Amryt Pharma plc

Good day, ladies and gentlemen, and welcome to AMRIT Pharma third quarter 2021 results webcast and analyst call. At this time, all participants are in listen-only mode. After speaker's presentation, there will be question and answer session. To ask a question, please press star 1 on your telephone. Please be advised, today's conference is being recorded. I will now hand you over to AMRIT Pharma. Please go ahead.

Thank you, Operator. On the call today to discuss Amrit's Q3 results are Dr. Joe Wiley, CEO, and Rory Nealon, the company's CFO and COO. In addition, Dr. Mark Summary, Amrit's Chief Medical Officer, and Sheila Frame, President of 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 you 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 indicated in these statements. Words that express and 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 a 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's press release and conference call. Wednesday, November 3rd, 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, we would refer you to the forward-looking statement section of the full-year financial press release issued earlier today, as well as the company's filing with the SEC. At this time, I will turn the call over to Dr. Joe Wiley. Joe, please go ahead. 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, MetroLepsin, MyCapsa, and Limitified. AudioGel 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 last-time ordering and myCAPSAT, 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 asset, AudioGel 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 30th. 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 policy, I'm now on slide five. Beginning with Metro-Lefton, revenues in Q3 were $36.3 million compared with $29.9 million in the same period of 2020. Metro-Lefton US 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, Metro-Lefton 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. We have previously shared with you our lifecycle plan in the U.S. to seek a label expansion for metroleptin to include the treatment of partial lipodystrophy in addition to the currently approved label for the treatment of general lipodystrophy. We received feedback from the FDA on a path forward for this initiative, which will require a Phase III study, and we are on track to initiate this study by the end of 2021. Let's move to Limitified on slide six. Limitified 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. Limitified, 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 paediatric study for Limitified and HOSH and we expect to have data mid-2022. Assuming positive data, we will seek approval of Lumicipide to treat children with HSH in both the US and Europe. Now onto myCAPSA on slide seven. myCAPSA, the first and only somatostatin analogue oral capsule, is a genuinely differentiated product. Given the robust clinical data supporting it and the patient preferences for orals, we believe myCAPSA 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 8,000 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 product, and we are excited to have it as part of our portfolio, and our entire team is energized to execute on the launch. Amherst held a virtual capital markets event on September 13th. The participants included Dr. Maria Flechereau of Oregon Health and Science University, who is a 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 Summeray, provided an update on our plans to develop mycapsa in patients with carcinoid symptoms stemming from neuroendocrine tubers, where the market opportunity is estimated at approximately $1.9 billion globally. We intend to pursue a 505 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 webcasted presentation and accompanying slides. Turning to the product's performance in the quarter. Like Capsule delivered sales of $1.45 million, this reflects sales from August 5th when we closed the Kiasma acquisition. Revenues in Q3 were impacted by pre-ordering in Q2. Normal ordering patterns were returned in September, and the product delivered $1.14 million for the month, and it delivered another strong month in October. This product 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 mycapsa, and they're certainly aware that there is an oral option available for octreotides. We also know that there's comfort from a physician perspective in making the switch from injectables. Furthermore, the product represents a compelling value to payers. At 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 had been exclusively focused on the pituitary centers. However, these centers were mostly closed due to the pandemic. Now, by combining the sales forces and medical teams of both organizations, Amrit is now in a position to take advantage of our MetroLeptin reps in the U.S. to accelerate the adoption of myCAPSET in the broader endocrinology community. We estimate that about 50% of the market is outside the PTCs. We already have depth of experience using an inside sales force to help identify where the patients are in the community. That helps us with metrolaptin, and we know that we can do the same thing again with mycapsa. We've combined our medical affairs teams to increase our share of voice in the field and across endocrinology. And finally, we have enhanced our patient support services to better support patient transition from injection to a morning and bedtime capsule. As these initiatives are being rolled out, we are pleased to see they've started to have an impact. And if we look at ordering patterns, we're very encouraged to see that monthly Metapsa orders in October were more than three times the orders in January. Now on to our lead pipeline asset, Oluogel S10, which will be marketed under the brand's name, FiltreVest, if approved. And now on slide eight. Oluogel S10 is a potential novel treatment for the continuous manifestations of severe EB, a rare and distressing genetic skin disorder affecting young children and adults. There is currently no approved therapy for this condition, and if approved, it would be the first to market for those patients suffering from this devastating condition. We continue to progress the regulatory pathway for Oliogel 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 producer 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. Our NDA is being assessed under priority review, and if approved, AMA will be eligible to apply for a priority review voucher. In Europe, we have responded to questions from the EMA that are on course for a THMP opinion in late Q4. Moving to slide nine, whilst the regulatory activities are ongoing, we are moving forward with our launch plans. If approved, we have the financial flexibility, teams, systems, and global infrastructure in place to bring all your gels to market and to execute our significant growth plans. EB represents a highly concentrated market. In the US, there are three world-class leading institutions, and then an additional seven that run specialized EB clinics. 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. One of the most important support services we can provide for patients is reimbursement. We've started to already engage with payers to make sure that they understand the burden of EB and the value that Oliogel S-CAN will bring to these patients. In parallel, we have been scaling up 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. With that, we intend to have a dual-sourcing strategy that will be executed across the supply chain and manufacturing scale-up in order to support commercial demands beyond this. We look forward to providing the next update on Audiovisual S10 once we have a decision from the FDA. Let me now turn the call over to our CFO and COO, Rory Miller, who will provide more details on the Q3 financials. Rory.

Thanks, Joe. My remarks today will take a little longer than normal as I plan to cover the acquisition accounting from the recent Chiasa merger. as well as my usual comments on the financials for the quarter. So let's start with revenues. Joe has already covered the revenue performance by product and by geography. And just to remind you of the headline numbers, we've seen an overall 14.6% improvement in our quarterly year-on-year revenues, which is predominantly driven by a 21.5% growth in our Metro-Lefton revenues. If we look at the growth in our Metro-Lefton business and ignoring the impact of the sporadic laptop orders, which were significant in Q3 last year, The growth, as Joe said, year on year was actually 51.6% in Metro-Lefton, which we're particularly pleased with. We, of course, also included revenues from my CAPSA for the first time following the acquisition, which completed on 5 August. On our recent analyst call, you will have heard Joe allude to the impact of a price increase put in place prior to the deal close, 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 being more reflective of reality. Joe 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. The next item I'd like to touch on is our gross margin performance, excluding the impact of non-cash items, which once again exceeds 75% for the quarter. This compares 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 Metroleptin making that product a lower-margin product as compared to Limitibide. As sales of Mycapsa now start to increase, we expect the combined group margin to edge upwards. Mycapsa has no third-party royalties, and we expect the gross margin on that product to be closer to 80%. Further, if Oliogel S10 is approved in EB, we expect additional upward trends in our gross margin given Oliogel 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 our intangible metraleptin and limitified 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 my caps intangible asset, which was $1.96 million for the month of August and September, being the period post the closing of the acquisition on 5 August. And finally, we once again have amortization of the fair value step-up of acquired inventory, this time from the chiasm acquisition. When a company acquires another company, the accounting rules for their IFRS or UF gap requires the acquirer, in this case Amarit, to fair value upwards the acquired Kiasma 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 upwards fair valuation and the subsequent amortization of this uplift are both non-cash accounting transactions. In calculating our EBITDA quarterly, we reverse out these non-cash amortization amounts, and this amounted to $400,000 for the quarter just gone. In total, the uplift in acquired inventory, Kiasma acquired inventory remaining as of 30 September was $40 million, and we estimate we will continue to see these fair value uplift amortization amounts for approximately two years as we sell the inventory, which we acquired on 5 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 Q1 and Q2, which is in part due to the preparation work for the commencement of our U.S. partial lipodystrophy study and also given the new R&D spend, which has come about following 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 compares to $17.8 million in Q1, and $18.9 million in quarter two, again, ignoring the impact of deal costs, and is obviously in large part driven by the inherited SG&A costs from Chiasma. Chiasma itself spent $15.7 million in SG&A for the three months of quarter one this year, being the last publicly reported results for Chiasma as a standalone entity, and for rating this $15.7 million for the three months in quarter one down to two months to approximate the August-September costs for AMRAD post-acquisition, would suggest an inherited incremental spend of approximately $10.5 million for those two months. As I just noted, Amrit's 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 Q3. This increase of $6.8 million in Q3 is not only due to the Chiasma cost base inherited, but is also driven by increased spend associated with the impending Oleogel S10 launch, if approved. Our goal at the outset was to rapidly reduce the significant inherited chiasma cost, and based on these numbers I've just given you, we're having a material impact already. I'll touch on this point again when I cover our EBITDA numbers. As we go forward into the remainder of H2, and as I just noted, we're also understandably starting to increase our pre-launch spend for AlioGel S10 and EB. In particular, we're actively recruiting to add a select number of additional customer-facing staff to the team, predominantly based in the USA. Accordingly, you should expect an additional increase in our total SG&A spend going into Q4 if AlioGel 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 in an acquisition can 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 Kiasma restructuring and acquisition costs, which is a better reflection of the underlying performance of the business, and I'll then provide some additional colour on those exceptional deal costs. EBITDA, before such exceptional costs, was $6.2 million for the quarter. This is a reduction from quarter two for three principal reasons, namely, one, a reduction in overall revenues given the significant $12.1 million in lumpy orders from Metroleptin into LATAM and Q2. The second one was an ongoing increase in our pre-launch spend, as I've mentioned, for Oliogel S10, In order to be prepared for launch, should the product be approved by the FDA in late Q4? And finally, and most significantly, the ongoing 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, one would expect approximately $12 million of operating losses for the month of August and September, being two-thirds of the $18 million loss in Q1. In reality, Amrit has reduced this pro forma $12 million by approximately half for the two months, which is a significant and rapid reduction in the Chiasma cost base. You will recall Amrit has a strong track record of rapidly taking costs out of an acquired business. We did it in our previous acquisition in 2019 within two quarters, and we're on track to achieve similar results with the Chiasma business. In particular, in both of these transactions, we have and are transitioning a sizable number of non-customer-facing functions and roles from Boston to Dublin, which results in significant economies of scale. We're also leveraging off the significant previous experience that the management team of Armut 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 are $36.8 million for the year to date. This is before restructuring and acquisition costs 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 of severance costs. These are the severance costs for those employees that have already left Chiasma. There will be ongoing severance costs for those Chiasma employees who are transitioning out of the group, and we're 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 in our income statement, you will note that the non-cash change in fair value of the contingent consideration and the non-cash contingent 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 a $6.4 million charge for net finance expense for the quarter, of which $3.1 million is non-cash and $3.3 million is predominantly 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 positions. You may recall we paid off a debt type arrangement which Chiasma had on closing the deal. Accordingly, excluding our convertible to venture, 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 of $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 Amrit's contribution to the repayment of a chiasma debt type instrument on closing of $21.6 million. This being the difference between the total debt amount of $116.6 million, less the inherited chiasma cash, which was also used to repay the debt. We obviously had significant Amrit and chiasma deal and restructuring-related costs that were 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 Amrit and Chiasma deal and restructuring-related costs. These costs were accrued in quarter three, but the actual cash payment was in quarter four, which will have a once-off effect on our cash in Q4. In addition to our term debt, we do have a convertible loan with a principal value of $125 million with a conversion price of $12.95 per ADS or $2.59 per ordinary share. Given the strong ongoing operational performance of the business, we believe that it's likely that this will get converted to equity before it is otherwise due for a payment in April 2025. As a result, we view this as more akin to equity than 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-co-to, and now that those two years are up, 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 5 in 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 are then permitted to update those valuations over the course of 12 months from the date of acquisition. The result of this exercise shows that we paid $260 million in consideration by way of amortized shares, and we effectively paid an additional $10 million by assuming the outstanding Kiasma employee share options and RSUs. In return, we received intangible assets being the value of ICAPSA 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 of $108 million and a third party debt type facility of $116.6 million. As noted earlier, this debt was repaid on closing, and we used a combination of the inherited Chiasma cash and $21.6 million of legacy Amra cash to repay it. Before concluding, I'd like to update you on our cap table. At the end of September, we have 316,904,642 ordinary shares in issue, or 63.4 million ADS equivalents, with the ADS being what's listed on that deck. We have no warrants in existence in the group. Regarding shared options and ORSUs, you will find a lot more detail in Note 4 of the quarterly financial statement. You will recall we inherited the legacy Chiasma equity scheme, and that remains alive, albeit no further shared options or ORSUs 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 average equity scheme. I'll summarize in note four of the quarterly financial statements and adding both the Amherst and Chiatan equity schemes together. We have share options outstanding over 45.4 million ordinary shares or 9.1 million ADF equivalents at strike prices ranging from sterling pounds 54 pence to sterling pounds 9 pounds and 35 pence per ordinary share or approximately $3.69 to $63.86 per ADF. We also have combined RSUs outstanding as at the end of September of 1.76 million ordinary shares or 352,000 ADS equivalents. As I noted, there's a lot more detail in Note 4 if anyone is interested. That's the end of my remarks, and I'll now hand back to you, Joe.

Thank you, Rory. I am now on slide 11. Let me summarize by reviewing where AMET stands today post-closing of the Chiasma acquisitions. We have a revenue-generating commercial portfolio that is now comprised of three marketed 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 AudioGel S10 in a global market estimated to be worth in excess of $1 billion, and we are also preparing to enter phase three with MICAPSA in neuroendocrine tumors, where we estimate that 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 ongoing relaunch of MICAPSA. And finally, we have global commercial infrastructure the financial flexibility to execute on our plans, as well as an experienced team to drive new product launches and growth. I will now hand over to our operator for Q&A. Operator.

Thank you. We will now begin the question and answer session. If you'd like to ask a question, please press star and one on your tablet and wait for your name to be announced. You can cancel your request at any time by pressing a hash key. So once again, it is star and one for any questions you may have. And your first question is from the line of Mani Sohar from SVB Living. Please go ahead.

Thanks for taking the question, and congratulations on the continued progress across the portfolio. I'll start with all your job as tenants. You guys are sketching out how concentrated this market is on a prescriber-based basis. Can you give us a sense of the timeline to reimbursement and about how you think about the split of this market by payer in the U.S., Medicaid versus commercial, and how long it would take to realize to achieve reimbursement approximately on Medicaid on a state-by-state basis? Then I have a quick follow-up.

Hi, Manny. Thanks for your questions. Yeah, obviously that is going to be dependent on the regular timelines. And as you know, we have the target for due for date of November 30th. So I'll hand over to Sheila. So Sheila, if approved, what are the timelines to reimbursement?

Sure. Thanks so much for the question. And 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 exception letter, but we have been working with those key centers to make sure that they're ready to get those medical exception 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 epidermalosis below suck. And so we will be focusing very quickly on those key states the minute we get that PI and the label and the approval.

Great. That's really helpful. So hopping over to my capsule, 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 them, from Chiasma, rather. Looking forward, how should we think about incremental spend as you expand the population of touch points as you look to go out in the community. Is that largely spend baked into your existing sales force? Should we expect further expansion of the sales force to drive that revenue growth? Can you scale that for us?

Sorry, go on, Mario. Okay, so let me talk to you about... the overall strategy, and I'll let Sheila come back in with maybe some more detail. But the idea here was that we have overlap in terms of call points, right? So, acromegaly patients are seen by endocrinologists, and endocrinologists are also treating lipodystrophy. In fact, endocrinologists also treat HFH. Therefore, we already have had in place prior to the closing of the deal, a full field force, but focused on the community, right? So we were very much focused on the community endos seeking to find those lipid dystrophy patients, which we generalized lipid dystrophy and put them onto therapy. The asthma elected to focus exclusively on the pituitary treatment centers or the PTCs. So they were detailing those centers. The problem, and that's a good strategy, given that there's the KOLs are treating acromegaly patients in these pituitary centers, obviously. However, during the pandemic, they closed and they closed to commercial. And 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 and there's no incremental really be further expected by combining our two sales force what we've done is we continue to focus on the pituitary centers we did that virtually but most importantly we've cross trained the two sales teams so both the mycapsa sales team have been trained on metroleptin and the metroleptin sales team have been trained on mycapsa 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, effectively combining our medical affairs function with theirs and deploying them in a similar fashion. And we have focused on the on the patient services side of things, bringing our model 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 Manny on that.

Sure. Although I think you covered it pretty well, Joe. Essentially, Manny, we've doubled the size of our footprint as it relates to endocrinologists. So we're not walking away from the pituitary centers, but we've been additive in terms of our Myelap team to be able to add my CAPSA at the community level. So I think the team is certainly ready, engaged, and, you know, excited to get out there. And I think, you know, what we found with the former organization is they struggled to get enough calls. 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 to 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, you know, really from August 6th until yesterday, we were able to be up and running with the team now integrated on the ground, in territory, and cross-trained. So I think going forward, we're expecting to see some acceleration fairly quickly just in terms of share of voice in that regard.

Great. That's really helpful. Thanks, guys.

We will now take our next question, and that is from the line of Michelle Gleason. Please go ahead.

Hi. This is Michelle Gleason from Canaccord Genuity. Congrats on the quarter and all the accomplishments in Q3. I guess, you know, starting with oleagel, you know, 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 label 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 oleagel?

Hi, Michelle. Yeah, look, given the proximity of the PDUFA, we're not in a position to disclose the details of the ongoing discussion. And you'll forgive us if we speak more generally. Mark Summery, our Chief Medical Officer is on the call. Mark, do you want to talk about the information requests and the recent PDUFA extensions we've seen in the market?

Yeah, sure. Hi, Michelle. So I think the short answer from an AMRIT perspective is that we have been very responsive to any information requests we've had and all information requests from the FDA. So we've always been able to turn around the information required very quickly and within the timeline, 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 Purdue for gold days, we're not expecting to be in that position based on any outstanding information requests on our side.

Okay. Thank you. And then maybe one on my CAPSA as well. You mentioned that as part of the relaunch, 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, you know, what kind of timeline are you thinking in terms of when you expect to be seeing your repositioning efforts starting to gain traction and, you know, result in kind of renewed growth in MICAPSA or accelerated growth, I guess, in MICAPSA?

Yeah, thanks, Michelle. Let me answer that last question first, and then I might hand over to Sheila to give you more color on the enhanced patient support. So, I've described before, in fact, when we took over at MetroLeptin, we said the same thing. So, you know, we've done this before, and if you look at the timelines on that, what we said at the time We completed this deal in August this year. We completed the previous acquisition in September 2019. I described at the time, and I actually described in our recent analyst call again, for Metroleptin, 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 turn it does. We did that with Metroleptin. Metroleptin, you may recall, was an asset in the US that was in decline. and we applied our methodology to that asset, and within Q1, Q2 2020, we have that asset growing again, and it's been growing ever since. So I think you should expect similar timelines here. We are encouraged by what we're seeing. We've only had control of this asset for a number of weeks, and as we alluded to in our prepared remarks, you know, we had a good September and October was even stronger again. So we are seeing the beginnings of it. But again, I would expect, you know, that similar timeframe, Q1, Q2, for us to see the fruit of what we are doing specifically with this asset. So hopefully that gives you a bit of color on that. And as I said, we've done this before. So, yeah. Sheila, maybe I'll ask you to answer the enhanced patient support services question.

Sure. Thanks, Michelle. I think the way I would describe it is 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, you know, 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's just to make it a lot simpler for both patients and HCPs in terms of getting access to this product. And certainly, you know, the experience that AMRIT has in doing that is certainly well evidenced on our existing products. So we're looking to do something similar with mycapsa in order to make it just simple and clear and fast.

Okay. And if I could just follow up quickly on that, what is kind of the prior authorization timeframe to approval right now? You know, how much of a delay should we see between, you know, an increase in orders or step up in orders versus when it actually hits the top line?

I think it's a similar question to what Joe said. I mean, you know, it's going to, we're relaunching this product essentially. So we've got the positive aspects that, there isn't that much awareness in the community, so we should start to see some acceleration. On the other hand, in terms of specifically with prior auth, you know 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 certainly is something that's accelerating as payers get used to seeing MICAPSA come through, and there's certainly good 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 1st, 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.

Okay. Thank you so much for taking my questions, and congratulations again on all the progress this quarter.

Thanks, Michelle.

Thank you.

Your next question is from the line of Mark Herman of Stifel. Please go ahead.

Great. Thanks very much for taking my questions, Marie, if I may. Obviously, another good quarter, and clearly a lot of progress on the integration already. Three questions. Firstly, just in terms of the revenue guidance, I wondered why you maybe chose not to increase the top end of the range, given obviously your quarterly trends suggest you could have done that. So that's the first question. Secondly, on my elect, you know, it's 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 in, you know, 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 my CAPSA, kind of interested in, you know, how many patients you've got on therapy and, you know, how you see that as a KPI going forward. Thank you.

Joe, have we lost you? Okay. Max, can you hear me?

I can hear you, Rory.

Yeah, we've obviously lost you, so 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 particularly when you go ex-US, 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. It hasn't been our policy to release 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 165.5 million, but a large chunk of that was the LATAM 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, you know, obviously my caps would increase as well as you go into the final quarter versus the two months, August, September. So we're still very comfortable with a 220 to 225. Don't feel we're in a position to increase that rate at the moment. So we're reiterating that guidance for the quarter. And then your other question about MetroLeptin, has Joe rejoined yet? No. I must admit, I missed a piece of that. Sheila, are you in a position to answer that question?

Yeah, maybe just on metraleptin in the United States and myoleptin in the 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 at the potential to, you know, launch the phase three and go into PL, because I think that will certainly make a difference in the U.S. market. And that's 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 MyoLept and patient consistency and persistence with the therapy has made a big difference.

Can I just follow up on that? I mean, in terms of the patient population size, I believe there were sort of 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?

It's both an increase in penetration and an increase in persistence to therapy.

But I don't think the market's bigger. You're not finding out that there are patients out there that you hadn't identified or hadn't been identified through epidemiology?

That's right. I don't think the market Great.

Thank you.

Thanks, Max.

Thank you. Your next question is from the line of from John's research. Please go ahead.

Hi. Thanks so much for taking my question. Congrats on the quarter. I had I did have one more on Metroleptin, particularly on the EMEA performance. I'm kind of curious about, you know, how much of that performance is driven by expansion into new geographic territories versus, you know, increased penetration in existing territories? And can you kind of elaborate on where you've seen the most growth? And, you know, how should we be thinking about that going forward?

Sure. Hi, Kathleen. Sorry, I'm back. My apologies, everyone. I got bumped off the call. In terms of Metroleptin, as you've seen, Metroleptin is growing significantly across the world, but in particular in Europe. And that's because, as we've said before, Metroleptin 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, whereas the label in the U.S. is only GL. And that really helps to drive growth. In terms of how both occurs in Europe, maybe I'll spend a moment or two just explaining how Europe works because it's a very different system to the US. In Europe, once you get approval for a product, you have to go through national reimbursement. Unlike the US, 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's system. So it really takes a long time to get experience. We have that experience evidenced by our performance, not just with Metro-Leptin in Europe, but also with the Metapies in Europe. When you get national reimbursement and you agree on how to get that patient's access to therapy, 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 national reimbursement in the UK, for example, And you see a large number of patients. There's pent-up demand as there's excitement among the treating physicians in that country that at last we have a therapy for patients. So they will put 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, it's growth not just in Europe, but it's also the Middle East. The growth is from EMEA, and that covers the Middle East as well. And we're also seeing significant growth, not just in Metrolapse Natural, but also in Lumetipine, And we're seeing now new territories open up in Eastern Europe and CIS. So it really is a combination of all of the above.

Okay, got it. Thanks so much. I also had one relating to the Chiasma acquisition. You know, given the acquisition 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 product acquisitions?

Yeah, that's a great question. 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 opportunity. The Chiasma folk always knew that this product or this technology, this platform technology could be broadly applicable. It's not just applicable to a creatide, but that there's a range of different assets that the technology could be applied to. And there's been a bunch 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 MetroLeptin or other assets? So we're excited by the potential of this platform technology, and we'll update the market as we learn and understand more ourselves.

Thank you. Got it. Thanks. Thank you very much.

Thank you. Your next question is from the line of Brandon Fawkes of Kantor. Please go ahead.

Hi, thanks for taking my questions, and congratulations on all the progress in the quarter. Firstly, maybe just on Aliajel S10, obviously 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 Limitapide. Maybe just any color in the impact you're seeing from Evkiza in the market during the quarter? Yeah, I think we've talked about growth in this franchise in the past. So maybe just, are patients staying on Lumitapide, or are you actually seeing any patient switches at this stage? Thank you.

Yeah, as I said earlier, Brandon, thanks for your questions, but we're not in a position given proximity of Purdue to give you color on the exact discussion with the FDA at this point. But we are responsive to all of the questions, as we've said. In terms of Lumitapide, We have been, obviously, in impact with Evernacumab coming onto the market, as you would expect with now a new competitive product in HOSH in the U.S. However, we're pleased to see that our juxtapid 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 further colors on that?

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 their launch into next year. So they haven't had huge penetration in the U.S. market yet.

But what I will add to that, Brandon, is that we have maintained patients, not just maintained patients on therapy, but actually we've been adding patients onto therapy as well. So, you know, we are still seeing new, juxtaposed patients coming onto therapy.

Thank you. And your final question today is from the line of Doug Laster from HC Wainwright. Please go ahead.

Hi, good morning. Thanks for taking the questions. I'm just curious, In terms of the endocrinology sales force, what percentage of the time are they spending promoting mycapsa versus myelapse? And then also just in terms of the pickup and growth that you're seeing in mycapsa, and I know it's still very early, but it sounds like the month-on-months have been sort of encouraging. If you can provide any color on that. where that's coming from and sort of some of the drivers. Is it just new awareness or is it some benefit from reopening? I'm just curious. Any color would be helpful. Thank you.

Yeah. Hi, Douglas. The problem, you don't give as much time, you folks. We've only had this asset since August 5th. So we're just in the process of integrating those two sales forces. We have a POA meeting next week in Dallas. 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 MyCapsa. The pickup and growth we have seen You can never really tell what's driving it. I think it's probably our more focused medical affairs effort, and that's across the piece. Again, I'll ask Sheila maybe to add a little bit more color.

Yeah, Dan, 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 MICAPSA 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 the rooting for our reps is very much now into the communities. So while they've had some coverage and 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, you know, we're going to make sure that our team are taking advantage of every single call for both products. In the context of my left, 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, you know, 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.

Thank you. There are currently no further questions.

Okay, so thank you all for joining us on today's call. We hope to see you all soon, hopefully in person. Thank you.

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