New coverage by HCW, price target @ $10.
Not able to post the link if the coverage, will try to copy and paste here;
Events tracking to our projection, interim analysis on tap for Sep/ Oct. As we edge closer and closer to REDUCE-IT’s topline results in 2018, this past quarter finally provided the investment community with some material updates regarding the trial progress, which has, until recently, only been a topic of speculation: (1) REDUCE-IT has reached its target enrollment and now has over 8,000 patients in the study; and (2) the onset of approximately 60% of target primary cardiovascular events have been reached, triggering preparations of the pre-specified interim analysis by the DMC, with a decision to be made (early stop/study continue; we expect the study to continue, see next bullet) in Sep/Oct. The first is self-evident; the second and more important announcement has potentially positive implications for the final outcome of the study: the actual ongoing event rate for the study is tracking not only very closely to the company’s internal projections, but also to our own independent projections (see appendix). For the past year, we have guided that under the assumption of a placebo event rate of 5.2% (used for study’s power calculation) and a 15% relative risk reduction (also for power calculation), the 967th event (60% of all events) is expected to occur in February-March 2016; company’s announcement of the 60% event trigger was made on the last day of March, likely with the actual event having occurred earlier that month (note: the data analysis time of 6 months is longer than we expected). Under this now publicly announced event timetable, assumptions can be made on the two factors at play here: if one assumes that the estimated relative risk reduction is actually below 15% (in which case, the study may not be powered to detect an effect), then that would require the placebo event rate to be not just lower than 5.2%, but starkly lower (at the level of ~4.7%). From our prior review of diabetes literature, we find it unlikely (but plausible) for the placebo event rates for extended MACE events to be that low: across 29 diabetes outcome trials for just the core MACE endpoint (without coronary revascularization and hospitalization for unstable angina, the extended MACE endpoint used in REDUCE-IT), with baseline CVD was 5.19% (Am Heart J 2011;161:210-219). Ahead of the expected heightened volatility, volume and likely share price appreciation, we believe, leading into the interim Events tracking to our projection, interim analysis on tap for Sep/ Oct. As we edge closer and closer to REDUCE-IT’s topline results in 2018, this past quarter finally provided the investment community with some material updates regarding the trial progress, which has, until recently, only been a topic of speculation: (1) REDUCE-IT has reached its target enrollment and now has over 8,000 patients in the study; and (2) the onset of approximately 60% of target primary cardiovascular events have been reached, triggering preparations of the pre-specified interim analysis by the DMC, with a decision to be made (early stop/study continue; we expect the study to continue, see next bullet) in Sep/Oct. The first is self-evident; the second and more important announcement has potentially positive implications for the final outcome of the study: the actual ongoing event rate for the study is tracking not only very closely to the company’s internal projections, but also to our own independent projections (see appendix). For the past year, we have guided that under the assumption of a placebo event rate of 5.2% (used for study’s power calculation) and a 15% relative risk reduction (also for power calculation), the 967th event (60% of all events) is expected to occur in February-March 2016; company’s announcement of the 60% event trigger was made on the last day of March, likely with the actual event having occurred earlier that month (note: the data analysis time of 6 months is longer than we expected). Under this now publicly announced event timetable, assumptions can be made on the two factors at play here: if one assumes that the estimated relative risk reduction is actually below 15% (in which case, the study may not be powered to detect an effect), then that would require the placebo event rate to be not just lower than 5.2%, but starkly lower (at the level of ~4.7%). From our prior review of diabetes literature, we find it unlikely (but plausible) for the placebo event rates for extended MACE events to be that low: across 29 diabetes outcome trials for just the core MACE endpoint (without coronary revascularization and hospitalization for unstable angina, the extended MACE endpoint used in REDUCE-IT), with baseline CVD was 5.19% (Am Heart J 2011;161:210-219). Ahead of the expected heightened volatility, volume and likely share price appreciation, we believe, leading into the interim Events tracking to our projection, interim analysis on tap for Sep/ Oct. As we edge closer and closer to REDUCE-IT’s topline results in 2018, this past quarter finally provided the investment community with some material updates regarding the trial progress, which has, until recently, only been a topic of speculation: (1) REDUCE-IT has reached its target enrollment and now has over 8,000 patients in the study; and (2) the onset of approximately 60% of target primary cardiovascular events have been reached, triggering preparations of the pre-specified interim analysis by the DMC, with a decision to be made (early stop/study continue; we expect the study to continue, see next bullet) in Sep/Oct. The first is self-evident; the second and more important announcement has potentially positive implications for the final outcome of the study: the actual ongoing event rate for the study is tracking not only very closely to the company’s internal projections, but also to our own independent projections (see appendix). For the past year, we have guided that under the assumption of a placebo event rate of 5.2% (used for study’s power calculation) and a 15% relative risk reduction (also for power calculation), the 967th event (60% of all events) is expected to occur in February-March 2016; company’s announcement of the 60% event trigger was made on the last day of March, likely with the actual event having occurred earlier that month (note: the data analysis time of 6 months is longer than we expected). Under this now publicly announced event timetable, assumptions can be made on the two factors at play here: if one assumes that the estimated relative risk reduction is actually below 15% (in which case, the study may not be powered to detect an effect), then that would require the placebo event rate to be not just lower than 5.2%, but starkly lower (at the level of ~4.7%). From our prior review of diabetes literature, we find it unlikely (but plausible) for the placebo event rates for extended MACE events to be that low: across 29 diabetes outcome trials for just the core MACE endpoint (without coronary revascularization and hospitalization for unstable angina, the extended MACE endpoint used in REDUCE-IT), with baseline CVD was 5.19% (Am Heart J 2011;161:210-219). Ahead of the expected heightened volatility, volume and likely share price appreciation, we believe, leading into the interim
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