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Cantor Link; I hope it works
https://drive.google.com/open?id=0B57g27wC5ShhM1BybzlMZTRXRlU
Cantor: I will try to attach the coverage soon. Working on it from home, hope it works
Cantor coverage initiation Buy, $6 PT
Hook, Line, and Sinker: Connecting Triglycerides and CV Risk; Initiating BUY, $6PT
Investment Summary: We are initiating coverage of Amarin Corporation, Inc. (AMRN) with a BUY rating and a $6 price target. Amarin's lead product is Vascepa (icosopent ethyl), which is approved with a proper diet to reduce very high triglyceride levels. We believe, however, that a potential positive read-out from the REDUCE-IT outcomes study expected in late 2017 could not just expand the indicated patient population of ~4M to ~74M, but also for the first time have an outcomes study that draws a straight line between triglyceride levels and cardiovascular risk, potentially changing how cardiovascular risk is managed and treated and creating a multi-billion dollar market opportunity.
Outcomes Studies Dictate Real-World Adoption: The main reason to own the name, in our opinion, is the potential of positive data from the REDUCE-IT outcomes study. Within the treatment of cardiovascular risk, outcomes studies hold the greatest clinical weight and drive real-world therapeutic adoption. REDUCE-IT is the first prospective cardiovascular outcomes study of any drug in a population with high triglyceride levels despite statin therapy, which if successful, would draw a direct line from high triglyceride levels to cardiovascular risk. The last cardiac event is expected in 2H:17 with full results and publication in 2018.
¦ Going Where No Fish Has Gone Before: Lead product Vascepa differentiates from OTC supplements and other prescription omega-3 options, namely on its purity levels. Vascepa is 96% pure icosapent ethyl (EPA), removing DHA which is found in other omega-3 compositions and is believed to increase LDL-C levels. With a safety and tolerability profile close to placebo, it also bypasses the side effects of statins and fibrates which we believe will bode well in the market.
¦ Patient Population: With positive results from REDUCE-IT, Vascepa's label is likely to expand to not just the 36M with high levels but also to the 34M with borderline levels, for a total marketable patient population of ~74M, a market 18.5x larger than the current label, or 4M US adults.
¦ Commercial Infrastructure in Place: As Vascepa is already a marketed product, we like that the commercial infrastructure is already in place. Amarin has ~130 sales professionals and partnered with Kowa Pharma in mid-2014 for an additional 250. Though Amarin agrees that if the outcomes study is positive, they will have to expand the sales force, we believe that the current 380 should be able to capitalize on the results and drive increased revenue.
¦ Valuation: Our $6 price target is based on an average of a 2026 DCF analysis and a 2021 discounted sales multiple
SunTrust Report Link (Page 5 AMRN)
https://drive.google.com/file/d/0B57g27wC5ShhOWtGSWNBQms3Nnc/view?usp=sharing
SunTrust Pharmaceuticals – Valuation & Catalyst Calendars for Week Ending 9/30/2016
AMRN (Buy; $6 PT) – On September 12, 2016, the independent data monitoring committee (DMC) for its Vascepa’s REDUCE-IT outcomes study completed its review of the first pre-specified interim efficacy. We expect AMRN to publish the REDUCE-IT trial design in a research publication such as New England Journal of Medicine. AMRN expects REDUCE-IT to attain ~80% of total target events in the first half of 2017, with the second pre specified interim efficacy analysis anticipated by mid- 2017. The REDUCE-IT trial is expected to conclude and have final data published & potential sNDA submission in 2018.
The Vascepa clinical trial application that was filed with the China State Food and Drug Administration was accepted, with AMRN expecting the sFDA to determine clinical trial requirements to support approval. The 5-year Vascepa co-promotion arrangement with Kowa Pharma (private) is scheduled to end in 2018.
Scripts Update for Week Ending 23/09
V
TRx: 17,717 {vs 17,917; -1.12%} Sector -1.45%
NRx: 6,923 {vs 6,908; +0.22%} Sector -0.37%
Ref: 10,794 {vs 11,009; -1.95%} Sector -2.11%
L
TRx: 2,040 {vs 2,105; -3.09%}
NRx: 738 {vs 797; -7.40%}
GenL
TRx: 59,855 {vs 60,762; -1.49%}
NRx: 22,830 {vs 22,900; -0.31%}
V TRx Market Share: 22.25% vs 22.18% -- ATH
V NRx Market Share: 22.71% vs 22.57% -- (ATH = 23.49%)
V Ref Market Share: 21.97% vs 21.94% -- ATH
Sts, I got the numbers from my Bloomberg terminal and used the closing price on each short interest release date. Having all those numbers, the graph was easily drawn :)
and your point is?
Short Interest
Latest Data released as of 15/09/2016
Short Interest = 8,215,239
Change of Shares = -5,954,605
Percentage Change = -42.02%
Date to cover = 1.69
This is the first time we are below 10,000,000 shares short since December 2011.
Well as can be seen from the above numbers and below chart, IMO what JL mentioned long time ago about shorting related to note holding (as in hedging method) is quite accurate to some extent
Soon the graph lines will cross again (Price & Short interest). It only happened once in 2012 and from there, short level kept on increasing and prices went south. Hopefully a reverse is being set and we experience the same upward pattern
Ideas / Conclusions are always welcomed
Thinking out loud in here, opinions are most welcomed
"Roxane Laboratories, Inc. and Dr. Reddy’s Laboratories, Inc., respectively, advising Amarin that such companies have filed abbreviated new drug applications (each, an “ANDA”) with the U.S. Food and Drug Administration (“FDA”) that seek regulatory approval for generic versions of Vascepa ® (icosapent ethyl) capsules."
Have filed with the FDA
Is there a chance that FDA will not consider them received?!
That might explain the surge in the SP
As always there is a leak and once it is official from FDA that it is not received, that will have positive effect on the price
Again, just a thought and your opinions are highly appreciated
Scripts Update for Week Ending 16/09
V
TRx: 17,917 {vs 17,038; +5.16%} Sector +4.77% --- ATH
NRx: 6,908 {vs 6,295; +9.74%} Sector +11.74% --- (ATH = 6,984)
Ref: 11,009 {vs 10,743; +2.48%} Sector +0.94% --- ATH
L
TRx: 2,105 {vs 1,949; +8.00%}
NRx: 797 {vs 734; +8.58%}
GenL
TRx: 60,762 {vs 58,116; +4.55%}
NRx: 22,900 {vs 20,360; +12.48%}
V TRx Market Share: 22.18% vs 22.10% -- (ATH = 22.23%)
V NRx Market Share: 22.57% vs 22.98% -- (ATH = 23.49%)
V Ref Market Share: 21.94% vs 21.61% -- ATH
Total Monthly Retail + Institutional Data August-2016
V
TRx: 81,932 {vs 75,220; +8.92%} – ATH -- Sector +5.41%
(Inst # 3,398 vs 4,428)
L
TRx: 13,799 {vs 11,833; +16.61%}
(Inst # 3,920 vs 2,507)
Gen L
TRx: 293,100 {vs 281,824; +4.00%}
(Inst # 21,400 vs 27,424)
V Monthly Retail + Inst. TRx Market Share: 21.07% vs 20.39% --- ATH
August-2016 vs August-2015 (Total Retail + Inst): Sector +3.48% (388,831 vs 375,736)
V: 81,932 vs 52,940; +54.76%
L: 13,799 vs 29,634; -53.44%
GenL: 293,100 vs 293,162; -0.02%
V Market Share Retail+Inst August-2016 vs August-2015: 21.07% vs 14.09%
Scripts Update for Week Ending 09/09
SHORT WEEK
V
TRx: 17,038 {vs 17,816; -4.37%} Sector -6.51%
NRx: 6,295 {vs 6,984; -9.87%} Sector -11.35%
Ref: 10,743 {vs 10,832; -0.82%} Sector -3.61%
L
TRx: 1,949 {vs 2,303; -15.37%}
NRx: 734 {vs 850; -13.65%}
GenL
TRx: 58,116 {vs 62,351; -6.79%}
NRx: 20,360 {vs 23,062; -11.72%}
V TRx Market Share: 22.10% vs 21.60% -- (ATH = 22.23%)
V NRx Market Share: 22.98% vs 22.60% -- (ATH = 23.49%)
V Ref Market Share: 21.61% vs 21.00% -- ATH
Having said that and since I am still on 1 post per day, I don’t know if this was mentioned before, but the latest short interest update ending 31-08-2016 showed that total short interest decreased by 25.67% down to 14,169,844 from 19,064,182 with 4.17 days to cover.
IMO that coincided with the latest price surge and market fear of interim analysis coming September. We have to wait for end of September Data to check if the notes conversion was used to cover short positions or not and if the shorties are back into the stock after the interim analysis continuation decision.
Still Long & Strong, what is 1.5 Year compared to 4 Years + investing in the stock especially if you believe in the science and the prospect of the drug (Thanks Zum, JL and all for the constant valuable learning)
Total Monthly Retail Data August-2016 + SunTrust Flash Note
V
TRx: 78,534 {vs 70,792; +10.94%} – Sector +7.65% -- ATH
NRx: 30,981 {vs 27,348; +13.28%} – Sector +9.76% -- ATH
L
TRx: 9,879 {vs 9,326; +5.93%}
NRx: 3,739 {vs 3,675; +1.74%}
Gen L
TRx: 271,700 {vs 254,400; +6.80%}
NRx: 100,370 {vs 92,060; +9.03%}
Monthly Retail TRx Market Share: 21.81% vs 21.16% --- ATH
Monthly Retail NRx Market Share: 22.93% vs 22.22% --- ATH
SUNTRUST FLASH NOTE
As Expected, REDUCE-IT Continues as Planned
REDUCE-IT next interim look expected in mid-2017
REDUCE-IT CV Outcomes study to continue as planned
AMRN announced that the independent data monitoring committee (DMC) for its REDUCE-IT outcomes study completed its review of the first pre-specified interim efficacy. As we expected, the independent DMC recommended that the trial continue as planned without modification. As per the study protocol, the first interim efficacy analysis was conducted after attainment of ~60% of the total target 1,612 primary cardiovascular (CV) events, & in order for the trial to stop early, the results would have had to show a very highly statistically significant benefit vs. placebo (p < 0.0076), which we didn’t expect to occur. Amarin remains blinded to the interim analysis & ongoing results of the REDUCE-IT study until after the study is stopped at either the next interim analysis in mid-2017 or at the final analysis. AMRN expects REDUCE-IT to attain ~80% of total target events in the first half of 2017, with the second pre-specified interim efficacy analysis anticipated by mid-2017. The criteria for early stop at the 80% target is less rigorous than the 60% interim criteria (early stop at 80% is triggered if p < 0.022), but still materially more onerous than the p < 0.05 criterion required for statistical significance. As such, we expect the DMC to recommend that REDUCE-IT continues until attainment of 100% of the target 1,612 primary events, which is estimated to occur in 2017, yielding publication of results in 2018. The REDUCE-IT trial design is modeled after nine previous outcomes trials for statins. We believe that Amarin will showcase the REDUCE-IT trial design in a peer-reviewed scientific journal [possibly the New England Journal of Medicine (NEJM)] in the near-term. AMRN indicated in its 2Q16 earnings call that the timing of the publication depends on the trial’s Principal Investigators & journal peer review. The REDUCE-IT trial is an important catalyst for AMRN, since it could contribute to meaningful expansion of the Vascepa label and commercial opportunity in patients with elevated triglycerides treated with statins. We see upside to our Vascepa 2016E sales estimate of $120M vs. Street’s $120M.
Vascepa TRx trends point to upside to our 3Q16E/2016E estimates
Our analysis of Vascepa TRx/NRx trends as reported by IMS Health (IMS, $29.86, Neutral, Sandy Draper) leads us to believe there is upside to our 3Q16E revenue estimate of $30.0M (+41% YoY). As of 9/2/2016, rolling 4- week adjusted TRx’s are ~69K, up +55% YoY, with TRx’s & NRx’s up in high 40% to low 60% range (YoY) since the beginning of 3Q16 as ANCHOR & JELIS promotions continue to volume growth. The robust Vascepa volume trends, along with the +6% price increase taken by AMRN at YE15, point to upside to our 3Q16 revenue estimate ($30M, +41% YoY). If these positive trends persist in 2H16, they could place upward pressure on AMRN’s $112M - $125M net product revenue projection for full-year 2016 (we model $120M in FY16 Vascepa revenue, above AMRN’s mid-point and in-line with the Street net product estimate).
Jefferies flasnote:
Amarin Corporation (AMRN) REDUCE-IT Continues as Planned After First Interim
Key Takeaway
The REDUCE-IT trial investigating Vascepa will continue as planned after the first interim analysis by the DMC. We've previously noted that the bar to stop the trial for overwhelming efficacy was high, therefore this comes as expected. The onset of ~80% of events for second interim is expected in H1'17, with analysis in mid-2017. We continue to model success on final analysis expected in early '18, and therefore make no changes to our PT. Maintain Buy.
REDUCE-IT Continues as Planned After First Interim: AMRN announced that the REDUCE-IT cardiovascular (CV) outcomes study investigating Vascepa will continue as planned after the first interim analysis of ~60% of the target aggregate primary CV events by the DMC. We have previously noted that the bar to stop the trial for overwhelming efficacy on the primary endpoint at this interim is high (p<0.0076 to hit significance) with certain secondary endpoints needing to be directionally favorable as well, therefore this outcome comes as expected. We make no changes to our PT and maintain our Buy rating.
Second Interim Analysis Expected in Mid-2017: The onset of ~80% of the target aggregate primary events for the second prespecified interim analysis is expected in H1 2017, with the analysis by the DMC expected in mid-2017. The p-value to stop the trial for overwhelming efficacy at this interim is p<0.0220 for the primary endpoint, with certain secondary endpoints directionally favorable as well. The addition of the second interim therefore gives them a second shot-on-goal, potentially moving up the timeline for Vascepa expansion, if successful. At this time, we continue to model a favorable outcome on final analysis where p<0.0422 is needed for success, expected in early 2018.
Scripts Update for Week Ending 02/09
ATH ACROSS THE BOARD
V
TRx: 17,816 {vs 17,444; +2.13%} Sector +5.08% --- ATH
NRx: 6,984 {vs 6,911; +1.06%} Sector +5.03% --- ATH
Ref: 10,832 {vs 10,533; +2.84%} Sector +5.11% --- ATH
L
TRx: 2,303 {vs 2,192; +5.06%}
NRx: 850 {vs 833; +2.04%}
GenL
TRx: 62,351 {vs 58,847; +5.95%}
NRx: 23,062 {vs 21,671; +6.42%}
Sector at ATH numbers for the 1st time since February-2016
V TRx Market Share: 21.60% vs 22.23%
V NRx Market Share: 22.60% vs 23.49%
V Ref Market Share: 21.00% vs 21.47%
Having said that and since i'm allowed only 1 post per day, i will be mixing another topic with the scripts update; IMO today we go much higher. I highly doubt Pyrr and his fellow shorties are courageous enough and they will not dare to sleep in the weekend with a short position knowing that DMC might be any day
Till Monday all, have a great weekend
Long & Strong
Pyrr,
I am not in here to argue with you, trust me i am not interested.
I've been in this stock for 4 years +, sold after marine approval and re-entered later on. Been averaging down all the way as i believe in science and now i am way positive.
So I don't think that i will loose faith and start doubting after 1st and 2nd IA or because of your scare tactics
As i said before, you're in for the pennies we are in for serious money
Having said that, it is the last time i reply to you or address you as it is not worth it with all the churning and none-logical and none-sense arguments of yours
adiós escéptico
Pyrr
If that is your investment expectation, well i wish you good luck. But be aware from HF and institutions, they might cover despite the DMC continuation recommendation and you a small retail shorty you'll know at the end, in other terms, you'll get burned in SFF's Volcano :):)
Good luck, but deep inside, nahhhhhhh !!!!
i hope and i am sure one day / night you'll burn and nothing better than seeing you burn and as a result (sorry for using your words Zum) you will "slithers" away.
Scripts Update for Week Ending 26/08
V
TRx: 17,444 {vs 17,176; +1.56%} Sector +0.44%
NRx: 6,911 {vs 6,851; +0.88%} Sector -0.50% --- ATH
Ref: 10,533 {vs 10,325; +2.01%} Sector +1.02%
L
TRx: 2,192 {vs 2,093; +4.73%}
NRx: 833 {vs 774; +7.62%}
GenL
TRx: 58,847 {vs 58,867; -0.03%}
NRx: 21,671 {vs 21,938; -1.22%}
V TRx Market Share: 22.23% vs 21.98% --- ATH
V NRx Market Share: 23.49% vs 23.17% --- ATH
V Ref Market Share: 21.47% vs 21.26% --- ATH
Zum, what's with the old updates today?!
:):):)
Jefferies Flash note 31-Aug-2016
Buy, PT $4.50
Amarin Corporation (AMRN) REDUCE-IT Set for First Interim Readout in September
Key Takeaway AMRN has randomized its final patient for REDUCE-IT investigating Vascepa. The first interim analysis by the DMC is expected in Sep, which is slightly more honed than previous guidance (Sep/Oct previously). To reiterate, the bar to stop the trial for overwhelming efficacy is high (p<0.0076 to hit significance), we therefore expect the trial to continue as planned and we continue to model success on final analysis.
REDUCE-IT Set for First Interim Readout in September:
AMRN announced that it has randomized its final patient for the REDUCE-IT cardiovascular outcomes study investigating Vascepa, with 8,175 individual patients randomized. The first prespecified interim analysis by the DMC on ~60% of the target aggregate primary cardiovascular events is expected in September, which is slightly more honed than previous guidance (September/October previously). As we have previously stated, the bar to stop the trial for overwhelming efficacy on the primary endpoint at this interim is high (p<0.0076 to hit significance), and the company has stated that it would like to see certain secondary endpoints directionally favorable as well. We therefore expect the trial to continue as planned.
Second Interim Analysis Expected in Mid-2017:
Assuming REDUCE-IT continues through the first interim in September, the second prespecified interim analysis on 80% of the target aggregate primary events is expected in mid-2017 (expected to reach the 80% of events in H1 2017). The p-value to stop the trial for overwhelming efficacy at this interim is p<0.0220 for the primary endpoint, with certain secondary endpoints directionally favorable as well. At this time, we continue to expect a favorable outcome on final analysis where p<0.0422 is needed for success, expected in early 2018.
Amarin PR
Amarin (AMRN) continues to expect the onset of the final primary cardiovascular event to occur in the second half of 2017 with publication of trial results likely in 2018. An independent Data Monitoring Committee (DMC) is expected to complete a protocol pre-specified interim efficacy and safety analysis after approximately 60% of the target aggregate primary cardiovascular events have occurred within the study. This interim analysis is most likely to occur in September 2016. A second interim efficacy and safety analysis with approximately 80% of the primary cardiovascular events is expected in mid-2017.
BB Holding as of 30-06-2016
ADR: 801,860
PRN: 15,000,000
Tekla PRN: 14,700,000
Zum those are for 31-03-2016
They decreased their position in the 1st quarter but increased the PRN
nothing changed for Q2, as of 30-06-2016
Scripts Update for Week Ending 19/08
V
TRx: 17,176 {vs 16,946; +1.36%} Sector -0.46%
NRx: 6,851 {vs 6,694; +2.35%} Sector +1.09%
Ref: 10,325 {vs 10,252; +0.71%} Sector -1.38%
L
TRx: 2,093 {vs 2,101; -0.38%}
NRx: 774 {vs 821; -5.72%}
GenL
TRx: 58,867 {vs 59,452; -0.98%}
NRx: 21,938 {vs 21,730; +0.96%}
V TRx Market Share: 21.98% vs 21.59% --- ATH
V NRx Market Share: 23.17% vs 22.89% --- ATH
V Ref Market Share: 21.26% vs 20.81% --- ATH
Merc
of course higher share count ain't good, but on a personal level, I've always did my homework with a fully diluted shares ~300million+
Totally agree with all these updates, with reduce it results it's a totally different game
Let's see how the stock will react and I guess we can get from the volume if those who were involved in the conversion are selling directly on Sep12
Merc, that's true. But at the same time you save interest paid on these notes.
As seen in the 2 previous links, they maintained their PT with narrowed losses
Suntrust update PT $6.00
Trimming ‘16E LPS on Higher Share Count From Issuer-Mandated Debt Conversion
Interest expense lowered, no material impact on out-years estimates or DCF
What's Incremental To Our View
Our ‘16E LPS narrows to -$0.32 (from -$0.37) on lower interest expense and a higher share count from AMRN’s mandatory conversion of $150M in convertible debt into 57.7M shares, effective Sept 12. The conversion has no material impact on out-year estimates or our valuation. The recent equity offering (~$65M) provides AMRN with ~$112M in cash exiting 3Q16E. The next catalyst includes the REDUCE-IT pre-specified interim analysis in Sept/Oct & publication of the trial design paper. Our model assumes AMRN turns cash flow (+) in 2017E (ex-REDUCE-IT expenses). Reiterate Buy / $6PT, supported by DCF.
’16E LPS narrowed by +$0.05 on lower interest & higher share count
Our ‘16E LPS narrows to -$0.32 (from -$0.37) on lower interest expense and a higher basic/diluted share count. Our total revenue remains at $121.6M vs. Street’s $125.0M & AMRN’s $112M-$125M product sales range. We maintained our expense estimates. The conversion of $150M in debt into 57.7M shares (effective Sept 12) causes our 2016E full-year diluted share count to increases by 17M to 211M (from 194M). We took our ’17E EPS to +$0.01 from a LPS of (-$0.02) on lower interest expense, partially offset by a materially higher share count (+57.7M shares from the conversion, as well as an additional 48.8M shares included in the diluted share count as AMRN’s net loss goes to positive net income). These changes place modest upward pressure on our out-year estimates from lower interest expense. We model +$29M of free cash flow for AMRN in 2017E, consistent with its projection of being cash flow positive in ‘17E (ex-REDUCE-IT expenses). We estimate 3Q16 cash at $112M (vs. $73M as of 2Q16) after AMRN’s equity raise (click here to view our note). The next catalyst is the REDUCE-IT interim analysis in Sept/Oct ’16. We look for AMRN & its lead investigators to publish a REDUCE-IT trial design paper (possibly NEJM). We reiterate our Buy rating/$6PT based on DCF analysis.
AMRN exercised option for mandatory conversion of $150M in debt
AMRN exercised its option to mandatorily exchange all $150M of its 3.50% 2014 Exchangeable Senior Notes ($118.7M) & its 2015 Exchangeable Senior Notes ($31.3M) into ordinary shares of AMRN (click here for AMRN’s press release). As a result, AMRN will issue 384.6154 shares per $1,000 principal amount, or ~57.7M shares, effective on September 12, 2016. As of September 12, the notes will be retired & will cease to accrue interest. Per the 2014 & 2015 Notes indentures, AMRN had the option to force conversion of the debt if “the daily volume weighted average pricing per ADS equaled or exceeded $2.86 for at least 20 trading days in the 30-trading-day period”, which took place from July 18, 2016 through August 26, 2016.
REDUCE-IT pre-specified interim analyses in Sept/Oct ’16 & mid-17
The most important catalyst for AMRN is the outcome of AMRN’s REDUCE-IT trial, since it could lead to a meaningful expansion of the Vascepa label & commercial opportunity in patients with high triglycerides treated with statins (click here for our note detailing our Bull/Bear scenarios that imply an attractive risk/reward). In its 2Q16 press release, AMRN announced amendments to the REDUCE-IT trial protocol: 1) finalizing details of the statistical analysis planning, 2) added a second pre-specified interim efficacy analysis at approximately 80% of the 1,612 primary events, & 3) expanded to over 30 pre-specified secondary & tertiary endpoints to measure a broader array of potential clinical effects. Amarin remains blinded to the interim analysis & ongoing results of the REDUCE-IT study until after the study is stopped at either the interim analysis or at the final analysis. The REDUCE-IT trial design is modeled after nine previous outcomes trials for statins. We believe that Amarin will showcase the REDUCE-IT trial design in a peer-reviewed scientific journal [possiblythe New England Journal of Medicine (NEJM)] in the near-term. AMRN indicated that the timing of the publication depends on the trial’s Principal Investigators and journal peer review. Given the nature of outcome study and the design of REDUCE-IT, Amarin expects the DMC to recommend that REDUCE-IT continues until attainment of 100% of the target 1,612 primary events, which is estimated to occur in 2017, yielding publication of results in 2018. However, it is possible that the trial could be stopped early, if Vascepa is highly statistically significant vs. placebo on the primary endpoint at the interim looks (p-value must be <0.0076 at the 60% interim look, & <0.022 at the 80% interim look), as well as showing robust efficacy on “certain secondary outcome measures”. The REDUCE-IT trial is expected to conclude & have final data published with a sNDA submission in 2018E. We would expect AMRN to be opportunistic if REDUCE-IT meets its study goals since the he company could require an additional capital raise to support the commercialization of the indication expansion and/or consider its partnership options especially after the Kowa (private) agreement is set to expire in 2018.
Jefferies flasnote PT $4.50
Amarin Corporation (AMRN)
Case Study Highlights Potential Benefit of Switching from Lovaza to Vascepa
Key Takeaway
A case report was published recently describing the experience of a pt with persistent dyslipidemia and high CV risk switching from Lovaza to Vascepa. After >2 yrs on Vascepa, she showed improvement in lipid parameters, incl TG (-35%) and LDL-C (-69%), v. Lovaza. While the study was not a RCT, we believe it suggests that many pts on Lovaza/generic could stand to benefit if switched. We believe her continued improvement after >2 yrs bodes well for REDUCE-IT.
Recent Case Study of Patient with Persistent Dyslipidemia and High CV Risk Suggests Favorable Impact from Switching from Lovaza to Vascepa: Crandell published a case report in July describing his experience with switching a patient with persistent dyslipidemia and high cardiovascular (CV) risk from Lovaza to Vascepa (Crandell, J. R. Clin Med Insights Cardiol 2016, 10, 123-128). The patient was a 55-year-old, overweight female with a history of severe dyslipidemia and insulin resistance. This patient furthermore had a strong family of history of CV disease. Prior to initiation of Lovaza, the patient was on rosuvastatin 40 mg/day and ER niacin 1,500 mg/day, and had continued elevations of atherogenic lipids despite therapy, including: triglycerides (TGs) of 240 mg/dL and LDL-C of 161 mg/dL. It was decided that Lovaza at 4 g/day be added to her existing therapy, the only FDA-approved omega-3 fatty acid product at the time. Yet despite treatment with Lovaza for ~10 months, while her TGs fell to 182 mg/dL (-24%), her LDL-C remained persistently high at 168 mg/dL (+4%). Given her profile, it was decided that this patient be switched to Vascepa. After ~1 yr of Vascepa as add-on therapy, her TGs decreased to 130 mg/dL (-29% from Lovaza tx; -46% from baseline) and her LDL-C decreased to 80 mg/dL (-52% from Lovaza tx; -50% from baseline). After >2 yrs of Vascepa, her TGs decreased further to 119 mg/dL (-35% from Lovaza tx; -50% from baseline) and her LDL-C decreased to 52 mg/dL (-69% from Lovaza tx; -68% from baseline). The patient’s other lipid parameters trended favorably as well and full detail can be found in the publication.
Patient’s Experience Reminds Us that Lovaza and Vascepa are Not Interchangeable: The results of this case study are consistent with the experience of previous case studies of switching from Lovaza to Vascepa (Hassan, A. et al. Cardiol Ther 2015, 4, 83-93 (n=10); Kedia, A. W. et al. Postgrad Med 2015, 127, 869-73; Castaldo, R. S. Postgrad Med 2014,126, 268-273). This study’s results remind us that Lovaza and Vascepa, despite both being omega-3 fatty acid products, are not interchangeable. In this setting, an EPA alone formulation could have more favorable clinical effects on a mixed dyslipidemia patient with high CV risk than an EPA + DHA mixture, and this data suggests that many patients currently on Lovaza/Lovaza generic could stand to benefit if switched to Vascepa. We remind that this study was not a randomized controlled trial, therefore the results are not necessarily generalizable to the entire patient population.
Continued Improvement in Lipid Parameters After Long-Term Vascepa Treatment Bodes Well for REDUCE-IT: We view the long-term results of this patient’s Vascepa therapy (>2 yrs) as encouraging, because it suggests that Vascepa has benefits on lipid parameters that extend beyond what was achieved in the 12 wks in MARINE and ANCHOR. The study by Hassan et al. (n=10), for instance, only reported a treatment period of Vascepa for ~3.9-8.4 mo after Lovaza, and so this case report helps us understand Vascepa’s longer term effects. The median treatment time and follow-up in REDUCE-IT is ~4 years, therefore the 22% reduction in TGs and 6% reduction in LDL-C from Vascepa v. placebo in ANCHOR likely do not fully represent Vascepa’s potential clinical effect in REDUCE-IT.
HS
Maybe its the new release date as BB mentioned. But nothing official yet. So we'll have to wait and see later today and next Friday too
Thanks for the info
No Data Update till now
I have a to leave.
Have a nice weekend all
Till Monday or if Andy (from ST) manages to get an update later today
Data: Terminal msg: Data is for Week Ending 12/08. Data for Week Ending 19/08 is delayed
I dunno how long it will be delayed, i will keep you guys posted
Total Monthly Retail + Institutional Data July-2016
V
TRx: 75,220 {vs 75,125; +0.13%} – ATH -- Sector -3.32%
(Inst # 4,428 vs 5,017; -11.69%, Inst Sector -13.29%; Inst Market Share 12.89% vs 12.66%)
L
TRx: 11,833 {vs 14,176; -16.53%}
(Inst # 2,507 vs 3,978)
Gen L
TRx: 281,824 {vs 292,251; -3.57%}
(Inst # 27,424 vs 30,631)
V Monthly Retail + Inst. TRx Market Share: 20.39% vs 19.69% --- ATH
July-2016 vs July-2015 (Total Retail + Inst): Sector -4.42% (334,518 vs 349,988)
V: 75,220 vs 51,206; +46.90%
L: 11,833 vs 32,823; -63.95%
GenL: 281,824 vs 298,176; -5.48%
V Market Share Retail+Inst July-2016 vs July-2015: 20.39% vs 13.40%
Raf,
NRx market share ATH = 22.96% (week ending 22-July-2016)
The market share of this week TRx (3rd High 21.69% - 21.63% & Today's 21.59%) - NRx (2nd High 22.96% & Today's 22.89%) & Refills (2nd High 20.93% & Today's 20.81%)
Scripts Update for Week Ending 12/08
V
TRx: 16,946 {vs 17,459; -2.94%} Sector -2.75%
NRx: 6,694 {vs 6,902; -3.01%} Sector -3.38%
Ref: 10,252 {vs 10,557; -2.89%} Sector -2.37%
L
TRx: 2,101 {vs 2,290; -8.25%}
NRx: 821 {vs 890; -7.75%}
GenL
TRx: 59,452 {vs 60,967; -2.48%}
NRx: 21,730 {vs 22,475; -3.31%}
V TRx Market Share: 21.59% vs 21.63%
V NRx Market Share: 22.89% vs 22.80%
V Ref Market Share: 20.81% vs 20.93%
Nothing Updated...i have to leave
Have nice weekend all
Jefferies Upside Scenario: PT $18
Upside Scenario
- De-risked Vascepa program in mixed dyslipidemia through positive REDUCE-IT data, leading to approval in this patient population
- Potential for REDUCE-IT to stop early for efficacy on second interim analysis expected in ~mid-2017
- Worldwide partnership
- DCF-based PT: $18.00
Downside Scenario
- REDUCE-IT runs to completion with negative results
- AMRN does not partner or successfully develop Vascepa ex-U.S.
- DCF-based PT (based on MARINE population alone): $0.50
I would take such risk at any day 85% downside compared to 456% upside
(personally: it's exactly 70.05% downside with regard to my average)
Long & Strong !!
Jefferies Update: New PT $4.50
https://drive.google.com/file/d/0Bxf3SeLDbKY6ODhRNTQ2T2VBUW8/view?usp=sharing
You got it :)
I will upload the coverage soon
:):):)
They did, it occurred to my mind, but everything is live, so we're cool :):)