Earnings Labs

Amarin Corporation plc (AMRN)

Q1 2018 Earnings Call· Wed, May 2, 2018

$14.02

+0.43%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+5.88%

1 Week

+9.69%

1 Month

+15.22%

vs S&P

+10.78%

Transcript

Operator

Operator

Welcome to Amarin Corporation's Conference Call to discuss its Financial and Operating Results for the First Quarter of 2018. This conference call is being recorded today, May 2, 2018. I would like to turn the conference call over to Elisabeth Schwartz of Amarin.

Elisabeth Schwartz

Management

Thank you all for joining us today. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, our current expectations regarding our commercial and financial performance, including levels of Vascepa prescriptions and wholesaler inventories, Vascepa product and licensing revenues, costs and other commercial metrics, gross margin, expenditures and the adequacy of our financial resources, our current expectations regarding our cardiovascular outcome study such as study completion, regulatory review and likelihood of success, our plans and preparation for extended promotion of Vascepa and related market positioning and potential and our goals regarding the timing and scope of international expansion. These statements are based on information available to us today, May 2, 2018. We may not actually achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially. So you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures or any other material agreements that we may enter into, amend or terminate. For additional information concerning the factors that could cause actual results to differ materially, please see the Forward-Looking Statement section in today's press release and the Risk Factors section of our Quarterly Report on Form 10-Q for the three months ended March 31, 2018. These documents had been filed with the SEC and are available through the Investor Relations section of our website at amarincorp.com. We encourage everyone to read these documents. This call is intended for investors in Amarin and is not intended to promote the use of Vascepa outside its approved indication. Please note that we are also providing slides to accompany this morning's call. These slides, which can be found on our website amarincorp.com, in the Investor Relations section under the overview section. Summarize some of key updates discussed on today's call. Finally, an archive of this call will be posted on the Amarin website, again, in the Investor Relations section. I will now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

John Thero

President

Good morning, everyone. This is a very busy and exciting time in Amarin. Last week I participated in Amarin's Annual Meeting of our sales team. The members of this team are full of confidence and passion for the work they're doing to help healthcare professional improve patient care with Vascepa. This is a very dedicated group of professional people. The majority of whom have been with us for multiple years. I go to such meetings hoping to inspire them only to find that they inspire me. Moreover, I regularly participate in meetings between Amarin's R&D team and key representatives from our CRO regarding the REDUCE-IT study. The results of this important study are near. We remain on track to achieve our estimated timeline of having results from this landmark study publicly announced before the end of Q3 of this year. For those of you who are counting, this means that we anticipate knowing the results of this important study less than five months from today. Mike Kalb, our CFO will focus on Q1 financial results in his comments. On this call I'll primarily discuss the status of the REDUCE-IT study. I will also comment on broader market dynamics which I view is favorable, but which at first glance may appear otherwise to some of you. Regarding REDUCE-IT as we recently announced based upon pool blinded data available to us and the industry standard projection methods. We estimate that the study has reached the onset of the targeted 1,612 primary Major Adverse Cardiovascular Events or MACE specified in the study design. Some people ask why Amarin didn't wait for final adjudication of all events in the study before having patients commence their final site visits. One of the reasons is that, according to the study protocol, some of the cardiovascular events…

Mike Kalb

Chief Financial Officer

Thanks John. The first quarter of 2018 showed continued growth of our commercial footprint despite challenging headwinds from seasonal factors. Amarin's net product revenue for Q1, 2018 was $43.8 million an increase of 27% over the same quarter of 2017. The core driver of this year-over-year increase in our Q1, 2018 net product revenue was continue growth in new and recurrent Vascepa prescriptions. Symphony and IQVIA data for Q1 showed estimated normalized total Vascepa prescriptions of approximately $381,000 and $392,000 representing respective increases of 25% and 27% over the same period of the prior year. Net product revenue in related prescription levels in the first quarter of each of the past several years appeared to have been held back certain seasonal factors. We have mentioned these factors previously including public reminders that the start of Q1 of this year, the most significant seasonal headwinds comes from beginning of the year medical deductible under patients insurance plans. There's been a growing trend in annual insurance coverage for patients to begin the year with patient deductible amounts of $1,000, $2,000 or sometimes much more than $2,000. Such deductible amounts cause many patients under such insurance plans to experience significant challenges. At the start of the year rather than paying the co-payment amounts they were accustomed to paying at the end of the prior year. When they go to fill the same prescriptions in the New Year they're faced with paying significantly more due to the high beginning of the year deductible under their insurance policy. Most Vascepa patients are on multiple therapies. Accordingly for example, a patient might go to fill five prescriptions and being accustomed to paying the co-payment amount of $20 for each prescription or $100 in the aggregate. Instead due to their high beginning of the year insurance deductibles,…

John Thero

President

Thank you, Mike. Before closing. I want to express my sincere appreciation for everybody listening today. Our employees, our stockholders, our partners and our REDUCE-IT patients in clinical sites. We look forward to updating you on our progress. With that, we conclude our prepared comments and would like to open the line for some questions. Operator?

Operator

Operator

[Operator Instructions] our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.

Louise Chen

Analyst · Cantor Fitzgerald. Please proceed with your question

So first question just regarding the Vascepa sale on a quarterly basis. I know you addressed it at length in your prepared comments, but how should we think about the quarterly progression. Is there a specific quarter of catch up given the results in the first quarter? and second question I had is, what actions are you taking now to drive the commercial uptick of the Vascepa prior to REDUCE-IT, is there anything going on there? And then last question, we get a lot is, how quickly you think the REDUCE-IT results supposing they're positive will drive the uptick of Vascepa. Thank you.

John Thero

President

Louise thanks for the three questions. Regarding revenues and how to look at them from a quarterly basis. I think we've always encouraged probably the best by look on revenues is year-over-year due to the seasonal factors. Embedded in your question maybe - Q1 was a decent quarter up little under 30%, Mike made the comments about record levels of Anarex and so it's Anarex growing in this case, achieving [indiscernible] which is tends to be good sign for the future, we've got a record number of physicians prescribing Vascepa also positive. That being said, when patients don't fill scripts as they didn't - medications in the first quarter. Our aim is to bring those patients back and somewhat difficult to predict when we come back, so they come back on their own and they wait and see, go back to their doctor. So we come into Q2 with little bit more of a deficit to start off with in terms of run rate than what we expected. We reiterated on this call. We think we'll get to $230 million for the full year, but I think as you sort of look at it, there were some headwinds here at the beginning of the year, our team is very motivated. As I said Anarex's up, number of prescribers are up, lot of positive signs but there is still a lot of work to do. Which sort of leads into your second question, what are we doing relative to commercial uptick now? I'll take one of those things off the board. The advertise we're doing on television could have some impact down the line, we did just start that in Q2, but that really isn't being run with enough frequency to significantly drive short-term demand, we do think that's going drive…

Louise Chen

Analyst · Cantor Fitzgerald. Please proceed with your question

Yes, thank you.

Operator

Operator

[Operator Instructions] thank you. Our next question comes from the line of Joel Beatty with Citi. Please proceed with your question.

Joel Beatty

Analyst · Joel Beatty with Citi. Please proceed with your question

What new FX you need to show as the minimum results for REDUCE-IT in order to maintain the current level sales?

John Thero

President

I'm trying to make sure I fully understand the question because currently we're selling off of biomarkers. If we've got positive statistically significant results on an outcome study that's a world of difference versus what we're selling on today. So our trial design around 15% relative risk reduction we're seeing tremendous excitement on PCSK9, at least by the cardiologist community in particular. And they're expensive and we've got a profile that's affordable, well tolerated, placebo like safety profile. Our marketing surveys was suggested that of physicians that anything from sort of 7% to 8% up, would be viewed as being a well-received result. We're aiming for higher than that, I think the data suggest that will be higher than that. What we saw when the initial results, the improvement study came out for [indiscernible] there was a lot of excitement, different population different drug, gaming out [indiscernible] of those drugs. But there was a lot of excitement and around 7% and we've got I believe a safer more pragmatic, more an affordable health profile that fits well there. So outcomes data was [indiscernible] but 96% of patients with elevated triglyceride received no therapy at all because there is no outcomes data. If there is a positive significant result from the REDUCE-IT study. I think that's a significant game changer. Obviously we love it be 15% or greater. Greater will be terrific but it's somewhat of a non-comparison really the idea of going off a biomarker is to going off of outcomes. The outcomes are positive. We're in a new game.

Joel Beatty

Analyst · Joel Beatty with Citi. Please proceed with your question

Great. Thank you.

Operator

Operator

Thank you. Our next question comes from the line of John Boris with Suntrust Robinson Humphrey. Please proceed with your question.

John Boris

Analyst · John Boris with Suntrust Robinson Humphrey. Please proceed with your question

First question just has to do with the primary endpoint and the secondary endpoint analysis, more specifically on the secondary analysis. Obviously you have an opportunity as agreed to with the FDA in the paper that you published on a clinical trial design that is a vast number of secondary endpoints, diabetic obviously is very big group but what are the important secondary endpoints that are important for market segmentation that you believe are important that you need to hit on. And then on the second question on the commercial pilot program, do you have any metrics in place to measure the return that you're getting on the $15 million to $20 million that you're investing in that commercial pilot program. in other words if you're doing the TV ad are you measuring the number of hits that are coming into the Vascepa website as an indication of patients looking for therapy and intent to see a physician.

John Thero

President

John thanks for the question and comments. Let me start with the second one, first. Relative to the pilot promotion program. We are doing that with one of the leading advertising firms in the world and they have all those kinds of metrics set up. So we're clearly measuring hits to a website and those kinds of things. Which have been pretty robust here to start with? What we're predominantly doing is, we took a measurement an unaided and awareness at the beginning of the study and we're going to be sort of running commercials for a bit and will pause for a little bit, take another unaided awareness measure and then we'll start up for a little bit and we'll pick another unaided awareness measure and the unaided awareness measure looking both at positions and consumers. To me right now I think that the position pieces is as important more important than the consumer piece because we know that the majority of the positions who could potentially write Vascepa start up in very low awareness of the product, largely because we still call on them. So going into REDUCE-IT results when those results come out, we'd like to those physicians to have some identity as to what Vascepa is. So we're definitely measuring it, it's still early. We're only been running the commercial for a month and we've been running it with considerably lower frequency then you would run it. If you're really trying to use it drive short-term demand but for the reasons I described earlier that's not where we're starting and that would be a considerably more expensive program. But I do think that this will position us and we're measuring along the way, pilot positions us for preparing for our REDUCE-IT results. So I hope those questions are useful. I've got both Craig Granowitz, our Chief Medical Officer and Steve Ketchum, who's running the REDUCE-IT study here with me. Craig maybe to jump in on secondary endpoints which ones you see from a physician's perspective to be most intriguing.

Craig Granowitz

Analyst · John Boris with Suntrust Robinson Humphrey. Please proceed with your question

John, thank you for your question. It's a very important one. And it's one that is it's always looked at very carefully in these large cardiovascular outcome stages, where they are very - a large number of important endpoints and important points for clinical practice beyond those that are specified by the health authorities. As you know the primary endpoint is a 5. MACE of cardiac death, non-fatal MI, non-fatal stroke, coronary vasculation and unstable angina requiring hospitalization for more than 24 hours. The secondary endpoints is a subset of those as well as each of the individual components of those. But I think above and beyond the primary and secondary endpoints from a clinical practice perspective. These patients sub groups are also extremely important and the ones that we hear most often from our steering committee and other scientific experts are the large sub groups of patients with diabetes and the secondary prevention group and just to decline secondary prevention. These are patients that entered the study having already experienced at least one primary cardiac events either unstable angina or vasculation procedure, non-fatal MI. So those groups from a clinical standpoint are extremely important and I think as we've communicated on prior calls and in the design paper which is published, is that these groups are significantly sized and stratified in the REDUCE-IT study. Roughly 70% of patients enrolled are secondary prevention and there is a significant fraction of patients with diabetes that are enrolled in the study. All of the primary prevention patients as you know have presence of diabetes as well as other coronary risk factor. So when you think that there is a significant fraction of those, with secondary prevention that has diabetes plus 100% of the primary prevention group have diabetes, so there is a significant number of overall patients in study. What we hear from most of the thought leaders are those are two very large and important groups that are particular risk and particular need for care beyond just LDL [indiscernible].

Elisabeth Schwartz

Management

[Technical difficult] we'll move to last question.

Operator

Operator

Yes. Our last question for today will be from Matthew Andrews with Jefferies. Please proceed with your question.

Matthew Andrews

Analyst · Jefferies. Please proceed with your question

As it relates to REDUCE-IT, assuming a positive outcome. Can you talk about your thoughts on how formulary placement with insurance plans could potentially change with the potentially first and only Omega-3 product to improve cardiovascular outcomes? Could it become the de facto first line drug of choice for mixed dyslipidemia and severe high triglyceride for insurance plans? What are your general thoughts and around how formula placement can change and impact on potential scripts and use there? Thank you.

John Thero

President

Matt, good morning. Thanks for the question. So I'll start this off, I'll start the response off sort of contrasting us to something like PCSK9. So PCSK9 comes into the market with very little or really no managed care coverage as of fairly short time ago. Positive results, but a price of $14,000 per year and docs like the drug it provide roughly 15% relative risk reduction. But indeed it's run into a managed care headwind. Managed care in many places, although that's - they're succeeding in breaking down that wall and hopefully more and more patients who need that therapy will receive that therapy. In contrast, the coverage for Vascepa today is with few exceptions pretty strong. I think more than the managed care challenge it's really convincing physicians that this is a patient population that should be appropriately treated and in the cardiovascular space - the preponderance of physicians are schooled [ph] or believe that outcomes data is how they should make their decision. So we have positive outcomes data. I think that's going to be really have a strong effect on the prescribing habits of physicians and could very well lead this to be a standard care or first line of therapy beyond LDL, cholesterol management in mixed dyslipidemia patients particularly given our cost and safety profile. Are there some insurance plans and or some individual plans under coverage, where we have coverage that where the coverage could improve. Absolutely. And outcomes data will some positive should help there as well because those plans will look at the data today and say it's encouraging but they're not wrong in saying it's not conclusive, the purpose of the outcome study is to make it conclusive. So I think there is an opportunity for us to increase insurance coverage, improve insurance coverage after a REDUCE-IT result. But I think the bigger opportunity is with physicians and I just wanted to remind everybody that this really is a very different paradigm than - PCSK9 were introduced and had get reimbursement from the beginning because our reimbursement that's out there today which is predominantly tier 2, - you have to have triglyceride of X or Y, the coverage is out there. It's strong and it docks right this after REDUCE-IT the coverage should be there, with few exceptions and we will as you suggest work on those exceptions, with outcomes data should help. Hopefully those comments are useful.

Matthew Andrews

Analyst · Jefferies. Please proceed with your question

Yes, they are. Thank you.

John Thero

President

As the operator suggested. I think ran out of time. [indiscernible] one hour. I appreciate that number of people sent it suggested topics for questions in advance of this. Hopefully, we were able to address those in our prepared comments. So we thank you for that. we thank you for your interest and we're going to continue to work on growing our business. based upon what we're doing today. We obviously look very much forward to the REDUCE-IT results and to keep you apprised of our progress along the way. So thank you for your interest and support. Have a wonderful day. Bye.

Operator

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. thank you for participation.