Aegerion Pharmaceuticals' (AEGR) CEO Mary Szela on Q1 2016 Results - Earnings Call Transcript

Aegerion Pharmaceuticals (NASDAQ:AEGR)

Q1 2016 Earnings Conference Call

May 16, 2016 5:00 PM ET

Executives

Amanda Murphy - Associate Director of Investor Relations

Mary Szela - Chief Executive Officer

Gregory Perry - Chief Financial Officer

Analysts

Jessica Fye - JPMorgan Securities LLC

Eun Yang - Jefferies LLC

Tazeen Ahmad - Bank of America Merrill Lynch

Jeff Chen - Cowen & Co. LLC

Operator

Good day, ladies and gentlemen, and welcome to the Aegerion Pharmaceuticals First Quarter 2016 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions following at that time. [Operator Instructions] As a reminder, this conference is being recorded.

Now I’ll turn the conference over to Amanda Murphy, Associate Director of Investor Relations. Please begin.

Amanda Murphy

Good afternoon, everyone. Thank you for joining us today on our call to review Aegerion’s financial results for the first quarter of 2016 and to provide a business update.

I’d like to introduce Aegerion’s management team with us today: Mary Szela, Chief Executive Officer; and Greg Perry, Chief Financial Officer. 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 & Presentations tab. If you’re 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 includes statements regarding our forecasted future financial and operating results, the commercial potential and growth and value creation opportunity for our products and business, our ability to impact commercial metrics, the potential timing and outcome of pricing and reimbursement decisions outside the U.S., the potential for named patient sales and future regulatory approvals, the potential impact of competitive products, anticipated developments in our negotiations with the DOJ and SEC relating to the investigations by these agencies and the terms of potential settlements with these agencies, the status of our long-term debt, our planned commercial, regulatory label expansion, clinical development and business development activities and the anticipated impact and results of such activities, as well as other statements which relates to future events.

These statements are based on the beliefs and expectations of management as of today. Our business is subject to risks, uncertainties and assumptions that are difficult to predict. And 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 today available on SEC’s website at 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 results and guidance. The difference between GAAP and non-GAAP operating results and guidance is addressed in today’s earnings release.

At this time, it is my pleasure to turn the call over to Mary Szela.

Mary Szela

Thank you, Amanda, and thanks, everyone, for joining us today. I am pleased to provide a corporate and financial update and to review the progress we’ve made in the first quarter. Over the past four months, I’ve spent significant time deepening my understanding of Aegerion’s operations and resource allocation.

While there are considerable areas for improvement, my analysis allowed me to recognize numerous underlying strength in which we can build and further reinforce my belief in Aegerion’s potential. These strengths include MYALEPT, which has significant opportunity for growth. A potential approval later this year for JUXTAPID in Japan and the expected filing of MYALEPT in the EMEA where currently over a 100 patients, both general and partial lipodystrophy, are on drugged on a name patient basis.

Most importantly, this analysis made abundantly evident the dedication of approximately 200 employees who are fully committed to transforming this Company back into a high performing rare disease Company. On our year end call in February, the management team and I unveiled the road map to transform Aegerion and swiftly tackle the challenges facing our Company.

We have made important progress executing against the strategy in the first quarter and today I’ll update you on advancements with regard to each of the four efforts included in this road map; repair, realign, pipeline enhancement, and transformative impact.

First, with regard to repair we are extremely pleased to have announced preliminary agreements in principle with the DOJ and the SEC related to ongoing investigations of our marketing and sales practices for JUXTAPID and related public disclosures. This represents a significant step forward for Aegerion.

These legal and regulatory investigations as well as the legal and other costs and uncertainties associated with them, posed roadblock to our execution of the strategy we outlined and we’re pleased to have these agreements in principle in place and to turn our attention to maximizing JUXTAPID and MYALEPT developing a broad and sustainable pipeline and building an organization of the right size and structure to support these activities.

As we disclosed last week under the terms of the preliminary agreements in principle, we will make payments equal to $40 million over a period of five years beginning with the $3 million upfront payment paid upon settlement and quarterly payments thereafter. We worked closely with the DOJ and SEC to develop the terms of these agreements in principle and believe that they’re in the best interest of shareholders one that helps to minimize the time and expense devoted to the investigation allows us to satisfy the DOJ and SEC without placing undue burden on our stakeholders and most importantly permits us to operate appropriately moving forward without placing overly significant constraints on our business.

More specifically under the terms of the preliminary agreements, we anticipate that we will not be precluded from doing business with government agencies nor will our products be excluded from Medicare and Medicaid coverage, which of course, is key to commercializing our products in the U.S.

Finally, the preliminary agreements are structured such that our payments to the government are backend waited. This enables us to pay smaller sums upfront and larger sums in the future after we’ve had an opportunity to realign our business and when cash flows are more readily available.

Our commitment to legal and regulatory compliance goes far beyond the settlement. As we discussed in February, we have recently incorporated compliance measures across all of our processes, established a new Board level compliance committee and began a number of educational efforts to ensure that employees fully embrace these core values.

Most importantly and broadly speaking, we are focused on earning the trust of doctor, patients, customers and investors everyday. Our goal is to provide stakeholders with the steady flow of innovative science-based transformative medicine and by doing that we will build growth.

The next pillar of our strategy is to realign. Recognizing that Aegerion was oversized in certain areas for the current state of the JUXTAPID business, we conducted a company-wide resource analysis in the first quarter and based on our findings, enacted a 25% reduction of the global workforce to a total of approximately 200 employees. We remain on track to pay related restructuring cost by the end of the second quarter.

In the first quarter, we deepened this resource analysis and also conducted a careful review of our JUXTAPID business and market opportunity. And as a result of this review which I’ll detail in a moment, we now have a new understanding of the JUXTAPID franchise and believe JUXTAPID should be able to generate approximately $65 million to $75 million in the U.S. revenue annually and $90 million to $100 million globally.

We believe with the appropriate scientific and patient focused strategy, we can stabilize JUXTAPID and return to modest growth. We’ve launched an initiative to reengineer our business, reduce costs and ensure that we are delivering operational excellence across our business.

While these decisions were difficult, we remain confident that a leaner structure will make Aegerion a nimbler and more efficient organization. And we believe that these cost changes will enable us realign our expenses with our topline sales and return to cash flow generation in operations in 2017.

The third element of our roadmap is product and pipeline revitalization. We are currently focused on maximizing our existing assets and extending their commercial reach and are working to add new products to business development initiatives and opportunities. In regards to our existing assets, which we continue to see as important value drivers and contributors both in the near and long-term for growth. I will begin by detailing our recent review of the JUXTAPID business and by outlining our new understanding of this franchise.

If you could please turn to Slide 4, as we discussed in the past, the introduction of PCSK9 inhibitors has dramatically changed the landscape of the HoFH marketplace. After careful review, we believe that just that JUXTAPID offers the strongest value proposition to adult HoFH patients who cannot be served by a PCSK9 inhibitor.

For example, those patients who have little little-to-no LDL receptor activity. This is a significantly smaller group of adult HoFH patients and previously envision for JUXTAPID. We now expect JUXTAPID to bring in about $100 million globally in the 2016 and approximately $65 million to $75 million annually in the U.S. moving forward.

This conclusion is reflected in our quarterly results and as of March 31 there are 498 active patients on JUXTAPID globally, 373 of whom are U.S. patients. Based on our recent review of the JUXTAPID franchise, we believe that the most of the impact of the PCSK9 launch and core JUXTAPID adult HoFH patient is behind us.

As evidenced by the fact that the rate of patient erosion due to PCSK9 inhibitors flattened in the quarter indicating a slower rate of patient switches. This is also true from a percentage standpoint; the proportion of patients dropping up therapy has continued to decrease and appears to be stabilizing in the low single-digits.

Now if you could please turn to Slide 5, we believe that the bulk of those on therapy today belong to our core treatment group. Patients with little or no LDL receptor activity and are likely to remain on treatment, roughly 80% of the current justification has been on therapy for 10 months or longer, which suggest that these patients adhere are responding the therapy and have staying power.

This belief is strengthened by long-term retention data, roughly 10% to 20% of all JUXTAPID patients remain on therapy for 10 months or longer and the majority of our existing patients have already achieved the expected long-term retention. We are also seeing few patients to return to JUXTAPID following treatment with PCSK9 as well as some patients undo therapy of both PCSK9 and JUXTAPID.

There is a major effort underway to revitalize our U.S. marketing strategy to target the core adult HoFH patients and their physician. This includes developing an evidenced based scientific and marketing strategy focused on encouraging healthcare petitioners to try JUXTAPID in adult HoFH patients who do not achieve their LDL targets following treatment with the PCSK9.

In addition on the medical side, we plan to publish and leverage data from the lower registry our global long-term perspective observational registry of the long-term safety and efficacy of JUXTAPID in clinical practice. Recent data shows that some patients experienced a 40% reduction of LDL-C similar to that seen in our Phase III pivotal trial at a much lower dose of around 10 milligrams to 15 milligrams and with the lower rate of GI and liver adverse events. All but one of these patients in lower last year were from the U.S.

In Europe, however, where there are many more patients are genotyped so we know what their receptor status is, we’ve seen similar results same or higher efficacy was up to 85% reductions in LDL-C at a lower average dose with improved tolerability. Data on this will be published in Europe and we’ll expect to be used to help physicians identify those adult patients who are most appropriate candidates for JUXTAPID treatment.

Additionally, we will continue to scientifically study JUXTAPID and HoFH. We inspect to enroll the first patient in our JUXTAPID pediatric trial at the end of the second quarter. And additionally, we have completed synthesis of six pro-drug candidates and are evaluating the return on investment in order to determine whether we should move forward with future development. We also plan to review our commercial registry data to understand the utilization of JUXTAPID in combination with the PCSK9 inhibitor.

Turning now to MYALEPT, you could please turn to Slide 6. We continue to have enormous enthusiasm for the potential of MYALEPT, which continues to perform well commercially and with important milestones on the horizon. At the end of the first quarter there are 87 active patients on MYALEPT a sequential increase of 10% over the fourth quarter of 2015.

Additionally, we now have 144 patients in expanded access and compassionate use program, of which 44 came through the NAH. Currently 27 additional patients are pending and we expect to include them in our expanded access programs in the near-term. We did experience additional access and reimbursement hurdles in Q1 as prior authorizations are taking longer and payers are requesting additional data.

However, we believe we can overcome these hurdles with the demonstration of the clinical benefits for these GL patients. I am unwavering in my commitment to and believe in the potential of MYALEPT. Our team will work closely with payers to improve the prior approval process and speed access to therapy for these patients.

We’ve bolstered our commercial and patient access efforts with MYALEPT in the first quarter. We launched a small dedicated sales team focused on academic centers and children’s hospital, which we believe will help raise awareness of generalized lipodystrophy and educate healthcare practitioners as well as our - we trained our entire sales force to educate physicians and payers on this rare disease.

We remain on track to file marketing authorization for MYALEPT in generalized lipodystrophy in the EU by end of the year and also pursuing discussions with regulatory authorities in the U.S. and the EU regarding a potential label expansion for MYALEPT to treat severe partial lipodystrophy.

Finally, we’re in the process of exploring next generation programs for MYALEPT. We’ve identified two next generation MYALEPT candidates for further review and we’ve requested a transfer of all available data and lab books associated with these two compounds from AstraZeneca.

And lastly, turning to transformative impact. Ultimately I believe there is meaningful amount of opportunity and value creation ahead for Aegerion, both near-term and long-term. With our new corporate structure in place, our preliminary agreement in principle with the DOJ and SEC, we are now able to focus our attention to growth initiatives and deliver transformative impact to patients in need.

We continue to educate - evaluate initiatives that will enable us to take advantage of our global commercial infrastructure, existing patient support services and breadth of capabilities to expand our rare diseases pipeline.

Over the past four months since I joined Aegerion, I have been impressed time and again by the engagement of this Company’s Board and Management team and by all of Aegerion’s employees who are dedicated to transforming our Company and rebuilding Aegerion as a leading global rare disease company. I’m certain that we have the resources and team in place to achieve this goal and look forward to updating on our progress in the months ahead.

With that, I’ll turn it over to Greg Perry, our CFO for a review of the financials. Greg?

Gregory Perry

Thanks, Mary. Please turn to Slide 7 and a review of our results. Total net product sales for the first quarter of 2016 were $35.7 million compared to total net product sales of $59.4 million in the first quarter of 2015. Looking at JUXTAPID, net product sales were $26.2 million in the first quarter compared to $57.3 million in the first quarter of 2015. About 90% of total JUXTAPID net product sales, in the first quarter of 2016, came from prescriptions written in the U.S. while 10% were from prescriptions written outside the U.S.

As we noted on our fourth quarter call, we typically receive a bulk order of JUXTAPID from the Brazilian Ministry of Health in the first quarter, but expected that this order and shipment would likely to be booked in the second quarter in 2016. In the second quarter, we have now in fact received net order for $6.2 million.

Turning to MYALEPT, net product sales in MYALEPT were $9.5 million in the first quarter of 2016 compared to $2.1 million in the first quarter of 2015 substantially all from prescriptions written in the U.S. Due to the current payer mix and the number of units and product ordered for each of these patients per month and following our MYALEPT price increase in January, we experienced a gross to net adjustment on MYALEPT for the first three months of 2016 of approximately 29% and of the 29%, approximately 26% related to Medicaid rebates.

We continue to expect a significant gross to net adjustment for Medicaid rebates, which will have a continued impact on the net revenue realized for Medicaid patients in future quarters. In fact, payer mix is the reason we haven’t yet seen more significant topline growth despite our ability to continue to identify and bring GL patients into MYALEPT.

As a result of the fair value allocation of net intangible associated with the acquisition of MYALEPT, amortization expense related to the intangible assets was approximately $5 million in the first quarter. Total operating expenses on a GAAP basis were $79.6 million for the first quarter of 2016 compared with $56.7 million in the first quarter of 2015. This increase was primarily related to $28.3 million recorded for the DOJ and SEC settlement provision.

Operating expenses include $39.7 million for SG&A compared to $46.9 million for the first quarter 2015. The $7.2 million decrease in selling, general and administrative expenses in the first quarter of 2016 over the comparable period last year was primarily attributable to decreases in salary and employee related costs and related stock-based compensation due to a reduction in headcount in both the selling and administrative functions as part of the reduction in force in February 2016 and changes in executives. This was partially offset by an increase in legal and consulting services.

Operating expenses also include $9.9 million for R&D compared to $9.8 million in the first quarter of 2015. Research and development expenses remain relatively flat compared to the same period in 2015 and the $100,000 increase was primarily related to an increase in severance expense.

We had a GAAP net loss of $65.6 million or $2.22 per share for the first quarter of 2016 compared with a GAAP net loss of $15.8 million or $0.55 per share for the first quarter of 2015. For reconciliation of our GAAP to non-GAAP adjustments, please see our earnings press release issued today.

Interest expense net for the first quarter of 2016, contains $5.4 million of amortization, related to the amortization of the debt discount and interest incurred in relation to the issuance of our $325 million convertible notes.

Turning to the balance sheet, we ended the first quarter with approximately $42.7 million in cash and cash equivalents as compared to $64.5 million as of December 31, 2015. We’ve booked a charge of $28.3 million in the first quarter representing the amount of the payment under the agreements in principle with the DOJ and SEC. Coming to an agreement in principle with the government authorities is important as it positions us to open discussions with Silicon Valley Bank regarding our $25 million term loan.

And with regard to our 2016 financial guidance, we’re revising our previously stated full-year net sales guidance we now expect total net product sales to be between $130 million and $150 million for the full-year 2016 including between $90 million and $100 million for JUXTAPID and between $40 million and $50 million for MYALEPT.

We are also currently analyzing all areas of investment and resources with the goal of reducing 2016 expenses with the objective of returning to cash generation from operations in 2017. We plan to move away from operating expense and operating cash flow guidance until we have finalized this analysis.

Now I’d like to turn it back over to Mary Szela. Mary?

Mary Szela

Thanks, Greg. We are encouraged and energized by the opportunity for a fresh start here at Aegerion. We’ve made important progress towards transforming our Company in the first quarter and continue to actively pursue opportunities that can create value for our shareholders and make a meaningful impact on patients with certain rare diseases.

At this point, I would like to ask operator to please open the call for question.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] Our first question is from Jessica Fye of JPMorgan. Your line is open.

Jessica Fye

Great, thanks for taking my questions. The first question is just on the JUXTAPID U.S. guidance, can you just give us a little bit of color on how you envision the cadence of the remaining quarters of the year. I guess if we subtract this quarter’s U.S. sales from your kind of U.S. sales range that you talked about because it can just a pretty low run rate as you exit the year and curious how you think about that and I think you mentioned you could see it returning to growth, would that be a 2017 event?

Gregory Perry

This is Greg. In terms of how we see the year unfolding for the guidance I mean sequentially we still saw some continued attrition in patient base - active patient base that’s continuing through to today. So we kind of think that mid-year is little bit further out and so I’d expect some sequential decline here again depending on some of the timing of orders or whatever, but again I think you’re exiting it a lower rate than what you saw in the first quarter. And then in terms of growth as Mary indicated, some of the activities that she sees to stabilize will take a bit of time and so the opportunity for stabilization and then modest growth is in 2017.

Jessica Fye

Okay. And then there is a diminishing kind of data on the percentage of patients who’ve been on therapy for various periods of time and I realize sort of that patients move from one group to the next over time, but can you think about that 80% of 10-month plus patient is having low attrition rate or I apologize if I missed it, but did you give the efficient for those kind of look at sort of sticky patients?

Mary Szela

Yes. So what we’re trying to do is look at an analysis of who was weaving who was staying and I think now we have and you can see it in the graph here the patients that went on therapy by year, we now have patients who have stayed on therapy for quite some time and these are patients that we believe are the true JUXTAPID patients. These are patients that are truly HoFH have meaningful reductions in LDL and have achieved tolerability with this therapy.

And so we believe we’re at that kind of core patient level and that has been fairly stable. And part of what we’re doing too is now that we are in the core patient base. We need to revitalize the marketing strategy here in the U.S. and as Greg mentioned that’s going to take some time, previously it was more of a promotional strategy that was employed and now what we’re trying to build is a very strong value proposition as well as extract all the medical data from our registry data, which we think will be quite powerful for physicians to share with them.

For these patients that don’t have LDL receptor activity just how successful they can be in terms of lowering their LDL-C for these very difficult patients. So that kind of take some time to implement and then we believe this will be relatively stable and then we can build off that base and have some modest growth in 2017 and beyond.

Jessica Fye

Okay. And maybe just a last one for Mary, I think in the prepared remarks you alluded to business development I guess with the Company and a little bit of a precarious cash position, can you elaborate on just what that would look like and whether or not that’s a near-term priority?

Mary Szela

It is a near-term priority and I’ll let Greg comment as well and like you said capital is obviously constrained for us as a Company, but there are some opportunities that we think companies would be very interested in what we can bring to the table and that is a global infrastructure for a rare disease company which many do not have.

We also have a very robust patient engagement capability which the company had previous build and I feel the key differentiator for us as a Company. So we believe there are some few transactions out there where our capabilities could be quite complementary to companies and their portfolio. That would potentially come with cash and/or would bring synergies that we think makes a lot of sense. So I don’t know Greg if you wanted to add any thing further.

Gregory Perry

Well, I think that sums it up.

Jessica Fye

Great. Thank you.

Operator

Our next question is from Eun Yang of Jefferies. Your line is open.

Eun Yang

Thank you. So when you provided revenue guidance in February. In terms of JUXTAPID that you are lowering now by 25% to 29%, so what did not come through that you had anticipated when you gave guidance in February?

Gregory Perry

Yes, this is Greg. I think Eun it was really two things. So we saw a much more dramatic and continued erosion of active patient base and so as you can see from the patient numbers those numbers decline, pretty significantly. I think in terms of what we’re anticipating for new patients from the first quarter, we weren’t really that far off there were some momentum clearly, probably from the back half of last year on new patients. So I’d say the majority of the myths in the reduced outlook in the first quarter was active patients going down and maybe a little bit longer-term thinking about longer-term guidance its also a more conservative look at new patient additions.

Eun Yang

Okay. What’s the growth in the discount for JUXTAPID currently?

Gregory Perry

It’s very minor so I think it’s 3% or something like that.

Eun Yang

Okay. And then last question is on your debt. So you have about $325 million convert debt, are you looking into restructure the debt?

Gregory Perry

Yes, I think with this decline in the sales forecast and it’s very challenging to try to adjust cost basis to match this type of a decline. So we’ll be looking at opportunities for financing that will include thinking about our debt and thinking about restructuring debt, but the debt is due in 2019 so we have sometime to address that as well.

Eun Yang

Thank you.

Operator

Thank you. Our next question is from Tazeen Ahmad of Bank of America. Your line is open.

Tazeen Ahmad

Hi, good afternoon. Thanks for taking my questions. Just a couple I don’t know if I heard correctly, but did you in your new guidance provide the breakout between what you expect for U.S. and rest of world sales for JUXTAPID this year?

Gregory Perry

We didn’t – I mean again, the trend is generally been about 90% U.S. so we’re still I’d say probably dips down a bit from that, so I think in the U.S. we’re probably in that $70 million, $75 million range?

Tazeen Ahmad

And do you expect that to stabilize and stay there for a certain amount of time?

Mary Szela

Yes, we do. I mean that’s why we wanted to share with you these core patients because we believe these are patients that have been on therapy for over 10 months. And you could actually look at this group of patients with cohort by 2013, 2014 and 2015. These groups of patients have adhered to therapy, have gotten really good results and continue to stay on therapy even in light of the entrance of PCSK9. So we think this is roughly about the base of patients that we could build on moving forward.

Tazeen Ahmad

Okay. And keeping with that, you’ve mentioned just now that you’ve seen much more dramatic erosion of the active patient base. We know from the PCSK9 launches as a whole that they’re not getting particularly soft uptake so is your share loss to PCSK9 coming from voluntary switches initiated by doctors or insurance companies requesting the change?

Mary Szela

I think both. The other thing if you look back at this as a historical perspective of the drug, about 50% of the patients leave therapy just due to having difficulty tolerating the therapy. So that’s a component of why patients leave. The other component is there are some patients who have left to PCSK9.

And just like MYALEPT, which I mentioned, we’re also seeing more payer pressures taking us longer to get a patient approved then what we saw even in the fourth quarter of 2015.

Tazeen Ahmad

And have you provided an updated timeline from requests from a doctor to the time the script gets dispensed to the patient and how long it takes to get on to the drug?

Gregory Perry

No, I don’t believe we have, but I know that we did see the cycle time in terms of getting authorizations expand pretty dramatically in the first quarter versus what we have been seeing in 2015.

Tazeen Ahmad

Okay. And then I guess lastly for MYALEPT, when you talk about in your slides, the global opportunity of $200 million to $250 million in peak sales. Are you assuming that you’re going to be able to see continued price increases because you’ve been pretty aggressive about price increases there and also – yes, go ahead?

Mary Szela

We don’t believe it’s really – we don’t see price increases and as we’ve developed our longer-term financials we have not included any price increase.

Gregory Perry

Yes. $200 million to $250 million peak sales numbers really predicated on approval in Europe as well as expansion of the indication of label to include to be a [partial lipodystrophy].

Tazeen Ahmad

And so I guess what you consider to be the number of patients that could be eligible for MYALEPT analysis [indiscernible].

Mary Szela

The treatable population, we’ve seen various different numbers, but we’re seeing treatable about one in a million.

Tazeen Ahmad

And so if you were to break that out geographically what would be the split in the U.S. and rest of the world?

Mary Szela

Basically, it would be a function of the population so I don’t want to quote numbers here that I haven’t looked at the actual world population lately. U.S. is roughly $350 million; EU is $500 million, rest of the world I have to get that number for you.

Tazeen Ahmad

Yes. It’s not really I’m not asking what the world populations are, is just based on the market data what you realistically think the addressable populations would be in each geography, but we can talk about that offline, it’s not a big deal. Okay. Thank you.

Operator

Thank you. Next question is from Jeff Chen of Cowen & Co. Your line is open.

Jeff Chen

Hi, thanks for taking my questions. On MYALEPT, in retrospect what lessons have you learned from Q4 where you only added one patient versus this quarter where patient acquisition reaccelerated. Is there something specific that you can point to? And also you mentioned for MYALEPT the payers are asking for additional data. Can you just kind of provide us with some information what type of data are payers asking for and if you have those data in hand? Thanks.

Mary Szela

Yes. What payers are requesting more, previously patients were readily able to go on therapy, now what we’re seeing payers and this is what we’ve seen also in JUXTAPID as well is just further conformation from the physician was a leptin deficiency tests completed, was there further justification from the physician, so that’s just lengthening the cycle to get patients on therapy. So it’s not specific – one specific thing by payer, it’s just taking more requests for physician justification and sometimes it’s taking two to three cycles to actually get these patients approved.

Jeff Chen

Thanks. And in terms of patient acquisition reacceleration in the quarter versus Q4, was there something particular or…

Mary Szela

There is really nothing fundamental there. When you look at in the rare disease world you can see patient enrollments very lumpy. Fourth quarter was slightly less and we started to see first quarter pop right back up, but because of some of the payer cycles lengthening, we’re not seeing the flow through as rapidly as we would like. We do believe that with the right value proposition, which we are assembling right now we can help speed that.

Jeff Chen

Okay. Thanks very much.

End of Q&A

Operator

Thank you. This ends the Q&A portion of today’s conference. I would like to turn the conference over to Mary Szela for any closing remarks.

Mary Szela

Thank you all for your interest and attention and we look forward to keeping you updated on our progress. Thanks again for joining us today.

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This concludes the program. You may now disconnect. Have a wonderful day.

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