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Amarin Corporation plc (AMRN)

Q4 2016 Earnings Call· Tue, Feb 28, 2017

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Transcript

Operator

Operator

Welcome to Amarin Corporation’s Conference Call to discuss its financial and operating results for the fourth quarter and full-year of 2016. This conference call is being recorded today February 28, 2017. I would now like to turn the conference over to Elisabeth Schwartz of Amarin.

Elisabeth Schwartz

Management

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 prescriptions and wholesaler inventories, perceivable 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 the timing of interim analysis, study completion, regulatory review and likelihood of success, our plans and preparation for expanded promotion of Vascepa, and related market positioning potential. Our plan to purchase additional Vascepa, our goals regarding the timing and scope of international expansion and our current expectations regarding the effect of our co-promotion agreement on our business. These statements are based on information available to us today, February 28, 2017. 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 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 Annual Report on Form 10-Q for the year ended December 31, 2016. These documents will be filed with the SEC and will be available through the Investor Relations section of our website 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 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 www.amarincorp.com in the Investor Relations section under the sub category of Events and Presentation, 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'll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

John Thero

President

Good morning everyone thanks for joining us today, 2016 was a year of substantial achievement for Amarin commercially, operationally and financially. Two obvious highlights for 2016, while record product revenues of $129 million and are moving to within approximately a year of the onset of the final target event in REDUCE-IT our landmark cardiovascular outcome study. As stated in our press release issued this morning, Vascepa product revenues in 2016 grew 59% over the prior year. Other notable achievement by Amarin in 2016 include improved gross margin on product sales to 73% in 2016 compared to 66% in 2015. Strengthening our balance sheet through transactions in 2016 and early 2017, which lessened Amarin's burden of exchangeable debt from a face value of 165 million to 30 million with the first foot date update on the remaining debt five years away. Improved our cash flow such that, excluding finance related cost and reducing R&D cost, we were cash flow neutral over the nine months of 2016. We are position to be cash flow positive on a similar basis in 2017. Enhanced our management team with experienced additions such as Dr. Craig Granowitz, Michael Kalb and Todd Grisco. Our Chief Medical Officer, Chief Financial Officer and Vice President Managed Care respectively. Expanded our Managed Care coverage for Vascepa, while during 2016 and leading into 2017. Surpass when 100,000 patients currently being treated with Vascepa therapy we see new chemical entity regulatory exclusivity designation for Vascepa. Reached the first of its kind first amendment agreement with the FDA supporting our broaden promotion of Vascepa. Completed patient enrollment in REDUCE-IT at 8,175 patients with all such patients randomized on a one-for-one basis between Vascepa arm and the placebo arm of this study. In biologic as our commercial partner for Vascepa in the Middle East…

Craig Granowitz

Management

Thank you, John. As referenced, I joined the Amarin approximately year ago after having considerable due diligence regarding Amarin and Vascepa, since my joining of the company my extensive excitement has only increased. Based on the medical need of patients with cardiovascular risk and elevated triglyceride, the quality and dedication of Amarin’s team, support the scientific community and the quality and direction of the science of EPA. Our understanding of CD risk factor is rapidly evolving, based on publishers vote from a large number genetic, epidemiologic and clinical outcome studies that have been reported in the past one to two years, the role of elevated triglyceride as an independent risk factor compared to low baseline HDL is much stronger in its validation. Along with elevated baseline LDL, high baseline triglyceride is increasingly associated as a major independent and causal factor for serious cardiac event such as myocardial infarction, stroke and cardiac death is our new and important findings in the fields of Lipidiology, diabetes, preventive and interventional cardiology and these results are currently being reported as you have seen in scientific meaning like the NLA, [ACCA] (Ph) and AHA amongst others. The science of Omega-3 is remarkable in its scope depth and breath. As we continue to explore the science the role of Omega-3 and particularly the role of EPA is increasingly recognized as a key players in efficient and effective lipoprotein transporter metabolism, improved endothelial function in a number of inflammatory process. These paleographic effects may play an important role in the manner in which prescription per EPA Vascepa impacts multiple [indiscernible] process in the health of patients with cardiovascular disease. Many of these findings have been reported in more than 30 scientific publications and posted presentations that Amarin has sponsored or supported during the prior year. This level…

Michael Kalb

Chief Financial Officer

Thanks Craig. All four quarters of 2016 resulted in strong growth over the corresponding quarters of the prior year. During the fourth quarter and full-year 2016, Amarin’s net product revenue increased to $38.4 million and $129.0 million respectively representing increases of 45% and 59% over the prior fourth quarter and full-year 2015. The core driver of our year-over-year increases in net product revenue was continued growth in new and recurrent Vascepa prescriptions. Net pricing in 2016 was relatively flat with net pricing in 2015. As we have stated previously, we believe that our U.S. product revenue growth will come from increased prescriptions of Vascepa, primarily generated from physicians educated by our sales team. We anticipate net pricing in 2017 to also remain relatively flat, thus continuing to achieve approximate net pricing parity with the generic earlier generation for prescription Omega-3 product. We continue to believe that measurement of Vascepa growth compared to corresponding periods of the prior year is a better measure of our progress in evaluating consecutive quarter growth, although our Q4 2016 growth was substantial from both measures. We emphasize comparison to prior years because we continue to experience and anticipate seasonal effects such as typical slower prescription levels in Q1 of each year as patients were slow to fill prescriptions when they encounter large, annual deductible amounts under their medical insurance plans. During 2016, whole purchasing patterns were inconsistent between quarters as they likely try to adjust to our overall growth, seasonal factors and other considerations. Overall, we estimated that for 2016 changes in channel inventory increased net product revenue by approximately $3 million to $6 million calculated based on estimated days of inventory on hand. Most of this occurred in Q2 2016 with other quarters including Q4 2016 experiencing some decline of channel inventory levels. These…

John Thero

President

Thank you Mike. Before closing, I want to thank our employees and collaborators for their tremendous contributions during 2016. I also want to thank our shareholders for your support. 2017 should be an exciting year for Amarin as we continue to grow revenues and as we prepare for the results of REDUCE-IT cardiovascular outcome study. The excitement is strong within Amarin for these results and we sense this excitement building amongst KOLs for this landmark study. We intend to be prepared to act quickly to broadly disseminate the study results once they are known to us. With that, we conclude our prepared comments and we would like to open the line for some questions. Operator.

Operator

Operator

Thank you. At this time, we will be conducting the question-and-answer session. [Operator Instructions]. Thank you. Our first question comes from the line of Joel Beatty with Citigroup. Please proceed with your question.

Joel Beatty

Analyst · Citigroup. Please proceed with your question

Hi good morning and thanks for taking my questions. I have two questions, the first is could you tell us a little bit about any feedbacks from physicians that might help add the perspective to the sales growth you have been seeing with Vascepa. And then the second question is could you tell us a little bit more about the timing of the primary outcomes analysis, the final outcome analysis and the timing that between when you have data in-house and when you will be able to share whether the trials succeeded or not with investors. Thanks.

John Thero

President

Joel good morning, good to hear from you. Sure, I’ll make a couple of quick comments and then I’ll actually ask Aaron Berg and Steve Ketchum to weigh in a little bit. So with regard to physician response, I remind people, because as I’m talking with investors they often hear this these might doesn’t know much about Vascepa. So our comments about physicians come in two categories those we are actually promoting to and those that we are not promoting to. As a reminder, we have sales force sales of about a 135 sales representatives that’s a specialty sales model and as there at parts of the country where we have good coverage, we have primarily a targeted physicians who are higher prescribers of earlier generation therapy, but this leaves a huge chunks of the country where we don’t have sales representation. Post REUDCE-IT results is our aim to expand our sales representation to cover that white space while increasing our sales promotion in the areas where we are currently calling. So my comments are going to be limited to the docs that we call on which is a universe of about 20,000 physicians and one of the nice thing about Vascepa is that I don’t go to sleep at night worrying about being woken up with a call about adverse event. It’s a safe drug, I’m yet to find a doctor who has anything negative to say about the drug, the challenge that is with any drug is that we are new or the incumbent drugs have been out there for a while and wherein we are changing behavior. And I think we are increasingly getting a share particularly of [indiscernible] from these physicians, there continues to be at first reaction from doctors about [indiscernible] it’s not true, but that’s the first reaction, if they get more experience with it not possibly in the Medicaid side, but in the Medicare Part B side or on the commercial side they continue to gain comfort or confidence in the product. I’ll turn things to Aaron in a moment just to talk about that but let me just briefly on your other comment, there you are going to go straight to Steve and that is the timing of the analysis so there is multiple steps to that which Steve will go through. We did go through some of this discuss when we moved from the 60% interim look last year to the final data for that and some of that was laid out in our press release I think at the end of March of late last year. And just a reminder we moved from the 50% of the advance to the actual read out of that by the Independent Committee that occurred somewhere in late September timeframe. So roughly a six month period, but Steve can cover that in more detail. Aaron do you want to add?

Aaron Berg

Analyst · Citigroup. Please proceed with your question

I’ll just build on what you said around the physician feedback. Hi Joel how are you? So first of it comes down to product itself, the clinical profile, physicians recognize that as being unique, they appreciate the jealous and anchor data increasingly and their experience also plays in as they use it the more they have good results the more they want to use it. And then the access, we have had good access for a long time, managed care access and that access continues to improve. So the fact that the product is different, physicians are getting good experience and they are able to get the product are what we are hearing and that should lead the future growth.

Steven Ketchum

Analyst · Citigroup. Please proceed with your question

Okay, thanks Aaron and thanks Joel for questions. So to elaborate on John’s comments regarding the first interim analysis, we clearly have that experience in hand and we will have a much better idea at the timing for the final analysis following our experience with the second pre-specified interim look by the independent Data Monitoring Committee which is we are sharing today, we expect to be completed within Q3 of this year. So to describe the process in a little bit more detail, once we get to the point where we are signaling attainment of a 100% of the pre-specified events, all patients will have to be brought back to the clinical sites for a verity of clinical laboratory and vital status measurements. And then that information has to be entered into the database, they to be have collected, cleaned, adjudicated, summarized and then progressed following a series of internal and independent, review committee reviews to the state of being deemed appropriate for final database lock. And then obviously after unbinding, we need to do further scrutiny through our independent review committees and operational team and our network of vendors, just to ensure that we are releasing complete and fair results.

John Thero

President

Just to add may be obvious [indiscernible] out, we just think that there is some efficiency by having gone through this process at the same time locked in. we will see to what extent that has impact, but at the same time just as a monumental study, we are now a little over five years into it, we want to get it right. As much as we want to get that data, and we really want to get to that data, we also want to make sure we get it right, so there are a number of very important quality control steps along the way to make sure that that data is complied correctly, complied independently, remains blinded to Amarin. So we want the data, but it’s got to be done in a way that’s unquestionable.

Joel Beatty

Analyst · Citigroup. Please proceed with your question

Very good. Thank you.

Operator

Operator

Thank you. Our next question comes from the line of Chiara Russo with Cantor Fitzgerald. Please proceed with your question.

Chiara Russo

Analyst · Chiara Russo with Cantor Fitzgerald. Please proceed with your question

Hey guys, good morning. So a couple of question, first of all when we do get a peak at the top line data, are we just going to get the top line data or do we get to see some of those secondary and tertiary endpoint in some of the sub populations. What sort of that do we get to see there?

John Thero

President

So I'll let Steven Ketchum weigh in on that Chiara. Good morning by the way.

Steven Ketchum

Analyst · Chiara Russo with Cantor Fitzgerald. Please proceed with your question

So we will present top line data, this possibly done we want to preserve our very detailed findings for publication presentation and major medical congress or simultaneous publication in a major medical journal. But we will be sure to touch on the high level points that summarizes our key findings.

John Thero

President

Yes. And both our Phase III study, MARINE and ANCHOR, I think we stroke appropriate balance there of having data that would, meaningful to investors, but also preserving what has been a very significant stream of subsequent publications. And we will be approaching it from the same prospective. We recognize that Vascepa and its study is very important to Amarin and its shareholders since that will be included in the balance. But undoubtedly with 30 pre-specified secondary and tertiary endpoints, we are not going to get to all that from the start, but hope it’s on the primary endpoint in other base line statistics and things I think will be important towards swinging the picture of the results and then working on a broader publication from there.

Chiara Russo

Analyst · Chiara Russo with Cantor Fitzgerald. Please proceed with your question

Okay, that makes sense. And just a couple of additional housekeeping questions, I have noticed sort of in the revenue ramps that there is a little bit of seasonality as such stated with first half versus the second half. Do you kind of expect that to continue for 2017 as well?

John Thero

President

We expect variability to continue yes, the first quarter in each of our years of selling has been relatively slow that’s because we believe and it’s not unique to Vascepa, deductibles for patients are beginning to get high and for drugs that are treating conditions that are asymptomatic, patients are making choices with their wallets [indiscernible] conceding not to fill certain prescriptions. So Q1 has typically been a quarter where prescriptions picks back up in the March timeframe, but it will sort of start slowly and that often ends up getting exaggerated by wholesalers looking at the slowdowns that typically occur early in the quarter and then adjusting their ordering patterns based upon that trend and then it often rebounds the opposite way that begin to pick back up in the second quarter and wholesaler move the patterns around the opposite direction. We don’t control all that but in terms of predicting quarter-to-quarter variability I would imagine that a lot of that probably [indiscernible] which is we encourage that folks looking at us to think of us more as year-to-year comparison as appose to consecutive quarter comparison as we think is the year-to-year comparison there are more meaningful.

Chiara Russo

Analyst · Chiara Russo with Cantor Fitzgerald. Please proceed with your question

Okay, I mean seasonality doesn’t exist, so it seems like it applies to you guys very well. And then the last couple of question, again a little bit more housekeeping. Does the SG&A spend have a little bit of a backend ramp, does the R&D have a little bit of a frontend weight to it and in terms of income tax expense, how should we think about that going for in 2017.

John Thero

President

Mike correct me on some of this, but I’ll just jump into it. So, SG&A expense our size of our sales force is flat and has remained flat. There are some periodic clocks that we start new promotional campaigns, periodically there are different costs to that. We have had a variety of different legal projects over the year including matters related to first amendments, NCEs and those have had some sort of periodic sights. We are doing some further planning for preparations for REDUCE-IT success on the commercial side and there are some project related costs there, although we have talked about the aggregate of that for 2017 being somewhere in the $3 to $6 million range. Obviously after we have success with REDUCE-IT which we believe we will have, there will be significant bump-up in SG&A related cost. The other piece of SG&A cost that is variable by quarter is that there is a full promotion to be in there for Kowa and as our revenue grow therefore our gross margin grows and we are - Kowa 8% of our gross margin represented with 19% last year, it’s in the low 20s for this year. So the percentage doesn’t have much of an impact, but as revenues grow and as revenues might be variable from quarter-to-quarter that could have an effect quarter-to-quarter on SG&A spending. Our R&D, our predominant spending on R&D is for REDUCE-IT and during periods of time when we are having patients coming back into the sites for vital data as Steve was describing that tends to be more cost in those periods, but we are not enrolling patients any further, but there are activities in the study, which create certain spikes, there are some cost around that analysis and at the end of the study there will be continued cost around our publication. On the income tax side that’s largely non-cash, as a reminder our parent company is domiciled, our IP is developed out of Ireland initially while we were in the U.S. commercially we have got certain operations in the U.S. which are taxed by the U.S. tax authorities and we had an overall company that has tax loss carry forward now of over $570 million, which we look forward to utilizing here at some point in the future. But back and forth between those various entities there are tax amounts that some get capitalized, some of it don’t, so some gets offset with various allowances and we could take offline more details of that if you are interested, but it’s all non-cash and sometimes it popped up as a provision, and sometimes it popped up as a [counter fit] (Ph) but where taxes really become important is when we get to profitable on a consolidated basis.

Chiara Russo

Analyst · Chiara Russo with Cantor Fitzgerald. Please proceed with your question

Okay all right. Great, guys. Thank you.

Operator

Operator

Thank you. Our next question comes from the line of Hugo Ong with Jefferies. Please proceed with your question.

Hugo Ong

Analyst · Hugo Ong with Jefferies. Please proceed with your question

Hey, guys. Thanks for taking the question and congrats on all the progress. My first question is I was curious if you have any thoughts on potential read-through from [indiscernible] trial that reported positive top line data. So I understand that it’s targeted different lipid parameter, but just curious on your thoughts if they had any to read-through to REDUCE-IT or maybe impact to visit the prescription chain? Thanks.

John Thero

President

Good morning Hugo. I’ll ask Craig Granowitz to comment in a second, but I’ll just remind that the audience that [indiscernible] are not directly competitive, so different population, different clinical facts, certainly different co-ops and administration. And generally we think that [indiscernible] brings attention to lipid management and the importance of lipid management is a positive for us, but beyond that yes let me turn things over to Craig for further comments.

Craig Granowitz

Management

Thank you, John and thank you Hugo I think the important thing to recognize always is that LDL represents part of the risk profile that even after a management of LDL there is going to be considerable residual even under studies like IMPROVE-IT and others at lower LDL, the very low level, there is at least 70% of the residual risk remains after lowering the LDL to that level. So we expect that LDL will manage part of the issue, but that there will be considerable residual risk post LDL management. I think the other aspect to really keep in mind with some of the outcomes studies that have come out around elevating HDL is that HDL is clearly not the answer. And I think the field is moving back to triglyceride and elevated base line triglyceride as the key driver of residual risk in addition to LDL. So we feel even more confident that the study population and we are looking at and REDUCE-IT is the right one. It is a population that has not been looked at before and we believe that a significant portion of the remaining residual risk after LDL management is driven by this high base non [TG] (Ph) group. And as a reminder, in REDUCE-IT we are managing LDL at very low levels as the base line, and that these stations has significantly elevated base line triglyceride and as Steve as mentioned with the timing of the interim analysis, these patients are proving events at significant rates. So that we know we are dealing with the population that has considerable risk despite having LDL managed to very low levels with optimal management on a statin. So we don’t think that PCS-K9 studies actually impact that, we are excited to see results, we are focused on improving the overall outcomes of cardiovascular patients and we believe independently managing both elevated base line triglyceride and elevating base line LDL are important for achieving results of lowering cardiovascular disease.

Hugo Ong

Analyst · Hugo Ong with Jefferies. Please proceed with your question

Got it. Okay great thank you, and my second question is, I'm just curious on how the uptake of the smaller half gram pill has been, have there been any noticeable trends here?

John Thero

President

Hugo, still relatively early on that, we had commented on last call, I mean someone had asked the question about why you introduce that, there are certainly some patients where that’s important. It is not a product that we ever see being our dominant product, but with us moving towards hopefully both REDUCE-IT populations measured in the multiple millions or tens of millions of patients. A small percentages can add up to an important value and I think based upon data that we have looked at somewhere in one in one in 30-ish kind of patients have potentially swallowing issues with the one gram capsule. Most do not, I take a sip every day, one gram is fine for me, but we are seeing its used, but it is not likely to be a major driver of prescription growth, but it can help some added patients along the way, so much the better.

Hugo Ong

Analyst · Hugo Ong with Jefferies. Please proceed with your question

Okay, great. Thanks for taking the questions.

Operator

Operator

Thank you. Mr.Thero there are no further questions at this time. I would like to turn the floor back to you for final remarks.

John Thero

President

Well thanks everybody for joining us here today. I appreciate your interest and look forward to providing you continued update on the progress Amarin is making. Take care, have a great day. bye.

Operator

Operator

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