Earnings Labs

Amarin Corporation plc (AMRN)

Q2 2014 Earnings Call· Fri, Aug 8, 2014

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Transcript

Operator

Operator

Greetings and welcome to the Amarin's Second Quarter 2014 Results Conference Call. At this time all participants are in a listen-only mode. A 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 host Mr. Mike Farrell, Controller and Senior Director of Investor Relations. 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 that EBIT sales and 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 expansion; our current expectations regarding our cardiovascular outcomes study, such as enrollment and the potential implications on such study of our regulatory process; our plans to protect the commercial potential of our product candidates and approved product through patents, regulatory exclusivity, trade secrets and manufacturing barriers to entry; and our current expectations regarding the effect of our new co-promotion agreement on our business. These statements are based on information available through us today, August 7, 2014. 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 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 quarterly report on Form 10-Q for the 3 and 6 months ending June 30th, 2014. These documents have been filed with the SEC and are 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 of its approved indication. Finally, an archive of this call will be posted to the Amarin website 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 will now turn the call over to John Thero, President and Chief Executive Officer of Amarin

John Thero

Analyst · Aegis Capital

Good afternoon. Thank you for joining us today. On today’s call, we will discuss Amarin’s recent commercial operational and financial performance, update our FDA recession appeal status for the FDA and then take questions from analysts and investors. In Q2 2014, we experienced further Vascepa prescription and revenue growth. Net product revenues for the three months ended June 30th 2014 were $12.6 million representing a 129% increase over net revenues of $5.5 million reported for the same period a year ago and a 15% increase over net revenues of $11 million reported for the first quarter of this year. Underlying this growth, our broader productivity increases as we achieve this growth with lower SG&A cost than a year ago. Our net cash burn dropped to $13.8 million in Q2 2014 resulting in year-to-date net cash burn through June 30th, a $41 million. These results put us on track to achieve our previously stated target of full year 2014 net cash outflow of not more than $80 million and reflects the pattern of significant cash flow improvement over the past several quarters. In comparison, our net cash burn in Q2 2013 are $52.4 million was more than three times higher than Q2 of this year. Our prescription and revenue growth in Q2 was lead by the focus of our sales team on educating the highest prescribers of competitive therapies on the benefits of Vascepa. Our growth came primarily from these targets which is important because these targets also holds the potential for significant future growth. As described previously, through each position that our sales team does not have the bandwidth to address, we entered into a co-promotional agreement with Kowa Pharmaceuticals, America. Under which Kowa will be promoting Vascepa to more than twice the number of physicians being called by the Amarin’s sales team. Kowa’s co-promotion efforts commence in May and further accelerated in June. While as we have guided in the past, enough time is not yet passed for such expanded promotional efforts to take route that Kowa’s sale team has now actively and enthusiastically promoting Vascepa to physicians, many of whom are being detailed for the first time on the benefits of Vascepa. We anticipate that Kowa’s co-promotion efforts of Vascepa will be one of the key drivers of further Vascepa sales growth later this year and beyond. Aaron and Mike will provide additional comments on our operational financial performance. I now turn the call over Aaron Berg, our Senior Vice President of marketing and sales for commercial update. Aaron?

Aaron Berg

Analyst

Thank you, John. During the second quarter, we witnessed an increase in the rate of Vascepa prescription growth. Normalized prescriptions for the quarter-ended June 30th 2014 as estimated based on data from Symphony Health Solutions and IMS Health, totaled approximately 110,000 and 93,000 respectively and grew approximately 18% and 19% respectively over prescription during the first quarter of 2014. Such prescription growth was primarily generated from higher decile physicians targeted by Amarin's sales representatives. We have also grown Vascepa total prescription market share and the prescription omega-3 market from 6% in March to 8% in June despite the availability of generic Lovaza. As was true in Q1, in Q2 the strongest performing group of targets were the highest decile physicians which we target with our sales force. I will talk in a moment about the recently commenced co-promotion efforts by Kowa which are now introduced in Vascepa to a larger audience of physicians. We know that Vascepa usage is impacted by sale detailing and the highest value group of highest decile prescription Omega 3 prescribing physicians those in decile’s 8 to 10 as targeted by Amarin's direct sales force, overall Vascepa new prescription share rose to 16% in June from 14% at the end of Q1. We regularly hear overwhelmingly positive feedback from clinicians regarding their patient’s favorable treatment responses to Vascepa. This includes comments regarding the safety and tolerability of Vascepa and consistent physician feedback regarding the positive effect on patient lipid management and an inflammatory parameters. We also continue to hear stories of patients being switched to Vascepa from other triglycerides lowering therapies and witnessing notable improvement, particularly with respect to obtaining desire triglyceride reductions without increasing LDL cholesterol. Some of these physicians have begun publishing their clinical experiences, one of physicians who began prescribing Vascepa a year…

Michael Farrell

Analyst · MKM Partners. Please state your question

Thank you, Aaron. While I’ll provide some comments regarding our recent financial results, you'll find a more detailed discussion of our results in our 10-Q and press release issued earlier today. In Q2 2014, we recognized $12.6 million in net revenues representing an increase as compared to $5.5 million in Q2 2013 and as compared to $11 million in net revenues in the first quarter of 2014. You may recall as discussed last quarter, the Q1 2014 results included approximately $1 million in revenue resulting from the change in accounting method. The 129% increase in Q2 revenues over a year ago also reflects increased productivity as it was achieved with SG&A expenses which were 38% lower than the same period a year ago. On a year-to-day basis, we have recognized $23.6 million in revenues through June 30, 2014 as compared to $7.8 million in the same period in 2013. Our average price per capsule sold in Q2 2014 approximated the average price in Q1 2014. Cash collections from the sale of Vascepa in the six months ended June 30, 2014 were approximately $26.4 million and all of our customers are recurrent in their payment. Gross margin during the quarter ended June 30, 2014 was 60% as compared to 48% in Q2 2013. Gross margins for the six months ended June 30, 2014 was 61% as compared to 47% for the same period 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 increased purchased volumes and source lower cost API. Our SG&A expenses in Q2 2014 were $21.1 million as compared to $34 million in Q2 2013 reflecting an intentional reduction in expenditure. SG&A expenses in the six month ended June 30th 2014 were…

John Thero

Analyst · Aegis Capital

Thank you, Aaron and Mike. Regarding REDUCE-IT, we now have over 7,000 of the targeted 8,000 patients enrolled. It is important to note that we remain scientifically committed to the REDUCE-IT trial and thus far we have not made any change to the progress or design of REDUCE-IT as a result of the FDA’s unwillingness thus far to approve the ANCHOR indication. However, as previously discussed, if we do not receive approval for the ANCHOR indication, we will be forced to reconsider whether to continue the REDUCE-IT study in its current form. We continue to pursue FDA approval of label expansion for the Vascepa for the ANCHOR indication with an effort that includes continuing to appeal the FDA recession of our ANCHOR SPA agreement and working towards label expansion for both an ANCHOR indication and ANCHOR data in the label. With respect to the status of our appeal, we previously expected based on FDA’s dispute resolution timing guidance that we will receive a determination from the FDA’s office of new drug in late July or early August. However, we were recently notified by the FDA that they require additional time prior to providing us with the determination. Based upon our communications with the FDA, we now anticipate as a standard response to our appeal to Dr. Jenkins in the office of new drugs by mid-September. Dr. Jenkins informed us that before reaching a determination on our appeal, he has asked to seek advice from a CDER Medical Policy Council. As you may know CEDR is an acronym for the FDA’s Center for Drug Evaluation and Research. The CEDR Medical Policy Council which includes Dr. Janet Woodcock and Robert Temple and other senior FDA officials provides a senior level form to establish medical policy to ensure it’s implemented in a consistent…

Operator

Operator

[Operator Instructions] Our first question comes from Lee Chan with Aegis Capital. Please state your question. Lee Chan – Aegis Capital: Thank you for taking my question. I’d like to know whether you have a plan to invoke a first amendment in marketing or promoting Vascepa off label for treatment of dyslipidemia?

John Thero

Analyst · Aegis Capital

Thank you for the question. This is a busy time here and earning season and competing with I guess several calls here hence I appreciate your question. Right now, we are pursuing avenues with the FDA and we feel that we need to exhaust those avenues before we can consider other alternatives. If we do not receive more favorable decision from the FDA, we will consider other alternatives and as we have discussed in the past, one of those possibilities doing the first commitment but we need to exhaust our possibilities with the FDA first.

Lee Chan - Aegis Capital

Analyst · Aegis Capital

Thanks. Second question is could you give us some color regarding how much Amarin has paid to Kowa under the co-promotion?

John Thero

Analyst · Aegis Capital

Our royalty under that agreement is in the single digit here in the third year. Some of the analyst have estimated it to be 7% to 9% range of revenues. They came on in the middle of the second quarter, so it’s not a whole lot that we have paid to them at this juncture and it’s percentage – is after gross margin as oppose to revenues so it’s a lower percentage if you calculated of a revenues. So that really is why we are very pleases with the enthusiasm and getting out and making calls on their accounts. They are just getting started, so the cost and impact from them in the second quarter as expected was fairly limited.

Lee Chan - Aegis Capital

Analyst · Aegis Capital

Thank you.

Operator

Operator

[Operator Instructions] our next question comes from Heather Roberts with 11:11 Capital. Please state your question.

Heather Roberts - 11

Analyst

11 Capital: Hi, would you raise money at current levels with your 300 million trials (ph) that you have just filed?

Michael Farrell

Analyst · MKM Partners. Please state your question

So concurrently with today’s 10-Q filing we did file a self-registration statement. We had a self-registration in place for the last three years, it recently expired. On our last quarterly investor call we had indicated that we plan to replace that shelf. There was particular rush to do that, so we did it here concurrently with the 10-Q. Our primary goals for this year were and remain to increase revenues based upon on our current indication to pursue expanded indication for (inaudible) and to preserve our cash. We think that we are executing on all three of those at this point in time, I have been on record for many years, talking about it being good governance to have a self-registration statement in place for any public company and our filing of that shelf today is consistent with that prior guidance.

Heather Roberts - 11

Analyst

11 Capital: Thank you.

Operator

Operator

Our next question comes from Jon LeCroy with MKM Partners. Please state your question.

Jon LeCroy - MKM Partners

Analyst · MKM Partners. Please state your question

Thanks for taking my call. So, you had some time now, I think about what you guys will do with the REDUCE-IT program if the FDA does reject your appeal, can you talk a little bit about kind of what your planning on that?

Michael Farrell

Analyst · MKM Partners. Please state your question

You are correct that we have had a lot of time to think about it. We are still waiting for a response from the policy level within the FDA. As described in this call, we don’t have that response yet and it has been considered at even higher level within the agency. Until we hear that response, it’s impossible for us to formalize our decision relative to the REDUCE-IT study. We remain fine typically committed to the study. We think it’s important for patient care, we think that the trial represent a very significant potential opportunity for Amarin shareholders, we think that the trial is positioned to be successful. But it has a lot of cost remaining to it and it needs to be clear to us that if we are to continue to study in it’s current form that it will result in appropriate approvals based upon the success of that study and until we have had further clarity from the policy level within the FDA, we are holding up and making a decision there. The choice is our – choice is range for everything from continuing to study in its current form to stopping the study to modifying the study in some way that potentially for example could lead to a results perhaps earlier. But amongst that spectrum which is quite broad, we aren’t going to make that decision until we have greater clarity from the FDA.

Jon LeCroy - MKM Partners

Analyst · MKM Partners. Please state your question

Okay thanks. And then can you just briefly run through the paragraph four filings, you guys received and what extent?

John Thero

Analyst · MKM Partners. Please state your question

I will ask Jo Kennedy, our General Counsel to weigh in on that one. Jo?

Jo Kennedy

Analyst · MKM Partners. Please state your question

Sure. We are at the early stages of the paragraph four litigation related to potential generic competition for Vascepa. So that process is a process that plays out over years and we are not yet at a stage where we have seen anything that troubles us in anyone to perform. I remind the group to be as -- 40 patents now that cover Vascepa and various usages and as I told you patent has gone through a long patent prosecution efforts with U.S. (inaudible) that many of you pay attention to during that process and we feel very good about those patents. And so we look forward to litigating those patents and see how litigation progress and of course anyone who is interested in the filing that litigation is welcome to file that litigation through the public filing system with the U.S. Courts.

Jon LeCroy - MKM Partners

Analyst · MKM Partners. Please state your question

And so you have filed suit against anyone filling the paragraph four?

Jo Kennedy

Analyst · MKM Partners. Please state your question

We have filed suit against everyone who has filed the paragraph four.

Jon LeCroy - MKM Partners

Analyst · MKM Partners. Please state your question

Okay and then is there a 30-month stay date or the FDA not, has it not gone that for you?

Jo Kennedy

Analyst · MKM Partners. Please state your question

So the 30-month day date is we have disclosed in our last quarterly filing is in September 2015.

Jon LeCroy - MKM Partners

Analyst · MKM Partners. Please state your question

Okay, thank you.

Operator

Operator

Our next question comes from David (inaudible). Please ask your question.

Unidentified Analyst

Analyst

Two questions, have you predicated whether your sales have to go to break-even?

Aaron Berg

Analyst

We have not given guidance on that at this juncture. There are too many variables involved including the conduct of the recent study for example.

Unidentified Analyst

Analyst

And if your ANCHOR study doesn’t go through and you decide to pull out or to reduce the study, does your burning drop in half?

John Thero

Analyst · Aegis Capital

We are currently spending on the REDUCE-IT study between $30 million and $40 million per year that during the enrolment phase study and it does vary from quarter to quarter. Whether to curtail or reduce the study, that number obviously is saving not immediately but it would be saving as trial might would wind down as to whether that represents – what fraction of our expenses that represent that you calculate.

Operator

Operator

Thank you. And ladies and gentleman there are no further questions at this time. I will turn the conference back to management for closing remarks. Thank you.

Mike Farrell

Analyst

Thank you everybody for joining us here today. We appreciate the interest and support and we look forward to further updates with you as we progress this year. Thank you and good day.

Operator

Operator

Thank you. All parties may disconnect. Have a great day.