AMRN - its from my private AMRN dd group (i'm one of the members and one member posted this today)
Reduce-It Conf Call notes
Never posted anywhere as far as I could see, so I listened again just now. Even more bullish this time around.
AMRN R-It conf call - Monday, September 24, 2018
CEO Thero
HR 25% - approximately
Safety profile comparable to placebo
Lipitor also had a 25% benefit, most successful cardio drug of all time
Exceeded projections of analysts and today we will help them revise models
The most significant advances in cardiovascular care since the advent of statins
Drugs such as fenofibrates and omega 3s were blockbusters even before outcomes trials, which then failed
We spent $300 million on the study
We have also invested in early stage research of our drug beyond that investigated in FDA trials
Note that in JELIS the patients did not have high triglycerides, and we view this as supportive of an even wider general benefit, with multiple modes of action
CSO Ketchum
Reduce-It was not designed to test the hypothesis that triglyceride lowering leads to reduction of cardiovascular events
Patients were followed for a median of 4.5 years
LDLc was low at baseline, evidence that benefit in the trial was not due to further lowering
TG median was 216
CEO Thero
Salesforce rising to 400 over the balance of this year from the current 150 AMRN reps (no mention of Kowa)
We are updating our sales literature to meet our obligations under the FDA agreement to provide truthful information
We do not expect our insurance coverage to change
We are focused on maximizing the value of this outcome, and not focused on selling the company, and will not address speculation on this topic
Q&A
We spent 10 $million to boost inventory in case of rapid uptake
Our suppliers can provide for well in excess of $1 billion revenue next year, and there are plans to expand further beyond that in the future
Results are consistent and robust across a wide range of secondary endpoints in this study
Consistency and robustness of the endpoints will be very interesting
Endpoint Components range from softer MACE to harder MACE such as heart attack, stroke and cardiovascular death, and I expect there will be commentary on all of these at AHA
We are priced today slightly below where statins were priced in their peak years. We will look again at pricing, but we want to be the first choice of doctors beyond statin therapy, we hope to help tens of millions of patients
We get insurance coverage today from managed care regardless of triglyceride level
The specific degree to which we achieved benefit is something that we promised the principal investigator that we would not reveal before AHA. We look forward to presenting the number needed to treat, etc
Currently there are 38 million in the USA on statins. Between 57 million and 70 million in the USA alone have high TG, however we are thinking of an even larger population who are at risk. This is a paradigm shifting therapy capable of helping we hope tens of millions, We are forging into an entirely new market space
Zetia with 6% benefit has sales five times more than our current revenue
Our research with doctors showed that 15% benefit would have been a major success, but 25% beyond wildest dreams
Expenditure, recently 10 million on inventory, expect $40-$50 million in 2019 on expanded salesforce, also DTC may have costs, but not much yet. We will provide a larger picture on expenditure in our next quarterly call
Thank you to our investors, we could not have gotten this far without you
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