Q3 2025 Krystal Biotech Inc Earnings Call

The speaker's presentation, there will be a question and answer session.

Speaker #2: Thanks for holding. We appreciate your time and patience. Please stay on the line, and we'll be back in just a moment.

As a reminder, today's conference is being recorded.

I'd now like to hand, the conference over to your host Stefan Packet Vice President of corporate development. Please begin.

Good morning, and thank you all for joining today's call.

Earlier today, we released our financial results for the third quarter of 'twenty 'twenty four.

The press release is available on our website at Www Dot Crystal bile duct call we.

Laurent Goux: This designation, which was only granted to 11% of the new drugs reviewed in 2024, acknowledged the added clinical benefit of VYJUVEK and may open up the possibility for EU-parity list pricing in France. Finally, I'm also proud to report that VYJUVEK was granted the Prix Galien in Italy under the Advanced Therapy Medicinal Product category, a prestigious award recognizing excellence in scientific innovation to improve the state of human health. This award is an important acknowledgment of the innovative and transformational nature of VYJUVEK and a helpful touchpoint as we start to engage with the relevant stakeholders in Italy. With these recent achievements, we are excited about the long-term growth trajectory in Europe and maximizing VYJUVEK access to the thousands of DEB patients in the region. I'll now hand the call back over to Krish.

Also filed our earnings 8-K, and 10-Q with the SEC earlier today.

Joining me today will be <unk>.

Speaker #1: Thank you for waiting. Your patience is appreciated. Please hold the line and we'll be right back with you.

Krish Krishnan, Chairman and Chief Executive Officer.

Summa Krishnan President of research and development.

So around Cook's scene.

Senior Vice President and general manager for Europe.

Kate Romano Chief Accounting Officer.

This conference call will and our responses to questions may contain forward looking statements.

You are cautioned not to rely on these forward looking statements, which are based on current expectations excuse me information available as of the date of this call and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected.

A description of these risks uncertainties and other factors can be found in our SEC filings.

Speaker #2: Thank you for holding. We look forward to talking with you soon. Please hold the line and we'll be right back with you.

With that I will turn the call over to Krish.

Thank you Stefan.

Good morning, and welcome to the call.

It gives me immense pride to realize.

Krish Krishnan: Thanks, Laurent. As I mentioned before, we have now also launched VYJUVEK in Japan. This summer, we were approved by the MHLW for the treatment of patients, and late last month, we successfully completed pricing negotiations with the Japanese authorities and launched VYJUVEK. We're very pleased with our pricing in Japan, and that is a testament to the clinical benefits achieved by DEB patients treated with VYJUVEK. Our core Japanese team has been in place for over a year and is now fully staffed to support the VYJUVEK launch. Our Japanese medical team has also been active for over a year, mapping key centers and patients, which will be the early focus of our launch. Although we expect contribution from Japan in 2025 to be modest, it will be another important revenue growth driver in 2026. Finally, I wanted to highlight one more contributor to the long-term growth of VYJUVEK.

So we're now in a position to help so many deaf patients within and outside the U S.

I would like to thank the entire team at crystal for their contributions.

In Q3.

Thanks, Vivek lunch continued to build momentum.

Speaker #1: Thanks for holding. We appreciate your time and patience. Please stay on the line and we'll be back in just a moment.

And the updated U S label.

Clearly strengthens long term outlook in the U S.

We're now launched in Germany.

France and Japan.

We successfully negotiated pricing in Japan.

And we believe the outcome bodes well for our payer conversations in Europe.

We are looking forward to a readout in <unk> this quarter.

And we're accelerating enrollment across our pipeline, including.

Speaker #3: Thank you for standing by and welcome to the Krystal Biotech third quarter 2025 earnings call. At this time, all participants are on a listen-only mode.

Including <unk> eight to one for NK.

We are initiating a new clinical program for Haley Haley disease.

Speaker #3: After the speakers' presentations, there will be a question-and-answer session. As a reminder, today's conference is being recorded. I would now like to hand the conference over to your host, Stephane Paquette, Vice President of Corporate Development.

It is a rare genetic disease of the skin that is a strong fit with our HSV one gene delivery platform.

Krish Krishnan: In addition to our direct VYJUVEK launches in the US, major European markets, and Japan, we've started contracting with regional specialty distributors to support the commercialization of VYJUVEK in rest of the world markets. We have executed agreements in place with multiple leading distributors covering key markets in Central and Eastern Europe, Turkey, and the Middle East, and expect to add more in the year ahead. Healthcare infrastructure and access vary significantly across rest of the world markets, but even after accounting for this variability, we estimate that a global distributor partner network could help bring VYJUVEK to thousands more DEB patients around the world and supplement our exciting growth strategy in the United States, Europe, and Japan. With that, I'll now hand it off to Suma to touch on recent pipeline progress. Suma.

And our commercial footprint.

The modal share more about this program later on the call.

Speaker #3: Please begin.

Speaker #4: Good morning, and thank you all for joining today's call. Earlier today, we released our financial results for the third quarter of 2025. The press release is available on our website at www.krystalbio.com.

Financially, we are strong and well positioned to execute on our strategic growth plans and deliver value to shareholders.

Moving now to our <unk> results.

Speaker #4: We also filed our earnings 8K and 10Q with the SEC earlier today. Joining me today will be Krish Krishnan, Chairman and Chief Executive Officer; Suma Krishnan, President of Research and Development; Laurent Goux, Senior Vice President and General Manager for Europe; and Kate Romano, Chief Accounting Officer.

We are pleased to report another quarter of revenue growth with net basically revenue coming in at $97 $8 million.

The patient pausing impacts due to summer holidays that we observed earlier last quarter were mitigated by patient adds and early traction in Europe.

Net voyage revenues reported here does include a contribution from Europe. Following our launch in Germany in late August.

Speaker #4: This conference call will, and our responses to questions may, contain forward-looking statements. You are cautioned not to rely on these forward-looking statements, which are based on current expectations using the information available as of the date of this call and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected.

This brings total net advisory revenues since launch to over $623 million.

Suma Krishnan: Thank you, Krish. I would like to start today by acknowledging the hard work of our development team here at Krystal. In recent months, we have dramatically transformed the scope and ambition of our clinical stage pipeline, expanding our clinical programs in respiratory and oncology, and starting up new studies in ophthalmology and dermatology. These are all important achievements, none of which would be possible without the outsized contribution of each Krystal team member. Our team also achieved another important milestone in recent weeks: a Platform Therapy Designation from the FDA. This designation, granted for our HSV1 gene delivery platform and currently applicable to our KB801 program, could significantly accelerate the path to approval, providing us the opportunity for more frequent interactions with the FDA, as well as the chance to leverage manufacturing and non-clinical safety data from VYJUVEK in our filings.

Gross margins were 96% for the quarter.

Gross to net dynamics were stable as with prior quarters.

Speaker #4: A description of these risks, uncertainties, and other factors can be found in our SEC filings. With that, I will turn the call over to Krish.

I'm happy to report continued acceleration in new reimbursement approvals in the U S.

Speaker #5: Thank you, Stephane. Good morning and welcome to the call. It gives me immense pride to realize that we're now in a position to help so many debt patients within and outside the U.S.

Our team added over 40, new approvals since our last earnings call update, bringing the total number of reimbursement approvals in the U S to over 615.

This is now our second sequential quarter of reimbursement approval acceleration and a reflection of our field team's efforts as well as the ongoing sales force expansion.

Speaker #5: I would like to thank the entire team at Krystal for their contributions. In Q3, Vaishavek launched continued to build momentum and the updated U.S.

Our expanded field force is now fully hired and being deployed as training is completed.

Speaker #5: label clearly strengthens long-term outlook in the U.S. We're now launched in Germany, France, and Japan. The successfully negotiated pricing in Japan and we believe the outcome bodes well for our payer conversations in Europe.

Full impact is expected in early 2026.

We're also happy to report continued expansion of our prescribers work.

<unk> increased penetration into the community setting with the total number of prescribers in the U S now exceeding 450.

Speaker #5: We are looking forward to our readout in CF this quarter, and we're accelerating enrollment across our pipeline, including KB 801 for NK. We are initiating a new clinical program for Haley-Haley disease; it is a rare genetic disease of the skin that is a strong fit with our HSV-1 gene delivery platform and our commercial footprint.

I would like to highlight a recent milestone achieved in the U S.

Suma Krishnan: The FDA may also consider previous inspectional findings related to drug manufacture. The Platform Therapy Designation is applied for on a program-by-program basis and is currently only granted to KB801, although we intend to apply for this designation for additional programs to ultimately secure the designation and associated efficiencies for our entire pipeline. I'm also excited to report that we remain on track to deliver multiple exciting readouts in the months ahead. We expect our next readout to come from our cystic fibrosis program, KB407. With the backing of the CFFTDM, we have expanded our clinical trial network and are now very close to study completion. We look forward to announcing interim data before year-end, including molecular data from non-CF patients to assess the ability of the HSV1 to deliver full-length wild-type CFTR to the lung.

Which was the FDA approval of our updated.

A playbook.

This label update <unk>.

Expanded device eligible patient population to include <unk> patients from birth and also provided patients with full flexibility in how they choose to dose regiment.

This change reinforces <unk> leadership position as the most flexible and convenient corrective therapy for <unk> and should serve as a tailwind for adoption in compliance in the future.

Speaker #5: Suma will share more about this program later on the call. Financially, we're strong and well-positioned to execute on our strategic growth plans and deliver value to shareholders.

Compliance to weekly therapy continued the trend we reported in previous quarters.

Speaker #5: Moving now to our 3Q results, we are pleased to report another quarter of revenue growth with net Vaishavek revenue coming in at 97.8 million dollars.

I mean in in the low eighties as more patients achieve durable wound closure and more mild and moderate patients come onto therapy.

Speaker #5: The patient-pausing impacts due to summer holidays that we observed early last quarter were mitigated by patient ads and early traction in Europe. Net Vaishavek revenues reported here do include a contribution from Europe following our launch in Germany in late August.

While the revised label change should have a positive impact of compliance in the future.

As always continue to expect some quarter to quarter way Venus in the U S revenues as we build on our long term growth trajectory.

With that I'll now hand, it off to low wrong to share his excitement in Europe.

Suma Krishnan: On success, we would expect to immediately move to a repeat dosing study, which would enable assessment of functionality, including longitudinal FEV1. With our now expanded trial network and without the requirement for bronchoscopies, we expect a repeat dosing study would enroll quickly, enabling a potential FEV1 data readout next year. Our KB408 program for AATD lung disease is also moving ahead well. Having already confirmed successful delivery of functional AAT in our single-dose study, this program is in repeat dosing, and we expect to be able to provide an interim data update in the first half of next year. Together with KB407, this will serve as a robust data set demonstrating our platform capabilities in the lung. In ophthalmology, strong enrollment is providing us with greater clarity on the timing of our first readout.

Speaker #5: This brings total net Vaishavek revenues since launch to over 623 million dollars. Gross margins were 96% for the quarter; gross to net dynamics were stable as with prior quarters.

Laura.

Thank you Krish.

It's my pleasure to share an update on our progress in Europe.

Our first European launch in Germany is off to a good start since launching in late August we have seen widespread interest and demand across the country.

Speaker #5: I'm happy to report continued acceleration in new reimbursement approvals in the U.S. Our team added over 40 new approvals since our last earnings call update bringing the total number of reimbursement approvals in the U.S.

Based on available aggregate level data we.

We estimate the number of patients prescribed by jewelry in Germany to be approximately.

Speaker #5: to over 615. This is now our second sequential quarter of reimbursement approval acceleration and a reflection of our field team's efforts as well as the ongoing sales force expansion.

Sure.

Just as importantly, we are seeing broad prescribing patterns across the country with prescription from over 10 centers to date.

This breadth of prescribing is particularly helpful. Given the requirement for patients to start therapy in the health care system.

By growing the number of centers prescribing <unk>, we can help patients to start therapy closer to home and avoid potential single center patient within bottlenecks.

Speaker #5: Our expanded field force is now fully hired and being deployed as training is completed. Full impact is expected in early 2026. We're also happy to report continued expansion of our prescriber network reflecting increased penetration into the community setting with a total number of prescribers in the U.S.

Based on current trends, we expect continued steady growth in patients inclusion in the months ahead.

We are also making rapid progress outside of Germany.

Speaker #5: now exceeding 450. I would like to highlight a recent milestone achieved in the U.S. which was the FDA approval of our updated Vaishavek label.

Suma Krishnan: Based on current rates, we expect to complete enrollment of our phase 3 trial evaluating KB803 for corneal abrasions in DEB patients by end of the year. Enrollment in our randomized, placebo-controlled study for KB801 in NK is also progressing well as we continue to onboard new sites globally, setting us for a potential data readout in 2026. I would also like to share a quick update on our work in oncology, which is increasingly focused on the development of intratumoral KB707 for the treatment of non-small cell lung cancer, or NSCLC. As we shared at ASCO over the summer, NSCLC is an indication where we have seen early evidence of monotherapy efficacy, even in heavily pretreated and checkpoint inhibitor failed patients. Building on that readout, we were recently granted an end-of-Phase Two meeting with the FDA to discuss a potential development pathway for intratumoral KB707.

In September the auto retail does okay.

Also known as H E S.

French HDA body.

Approved early buy direct access and the post marketing authorization.

Of course too.

Speaker #5: This label update expanded the Vaishavek eligible patient population to include debt patients from birth and also provided patients with full flexibility in how they choose to dose Vaishavek.

And last month, we formally launched Baidu raking fronts.

Importantly, the relevant authorities in France are also allowing <unk> to be dispensed outside the hospital setting.

Speaker #5: This change reinforces Vaishavek's leadership position as the most flexible and convenient corrective therapy for DEB and should serve as a tailwind for adoption and compliance in the future.

This is the first time, a gene therapy has been approved in such as <unk> in France.

Tremendous milestone to our local team and patients across the country.

Last month.

Also our prices by <unk> under the and then Youll actually only salaries medical or Hungary, or ASMR classification system.

Speaker #5: Compliance to weekly therapy continued the trend we reported in previous quarters coming in in the low 80s as more patients achieved durable wound closure and more mild and moderate patients come onto therapy.

Initial step for pricing and reimbursement discussions in France, <unk> received an ASMR III designation. This designation, which was only 22, 11% of the new drugs reviewed in 2024 analyst the added clinical benefit of <unk> and May open up.

Speaker #5: While the revised label change should have a positive impact to compliance in the future, we as always continue to expect some quarter-to-quarter waviness in the U.S.

The possibility for EU Burlington lease pricing in France.

Speaker #5: revenues as we build on our long-term growth trajectory. With that, I'll now hand it off to Laurent to share his excitement in Europe. Laurent,

Finally, I'm also proud to report that <unk> was granted the <unk> in Italy under the advanced therapy medicinal product category, a prestigious award recognizing excellence in scientific innovation to improve the state of human health.

Suma Krishnan: Based on FDA's feedback, we now expect that a single phase 3 study evaluating intratumoral KB707 in combination with chemotherapy versus chemotherapy alone in patients with advanced NSCLC could be sufficient to support a potential registration in combination for second-line NSCLC. In support of this potential registration pathway, we have opened a new cohort in our ongoing phase 1/2 KINITE-1 study to evaluate a fixed dose of intratumoral KB707 in combination with chemotherapy. Enrollment in KINITE-1 is ongoing. Our current expectation is to report interim data from KINITE-1 in the second half of 2026, at which point we would also be able to provide an update on registrational study plans and potential for phase 3 initiation. Finally, I'm also happy to introduce today a new addition to our clinical pipeline, KB111, for the treatment of Hailey-Hailey disease.

Speaker #6: Thank you, Krish. It is my pleasure to share an update on our progress in Europe. Our first European launch in Germany is off to a good start.

This award is an important acknowledgment of the innovative and transformational nature of <unk> and a helpful touch points as we start to engage with the relevant stakeholders in Italy.

Speaker #6: Since launching in late August, we have seen widespread interest and demand across the country. Based on available aggregate label data, we estimate the number of patients prescribed Vaishavek in Germany to be approximatively 20.

With this recent.

Achievements, we are excited about the long term growth trajectory in Europe, and maximizing baidu like access to the thousands of patients in the region.

Speaker #6: Just as importantly, we are seeing broad prescribing patterns across the country with prescription from over 10 centers to date. This breadth of prescribing is particularly helpful given the requirement for patients to start therapy in a healthcare setting.

I'll now hand, the call back over to Krish.

Thanks, Laura.

As I mentioned before.

We have now also launched <unk> in Japan.

This summer we were approved by the <unk> for the treatment of patients.

Speaker #6: By growing the number of centers prescribing Vaishavek, we can help patients to start therapy closer to home and avoid potential single-center patient visit bottlenecks.

Late last month, we successfully completed pricing negotiation with the Japanese authorities and launched by July.

Speaker #6: Based on current trends, we expect continued steady growth in patient inclusion in the months ahead. We are also making rapid progress outside of Germany.

We're very pleased with our pricing in Japan and that is a testament to the clinical benefits achieved by that patients treated with <unk>.

Our core Japanese team as it's been in place for over a year and is now fully staffed to support device of our clients.

Speaker #6: In September, the Authorité de Santé also known as HAS, the French HDA body, approved early Vaishavek access under the post-marketing authorization accès précoce II, and last month we formally launched Vaishavek in France.

Suma Krishnan: Hailey-Hailey disease is a genetic blistering disease of the skin linked to the mutation in the ATP2C1 gene and low expression of its encoded cation-transporting ATPase. HHD is a rare disease with a prevalence that's not well understood. The most common estimate of prevalence is one case per 50,000 patients, although underreporting is possible. HHD is characterized by painful rash and blistering in skin folds with a relapsing-remitting course that is exacerbated by heat and sweat. Patients often report debilitating symptoms of pain, itch, burning, body odor, as well as infections, resulting in severe negative impacts on quality of life, psychological distress, and intimacy issues. There are no specific therapies available for treatment of this disease. Building on our experience and clinically validated HSV1 platform for skin delivery, we designed KB111 to deliver ATP2C1 directly to skin cells, increase ATPase levels, and hopefully change the course of this terrible disease.

Our Japanese medical team has also been active for over a year mapping key centers and patients which will be the early focus of our launch.

Although we expect contribution from Japan in 2025 to be modest it will be another important revenue growth driver in 2026.

Speaker #6: Importantly, the relevant authorities in France are also allowing Vaishavek to be dispensed outside the hospital setting. This is the first time a gene therapy has been approved in such a setting in France, a tremendous milestone to our local team and patients across the country.

Finally, I wanted to highlight one more contributor to the long term growth device right.

In addition to our direct advisor tech launches in the U S major European markets and Japan. These started contracting with regional specialty distributors to support the commercialization of ice vivek in rest of the world markets.

Speaker #6: Last month, HAS also appraised Vaishavek under the amélioration du service médical rendu or ASMR classification system a key initial step for pricing and reimbursement discussions in France.

We have executed agreements in place with multiple leading distributors covering key markets in central and Eastern Europe.

Speaker #6: Vaishavek received an ASMR III designation. This designation, which was only granted to 11% of the new drugs reviewed in 2024, acknowledges the added clinical benefit of Vaishavek and may open up the possibility for EU priority list pricing in France.

Turkey, and the middle East and expect to add more in the year ahead.

Health care infrastructure and access vary significantly across the rest of the world markets, but even after accounting for this variability.

Speaker #6: Finally, I'm also proud to report that Vaishavek was granted the PRIGALIAN in Italy under the Advanced Therapy Medicinal Product category, a prestigious award recognizing excellence in scientific innovation to improve the state of human health.

Estimate that our global distributor partner network could help bring buys your bag.

It's more depth patients around the world and supplement our exciting growth strategy in the United States Europe and Japan.

Suma Krishnan: As with VYJUVEK, KB111 is formulated for a topical administration directly to the lesions of HHD patients. We have already confirmed in preclinical studies that KB111 can efficiently transduce skin cells, resulting in functional ATPase expression, and last month cleared our IND. We expect to start an intrapatient randomized double-blind placebo-controlled multicenter study evaluating KB111 in HHD patients in the first half of next year. With strong execution across our pipeline, and now the added benefits of the platform designation for KB801, we are well positioned to make rapid progress with multiple readouts in months ahead. With that, I'll hand the call over to Kate.

With that I'll now hand, it off to Sumer to touch on recent pipeline progress.

Speaker #6: This award is an important acknowledgment of the innovative and transformational nature of Vaishavek and a helpful touchpoint as we start to engage with the relevant stakeholders in Italy.

Sure.

Thank you Chris.

I would like to start today by acknowledging the hard work of our development team.

Speaker #6: With this recent achievement, we are excited about the long-term growth trajectory in Europe and maximizing Vaishavek's access to the thousands of deceased patients in the region.

At Crystal.

In recent months, we have dramatically transformed the scope and ambition of our clinical stage pipeline.

Spending on our clinical programs and respiratory and oncology and.

Speaker #6: I'm now handing the call back over to Krish.

Starting up new studies in ophthalmology and dermatology.

Speaker #1: Thanks, Laurent. As I mentioned before, we have now also launched Vaishavek in Japan. This summer, we were approved by the MHLW for the treatment of patients and late last month we successfully completed pricing negotiations with the Japanese authorities and launched Vaishavek.

These are all important achievements.

None of that would be possible without.

Contribution of each team member.

Our team also achieved another important milestone in recent weeks.

A platform therapy designation from the FDA.

Speaker #1: We're very pleased with our pricing in Japan and that is a testament to the clinical benefits achieved by dead patients treated with Vaishavek. Our core Japanese team has been in place for over a year and is now fully staffed to support the Vaishavek launch.

This designation granted for our agency one gene delivery platform and currently applicable to our <unk> one program.

Kate Romano: Thank you, Suma, and good morning, everyone. I'd like to provide some highlights from our third-quarter financial results reported in our press release and 10-Q filing earlier this morning. VYJUVEK net product revenue for the third quarter was $97.8 million. This marks sustained growth as compared to the prior quarter, including the early sales from our German launch. Gross-to-net dynamics remain consistent with prior quarters. Cost of goods sold was $4.3 million, and gross margin was 96% for the quarter as compared to 93% last quarter. Note that the increase in gross margin this quarter was the result of US product manufacturing process optimizations and the benefit of lower cost batches after FDA approval of this optimized process. While we expect these manufacturing efficiencies to continue benefiting our US operations, the optimized process has not yet been approved for products sold outside the United States.

Significantly accelerates the path to approval, providing us the opportunity for more frequent interactions with the FDA and as well as the chance to leverage manufacturing and non clinical safety data from widespread in our filings.

Speaker #1: Our Japanese medical team has also been active for over a year mapping key centers and patients which will be the early focus of our launch.

The FDA may also consider.

Speaker #1: Although we expect contribution from Japan in 2025 to be modest, it will be another important revenue growth driver in 2026. Finally, I wanted to highlight one more contributor to the long-term growth of Vaishavek.

He is inspections findings related to drug manufacturer.

The platform technology designation is applied for.

<unk> on a program by program basis and is currently only granted to <unk> eight to one.

Although we intend to apply for this designation for additional programs to ultimately secure the designation and associated <unk> of our entire pipeline.

Speaker #1: In addition to our direct Vaishavek launches, in the U.S., major European markets, and Japan, we've started contracting with regional specialty distributors to support the commercialization of Vaishavek in the rest of the world markets.

I'm also excited to report that we remain on track to deliver multiple exciting readouts in the months ahead.

Speaker #1: We have executed agreements in place with multiple leading distributors covering key markets in Central and Eastern Europe, Turkey, and the Middle East, and we expect to add more in the year ahead.

Kate Romano: As ex-US sales grow over the coming quarters, we anticipate gross margins will normalize towards historical levels until the optimized process is approved for products sold outside the United States. Research and development expenses were $14.6 million, and general and administrative expenses were $37.6 million. Operating expenses for the quarter included non-cash stock-based compensation of $13.2 million. You'll note on slide 13 that we are revising our full-year non-GAAP R&D and SG&A guidance to $145 to $155 million, compared to our prior guidance of $150 to $175 million. This represents both a reduction and narrowing of the range to better reflect our performance so far this year, as well as our continued confidence in our ability to execute with discipline for the remainder of the year.

We expect our next readout to come from our cystic fibrosis program <unk> 407.

With the backing of the CSF TVN.

Speaker #1: Healthcare infrastructure and access vary significantly across the rest of the world markets. However, even after accounting for this variability, we estimate that a global distributor partner network could help bring Vaishavek to thousands more patients around the world and supplement our exciting growth strategy in the United States, Europe, and Japan.

We have expanded our clinical trial network and then a very close the study completion.

We look forward to announcing interim data before year end, including molecular data from now CF patients.

Assess the ability of the HFC one to deliver full length wild type CFT are stood alone.

Speaker #1: With that, I'll now hand it off to Suma to touch on recent pipeline progress. Suma,

On success, we would expect to immediately move to repeat dosing study, we could enable assessment of functionality.

Speaker #7: Thank you, Krish. I would like to stop today by acknowledging the hard work of our development team here at Krystal. In recent months, we have dramatically transformed the scope and ambition of our clinical-stage pipeline, expanding our clinical programs in respiratory and oncology, and starting up new studies in ophthalmology and dermatology.

Including longitudinal F N D. One.

With our now expanded trial network.

And without the requirement for bronchoscopy, we expect a repeat dosing study would enroll quickly enabling a potential FTB one data readout next year.

Kate Romano: During the quarter, we released a majority of the valuation allowance that was previously recorded against our deferred tax assets, reflecting our confidence in Krystal's future profitability. This release resulted in a one-time non-cash tax benefit that increased our reported EPS. We also benefited from the reversal of the Section 174 R&D capitalization requirement under the One Big Beautiful Bill legislation. This reversal was also non-recurring. Net income for the quarter was $79.4 million, which represented $2.74 per basic and $2.66 per diluted share, reflective of these one-time benefits. Finally, our balance sheet continues to be a key point of strength for Krystal. We ended the third quarter with over $864 million in combined cash and investments, and we remain well positioned to support our commercial launches globally, as well as our significant pipeline programs in the upcoming quarters. Now I will turn the call back over to Krish.

Okay before OE program for <unk> lung disease is also moving ahead well.

Speaker #7: These are all important achievements; none of which would be possible without the outsized contribution of each Krystal team member. Our team also achieved another important milestone in recent weeks.

Having already confirmed successful delivery.

Functionally AAP in our single dose study.

This program and repeat dosing and we expect to be able to provide an interim data update in the first half of next year.

Speaker #7: A platform therapy designation from the FDA, granted for our 83.1 gene delivery platform and currently applicable to our Kb801 program, could significantly accelerate the path to approval. This designation provides us the opportunity for more frequent interactions with the FDA, as well as the chance to leverage manufacturing and non-clinical safety data from Vaishavek in our filings.

Together with gave me four to seven.

So as a robust dataset demonstrating a platform capability in the lung.

In ophthalmology strong enrollment is providing us with greater clarity on the timing of a first readout.

Based on current rates, we expect to complete enrollment of our phase III trial evaluating <unk> three for corneal abrasion and Deb patients.

Speaker #7: The FDA may also consider previous inspectional findings related to drug manufacture. The platform technology designation is applied for on a program-by-program basis and is currently only granted to Kb801.

And up the <unk>.

Enrollment in our randomized placebo controlled study <unk> eight to one.

<unk> is also progressing well as we continue to onboard new sites globally, setting us potential data rich in.

Operator: Thanks, Kate. As we close today's call, I'd like to emphasize our excitement for the path ahead at Krystal in 2026. With launches in Germany, France, and Japan, VYJUVEK has now truly gone global, providing us the opportunity to dramatically expand the number of patients benefiting from VYJUVEK therapy in the months ahead. The hard part of a global VYJUVEK launch is now behind us, and Krystal's focus in 2026 is on our clinical pipeline. We have our first readout in CF before year-end. We're working towards readouts in KB801 for NK and KB803 for eye lesions in DEB patients by mid-year, and we shall update once enrollment is complete in these programs. These programs, along with KB111 for Hailey-Hailey, fit neatly within our core global commercial capabilities.

Speaker #7: Although we intend to apply for this designation, for additional programs to ultimately secure the designation, and associated efficiencies of our entire pipeline. I'm also excited to report that we remain on track to deliver multiple exciting readouts from the months ahead.

In 2026.

I would also like to share a quick update on our work in oncology, which is increasingly focused on the deadline of in health can be seven seven for the treatment of non small cell lung cancer or SCLC.

Speaker #7: We expect our next readout to come from our cystic fibrosis program, KB407. With the backing of the CFFTDM, we have expanded our clinical trial network and are now very close to study completion.

As we shared at our ethical over the summer and CLC is an indication that we have seen early evidence of monotherapy efficacy ease.

Even in heavily pre treated and checkpoint inhibitor failed patients.

Speaker #7: We look forward to announcing interim data before year-end. Including molecular data from Null CF patients to assess the ability of the 83.1 to deliver full-length wild-type CFTR to the lung.

Building on that readout, we were recently granted an end of phase two meeting with the FDA to discuss potential development pathway for inhaled <unk> 707.

Based on Fda's feedback, we now expect that a single phase III study.

Speaker #7: On success, we would expect to immediately move to a repeat dosing study, which would enable assessment of functionality, including longitudinal FEV1. With our now expanded trial network and without the requirement for bronchoscopies, we expect a repeat dosing study would enroll quickly, enabling a potential FEV1 data readout next year.

Operator: At the same time, we recognize the significant optionality that HSV1 provides as a re-dosable, non-integrating, large-capacity gene delivery platform and the potential upside opportunities that exist in large market indications. We will continue to invest in these programs with the same operational discipline as we have in the past to ensure that we maximize the value that we believe exists in our pipeline and platform before entering into partnerships for these programs. Thanks for listening, and I'd like to now open the call for Q&A.

Do anything in <unk>, seven or seven in combination with chemotherapy versus chemotherapy alone in patients with advanced SCLC.

Could be sufficient to support a potential registration in.

In combination with second line and that's C. L P.

In support of this potential registration pathway there.

We have opened a new cohort in our ongoing phase one two <unk> one study to evaluate a fixed dose of inhaled <unk> 707 in combination with chemotherapy and.

Speaker #7: Our Kb408 program for AETD lung disease is also moving ahead well. Having already confirmed successful delivery of functional AAT in our single-dose study, this program is in repeat dosing and we expect to be able to provide an interim data update in the first half of next year.

Enrollment in <unk> one is ongoing.

Our current expectation is to report interim data from Cryolife, one in the second half of 2026.

Kate Romano: Certainly. At this time, we will be conducting a question-and-answer session. If you have any questions or comments, please press star one on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. Your first question for today is from Alec Stranahan with Bank of America.

At which point, we would also be able to provide an update on Registrational study plans and potential for phase III initiation.

Speaker #7: Together with Kb407, this will serve as a robust data set demonstrating our platform capabilities in the lung. In ophthalmology, strong enrollment is providing us with greater clarity on the timing of our first readout.

Finally, I'm also happy to introduce today, a new addition to our clinical pipeline.

Maybe 111 for the treatment of Hilli Hilli disease.

Speaker #7: Based on current rates, we expect to complete enrollment of our Phase 3 trial evaluating Kb803 for corneal abrasions in dead patients by end of the year.

Can you hear me disease, it's a genetic blistering diseases of the skin.

[Analyst] (Bank of America): Hey, guys. This is Matthew on for Alec. Congrats on the quarter. Appreciate you taking our questions, maybe just two from us. On the ex-US launch, I guess whether your focus is on expanding the breadth of prescribers or depth of prescribers that have already made some prescriptions, and then maybe on the optimized process that led to better gross margins. Just curious what was sort of optimized in this process and whether you can speak to timelines for this optimized process to be expanded to ex-US markets. Thanks.

To the mutation in the ATP to see one gene.

And low expression of its encoded.

Speaker #7: Enrollment in our randomized, placebo-controlled study for Kb801 in NK is also progressing well. As we continue to onboard new sites globally, we are set for a potential data-rich 2026.

<unk> 10, sporting ATP is.

Inc. HD is a rare disease with a prevalence that's not well understood.

The most common estimate a prevalence is one case, where 50000 patients.

Although underreporting as possible.

Speaker #7: I would also like to share a quick update on our work in oncology, which is increasingly focused on the development of inhaled Kb707 for the treatment of non-small cell lung cancer (NSCLC).

H H D. S is characterized by painful rash and blistering skin photos.

With the relapsing Remitting course.

Krish Krishnan: Thank you, Matthew. Hey, in terms of your first question on ex-US launch, breadth of prescribers versus depth, I mean, our focus, I mean, our objective in Europe is primarily to accelerate getting a patient to meet the physician as soon as possible, because the first clinical visit has to be in a physician office. Now, purely logistically, that's a lot easier if you start focusing on centers of excellence, as you heard from Laurent, to begin with, but at the same time, slowly spreading out into the community. On the question about optimized process, this is essentially moving to a larger bioreactor. It's got approved in the US, and we're working towards an application in Europe. I'll ask Suma to comment on the timing.

That is exacerbated by heat and sweat.

Patients often report debilitating symptoms of pain each bunny.

Speaker #7: As we shared at ASCO, over the summer, NSCLC is an indication where we have seen early evidence of monotherapy efficacy even in heavily pretreated and checkpoint inhibitor failed patients.

Body odor aslef infections, resulting in severe negative impact on quality of life.

Psychological distress and intimacy issues.

And I know specific therapies available for treatment of this disease.

Speaker #7: Building on that readout, we were recently granted an end-of-phase 2 meeting with the FDA to discuss potential development pathway for inhaled Kb707. Based on FDA's feedback, we now expect that a single Phase 3 study evaluating inhaled Kb707 in combination with chemotherapy versus chemotherapy alone in patients with advanced NSCLC could be sufficient to support a potential registration in combination for second-line NSCLC.

Building on our experience and clinically validated HSV platform for skin delivery, we designed KD 111 to deliver ATP to see one directly to skin cells.

Increased ATP AST levels, and hopefully change the course of this terrible disease.

As we advised you that gave me 111 is formulated for the topical administration directly to the lesions of HD patients.

Suma Krishnan: What the.

Krish Krishnan: For the approval in Europe with respect to the optimized batch.

They've already confirmed in preclinical studies that gave me 111 can efficiently transfused skin cells, resulting in functional ATP is fresh.

Suma Krishnan: I mean, we have already started the process. We have filed the scale-up. I mean, it's pretty straightforward because we have a lot of data from the US. We expect, hopefully, sometime next year to have the optimized and scaled-up process approved.

Speaker #7: In support of this potential registration pathway, we have opened a new cohort in our ongoing Phase 1-2 kinite-1 1 study to evaluate a fixed dose of inhaled Kb707 in combination with chemotherapy.

<unk>.

And last month cleared or I E.

We expect to stop an intra patient randomized double blind placebo controlled multicenter study evaluating <unk> in ADHD patients in the first half of next year.

[Analyst] (Bank of America): Great. Thanks.

Speaker #7: Enrollment in kinite-1 is ongoing. Our current expectation is to report interim data from kinite-1 in the second half of 2026, at which point we would also be able to provide an update on registration study plans and potential for Phase 3 initiation.

Kate Romano: Your next question is from Roger Song with Jefferies.

With strong execution across our pipeline.

[Analyst] (Jefferies): Great. Congrats for the quarter, and thank you for taking our question. Also related to the question on ex-US launch. I understand the contribution in Q3, probably not too much from Germany. Just curious about your expectation moving to next year, maybe Q4 and the next year. How should we think about ex-US versus US revenue contribution, and when on EF you will give us some breakdown later on? Also related to this ex-US launches, how should we think about the pricing? I understand you need to negotiate on top of the list price, and then how this will change over time, particularly with the US MFM policy. Thank you.

All of the added benefits of the platform designation for <unk> hundred one developed position to make rapid progress with multiple readouts in months ahead.

Speaker #7: Finally, I'm also happy to introduce today a new addition to our clinical pipeline. Kb111 for the treatment of Hali-Hali disease. Hali-Hali disease is a genetic blistering disease of the skin linked to the mutation in the ATP2C1 gene.

With that I'll hand, the call over to Kate.

Thank you <unk> and good morning, everyone.

I'd like to provide some highlights from our third quarter financial results reported in our press release and 10-Q filing earlier this morning.

<unk> net product revenue for the third quarter was $97 $8 million.

Speaker #7: And low expression of its encoded catching-transporting ATPase. HHD is a rare disease with a prevalence that's not well understood. The most common estimate of prevalence is one case per 50,000 patients.

This marks sustained growth as compared to the prior quarter, including the early sales from our German launch.

<unk> to net revenues remained consistent with prior quarters.

Cost of goods sold was $4 3 million and gross margin was 96% for the quarter as compared to 93% last quarter.

Krish Krishnan: Great, Roger. Thanks for both those questions. Look. The only requirement, as I mentioned in the prior response, is to start in a healthcare setting. In spite of that, we think Germany is off to a really good start with like 10-plus centers starting to prescribe. The only point I'll make with respect to the EU launch, I would expect it to be a steady launch upwards as opposed to expecting any kind of bolus early on in either country, whether it be Germany or France. The demand, the physicians, and the patients are pretty excited, I would say, both in Germany, France, and Italy is starting to go that way too. With respect to pricing, we know Germany affords free pricing for the first six months. Internally, we'll make a determination to start accruing for the next 12 months, depending on how pricing's proceeding, negotiations are proceeding.

Speaker #7: Although underreporting is possible. HHDS is characterized by painful rash and blistering in skin folds with a relapsing remitting course that is exacerbated by heat and sweat.

Note that the increase in gross margin. This quarter was the result of U S product manufacturing process optimizations and the benefit of lower cost packages. After FDA approval of this optimized process.

While we expect these manufacturing efficiencies to continue benefiting our U S operations. The optimized process has not yet been approved for products sold outside the United States.

Speaker #7: Patients often report debilitating symptoms of pain, itch, burning, body odor, as well as infections resulting in severe negative impacts on quality of life, psychological distress, and intimacy issues.

As ex U S sales grow over the coming quarters, we anticipate gross margins will normalize towards historical levels until the optimized process is approved for products sold outside the United States.

Speaker #7: There are no specific therapies available for the treatment of this disease. Building on our experience and clinically validated HSV platform for skin delivery, we designed Kb111 to deliver ATP2C1 directly to skin cells, increase ATPase levels, and hopefully change the course of this terrible disease.

Research and development expenses were $14 6 million and general and administrative expenses were $37 $6 million.

Operating expenses for the quarter included noncash stock based compensation of $13 $2 million.

You'll note on slide 13 that we are revising our full year, non-GAAP, R&D and SG&A guidance to $145 million to $155 million.

Krish Krishnan: In France, obviously, we start accruing from day one. It's very country-specific. I will say, based on the ASMR rating, based on the pricing we got in Japan, I think it bodes well. It remains to be seen, but I think the efficacy and the debilitating nature of the disease, I think that message, we're doing a really good job of conveying that, and it's being received well by these authorities in different countries.

Speaker #7: As with Vigevex, Kb111 is formulated for a topical administration directly to the lesions of HHD patients. We have already confirmed in preclinical studies that Kb111 can efficiently transfuse skin cells resulting in functional ATPase expression and last month cleared our INE.

Compared to our prior guidance of $150 million to $175 million.

This represents both a reduction and narrowing of the range to better reflect our performance so far this year.

As well as our continued confidence in our ability to execute with discipline for the remainder of the year.

Speaker #7: We expect to start an inter-patient randomized double-blind placebo-controlled multicenter study evaluating Kb111 in HHD patients in the first half of next year. With strong execution across our pipeline and now the added benefits of the platform designation for Kb801, we are well positioned to make rapid progress with multiple readouts in the months ahead.

During the quarter, we released a majority of the valuation allowance that was previously recorded against our deferred tax assets, reflecting our confidence in crystals future profitability.

[Analyst] (Jefferies): Got it. Thank you.

Kate Romano: Your next question for today is from Ritu Baral with TD Cowen. Ritu, your line is live.

This release resulted in a onetime noncash tax benefit that increased our reported EPS.

We also benefited from the reversal of the section 174, R&D capitalization requirements under the one big beautiful Bill legislation.

[Analyst] (TD Cowen): Hi, guys. Apologies. I was muted. Good morning. Thank you for taking the questions. I have been getting a lot of questions on NK timing. Specifically, Krish, could you take us through sort of what the gating aspects of getting that trial up and going is? How many sites and how difficult it is to open those sites? Has formal enrollment actually started? I think there's a lot of focus on the rapidity of getting to data, and what that says about the overall NK population prevalence. I have a quick follow-up on CF.

Speaker #7: With that, I'll hand the call over to Kate.

This reversal was also nonrecurring.

Speaker #2: Thank you, Suma, and good morning, everyone. I'd like to provide some highlights from our third quarter financial results reported in our press release and 10 Q filing earlier this morning.

Net income for the quarter was $79 4 million, which represented $2 74 per basic and $2.66 per diluted share reflective of these onetime benefits.

Speaker #3: Vigevex net product revenue for the third quarter was $97.8 million. This marks sustained growth as compared to the prior quarter, including the early sales from our German launch.

And finally, our balance sheet continues to be a key point of strength for crystal.

We ended the third quarter with over $864 million in combined cash and investments and we remain well positioned to support our commercial launches globally as well as our significant pipeline programs in the upcoming quarters.

Speaker #3: Gross to net revenues remain consistent with prior quarters.

Speaker #2: Cost of goods sold was $4.3 million, and gross margin was 96% for the quarter, as compared to 93% last quarter. Note that the increase in gross margin this quarter was the result of U.S.

Krish Krishnan: Gotcha. On NK, I will just say, look, I think we have started to enroll patients in the study. Maybe Suma, you could add some color on how we're proceeding.

And now I will turn the call back over to Chris.

Thanks Kate.

Speaker #2: Product manufacturing process optimizations and the benefit of lower-cost batches after FDA approval of this optimized process. While we expect these manufacturing efficiencies to continue benefiting our U.S.

As we close today's call I'd like to emphasize our excitement for the path ahead at Crystal in 2026.

Suma Krishnan: Absolutely. I mean, we have quite a few sites up and running. We are actively adding additional sites. We really intend not just in the US, but globally, because there's a lot of NK patients in Europe and the rest of the world, and we want to make this a global filing. As you know, it takes a little while to get them up and running for the global studies, but we are right in the process. I think we will have most of our sites all completely signed up and ready to go, hopefully, by the end of the year. As you know, we are enrolling patients. This is one of our top priority projects. We are excited to see the progress on this particular trial.

With launches in Germany, France, and Japan, where <unk> is now truly gone global <unk>.

Speaker #2: Operations: the optimized process has not yet been approved for products sold outside the United States. As XUS sales grow over the coming quarters, we anticipate gross margins will normalize towards historical levels until the optimized process is approved for products sold outside the United States.

Providing us the opportunity to dramatically expand the number of patients benefiting from bodies Vic therapy in the months ahead.

The hard part of a global base of our client is now behind us.

And crystals focus in 2026 is on our clinical pipeline.

Speaker #2: Research and development expenses were $14.6 million and general and administrative expenses were $37.6 million. Operating expenses for the quarter included non-cash stock-based compensation of $13.2 million.

We have our first readout in CF before year end.

We're working towards Readouts in either one for NK and <unk> III, but I lesions had dipped patients by midyear and.

And Vishal update once enrollment is complete in these programs.

Speaker #2: You'll note on slide 13 that we are revising our full year non-GAAP R&D and SG&A guidance to 145 to 155 million dollars. Compared to our prior guidance of 150 to 175 million dollars.

These programs along with gave me 111 for Haley Haley fit neatly within our core global commercial capabilities.

Krish Krishnan: I will add, Ritu, our internal timing target is to announce some kind of interim data by the middle of next year.

[Analyst] (TD Cowen): Got it. Can you say what percentage of sites you have up, the percentage of planned sites that you have up and running at this point?

At the same time, we recognize the significant optionality that <unk> provides.

<unk> non integrating large capacity gene delivery platform and the potential upside opportunities that exist in large market indications.

Speaker #2: This represents both a reduction and narrowing of the range to better reflect our performance so far this year, as well as our continued confidence in our ability to execute with discipline for the remainder of the year.

Suma Krishnan: I mean, we have quite a few sites. I mean, within the US, we got most of the academic sites up and running. We have a few more to go, but I think we should have most of the US sites up and running by the end of the year.

We will continue to invest in these programs with the same operational discipline as we have in the past to ensure that we maximize the value that we believe exist in our pipeline.

[Analyst] (TD Cowen): Got it. For CF, can you tell us how many null patients you plan to provide data on by the year-end update? What constitutes success on molecular response? What aspects of molecular response will you be reporting, and what's success in a null patient?

Speaker #2: During the quarter, we released a majority of the valuation allowance that was previously recorded against our deferred tax assets, reflecting our confidence in Crystal's future profitability.

And platform before entering into partnerships for these programs.

Speaker #2: This release resulted in a one-time non-cash tax benefit that increased our reported EPS. We also benefited from the reversal of the Section 174 R&D capitalization requirement under the One Big Beautiful Bill legislation.

Thanks for listening.

And I'd like to now open the call for Q&A.

Certainly at this time, we will be conducting a question and answer session. If you have any questions or comments. Please press star one on your phone at this time, we ask that we're posing your question you. Please pickup your handset if listening on speaker phone to provide optimum sound quality.

Krish Krishnan: Yeah. Ritu, thanks for that question. We are looking at a minimum of three null patients, primarily focused on molecular correction. Because it's a single-dose study. Suma, anything else?

Speaker #2: This reversal was also non-recurring. Net income for the quarter was $79.4 million, which represented $2.74 per basic and $2.66 per diluted share, reflective of these one-time benefits.

Suma Krishnan: Yeah. I mean, obviously, we are bronching these patients, these three null patients, after the drug is administered. The biopsies, we will take across all the different areas of the lung. We will look for expression of CFTR by immunofluorescence across, and we will see what kind of expression. We are expecting to see robust expression. I mean, based on our NHP primate study, hopefully, if we can recreate that, we see expression all the way up to 28 days. We see full-length molecular CFTR expression across all of our biopsies. We think we feel pretty confident. Nobody is able to today show full-length expression of CFTR. Hopefully, we can break that cycle. That's our goal.

Please hold while we poll for questions.

Your first question for today is from Alec Stranahan with Bank of America.

Speaker #2: And finally, our balance sheet continues to be a key point of strength for Crystal. We ended the third quarter with over $864 million in combined cash and investments, and we remain well positioned to support our commercial launch's globally as well as our significant pipeline programs in the upcoming quarters.

Hey, guys. This is Matthew on for Alex.

Congrats on the quarter I appreciate you taking our questions maybe just two from us.

On the ex U S launch I guess weather.

Your focus is on expanding the breadth of prescribers or.

Speaker #2: And now, I will turn the call back over to Krish.

Prescribers at maturity.

And prescriptions.

Speaker #1: Thanks, Kate. As we close today's call, I'd like to emphasize our excitement for the path ahead at Crystal in 2026. With launches in Germany, France, and Japan, Vigevex has now truly gone global, providing us the opportunity to dramatically expand the number of patients benefiting from Vigevex therapy in the months ahead.

Then maybe on the optimized process that led to better gross margins just curious you know what.

It was sort of optimizing this process and whether you can speak to the timeline for this optimized process to be extended to ex U S markets. Thanks.

No.

[Analyst] (TD Cowen): What will you report as percentage of normal, and sort of what threshold could result in FEV1 changes at a later time point?

Thank you Matthew.

Hey in terms of your first question on <unk>.

Ex U S launch breadth of prescribers versus step.

Speaker #1: The hard part of a global Vigevex launch is now behind us, and Crystal's focus in 2026 is on our clinical pipeline. We have our first readout in CF before year-end.

I mean, our focus I mean, you know.

Suma Krishnan: I mean, we know that you don't need much, right? Even these patients don't produce any CFTR. Even if we can produce anywhere between 5% to 10% of CFTR expression, I think that's pretty robust. Our intent is in these multiple biopsies across the lung, we will hopefully, we want to show expression in most of these biopsies, and that will give us some confidence that, yes, we can express and we have enough molecular correction. Especially in these null patients, don't produce any CFTR.

Our objective is.

In Europe, it's primarily.

Celebrate.

Getting a patient to meet the position as soon as possible.

Speaker #1: We're working towards readouts in 801 for NK and Kb803 for eye lesions and deaf patients by mid-year. And we shall update once enrollment is complete in these programs.

Because the first clinical visit has to be in a physician office.

Now purely logistically, that's a lot easier.

Focusing on centers of excellence.

As you heard from thereon.

Speaker #1: These programs, along with KB111 for Haley Haley, fit neatly within our core global commercial capabilities. At the same time, we recognize the significant optionality that HSV-1 provides as a re-dosable, non-integrating, large capacity gene delivery platform and the potential upside opportunities that exist in large market indications.

To begin with.

But at the same time slowly spreading out into the community.

On the question about optimized process.

Hum.

Essentially moving to a larger bioreactor, it's got approved in the U S and we are working towards an application in Europe.

[Analyst] (TD Cowen): Got it. Thanks for taking all the questions.

Kate Romano: Your next question is from Gavin Clark-Gartner with Evercore ISI.

I'll ask somebody to comment on timing.

The approval in Europe.

[Analyst] (Bank of America): Hey, guys. Thanks for taking the questions. On NK, what makes you confident that you don't need to test any different doses, and why the one that you picked is the right dose? Somewhat on this topic, do you think you need two efficacy studies for approval, or may one be sufficient?

Back to the optimized patch I mean, we have already started the process we have filed.

Speaker #1: We will continue to invest in these programs with the same operational discipline as we have in the past to ensure that we maximize the value that we believe exists in our pipeline and platform before entering into partnerships for these programs.

Scale up I mean, it's pretty straightforward because we have a lot of data from the U S. So.

We expect hopefully sometime next year to have you.

Suma Krishnan: The confidence for the dose comes from our animal studies. I mean, we clearly see expression. We have a clear pharmacokinetic profile. We know how long the expression lasts. That has guided us into the dosing regimen in the clinic. Yes, we feel pretty sure that we just need one efficacy trial because this is, again, a rare disease. It meets the regulatory guidance for what the requirement is. Based on our study and the way we have powered the study based on our animal studies and what oxalate studies have achieved, we have powered it to hopefully see clinical significant improvement from placebo. That's the goal of this study. If successful, we expect this to be the registrational trial. Obviously, we have the platform technology, and we have guidance on what we need from a CMC perspective. I think we're aligned. That's something that's positive for this program.

E optimized and scale up process.

Okay.

Great.

Speaker #1: Thanks for listening. And I'd like to now open the call for Q&A.

Your next question is from Roger song with Jefferies.

Speaker #4: Certainly. At this time, we will be conducting a question-and-answer session. If you have any questions or comments, please press star one on your phone at this time.

Great Congrats for the quarter and thank you for taking my question also relates to the question the ex.

Speaker #4: We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions.

Ex U S launch.

So I.

I understand the contribution in the streets here, probably not too much from Germany, but just curious about your expectation moving into next year, maybe <unk> in the next year, how should we think about ex U S versus the U S revenue contribution and went on it yes, you will give us some breakdown at all and then also really.

Speaker #4: Your first question for today is from Alec Stranahan with Bank of America.

Speaker #5: Hey, guys. This is Matthew on for Alec. Congrats on the quarter. Appreciate you taking our questions. Maybe just two from us. On the XUS launch, I guess whether your focus is on expanding the breadth of prescribers or depth of prescribers that have already made some prescriptions.

Sure.

There too this ex U S launches are how should we think about the pricing understanding you need to negotiate on top of the list price.

And then how this will change over time, particularly with the U S. M. S N.

Policy. Thank you.

[Analyst] (Bank of America): Is there any commentary you can provide on the safety you're seeing in the ocular depth study or even the NK study on a blinded basis?

Speaker #5: And then maybe on the optimized process that led to better gross margins. Just curious what was sort of optimized in this process and whether you can speak to timelines for this optimized process to be expanded to XUS markets.

Great Roger Thanks for those questions.

Look I.

Suma Krishnan: I mean, so far, we have not seen any adverse events of concern.

Any requirement as I mentioned in the past in the prior response is to start in a health care setting.

[Analyst] (Bank of America): All right. Great. Thanks.

In spite of that we think Germany is off to a really good start look like 10 plus centers.

Speaker #5: Thanks.

Speaker #6: Thank you, Matthew. Hey, in terms of your first question on XUS launch, breadth of prescribers versus depth, I mean, our focus, I mean, you know our objective in Europe is primarily to accelerate getting a patient to meet the physician as soon as possible because the first clinical visit has to be in a physician office.

Starting to prescribe.

Kate Romano: Your next question is from Sami Corwin with William Blair.

But the only point I'll make with respect to the EU launch.

I would expect it to be a steady.

[Analyst] (Jefferies): Good morning. Congrats on the progress, and thanks for taking my questions. I also have one on NK. Could you remind us if you're excluding patients that have had a prior ocular HSV infection, and if you think a prior HSV infection could impact the efficacy or safety of treatment? In terms of the initial data set, what exactly will we see in that? Thank you.

Larger ports as opposed to expecting any kind of bolus.

And in either country, but Germany or France.

But the demand in the.

The physicians and the patients are pretty excited I would say both.

In Germany, France and.

Speaker #6: Now, purely logistically, that's a lot easier if you start focusing on centers of excellence as you heard from Laurent to begin with. But at the same time, slowly spreading out into the community.

And Italy is starting to go that way too.

With respect to pricing look we know Jeff Germany efforts three pricing for the first six months and then internally, we'll make a determination to start accruing for the next 12 months.

Suma Krishnan: Regarding your first question, no, we do not. We do not exclude patients that have tried infection. The only requirement is they should not have an active infection. That's the only exclusion criteria. I mean, one second.

Speaker #6: On the question about optimized process, this is essentially moving to a larger bioreactor. It's got approved in the US, and we're working towards an application in Europe.

Spending on how pricing is proceeding negotiations are proceeding in France.

Obviously, we start accruing from day, one so it's very country specific.

But I will say based on the anthem our rating based on the pricing regarding Japan.

Speaker #6: I'll ask someone to comment on the timing for the approval and Europe, with respect to the optimized batch.

Krish Krishnan: What?

Suma Krishnan: The data set, what are we going to announce?

Krish Krishnan: What?

Suma Krishnan: What are we going to announce? Yeah. Data set, this is a randomized one-to-one placebo-controlled study, eight-week. We look at complete healing using, I mean, complete healing with an independent reader. If you see complete healing against placebo, then that's what we're just exactly like oxalate.

I think it bodes well.

Speaker #7: I I mean, we have already started the process. We have filed the scale-up. I mean, it's pretty straightforward because we have a lot of data from the US.

It remains to be seen but I think the efficacy and the debilitating nature of the disease I think that message, we're doing a really good job of conveyed that and it's being received well.

Speaker #7: So we expect, hopefully, sometime next year to have the optimized and scaled-up process approved.

By these authorities in different countries.

Got it thank you.

Okay.

Speaker #5: Great. Thanks.

[Analyst] (Jefferies): Got it. Great. Just one question on VYJUVEK. Do we expect some guidance or full-year revenue guidance for VYJUVEK early next year? Thanks.

Your next question for today is from Ritu <unk> with TD Cowen.

Speaker #4: Your next question is from Roger Song with Jefferies.

Speaker #8: Great, congrats for the quarter, and thank you for taking our question. Also, related to the question, XUS launch, so I understand the contribution in 3Q is probably not too much from Germany.

Krish Krishnan: No. Because we have so many launches and the distribution you see, it runs, it will take us some time to kind of get comfortable with how the different launches are going in different countries. Fortunately, Sammy, we will not be guiding on revenue for 2026.

Ritu Your line is live.

Hi, guys apologies I was muted good morning. Thank you for taking the questions I have been getting a lot of questions on <unk>.

Speaker #8: But just curious about your expectation moving to next year, I mean, before Q and then next year. How should we think about XUS versus the US revenue contribution, and when on ESG will give us some breakdown later on?

N K timing and specifically, Chris could you take us through sort of what the gating aspects of getting that trial up and going is.

[Analyst] (Jefferies): Got it. Thank you.

Kate Romano: Your next question is from Josh Schimmer with Cantor Fitzgerald.

How many sites and how difficult. It is to open those sites have has enrollment formal enrollment actually started I think there's a lot of focus on the rapidity of getting two data.

Speaker #8: And then also related to this XUS launch, how should we think about the pricing? I understand you need to negotiate on top of the list price.

[Analyst] (TD Cowen): Hi. This is Alexa Diemer on for Josh Schimmer, and congrats on a great quarter. Can you please provide some more color on the contribution of US and ex-US sales in the third quarter for VYJUVEK? More specifically, what was the percentage breakdown from the US versus Germany? Thank you.

Speaker #8: And then how this will change over time, particularly with the US MFN policy. Thank you.

And what that says about the overall NK population prevalence and then I have a quick follow up on <unk>.

Speaker #6: Great, Roger. Thanks for both those questions. Look, the only requirement, as I mentioned in the prior response, is to start in a healthcare setting.

Krish Krishnan: Yeah. Look, the decision not to break down in this particular quarter was somewhat accounting auditor-driven, and the goal is to establish a consistent long-term practice on segment reporting. If you follow that thought, we will be starting to break down geographies at some point in 2026. It's just that now it is so modest, the contribution relative to the overall net revenues of the company.

Yes.

Gotcha.

Hey.

I would just say look I think we have started to enroll patients in the study maybe somebody you could add some color on how we're absolutely I mean, we have a we have quite a few sites up and running we are actively adding additional sites. So really intend not just in the U S, but globally because there's a.

Speaker #6: But in spite of that, we think Germany is off to a really good start. But like 10-plus centers, starting to prescribe. But the only point I'll make with respect to the EU launch: I would expect it to be a steady launch upwards as opposed to expecting any kind of bullish early on in either country, whether it be Germany or France.

A lot of <unk> patients in Europe, and the rest of the world and we want to make this a global filing.

Speaker #6: But the demand and the physicians and the patients are pretty excited, I would say, both in Germany, France, and Italy is starting to go that way too.

So as you know it takes a little while to.

[Analyst] (TD Cowen): Got it. Can you provide any more specifics on how US sales were in the second quarter versus the third quarter?

Get them up and running for a global.

Global study, but you are right in the process I think we will have most of our sites are completely signed up and ready to go hopefully by the end of the year.

Krish Krishnan: Yeah, definitely. I would say that the US was a bit lower than what we saw in Q2, but not to the extent based on my comments from the last quarter. Definitely, reimbursement approvals were on an uptick, so overall, we ended up getting to a number that was higher than Q2.

Speaker #6: With respect to pricing, we know Germany affords free pricing for the first six months. And then internally, we'll make a determination to start accruing for the next 12 months.

And as you know we are enrolling patients. This is one of our top priority projects. So.

We are excited to see the you know.

Speaker #6: Depending on how pricing is proceeding, negotiations are proceeding. In France, obviously, we start accruing from day one. So it's very country-specific. But I will say, based on the ASMR rating, based on the pricing we got in Japan, I think it bodes well.

Our progress on this particular trial.

And I will add.

Internal timing target set out some kind of interim data by the middle of next year.

Got it and can you say what percentage do.

[Analyst] (TD Cowen): Got it. Thanks so much.

Do you have.

The percentage of plant sites that you have up and running at this point.

Speaker #6: It remains to be seen, but I think the efficacy and the debilitating nature of the disease I think that message we're doing a really good job of conveying that.

Kate Romano: Your next question for today is from Andrea Newkirk with Goldman Sachs.

I mean, we have quite a few sites I mean within the U S. We got most of the academic sites up and running.

Krish Krishnan: Hi. This is Morgan on for Andrea. Thank you for taking our question. With 615 reimbursement approvals, what do you attribute this growth to? Are you seeing more patient ads from the community setting? How are you thinking about the path to 60% penetration from here? Thank you.

We have a few more to go but I think we should have most of the U S side.

Speaker #6: And it's being received well. By these authorities in different countries.

Up and running by the end of the year.

Got it and then yeah.

Speaker #8: Got it. Thank you.

Can you tell us how many patients that you plan to provide data on by the year end update and sort of what constitutes success on molecular.

Speaker #4: Your next question for today is from Ritu Baral with TD Cowan. Ritu, your line is live.

Krish Krishnan: Great question, Andrea. Look, like I mentioned maybe last quarter or the one before, it was taking us a bit longer to pull through a start form as we are getting patients more out in the community and physicians who are far away from a center of excellence. By just increasing the size of the sales force, I believe we have turned that issue around. We saw some acceleration last quarter, and we see a continued acceleration this quarter. We expect that to go forward as more reps are being trained and out into the field. In terms of 60% market share, look, that's a number around 720. We reported 615, so we're maybe a quarter or two from hitting that number. If you just do simple math on that metric, we feel really good about the way the launch is going and how we've been able to reverse this.

<unk> response, what aspects of the molecular response will you be reporting and what success in and I'll take that.

Yes.

Speaker #9: Hi, guys. Apologies, I was muted. Good morning. Thank you for taking the questions. I have been getting a lot of questions on NK timing, and specifically, Krish, could you take us through sort of what the gating aspects of getting that trial up and going are?

Thanks for that question, we are looking at a minimum renal patients.

Primarily focused on molecular correction.

Because it's a single dose study.

So by anything Oh, Yeah, I mean, obviously the Bronco <unk> these patients between our patients.

After the drug is administered and the biopsies will take across the different cros.

Across all the different areas of the lung and even look car expression of CFT are by immunofluorescence.

And we will see what kind of.

Expression, you're expecting to see robust expression I mean based on our NSP.

Primate study I mean, this hopefully we can recreate that VC expression, all the way up to 28 days.

Krish Krishnan: One or two, one quarter of deceleration in RAs.

A simple act molecular molecular CFT had expression across.

Krish Krishnan: Great. Thank you so much.

All of our biopsy, we think we feel pretty confident nobody is able to do that so full length expression of CFT are so hopefully we can break that cycle. That's our goal.

Kate Romano: Your next question is from Yigal Nochomovitz with Citigroup.

[Analyst] (Bank of America): Hi. This is Joan Kim on for Go. Thanks for taking our question. Maybe just two quick ones from us on KB408. Can you just talk a little bit about your expectations there, whether you're expecting a significant uptick in AAT with repeat dosing versus a single dose, and what sort of boost you'd be expected to see or what you want to see?

Thank you.

Like percentage of abnormal and sort of what what threshold.

It could result in F&B changes at a later time point.

They know that they don't need much right. Even these patients don't place any see FTR. So even if we can produce anywhere between 5% to 10% of the FTR expression I think that's pretty robust.

Krish Krishnan: Yeah. Obviously, we're expecting an uptick. We're not particularly talking right now about how much of an uptick.

Again, our intent in these multiple biopsies across the across the long vivo hopefully we want to show expression.

Suma Krishnan: I mean, we are doing repeat dosing of A180, I mean, of 408, and we'll be collecting bronch and LAVOD samples. That's something that's ongoing. We will show repeat dosing and expression of A180.

In most of these biopsies and that will give us some confidence that yes, we can express them do you have enough politically correct.

So starting as validation studies any CFT.

Got it thanks for taking all the questions.

[Analyst] (Bank of America): Got it. Can you speak on whether opening up more sites is also a priority for that program to continue enrolling patients, given that there are quite a number of AATP programs ongoing right now?

Sure.

Your next question is from Gavin Clark Gartner with Evercore.

Suma Krishnan: I mean, right now, we have a couple of sites that's open because, remember, again, these sites have to be able to do bronchoscopy. In case of 408, it's a little more complex because it's not just biopsies. They also need to take lung lavage fluids out to measure the A180 and the protein levels. There's only a few sites that are capable of doing this. We have those sites, we have the patients. Hopefully, once we finish that cohort with the repeat dose administration and A180 levels, we hope to have a meeting with the agency to potentially talk about a path forward.

Hey, guys. Thanks for taking my questions on N. K, what makes you confident that you don't need to test any different doses and why the one that you picked as the right dose and somewhat on this topic do you think you need two efficacy studies for approval or may won't be sufficient.

So the confidence for the dose comes from our animals.

I mean, we clearly see expression gave us clear pharmacokinetic profile.

How long they expressed in last so that has guided us into the dosing regimen in the clinic, yes.

Yes.

Paresh Shah that we just need one efficacy trial because this is again a rare disease. It meets the regulatory guidance on what the requirement is so.

[Analyst] (Bank of America): Got it. Thank you.

So based on our study and the way we have powered the study based on our animal studies and what oxalate.

Uh because it's a single dose study.

um,

Kate Romano: There are no further questions. Thank you. Thank you. We've reached the end of the question and answer session and today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.

Studies are achieved.

Powered it to hopefully see a clinical significant improvement from placebo. So that's the goal of this study is successful then we expect this to be the Registrational trial, and obviously you have the platform technology.

And we have guidance on what we need from a CMC perspective, though.

I think you are.

Right. So that's.

That's something that's positive for the program.

And is there any commentary you can provide on the safety you're seeing in the ocular study or even the end case study on a blinded basis.

so anything else? Yeah I mean obviously we have Broening these patients, these 3 null patients. Uh after the drug is administered and the biopsies we will take across the different, you know, across all the different areas of the lung. And we will look for expression of cftr by imop florescent, you know, across and we will see, uh, what kind of, uh, you know. Um, expression we are expecting to see robust Expressions. I mean, based on our nhp uh, primate study. I mean we've hopefully we can recreate that we see expression all the way up to 28 days.

We see full-length molecular CFD at expression across.

I mean.

So far we have not seen any adverse events of consoles.

Alright, great. Thanks.

Is able to today. So full length expression of cftr, so hopefully, you know, we can break that cycle. That's our goal.

Your next question is from Sami Corwin with William Blair.

Good morning, Congrats on the progress and thanks for taking my questions. I also have one on N. K could you remind us if you are excluding patients that have had a prior ocular HSV infection and if you think a H S. Prior HSV infection could impact the efficacy or safety of treatment and then.

You it's like percentage of of normal and sort of what, what threshold should could result in fehb changes at a later time point.

We know that you don't need much, right? Even these patients don't produce any CFTR. So, even if you can produce, you know, anywhere between 5% to 10% of CFTR expression, I think that's pretty robust.

And in terms of the initial dataset, what exactly will be seeing that thank you.

Regarding your first question no we did not.

We did not exclude patients that have tried infection, the only requirement and that should not have an active infection.

So again, uh, our intent is in these multiple biopsies across, you know, the, uh, across the lung we will, hopefully, we want to show expression in, you know, most of these biopsies and that, you know, give us some confidence that yes we can express. And we have enough molecular correction.

The only exclusion criteria I mean that.

So, especially in this, now patients don't produce any CFD on.

No.

Got it. Thanks for taking all the questions.

Okay.

Alright.

Whenever you can announce what what are we going to announce data said this is a randomized one to one placebo controlled study eight week.

Your next question is from Gavin, Clark Gartner with evercore.

Hey guys, thanks for taking my questions.

So we look at complete healing, but using.

Hum.

I mean complete healing ship with that independent reader.

If you see complete healing at eight against placebo then that's a win just exactly like all correct.

On NK. What makes you confident that you don't need to test any different doses, and why the one that you picked is the right dose? And somewhat on this topic, do you think you need two efficacy studies for approval or may one be sufficient?

Got it great and then just one question on <unk>.

We expect seven guidance, our full year revenue guidance for advisory back early next year. Thanks.

So the confidence for the dose comes from our animals studies. I mean, we clearly see expression, we have a clear form of kinetic profile. So, we know how long the expression lasts, so that is guided us into the dosing regimen in the clinic.

Okay.

No.

yes, we we we pretty

Because we'd have so many launches and that distribution, you'll see that it will take some time to kind of get comfortable with how the different launches are going in different countries. So.

Sure, that we just need 1 efficacy trial because this is again, a rare disease. It meets the regulatory guidance for what the requirement is.

Fortunately savvy, we will not be guiding on revenue for 2026.

Got it thank you.

Your next question is from Josh Shimmer with Cantor Fitzgerald.

Hi, This is <unk> on for Josh Shimmer and congrats on a great quarter. So can you. Please provide some more color on the contribution of U S and ex U S sales in the third quarter for Bijac more specifically what was the percentage breakdown from the U S versus Germany.

So based on our study and the way we have powered the study based on, you know, our animals studies, and what oxalate, uh, Studies have achieved. We have powered it to hopefully see uh, clinical significant improvement from Placebo. So that's the goal of, this study is successful, then we expect this to be the registrational trial. And obviously, we have the platform technology and we have guidance on, you know what we need from a CMC perspective. So,

Yeah, I think you're aligned. So that's

That's something that's, you know, positive for this program.

You.

Yes look the decision not to break down.

And is there any commentary? You can provide on the safety you're seeing in the ocular Deb study or even the NK study on a blinded basis?

In this particular quarter was.

Accounting auditor driven in the coal space.

I mean, to, you know, I mean, so far, we have not seen any adverse events of concern.

Our consistent long term practice on segment reporting.

All right, great. Thanks.

And if you follow that thought.

We will be starting to breakdown geographies at some point in 2026.

Your next question is from Sammy Corwin with William Blair.

It's just that now it is so modest contribution.

Relative to the overall net revenues of the company.

Okay got it and can you provide any more specifics on how U S sales were in the second quarter versus the third quarter.

Yeah, Jeff.

In Italy.

I would say that the U S.

Good morning. Congrats on the progress and thanks for taking my question. Um, I also have 1 on NK, could you remind us if you're excluding patients that, um, have had a prior ocular HSV infection? And if you think a HS prior HSC infection could impact to the efficacy or safety of treatment and then and in terms of the initial data set, what exactly will we see in that? Thank you.

A bit lower than what we saw in Q, but not to the extent like based on my comments from the last quarter.

Um, regarding to your first question? No, we do not.

Currently the embarrassment approvals, but another uptick.

Uh, we do not exclude patients with a prior infection. The only requirement is that they should not have an active infection.

And so overall we ended up.

Uh, that's the only exclusion criteria. I mean that. So

Getting to a number that was higher than Q2.

Got it thanks, so much.

Your next question for today is from Andrea Newkirk with Goldman Sachs.

When are we going to announce? What are we going to announce? Yeah, data set. This is a randomized 1-to-1 placebo control study, 8 weeks.

Hi, This is Morgan on for Andrea Thank you for taking our question.

Uh, so we look at complete healing using, uh, you know, um.

With 615 reimbursement approvals what do you attribute this growth to them are you seeing more patient adds from the community setting and then how are you thinking about the path to 60% penetration from here. Thank you.

I mean, complete healing with the independent reader. So if you see complete healing at any against placebo, then that's how we're just exactly like ox away.

No great question Andrea look.

Got it, great. And then just one question on Vivac. Um, could we expect some guidance or full-year revenue guidance for Vivac early next year? Thanks.

Like I mentioned, maybe last quarter or the one before it was taking us a bit longer to pull through a start form.

um,

no.

We are getting patients more out in the community and physicians, who are not far away from our center of excellence.

And by just increasing the size of the sales force I believe we have turned that issue at all or we saw some acceleration last quarter, we see a continued acceleration this quarter.

Uh, because we have so many launches and the distribution, you see lines, it will take you some time to kind of get comfortable with how the different launches are going in different countries. So,

fortunately Sammy we will not be guiding on revenue for 20206.

Got it. Thank you.

We expect that to go forward as more and reps are being trained and out into the field.

In terms of 60% market share so thats a number around 720.

We reported 615, so we're maybe a quarter or two from hitting that number.

If you just do a simple math on that on that metric, which so we feel really good about the way the launch is going and how we've been able to reverse this.

Hi, this is Alexa Deemer on for Josh Shimmer, and congrats on a great quarter. Can you please provide some more color on the contribution of U.S. and ex-U.S. sales in the third quarter for buyback? More specifically, what was the percentage breakdown from the U.S. versus Germany?

Thank you.

Uh huh.

So wanted to one quarter of deceleration in Orange.

Great. Thank you so much.

Your next question is from Yigal <unk> with Citi.

Yeah, look, the decision not to break down, uh, in this particular quarter was somewhat accounting- and audit-driven, and the goal is to establish a consistent long-term practice on segment reporting.

Hi, This is John Kim on for Yigal. Thanks for taking our question maybe just two quick ones for from Us on Q4 or eight.

Um, if you follow that thought, we will be starting to break down geographies at some point in 2026. Um, it's just that now it is so modest, the contribution um,

Can you just talk a little bit about your expectations, there or whether you're expecting a significant uptick in AG with repeat dosing versus the single dose and what sort of boost you'd be expecting to see or would you want to see.

Relative to the overall net revenues of the company.

Can you provide any?

Quarter versus the third quarter.

Yeah, obviously, we're expecting an uptick, but we're not particularly talking right now about how much of it I'm correct, but I.

We are doing repeat dosing of <unk> of four eight and we will be collecting bronchial lavage samples. So that's something.

Um, yeah, uh, definitely. Uh, you know, I would say that the U.S. was a bit lower than what we saw in Q2, but not to the extent, like based on my comments from the last quarter. Uh, definitely, reimbursement approvals were on an uptick.

Something that's ongoing.

So we will show repeat dosing in an.

Um and so overall, we ended up getting getting to a number that was higher than Q2.

An expression of anxiety.

Got it and can you speak on whether opening up more sites is also a priority for that program to continue enrolling patients given that there are quite a number of ATB programs ongoing right now.

Got it. Thanks so much.

Your next question for today is from Andrea Newkirk with Goldman Sachs.

I mean right now we have a couple of sites that are open because remember <unk> sites have to be able to do bronchoscopy in case of a 408, it's a little more complex because it's not just biopsy. They also need to take lung lavage fluids out to measure the <unk> in the protein level.

There's only a few sites that are.

Hi. This is Morgan on for Andrea. Thank you for taking out, question. Um, with 615 reimbursement approvals. What do you attribute this growth to? Um, are you seeing more patient ads from the community setting? Um, and then how are you thinking about the path to 60% penetration from here. Thank you.

That are capable of doing that so we have those sites you have the patients hopefully once we finish.

No, uh, great question. And we are look, um,

That cohort with a repeat dose administration in <unk> level, and we hope to have a meeting with the agency.

Potentially talk about our path forward.

Like I mentioned, maybe last quarter or the one before it, it was taking us a bit longer to pull through a start form. As we are getting patients more out in the community and physicians who are far away from a center of excellence,

Got it thank you.

There are no further questions in queue.

and by just increasing the size of the sales force. The, I believe we have turned that issue around. Uh, we saw some acceleration last quarter, we see a continued acceleration. This quarter will be expect that to go forward as more in reps are being trained and out into the field.

Thank you we've reached the end of the question and answer session and today's conference call. You may disconnect. Your phone lines at this time and have a wonderful day. Thank you for your participation.

Um, in terms of 60% market share, that's a number around 720.

We reported 615. So we're maybe a quarter or 2 from hitting that number. Uh, if you just do a simple math on that on that metric which so we feel really good about the way the launch is going and how we've been able to reverse this, uh,

the 1 or 2 1 quarter of deceleration in RS.

Great, thank you so much.

Your next question is from yall not to move its with City.

Hi, this is Jan Kim on. Thanks for taking our question, maybe just to quick ones for uh, from us on KB. 408, can you just talk a little bit about your expectations there where whether you're expecting a significant uptick in a at with repeat dosing versus a single dose and what sort of boost you'd be expected to see, or would you want to see?

um,

Yeah. Obviously, we're expecting an uptick, but we're not particularly talking right now about how much of an uptick. I mean, we are doing repeat dosing of A180, I mean, of 408, and we'll be collecting Braun and load samples. So that's something that's ongoing.

So once so, we will show, repeat those things and.

Got it. Can you speak on whether opening up more sites is also a priority for that program to continue rolling patients, given that there are quite a number of the ATP programs ongoing right now?

I mean, right now we have a couple of sites that are open.

Once we finish up that cohort with the repeat dose administration and A180 levels, then we hope to have a meeting with the agency.

To potentially talk about a path forward.

Got it. Thank you.

There are no further questions in the queue.

Thank you. We've reached the end of the question and answer session and today's conference call, you may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.