Amryt Pharma plc (AMYT) on Q3 2021 Results - Earnings Call Transcript
Operator: Good day ladies and gentlemen and welcome Amryt Pharma Third Quarter 2021 results webcast and analyst call. At this time all participants are in listen-only mode. After speaker’s presentation there’ll be question and answer session. Please be advised today’s conference is being recorded. I will now hand you over to Amryt Pharma. Please go ahead.
Simon Loughrey: Thank you, operator. On the call today to discuss Amryt’s Q3 results are Dr. Joe Wiley, CEO and Rory Nealon, the company’s CFO and COO. In addition, Dr. Mark Sumeray, Amryt’s Chief Medical Officer and Sheila Frame, President, Americas will be available to answer questions during the Q&A session. Joe will provide an update on the business and then Rory will go through the financials in detail. Before I hand it over to Joe for his formal remarks, let me remind you that this webcast and conference call contains forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict and which may be outside of the company's control, including, among other things, the development of its business, the trends in its operating industry, changing economic, financial or other market conditions. In light of these risks, uncertainties and assumptions, the events or circumstances referred to in the forward-looking statements may differ materially from those indications in the statements. Word expressing reflect optimism, satisfaction with current progress, prospects or projections, as well as words such as believes, intends, estimates, expects, plans, projects, anticipates and other similar variations identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Such forward looking statements are not a guarantee of performance, and the company's actual results could differ materially from those contained in such statements. Any forward-looking statements made, speak only as of the date of today press release and conference call Wednesday, November 03, 2021. And the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the circumstances after the date of this call. For more information, I would refer you to the forward-looking statements section of the full year financial press release issued earlier today, as well as the company's filings with the SEC. At this time, I will turn the call over to Dr. Joe Wiley. Joe, please go ahead.
Dr. Joe Wiley: Thank you, Simon. I am on slide four of the presentation. We are pleased to be reporting strong operational and financial results for Q3 with positive momentum in both our commercial business and our pipeline. The closing of the Chiasma acquisition in August means that we now have three growing commercial products, metreleptin Mycapssa, and lomitapide. Oleogel-S10, if approved will be the fourth. Total revenues in Q3 were $56.5 million, which represents growth of 14.6% year-over-year. Excluding the impact of sporadic LATAM orders and Mycapssa, revenues grew 26.3% year-over-year and 5.7% sequentially quarter-over-quarter. We generated EBITDA of $6.2 million, excluding non-cash items share based compensation expenses, and restructuring and acquisition costs. This represents the seventh consecutive quarter of positive EBITDA generation. During the quarter, we made significant progress on the regulatory pathway for our lead pipeline Oleogel-S10 in both the U.S. and Europe. Our commercial launch plans for this product are now well advanced. We have a strong balance sheet with cash of $123.2 million at September 30. Today, we are reaffirming our full year 2021 revenue guidance of between $220 million to $225 million, representing 20% to 23% growth on 2020. As a reminder, we had raised this guidance at the time of our capital markets event in September. Moving on to our commercial products, I'm now on slide five. Beginning with Metreleptin, revenues in Q3 are $36.3 million, compared with $29.9 million in the same period of 2020. Metreleptin U.S. revenues grew 18% year-over-year, and the EMEA delivered a very impressive 143% revenue growth in the quarter. This strong performance in EMEA was driven by improved market access, and significant numbers of patients accessing therapy. As a reminder, Metreleptin was approved in Europe in 2018 and is still relatively early in its growth trajectory, and also has a broader label than in the U.S. encompassing both general lipodystrophy and partial lipodystrophy. With previously served to our life cycle times in the U.S. seek a label expansion for metreleptin to include the treatment of partial lipodystrophy, in addition to the currently approved label for treatment of general lipodystrophy. We received feedback from the FDA on a path forward for this initiative, which will require a Phase 3 study, and we are on track to initiate this study by the end of 2021. Let’s move to the next slide on slide six, lomitapide revenues were $18.5 million in Q3, compared with $19.1 million in the same period last year, a reduction of 3% year-over-year. The relative performance in Q3 2021 was due to some pre ordering that occurred in Q3 2020, due to the impact of the COVID pandemic. Lomitapide, however delivered $56.2 million for the first nine months of 2021 versus $54.6 million for the first nine months of 2020 and is on track to deliver expected growth for the full year 2021. We are conducting a pediatric study for Familial HoFH and we expect to have data mid-2022, a semi positive data; we will seek approval of lomitapide to treat children with HoFH in both the U.S. and Europe. Now, on Mycapssa on slide seven, Mycapssa, the first and only somatostatin analogue oral capsules is a genuinely differentiated product. Given the robust clinical data supporting it, and the patient practices for orals, we believe Mycapssa has the potential to become the new standard of pharmacological care for the maintenance treatment of patients with acromegaly. The market opportunity is compelling. In the U.S. market research suggests there are approximately 8000 acromegaly patients on chronic SSA injectable therapy. And this translates into a market that we estimate to be worth approximately $400 million. We estimate that the global market is worth $800 million. We strongly believe there is a place in therapy for an oral products, and we are excited to have it as part of our portfolio, and our entire team is energized to execute on the launch. Amryt held a virtual capital markets event on September 13. The participants included Dr. Maria Fleseriu, of Oregon Health & Science University, who is leading KOL in acromegaly. She presented a detailed overview of the current treatment landscape in this disease. In addition, our Chief Medical Officer, Dr. Mark Sumeray provided an update on our plans to develop Mycapssa in patients with carcinoid symptoms stemming from neuro endocrine tumors, where the market opportunity is estimated at approximately $1.9 billion globally. We intend to pursue a 505 B2 regulatory pathway in the U.S. for this indication. This event is archived on our website. And I would encourage those investors who were not able to participate on the day to watch this webcast presentation and accompanying slides. Turning to the positive performance in the quarter. Mycapssa delivered sales of $1.45 million this reflects sales from August 5 when we closed the Chiasma acquisition. Revenues in Q3 were impacted by pre-ordering in Q2. Normal ordering patterns have returned in September, and the product delivered $1.14 million for the month and it delivered another strong month in October. This policy was the principal asset in our acquisition of Chiasma, so I want to spend a few minutes explaining why we're excited about it, and how we are currently leveraging our sales, marketing and medical affairs infrastructure to accelerate adoption and revenue growth. Patients are familiar with Mycapssa and they certainly were if there's an overall option available for octreotide. We also know that there's comfort from a physician perspective in making the switch from injectables. Furthermore, the product represents a compelling value for payers. As an oral option, it addresses unmet need, and it has been priced at a level designed to facilitate broad access. In order to maximize the potential of this product, we're effectively undertaking a relaunch. Prior to the acquisition, the commercial efforts have been exclusively focused on maturity centers. However, these centers were mostly closed due to the pandemic. Now, by combining the sales forces and medical teams of both organizations, Amryt is now in a position to take advantage of our metreleptin in the U.S. to accelerate the adoption of Mycapssa in the broader endocrinology community. We estimate that about 50% of the market is outside the PTC. We already have depth of experience using an inside salesforce to help identify where the patients are in the community. That does it with metreleptin and we know that we could do the same thing again with Mycapssa. We've provided our medical affairs team to increase our share force in the field and across endocrinology. And finally, we have enhanced our patient support services to better support patient’s transition for injection to a morning and bed time capsule. As these initiatives are being rolled out, we are pleased to see they started to have an impact. And if we look at ordering patterns, we're very encouraged to see that mostly multi Mycapssa orders in October were more than three times the orders in January. Now onto our lead pipeline asset Oleogel-S10, which will be marketed under the brand’s name, Filsuvez if approved. And now on slide eight, Oleogel-S10 is a potential novel treatment for the continued manifestations of severe EB, a rare and distressing genetic skin disorder affecting young children and adults. There's currently no approved therapy for this condition, and if approved, it would be the first to market for those patients suffering from this devastation condition. We continue to progress the regulatory pathway for Oleogel-S10 in the quarter, having submitted the file to both the FDA and EMA in March of this year. In the U.S. the target PDUFA date is the 30th of November. And we've been responding to information requests received from the FDA, all of which have been submitted on time. While NDA is being assessed on the priority review, and if approved, we will be eligible to apply for a product priority review voucher. In Europe, we have responded to questions from the EMA who are on course for a CHMP opinion in late QW4. Moving to slide nine, whilst the regulatory activities are on-going, we are moving forward with our launch plans. If approved, we have the financial flexibility teams, systems and global infrastructure in place to bring Oleogel to market and to execute our significant growth plans. EB represents a highly concentrated market. In the U.S., there are three world class leading institutions, and then an additional seven that runs specialized EB fillings. In addition, there's about 21 community based clinics that support patients across the country. We already have in place a medical affairs team working with each of these EB centers. We have recruited two sales directors and have begun recruitment of a dedicated dermatology commercial team. With the most important support services we can provide per patient is reimbursement and we've started to already engage with payers to make sure that they understand the burden of EB and the value that Oleogel-S10 will bring to these patients. In parallel, we have been scaling of our manufacturing and supply chain to ensure adequate drug supply to meet expected demand. We have inventory that's ready to be shipped as soon as day one. Our existing manufacturing facility should be sufficient to build enough API for launch volumes through 2023. Through that we attempt to have a two sourcing strategy that will be executed across the supply chain and manufacturing scale up in order to support commercial demand beyond this. We look forward to providing the next update on Oleogel-S10 once we have a decision from the FDA. Let me now turn the call over to our CFO and CEO Rory Nealon, who will provide more details on the Q3 financials. Rory?
Rory Nealon: Thanks, Joe. My remarks today will take a little longer than plan to cover the acquisition accounting from the recent Chiasma merger, as well as my usual comments on the financials for the quarter. So let's start with revenues. Joe's already covered the revenue products of performance by product and by geography. And just remind you of the headline numbers. We've seen an overall 14.6% improvement in our quarterly year-on-year revenues, which was predominately driven by a 21.5% growth in our metreleptin revenues. If we look at the growth in our metreleptin business and ignoring the impact of the sporadic LATAM orders, which were significant in Q3 last year. The growth as Joe said year on year was actually 51.6% in, which we're particularly pleased with. We of course also into the revenues from Mycapssa for the first time following the acquisition, which completed on five August. On our recent analyst call you will have heard Joe allude to the impact of the price increase put in place prior to the data flows, which resulted in increasing revenues in the month of June, with a corresponding significant decrease in both July and August. As a result, our revenues for the quarter were approximately $310,000 in August and $1.14 million in September with September be more reflective of reality. Joe who has previously covered our relaunch efforts and we're starting to see positive developments with revenues for October being higher again than those of September. Next I'd like to touch on as our gross profit or gross margin performance excluding the impact of non-cash items which once again exceeds 75% for the quarter when compared to 73.5% for the year as a whole in 2020. As I noted with our Q2 results within these numbers, the mix varies by product and by geography, with the higher third party royalties on metreleptin, making that product a lower margin product as compared to lomitapide. I'd say as Mycapssa start to increase we expect the combined group margin to edge upwards. Mycapssa has no third party royalties, and we expect the gross margin on that product to be closer to 80%. Further, if Oleogel-S10 is approved and EB, we expect additional upward trends in our gross margin, given Oleogel-S10, has relatively low 9% third party royalties. Regarding the non-cash items in our cost of sales that we adjust out in calculating EBITDA, they consist of a number of distinct items that impact our gross margin. Firstly, there's the amortization of intangible metreleptin and lomitapide assets of approximately $10.7 million per quarter, which has been the case for some time now. In addition, we now also have the amortization of Mycapssa intangible assets of Mycapssa intangible assets, which was $1.96 million for the month of August and September, being the period post the closing out the acquisition on five August. And finally, we once again have amortization of the fair value step of acquired inventory, this time from the Chiasma acquisition. When a company acquires another company, the accounting rules whether IFRS or U.S. GAAP requires the acquirer in this case Amryt to fair value upwards the acquired Chiasma inventory on the date of acquisition to something approaching the future selling price of that inventory. When that inventory is subsequently sold, this results in a higher cost of goods hitting the income statement and reduces gross margin. However, what is really important to understand is that this is all non-cash accounting adjustments. The initial awkward fair valuation and the subsequent amortization of this uplift are both non-cash accounting transactions. In calculating our EBITDA quarter, we’ve reversed out these non-cash amortization amounts and this amounted to $400,000 for the quarter just gone. In total, the uplift and acquired inventory for Chiasma quarter inventory and the remaining as of 30 September was $40 million. And we estimate it will continue we will continue to see these fair value uplift amortization amounts for approximately two years as we sell the inventory which we acquired on five August. Moving on to our SG&A and R&D spend. Our R&D spend of $11 million for Q3 is an increase on the average of $8.7 million per quarter for quarter one and quarter two, which is in part due to the preparation work for the commencement of our U.S. partial lipodystrophy study and also getting the new R&D spend, which has come about solving the acquisition of Chiasma. Ignoring the impact of Chiasma restructuring and acquisition costs are exceptional items, our SG&A spend for the quarter was $25.7 million. This comparison to $17.8 million in quarter one, and $18.9 million in quarter two, again, ignoring the impact of deal cost, and is obviously in large part driven by the inherited SG&A cost from Chiasma. Chiasma itself spent $15.7 million on SG&A for the three months a quarter one this year being the last public reported results for Chiasma as a standalone entity, and prorating this 15.7 million for the three months in quarter one down to two months. to approximate the August, September cost post acquisition would suggest an inherited incremental span of approximately 10.5 million for those two months. As I just noted, amortized SG&A did not increase by this amount but rather increased by a lower amount, namely $6.8 million to $25.7 million total for quarter three. This increase of $6.8 million in Q3 is not only due to the Chiasma cost base inherited, but it's also driven by increased spend associated with the impending Oleogel-S10 large difficult. Our goal at the outset was to rapidly reduce the significant inherited Chiasma costs. And based on these numbers I've just given you, we're having a material impact already. I'll touch on this slide again when I cover our EBITA numbers. As we go forward into the remainder of H2, and as I just noticed, we're also understanding, we are starting to increase our prelaunch span for Oleogel-S10 and EB in particular, we're actively recruiting to add a select number of additional customer facing staff the team predominantly based in the USA. Accordingly, you should expect an additional increase in our total SG&A spend going into Q4 if Oleogel-S10 is approved. The next key metric I'd like to focus on is EBITDA, which is a key metric for us given it was a good proxy for our cash from operations in 2020. Obviously deal related costs and an acquisition could also have an impact on cash balance, and I will deal with that particular point later. When talking about EBITDA I'm initially going to talk about EBITDA before Chiasma restructuring and acquisition costs which is a better reflection of the underlying performance of the business and I'll then provide some additional color on those exceptional deal costs. EBITDA before such exceptional cost was $6.2 million for the quarter. This is a reduction from quarter two for three principles. Namely, one a reduction in overall revenues given the significance $12.1 million in lumpy orders for metreleptin and to LATAM in Q2. Second one was an on-going increase in our prelaunch spend, as I mentioned, as I’ve mentioned for Oleogel-S10, in order to be prepared for launch to the product be approved by the FDA in late Q4. And finally, and most significantly, the on-going operating losses we assumed when we acquired Chiasma. In quarter one again, Chiasma had operating losses of approximately $18 million. All other things being equal and given we acquired Chiasma on the 5th of August, we would expect approximately $12 million of operating losses for the month of August and September, nearly two thirds of the $80 million loss in Q1. In reality, Amryt has reduced this pro forma $12 million by approximately half for the two months, which is significant and rapid reduction in the Chiasma base. You will recall Amryt has a strong track record of rapidly taking costs out of an acquired business. We did in our previous acquisition in 2019 within two quarters, and we're on track to achieve similar results with the Chiasma business. In particular, and both of these transactions we have and are transitioning a sizable number of noncustomer facing functions and roles from Boston to Dublin, which results in significant economies of scale. We are also leveraging off the significant previous experience that the team -- the management team of Amryt has of acquisition, integrating processes and extracting synergies. Before going off the topic of EBITDA I will draw your attention to slide 10 where we adjust our Q2 operating loss for non-cash items and get to adjusted EBITDA before Chiasma restructuring and acquisition costs of $6.2 million for the quarter at $36.8 million for the year-to-date. This will before restructuring our acquisition cost of $14.7 million associated with the Chiasma deal, $11.2 million of which was incurred in Q3 and the remainder predominantly in Q2. This $14.7 million consists of approximately $9.4 million of legal advisory fees and other due diligence related costs and approximately $5.3 million and severance costs. These are the severance cost for those employees that have already left Chiasma, there will be no -- there will be on-going severance costs for those Chiasma employees who are transitioning out of the group and we are obliged to account for those particular costs over the period of their transition. We expect this will amount to approximately $1.2 million over the next two quarters. Beneath the operating loss line and our income statement, you will note that the non-cash change and fair value of the contingent consideration and the non-cash continued value rights expense are broadly consistent with quarter one and quarter two. And finally, in that section of our income statement, you will note that of $6.4 million charge for net finance expense for the quarter of which $3.1 million is non-cash and $3.3 million is predominately the cash interest accrued in the quarter on our convertible bonds and term debt. Before discussing the impact of the Chiasma deal on our balance sheet and our revised cap table, I'd like to summarize our current net debt position. You may recall, we paid off the debt pipe arrangements which Chiasma had on closing the deal. Accordingly, excluding our convertible debenture, which I’ll cover in a minute, we have net cash of $31.4 million as at the end of September being cash of $123.2 million and term debt of $91.8 million. This compares to net cash at the end of March at $29.8 million and at the end of June of $52.6 million. The reduction of $21 million from the end of June was almost entirely driven by Amryt’s contribution to the repayment of a Chiasma debt type instrument on closing of $21.6 million. This being the difference between the total amount of debt amount of $116.6 million versus the inherited Chiasma cash which was also used to repay the debt. We obviously had significant Amryt and Chiasma deal and restructuring related costs and we're also paid during the quarter, amounting to approximately $13.3 million. As we move into quarter four, we expect to have an additional $8.6 million in cash spend related to Amryt and Chiasma deal and restructuring related costs. These costs were accrued in quarter three with the actual cash payment within quarter four, which will have a once off aside from our cash in Q4. In addition to our term debt, we do have a convertible loan with a principal value of $125 million, but a conversion price of $12.95 per ADF or $2.59 per order in this year. Given the strong on-going operational performance, we believe that it's likely that this will get converted to equity before it is otherwise due for payment in April 2025. As a result, we view this as more akin to equity and debt. Before closing on our financing, I will just note that our $92 million term loan facility was drawn down in late September 2019 and was non call to and now that those two years are off we plan to initiate a refinancing process very soon. Before covering our revised cap table, I will briefly discuss the acquisition accounting for the Chiasma acquisition. And I draw your attention to note five and the quarterly financial statements if anyone is interested in the detail. The accounting rules require us to fair value the assets and liabilities as of the date of acquisition to the best of our ability, and we're then permitted to update those valuations over the course of 12 months from the date of acquisition. The results of this exercise shows that we paid $260 million in consideration by way of Amryt shares, and we effectively paid an additional $10 million by assuming the outstanding Chiasma employee shared options and RSUs. In return, we received intangible assets being devalued Mycapssa and goodwill of $282 million. We also received inventory with a value of $62 million being the fair value assessed, which as noted earlier, approximates the future selling value of this inventory. The other big items we inherited were cash amount of $108 million, and a third party debt type facility of $116.6 million. As noted earlier, this task was repaid on closing and we use a combination of the inherited Chiasma cash and $21.6 million of legacy Amryt cash to repayers. Before concluding, I'd like to update you on our cap table. As at the end of September, we have 316,904,642 ordinary shares an issue or 63.4 million ADS equivalents with ADS being what's listed on that deck. We have no words that existed for the group. Regarding shared options and RSUs, you will find a lot more detail and a note for the quarterly financial statements. You will recall we inherited the legacy Chiasma equity scheme and that remains alive all the years no further share options or RSUs will be issued under this particular equity scheme. It will simply reduce overtime to zero as instruments are exercised or lapse. Any new issuances for all employees will have to come from the legacy Amryt equity scheme. I've summarized in note four of the quarterly financial statements and adding both the Amryt and Chiasma equity schemes together, we have shared options outstanding over 45.4 million ordinary shares or 9.1 million ADS equipments. Our strike prices ranging from £0.54, to sterling pounds, £9.35 per ordinary share for approximately $3.69 to $63.86 per ADF. We also have combined RSUs outstanding as of the end of September of 1.76 million ordinary shares or 352,000 ADS equivalents. As I noted, there's a lot more detail to note for if anyone is interested. That's the end of my remarks. And I will now hand back to you, Joe.
Dr. Joe Wiley: Thank you Rory. I am now on slide 11. Let me summarize by reviewing where Amryt stands today post-closing of the Chiasma acquisition. We have a revenue generating commercial portfolio that is now comprised of three markets and products, each of them growing and addressing large, attractive markets. We have an exciting pipeline of development stage assets with the potential to drive near and long term growth. There is potential near term approval for Oleogel-S10 in a global market estimated to be worth in excess of $1 billion. We are also preparing to enter Phase 3 with Mycassa in neuro endocrine tumors where the estimate of the global market opportunity is $1.9 billion. We have a track record of successful integration, execution, performance and growth. And we are currently leveraging those capabilities in the on-going re-launch of Mycassa. And finally, we have global commercial infrastructure, the financial exhibit, flexibility to execute our plans, as well as an experienced team to drive new product launches and growth. I will now hand over to the operator for Q&A. Operator?
Operator: Thank you. We will now begin the question-and-answer session. And your first question is from the line of Mani Foroohar with SVB Leerink. Please, sir, go ahead.
Mani Foroohar: Thanks, thanks, taking the question and congratulations on the continued progress across the portfolio. I'll start with Oleogel-S10 or if guys are sketching out how concentrated this market is on a prescriber basis. Can you give us a sense of timeline to reimbursement and about how you think about the split of this market and term by payer in the U.S. Medicaid versus Medicaid versus commercial? And how long would it take to realize to achieve reimbursement approximately on Medicaid on a state by state basis? I’m going to have a quick follow up.
Dr. Joe Wiley: Hi Mani, thanks for your question. Yes, obviously that is going to be dependent on the regular timelines. And as you know, we have the target PDUFA days of November 30. So I'll hand over to Sheila. So Sheila if approved, what are the timelines to reimbursement?
Sheila Frame: Sure, thanks so much for the question. Obviously, you know that when you launch into a new market, like this prior authorization, and medical exception is what we're anticipating from payers immediately following approval. So those timelines, we hope that we have done enough prelaunch education on the high unmet medical need that these patients suffer from. So it will be very much a payer by payer in terms of how long it takes to get a medical exemption letter, but we have been working with those key centers to make sure that they're ready to get those medical exemption letters into payers as quickly as possible. In terms of the Medicaid population, as you know, it's very difficult to speak to Medicaid until after you get your label. But we are certainly geared up. We've done a lot of investigation on each one of the 50 state Medicaid programs and know which ones are much more experienced with Epidermolysis Bullosa. And so we will be focusing very quickly on those key states the minute we get that PI on the label and the approval.
Mani Foroohar: Great, that's really helpful. So hopping on to Mycapssa, you guys did a good job of sketching out how far ahead of schedule you are in terms of right sizing the revenue spending inherited from Chiasma, rather. Looking forward, how should we think about incremental spending to expand the population of touch points, as you look to go out into the community? Is that largely spend baked into your existing threat -- your existing Salesforce? Should we expect further expansion of the Salesforce to drive to drive that revenue growth just to scale that force?
Dr. Joe Wiley: Mani, its Joe here. Okay, so let me let me talk to you about the overall strategy. And I’ll let Sheila come back in with maybe some some more details. But the idea here was that this is we have overlap in terms of call points, right. So acromegaly patients are seen by endocrinologist and endocrinologist are also treating lipodystrophy. In fact, endocrinology is also treated to FH. But the and therefore we already have had in place prior to the – prior to close of the deal, a full field force, but focused on the community, right? So the, we were very much focused on the community and those seeking to find those lipodystrophy patients, and which -- lipodystrophy and to put them onto therapy. elected to focus exclusively on the pituitary treatment centers or the PPCs. So they were detailing those centers a problem. And that's a good strategy. Given that there's the Kayla's are treating achromatic patients in this pituitary centers, obviously. However, during the pandemic, they closed and they closed to commercial. And the -- so really, there was a huge access issue. By combining our two sales forces and that's what we've done, so that spend is already locked in. There's no incremental really be further expected. By combining the two sales force, what we've done is we continue to focus on pituitary centers, which is actually and what most importantly, we're we've cross trained to two sales, sales teams. So both Mycapssa sales who have been trained on metreleptin and the metreleptin sales team have trained on Mycapssa. And we've redeployed them and I’ll hand you over to Sheila who will talk to you a little bit more about that redeployment. But we've therefore, increased significantly our share of voice across the United States among the endocrinology community. We've done the exact same thing with the medical affairs team, and effectively combining our medical affairs function with bears and deploying them in in a similar fashion. And we have focused on the patient services side of things, bringing our model to, to bear rather than the one that we inherited. And we feel that that's also an important component. So Sheila, maybe I'll hand over to you and you can give a little bit more color to on that.
Sheila Frame: Sure, although I think you covered it pretty well, Joe. Essentially Mani we've doubled the size of our footprint as it relates to endocrinologist. So we're not walking away from the pituitary centers, but we've been additive in terms of our mile up team to be able to add Mycapssa at the community level. So I think the team is certainly ready, engaged. And we're -- excited to get out there. And I think, what we found with the former organization as they struggled to get enough call. So the reach and frequency was a bit of a challenge, of course, because of the pandemic, which everybody experienced during the pandemic, but this should give us a significant lift as we go forward. And then as Joe said, the Medical Affairs organization, they have the depth of experience that we have in endocrinology combined with the depth of experience that the Chiasma organization had in the pituitary centers I think will also give us a lift. So we believe that about 50% of the patients are in the community and treated in the community regularly and about 50% in the pituitary centers. So we're now going to have access to that significant portion of the marketplace. So really from August 6, until yesterday, we were able to be up and running with the team now integrated on the ground in territory and cross train. So I think going forward, we're expecting to see some acceleration fairly quickly just in terms of share voice in that regard.
Mani Foroohar: Great. That's really helpful. Thanks, guys.
Operator: We will now take our next question. And that is from the line of Michelle Gilson. Please go ahead.
Michelle Gilson: Hi, this, Michelle Gilson from Canaccord Genuity. Congrats on the quarter. And in all the accomplishments in Q3. I guess, starting with Oleogel, are you guys, maybe you can give us kind of an update on where you are in the regulatory process. Obviously, the PDUFA date is approaching here pretty quickly. Are you guys in active labor negotiations? And also, you mentioned in your prepared remarks that you've responded to information requests. Are you expecting those information requests to, maybe result in a PDUFA extension here? I know that this has been kind of a more common occurrence. Recently, so I guess, maybe, can you just give us you know, an update on the regulatory landscape for only a job?
Dr. Joe Wiley: Hi, Michelle. And yes, look, given the proximity of the PDUFA. We're not in a position to disclose the details of the on-going discussion. So you'll forgive us if we if we speak more generally. And Mark Sumeray, our Chief Medical Officer is on the call, Mark, do you want to talk about the information requests and the recent PDUFA extensions we see in the market?
Mark Sumeray: Yes, sure. Hi, Michelle. So I think the short answer from an Amryt perspective is that we have been very responsive to any information requests, we've had an all information requests from the FDA. So we've always been able to turn around the information required, very quickly and within the timelines, so as not to delay the process going forward. So I would say, although, as you point out, there have been other examples of extensions to the PDUFA days. We're not expecting to be in that position based on any outstanding information requests on our side.
Michelle Gilson: Thank you. And then maybe one on Mycapssa as well. You mentioned that as part of the re-launch, there's going to be enhanced patient support. I was wondering if you could maybe expand on that comment. And then also, when should we start thinking about, I guess, like, should we start thinking about an inflection point, or, I guess, no, what, what kind of timeline are you thinking in terms of when you expect to be seeing your repositioning efforts starting to gain traction, and result in kind of renewed growth in Mycapssa, or accelerated growth, I guess, in Mycapssa?
Dr. Joe Wiley: Yes, thanks Michelle. Let me let me answer that last question first, and then I might hand over to Sheila who is giving more color on the enhanced patient support. So I've described before, in fact, when we took over metreleptin we, we said the same thing. So we've done this before. And if you look at the timelines on that, what we said at the time, we can do this deal in August this year, we completed the previous acquisition in September 2019. I describe the time and actually described in our recent Amryt call again for Mycapssa. For metreleptin it's like it's like turning the wheel on a ship. You turn the wheel and it takes a little bit of time for the ship to turn, but return it does. We did that with metreleptin, metreleptin, you may recall was a an asset in the U.S. that was in decline. And we applied our methodology to that asset and within a Q1 to Q2 2020 we have that asset growing again and it's been growing ever since. So I think you should -- you should expect similar timelines here. We are encouraged by what we're seeing and we've only had control of this asset for a number of weeks. And as we seen from our prepared marks, we had a good September and October it was even stronger again. So we are seeing the beginnings of it. But again, I would expect, that similar timeframe, Q1 Q2, for us to see the fruits of, of what we are doing specifically up with this asset. So hopefully I could give you a bit of color on that. And as I said, we've done this before. So Sheila, maybe I’ll ask you to answer the enhanced patient support services question.
Sheila Frame: Sure. Thanks, Michelle. I think the way I would describe it is the, the way in which patient support services were provided, there were a number of handoffs and a number of different internal and external providers. So an individual patient could be contacted by a number of different people, whether it was reimbursement support, or AEs or titration support and that kind of thing. So what we're looking to do is really streamline that, so that it's a one point of contact for the patient, along with the support in the marketplace that's required. A number of the physician offices for example, have to complete prior authorizations as you do in all orphan diseases like this. And so I think that support was a bit of a gap in terms of what was being offered previously. So we're streamlining it just to make it a lot simpler for both patients and HCPs, in terms of getting access to this product. And certainly, the experience that Amryt has in doing that is, is certainly well evidenced on our existing products. So we're looking to do something similar with Mycassa in order to make it just simple and clear and fast.
Michelle Gilson: Okay. And if I could just follow up quickly on that, what is kind of the prior authorization timeframe to approval right now, how much of a delay should we see between an increase in orders or step up in orders versus when it actually hits the top line?
Sheila Frame: I think it's a similar question to what Joe said. I mean, it's, we're relaunching this product, essentially. So we've got the positive aspects that there wasn't that much awareness in the community. So we'll we should start to see some acceleration. On the other hand, in terms of specifically with priority, as well as we do that it depends on the payer, and how quickly that information gets into the system. We haven't seen any major barriers to gaining access. It's just the timeline of what's required for every single payer. And so that that certainly is something that's accelerating as payers get used to seeing Mycassa come through. And there's certainly good reception in the marketplace, both from patients and HCPs in order to get that. So I would expect that we'll see some acceleration in terms of that. Timing, but it's all over the map right now. Right. It just depends on the payer and the HCP office and coverage. So as we head into this coverage, transformation right for January 1, we're working with the patients that we have on therapy and new patients coming in to make sure that that prior authorization process starting in January, again, is as smooth as it can be.
Michelle Gilson: Okay, thank you so much for taking my questions. And congratulations again on on all the progress this quarter.
Dr. Joe Wiley: Thanks, Michelle.
Operator: Thank you. Your next question is from the line of Max Herrmann of Stifel. Please go ahead.
Max Herrmann: Great, thanks very much for taking my questions. Three of I may. Obviously, another good quarter, and clearly a lot of progress on the integration already. I have three questions. Firstly, just in terms of the revenue guidance. I wondered why you may because not to increase the top end of the range given obviously, your quarterly trends suggest you could have done that. So that's first question. Secondly, on Myalept. You've been in the U.S. market now for quite a while, but it's still getting remarkably strong growth there obviously Europe was exceptional. And I wondered if you could give some more color and what sort of penetration you've got in the U.S. and where you think it could go in terms of the GL population. And then finally, just on Mycapssa kind of interested in, how many patients you've got on therapy and how you see that as a KPI going forward? Thank you.
Operator: Joe, we lost you?
Rory Nealon: Okay, can Max, can you hear me?
Max Herrmann: I can hear you Rory.
Rory Nealon: We -- fill up for Joe, apologies for that. I think in relation to the patient numbers, it's not something we've given out. I guess, particularly by region, in that, as particularly when you go ex U.S., it's been our policy not to release patient numbers, because then you can work out very quickly what the average price per patient is. And then you get all sorts of discussions with individual jurisdictions. So it hasn't been our policy to these patient numbers. So forgive me on that one. In terms of guidance, you will recall and for those who go back and look at the numbers, for the nine months to date, I think we did 65.5 million, but a large chunk of that was LATAM and lumpy orders, sporadic orders of 13.6. So if you take out that 13.6 and I do not expect further LATAM orders in Q4, just to be clear. You take that out, you'd expect somewhere just north of $50 million in the final quarter. So obviously my capsule would increase as well as you go into the final quarter versus the two months, August, September. So we're still very comfortable the 220 to 225. Don't feel we are in a position to increase that right at the moment. So we're reiterating that guidance for the quarter. And then your other question about metreleptin. Has Joe rejoined us? Now, I must admit, I missed a piece of that. Sheila are you in a position to answer that question?
Sheila Frame: Yes, maybe just on metreleptin in the United States and Myalept and continued growth. I think one of the things that we mentioned earlier in the discussion, Max is just our experience using inside sales to support our field force has been very, very successful in terms of identifying those patients. And certainly, I think one of the things that's really been impressive is the consistency and persistence on therapy. Now, obviously we're pretty excited about the potential to launch the Phase 3and go into PL because I think that will certainly make a difference in the U.S. market. But and that certainly helping in Europe with respect to the broad label that they have in Europe, and that certainly contributes to the overall growth. But for sure, in the U.S. we continue to be able to find those patients. And the success rate with Myalept and patient consistency, and persistence with the therapy has made a big difference.
Max Herrmann: Can I just follow up on that? I mean, in terms of the patient population size, I believe there was sort of through about 300 patients with generalized lipodystrophy in the U.S. Are you saying that perhaps the market is bigger, there are more patients, or that your penetration of those patients is performing better than you had anticipated?
Sheila Frame: It's both an increase in penetration and an increase in persistence to therapy. And I don't think the market is bigger.
Max Herrmann: No, no, you're not finding out that there's a there are patients out there that you haven't identified or haven't been identified through epidemiology?
Sheila Frame: That's right. I don't think 330.
Max Herrmann: Great, thank you.
Rory Nealon: Thanks, Max.
Operator: Thank you. Your next question is from the line of Catherine Novack from Jones Research. Please go ahead.
UnidentifiedAnalyst: Hi, thanks so much for taking my questions. Congrats on the quarter. I had did have one more on metreleptin particularly on the EMEA performance. I'm kind of curious about how much of that performance is driven by expansion into new geographic territories versus, increased penetration in existing territories? And can you kind of elaborate on where you've seen the most growth? And how should we be thinking about that going forward?
Dr. Joe Wiley: Sorry, Rory. I'm back. My apologies, everyone, I got off the call. So in terms of metreleptin, as you've seen, metreleptin is growing significantly across the world, but in particular, in Europe. And that's because, as we've said before, metreleptin was only approved in July 2018 in Europe and also has a broader label. It has a label for both GL and PL in Europe whilst the label U.S. has only GL. So we're and that really helps to drive growth. In terms of how both occurs in Europe and maybe I spend a moment or two just explaining how Europe works because it's a very different system to the U.S. In Europe, once you get approval for a product, you have to go through national reimbursement and each unlike the U.S. almost no patients are reimbursed through private insurance. It's all national reimbursement. So -- you go through a process with each individual country, whereby you apply for market access, and each country in Europe is different. And that's why Europe is so challenging for companies who are not based over there because it's very difficult to understand how each system is completely different to the next country system. So it takes a long time to get experienced. We have that experience evidenced by our performance, not just with metreleptin Europe, but also with metreleptin in Europe. So it when you get national reimbursement and you agree on, on how to get that patients access to therapy, it's it basically opens up all patients in that country, to the product, so you tend to get a surge of patients going on to therapy. So for example, in this last year, we've had ration reimbursement in the U.K. for example. And you see a large number of patients, there's tent up demand as is excitement among the treating physicians in that country, that we have a therapy for patients. So they were probably a bunch of patients on. And then you see steady growth in the country beyond that. And we've seen that. So we see that across our European landscape. And that is driving growth. So we're seeing incremental patient growth in all of the major European markets that we've achieved national reimbursement. And then we expect future growth to come from further successes on national reimbursement in other countries, and also, its growth, not just in Europe, but it's also the Middle East as the growth is from EMEA. And that covers the Middle East as well. And we're also seeing significant growth, not just in metreleptin actually but also in the lomitapide. And we're seeing now new territories opened up in Eastern Europe, and CIS. So it really is a combination of both all of the above.
UnidentifiedAnalyst: Okay, got it. Thanks. Thanks so much. I kind of I also had one relating to the Chiasma acquisition, given the position of their TPE platform, do you have thoughts on how that might apply to your existing product portfolio, or how that might potentially shape the strategy of future products acquisitions?
Dr. Joe Wiley: Yes, that's, that's a great question. And I'm actually going to Israel, in two weeks’ time where this technology was developed to really further understand this exact point. We have already done significant work with the team over there, assessing the choosy. The Chiasma folk always knew that this product would go this technology is tough on technology could be broadly applicable. And it's not just applicable to octreotide but that there's a range of different assets that the technology could be applied to and there's been a bunch of, of research and work done on that. We're spending time really understanding that and looking and seeing whether, for example, could this technology be used with metreleptin or, or other assets. So we're excited by the potential of this platform technology. And we will update the market as we learn and understand more ourselves.
UnidentifiedAnalyst: Thank you very much.
Operator: Thank you. Your next question is from the line of Brandon Folkes of Cantor. Please go ahead.
Brandon Folkes: Hi, thanks for taking my questions. And congratulations on all the progress in the quarter. Firstly, maybe just Oleogel-S10 or see hearing what you did say earlier in the call. But given the questions you've been answering from the FDA at this stage, any change in your label expectations today. And then the next one is on lomitapide maybe just any color and the impact you're seeing from in the market during the quarter. I think we've talked about growth in this franchise in the past and maybe just are patients staying on lomitapide or are you seeing any patients which is at this stage? Thank you.
Dr. Joe Wiley: Yes, Brandon thanks for your questions, but we're not in a position given proximity of PDUFA to give you color on the exact discussions with the FDA at this point. But we are responding to all of the questions as we've said. In terms of the lomitapide we have been obviously an impact with coming onto the market and as you would expect with now in you competitive products in HoFH, in the U.S. However, and we're pleased to see our juxtaposed business in the U.S. has held up well, despite the fact that there is this new product on the market. Sheila, do you want to add any particular to the math.
Sheila Frame: Sure. We’ve certainly been able to maintain the patients that we have Brandon. And while we've seen a little bit. As you know, they've only had recently their discussions with payers, so I would expect that we might see more activity from the their launch in into next year. So I haven't had huge penetration in the U.S. market yet.
Dr. Joe Wiley: But what I will add, though, to that, Brandon is that we have maintained patient not just maintained patients on therapy, but actually we've been adding patients on to therapy as well. So we are still seeing new juxtapositions coming on to therapy.
Operator: Thank you. And your final question today is from the line of Douglas Tsao from H.C. Wainwright. Please go ahead.
Douglas Tsao: Hi, good morning. Thanks for taking the questions. I'm just curious. In terms of the endocrinology salesforce, what percentage of the time are they spending, promoting Mycapssa versus Myalept? And then also just in terms of the pickup in growth that you're seeing in Mycapssa and I know, it's still very early, but it sounds like the month a month have been sort of encouraging. If you can provide any color on where that's coming from, and sort of some of the drivers, is it just new awareness, or some benefit from reopening? I'm just curious, any color would be helpful? Thank you.
Dr. Joe Wiley: Yes, hi, Doug, this problem. You don't give us much time you folks we've already had exhausted since August 5. So we're, we're just in the process of integrating those two sales forces. We have a POA meeting next week in Dallas, where that so the folks that are our sales teams have been trained at this point cross trained. And we are really kicking off at our POA meeting next week. The new strategy for Mycapssa. With the pickup and growth we have seen, you can never really tell what's driving it. I think it was probably, our more focused medical affairs effort. And that's across the piece. And again, I'll ask Sheila, maybe to add a little bit more color.
Sheila Frame: Yes, then what I might add is, in most specialty launches, it takes at least eight calls before you get the first sort of trial prescription written. And during the pandemic, because of the difficulty in accessing the pituitary centers when we brought the Mycassa team on board, they really had only reached the target audience by I think like two and a half, maybe three calls in total. So in the last six weeks, what we're really focused on right now is making sure that they're rooting for our reps, is very much now into the community. So while they've had some coverage in our medical affairs team are certainly continuing to ensure awareness in the pituitary centers, our biggest opportunity now is into the community. So I guess what I would advise is maybe think about in some of the community, endocrinology, we're starting from, as if the product is just launching. And I think that's the way we need to consider it. In terms of effort between the two products, we're going to make sure that our team are taking advantage of every single call for both products. In the context of Myalept, of course, it's fewer total patient numbers in terms of what the opportunity is. So I think we'll see probably significant difference between the two products once it gets going. But I think we should be thinking about this, as eight calls to get the first prescription, usually between 14 and 18 calls, you'll start to see an acceleration. And then beyond that, you start to see more of a habit forming, and just given the impact of the pandemic and the previous company's focus. I think that's just going to take us some time as we get access into those community centers.
Operator: Thank you. There are currently no further questions.
Dr. Joe Wiley: Okay, so thank you all for joining us on today's call. And we hope to see you all soon hopefully in person. Thank you.
Operator: That concludes presentation. Thank you for participating. You may now disconnect.
