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Raf, you can't use "early" and "outstanding" in the same sentence if the actual event rate is indeed @ 5.2%.
HD, great point as always. Have a good night.
AK, don't be an A_sh_le. Just try to bring out a talking point.
I see 967 events to be triggered on Dec 2015, based on the chart on CO-73.
Amarin management had stated that R-I trial's current event rate is tracking to its initial expectation. Looking at page CO-73 of the briefing doc, that means the 967 events should be triggered at end of 2015. Anybody disagree?
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM371763.pdf
For ANCHOR population, 4g/day Vascepa produces the following statistically significant results:
Lp-PLA2 reduction of 19%
hsCRP reduction of 22%
total LDL reduction of 7.7%
Small LDL reduction of 13.5%
LDL-C reduction of 6.2%
Apo B reduction of 9%
Non-HDL-C reduction of 13.6%
median RLP-C reduction of 25.8%
ApoC-III reductions of 25.1%
VLDL reduction of 12.2%
TG reduction of 21.5%
For those belongs to ANCHOR population and takes DS fish oil, show your PCP the above benefits of Vascepa and get a Vascepa script. For $9/month with coupon, you can avoid following the footsteps of Tim Russert, James Gandolfini, John Henson...
http://www.nytimes.com/2014/06/19/health/scientists-identify-mutations-that-protect-against-heart-attacks.html?_r=0
Unless you are on Medicare, you should be eligible for the $9 coupon.
Another genetic study bodes well for the success of R-I,
http://www.uvm.edu/medicine/?Page=news&storyID=20173&category=comstude
Philips to acquire Volcano to expand global leadership position in image-guided therapy market,
http://ir.volcanocorp.com/releasedetail.cfm?ReleaseID=887996
Wish we know about Volcano Corp. couple months ago.
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
https://clinicaltrials.gov/ct2/show/NCT02354976?term=epanova&rank=11
Thanks HD for your feedback. Your post, like Vascepa, is always of the highest quality.
BC, big congrats to you and family for your Year of the House new addition. To quote the infamous JZ, I see a very exciting 60-90 days ahead.
Your sentence implies that TG>200 is not a normal lipid panel, i.e., has to be treated. And we know less than 5% of population can stick to a strict diet and exercise routine.
We all know diet and exercise leads to better health and as you said diet and exercise also leads to lower TG. Does that mean lower TG means better health? That's why treating TG>200 is a no brainer because diet and exercise is easier said than done.
AK, what's the ATP guideline for TG>200? TIA.
How Amarin knows if a Vascepa script was writen due to Kowa sales reps' effort, Amarin rep's effort or neither? like in my case where I just ask my PCP wrote an off-label script. I'll assume my type of script has a higher profit margin since there is no need to kick back any commission to the rep.
Late morning of Oct 11, 2013.
Seems like JT is going all out to generate Vascepa awareness,
http://www.napsnet.com/articles/71108.html
Thanks Benny. You can see the blue line dip slightly below the pink line in Oct 2013. Perhaps Amarin management could see further divergence by now.
HD, I agree with you especially your last statement. Have you seen page CO-73 of Amarin's adcom slide? I have trouble posting it on this board.
Bid, why you still hold FDA in such a high regard? You shouldn't expect FDA to do anything proactively to improve patient care.
Zum, that's great news indeed. Thanks for the reply.
Is the following really happening in the real world?
"the blood work of those who got switched to generic is even worse than Lovaza - this increase in LDLs from Generic L is having the effect of Docs mandating that existing Patients on Generic L get switched to V"
Happy with 228 scipt increase in NRx. Hoping for at lest 100 scipt increase per week till year end.
AK, great deal indeed. I was like you last year paying out of pocket due to the lack of insurance coverage. I make sure to switch to an insurance that covers V this year as I have 3 adults in my household getting off-label V scripts.
NYC.
Just pick up Vascepa from the pharmacy. $9 with coupon, off-label script (my TG is @ 106) with Emblem Health at T3. I am very impressed with the expiration date of my bottle of V, March 2017. The pharmacist told me they've been filling lots of V scripts since the begining of the year. Hope the trend keeps improving.
Anybody know why 6% improvement is good enough for IMPROVE-IT while R-I requires 15%?
Is it too much to ask Amarin to disclose the number of events to date at the quarterly conference call? since it's on track. There is nothing to hide and would drum up investor interest.
Does anybody know when Amarin says the R-I trial is on track, it means that the actual events rate to date is close to 5.2% per year? Or close to to (5.2% + 5.2%*.85)/2, i.e., 4.81% per year?
Couldbebetter, thanks for the link. Colman said it best. The purpose of the Adcom is to "PREVENT"...
The bad deeds that Colman, Parks and other FDA officials have done is obvious by watching this short video. Colman paid the ultimate price for it.
In Zum we trust. I am going to spread the rumor.
I am encourgaed by 3 things that JT mentioned yesterday:
1) Regarding R-I, "opportunity for potential early termination in 2016"
2) "Strategic opportunities including partnership outside U.S. been moving along encouragingly"
3) Lovaza coupon expiring in 2015 makes taking market share from L easier.
Overall, it's JT's best presentation to date. He sounded very confident on the success of R-I trial. Anybody wants to add further comments regarding the presentation?
Dude, so Vascepa is not available in Canada?
HD, for the IMPROVE-IT placebo group, do you know their lipid profile? TIA.
Summary
•Amarin expects its year-end cash balance to be approximately $120 million.
•This represents cash outflows of $71.5 million during 2014, better than its target of $80 million.
•Amarin has done an excellent job conserving cash, and better than I anticipated. However, the ability to again use working capital changes for cash flow will be limited in 2015.
•Focus will be on sales growth. NRx growth of 70 per week would likely achieve $100+ million 2015 revenue and a year-end cash balance of $55 million to $60 million.
•If Vascepa is at around 5,700 to 5,800 NRx by the end of March, it will be on that trajectory.
Amarin (NASDAQ:AMRN) announced that it expects cash and cash equivalents to be approximately $120 million at the end of 2014. Amarin's cash outflows during 2014 would therefore be $71.5 million, better than its target of $80 million. Amarin has done an excellent job of conserving cash to date, although the ability to use working capital changes as a source of cash flow will be much more limited in 2015.
Amarin's cash outflow during Q4 2014 was $15.4 million. I expect Q4 2014 revenue to come in at $15.9 million, which would translate into approximately $10 million in gross margin. Cash expenditures include $1.4 million for the BioPharma repayment. If cash SG&A and R&D expenditures equal $30 million, then approximately we'd expect a cash outflow of $21.4 million without working capital changes or other inflows. A significant proportion of the $6 million difference between this number and actual cash outflow is likely due to lower inventory levels. As I mentioned before, inventory levels could likely be reduced by up to $7 million from Q3 2014 levels. If Amarin did reduce inventory levels by $6 million in Q4 2014, the decrease in inventory would have contributed $15 million to cash flow during 2014. With inventory near industry standard levels now, inventory decreases will not significantly contribute to cash flow in 2015.
This means that Amarin must focus on growing sales to reduce its cash burn during 2015. My previous expectation was $102 million in revenue during 2015, which would translate into approximately $60 million to $65 million in cash outflow during the year. This would result in Amarin ending up with around $55 million to $60 million in cash and cash equivalents at the end of 2015, and likely on track to end 2016 with $25 million to $30 million in cash and cash equivalents. To get to $102 million in revenue during 2015 would require Vascepa NRx growth of approximately 70 per week. If Vascepa is on track for that type of growth, it should be doing approximately 5,700 to 5,800 NRx by the end of March 2015.
R&D expense should also come down some in 2015 as R-I trial completes its enrollment. The key for good script growth for 2015 is insurance coverage and holding off Epanova marketing.
Assuming $50M cash burn in 2015 due to decent script growth, perhaps we can push out dilution decision until 2016. By then, the stock price should be higher because of the imminent interim R-I data release. JT may not be a great speaker but he is definitely a good bean counter.