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Heartware International Inc. Message Board

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  • Company Rating Price Target
    Biomedical Devices and Services
    Buy US$54.76 US$106.00
    Hold US$63.10 US$63.50
    Share price data as of Sep 25 2015

  • Thoratec's HM3 results good, but not the
    HeartWare knockout blow some expected; buy
    HTWR aggressively at current levels
    CE Mark trial results from Thoratec’s HeartMate 3 system, presented Sunday at
    the HFSA meeting, were largely positive, but the adverse event profile seemed
    underwhelming relative to the lofty expectations by the Street (i.e., HTWR bears), and
    discussed below. The results met the primary endpoint – six-month survival rate of 92%
    (vs. 88% OPC), representing the highest six-month survival reported in a European CE
    Mark VAD trial.
    Adverse event rates were generally in line with current LVAD systems – GI bleeding
    events of 8% compared to reported rates of 11-25% in literature (Figure 1), while there
    were no reports of major pump thrombosis, pump exchange, or hemolysis at the sixmonth
    time period. With regard to the closely-watched stroke rate, 12% of patients had
    strokes (8% ischemic and 4% hemorrhagic); half of these events were determined to be
    procedure-related and may or may not be associated to the device. While the adverse
    event rates in Thoratec’s HM3 CE Mark study were solid from a clinical standpoint
    and were mostly in line with the event rates for HM2 and HeartWare’s HVAD, we think
    clinicians and investors heading into the meeting were looking/hoping for superior
    event rates given 1) the innovative pump design which could minimize blood component
    trauma and result in more stable coagulation; and 2) St. Jude Medical’s acquisition of
    Thoratec, which to many implied auspicious validation of the HM3 technology relative
    to HeartWare’s MVAD. We would say “not so fast.” Notably, the HM3 CE Mark study
    enrolled a modestly less sick patient cohort than the typical LVAD population: 40% of
    patients in the study had an INTERMACS 4 profile compared to 15% of patients in the
    overall INTERMACS registry population. Importantly, based on the INTERMACS scores
    of the enrolled patients, overall bleeding rates were expected to be 15% vs. 38% in
    the trial, and overall stroke rates were expected to be 8% vs. the 12% reported in the
    study. That being said, we caution investors not to over-interpret the results of this small,
    non-randomized trial and look for results from the MOMENTUM 3 US pivotal study to
    determine if HM3 will realize its full potential.
    Implications for HTWR: We think that solid but not “knockout” results of the HM3 study
    represent a net positive for HTWR common. Indeed, given the above-mentioned factors,
    coupled with a fair degree of skepticism from some investors with regard to the Valtech
    acquisition, we believe investors were losing comfort in MVAD’s prospects relative to
    HM3 heading into this data. The HM3 results should, at the very least, signal to investors
    that MVAD remains a viable next-gen system, notwithstanding the recent delays in
    HeartWare’s own CE Mark trial.

  • and has been milked to death.
    No earnings since forever and recent prices in the 90's.

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  • It's a much better company then this one. Take a look.

  • ...Driven By Strong Global Unit Growth…
    • Record 773 HeartWare HVAD Systems sold worldwide in Q2’15, with record unit sales in both U.S. & Intl. markets
    • U.S. revenue grew 16% to $42.9mm, compared to Q2’14
    • Intl. rev. of $30.7mm, an increase of 10% from Q2’14 on a constant-currency basis
    • Conference call today at 8:00amET

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