Q2 2026 Egetis Therapeutics AB (publ) Earnings Call

August 21, 2026

Speaker #2: Your line is muted.

Speaker #3: Call recording is on.

Speaker #4: Welcome to Egetis Therapeutics' Q2 report 2026. For the first part of the conference call, participants will be in listen-only mode. During the question-and-answer session, participants are able to ask questions by dialing #Key5 on their telephone keypad.

Operator 2: Welcome to Egetis Therapeutics Q2 Report 2026. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing #5 on their telephone keypad. Now, I will hand the conference over to CEO Nicklas Westerholm. Please go ahead.

Operator: Welcome to Egetis Therapeutics Q2 Report 2026. For the first part of the conference call, the participants will be in listen-only mode. During the questions-and-answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now, I will hand the conference over to CEO Nicklas Westerholm. Please go ahead.

Speaker #4: Now, I will hand the conference over to CEO Nicholas Westerholm. Please go ahead.

Speaker #5: Thank you. I'm the operator. Good afternoon, good morning, and a warm welcome to the Egetis Therapeutics Q2 results webcast, planned for the coming 30 minutes. For those who haven't had the privilege to meet me before, my name is Nicholas Westerholm, and I am the CEO of the company.

Nicklas Westerholm: Thank you, operator. Good afternoon, good morning, and a warm welcome to Egetis Therapeutics Q2 Results webcast planned for the coming 30 minutes. For those who I haven't had the privilege to meet before, my name is Nicklas Westerholm, and I am the CEO of the company. I will start today's session with a short business update. This will be followed by Anny Bedard, President of our US and North American business, who will discuss the launch preparations for the planned Emcitate launch in the US, subject to approval. Henrik Krook, Vice President Commercial Operations, will give a commercialization update of Emcitate in the European Union as well as other international markets. Finally, Yilmaz Mahshid, Chief Financial Officer, will provide a financial update before we're looking ahead to the exciting upcoming key value-enhancing milestones. We aim to leave ample time for Q&A at the end of the session.

Speaker #5: I will start today's session with a short business update. This will be followed by Annie Bedard, President of our U.S. and North American business, who will discuss the launch preparations for the planned MCTATE launch in the U.S.

Speaker #5: Subject to approval, Henrik Krook, Vice President of Commercial Operations, will then give a commercialization update on MCTATE in the European Union, as well as other international markets.

Nicklas Westerholm: Henrik Krook, Vice President Commercial Operations, will give a commercialization update of Emcitate in the European Union as well as other international markets. Finally, Yilmaz Mahshid, Chief Financial Officer, will provide a financial update before we're looking ahead to the exciting upcoming key value-enhancing milestones. We aim to leave ample time for Q&A at the end of the session. The most significant event during the H1 2026 was the acceptance of our US new drug application, NDA, for Emcitate.

Speaker #5: Finally, Yilmaz Mashid, Chief Financial Officer, will provide a financial update before we look ahead to the exciting upcoming key value-enhancing milestones. We aim to leave ample time for Q&A at the end of the session.

Speaker #5: The most significant event during the first half of 2026 was the acceptance of our U.S. new drug application (NDA) for MCTATE. The grant of a priority review by the FDA, with a PDUFA date set for the 28th of September.

Nicklas Westerholm: The most significant event during the H1 2026 was the acceptance of our US new drug application, NDA, for Emcitate. The grant of a priority review by the FDA with a PDUFA date set for 28 September. So far, it has been a collaborative dialogue with the agency throughout the review. The FDA has confirmed that it expects to finish its review by the PDUFA date on 28 September and does not plan to hold an advisory committee meeting. Subject to approval, the Emcitate launch in the US is planned for the Q4 this year. During the Q2, we were also granted our first patent for Emcitate by the US Patent and Trademark Office. The patent provides protection for a novel composition with tiratricol as the active ingredient.

Nicklas Westerholm: The grant of a priority review by the FDA with a PDUFA date set for 28 September. So far, it has been a collaborative dialogue with the agency throughout the review. The FDA has confirmed that it expects to finish its review by the PDUFA date on 28 September and does not plan to hold an advisory committee meeting. Subject to approval, the Emcitate launch in the US is planned for the Q4 this year. During the Q2, we were also granted our first patent for Emcitate by the US Patent and Trademark Office. The patent provides protection for a novel composition with tiratricol as the active ingredient.

Speaker #5: So far, it has been a collaborative dialogue with the agency throughout the review. The FDA has confirmed that it expects to finish its review by the PDUFA date on September 28, and does not plan to hold an advisory committee meeting.

Speaker #5: Subject to approval, the MCTATE launch in the U.S. is planned for the fourth quarter this year. During the second quarter, we were also granted our first patent for MCTATE by the U.S.

Speaker #5: Patent and Trademark Office. The patent provides protection for a novel composition with theatrical as the active ingredient. The claims cover, amongst other things, a method of treatment for MCTATE deficiency, with the claimed pharmaceutical composition that encompasses theatrical, dosing regimens, and theatrical composition with specific excipients.

Nicklas Westerholm: The claims cover, amongst other things, a method of treating MCT8 deficiency with a claimed pharmaceutical composition that encompasses tiratricol dosing regimes and tiratricol composition with specific excipients. This patent is a significant milestone in strengthening our intellectual property portfolio. We expect the granted patent to be Orange Book listable with an expiration date of 2045. Revenue for Q4 was 17.4 million SEK, corresponding to year-on-year growth of 23% at constant exchange rate. As Henrik will describe further, the MCT8 price negotiations within the German reimbursement process, AMNOG, were successfully concluded in Q2. Furthermore, in the quarter, we also successfully carried out a substantially oversubscribed directed share issue amounting to 350 million SEK, approximately $38 million, at the closing price on Nasdaq Stockholm on the day of the raise.

Speaker #5: This patent is a significant milestone in strengthening our intellectual property portfolio. We expect the granted patent to be Orange Book listable, with an expiration date of 2045.

Speaker #5: Revenue for the fourth quarter was SEK 17.4 million, corresponding to a year-on-year growth of 23% at constant exchange rates. As Henrik will describe further, the MCTATE price negotiations within the German reimbursement process, AMNOG, were successfully concluded in the second quarter.

Nicklas Westerholm: Revenue for Q4 was SEK 17.4 million SEK, corresponding to year-on-year growth of 23% at constant exchange rate. As Henrik will describe further, the MCT8 price negotiations within the German reimbursement process, AMNOG, were successfully concluded in Q2. Furthermore, in the quarter, we also successfully carried out a substantially oversubscribed directed share issue amounting to SEK 350 million, approximately $38 million, at the closing price on Nasdaq Stockholm on the day of the raise.

Speaker #5: Furthermore, in the quarter, we also successfully carried out a substantially oversubscribed directed share issue, amounting to SEK 350 million (approximately $38 million), at the closing price on Nasdaq Stockholm on the day of the raise.

Speaker #5: We were particularly pleased to see strong participation from both existing shareholders and several new international specialist healthcare investors, which will further broaden our shareholder base.

Nicklas Westerholm: We were particularly pleased to see strong participation from both existing shareholders and several new international specialist healthcare investors, which will further broaden our shareholder base. Last but not least, we are pleased to welcome Tiago Nunes, a very seasoned drug developer, as our new Chief Medical Officer in May. One of Tiago's main tasks will be to drive MCT8's exciting indication expansion opportunity in Resistance to Thyroid Hormone beta forward in the short-term future. I will now hand over to Anny. Anny, please go ahead.

Speaker #5: Last but not least, we're pleased to welcome Tiago Nunes, a very seasoned drug developer, as our new Chief Medical Officer in May. One of Tiago's main tasks will be to drive MCTATE's exciting indication expansion opportunity in resistance to thyroid hormone type beta forward in the short-term future.

Speaker #5: I will now hand over to Annie. Annie, please go ahead.

Speaker #6: Thank you, Nick. Good afternoon and good morning, everyone. We're approaching an exciting milestone—one that could bring the first approved therapy to a community that has waited a long time for it.

Anny Bedard: Thank you, Nik. Good afternoon and good morning, everyone. We are approaching an exciting milestone, one that could bring the first approved therapy to a community that has waited a long time for it. With fewer than 30 business days to the PDUFA date, our focus is now on disciplined execution to enable the US launch in Q4. Since our Q1 update, we have completed the build-out of our US commercial organization. Our medical affairs and field team are fully trained and deployed, and an experienced team of rare disease professionals is now executing a single integrated launch plan. The organization is just over 20 employees to date, supplemented by specialized consultants, and will scale to around 25 at launch. Launch readiness activities are advancing across all critical work streams depicted on this slide. The patient support services operating model has been established.

Speaker #6: With fewer than 30 business days to the PDUFA date, our focus is now on disciplined execution to enable the U.S. launch in Q4. Since our Q1 update, we've completed the build-out of our U.S. operations.

Speaker #6: Our commercial organization, medical affairs, and field team are fully trained and deployed, and an experienced team of rare disease professionals is now executing a single integrated launch plan.

Speaker #6: The organization is just over 20 employees today, supplemented by specialized consultants, and will scale to around 25 at launch. Launch readiness activities are advancing across all critical workstreams depicted on this slide.

Speaker #6: The patient support services operating model has been established; payer engagement and value communication activities are underway; and specialty distribution and supply partners have been contracted.

Anny Bedard: Peer engagement and value communication activities are underway, and specialty distribution and supply partners have been contracted. We continue to expand engagement with the specialist physicians most likely to diagnose and treat MCT8 deficiency. These are the pediatric endocrinologists, pediatric neurologists, and geneticists, while expanding patient identification efforts to increase diagnosis and support long-term market development. Our continued engagement with patient advocacy organization helps increase disease awareness, support patient identification efforts, and inform our understanding of community needs. Our top priority at launch will be continuity of care for patients currently receiving tiratricol through the expanded access. Ensuring a seamless transition to commercial supply reduces the risk of interruption and supports initial commercial adoption. To date, approximately 60 patients across 17 sites nationwide are being treated under the expanded access program, a number that continues to grow month-over-month.

Speaker #6: We continue to expand engagement with the specialist physicians most likely to diagnose and treat MCTATE deficiency—these are the pediatric endocrinologists, pediatric neurologists, and geneticists—while expanding patient identification efforts to increase diagnosis and support long-term market development.

Speaker #6: Our continued engagement with patient advocacy organizations helps increase disease awareness, support patient identification efforts, and inform our understanding of community needs. Our top priority at launch will be continuity of care for patients currently receiving therapy through the expanded access.

Speaker #6: Ensuring a seamless transition to commercial supply reduces the risk of treatment interruption and supports initial commercial adoption. Today, approximately 60 patients across 17 sites nationwide are being treated under the expanded access program, a number that continues to grow month over month.

Speaker #6: We're prepared to support each patient's transition across the key touchpoints, confirming the treating physicians, enabling prescription, and coordinating access support. This includes prescriber and caregiver education ahead of approval, along with affordability programs and bridging support designed to keep treatment access uninterrupted throughout the transition.

Anny Bedard: We're prepared to support each patient's transition across the key touch points, confirming the treating physicians, enabling prescription, and coordinating access support. This includes prescriber and caregiver education ahead of approval, along with affordability programs and bridging support designed to keep treatment access uninterrupted throughout the transition. We're also establishing coordination across physicians, the specialty pharmacy, patient services, and payers so any potential barrier can be identified and resolved quickly. In parallel, we'll continue to engage known patients not yet on therapy while expanding diagnosis and patient identification. With the organization built, the infrastructure being activated, and patient transition plans advancing, we believe the US business is positioned to execute at approval and deliver on a successful launch in Q4. Most importantly, we're doing this for a patient community that has had no approved therapy options to date, and we're really energized by the opportunity to change that.

Speaker #6: We're also establishing coordination across physicians, the specialty pharmacy, patient services, and payers, so any potential barrier can be identified and resolved quickly. In parallel, we'll continue to engage known patients not yet on therapy, while expanding diagnosis and patient identification.

Speaker #6: With the organization built, the infrastructure being activated, and patient transition plans advancing, we believe the U.S. business is positioned to execute at approval and deliver on a successful launch in Q4.

Speaker #6: Most importantly, we're doing this for a patient community that has had no approved therapy options to date, and we're really energized by the opportunity to change that.

Speaker #6: Thank you, and I will now turn it over to Henrik for an update on commercialization in Europe and international markets.

Anny Bedard: Thank you, and I will now turn it over to Henrik for an update on commercialization in Europe and international markets.

Speaker #5: Thank you, Annie. For Europe and other international markets, Q2 was another quarter of progress for MCTATE, with continued revenue growth, the conclusion of the German reimbursement process, and further expansion of access beyond our initial launch market.

Henrik Krook: Thank you, Anny. For Europe and other international markets, Q2 was another quarter of progress for Emcitate with continued revenue growth, the conclusion of the German reimbursement process, and further expansion of access beyond our initial launch market. Revenue in Q2 was 17.4 million SEK, with Germany as the largest contributor. This corresponds to 23% growth at constant exchange rates compared with Q2 last year and approximately 30% sequential growth compared with Q1. In Germany, the AMNOG price negotiations with GKV were concluded during the quarter. We are pleased that the German authorities recognize the value of Emcitate. The new negotiated price and further insights into daily dosing leads to an estimated average annual treatment cost just below 200,000 euros. This is an important step whilst we continue our field-based work with pediatric endocrinologists, pediatric neurologists, other specialist physicians, and relevant treatment centers to develop the German market further.

Speaker #5: Revenue in Q2 was SEK 17.4 million, with Germany as the largest contributor. This corresponds to 23% growth at constant exchange rates compared with Q2 last year, and approximately 30% sequential growth compared with Q1.

Speaker #5: In Germany, the MNOG price negotiations with GKV were concluded during the quarter. We are pleased that the German authorities recognized the value of MCTATE. The new negotiated price and further insights into daily dosing lead to an estimated average annual treatment cost just below €200,000.

Speaker #1: Euros This is an important step . Whilst we continue our field based work with pediatric endocrinologists , pediatric neurologists , other specialist physicians and relevant treatment centers to develop the German market .

Speaker #1: Further, and here I would like to make a clarification, because once we did this, analysts have misunderstood how sales revenue is accounted for in Germany. In May 2025, we started commercial sales based on an initial price, in line with how the German system works.

Henrik Krook: Here I would like to make a clarification because one Swedish analyst has misunderstood how sales revenue is accounted for. In Germany, in May 2025, we started commercial sales based on an initial price. In line with how the German system works, our reported sales have reflected the final negotiated price based on our assumptions, meaning that all our reported sales revenue since November 2025 accounts for the final negotiated price. Beyond Germany, we are progressing toward reimbursed access in additional European countries. In Spain, the national pricing and reimbursement dossier has been submitted. In Italy and France, we plan to strengthen the value dossiers with Emcitate survival data once it has been published in a peer-reviewed journal. At the same time, we continue to use funded access routes where available in other European countries, helping treatment reach patients through the most appropriate access pathway in each country.

Speaker #1: Are reported. Sales have reflected the final negotiated price. Based on our assumptions, meaning that all our reported sales revenue since November 2025 accounts for the final negotiated price and beyond.

Speaker #1: In Germany, we are progressing toward reimbursed access in additional European countries. In Spain, the national pricing and reimbursement dossier has been submitted, as well as in Italy and France.

Speaker #1: We plan to strengthen the value dossiers with survival data once it has been published in the peer-reviewed journal. At the same time, we continue to use funded access routes where available in other European countries, helping treatment reach patients through the most appropriate access pathway in each country.

Speaker #1: Internationally , we also see growing reach through our distribution partners . We are supported by Akim in Turkey , central , Eastern and southeastern Europe and by time barrier in the Gulf region .

Henrik Krook: Internationally, we also see growing reach through our distribution partners. We are supported by Er-Kim in Turkey plus Central Eastern and Southeastern Europe and by Taiba Healthcare in the Gulf region. Both Er-Kim and Taiba Healthcare are actively identifying patients and initiating the processes aiming for funded treatment, which contributed to main patient sales revenues in Poland and Turkey in the quarter. After the quarter, we also signed a collaboration and supply agreement with Auspex Pharma for Australia and New Zealand, further broadening the geographic reach for Emcitate. Taken together, this reflects solid commercial progress. Germany now has an agreed reimbursed price. We are advancing funded pathways in key European countries, and our partner model is helping us reach patients in additional geographies. With that, I would like to hand over to our CFO, Yilmaz.

Speaker #1: Both Kemal and Ty Burrell are actively identifying patients and initiating the processes, aiming for funded treatment, which contributed to named patient sales revenues in Poland and Turkey in the quarter after the quarter.

Speaker #1: We also signed a collaboration and supply agreement with Auspex Pharma for Australia and New Zealand, further broadening the geographic reach. Taken together, this reflects solid commercial progress. Germany now has an agreed, reimbursed price.

Speaker #1: We are advancing funded pathways in key European countries, and our partner model is helping us reach patients in additional geographies. With that, I would like to hand over to our CFO, Yilmaz.

Speaker #2: Thank you Henrik . And to start with , all numbers , unless called out , are in our reporting currency . Swedish krona revenue for the first three months were 17.4 million versus 14.5 million in the same period last year , corresponding to a year over year growth of 23% in constant exchange rates .

Yilmaz Mahshid: Thank you, Henrik. To start with, all numbers, unless called out, are in our accounting currency, SEK. Revenue for the first 3 months was SEK 17.4 million versus SEK 14.5 million in the same period last year, corresponding to a year-over-year growth of 23% in constant exchange rates. The gross profit is SEK 3.6 million. This comes back to the continued depreciation of balance sheet R&D, a non-cash item. Excluding the quarterly depreciation of SEK 10.1 million, gross profit would have been SEK 13.7 million, corresponding to an adjusted gross margin of approximately 79%, which is considerably stronger than the 74% in the last quarter. As long as we are in an initial ramp-up phase in Europe, the depreciation will have a meaningful impact on the reported gross margin. However, we anticipate this to gradually dissipate as we start rolling out Emcitate in the US post a potential FDA approval.

Speaker #2: The gross profit is $3.6 million. This comes back to the continued depreciation of balance sheet R&D, a non-cash item. Excluding the quarterly depreciation of $10.1 million.

Speaker #2: Gross profit would have been SEK 13.7 million, corresponding to an adjusted gross margin of approximately 79%, which is considerably stronger than the 74% in the last quarter.

Speaker #2: As long as we are in an initial ramp up phase in Europe , the depreciation will have a meaningful impact on the reported gross margin However , we anticipate this to gradually dissipate as we start rolling out Mct8 in the in the US Post , a potential FDA approval Q2 2026 operating results were negative .

Yilmaz Mahshid: Q2 2026 operating results were -SEK 109.3 million versus -SEK 78.5 million in the prior period. Just want to highlight that SEK 5.6 million of the administrative costs booked in the quarter are ESOP related bookings and a non-cash item. This is a year-over-year delta of SEK 12.5 million, as the Q2 2025 numbers included a positive booking of SEK 6.9 million. Also, a one-time cost of approximately SEK 4 million was booked during this quarter for social charges in connection with the ESOP exercise. These numbers help you understand the underlying administrative cost line item during the quarter. Overall, the lower results are due to our continued investments and work with the US NDA, US commercial and corresponding pre activities.

Speaker #2: 109.3 million versus -78.5 million in the prior period. Just want to highlight that 5.6 million of the administrative costs are booked in the quarter.

Speaker #2: Our employee stock option plan related bookings and the non items This is a year over year delta of 12.5 million . As the Q2 2025 numbers included a positive booking of 6.9 million .

Speaker #2: Also , a one time cost of approximately 4 million was booked during this quarter for social charges in connection with the Aesop exercise These numbers should help you understand the underlying administrative cost line item during the quarter Overall , the results are due to our continued investments and with the US NDA , US commercial Product and corresponding preload activities .

Speaker #2: The management, the Board, and our main shareholders are all aligned that investing in the US is a key priority as we—.

Yilmaz Mahshid: The management, the board, and our main shareholders are all aligned that investing in the US is a key priority, as we believe this will be our most important market and where we need to succeed. For the second quarter, cash flow from operating activities were at -SEK 93.9 million versus -SEK 59 million. As highlighted in the report, we did strengthen the cash position on 21 April. In total, we did raise SEK 300 million corresponding to approximately $30 million cost basis. The high demand for the shares are depicted by the fact that they were issued at a share price of SEK 5.25, corresponding to a 0% discount to the market close the same day. With the cash from this transaction, we ended the quarter with a healthy cash position of SEK 378 million, corresponding to approximately $40 million.

Speaker #2: This will be our most important market, and where we need to succeed for the second quarter. Cash flow from operating activities was at -SEK 93.9 million versus -SEK 59 million, as highlighted in the report.

Speaker #2: We did the cash position on April 21st . In total , we did . 300 million , corresponding to approximately 30 million USD of spaces The high demand for the shares are depicted by the fact that they were issued at a share price of 5.25 , which correspond to a 0% discount to close the same day with the cash from this transaction , we ended the quarter with a healthy cash cash position of 378 million , corresponding to approximately 40 million USD .

Speaker #2: With that, I would like to hand back to Niklas.

Yilmaz Mahshid: With that, I would like to hand back to Niklas.

Yilmaz Mahshid: With that, I would like to hand back to Nicklas.

Speaker #1: Thank you . Yilmaz . Let me summarize . And whilst reflecting for the first two quarters of 2026 , it's . I'm very proud to say that we have had several key deliverables that has been with a very successful outcome Let me also remind you of the upcoming milestones for the GTC .

Nicklas Westerholm: Thank you, Yilmaz. Let me summarize. Whilst reflecting for the first two quarters of 2026, I am very proud to say that we have had several key deliverables that has been with a very successful outcome. Let me also remind you of the upcoming milestones for Egetis. We have a PDUFA date set for 28 September. Subsequently, subject to approval, we expect to launch Emcitate in the US in Q4, our most important market. Also worthwhile noting is being granted a priority review voucher upon approval. It is likely that monetization of such a priority review voucher could take place in Q4. Of note is that PRV sold in 2026 have fetched between $180 and $220 million each. Last but not least, the preparation of indication expansion into RTH-beta, our next exciting pipeline opportunity, is now progressing at pace.

Speaker #1: We have a date set for the 28th of September, subsequently subject to approval. We expect to launch MCT8 in the US in Q4.

Speaker #1: Our most important market. Also worthwhile noting is being granted a Priority Review Voucher upon approval. It is likely that monetization of such a Priority Review Voucher could take place in Q4.

Speaker #1: Of note is that PRVs sold in 2026 have fetched between $180 million and $220 million each. Last but not least, the preparation of indication expansion into beta.

Speaker #1: Our next exciting pipeline opportunity is now progressing at pace. We are convening a scientific advisory board with key opinion leaders in the field to finalize the development program for MCT8 in beta, and are in parallel preparing for regulatory interactions to agree on the overall development pathway, with the aim of starting a clinical study during 2027.

Nicklas Westerholm: We are convening a scientific advisory board with key opinion leaders in the field to finalize the development program for Emcitate in RTH-beta and are in parallel preparing for regulatory interactions to agree the overall development pathway with the aim of starting a clinical study during 2027. Of note is that we have today over 50 patients with RTH-beta that are being treated with Emcitate as a part of a managed access program. In summary, we believe that the commercial opportunity here could be on par with the one for MCT8 deficiency. With that, I will hand over to the operator for Q&A. Thank you.

Speaker #1: Of note is that we have today over 50 patients with our beta who are being treated with MCT8 as a part of a managed access program.

Speaker #1: In summary, we believe that the commercial opportunity here could be on par with the one for MCT8 deficiency. With that, I'll hand over to the operator for Q&A. Thank you.

Speaker #3: If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key on your telephone keypad. The next question comes from Kristin Kluska from Cantor Fitzgerald.

Operator 2: If you wish to ask a question, please dial pound key 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Kristin Kluska from Cantor Fitzgerald. Please go ahead.

Operator: If you wish to ask a question, please dial pound key 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Kristin Kluska from Cantor Fitzgerald. Please go ahead.

Speaker #3: Please go ahead

Speaker #4: Hi. Good afternoon, everybody, and congrats on all of the progress over this last while, respecting you're still very much in an active review with the FDA.

Kristen Kluska: Hi, good afternoon, everybody, and congrats on all of the progress over this last quarter. While respecting you are still very much in active review with the FDA, can you give us any high-level feedback on the mid to late cycle meeting? Was there anything substantial that came up? Anything that surprised you, for example?

Speaker #4: Can you give us any high level feedback on the mid to late cycle meeting ? Was there anything substantial that came up ? Anything that surprised you ?

Speaker #4: For example

Speaker #1: Thank you . Kristen , and great to hear from you . Well , in essence , we as always , don't come communicate around ongoing regulatory interactions , having said that , though , to give some more color .

Nicklas Westerholm: Thank you, Kristin, and great to hear from you. Well, in essence, we, as always, don't communicate around ongoing regulatory interactions. Having said that, though, to give some more color, as mentioned during the call, it's been a very constructive and productive dialogue with the FDA. The FDA has also reiterated that they will hold true to the PDUFA date set on 28 September. They are not planning to hold an advisory committee. Of course, with respect to that, if something would have materially deviated with our internal plans, i.e., PDUFA date on the 28th, that would have been seen as material, and subsequently we would have to notify the market. So I think all in all, internally, we are very pleased with the dialogues with the agency so far and looking forward to the PDUFA date on the 28th.

Speaker #1: As mentioned during the call, it's been a very, very constructive and productive dialogue with the FDA. The FDA has also reiterated that they will hold true to the date set on the 28th of September.

Speaker #1: They are not planning to hold an advisory committee and of course , with respect to that , if something would have materially deviated with our internal plans , I date on the 28th , that would have been seen as material and subsequently we would have to notify the market .

Speaker #1: So, I think all in all, internally we are very pleased with the dialogues with the agency so far and looking forward to the date on the 28th.

Speaker #4: Okay . I appreciate those comments . Thank you . And then on the survival data , I know we could expect this perhaps in a peer reviewed journal at some point , but can you just remind us , has the FDA reviewed these data yet ?

Kristen Kluska: Okay. I appreciate those comments. Thank you. Then on the survival data, I know we could expect this perhaps in a peer-review journal at some point, but can you just remind us, has the FDA reviewed these data yet? I know you can't comment on all of the findings, just to hold it for that journal. But again, high level, what do those data perhaps include that haven't been reported, again, without getting into the specifics of the findings? Thank you very much.

Speaker #4: And I know you can't comment on all of the findings just to hold it for that journal . But again , like high level , what do those data perhaps include that , you know , haven't been reported ?

Speaker #4: Again, without getting into the specifics of the findings. Thank you very much.

Speaker #1: Thank you . Kristen . And again , here I fully appreciate your question . Can't give too much more granularity on on that .

Nicklas Westerholm: Thank you, Kristin. Again, here, I fully appreciate your question. Can't give too much more granularity on that, unfortunately. The data, as you mentioned, has not yet been published in a peer-reviewed journal. But as mentioned previously, both during calls like this and through reports, if you think about the new drug application that was submitted, it included data from numerous clinical studies, clinical trial, TRIAD trial 1, TRIAD trial 2, the re-trial study, and also the survival study. Of course, that being part of a submission package, the FDA have reviewed and looked across the different studies to provide a view on the benefit risk profile of the drug.

Speaker #1: Unfortunately , the data , as you mentioned , has not yet been published in the peer reviewed journal . But as mentioned previously , both during calls like this and through reports , if you think about the new drug application that was submitted , it included a data from numerous clinical studies , clinical trial , trial , trial , one trial , trial two , the recharge study , and also the survival study .

Speaker #1: And of course , that being part of a submission package . The FDA have reviewed and looked across the different studies to view to provide a view on the benefit risk profile of the drug

Speaker #4: Thank you so much .

Kristen Kluska: Thank you so much.

Speaker #1: Thank you . Kristen

Nicklas Westerholm: Thank you, Kristin.

Speaker #3: The next question comes from Chiara Montironi from Van Lanschot Kempen. Please go ahead.

Operator 2: The next question comes from Chiara Montironi from Van Lanschot Kempen. Please go ahead.

Operator: The next question comes from Chiara Montironi from Van Lanschot Kempen. Please go ahead.

Speaker #5: Hello, Tim. Thanks for taking my question, and congrats on the progress. So, you now disclose that 60 patients are treated in the Early Access Programs, versus the first 40 at the beginning of the year.

Chiara Montironi: Hello, team. Thanks for taking my question, and congrats with the progress. You now disclose that 60 patients are treated in the early access programs versus 40 at the beginning of the year. I was wondering whether the new 20 patients are previously identified patients, or these are completely new diagnoses.

Speaker #5: I was wondering whether the new 20 patients are previously identified patients, or if these are completely new diagnoses.

Speaker #1: Now thank you . And you're absolutely right , Karen , thank you for your question . By the way . That's on at the start of the year , we had roughly or approximately 40 patients on the EAP program .

Nicklas Westerholm: No, thank you. You are absolutely right, Chiara, and thank you for your question, by the way. At the start of the year, we had roughly or approximately 40 patients on the EAP program. The progress here has been very good. We have now around 60 patients, as Anny mentioned, enrolled. We do not give the granularity if these are patients newly identified or previously identified. But I will invite Anny to comment further, if any.

Speaker #1: So the progress here has been been very good . We have now around 60 patients , as Annie mentioned , enrolled . We don't give the granularity if these are patients newly identified or previously identified , but I will invite Annie to comment further if any .

Speaker #6: Yes , we thank you . We we have 17 sites , so across the country that are engaged in treating these patients pre-approval .

Anny Bedard: Yes. Thank you. We have 17 sites across the country that are engaged in treating these patients pre-approval. Of course, these are now serving as reference sites for other physicians who identify patients. So having those physicians with experience with treating these patients and with tiratricol is significantly raising awareness across the other physicians and in the community. So that has been a contributor to having more patients wanting and requesting to join this program.

Speaker #6: And of course , these are now serving as reference sites for other physicians who identify patients . So having those physicians with experience with the with treating these patients and with theatrical is significantly raising awareness and across the other physicians and in the community .

Speaker #6: So that has been a contributor to having more patients wanting and requesting to, to, to join this program.

Speaker #5: Clear . Thank you . I appreciate the color . And if I may , a follow up question . So if I'm were to be approved in September , how long it will take to convert the early access program , patients to the commercial product and which elements could delay the transition in your opinion ?

Chiara Montironi: Clear. Thank you. I appreciate the color. If I may, a follow-up question. So if Emcitate were to be approved in September, how long it will take to convert the early access program patients to the commercial product, and which elements could delay the transition, in your opinion?

Speaker #1: Thank you . Karen . Of course , a very valid question . I think it's it's again here premature to comment on in detail around how long time will take to transition the EAP patients over to commercial type patients .

Nicklas Westerholm: Thank you, Chiara, and of course, a very valid question. I think it is, again here, premature to comment on in detail around how long time it will take to transition the EAP patients over to commercial-type patients. This is obviously something the team is working very hard on mapping out the different patient flows throughout the value chain. But I invite Anny to comment somewhat further, if you can add some more granularity to this.

Speaker #1: Right. This is obviously something the team is working very hard on, mapping out the different patient flows throughout the value chain.

Speaker #1: But I invite Annie to comment further. If you can, please add some more granularity to this.

Speaker #6: Yes. So this will be a main priority for us because we want to make sure that treatment is uninterrupted for those patients.

Anny Bedard: Yes. This will be a main priority for us because we want to make sure that treatment is uninterrupted for those patients. As it is standard in rare disease, we will have affordability support and bridge mechanisms in place in order to safeguard this continuity of care. As we are doing that, we will stay in close communication with the physicians and with the payers as well. As Nick mentioned, we are not going to go into the detail at this time on specific number of days for transition. That will be the core focus of our activities at the time of the launch. We anticipate that this will be successful.

Speaker #6: And as is standard in rare disease, we'll have affordability support and bridge mechanisms in place in order to safeguard this continuity of care.

Speaker #6: And and as we're doing that , we'll be in close communication with the physicians and with the payers as well . And as Nick mentioned , we're we're not going to go into the detail at this time on specific number of days for transition , but that will be the core focus of our activities at the time of the launch .

Speaker #6: And we anticipate , you know , that , you know , this will be successful .

Speaker #1: And maybe to build on for the rest of the show , Chiara , that this is a key priority . Just reiterating what Annie said before for the organization to ensure a very swift , smooth , coordinated transition from the expanded access program to commercial supply .

Nicklas Westerholm: Maybe to build on further, rest assured, Chiara, that this is a key priority, just reiterating what Anny said before, for the organization to ensure a very swift, smooth, coordinated transition from the expanded access program to commercial supply. Obviously driven to a certain extent by minimized treatment disruption, but also support earliest commercial uptake once approved.

Speaker #1: Obviously driven to a certain extent , driven by minimize treatment disruption , but also support earliest commercial uptake . Once approved . So thank you for the question , Karen .

Chiara Montironi: Thank you.

Nicklas Westerholm: Thank you for the question, Chiara.

Speaker #5: Of course

Chiara Montironi: Of course.

Speaker #3: The next question comes from Clemens Tiara from Stifel. Please go ahead.

Operator 2: The next question comes from Clémence Thiers from Stifel. Please go ahead.

Operator: The next question comes from Clémence Thiers from Stifel. Please go ahead.

Speaker #7: Hi . Thanks for the presentation and thanks for taking my question . Just a bit of focus on Europe might be a candid question , but regarding the price in Germany , you mentioned just below 200 zero zero €0 , right ?

Clémence Thiers: Hi. Thanks for the presentation and thanks for taking my question. Just a bit of focus on Europe. Might be a candid question, but regarding the price in Germany, you mentioned just below 200,000 EUR, right? Can you confirm that this is a negotiated reimbursement price? Obviously you can disclose anything, do you expect a material difference with the net price? That would be the first question.

Speaker #7: Can you confirm that this is a negotiated reimbursement price? And obviously, you can't disclose anything. Do you expect a material difference with the net price?

Speaker #7: That would be the first question.

Speaker #1: Thank you . Clemens . I can start and I might Hendrik to to comment . As we mentioned during the the launch process , May 2025 , the estimated average annual treatment cost per patient was just above 200 zero zero €0 per patient per annum .

Nicklas Westerholm: Thank you, Clémence. I can start, and I invite Henrik to comment. As we mentioned during the launch process, May 2025, the estimated average annual treatment cost per patient was just above 200,000 EUR per patient per annum. With the new negotiated price and further insights about daily dosing, which is important component looking at annual treatment cost, the average annual treatment cost now is estimated to be just below 200,000 EUR. We do not go into sharing any confidential rebates, et cetera, but this is based on the list price available for pharmacies in Germany.

Speaker #1: With the new negotiated price and further insights about daily dosing , which is important component . Looking at three annual treatment costs , the average annual treatment cost now is estimated to be just below 200 zero zero €0 .

Speaker #1: We don't go into sharing any confidential rebates, etc., but this is based on the list price available for pharmacies in Germany.

Speaker #7: Okay , perfect . Thank you . And maybe looking ahead on earth , beta , as you finalize the development plan , can you say sorry , am I interrupting

Clémence Thiers: Okay. Perfect, thank you. Maybe looking ahead on RTH-beta, as you finalize the development plan, can you say, sorry, am I interrupting?

Speaker #1: No, no, not at all. I just got so excited about the question. So,

Nicklas Westerholm: No, not at all. I got so excited about the question.

Speaker #7: I was saying, can you say at this stage what an approvable program could look like in terms of number and size of studies, endpoints, and how much of the existing clinical and safety package could help streamline that program?

Clémence Thiers: I was saying, can you say at this stage what an approvable program could look like in terms of number and size of studies, endpoints, and how much of the existing Emcitate technical and safety package could help sort of streamline that program?

Speaker #1: Sure . Clemens . That's a really good question . And I got so excited by you asking it . Since this is a very important feature of the , the long term future of the company building a sustainable rare disease organization , it's somewhat premature to comment on some of the questions you had .

Nicklas Westerholm: Sure. Clémence, that is a really good question, and I got so excited by you asking it since this is a very important feature of the long-term future of the company building a sustainable rare disease organization. It is somewhat premature to comment on some of the questions you had there. What we are doing today is that we are in the last stages of finalizing a target product profile, a clinical development plan. As I mentioned, we are convening an advisory board of key opinion leaders, which will be gathering face-to-face around the European Thyroid Association Conference in Portugal in September. Subsequent to that, we have an ambition to finalize the design and start engaging with FDA and EMA on the regulatory pathway. The ambition here is, of course, to utilize as much data as possible from MCT8 deficiency when it comes to safety database.

Speaker #1: There. What we're doing today is that we are in the last stages of finalizing a target product profile and a clinical development plan.

Speaker #1: As I mentioned, we are convening an advisory board of key opinion leaders, which will be gathering face to face around the European Thyroid Association conference in Portugal in September.

Speaker #1: Subsequent to that, we have an ambition to finalize the design and start engaging with FDA and EMA on the regulatory pathway. The ambition here is, of course, to utilize as much data as possible from MCT8 deficiency when it comes to the safety database. We have a huge safety database with a substantial number of years with patient exposure.

Nicklas Westerholm: We have a huge safety database with a substantial number of years with patient exposure. That is, of course, something to be utilized further in the RTH-beta development program. The same goes for non-clinical and the studies being carried out there ahead of the US approval. With that in mind, it is a bit premature to comment on endpoints, sample size, number of centers, et cetera, but rest assured that is something we will update the market on as soon as we have concluded that internally.

Speaker #1: So, that is, of course, something to be utilized further in the beta development program. The same goes for nonclinical and the studies being carried out there ahead of the US approval.

Speaker #1: And so with that in mind , it's a bit premature to comment on endpoints . Sample size , number of centers , etc. .

Speaker #1: But rest assured, that is something we'll update the market on as soon as we have concluded that internally.

Speaker #7: Okay, perfect. Thank you so much.

Clémence Thiers: Okay, perfect. Thank you so much.

Speaker #1: Thank you. And I think that brings us to the end of the call. We appreciate your participation and wish you a great rest of the day.

Nicklas Westerholm: Thank you. I think that brings us to the end of the call. We appreciate your participation and wish you a great rest of the day. Thank you.

Speaker #1: Thank you

Operator 2: The host has ended this call. Goodbye.

Operator: The host has ended this call. Goodbye.

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