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Alimera Sciences, Inc. (ALIM) Message Board

  • paultradestoday paultradestoday Mar 1, 2012 11:25 AM Flag

    Complete Citi Summary FYI

    * What's New - We hosted ALIM at our 2012 Healthcare Conference in NYC,
    and highlights from mgmt include further detail on EU commercialization
    plans/market dynamics, timing of discussions with the US FDA, and
    potential financing. We remain Neutral on ALIM as we wait for better
    visibility on the launch plans for Iluvien in Europe.

    * Europe Launch Timing - ALIM announced EU approval of Iluvien in chronic
    DME on Tuesday (2/28) and is currently in a 30-day National Phase to
    complete label translation in each country. The marketing authorization
    to begin selling is expected on March 28, but mgmt is not expected to
    launch until the end of 2012 as distribution & reimbursement requirements
    need to be completed. The launch will most likely begin in Germany since
    the reimbursement hurdles are lower compared to other countries.

    * Europe Market Dynamics - At this point mgmt remains undecided on
    partnering for the European opportunity but expects to make a decision
    over the next few months - the decision would be "all-or-none" since
    distributors would be unwilling to sell in only certain countries without
    access to the rest of Europe. Mgmt indicated that while only 7 countries
    have approval, 80% of the diabetics in Europe (23M people vs. 25M in the
    US) are in those 7 countries. The number of retina specialists is also
    similar to the US and would require roughly the same size sales force as
    the US (about 20-30 reps).

    * EU DME Treatment Regimens - The treatment of DME in Europe is somewhat
    similar to the US. Laser photocoagulation, generic steroids, and
    anti-VEGF therapies are used to treat the disease. Interestingly, some
    injections are performed in the hospital setting which may be a
    consideration when determining Iluvien pricing in Europe.

    * Europe Reimbursement - ALIM is working on a pricing plan for Europe and
    has started conducting its health economic analysis in preparation for
    future reimbursement meetings, including a meeting with NICE in the UK in
    late summer (August). Our initial thinking is that the EU pricing range
    will be modestly below the $5-10K range that the company was considering
    for the US market.

    * US FDA Discussions - Mgmt has been in contact with FDA after receiving
    the Complete Response Letter in November and expects a meeting in 2Q to
    discuss a path forward to obtain US approval. As a reminder, the FDA
    would like ALIM to conduct two new clinical trials for Iluvien - mgmt has
    not yet committed to this investment.

    * Financing - ALIM has $34M of cash as of the end of December 2011 and
    does not expect to raise capital in 2012. If ALIM chooses to
    commercialize via a partnership we believe there would likely be a large
    upfront payment by ALIM as part of the agreement, and if the company goes
    direct there would likely be sizeable infrastructure investments before a
    ramp in sales would yield P&L leverage.

 
ALIM
5.85-0.02(-0.34%)Jul 10 4:00 PMEDT

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