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Aegerion Pharmaceuticals (NASDAQ:AEGR)

Q4 2013 Earnings Call

February 26, 2014 8:30 am ET

Executives

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

Marc D. Beer - Chief Executive Officer and Director

Craig E. Fraser - President of US & International and Global Supply

Mark Sumeray - Chief Medical Officer

Analysts

Salveen J. Richter - Canaccord Genuity, Research Division

Nicholas Bishop - Cowen and Company, LLC, Research Division

Cory William Kasimov - JP Morgan Chase & Co, Research Division

Steve Byrne - BofA Merrill Lynch, Research Division

Eileen Flowers - Jefferies LLC, Research Division

Joseph P. Schwartz - Leerink Swann LLC, Research Division

Operator

Good day, ladies and gentlemen, and welcome to the Aegerion Pharmaceuticals Fourth Quarter and Full Year 2013 Earnings Conference Call. [Operator Instructions] As a reminder, today's conference is being recorded. I would now like to introduce your host for today's conference call, Mr. Mark Fitzpatrick, Chief Financial Officer. You may begin, sir.

Mark J. Fitzpatrick

Good morning, everyone. Thank you for joining us today on our call to review Aegerion's financial results for the fourth quarter and full year of 2013 and to provide a business update on our progress during the last quarter. I would like to introduce the members of Aegerion's management team with me today on the call: Marc Beer, Chief Executive Officer; Martha Carter, Chief Regulatory Officer; Mark Sumeray, Chief Medical Officer; Anne Marie Cook, Senior Vice President and General Counsel; and Craig Fraser, President, U.S. and International Commercial and Global Manufacturing and Supply.

At the conclusion of the prepared remarks, we will open the call up for questions. Please note that we have slides posted in conjunction with the webcast that supplement some of the information we will be discussing during today's call. These slides can be found on the Investor Relations section of our website under the Events and Presentations tab. If you are following along, please turn to Slide 2.

Before we begin, please remember, we will be making certain forward-looking statements on today's call, which may include our statements, forecasts and expectations regarding the commercial potential and growth opportunity for lomitapide; the estimated market size; our forecasted future financial and operating results; the potential timing and outcome of pricing and reimbursement decisions; the timing and ramp of potential revenues in countries outside the U.S., including from named patient sales; the potential for future approvals; the potential impact of competitive products; the potential impact of the government investigation; and our planned commercial, regulatory and clinical activities and anticipated results of such activities, 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 described in our earnings release and in our reports filed with the SEC, including the Risk Factors section of our Form 10-Q filed on November 8, 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. Also, during this call, we will discuss non-GAAP operating expense results and guidance. The difference between GAAP and non-GAAP operating expense results and guidance is addressed in today's earnings release.

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

Marc D. Beer

Thanks, Mark and thanks, everyone, for joining us on Aegerion's fourth quarter and full year 2013 conference call. We're pleased to update you on the continued progress in the fourth quarter and to discuss the full year 2013 results. I'll be providing an update on our business activities and then I'm going to turn it over to Craig Fraser to provide additional color on our U.S. launch experience to date. Then Mark Fitzpatrick will provide analysis and insight into the fourth quarter and full year 2013 financial results and our 2014 revenue and OpEx guidance.

Again, please note that Muffy Carter, and Dr. Mark Sumeray and Anne Marie Cook are also here during the Q&A portion, if you'd like to address any questions to them.

Now, let me turn to Slide 3. 2013 was an important year for Aegerion. We've made significant progress in our mission to deliver lomitapide HoFH patients globally. There were many highlights during the year. We launched JUXTAPID in the U.S., we had a strong year in the launch, we obtained marketing authorization for lomitapide under the brand name LOJUXTA in the EU, we began making lomitapide available on a named patient sales basis in several countries outside the U.S. and we filed for approval in a number of key countries. Our success in executing on these activities was reflected in our financial results as well. We achieved fourth quarter and full year 2013 lomitapide net product sales of $24.5 million and $48.5 million, respectively.

We made progress in 2013 in laying the tracks for the successful U.S. and x U.S. commercialization of lomitapide and we believe we are well positioned to execute across all areas of our business in 2014.

With just 1 year of commercial experience now in hand, we've experienced confidence in our estimate of the total addressable adult HoFH market and continued to foresee long-term potential for 4,000 to 5,000 patients on therapy globally and $1 billion in annual net product sales in the future, assuming pricing and market acceptance consistent with our expectations.

We continue to believe HoFH is an underdiagnosed disease and that a significant number of HoFH patients are in need of therapy. This belief is also shared by more experts in the medical community and in peer-reviewed publications. Having now completed the first year of launch, we believe we have only just begun to penetrate the total addressable adult HoFH patient population.

Additionally, our thinking about the potential future market now reflects the results of a recent primary and secondary market research study in the pediatric population, which suggests that there may be between 1,000 and 1,500 pediatric HoFH patients in the U.S. As you know, the safety and efficacy of lomitapide have not been established in pediatric population and we cannot and do not promote or market JUXTAPID to the pediatric patient population. We look forward to commencing a planned clinical trial of lomitapide in the pediatric HoFH population in pursuit of a possible future label extension.

In the meantime, we are currently focused on identifying physicians who have potential adult HoFH patients, bringing them on to therapy and keeping those patients on therapy.

There is a substantial need for raising HoFH disease awareness and education. We believe an important factor that will support our ability to achieve these objectives is to enhance physician and patient education and support programs, we had further established at the outset of 2014.

The expansion of our customer-facing organization is largely now complete. In the second half of last year, we made the decision to increase the scale of our business for the start of 2014. This increased investment includes adding more lipid specialty managers, which we call our sales reps, to extend reach to more physicians who may be treating HoFH patients in more territories.

In addition, it also includes hiring additional COMPASS care manager responsible for patient support activities. We also added a new level of patient focus with nurse educators in the field, who will assist with patient and physician education about HoFH and JUXTAPID, particularly during the important onboarding phase and who will support HoFH patients in successfully managing their transition to lomitapide therapy. We expect these patient-facing initiatives to have a meaningful long-term impact on our business.

Now I'd ask you to turn to Slide 4. As you know, our goal has been to move away from providing detailed lomitapide prescriptions and patient metrics and shift focus to our top line revenue guidance, with revenue results serving as the best barometer of our business. We do understand though, however, that the investor desire to have more visibility into the business. So I do not plan to go back necessarily to the detailed metrics that we laid out in the first half of '13, nor do I plan on revisiting metrics for each of our quarterly calls this year. However, I'd like to summarize a few key points from 2013 so that you can come into 2014 with a more accurate view of our business.

We went into the launch at the beginning of 2013, assuming an average compliance rate of 75% and we believe we executed to achieve a compliance -- we executed well because we achieved a compliance range between 80% and 90% throughout the year in 2013.

At the outset of the launch, we assumed an average dropout rate of 15% and we were successful in maintaining a dropout rate at the end of 2013 that was consistent with this estimate that we began the year with.

We recognized that we will always have to maintain a strong focus on dropout and we plan to do additional work in that area. In addition, a dynamic that we began to understand in a more meaningful way in the second half of the year was that we had patient-elected nonstarts in circumstances. These are patients for whom a prescription is written, possibly even with reimbursement approval achieved, but whom chose not to start therapy. These patients never received a shipment. Obviously, we never received revenue and thus are not factored into a dropout rate. These are patients to whom a physician has made a prescribing decision and we believe many of them may in the future be willing to consider JUXTAPID therapy. Craig will further address patient nonstarts and steps we're taking to address this dynamic during his prepared remarks.

When we ended 2013, we ended with over 430 net revenue U.S. patients on therapy, and 37 x U.S. net revenue patients on therapy. As to the components of net product sales, 87% of our net product sales in 2013 were from our United States business. 13% came from x U.S. countries, primarily driven by named patient sales in Brazil. We are gaining a better understanding for the unevenness of international orders. In the majority of cases, products shipped to fill named patient sale orders were from multiple months of therapy.

For example, in Brazil, when a patient has successfully obtained access to treatment through the judicial process, we typically receive an order for 6 for 12 months of therapy for that patient. Also contributing to the unevenness of named patient sales are economic pressures, government actions and political unrest in international markets and our inability to promote lomitapide in countries where we do not have approval. As a result of these factors, we expect the number of patients on therapy in named patient sales countries and revenues from these named patient sales to fluctuate quarter-to-quarter.

We continue to acquire better understanding of the impact of seasonality on our business, as well as the impact of the variability of other dynamics of patient onboarding to JUXTAPID treatment, which we believe when done well, leads to a more steady flow of new patient starts. We have trained our best practices in the field from onboarding to optimize these key growth metrics.

We believe we've executed well in identifying the key business trends. We have acted swiftly to take action on these trends to continually improve the performance of our business. We continue to feel strongly about the long-term potential opportunity for lomitapide, as well as the learnings that will help us forecast the business with increased precision.

Our 2014 guidance is based on a forecast model that is continued to refined to reflect a deep understanding of the business and which captures these variables that we've discussed. Now let me turn it over to Craig and have him discuss with further color the U.S. commercial progress. Craig?

Craig E. Fraser

Thanks, Mark. Turning to Slide 5. We continue to focus on solid execution in the U.S. commercial launch of JUXTAPID. With recent initiatives for extended reach in place, I'm looking forward to our ability to build meaningfully off of our positive experience in 2013.

Physician interest in JUXTAPID for their HoFH patients remains high. This is true of both lipidologists and the cardiologists that we've reached. Doctors are generally pleased with the product's performance and the potential when added to other lipid-lowering drugs to reduce LDL to levels they typically have not been able to previously achieve in their HoFH patients. And they understand the risk profile, including the Boxed Warning for JUXTAPID citing the risk of hepatotoxicity. Based upon the clinical performance of the product, physicians commonly become repeat writers for additional new HoFH patients.

It also remains clear to us that there are more HoFH patients than historically reported and that many of these HoFH patients are undiagnosed across the community. Leveraging our continued optimization and substantial commercial expansion, we believe there is growth potential by reaching further into the lipidologist and broader cardiology community segments where physicians may have HoFH patients. The extended team was deployed last month and its extended reach should begin to continue in the months to come. We are addressing both these opportunities, as well as barriers to entry associated with creating a treatment paradigm in a new market.

As Marc referenced, one notable behavioral dynamic that emerged as a factor in our business is that of patient elected nonstarts. While we've been clear in the past that not every prescription leads to a patient going on to therapy, this dynamic is more meaningful than we had previously anticipated, and it became apparent to us that patient education and comprehensive health care provider engagement are critical to successful patient onboarding. Some form of this dynamic is present in nearly every disease area. For HoFH patients, a reluctance to start JUXTAPID can often stem from a lack of understanding about the nature and severity of their disease.

We believe we have a solid understanding of best practices for increasing patient commitment and effecting higher prescription conversion rates. We have begun to implement programs designed around these best practices and to make the investments we believe are necessary to apply these learnings to our everyday activities.

These programs and investments include the addition of field-based Nurse Educators, peer-to-peer patient ambassadors and an even greater focus on patient onboarding and education. We believe, based on the work that we've done, that the rate of patient-elected nonstarts should decline with the full implementation of these initiatives. We also believe that many of these non-starts may consider JUXTAPID in the future and we plan to maintain ongoing interaction with physicians and patients to support potential onboarding of previously scripted patients in the future.

Increasing patient education and commitment is necessary, and we expect it to have a positive effect on adherence as well. Mirroring what we saw in our Phase III study, we see drop-offs happen most frequently during the first 1 to 2 months of treatment. When we maintain patients on therapy during this critical time, including through dietary counseling and support, patients generally remain on therapy. In addition to our field-based Nurse Educators, we have created a patient engagement team, increased the size of our COMPASS team for more frequent patient contact and added to our team of dietitians with the goal of ensuring a solid start to JUXTAPID therapy with high patient support and contact to optimize therapeutic adherence. We are careful, of course, not to minimize the risk of therapy or to interfere with the decisions of patients and their doctors to cease therapy in view of safety issues or risks.

Reimbursement continues to be very encouraging. The majority of prescriptions approved by payers continue to receive first-cycle approval. We're pleased with broad success and access. We continue to work to improve coverage policies in cases there have been restrictive conditions and we continue to feel confident in the support our team is providing physicians and patients to assist them in their efforts to obtain reimbursement for therapy.

We are applying our learnings from 2013. I believe coming into 2014, we are optimized with our teams and processes and well prepared to build upon 2013 and to achieve our revenue targets.

With that I'll turn back to Marc for an update on our EMEA and international businesses. Marc?

Marc D. Beer

Thanks, Craig. Moving to Slide 6. Our efforts in the EU to bring LOJUXTA to market are progressing. We have submitted global value dossiers to the necessary authorities in key markets according to our prioritized plan country by country, which are required to set in motion the reimbursement discussions. In addition, educational materials required by the risk management plan or called -- it's called the RMP, are now approved in certain countries. While we are able to sell in Germany and the U.K., we continue to expect very little uptick of LOJUXTA until each reimbursement approval decision is made country by country. We anticipate pricing and reimbursement decisions in some EU countries beginning later in 2014.

As we have said, while Europe is an important market and we believe in the long-term potential of our business there, it is a challenging reimbursement environment, and our strategy is to keep our operating expenses low. We have been conservative in our investments in this region, and we'll continue to be, at least until we begin securing reimbursement country by country.

We have country managers that are in place in the key markets who are identifying physicians who potentially treat HoFH patients, working with reimbursement authorities and establishing relationship with key opinion leaders.

If we achieve reimbursement approval at an acceptable level, we plan to execute a measured launch in Europe. We believe it's a prudent approach to this market in a stepwise fashion. We continue to believe that the majority of our revenue in 2014 will come from the U.S. and to a lesser extent, from the non-European international markets, primarily Brazil. We're executing on our plans for global expansion with lomitapide. We are pleased to announce approval of marketing authorization applications in Mexico and Canada. Both are well-characterized markets and we believe they will contribute to our long-term growth.

We also have regulatory filings submitted in Brazil, Taiwan, Columbia, Argentina and Israel. The regulatory team is actively pursuing our goal to bring lomitapide to HoFH patients in need in key markets around the world and continue to make substantial progress on this front.

Now turning to Slide 7, an update on our clinical progress. We continue to expect that we will initiate a therapeutic bridging study of lomitapide in Japanese HoFH patients in the first quarter. This study is intended to generate data to support a planned filing for marketing authorization in Japan. Assuming we are able to file for approval, following the completion of the 26-week efficacy phase, our goal is to submit our Japanese NDA as early as the end of first half of 2015. Regarding our pediatric initiative, we are currently working with the FDA and the pediatric committee of the EMA, on a unified protocol for a clinical trial of lomitapide in the treatment of pediatric HoFH patients. Assuming we are able to gain alignment with the agencies and receive a written request, our goal is to initiate this study late in 2014.

Finally, as part of our postmarketing commitment to both the FDA and the EMA, we expect to initiate an observational cohort study in the first quarter to generate additional data on the long-term safety profile of lomitapide, the patterns of use and the compliance of the long-term effectiveness of lomitapide in controlling LDL-C levels. We look forward to the opportunity to publish data from this registry study in the coming years and believe it will be important insight into the use of lomitapide in safety and will ultimately foster a better understanding of HoFH.

Now I'd like to turn the call over to Mark Fitzpatrick to review our financials. Mark?

Mark J. Fitzpatrick

Thanks, Marc. Turning to a review of our financials on Slide 8. Net product sales of JUXTAPID were $24.5 million in the fourth quarter compared to $16.3 million in the third quarter of 2013. This brings total JUXTAPID net product sales in the first year of commercial availability to $48.5 million. 87% of net product sales this year came from prescriptions written for U.S. patients and 13% were from prescriptions written for x U.S. patients. As a reminder, in the majority of cases, products shipped to fulfill named patient orders outside the U.S. were for multiple months of therapy. Total operating expenses were $35.7 million for the fourth quarter ended December 31, 2013, including $27.2 million for SG&A and $8.5 million for R&D.

This compares with operating expenses of $21.6 million, including $13.1 million in SG&A and $8.6 million for research and development in the fourth quarter of 2012.

Operating expenses for the fourth quarter of 2013 contain $9.9 million of stock compensation expense. We had a GAAP net loss of $13.9 million or $0.47 per share for the fourth quarter of 2013 compared with the GAAP net loss of $21.8 million or $0.86 per share for the fourth quarter of 2012.

Non-GAAP net loss was $4 million or $0.14 per share for the fourth quarter of 2013 compared with the non-GAAP net loss of $18 million or $0.71 per share for the fourth quarter of 2012.

Operating expenses were $105.9 million for the year ended December 31, 2013, including $76.1 million for SG&A and $29.8 million for R&D. This compares with operating expenses of $60.6 million, including $34.1 million for SG&A, $25.2 million for research and development and $1.4 million for restructuring costs for the year ended December 31, 2012.

Operating expenses for the full year of 2013 contained $27.7 million of stock compensation expense.

We had a GAAP net loss for the year ended December 31, 2013, of $63.4 million or $2.19 per share versus a GAAP net loss of $62.3 million or $2.64 per share for the year ended December 31, 2012.

Non-GAAP net loss for the year ended December 31, 2013, was $35.7 million or $1.24 per share versus a non-GAAP net loss of $50.5 million or $2.14 per share in 2012. The increases in selling, general and administrative expenses in the fourth quarter and full year of 2013 over the comparable periods in 2012 were primarily related to the increased headcount in both selling and administrative functions, as well as outside services required to support the commercial launch of JUXTAPID in the U.S. and our global expansion.

The increase in research and development expenses for the full year of 2013 over the comparable period in 2012 was primarily related to increased employee costs related to the company's medical affairs and international regulatory activities, as well as increased clinical development expenses in connection with work to support our clinical development of JUXTAPID in Japanese HoFH patients, partially offset by a decrease in manufacturing costs that were expensed in 2012 prior to FDA approval and are now being capitalized as inventory.

Turning to the balance sheet. We ended the year with $126.2 million in cash, cash equivalents and marketable securities as compared to $82.2 million as of December 31, 2012 and $126.2 million as of September 30, 2013.

Our cash used in operating activities was approximately $610,000 and $38.4 million for the fourth quarter and full year of 2013, respectively. We continue to believe that we have sufficient cash to achieve cash flow positive operations, which we expect to occur in the second half of this year.

As we noted in January, we have forecasted global lomitapide net product sales in 2014 of between $190 million and $210 million. We expect total operating expenses excluding stock-based compensation expense, to be between $145 million and $155 million in 2014. Including stock-based compensation expense, we expect total operating expenses to be between $185 million and $195 million in 2014. Based upon our current forecasts, we believe the upfront investments we've made have optimized our U.S. commercial operations to a scale that should support our U.S. growth for the next 3 years.

We expect to see substantial leverage from these investments beginning in 2015.

Now I'd like to turn it back over to Marc Beer.

Marc D. Beer

Thanks, Mark. In closing, we're proud of our accomplishments in 2013 to support HoFH patients and to grow our business. Looking ahead, we continue to be keenly focused on planning and execution to support meaningful growth. The fundamentals of our business are strong and we've entered into 2014 with actionable insights from our first year of launch.

We are a nimble organization and we believe we're very good at managing risk and capitalizing on opportunities quickly. We're also intently focused on transparency and fostering a continued trust in this management team to achieve the goals that were set forth to accomplish.

So with that, let me bring it to close and turn it back over to the operator to open it up for questions. Operator?

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from Robyn Karnauskas with Deutsche Bank.

Unknown Analyst

This is for Mohit [ph] for Robyn. My question relates to seasonality. Do you expect first quarter to be impacted due to some seasonal trends you saw in previous quarters due to holiday seasonal? And then how do you plan to communicate these trends? Would you provide it true demand versus process seasonality? And then I have a follow-up.

Marc D. Beer

Mohit [ph], I'm sorry, could you ask specifically the question you're asking me to answer around seasonality. If you could just be little more specific what you're asking me to comment on seasonality.

Unknown Analyst

Yes, so I mean, I'll explain. So it's like do you expect first quarter to be impacted due to seasonality? You saw in fourth quarter, because of holiday season because there was a -- there could be a lower demand in fourth quarter it could impact first quarter. And then do you expect to communicate the true demand in first quarter versus the impact due to seasonality in first quarter?

Marc D. Beer

I understand, thank you for repeating it. As stated before, I don't want to get into the practice of commenting on quarters other than seasonality, if we see it coming. So we did comment about the fourth quarter seasonality because at the end of the third quarter, we could see the patients that were scheduled for onboarding. Because as a reminder to all, we go into that practice on the day of onboarding to offer nutritional counseling and the services of just making sure that patient education is conducted by the caregiver. And so we see an outlook of that. And when we saw seasonality, we gave guidance that took into account seasonality. So I do believe that we'll see that on an ongoing basis, we'll understand it better and better as years go on. But if you think about the launch timing, we launched in the first quarter in January, so that was our first opportunity to see seasonality. I have seen seasonality in the rare disease products that I've launched and that I've commercialized, and in my past, with the lysosomal storage disorder products, I saw it around vacations, when patients took a holiday and they did not want to onboard to a new therapy. I have to remind everybody that this is a severe disease and the patient is going through a lot and we ask them to go through a little bit more, which is to go through some nutritional counseling. So patients consciously made the decision in fourth quarter that they wanted to postpone that past Thanksgiving or Christmas. But in the rare disease business, I have never seen a bolus. Even in my past, with lysosomal storage disorder products, if somebody delayed therapy because of the operational focus of a sales rep going into practice, they were focused on onboarding that patient and not focused on working on new patients. So typically, in this business on an ongoing business in years to come, I'm not going to expect boluses. But seasonality, I do believe, will be in the fourth quarter, based around the holidays. Did you have a follow-on question, Mohit [ph].

Unknown Analyst

Yes. So this was helpful. And then I have one follow-on on Brazil. So could you provide more color on like what percentage of sales in fourth quarter came from Brazil? And are you going to communicate the impact of Brazil on named patient program quarter-over-quarter as well?

Marc D. Beer

Yes. So we wanted to give more clarity coming out of the end of year because of the unevenness and the chunkiness of international sales that we saw primarily later in the year, because one of the things we previously communicated and I'll emphasize again, the process of onboarding a patient in international markets takes longer because we have this judicial process. So it's not as efficient as in the U.S. where we get a prescription, we work through the pre-auth and then we ship the product. In Brazil, where the majority of our x U.S. sales come from, on a named-patient basis, 2 things taken into consideration. One, we can't and do not promote the product in Brazil. It is only disease awareness down there. And two, once the prescription is written, it's up to the patient association to help these patients through the process. And it's a judicial process that's tough to forecast the timing of. Once we do get the judicial process completed and accepted, we ship 6 to 12 months of therapy. So you can imagine it's difficult to forecast and it can hit quarter-to-quarter in different ways. So we're just trying to communicate the chunkiness of this, is -- will create and has created unevenness in our quarterly revenue numbers. That will be the case, I believe, going forward. I look forward to the business becoming large enough on a global basis where that evens out and it doesn't make it as difficult to forecast. So that will only, I think, be corrected, not by the process being more efficient in international markets because we can't count on that. It's probably going to remain the same. But hopefully, the size of our business will make that more -- less of an impact on a quarter-to-quarter basis.

Operator

Our next question comes from Salveen Richter with Canaccord.

Salveen J. Richter - Canaccord Genuity, Research Division

Just one, just around the point of bolus, I guess. In 4Q, there was maybe some question about whether patients due to holiday periods were delaying coming on drug to post that period. And I'm just wondering if we should expect a lot of them then to come on in 1Q or whether that would be spread out more over the year, just how to think about that. And I have a follow-up.

Marc D. Beer

Okay. We'll go to follow-up, pretty quickly, Salvi, because that's a same question asked differently. I want to stay away from quarterly comments only because it's just not the right thing. I want to emphasize this, though. Coming out of '13 and the understanding of this business and the, I would say, diligent process that Craig and Mark Fitzpatrick have done to just understand the variables of our model. It makes me feel very comfortable coming into '14 that our guidance for the year of $190 million to $210 million, I feel good about. I also feel good about the cash flow that the company is going to achieve in the back half of the year. So I had previously stated that in my experience in rare diseases, you don't see a bolus and it's because of the operational nature of the business. You have your sales reps either onboarding patients or they're focused on new patients. And the onboarding effort is time-consuming. So I don't typically see bolus in a steady-growth rare disease business. But the one thing I do want to comment coming out of '13, the understanding of this business and the focus on dashboards and really what's happening at the physician level in the number of patients that we see out there in the marketplace and the understanding of the effect in the eyes of the physician, what gets communicated back to us from the physician of the impact of the product. Those fundamentals, when you have a product that in the eyes of the physicians is performing, and you have, when onboarding is done effectively, patients staying on therapy, which I emphasized in our dropout rate, you have a great fundamental business. Now it's a matter of just understanding those metrics and optimizing them and that's what Craig and Mark Fitzpatrick have worked hard in understanding those metrics and optimizing them. Our expansion in the back half of the year was because of the size of this market that we see and the number of physicians that we need to call on to get to that optimized peak sales and we feel good about that. I'll emphasize one thing that Craig emphasized that we expand the sales force at a level that will carry us for a couple of years now. We really went to an optimized sales force because of the potential of patients that we see out there and it will carry us for a couple of years. So once we go through cash flow positivity, it is my goal and my focus to create a lot of leverage in the P&L, which I believe this product and this organization has the ability to do. And your follow-up?

Salveen J. Richter - Canaccord Genuity, Research Division

Sure. Just looking at the patient numbers you provided, it looks like roughly 50 patients a month over the last 5 months. Just wondering how consistent that was, or how much seasonality affected that when you look at that trend over the past 5 months?

Marc D. Beer

Yes. So seasonality again, it does impact the business. But it's something that I think we'll learn how to manage more effectively. But I do think seasonality does impact the business. Our focus, Salveen -- I want to emphasize this, our focus has really been how do we more effectively onboard patients? We have our best practices' ability of looking at the top territories. And I don't think the top territories in any company that I'm running are the ones who onboard the most patients. It's a combination of onboarding the patients and then making sure that we manage with the right support mechanisms, the best chance for positive care. So Craig has studied with the top sales force -- excuse me, the top reps of both who are effectively bringing patients on and then how does the onboarding happen. And I've commented in the past some of the ahas for onboarding and we at the sales meeting in January, the focus that Craig and team had, was to make sure that best practices were trained across the organization. And I think significant improvement, I think significant improvement in how we onboard is going to be achieved in 2014. That's the metric I would steer you to. If you're really saying, what is functionally being done to improve and optimize the metrics, it's how we onboard patients.

Operator

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

Nicholas Bishop - Cowen and Company, LLC, Research Division

I have 2 related questions, so I'll ask the first one and then follow up with second. The first one is around the mention that you made kind of the surprise in patient-elected nonstarts. Just kind of curious if you can comment on kind of the fraction of the market you think that you have touched this point, in the terms of getting a physician to prescribe for them and then either starting the drug or not.

Marc D. Beer

Nick, could you repeat the end of that? Your phone or ours went out. The specific question you're asking regarding [indiscernible]

Nicholas Bishop - Cowen and Company, LLC, Research Division

Just kind of trying to understand sort of the fraction of the TAM here that has sort of had an attempted to start, whether that was ultimately successful or not, for whatever reason.

Marc D. Beer

Okay, all right. I understand. That's a good question. I did not address that in the prepared remarks. So let me comment with 2 responses. Then I'm going to ask Craig to give some more color, because he's obviously closer to it, Nick. The first thing I want to emphasize is that from my experience in the lysosomal storage disorder products, patient nonstarts were a reality there as well and different things motivated a patient nonstart. And the most frustrating ones to us, obviously, is when a physician makes a risk-benefit decision and diagnoses the patient as an HoFH patient and has the desire of putting them on product. And then we go through the pre-auth and we get the product pre-auth approved, which again, can take -- sometimes can happen very fast and sometimes happens longer. And then the patient at that point in time goes into denial and doesn't start. From my experience in the past, we had the exact same experience on the launch of [indiscernible] and in that situation, when a patient became more symptomatic, got [indiscernible] of bone disease, so they rolled over in bed and broke a hip or something, that motivated the patient to go on therapy. So we're studying this more and more. We look at the patients that have had a prescription and we've achieved authorization for insurance. We look at that as a patient pool, HoFH patient pool that we need to study more and educate the patient and the physician through the physician better. It's a great pool of future patients, if we effectively educate the patient through the physician. And that's where the focus has been. So I think there's a lot of potential in those numbers. I can tell you this, still the majority of the patients, we haven't scraped the surface of this market yet because we just didn't have the reach to do it. We launched with 25 reps, we significantly increased the sales force in the back half of the year. We did that because we didn't have the reach to get to all the cardiologists that we need to get it to. So I do believe that the majority of this market's out in front of us and we're now sized appropriately to get to those patients. And I have a lot of confidence in Craig optimizing this nonstart metric. That's clearly more frustrating to me than the patients that we haven't educated yet. Because either patients [indiscernible] physicians made their decisions. So it's frustrating to us but we'll optimize that metric. Craig, can you comment about specific things that we're doing to optimize that?

Craig E. Fraser

Sure. We have an understanding as we look at this, that patients do have a varied understanding about the nature and the severity of their disease in relationship to the potential benefits and risks associated with going on to therapy. And this is something that I've experienced and we've seen in most disease areas and when we look in general terms across other rare disease companies and look at their conversion rates, you see this probably embedded in it as well. For us, we specifically looked at our patients. We understand how the patients do have varied understandings of this. We've seen where it works really well with regard to education. And as Mark mentioned it is truly a partnership of making sure that the healthcare provider has all the education and support and tools that they need to be able to pause and successfully educate their patients about their disease and the therapies and so forth. And we've put together a whole engagement team to be part of that effort, because we see that, when that's in place, that's what works. Now Mark mentioned earlier as well, we don't plan to provide a specific metric, because you're asking about a metric question, on this. But I wanted you to know that we've made a lot of effort and a lot of investment to -- with the idea of optimizing in this area. I also mentioned in my part of the script, a side benefit, an important benefit is when you do this the right way, right upfront, you not only have positive effect on conversion rates in patients going onto drug, but you've educated them in a manner that sets up better support of optimizing adherence once they are on therapy, both compliance and drop. So we see that as a key area and a key focus for us that we've done, heading into this year.

Nicholas Bishop - Cowen and Company, LLC, Research Division

Okay. Thanks, that's helpful. And just the follow-up was, Marc, in your prepared remarks, you indicated that you're seeing a discontinuation rate consistent with your initial expectation of about 15%, which is a little higher than you've indicated in the past. Is that accurate perception? Are you seeing an uptick? And I guess once patients are on the drug, can you comment at all on what the discontinuation rate is after the first couple of months?

Marc D. Beer

Yes. So, Nick, 2 comments. One, if we lose a patient to dropout, it is typically in the first order and then it trails off a little bit to the second order and then it's -- we're really good about keeping patients on therapy. It really ties to our effective onboarding successfully. And the number that I gave midyear, I think, was 10% or less at that time on smaller numbers. I think what you can trust now is a bigger add [ph]. So I'm clearly communicating to you that rate [ph], 15% and that was maintained throughout the year, but that's really a metric of, at the end of the year, how many patients took a capsule and how many patients do we still have on therapy? And that's a straight calculation. We just want to be as accurate as we can. And I want to see that improve, but I think I trust that metric right now because it's off a bigger end than midyear. So we're just trying to get clarity. If there's one thing that I've picked up at the JPMorgan conference is that people really want to have a little bit more clarity around the business. I always say that investors want to trust management, and then they want clarity around your business. I hope everybody trusts this management team and the objective of giving you some more specific and clarity around the business was to have you understand the business and the dynamics of the business. So I'm proud of how Craig and his team are managing compliance with 80% to 90% on a small molecule it's unprecedented. We take that very seriously. Compliance on an ongoing basis is a significant driver of our future growth and revenue. And I'm also proud of how he's managing dropout. And we'll get our arms around this nonpatient start. We're studying it carefully. We look at every one of those patients as a potential future patient and we're working it hard. But the dropout rate from midyear to now, I would just say it's a smaller number at midyear. So less than 10% midyear, it's 15% over the course of the year. I trust the 15% more than the 10% because it's just off a bigger number. And I just want everybody to be comfortable how we're calculating that. Does it make sense, Nick?

Nicholas Bishop - Cowen and Company, LLC, Research Division

It does.

Operator

Our next question comes from Cory Kasimov with JP Morgan.

Cory William Kasimov - JP Morgan Chase & Co, Research Division

My first question is on this patient-elected nonstart issue. Is this something you saw throughout the year, or is this dynamic relatively new and really just emerged around the holidays? And then I have a follow-up.

Marc D. Beer

Yes. Let me comment on it, and then I'll have Craig comment on it, Cory. Obviously you're in first half of the year dealing again with smaller numbers and you can't decipher whether a patient nonstart is just a fear of the diet and you're going to eventually get them on therapy. So as the numbers got larger, as the script numbers got larger in the back half of the year and we started to study those more carefully, we really deciphered out this person doesn't today have the intent to go on therapy. And this person is, and they've got an appointment scheduled. So this definitely emerged and we understood it much better in the back half of the year. And it was never something that we looked at as a dropout because the patient wasn't shipped and we didn't count the revenue. So it's not a dropout component. It's just a patient that we never realized the revenue and is pushing the shipment off and pushing the shipment off. So we got a better understanding when we went and spoke to these patients and got more clarity but it was definitely a back half of the year kind of emerging metric. Craig you want to add on it for a little bit?

Cory William Kasimov - JP Morgan Chase & Co, Research Division

But back half of the year is different than holiday specifically, right?

Marc D. Beer

Yes. Let me be clear about this. This is not the holiday seasonality. That's a patient that -- I want to be clear about that, Cory. These are patients that have turned down therapy, of ever going on it. Seasonality is where they communicated to us clearly, I'm not onboarding on the 27th of December. I'm pushing it because of the holidays. So patients can be clear about the seasonality versus the elected nonstart. So just want to be very clear, those are 2 separate issues. There's seasonality in this business and then there's nonstart elected patients. We're working hard to study the nonstart elected patients. Craig, do you want to comment any further or did that cover it?

Craig E. Fraser

No, I think that covered it.

Marc D. Beer

Cory, do you have a follow-on?

Cory William Kasimov - JP Morgan Chase & Co, Research Division

Yes, my follow-up is on the seasonality issue, I'm just trying to understand that a little bit better. But for your patients who are already on drug heading into the holidays, did you have a meaningful number who, temporarily, perhaps, stopped using JUXTAPID to get some freedom from the diet. And when a patient does stop, how long of a break could one take without having to re-titrate when starting back up?

Marc D. Beer

Let me turn that over to Craig. He's closer to that, Cory. Craig?

Craig E. Fraser

Yes, Cory, we didn't see that in a very meaningful way. I think what I've experienced with the number of therapeutics that have implications regarding diet and people head into Thanksgivings and Christmas and so forth, that certainly comes up with the idea of people wanting to take a drug holiday for a few days. We headed into the holidays with a lot of support and a lot of communication around here is how to do your holiday meal with the low fat and the importance of staying on therapy. At the same time this is not a product that you can just stop taking the pill one day and the next day eat whatever you want. There still is the half-life issue and we make sure that physicians and patients understand, you don't just turn off and turn on this product that quickly for the type of a drug holiday. We think due to that type of education and communication, what you're asking about was minimal. I'm sure it happened in some places, but we didn't see it in a very meaningful way that we noticed.

Marc D. Beer

And specifically, Cory, Craig's talking about patients that are already on drug that we don't see as the seasonality effect. So yes, okay, I just want to make sure that, that was clear to everybody.

Operator

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

Steve Byrne - BofA Merrill Lynch, Research Division

Would it be reasonable to interpret your discontinuation data to suggest that in the first 6 months on therapy perhaps the discontinuation rate is near 10%? And then in that second 6-month period, it could be in the 5% range so that your denominator is all patients that go on drug is that correct? So over time you would expect that to creep up?

Marc D. Beer

Can you ask that question again? I'm not following your math.

Steve Byrne - BofA Merrill Lynch, Research Division

Is your discontinuation rate metric time-specific, or is it just the aggregate of all patients that have started on drug? And if it's the latter, then wouldn't it be reasonable to assume that initially, that discontinuation rate would be x and then over time, it would gradually creep up because you're just including patients that are just on drug longer.

Marc D. Beer

Let me turn the question over to Craig and Fitz and see if they understood your question a little bit better because I want to answer it accurately. I'm not following your question, Steve, probably as closely as I need -- Craig, go ahead and answer, if you think you understand the question.

Craig E. Fraser

Yes, the discontinuation rate is calculated across all of the patients that we sent a shipment to, at least one shipment to. And those that at the point in time that you're looking at, in this case we're talking about the entire year, that are no longer active on the therapy. So they received at least one shipment and they dropped. They're no longer active on the therapy and it's a straight calculation of the rate. And what we're talking about was the rate for the entire year of 2013. You could say exit would be saying the same thing, because it's looking all the way across 2013. And if you're talking about the first month or 2, back to the time factor, if you're talking about the first month or 2 of launch, yes, you're right, you would not have had time to fully bake, if you will, and give the opportunity for people to -- for you to run the course of the drop-off timing. As Mark mentioned, the majority certainly do come off early when they do drop, particularly between shipment 1 and shipment 2 and then some more between shipment 2 and shipment 3, and then it becomes a much lower factor as time goes on. So you do have a bit of a factor of time. Most of that is frontloaded, though, when you are getting the drop-offs. Marc, if you have any...

Marc D. Beer

That's my answer, my complete answer.

Steve Byrne - BofA Merrill Lynch, Research Division

Yes, that's helpful. Would it also be reasonable to interpret your x U.S.-U.S. revenue split versus patient split data that you provided to suggest that you had perhaps a few million dollars of inventory build x U.S. at the end of the year, that you're heading into the year with maybe having pulled some revenue from subsequent months?

Marc D. Beer

No, I wouldn't take it that way, Steve. I would just take it that -- when I say unevenness and chunkiness, it is just that. If I go back to the back half of last year, there was chunkiness in the back half, not the first half because it takes a number of months longer than the U.S. to get these patients on therapy. But 37 patients, if you're shipping 6 to 12 months is meaningful and 13% of revenue. We really want to give you clarity about the x U.S. and U.S. and the chunkiness of international so you're not caught off guard on a quarterly basis of the impact that this can have. So we look at it as chunkiness. It's not like you got a backlog. Obviously, we have clarity about what's happening in international markets from a prescription standpoint and so forth and we're excited about growing the company globally country by country. But it's just as those orders come in to some of these meaningful countries on a named-patient basis, they're going to be chunky, and it makes it a little difficult for us to look at the business quarterly with you. On an annual basis, we see -- don't see the same risk. On an annual basis, it's easier to forecast international. Obviously, in our LRP, our long range plan, in our model that leads to the $190 million to $210 million, there's a component of international that we think we can accurately forecast. But on a quarterly basis, we're just messaging that it's chunky, that's all.

Steve Byrne - BofA Merrill Lynch, Research Division

And would you say that, that proportion of that $190 million to $210 million that's x U.S. is roughly comparable to what you realized in 2013?

Marc D. Beer

No. We don't want to give the guidance on a geographical basis, Steve. I'd like to avoid that. We just wanted to clarify '13. And I think the metrics, once investors go back and they look at our business, they're going to have better clarity and they're going to look at it and go, okay, now we understand the growth of this business. The other thing I would mention that Craig and I tried to mention is 2 things. One, we see the patients out there, this market is underdiagnosed and there's an educational awareness that is needed and we think we're sized right to do that over the next couple of years. So the patient potential is out there. The other thing I'll emphasize is that I see 4,000 to 5,000 patients on a global basis being on this product and I see us exceeding the $1 billion revenue annually. That's all built in. When I say that, it's not me looking at we're going to pick up 39% of the market in Italy. We're going to pick up x percent of the market in Germany. It's a country-by-country patient build market analysis that fits runs. So I would just take it to an emphasis that we really feel like the long-term potential and the potential is, we feel stronger. Craig and I feel stronger today about the fact that we're going to get the 4 million to 5 million patients and it will be a $1 billion revenue business. That's how we take that comment versus looking granularly at '14 and saying you can be consistent with 13% of the x U.S. market. That's not what we're trying to message. We do feel good about the model we have and the guidance we've given in 2014.

Operator

Our next question comes from Eun Yang with Jefferies.

Eileen Flowers - Jefferies LLC, Research Division

It's actually Eileen Flowers filling in for Eun. My first question is of the patients currently treated with JUXTAPID, what is the ratio of adult to pediatric HoFH patients? And then I have a follow-up.

Marc D. Beer

So Eileen, specifically, your question is how many pediatric patients versus adult?

Eileen Flowers - Jefferies LLC, Research Division

Yes.

Marc D. Beer

Well, I'll emphasize that we are religious about compliance and who we can market to and marketing our labels. So we don't market to pediatric patients, a matter of fact, we don't pay commission on pediatric patients. So that really directs everybody to avoid pediatric cardiology practices and pediatricians, et cetera, so we just don't call on that. And because of that, we don't have a lot of patients on therapy. Now, a physician can sign the attestation that we do not have any clinical development on pediatric, but they have to sign that and tell us that they're well aware and they're educated that we do not have clinical development on pediatric patients. Because of acting that way as an organization from a marketing and medical affairs standpoint, obviously, we have very few pediatric patients. So the vast majority of our patients are adult.

Eileen Flowers - Jefferies LLC, Research Division

Okay, that's helpful. And on PCSK9 inhibitors, what percent of the current JUXTAPID-treated patients do you expect would switch over to that class of drugs from JUXTAPID and what are the specific characteristics of these patients?

Marc D. Beer

So, Eileen, that's a good question, I didn't make any comments in the prepared comments on PCSK9, and it's obviously because we have commented several times in the last year on quarterly calls. But let me turn it over back to Mark and have him comment about your question.

Mark Sumeray

Sure. Certainly a PCSK9 inhibitor might be expected to cause an LDL cholesterol reduction in a homozygous FH patient. There's some fairly limited data that's been presented and studies that are still ongoing in this area with Amgen's PCSK9 inhibitor in particular. We think it's logical that a physician would consider using a PCSK9 inhibitor in a patient that may have homozygous FH. Obviously, that's not the focus of the development for those drugs that have a much broader application in a different market, which is the patients who [indiscernible] maybe statin intolerant or resistance to statin therapy. I think clearly, it's worth emphasizing again the mechanism of action of PCSK9 inhibitors is thought to be through upregulation of LDL receptors. And this is a disease -- homozygous FH is a disease of dysfunction or absent function of LDL receptors. So again, our expectation is that many of these homozygous FH patients will either respond poorly or respond but not adequately in terms of the reduction that they would achieve with LDL -- with their LDL cholesterol. So while we would expect physicians to try a PCSK9 inhibitor, our expectation is that many of those patients would need additional treatment to get their LDL cholesterol down to an appropriate level.

Operator

Due to time constraints, our last question comes from Joseph Schwartz of Leerink Partners.

Joseph P. Schwartz - Leerink Swann LLC, Research Division

So I was curious, beyond Canada, Mexico and Brazil. Are there any other non-EU countries that could contribute to sales in 2014? I'm thinking places like South Africa and Australia where there might be some good numbers of HoFH patients?

Marc D. Beer

Yes. Let me turn it over to Craig, because you're talking non-EU and that's under his leadership. We do have people in other countries and we have regulatory oversight by [indiscernible] in those countries and we have legal oversight in those countries preparing for future approvals. And in countries where we can do named-patient sales. We do have individuals in those countries that are contributing. The majority this year, I'll steer you towards Brazil. But we do have contribution coming from other countries. So Craig, do you want to comment on that?

Craig E. Fraser

Sure. So 2 quick things. I think we've said in the past that areas particularly down through Latin America are a key focus for international. There's certain parts of Asia Pacific as well. Beyond the EU itself, EMEA, we've also commented on Turkey. I think this whole industry is looking at Turkey and advances that Turkey has made as being an important market to pay attention to and develop in as well. You happen to mention 2 markets, specifically South Africa, which are important for this disease, because there is a such a pronounced founder effect and we've done trial work there and continue to stay very close to those key opinion leaders and you mentioned Australia. Those also happen to be the 2 markets that typically are the most challenging by far, for reimbursing for high-priced therapeutics in rare disease products, particularly, unfortunately, South Africa. And as such, those are, when we look at South Africa and the patients, those are patients that we're committed to. And we're committed to those key opinion leaders that are there, but it's going to be a commitment that is seen more through no-charge, non-revenue type of activity of continuing to help people there and not markets that we should look for reimbursement and development in. And Australia is only a step behind those statements as well.

Joseph P. Schwartz - Leerink Swann LLC, Research Division

Okay, great. That's helpful color. And then, I just wanted to try to understand a little bit better logistically what you're able to do after a patient receives a prescription regarding this patient-elected nonstarts phenomenon. I was wondering, do you assign -- do you have the information that's sufficient to assign a care coordinator immediately who is tasked with onboarding them? Do you get that information right after a prescription is written? Is this an Aegerion employee? And then, what do they do to encourage them to come on board? And what's been sufficient or insufficient? And what more can they do to implement best practices here?

Marc D. Beer

That's a great question. Well, the most important thing that happens upfront is when a physician talks to the patient about therapy, one of the things that has to be into place is that the patient consents into -- it's essentially a HIPAA waiver consent into a relationship with our support systems, with COMPASS. If the patient consent is not there, then we don't know that patient's name and have no involvement with that patient. Now most patients, as we've said in the past, do consent into the process and into working with us. And at that point in time, there is a lot of educational support in conjunction with the healthcare provider. But yes, that prescription and the other information and begins the process with COMPASS, which are Aegerion employees, in conjunction with our specialty pharmacy provider, begin the process of intaking the patient, educating them on the process itself, supporting access and reimbursement activities, moving them over to a dietary consult, which are registered dietitians that are in Aegerion consultants and employees as well. And so all of that is assigned based on geography to a very specific case manager within COMPASS. And as Marc mentioned, we also now have at the field level these Nurse Educators, who are used to educating both the nurses and when asked, and agreed to help support the education of the patient in conjunction with that local staff.

Joseph P. Schwartz - Leerink Swann LLC, Research Division

And what can you convey to the patients in a nonsymptomatic disease to help them appreciate that would be in their best interest to treat this disease? Is there natural history data, or anything that can help them appreciate what otherwise would be invisible?

Craig E. Fraser

That's a good question. That's really for the health care provider. That's not our role. We don't talk about the disease education or the severity of the disease, JUXTAPID. We can talk about JUXTAPID, we talk about the safety and the risks and the proper way to take JUXTAPID. We can talk about the diet, because that is something that's important for both safety and tolerance as well. But what you're referring to with regard to their disease in conjunction with the broader condition that they have clinically, that's really for the physician. And our role is to make sure that we gained physician commitment to be committed to educating their patient. And that's what we do.

Operator

I would now like to turn the conference back over to Marc Beer for closing remarks.

Marc D. Beer

Thank you, operator. We look forward to keeping everybody updated on the progress and traction as we progress through 2014 and we feel excited about this year and the potential of the year. So we look forward to reconvening with everybody after Q1. Thanks.

Operator

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

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