of Gelnique 3%, AIS will receive royalty revenues from both products. We expect Gelnique 3% royalties to AIS could be $15 million/year at peak and at least $2 million in 2012.



    1Q 2012 Results: Antares reported a net loss of $0.1 million or ($0.00) per share below our estimate of a net loss of $2.2 million and ($0.02) per share. Antares reported total revenue of $6.9 million, which was $3.7 million higher than our estimate. Expenses of $6.96 million were higher than our estimate of $5.4 million. AIS ended 1Q 2012 with $33.2 million in cash. Despite an increase in R&D, we expect cash requirements to be in the $4 to $5 million range for the remainder of 2012 due to higher revenues and milestone payments related to partnered products and projects.



    We reiterate our Buy rating and our $5 price target. We continue to believe AIS represents an outstanding buying opportunity with significant upside potential for the stock and we encourage investors to purchase the shares.

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