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Aegerion Pharmaceuticals (NASDAQ:AEGR)

June 03, 2013 8:30 am ET

Executives

Mark J. Fitzpatrick - Chief Financial Officer and Principal Accounting Officer

Marc D. Beer - Chief Executive Officer and Director

Martha J. Carter - Chief Regulatory Officer and Senior Vice President

Analysts

Salveen J. Richter - Canaccord Genuity, Research Division

Steve Byrne - BofA Merrill Lynch, Research Division

Nicholas Bishop - Cowen and Company, LLC, Research Division

Joseph P. Schwartz - Leerink Swann LLC, Research Division

Kimberly Lee - Janney Montgomery Scott LLC, Research Division

Operator

Good day, ladies and gentlemen, and welcome to the Aegerion Pharmaceuticals, Inc. Investor Update. [Operator Instructions] As a reminder, today's conference call is being recorded. I'd now like to turn the conference over to your host, Mr. Mark Fitzpatrick, Chief Financial Officer. Please go ahead.

Mark J. Fitzpatrick

Good morning, everyone. Thank you for joining us today on our call to update you following the recent CHMP positive opinion for LOJUXTA, which is the newly established commercial name for lomitapide in the EU.

I would like to introduce the member of Aegerion's management team with me today on the call: Marc Beer, Chief Executive Officer; Anne Marie Cook, Senior Vice President, General Counsel and Secretary; Mark Sumeray, Chief Medical Officer; and Martha Carter, Chief Regulatory Officer. At the conclusion of the prepared remarks, we will open up the call for questions.

Before we begin, please remember, we'll be making certain forward-looking statements on today's call, including statements and forecasts regarding the potential and expected timing of the EC's ratification of the CHMP opinion and our launch of LOJUXTA in the EU; the estimated market size, pricing and commercial potential for LOJUXTA in the EU and international markets; our anticipated patient numbers, market opportunity and revenue potential globally; potential regulatory filings and approvals in international markets; and our regulatory clinical and commercial finance goals and estimates; as well as other statements which relate to future events.

These statements are based on the beliefs and expectations of management as of today. Our actual results may differ materially from our expectations. Investors should read carefully the risks and uncertainties describing our earnings release and in our reports filed with the SEC, including the Risk Factors section of our 10-Q filed on May 10, 2013, available on the SEC's website at www.sec.gov. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events or otherwise.

At this time, it is my pleasure to turn the call over to Aegerion's Chief Executive Officer, Marc Beer.

Marc D. Beer

Thank you, Mark. Thanks, everyone, for joining us on our update call regarding the positive opinion for the CHMP recommendation, recommending marketing authorization for LOJUXTA in the EU as an adjunct to a low-fat diet and other lipid-lowering products with or without apheresis in adult HoFH patients.

I'm extremely proud that through our articulation of the risk-benefit of LOJUXTA, the CHMP voted unanimously in favor of marketing authorization. Following the 13-to-2 vote from the FDA advisory panel, this is a solid confirmation from the 2 most sophisticated regulatory agencies in the world that the risk-benefit of this product is positive in the HoFH population. We believe this is an important precedent for our continued success globally, particularly since CHMP, a vote represented by 27-member-state vote, I'd like to take a few minutes to review our expectations for the commercial launch in Europe and touch upon our continued early success in the U.S. commercial launch.

With our estimate of approximately 3,000 adult HoFH patients, the EU is a critical market for Aegerion, and the CHMP positive opinion is an important milestone for patients with this disease. We anticipate the European Commission will ratify the positive opinion to grant marketing authorization of LOJUXTA in all 27 union-member countries in the third quarter this year. Upon that approval, we will begin our launch on a country-by-country basis.

As many of you are aware, we can begin selling in countries such as Germany and the U.K. upon approval. Whereas in countries such as France, it may take up to 9 months, or even longer, to obtain approval for reimbursement. For that reason, we've been cautious to guide you that we do not expect material revenue from Europe in 2013. Revenue contribution from the EU will begin in a meaningful manner beginning in 2014 and will accelerate from there.

Our regulatory and clinical team, led by Martha Carter and Dr. Mark Sumeray, respectfully, have done a masterful job of creating positive working relationships with the regulatory agencies in both the U.S. and EU. We are comfortable with the language in the proposed summary of product characteristics or SPC, which is the EU-prescribing information. The draft SPC indicates the genetic confirmation of HoFH should be obtained whenever possible. We believe this will allow position to use appropriate judgment with respect to treating HoFH patients with LOJUXTA.

The European commercial team, led by Massimo Boriero, our President of the EMEA region, is established and has been preparing for launch with activity similar to what we undertook in the U.S. prior to launch. While we recognize the current economic environment in the EU makes launching an orphan-priced product challenging, this team has a great depth of experience and has extensive knowledge about how to obtain reimbursement approval in each respective country. We plan to price LOJUXTA comparably to the U.S. and globally.

In addition to the European market, we have made significant regulatory progress globally. We have filed for approval of lomitapide in Brazil, which is critically important to our long-range plan as we anticipate Brazil will be 1 of the top 3 markets. We also met with the Mexican regulatory authorities recently and came away from the meeting with clear guidance on our path to commercialization in that country. We received exceptions from a -- exemptions, excuse me, we received exemptions from a number of requirements typically expected of new molecules, and we're optimistic that the registration process will be rapid. We expect Mexico will also be a significant market for lomitapide.

In Canada, our filing has been accepted and is under review. There's a founders effect in the French-Canadian population, and we have a meaningful number of patients already identified in Canada. Finally, as you're aware, the Japanese market is an important one. Following the successful completion of the Japanese PK/PD study expected in the fourth quarter, we plan to have discussions with the Japanese regulatory authorities and a contract with a CRO at that time to conduct a small therapeutic study in Japanese HoFH patients. If we receive no further request for additional data or analysis, we plan to dose the first patient in this therapeutic study in either the fourth quarter of 2013 or in the first quarter of 2014. Assuming we are able to file, following completion of the 26-week efficacy phase, we plan to be in a position to submit our Japanese NDA as early as the first half of 2015.

Switching over to the U.S. commercial launch briefly. We continue to see -- we continue to be in acceleration mode. I have great confidence about the positive metrics regarding prescriptions, reimbursement, compliance and dropout that we see to date. I also remain highly optimistic about the significant global opportunity. You may have heard my comments during the recent webcast presentation that I see the potential for $1 billion revenue opportunity for a year, with 4,000 to 5,000 patients on therapy in the future. As a management team, we are careful about setting expectations appropriately and maintaining transparency, and I firmly believe that this is an achievable future revenue goal. In the near term, we remain intensely focused on optimizing the U.S. launch and for maximizing this accelerated revenue growth.

Finally, I want to thank all of you for your continued support, for the trust you placed in this management team. About the short a year ago, we began our preparation for the FDA advisory committee meeting. We were representing that we could drive this product through the FDA's arduous approval process to an approval, and we were successful. Due to lomitapide's benefit-risk profile, we also believe in our ability to -- we also believe that our ability to achieve a positive CHMP opinion in the EU despite the challenges that others have faced in that area. We are as, if not more, confident in our ability to continue our U.S. commercial launch and execution. We have built a culture at Aegerion that I'm extremely proud of, one that is first focused on patients, the highest caliber people and thorough planning and infrastructure of processes. With this infrastructure in place, we feel that a significant global commercial opportunity lies ahead.

Now I'd like to open it up to the operator for Q&A.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from Salveen Richter of Canaccord.

Salveen J. Richter - Canaccord Genuity, Research Division

Just curious, in the EU, which countries currently use genetic confirmation? And in those specific countries, are there identified pools of patients and where are they concentrated? And just curious, just given the label, could countries that don't use genetic confirmation opt to use it in identifying patients?

Marc D. Beer

So, Salveen, thanks for the question. I -- let me emphasize that genetic confirmation and testing is not required; it is recommended. And we believe this gives the physician, in all 27 member countries, the ability to use their judgment on how to diagnose these patients. Genetic testing in Europe is done slightly more frequently than the U.S., but it is still rare. It is not done broadly in either area, or anywhere in the world, frankly. So we feel comfortable that, again, the EMEA, they got it right. They understand the risk benefit of this product, and they're allowing the physician to make a diagnosis-judgment call, and they're recommending, if possible, to do genetic testing, but not required. So it's not required to be very specific. About your question, you had asked, where is it required and what countries now? There's no requirement in any country now. And we hope that in the next 2 months, we'll move towards approval. And in this language, allows us to, I think commercialize the product effectively in the right patients.

Salveen J. Richter - Canaccord Genuity, Research Division

And then, Marc, just one follow-up, when you talked about all the other countries x U.S., I think Turkey is a market you've mentioned as potentially being one of the large ones. What's the process here to get it approved in that country?

Marc D. Beer

So I'm going to turn that over to Martha in just a second to comment about Turkey from a regulatory approval process. But let me just say that right now, in Turkey, we can commercialize on an named-patient basis and ask for approval patient by patient, like we're doing in Brazil. So we have scripted patients in Turkey today. We have over 100 patients that have been identified in Turkey. And we've gotten a good -- we've received good traction early on with scripts in Turkey. So we can sell again, at a U.S. price, named-patient basis in Turkey today. Martha, do you want to comment anything specific on Turkey at this time or not?

Martha J. Carter

I think just to say that the global strategies are being taken into consideration whether or not we have the opportunity for named-patient sales in an individual country. If we don't, then the country would go higher on the priority list for attention. That's the general strategy here.

Operator

Our next question comes from Robyn Karnauskas of Deutsche Bank.

Unknown Analyst

This is Mohit [ph] for Robin. My question is regarding the delay. You are expecting, in terms of patients getting prescription and patients actually starting on therapy, what will be the time difference between that in Europe? Is it going to be similar to U.S. or is it going to be different?

Marc D. Beer

I'm sorry, can 'you ask that question again?

Unknown Analyst

Yes, so my question is, what kind of delay you expect between -- in Europe, between patient getting a prescription and then patient actually starting on therapy? I think it is roughly 3 to 4 months in the U.S., so do you expect that -- a similar difference between patients starting on therapy in Europe as well?

Marc D. Beer

Yes, that is a good question. It is one of -- it's going to depend country by country. And in certain countries, we will need to wait for reimbursement, and we'll do that and we'll work through that process. We're well on our way with the reimbursement dossier that will be filed by country. We feel very good about where we are and the quality of that document. We also feel very good about the country management that we have in Europe. They've been in place for now over a year, and then some of them, 2 years, and they've done the preparatory work and the preparation with the government authorities and the reimbursement authorities. So when we file the dossier, we're expecting success of commercializing the product at or similar -- at the same price or similar price. In each European country, the time from prescription to approval will be different. And it will be relatively the same timing as the U.S. or slower. That's one element that will slow down the revenue growth in Europe. The other thing I would caution you about in Europe is that the European revenue business, in our field, the last 5 years, has slowed. And I think companies have gotten out over their skis in expectations, and we're just guiding you to be cautious about the revenue growth in Europe. It will not be at the pace of the U.S. It's going to be a critically important market to us. We see it being the same size roughly as the U.S. market, but it will build slower than the U.S. growth.

Operator

Our next question comes from Steve Byrne of Bank of America.

Steve Byrne - BofA Merrill Lynch, Research Division

Marc, with respect to the 4,000 to 5,000 patients on therapy that you envision down the road, what portion of that would you estimate could be U.S., Europe and then outside of both of those regions?

Marc D. Beer

So, Steve, I think I -- we're not going to give guidance on what percentage of -- let me first start on -- point out how we manage the globe. We've got a management team that focuses on international, which is defined as everything other than Europe and the U.S., and we've got a U.S.-specific team and a Europe team. All 3 teams are going to deliver meaningful value creation through successful commercialization of lomitapide. So all of them are going to be very meaningful in that 4,000 to 5,000 number. But I think that you'll just see in the 27 EU, you'll see slower growth there than you will in the U.S., and frankly, in some international markets. The economic crisis that's going on, the focus on health care dollars in general, they're going to slow down the expenditures in Europe, I believe, in the next 5 to 10 years. But even with that, because the unmet medical need is so defined in there, we're going to have very meaningful revenue coming out of Europe and in the international markets. So if I go out 5 to 7 years and if I look at our LRP, our long-range plan, all 3 areas are very meaningful. But we're not going to give necessarily a breakdown quantitatively of what percentage the U.S., international and Europe will be.

Steve Byrne - BofA Merrill Lynch, Research Division

And does this CHMP recommendation change your plans for building out the commercial infrastructure in that region?

Marc D. Beer

No. No, it actually confirms our plans. We've got significant firepower on the ground and half for over 1 year in Europe. The EAS meeting is going on right now. We just had a presentation by global thought leaders at the EAS. I understand, from an update I received this morning at 7:30, that it was standing-room only with several hundred people in a standing-room-only conference, and everybody from Europe who's a thought leader was there. We actually had a presentation that was represented by the thought leader in Latin America, Santos [ph], as well as U.S. thought leaders and European thought leaders on the agenda for that presentation, and I heard it was very well received. So I think we're poised with European thought leaders and treaters that clearly communicated to us that they've got a lot of patients that are in harm's way that need an effective therapy, and there's not anything out there that can treat these patients right now. So there's a lot of pent-up excitement and demand. I just caution you that we're not going to see the benefit of that pent-up demand in '13; it becomes meaningful in '14 and '15.

Steve Byrne - BofA Merrill Lynch, Research Division

And just one last one on you, Marc, on Brazil, you mentioned it could be your #3 country down the line, is the per capita prevalence any different there than other regions? And can you just comment on reimbursement rates there?

Marc D. Beer

Yes, so 2 quick questions. We're charging U.S. pricing down there, plus a slight acceleration above U.S. pricing for distribution costs. So we're getting net to -- we should be getting net to the company similar that revenue as we are in the U.S. That's the value per patient. You have to be determined because, as you know, I'd like to see at the end of 100 or so before I tell you whether that's succeeding or not. But that's the intent, that's the plan, and we're in the process of implementing that. The second thing I want to emphasize, I don't know what the prevalence is going to play out in Brazil. It's too early to tell. We have a good amount of momentum of scripts in Brazil, so we can start to get a picture, but it's still too small. I can't get an accurate picture of what the clinical utility is in Brazil, is it going to mimic what is happening in the U.S.? So as the next quarter or 2 goes by and those scripts become a material number, I'll give you more insight on what the clinical utility is there and whether it's similar to the U.S.

Operator

Our next question comes from Nicholas Bishop of Cowen and Company.

Nicholas Bishop - Cowen and Company, LLC, Research Division

The first one is on country-by-country pricing negotiations in Europe. Marc, is that 3,000 number that you put out there for European patients, is that kind of considering the countries only that you have high confidence of getting your target pricing in, or could there be some countries that you have more difficulty getting access to in that number? And then second question on pricing is just, in the countries where you're already selling on in-patient basis, does that make negotiations easier on pricing?

Marc D. Beer

So, Nick, the first part of that question I got which is, is the 3,000 is taking into consideration the countries that in the next 5 years we're probably not going to go into with any significant firepower? It doesn't look at those countries. I try represent the number in an accurate way of what we're going to market to and where we plan on going. So in the countries that we plan on going commercially into, there are some countries in the 27-member countries that they get very challenged in reimbursement, if at all, and the size of those markets are markets that we may, in the future, set up a local distributor until it becomes sizable enough where we'd replace the local distributor with, with one of our own employees. But some of those countries, we don't plan on being in, in a meaningful way in the next 5 years. And those countries are not included in that number. The second part of your question, Nick, can you repeat it?

Nicholas Bishop - Cowen and Company, LLC, Research Division

Yes. I'm just wondering, on the named-patient programs, I guess, you're getting revenue currently from those patients roughly similar to the U.S. as well. I mean, I'm wrong about that. But that does that at all need negotiations with the government for a more broadscale pricing reimbursement in Europe, if there's any influence to that?

Marc D. Beer

To answer your question. So the process on named-patient basis does not indicate whether it will be successful with reimbursement in any country. It is a completely different process, and just because we may or may not successful in any one of the countries that we could do named-patient sales, which we have [indiscernible] are going on as we speak, that doesn't give me an indicator as to whether that will be successful on reimbursement in that country. However, that said, I do believe, given the risk-benefit of this patient population and the 27-to-0 vote right on the heels of a -- of both the tobacco or compounds direction in the same patient category, I think the EU has spoken strongly about the confidence in our product. And that gives us a tremendous amount of confidence going in there and talking to reimbursement authorities. I've been in this business about 20-plus years and I've been attached to about 5 products that have been in the EU, and I have personally not seen a 27-to-0 vote. So I just think that this is a tremendous build of confidence for this organization going in there and going country by country with a very thoughtful reimbursement dossier and making the plea for the right reimbursement. And I believe we'll get it. And we've taken into account -- Mark Fitzpatrick has a very detailed long-range plan that goes country by country. We know the average discount country by country in Europe, and we are pricing accordingly country by country to yield a net price to the company similar to the U.S. It'll be very, very close. It's a very detailed pricing plan on a Pan-European basis. And the management team that is over there that's going to execute on this plan, I can tell you, they're best-in-class. They're similar to the expertise in the U.S. that we have, but very specific to each country. Every country manager over there has got over 10, if not, 20 years experience. And I feel very confident in them that they'll receive the right reimbursement country by country.

Operator

Our next question comes from Joseph Schwartz of Leerink Swann.

Joseph P. Schwartz - Leerink Swann LLC, Research Division

I understand that you don't view the recommendation for genetic confirmation of HoFH as a meaningful constrain. I was wondering if you could talk about some other aspects of the draft SPC in terms of how broadly the condition of HoFH is described relative to the U.S., as far as how easy it is going to be to actually include a patient with high cholesterol in the diagnosis?

Marc D. Beer

Yes, Joe, I think that we're going to learn, market by market, that physicians will establish either a more-aggressive or less-aggressive approach of this disease. That's been my experience with other launches. And just looking at the scripts, even though they're small numbers outside the U.S., we're starting to understand nuances country by country. But in Europe, Pan Europe, across the patient numbers that we're going to market to, I don't know that it's going to be -- that the intent for the physicians to treat will be any different. We'll educate you on that as we see meaningful numbers and prescriptions coming in, and we can look at the clinical utility, and then we can compare to our market research and we can look at it relevant to the U.S. on prevalence. I'll be very transparent about that in the first year or 2 as we see those scripts build. But I don't have anything that tells me proactively that the European treaters are going to be more aggressive or less aggressive. We've got the right sales and marketing plans in place and the right dashboards to measure what's happening early in the launch, and then we'll push, correct, if we need to invest more in the cardiologist versus the lipidologist like we have in the U.S. But right now, there's no indicator that tells me that the Europe market, specifically, is going to be more aggressive or less aggressive in how they treat.

Joseph P. Schwartz - Leerink Swann LLC, Research Division

That's great. Can I just ask one more thing on your go-to-market tactics? Relative to the U.S. where you're able to interact more with a product like this than, say, a mass-market product by going around HIPAA and things like that, how do you see the -- yourselves being able to guide patients to manage diet and liver panel results and things like that in Europe relative to the U.S.? What's your strategy there?

Marc D. Beer

Yes, it's really going to be important that we manage what we're doing in the U.S. through the clinicians' office. And we have plans to do just that in Europe, you may -- by the nature of your question, Joe, it sounds like you're very familiar with the fact that you can't have the same level of direct contact with the patient in Europe than we have in the U.S. We're very cautious with that contact in the U.S., but it can actually exist in the U.S., where it's more challenging than Europe. So the sales and marketing tactics and the plan is to work through the office and to adhere to not contact the patient directly, but to work effectively through the office. So we're going to partner with clinician by clinician, organizations that do support these patients. So we can partner with other organizations that have direct contact with the patients. And we can also partner with the physician office. But we'll wrap high level of service around that, because as you heard me say over and over again, we can get the second bottle to them. We can get the patient, through 60 days, a therapy with a very low dropout rate. It's not material in the U.S. And we succeeded early on with wrapping a lot of service around them on diet that it becomes habitual. And it's amazing, as I talk to these patients and have the opportunity to do it since launch in the U.S., they'll tell you that it's just making them aware. They didn't know how to eat before, and when they walk into a restaurant, they pay attention now. And our dietitian and nutritionist are really good about, on a weekly basis, reminding these patients of certain diets, certain meal plan and menus that they may want to consider. We've actually taught patients to eat outside the home and inside the home. There's a different approach to eating outside the home and staying on this diet versus eating inside the home. So we've been, I think, fairly sophisticated in the U.S. about how to manage success on the product. And I'm proud of the sales and marketing organization for doing that because if the patient stays on this drug, it's amazing how fast we can drop their LDL and really take out the potential risk. And we can only do that if they stay on the drug, so that's been the key driver to not having a dropout problem in the U.S. And we'll do it in a different way in Europe, through partnerships with other organizations and partnering with the office.

Operator

Our next question comes from Kim Lee of Janney Capital.

Kimberly Lee - Janney Montgomery Scott LLC, Research Division

First one is, do you still -- are you still standing by the fact that if you do not get the pricing that you want in European countries, that you will not sell in those countries?

Marc D. Beer

Yes, Kim, that's very important in our strategy on global basis. If you give on price in any area of the world, it's a slippery slope. Precedent [ph] pricing, I think, is appropriate. I'm a complete supporter of precedent pricing. I don't know why we should feel comfortable pricing a product 40% less in a certain market. We should -- so we will hold price. If it takes a little bit longer in certain countries, we will wait it out and we'll hold price on a global basis.

Kimberly Lee - Janney Montgomery Scott LLC, Research Division

Right. And then, can you remind us how many sales people you're going to have in Europe detailing this drug?

Marc D. Beer

We're in the process of looking at that closer, and we haven't made a public on the number of sales reps that we will launch within Europe. We're looking at it country by country. And I can tell you this, that they'll be tranched just like a tranche expenditure here. I held back a significant amount of expenditure on my OpEx and until May 1, based on real data. We pushed, corrected and spent more money, and those programs are just kicking in now. I just can't wait to see the outcome of these programs. We have over 45 speaker programs scheduled in Q2 and Q3 in the U.S. for cardiologists. Our sales force have done a spectacular job of getting those all on the calendar very rapidly. We will have that kind of tranched expenditure in Europe. We'll lay in the infrastructure as we get reimbursement. We've already begun delaying the infrastructure where we can sell immediately upon approval. As a reminder, we don't have formal approval, we have a positive opinion. Upon formal approval, we will invest country by country based on how we see the size of the market and when we can actually sell. So we'll build infrastructure a little bit slower in France because it's going to be 9-plus months in France. We'll build more rapidly in Germany, just to give you an example.

Operator

And with no further questions at this time, I would like to turn the conference back over to Mr. Marc Beer for any closing remarks.

Marc D. Beer

Great. Thanks, operator. Thanks, everybody, for joining us today. This is really an important milestone for patients in Europe. We really are proud of this, and I want to close by thanking Martha Carter and Dr. Mark Sumeray again. They really have done a remarkable job working in partnership with the EMA on this, unbelievable statement of confidence in this compound in Europe, 27 to 0 is a spectacular vote of confidence, so I'm going to thank them for their hard work. They really put a tremendous amount of time on the ground in Europe working very effectively with the agency. And we look forward to updating you on our progress. The next time we would probably be in touch with you will be on our Q2 call. So we look forward to updating you on our Q2 progress of revenue growth on that call. Thanks, everybody.

Operator

Ladies and gentlemen, this does conclude today's conference. You may all disconnect and have a wonderful day.

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