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Amarin Corporation plc (AMRN)

Q4 2014 Earnings Call· Tue, Mar 3, 2015

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Transcript

Operator

Operator

Greetings, and welcome to the Amarin Corporation Year-End 2014 Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mike Farrell, Vice President of Finance. Thank you, you may begin.

Mike Farrell

Analyst

Welcome, and thank you 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 sales, revenues and other commercial metrics, expenditures, supply-related activities and the adequacy of our financial resources; our current expectations regarding regulatory filings, government agency decisions and potential label expansions; our current expectations regarding our cardiovascular outcome study, such as enrollment and the potential implications of our regulatory process on such study; our plan to protect the exclusivity and commercial potential of our product; and our expectations regarding the effect of our co-promotion agreement on our business. These statements are based on information available to us today, March 03, 2015. We may not actually achieve our goals, carryout 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 if 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 material agreement 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 Statements section in today's press release and the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2014. These documents have been filed with the SEC and are available through the Investor Relations section of our Web site at www.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 of its approved indication. Finally, an archive of this call will be posted to the Amarin Web site in the Investor Relations section. In addition to myself, on today's call from Amarin are John Thero, our President and Chief Executive Officer; Steve Ketchum, our President of R&D; Joe Kennedy, our Senior Vice President and General Counsel; and Aaron Berg, our Senior Vice President of Marketing and Sales. I’ll now turn the call over to John Thero, President and Chief Executive Officer at Amarin.

John Thero

Analyst · Oppenheimer. Please proceed

Good afternoon. Thank you for joining us today. Amarin made important and significant progress during the fourth quarter of 2014 and during 2014 as a whole. On today’s call, we will discuss Amarin’s recent commercial, operational and financial performance, provide a regulatory update, discussion our recently announced agreement for the development and commercialization of Vascepa in China and then take questions from analysts and investors. We commenced 2015 as a much stronger Company than we were a year ago. Our priorities in 2015 are to support improved patient cares with Vascepa, increase revenues, continue to position our cardiovascular outcome study REDUCE-IT for success, and to manage our business in an opportunistic and cost effective manner. 2015 is off to a good start for Amarin highlighted by our recently announced plan to commercialize Vascepa in China through our new partner Eddingpharm. After completing our U.S. co-promotion deal with Kowa which launched in mid-2014, we increased focus on other strategic opportunities including opportunities to introduce Vascepa to markets outside of United States. We increased our interaction and evaluation of third-party companies which are expert in operating in these geographies. Our announced partnership with Eddingpharm is the first of what we anticipate to be multiple partnerships for Vascepa in territories outside the United States. Our Eddingpharm agreement covers the commercialization of Vascepa in Mainland China, Hong Kong and Macao Special Administrative Regions and Taiwan. The agreement is with Eddingpharm Limited a private held and aggressively growing pharmaceutical company which specializes in commercialization of products in the greater China market. Eddingpharm has significant experience in gaining regulatory approval, government and hospital imbursement and prescription growth for new drugs. Eddingpharm is responsible of their expense for Vascepa development and commercialization activities in the territory. Amarin will provide development assistance and be responsible for supplying Vascepa…

Aaron Berg

Analyst

Thank you, John. During Q4 2014, we witnessed prescription growth from physicians called on solely by Amarin sales reps from physicians called on jointly by Amarin and Kowa sales reps and from physicians called on by Kowa sales reps only. Underlying these positive trends in 2014, we witnessed prescription growth from physicians who had an early 2014 reduced their prescribing of Vascepa following the intentionally narrower sales target focus we implemented earlier in the year. We attribute some of this positive trend to the early impact of our co-promotion partner Kowa. Much work remains to be done to grow prescriptions further, our sales and marketing team is energized and optimistic regarding continued growth in 2015. Our 63% Vascepa revenue growth in Q4 2014 over the corresponding period in 2013 and 105% revenue growth in 2014 over 2013 was achieved with the net price of our products remained relatively flat in 2014. We increased the wholesale price for Vascepa by 7% in late November 2014. This increase which during 2015 is likely to be largely offset on a net price basis by rebates for expanding Tier 2 coverage continues to position the price of Vascepa at a level that is below the net price of generic Lovaza for most payors with of course the clinical differentiation that drove our Tier 2 coverage before generic Lovaza became available. Normalized prescriptions for the quarter ended December 31, 2014 based on data from Symphony Health Solutions and IMS Health, totaled approximately 146,000 and 131,000, respectively, representing growth of approximately 11% and 16% respectively over prescriptions during the previous quarter this year and representing growth of 55% and 66% respectively as compared to the same period in 2013. Such prescription growth continues to be primarily generated from higher docile physicians targeted by both Amarin and…

Steve Ketchum

Analyst · Oppenheimer. Please proceed

Thank you, Aaron. Regarding the sNDA for the ANCHOR indication, we have no new updates to provide since our last investor call in November 2014. The FDA continues to assure us that they're working on the sNDA review. When we have a definitive update, we'll share it publically. We note that during today's call we're not going to comment further on the pending sNDA. Our primary R&D efforts continue to be in support of bringing the REDUCE-IT study to a timely and successful conclusion. REDUCE-IT is the first perspective double blinded cardiovascular outcome study of any drug in the population of patients who despite stable statin therapy have elevated triglyceride levels. Within the REDUCE-IT study we seek to demonstrate the benefit of EPA-only therapy in augmenting as opposed to replacing statin therapy. I would like to move into some of the design elements of the REDUCE-IT study. This is an events-driven trial that is designed to be completed upon documenting 1,612 patients with primary endpoint events. The study was initially designed for 6,990 patients. For added statistical rigor, before the trial started Amarin expanded target enrollment to 8,000 patients. Thus far, over 7,300 patients have been enrolled in REDUCE-IT representing over 90% of the total targeted enrollment. We anticipate completing study enrollment in 2015. The REDUCE-IT study was designed with 90% power to detect a 15% relative risk reduction and the study protocol pre-specifies one interim analysis of the efficacy and safety results of the trial after 60% of events accrue. Thus far, the accrual blinded event rate in the REDUCE-IT study is tracking to our expectations for the 60% interim look by the independent data monitoring committee or DMC to occur during 2016. Based on the efficacy and safety results at that interim look, the DMC could recommend to…

Mike Farrell

Analyst

Thank you, Steve. My comments will address our recent financial results. You'll find a more detailed discussion of our results in our 10-K and press release issued earlier today. In Q4 2014, we recognized $16.5 million in net revenues representing an increase of 63% as compared to net revenues of $10.1 million in Q4 2013 and an increase of 17% as compared to $14.1 million in net revenues in the third quarter of 2014. The timing of shipments to wholesalers upon which revenues are recognized and prescription levels can vary between periods. In 2014, we recognized 54.3 million in net revenues compared to $26.4 million in 2013 a year-to-date increase of 105%. Our average net price per capsule sold in Q4 2014 approximated the average price in the first three quarters of 2014. Cash collections from the sale of Vascepa in the year ended December 31, 2014 were approximately $66.4 million and all of our customers remained current in their payments. Gross margin during the quarter ended December 31, 2014 was 65% as compared to 59% in Q4 2013. Gross margins for the year ended December 31, 2014 was 62% as compared to 55% in 2013. While our gross margin may fluctuate from quarter-to-quarter, overall we expect our gross margin percentage to improve further beyond 2014 as we source lower cost API. Our SG&A expenses in Q4 2014 were $18.4 million as compared to $22.3 million in Q4 2013 reflecting an intentional reduction in expenditures. SG&A expenses in the year ended December 31, 2014 were $79.3 million as compared to $123.8 million for the same period in 2013. The 36% decrease in SG&A expenses was primarily intentionally driven by previously announced decisions to decrease salesforce staffing, marketing program spend and other costs associated with the commercialization of Vascepa following the…

John Thero

Analyst · Oppenheimer. Please proceed

Thank you, Mike. The more than doubling of Vascepa product revenues in 2014 illustrates the broad progress made by Amarin in our second year of Vascepa promotion. The value we believe we're creating through progressing the REDUCE-IT study are hopefully towards our current commercial progress. As we move forward in 2015 we're confident in our employees’ initiatives and the significant market potential for Vascepa both in the U.S. and internationally. With that I would like to now open the line for some questions, operator?

Operator

Operator

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first question comes from the line of Akiva Felt from Oppenheimer. Please proceed.

Akiva Felt

Analyst · Oppenheimer. Please proceed

I am wondering if you can may be give a little bit more color on exactly what the interim hurdle is for REDUCE-IT and what are the hurdles that the DMC is looking at in your view would be similar to the FDA's hurdle for a label expansion to include a cardiovascular outcome? Thanks.

John Thero

Analyst · Oppenheimer. Please proceed

Steve do you want to jump in on that one?

Steve Ketchum

Analyst · Oppenheimer. Please proceed

To maintain the integrity of the study we have purposely described few details regarding that 60% interim look by the independent DMC. It will be looking as you mentioned at efficacy and there is an overwhelming efficacy boundary that is pre-specified but we haven't publicly disclosed exactly how we arrived at that efficacy boundary in terms of looking at prior cardiovascular diabetes outcomes trials and those types of considerations that in conjunction with the steering committee and the DMC were settled upon and the protocol that was the subject of the FDA agreement. So there was obviously also discussion with FDA to arrive at those provisions.

Akiva Felt

Analyst · Oppenheimer. Please proceed

Okay.

John Thero

Analyst · Oppenheimer. Please proceed

And so I think you'd look at those data for maybe other people’s benefit while we haven't disposed that difficult hurdle within the JELIS study if you look at the subset population there, patients with high triglyceride low HDL are low population of the study there was a pretty significant divide that began to occur about less than a year and a half in average patient life is such study it was in that trial so that in the patient population we have elevated triglycerides in that study in less than a year and half into it, the divide between the patients being treated with EPA and those not being treated with EPA being treated by that statin alone was up over 45%. So we are again blinded to the results of the REDUCE-IT study but it's certainly possible that we could get surprised with a very nice Delta here when that interim look does occur but we haven't as Steve described we haven't described the specifics of the statistical hurdle at this juncture may be you could…

Steve Ketchum

Analyst · Oppenheimer. Please proceed

Yes and Akiva those, the separation that John was referring to was true, but not only at the total cohort but also the primary prevention and secondary prevention cohorts including that subgroup which numbered about 1,000 patients that had the elevated triglycerides and the other HDL parameter.

Akiva Felt

Analyst · Oppenheimer. Please proceed

Then maybe as a quick follow-up, because you didn't mention that subgroup these are high trig low HDL, is that sort of implications demographics that you're referring to with REDUCE-IT and why you guys are increasingly optimistic about that study? Or is it just the combination of a bunch of different factors?

Steve Ketchum

Analyst · Oppenheimer. Please proceed

John, did you want to a make a referencing comment and then I can add as you see that.

John Thero

Analyst · Oppenheimer. Please proceed

Sure, I'll try. So, there are a number of reasons why we're excited about REDUCE-IT be a potential results including the epidemiological genetic mechanistic kind of clinical data that was referred to previously but one of those pieces of data certainly is the JELIS study and that is EPA on top of statin therapy so it's a closest to what we’re doing here. Now, there are differences between this JELIS study and our study. If they're designed there was a guy in Japan and ours is taking out sort of worldwide pretreatment, their population was largely a populations of patients with elevated cholesterol and did showed net overall population benefit but if when looks at the a subset population of patients with the high triglyceride above 150, we see that benefit jump from 19% and 19% is impressive than reducing in these but jumping that to 53% is really eye catching. We try to have for REDUCE-IT a certainly higher risk patient population than we studied in JELIS so all of our patients have elevated triglyceride we commented in the past that the mean and median baseline triglyceride levels during the study are above 200. We are studying with four grams per day of Vascepa versus the JELIS study, it was done with 1.8 grams per day, we noted in the ANCHOR study that the dosing of four grams per day brought EPA levels up at the blood plasma levels to the same level that was occurring in the Japanese patient population for the dosing in the active arm at the 1.8 grams of EPA there and that' notable in that. In our study we're bringing patients up on the active arm to that same level of EPA in the blood but in the control arm in the Japanese study because of the diet there levels of EPA would be higher than what we're anticipating seeing in our study so that is even further divide in our study between what was done in the JELIS study. So, all that data and some of those factors contributed to our confidence as does the fact that monitoring committee has continued to look at the safety, within the study and continues to give us the thumbs up to move forward and this part of the study that's incurred into also low course of it is not efficacy but those are some comments statically I know you've looked at this in much more detail whenever you want to jump in on anything I may have left out.

Operator

Operator

Thank you. Our next question will come from the line of John Boris of SunTrust Robinson Humphrey. Please proceed.

John Boris

Analyst · SunTrust Robinson Humphrey. Please proceed

Just on revenues as you exit the year at 50.4 [indiscernible] able to achieve that same increment the lower end of the limit would probably take you right about 80 million, John what are some of the variables that we should see to impact in terms of being able to hit that number or the consensus which is obviously closer to the upward 90 level what are some of the variables in terms of throughput coverage and contribution from Kowa that we should be thinking and are going to drive revenue going forward here?

John Thero

Analyst · SunTrust Robinson Humphrey. Please proceed

Yes that is a fair question as you know we haven’t specifically given guidance relative to the revenue level but as Aaron stated we increased revenues at a pretty good cliff this past year and aim to do at least that well in the coming year on a dollars basis. And some of the factors we’re looking at domestically in terms of that increase are levels continuing to expanding levels of Tier 2 coverage that should be as I have commented potentially helped by GSK no longer rebating and our ability to get into some of those plans. We are continuing to learn from our experiences in the field and continuing to improve the messaging that we’re doing but also building off the success that we’ve had with patients and talking to doctors and looking at the results they had and trying to snowball that into a positive effect but also having doctors talk with other doctors about experiences with Vascepa we think are taking hold. This is largely an education way and we think that the combination of what we’re doing with our salesforce and the Kowa salesforce is taking room to as Aaron mentioned that the Kowa salesforce is still relatively early on average two times calls on their -- they're doing a broad reach strategy as we’re looking forward to that have more of an impact as well and of course we’re reaching out on digital strategy and doing supporting various CME programs. But it’s largely blocking tackling execution we’ve got a terrific product, it works, it was proven in clinical studies, it’s been proven here in the market place and we think we’re going to just keep building. We are continuing with our salesforce to take very much a targeted approach to that growth that’s then working so far and we’re looking to continue to leverage that. We’ve got the generic Lovaza in the marketplace we’re not anticipating any significant change in terms of generic competition. There is possibility of others entering the field we believe as we have commented previously that we’re well differentiated if that should happen and we’re continuing to look at stimulate data that we think will allow us to continue to differentiate Vascepa from those and other potential products. So those are some of factors that we’re looking at.

John Boris

Analyst · SunTrust Robinson Humphrey. Please proceed

And just on the spending side of the equation, John, it would seem as though you gave some good clarity on the R&D side where there is probably less flexibility but just your thoughts around the SG&A side of the equation if your revenue starts to ramp faster, would you consider increase in spending or maintaining it at the current level, but I think you’ve currently indicated that SG&A would be similar to 2014 levels, but just your thoughts around that label?

John Thero

Analyst · SunTrust Robinson Humphrey. Please proceed

Yes again revenues really took off, we might have to reconsider but we think that we’re targeting the right set of docs today between high frequency tight target groups that our salesforce is going after combined with the broader reach approach Kowa we think we’re going after the right docs and within those docs we’re targeting we think that there is significant opportunity for growth. So right now we’re not feeling compelled to go after a broader set of docs than what we are doing and so as such don’t see immediate lead towards increasingly the number of feats that we have on the street. So as we look at SG&A costs aside from the royalty going to Kowa which we hope have that continue to increase that means revenues are ageing and to increasing and that’s the formula if paid off of gross margin, but obviously that’s high to derivatives. Other than that we see the SG&A cost in relatively flat year-to-year. The R&D cost as Mike had commented, would continue to be variable from quarter-to-quarter particularly here as we’re finishing out enrollment in the REDUCE-IT study probably get a little bit of an uptick in cost, and then the cost will receive a bit after that enrollment is completed. The other piece from a modeling perspective of course is supply this past year we entered the year with pretty hearty inventory levels and began purchasing supply as the year went on and we are anticipating buying more supply in 2015 than we brought in 2014 that's not P&L but that is cash flow related. So those are sort of in addition revenues those are some comments on some of the out flows.

Operator

Operator

. :

Thomas Wei

Analyst

And just a couple of quick ones, one is that you could be a little bit more specific on the timing of the REDUCE-IT interim in 2016. I think I remember from the FDA 10 or maybe it was in the fourth quarter but if you could help clarify that and then I just had one other follow-up?

John Thero

Analyst · Oppenheimer. Please proceed

Thomas it is a events-driven process and then there is adjudication events and locking out down a database at this point in time we've not given any tighter guidance than that in terms of when it might be in 2016 this is obviously the rules up the average as they are only is possible in 2016 but because it is events-driven we don’t entirely control it. We may provide greater guidance on that as the year progresses but at this point in time we've not narrowed it down to a specific timeframe within 2016.

Thomas Wei

Analyst

And then sort of to clarify what you said in the prepared comments you had mentioned that if the resolve at the interim are comparable to JELIS you could potentially stop this study early. I just wanted to make sure were you referring to the 53% from JELIS or to the overall 19%?

John Thero

Analyst · Oppenheimer. Please proceed

So it's a statistical hurdle for the interim looked at both primary and secondary endpoints, and yes I would -- I think the results in JELIS were impressive at both the co-cohort and the subset cohort, I think the subset cohort in patients actually realized by triglycerides is more applicable here. So with that subset cohort of the 53% overall and potentially greater than north of 45% about a year and into the average patient study life that I was referring to it doesn’t need to be that high but that's just illustrative of what could be possible.

Thomas Wei

Analyst

And then just lastly on the lower bound if it is anything of one does the study keeps going, because it have to be actually at a house abrasion that is negative for the futility trigger?

John Thero

Analyst · Oppenheimer. Please proceed

Steve do you want to jump in on that one?

Steve Ketchum

Analyst · Oppenheimer. Please proceed

Yes so I apologize I got dropped off a little bit earlier. So Thomas we have not shared the specifics and as John was mentioning it's -- the DMC and the set interim look we will look at not just the primary efficacy endpoint but also on the robustness and consistency of secondary endpoint. So it won't be based purely on a hazard ratio observation and isolation, they will be looking at the totality of the efficacy and the safety data.

Operator

Operator

Thank you. At this time, I’d like to return the floor back over to the management for closing remarks.

John Thero

Analyst · Oppenheimer. Please proceed

Thank you everybody for joining us today. I look forward to our providing you with the continued update as we progress through 2015 and we appreciate your support. Good evening.

Operator

Operator

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