Q1 2025 Krystal Biotech Inc Earnings Call and Business Update
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Speaker Change: Thank you for standing by, and welcome to the Krystal Biotech First Quarter 2025 Erning School. At this time, all participants are on a listen only mode. After the speaker's presentations, there will be a question and answer session. As a reminder, today's conference is being recorded, I would now like to hand a conference over to your host, Stphane Paquette, Vice President of Corporate Development. Please begin.
Speaker Change: Good morning and thank you all for joining today's call. Earlier today we released our financial result for the first quarter of 2025.
Speaker Change: The press release is available on our website at www.crystalbio.com We also file our earnings 8K and 10Q with the SEC earlier today
Speaker Change: Joining me today will be Krish Krishnan, Chairman and Chief Executive Officer
Suma Krishnan: Suma Krishnan, President of Research and Development, Jennifer McDonough, Senior Vice President of Patient Access, Analytics and Operations,
Speaker Change: Christine Wilson, Senior Vice President and Head of U of Sales and Marketing, and Kate Romano, Chief Accounting Officer
Speaker Change: A description of these risks, uncertainties, and other factors can be found in our SEC Fox.
With that, I will turn the call over to Krish.
Krish Krishnan: Thank you, Stephane. Good morning, everyone. I'd like to start today by thanking the Krishal team.
Krish Krishnan: and we're fortunate to be in such a good position commercially, clinically and financially to help patients.
Amidst the turbulent macro and FDA backdrop
Speaker Change: I'd like to briefly touch on four topics. Why is your way going global?
The upcoming clinical readouts in 2025.
Speaker Change: Primarily CF-Alpha-1, a very exciting second-off-tollmic program to treat neurotropic keratitis that just ended the clinic.
Speaker Change: and briefly discuss in the end how Krystal is insulated in the current macro and FDA situation.
Speaker Change: With the positive EC decision now behind us and the broad label that we were fortunate to receive, were excited about launching in Europe where the burden of finding genetically confirmed patients is much lower than it has been in the US.
Speaker Change: We're planning to launch in Germany and France in Q3 while simultaneously working on preparations to move the other EU countries towards launch.
Speaker Change: With a large number of already identified deputations across the continent, it's my belief that the opportunity in EU could be bigger than what the market presently anticipates.
Speaker Change: With respect in Japan, the regulatory review is progressing well, and as noted in the slide, the manufacturing inspection is now complete.
Speaker Change: We expect to obtain approval in Q3F 2025 and commence treating patients in Japan as early as Q4 2025.
Speaker Change: NetVisual could have been you for the quarter, came in at 88.2 million, and gross margins and GTM were pretty consistent, but prior quarters.
Speaker Change: As you all know, one queue tends to be a bit light for most companies in this industry and something that's not unique to Krystal
And we saw this last year also.
But more importantly, [inaudible]
Speaker Change: We saw patients pausing after an intensive induction period based on their individual needs.
Visewek is allowing patients to achieve durable wound closure
Speaker Change: and in turn enabling patients to take control of their lives. Dr. Chattopadhyay, Dr. Chattopadhyay,
This is a fantastic outcome for patients and for crystal.
These are the outcomes that will drive our long-term success.
Speaker Change: Building trust and supporting the utilization of Isaac in the US for patients' lifetimes.
Speaker Change: I sometimes refer to this as the tail on the drug which we believe will be long
Speaker Change: These success stories also activate new patients to seek out therapy, build anticipation and momentum in our ex-ceivers launches.
and Enrich our Access Discussions Overseas [inaudible]
Speaker Change: This is why we pay so much attention to patient experience on Visivak and Gen will elaborate more on this.
Speaker Change: However, in the near term it will be important to understand that patient-positing parents, particularly as patients come off intensive induction therapy for the first time, are inherently unpredictable according to quarter.
Speaker Change: and any number we could potentially provide to estimate pausing may not be repeatable in future quarters as patients come back on treatment.
Speaker Change: We're confident that patient ads in the US, Europe and Worldwide will continue to drive long-term growth for years to come.
Speaker Change: But the upcoming quarters may have some waviness as they bring on new patients.
Speaker Change: It's really key to recognize that death is a chronic disease.
and Baigevac has a strong regulatory and a patent life. [inaudible]
Speaker Change: As we move into our second full year on the market, we're excited that Vajjovek is being established as a lifelong first-line therapy for wound management
Speaker Change: Let's respect to the clinical pipeline in 2025. We have four upcoming clinical readouts for CF, AATD,
and CF and AATD. [inaudible]
Speaker Change: Having already demonstrated that we can safely deliver to the lung with high weights of transduction and functional cargo expression were optimistic heading into molecular data updates for both programs later this year, starting with KB407 this summer.
Speaker Change: in aesthetics with the expected KB-304 readout and initiation of our KB-301 phase 2 later this year, momentum is building as we work to establish the first truly rejuvenative platform in aesthetics.
Speaker Change: We're excited to have Mark Ford, join the team in support of the effort, Mark's extensive commercial experience in bringing many years managing the Botox brand will be invaluable as we work to unlock the significant value that exists in our set explain why.
Speaker Change: We plan to dose our first patient later this month, and when we do, we'll provide a detailed overview of study design, dosing regimen, end points, etc. So stay tuned
Speaker Change: The Vajavak franchise globally will be further strengthened when we get KB 803 approved.
Speaker Change: Now, want to our new exciting ophtalmic program that's entering the clinic?
Speaker Change: Neutropic Heratitis is a rare degenerate of corneal disease caused by nerve damage in the eye, leading to corneal epithelial defects, ulcers, and perforation [inaudible]
Speaker Change: Estimates of disease prevalence vary, but typical range from 10 to 50 for 100,000
Registry, the prevalence is approximately 21 for 100,000 patients . . .
There is presently only one specific therapy available.
Speaker Change: for a common nerve growth factor, OxaVay, OxaVay targets underlying nerve defect and has been shown to improve healing but must be those six times daily for eight weeks
which is highly burdensome on patients.
Speaker Change: I-Pain is also a frequently reported complications for patients receiving
Simo will discuss the exciting pre-tunical data. Yeah.
Speaker Change: and our value proposition and next steps with respective NK shortly.
Speaker Change: Finally, in the current environment we thought it was important that investors understand how insulated crystallists from external turbulence.
Speaker Change: All of our commercial and pipeline products are manufactured in the US.
Speaker Change: Alkasel IP, composition of matter, method of use, formulation are also constant in the U.S.
Alliding any kind of complications in our home market?
Speaker Change: On the financial side, as many of you know, we run a tight ship. We've had seven quarters of profitable EPS, and as I've mentioned before, they expected revenue from Bayshevik far exceeds our anticipated operating expense for the next few years.
Speaker Change: This financial stability gives us the optionality to maximize shareholder value at the right time.
Speaker Change: and allowing us to continue forward in our mission of being a lifelong first-line therapy for our patients and delivering long-term profitable growth.
Speaker Change: I'll now hand it off to Jennifer to share more power on U.S. lunch dynamics.
Jennifer: Thank you, Krish. I am happy to share continued growth in the number of U.S. patients gaining access to Vijuvak with the number of patients with reimbursement approvals exceeding 540 as of April 2025.
The access landscape across the United States remains very strong.
We are seeing no friction with reauthorizations.
Jennifer: All have either better proofs or arm process and changes in insurance that occurred in the first quarter were also processed smoothly with timelines in line with industry standards
Jennifer: William Wilson approvals were against similar to recent quarters with roughly even splits between commercial and government plans. We also continue to see approvals across the entire Deb population, including patients of all ages with either dominant or recessive forms of the disease.
Jennifer: Payton Profford, Faradham Administration is, again, effectively unchanged with 97% of treatments occurring in the home setting [inaudible]
Speaker Change: Successful by Juvec brings about patients and caregivers' recognition that by Juvec is reliable and effective in treating and retreating wounds, which will change the course of the disease and enable patients to take control of their lives.
Speaker Change: In turn, successful outcomes result in Lifetime by Juvec usage support better understanding of the benefits of Lifetime by Juvec usage in the medical community and encourage new dead patients to seek out usage of ijuvec, all of which will drive Krishnan's long-term success.
Speaker Change: The benefits of patient success on Vijuvik is why we pay so much attention to patient experience.
Speaker Change: Our commitment to patients via Krishnan connect those far beyond simply treating patients.
Speaker Change: Because by Juvek is a lifelong therapy, our goal is to support patients and they integrate treatments into their normal wounds to care routines.
Speaker Change: And because wound closure and wound durability is personalized, we strive to build long-term partnerships with each patient and their family. Our goal is to support their success at every stage of life and throughout their treatment journey, helping them heal and live more fully.
Speaker Change: Treatment Persistence is a priority education topic for our patients, their caregivers and their prescribers, and is continually reinforced by our patient support team at Krystal Connect.
Speaker Change: We have invested in educational campaigns drawing on rural world outcomes to emphasize the importance of regular treatment and the potential links between wound closure and known complications of Deb. Debjit Chattopadhyay, Suma Krishnan, Yigal Nochomovitz,
Speaker Change: We also work closely with our patient's setting expectations that Bayjuvac is a lifelong therapy as they monitor their wounds, so patients are well prepared to define and meet their treatment goals and ultimately get the most from their Bayjuvac treatments.
Speaker Change: This is all in addition to our comprehensive Crystal Connect services that include onboarding education, periodic check-ins, and live and virtual patient programs, all of which are designed to maximize engage with to build strong, trust-based relationships for the long term.
Speaker Change: With our Kristle Connect team, we look forward to working lock-step with patients as they integrate by Juvek into their first-line wound care routine throughout their lives, helping them reduce the disease burden and improve their quality of life. I will now hand it off to Christine.
Thank you Jen [inaudible]
Speaker Change: With the steady stream of new patients over the past few months, we continue to make progress towards our goal of making Vizuvik available to as many dead patients as possible across the U.S.
Speaker Change: Each patient's journey is unique. For example, one long-time patient believed that Deb had a minimal impact on his career, or quality of life until he began treatment with Bijubek [inaudible]
Speaker Change: After experience wound improvement, he realized how much pain he had simply learned to live with.
Stories like this are exactly why our work matters [inaudible]
Speaker Change: These personal experiences are a key element of our consumer communication strategy.
Speaker Change: In the last quarter, we observed a slowdown compared to the previous quarters in the number of reimbursement approvals, and this is directly tied to the pace of patient start forms you received in 1Q. [inaudible]
Speaker Change: We're entering a phase where the patients we aim to reach are further embedded in their communities [inaudible]
Speaker Change: Often under the care of HCPs who may have limited experience with Deb and in understanding the importance of treatment and who see their patients less frequently [inaudible]
Speaker Change: Our reps are dealing with longer interaction times with each physician to meet and educate and pull through a patient's dark form.
Speaker Change: We started to address this in one cue by enhancing the size of our field sales team and bolstering our field activities.
Speaker Change: While the pace of start forms slowed in one queue, we remain confident in the total opportunity in the U.S. starting with the 1200 diagnosed Deb patient. [inaudible]
Speaker Change: Our near term claims data and field insights continue to show that there is still a large group of already diagnosed dead patients. We have yet to reach and start on by view back.
Speaker Change: With our growing toolkit of real-world experiences and powerful success stories from early adopters, we are confident in the strong growth potential ahead.
Speaker Change: At the time of launch, we set for ourselves an ambitious goal to obtain 60% market share in two years.
Speaker Change: With that being said, without question, that by Judith launch has gone extremely well to date, and we are confident that with the efforts we are putting in place, that momentum will continue [inaudible]
Our mission remains unchanged
Speaker Change: To support the Deb community and help all Deb patients, regardless of the severity of their disease, and those who may believe a treatment is out of reach, understand that Vajubik is safe, effective, and easy to use treatment to dramatically improve the quality of their life. We are confident in the opportunity ahead.
Speaker Change: ROLE study published in the American Journal of Clinical Dometology includes findings from an expanded study population across all ages and ethnicities with a medium-visuic exposure
Speaker Change: These data clearly demonstrated that long-term use of IJVAC is safe and delivers durable wound closure with clinical benefits compounding over time
Speaker Change: Dramatic improvements were also reported for patients with large and chronic wounds, reinforcing that wounds of any size can benefit from widespread therapy.
Speaker Change: The second publication in the British Journal of Dermatology describes a case-of-vigivac therapy successfully promoting wound healing, following surgical excision of a large, squamous cell carcinoma lesion in a recessive, deaf patient.
Speaker Change: Notly did the authors report that this patient achieved closure of large wound over 100 centimetre square in size within a few months.
It remained closed at four and ten month follow-up.
Speaker Change: Both these studies reinforce the versatility of YGVAC in treating wounds of all types and sizes.
Speaker Change: The benefits of IJVAC therapy for the treatment of large and chronic wounds, in particular, are showcased here
Speaker Change: with multiple examples of large wound healing among our oily participants.
Speaker Change: On the left, we have a case where at the start of the OLE, the patient's entire upper back was an open wound.
Speaker Change: With regular treatment, we saw steady and continual improvements approaching complete closure at the one-year mark [inaudible]
Speaker Change: On the right, we have images from the patient that started in our face-free study and continued on the OLE.
Speaker Change: Here we can see not only compelling initial woundling outcomes with the context of the Phase 3, but also further improvements over the course of the OLE.
Speaker Change: We are excited for more patients to access and benefit from YGREC therapy as we progress in our launch in the US and worldwide.
Speaker Change: Sifting focus to our pipeline, we are now rapidly approaching a critical juncture for our lung program
Speaker Change: Foundation, we are on track to report molecular data in CF patients this summer, followed by the digital molecular data in AATD patients before year end.
With initial KB 408 data, already demonstrating that we can deliver
Speaker Change: Safely, functional genetic cargo to the airways of the long, we look forward to validating the breadth of our platform for long delivery in a broader population of CF and AATD patients, and then moving quickly to repeat dosing.
Speaker Change: At the same time, we are pushing ahead our development efforts in the eye.
Speaker Change: A lead ophthalmology program, an eye-drop formulation of BVAC, re-reported to FKB 803, is on track for the Registered Facial Study Start later this month.
Speaker Change: With our IND cleared, approximately 50 patients in a natural history study and potential to roll over into a phase 3, we continue to expect a top line data readout before year end.
Speaker Change: Additional details on the study design and end points will be disclosed at the time we
Speaker Change: We are excited to announce today a second clinical stage of topology program, KB-801, for the treatment of neurotopic keratitis
Speaker Change: Until now, rapid clearance rate and high soil turnover in the front of the high have severely limited the therapeutic potential of biologics and gene therapies for the treatment of corneal
Speaker Change: with a reducible Dr. Platform already shown to be safe in the clinic. [inaudible]
KB 801, leverages these exact features. [inaudible]
Speaker Change: Developed using a proprietary HSV-1 vector platform, KD-801 is an eyedrop [inaudible]
Speaker Change: Design to deliver two sensing copies to the corneal epithelium and enable sustained local production of nerve growth factor
Speaker Change: with the therapeutic goal of maintaining more consistent nerve growth factor levels and potential healing advantages in the NK patient.
Speaker Change: Or while also significant day reducing the treatment burden for patients when compared to the currently approved recombinant protein dosing regimen of six times per day.
We recently presented pre-clinical data on KD-801 at RO
The presentation has been filed as an 8K.
Speaker Change: On the back of this data and with recently cleared IND, we are on track to dose the first patient with KB 801 in a phase 12 study later this month.
Speaker Change: Mouse Carnias were wounded to approximate the corneal regions that are observed in the Neuvertropic
Speaker Change: and then treated with a single dose of either KB 801 or dilution factor matched recombinant human
Speaker Change: Whereas detectable NGF levels dropped rapidly after the administration of a recombinant protein, a single dose of KB 801 resulted in sustained expression speaking at 24 hours at levels higher than those achieved with recombinant protein and remaining elevated for many days thereafter.
Speaker Change: and the approximation of the current label treatment regimen of oxal rate, we found that within 15 minutes of the sixth recombinant protein dose, NGF levels were higher in KB-801 treated eyes and remained elevated through 24 hours after last dose.
Speaker Change: gives us strong conviction in the potential of KBA to 1 to achieve and maintain therapeutic NGF levels with infrequent dosing.
Speaker Change: Based on the preclinical data generated to the date, as well as previously generated preclinical data and clinical data with Optalmic Debak.
Speaker Change: Last month, the FDA cleared RIND to evaluate KB-8-1 in NK patients [inaudible]
Speaker Change: Study preparations are underway and we expect to dose the first patient in a 2-1 randomized placebo controlled.
Blinded Multicenter, Phase One Study, in moderate to severe end-capitation later this month.
Speaker Change: With upcoming readouts in the long eyes and aesthetics, we remain on track to meet our ambitious
All while adding on new clinical stage program, KB 801.
Speaker Change: We look forward to delivering a first molecular readout in CF this summer, followed by readouts for KB 408 in AATD
Speaker Change: Finally, you all probably saw the announcement regarding our ASCO presentation.
Speaker Change: will present efficacy and safety data from Inhealth KB707, a novel HSC-based immunotherapy as the monotherapy in patients with solid tumor malignancies affecting the lung.
Speaker Change: We are excited about this upcoming announcement and cannot wait to share this data with you.
Speaker Change: This update will build on the interim data readout, be provided at end of last year, in which we saw early evidence of monotherapy activity.
in patients in non-small cell lung cancer. [inaudible]
Speaker Change: We also continue to enroll in both our Intertumal and Inheld KD707 clinical studies.
Speaker Change: We believe that we have only begun to tap in the opportunity that exists with HSV1-based gene delivery and are excited about the work ahead.
Kate: With that, I would like to turn the call to Kate.
Thank you, Suma and good morning, everyone!
Kate: I'd like to provide a few highlights from our Q1 financial results that were reported in our press release earlier today.
Kate: As Krish noted, our net product revenue for Vajavek was $88.2 million for the first quarter of 2025. This marked meaningful growth from the first quarter of 2024 up 95% from the prior year.
Kate: Cost of Good Sold was $5 million, compared to $2.4 million in the prior year's first quarter, and Gross Margin remain relatively consistent at 94% in 1 Q2 025.
Kate: Research and development expenses were $14.3 million compared to $11 million in the prior year, primarily due to an increase in personnel related expenses, including stock compensation expense.
General and administrative expenses were $32.7 million. $32.7 million.
compared to $26.1 million in the prior year. [inaudible]
Kate: primarily due to an increase in personnel related expenses, including stock compensation expense.
as well as charitable contributions and increased professional service expenses.
Kate: Operating expenses included non-tash stock-based compensation of $13.5 million as compared to $9.3 million in the prior year's first quarter.
Kate: In closing, we ended Q1 well-capitalized with $765.3 million in total cash plus investments.
Kate: noting quarterly growth in our overall cash and investments position and putting us in excellent shape to execute on our European launch and to invest in our significant clinical programs this year.
Krish Krishnan: and now I will turn the call back over to Krish.
Thanks, Kate. [inaudible]
Krish Krishnan: You heard from Jen that the successes that patients are achieving today characterized by pauses drive our success tomorrow and are the tailwinds that will support long-term utilization for the market adoption and penetration in the US and abroad and productive access discussions with ex-US players.
Speaker Change: You heard from Christine that our reps are dealing with longer interaction thanks with each physician and we've already started to address this in one cue by enhancing the size of our field sales team.
Krish Krishnan: That said, with strong patient outcomes demonstrating the value of regular vice-vec therapy.
Our conviction on the total market opportunity.
Have only been strengthened. [inaudible]
Krish Krishnan: You heard from Suma on the upcoming readouts and productive clinical pipeline and Kate confirmed the strength of our financial situation.
Krish Krishnan: All of the above give us plenty of our ammunition to deliver on shareholder value in 2025.
Speaker Change: 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. Thank you.
Please hold while we pull for questions.
Speaker Change: Your first question for today is from Alec Stranahan with Bank of America
Alec Stranahan: Hey, guys. Thanks for taking our questions. Just a couple from us. First, you know, on the side, you have the sales in one queue. Curious how insurance changes or any other effects, sort of impact the trends you're seeing in one queue? Is it fair to maybe model a bit of a rebound at 2Q, just given what the trends we saw last year? I'm going to hit a follow.
Um...
Look the world up! [inaudible]
Speaker Change: Impact from insurance changes, it wasn't as prominent as it was last year because we already have a J-Core in place, but this is something we expect.
Speaker Change: Every year, and especially those with insurance changes, there's a time lag, and that part of it makes it up in 2Q, makes up that component of it.
Catch us up!
Okay.
Speaker Change: Okay, that makes sense. And then it looks like the new reimbursement approval is slowing down as well. Since the percent access to terminations appears in a stable at 97%. Is this sort of a natural shrinking in the addressable population? Or should we maybe expect some swings on this number as well? Thanks a lot. No, look, I was clear in my opening...
Conversation, that look we have...
Speaker Change: No hesitation, no questions about the total market opportunity, which we defined as about 12 hundred identified patients and the total prevalence of close to 3,000 in the US.
and as but as Christine mentioned, it is taking longer.
Speaker Change: for our reps to pull through a patient's star form, especially if they get deeper into the community. And so, to address that, we have been.
Speaker Change: We already started increasing the size of the commercial effort to address that slowness.
Speaker Change: Okay, make sense. Yeah, thanks for the color and congrats on the continued progress . . .
Thanks everyone.
Your next question is from Roger Song with Jeffries.
Great, thanks for that being and taking all questions.
Speaker Change: A couple questions from us as well. The first one is related to the compliance, total understanding.
Speaker Change: The patients are doing great and are in treatment as they won't close and in a standing [inaudible]
Speaker Change: The fluctuation of the situation. Just curious about what's your updated thoughts around the long-term compliance you're going to look like? [inaudible]
Speaker Change: and also given your well, your the treatment patient for a year. Do you have any patience with the restarting the Vaturak? [inaudible]
A health experience you look like. [inaudible]
Speaker Change: What's the duration of the use of the Magi-Back at the restart? Thank you
Speaker Change: Look, with respect to compliance, Roger, when we launched about 18 months ago, we had expected that we'd be at 50% of compliance 18 months post-launch. We're not there, we're way ahead, like as you noted, but as the mix of RDEB and DLA patients get closer and closer to each other, we expect the compliance to hit.
Speaker Change: 50% in the long term and it's not to predict when that would happen.
Speaker Change: But it's definitely heading in that direction, but a lot slower than we have anticipated it to be.
Speaker Change: And on your second question, which was specific, I think, to pause and then restart? Sorry.
Speaker Change: You know, as I mentioned in the script, it is very individualized for every patient, wound closure, and wound glorability is just very specific to patients and where their wounds are located and the type of friction and some other, you know, outside influences that do impact [inaudible]
Speaker Change: The behavior of the wounds and the reopening, but yes, we definitely are seeing patients pause and then come back as their wounds all repair, reopen or otherwise the wounds are created. So yeah, so we are seeing all that behavior.
Speaker Change: I mean, which is a good thing. I mean, this is what we want to see in this patient. Thank you.
Speaker Change: What we can see is our treatment is effective, it's durable.
And as you know, these patients, even if they're durable, [inaudible]
Speaker Change: As Dan mentioned, sometimes they get more confident and they do more activities because of mood healing and sometimes that can result in, you know, created mood because of those additional activities and then obviously they're so used to getting these moods treated they, you know, signal that they need them.
Speaker Change: Drug again. So the flexibility is really just how these patients, the drugs.
Speaker Change: Got it. Yeah, thank you for the comment. And then just one more question from the ASC.
Speaker Change: The German label on this label seems pretty favorable, and then you see where you will launch the
Speaker Change: in the year, so how should we think about the trajectory of that compared to US, I believe in the past, you also benchmarked US knowledge, so do you still hold the hands? Thank you, here. Thank you.
Speaker Change: Yeah, so look about Germany, we planned to launch in Q3.
Speaker Change: As I mentioned in the call, patient identification is less of an issue in your, they're all genetically
and it really helps because now.
Speaker Change: In terms of our growth targets, we have the same objective in every country, trying to get to like a 60% market share in two years . . . . . . . . . .
Speaker Change: It is a really big stretch, it's a really big goal, but even getting close to it means that the launch has gone really, really well, but
Speaker Change: In terms of trajectory, I think we need a quarter or so after launch to kind of determine, but that has there is.
Speaker Change: Quite a bit of existing demand to get on drugs, both in Germany and in France [inaudible]
Action, thanks, congrats for the quarter.
Speaker Change: Your next question for today is from Ritu Baral with TD Cowan.
Ritu Bharal: Good morning guys, thanks for taking the question. On the increase in Salesforce, Krish, how much, by how much are you increasing headcounts? And are these sort of booths on the ground reps, or are they sort of back office helping with...
Reimbursement and Patient Support, and how much of this? [inaudible]
Ritu Bharal: New Initiative, essentially, for increasing the sales forces related to rising D-Deb, how much is potential increasing competition coming up in the next 12 months?
Ritu Bharal: Do you want to take the first step? Yeah, I'll take I'll take a stab at this
Ritu Bharal: So, we started our efforts here in Q1 based on, you know, as mentioned, as we get deeper in the community, it takes more educational efforts of both the ACP's
as well as to work to engage the patients.
Andrew into the ECP officers.
Ritu Bharal: Starting in Q1, we're still monitoring the impact of that and then evaluating how we want to perceive from there. But it's really about where our goal is to achieve and strive to reach every deaf patient and in doing that. It's taking more time, so we're adding effort to support that.
Ritu Bharal: The time to get a PSS is taking longer as we go further into the company.
Speaker Change: And how much of this, Krish, is related to Dedeb? In our last tracking survey, we were seeing, you know, rapid uptake in DDEB patients and intend to treat by clinicians in more DDEB. So we're just wondering how that impacts numbers, return to treatment, whether these patients, you know, resolve their lesions faster, etc.
Um...
Speaker Change: Yet, I mean, now, percentage of either patients is definitely on the rise [inaudible]
Speaker Change: Data Patients, because an entrepreneur needs a little bit more education in terms of getting on
Speaker Change: We make a strong case, we have seen a lot of dominations.
Speaker Change: Not a lot, but a percentage of dominant patients who just have severe suicidal sometimes it's learned to live at the disease and so to pull them through requires education on the part of the physician education with respect to how the disease can
Speaker Change: Potentially get, there's always a chance of getting squamous settled.
Ritu Bharal: and so yeah so you're right Ritu, I think as we go into the community as we start to get more to dominate patients.
Speaker Change: The final time of getting a piece of the staking longer and by having additional reps and having reps cover a test show that was not as big as prior will definitely help bring it forward.
Andrew
Speaker Change: Your next question is from Gavin Clark Gartner with Evercore ISI.
Gavin Clark: Hey guys, thanks for taking the questions. On the compliance side, the figure your report is still reported as since launch. I was curious how it's tracking on more of a quarterly or a run rate type of basis.
Speaker Change: Look, Gavin, I'll answer, look, we've been consistent in mentioning compliance since launch.
Speaker Change: It has served well over the last 1250 months or so, but...
Speaker Change: Paying a slightly different picture than what happens in an quarterly basis, and I'll turn it over to Jen to describe the quarterly behavior, the only point I'll make. The reason we're not putting up another stat in terms of your answer. As I mentioned in the call. I'll call.
Speaker Change: It's tough to predict pausing, right? Let's say it was a separate particular number and they all come back over the next quarter, and all of a sudden you're in this wavy pattern again, so we're being cautious about...
Stphane Paquette, Kathryn Romano, Unknown Executive, Krish Krishnan, Stphane Paquette
Speaker Change: Got it. That makes sense. And just to follow up on the same topic, I believe the way you do the calculation, if a patient has been completely off-drug for a certain amount of time, I think they get excluded from the denominator of the calculation. Is that right? And what's that period of time again?
Speaker Change: No, actually, it's while they're on therapy, so if they do come back, then we look at that start date and they come the entire time that they had experience with my Juvec, so they would always be in the denominator. We don't take them out.
Speaker Change: So if they come back on, like I said, their compliance percentage would go down. It's when they stay off that it just maintains where they were at while they were on therapy.
Speaker Change: Okay, silly another word, if someone comes off drug, they don't get counted until they come back on.
Speaker Change: Let's stay in the calculation where they were out while they were on therapy. [inaudible]
Okay, got it. Thank you.
Speaker Change: Hey guys, congrats on the progress, and thanks for taking my question.
Speaker Change: Um, I was wondering if you talk a bit more about the EU launch and how we should think you out the kid into patient starts given the first dose needs to be administered in office by a physician. And then kind of going back to the, you know, patient start stops. I mean, any statue could really provide us on patients that have stopped therapy and not restarted. Thank you.
With respect to the Elon Timmy. [inaudible]
Speaker Change: I think if there were to be a gaining factor in which we are proactively addressing, it's the time it takes for the first appointment with the physician and how many can a center or doctor accommodate in the early stages of the switch. But if we can figure that part out.
Speaker Change: Once they have actually had met with the physician there's an opportunity for the patient to quickly transfer it into a home dosing situation where they can actually have care given administration or in some case a self administration.
So,
Speaker Change: and the rate of which, I mean, how quickly can you get an appointment? It varies by country, but...
Speaker Change: We have anticipated this issue over the last six months or so.
Speaker Change: Laurent, who is the General Manager of Europe , is working pretty aggressively to facilitate this. We'll know more in the after the first one or two months of launch, how quickly this is happening and provide color. But we feel good in the sense that...
Speaker Change: I mean, this is probably the best question that we're going to launch. [inaudible]
Speaker Change: and we talked to her in our taking steps towards mediating them. I can add, our MSO's have already reached out to the centers. They've educated the positions. Everybody's pretty excited, because keep in mind there was no corrective therapy for any of these patients.
And on your second person, Sammy, on Stutz & Staubs. [inaudible]
Look.
Speaker Change: There are a very small percentage of patients who do not come back on drug and most of the time the rationale is they are undergoing a complication that's more severe than the nature of DEB itself, which is a skin manifestation.
Speaker Change: Um, you know, square myself, our Sonoma, mortality, um, and in terms of coming back, um, we all side of that factor is, I don't want to call them the beyond, that has nothing to do with the safety of the drug or the efficacy of the drug or the convenience.
Speaker Change: locations to come back on trial, some come back in 30, some come back in 60, some come in 90, some 120 plus, it all depends on it's highly individual, different from where the wound is, if they're sensitive, if they're dominant, but we honestly have had no
Speaker Change: Concerned all with respect to them coming back onto it, and we actually liked that pattern because that's...
Speaker Change: The tale on the drug that we believe will continue for a very long time, but Jen does an routine, they don't have a great job of managing the patient experience while on drug and it's really service well.
Got it. I appreciate the call.
Your next question is from Andrea Newkirk with Goldman Sachs
Andrea Newkirk: Good morning. Thank you for taking the question. Krish, in the context of the approval of a competitor product last week, just curious based off of your market research, how you're thinking about Vigivac utilization on the forward and how those two products can coexist. And then, Suma, just quickly, if you could speak a little bit more about what we should be looking for at ASCO, how many more patients or extend a follow-up will be included. Thank you.
Andrea Newkirk: Look, I'll start on the, on the recent approval question, look, when Pistol was founded in 2016, he was founded on the principle that Suma felt that the anatologist way of treating D.E.B. is not sustainable. That was the premise, of course, still founding.
Um...
Speaker Change: and I'll turn it over, there are issues on this, I mean, there's so many differences on safety side, efficacy side, convenience side, so much, you can quickly talk about that. I mean, as we don't consider the product competition at the moment because of the differences, obviously it's indicated for just our dad.
Speaker Change: and clearly there are safety differences, as you can see, on good analysis and a blaster and also the graft is not sterile, so that itself can cause infection in these patients. So there are a lot of safety issues from an efficacy perspective. There is a controlled study not blinded.
Speaker Change: and it's done at just a majority of the patients came on on-screen for, so it's an unblinded study, unlike on-
Speaker Change: We are randomized, blinded, multi-site study, and if you look at efficacy, the efficacy is pretty robust for us, 100% closure at six months, there's 50% at six months, I mean, though they say there's improvement in pain, adverse events, there's pain in use during surgery, the patient has to be biopsy [inaudible]
Speaker Change: Often these wounds are not exactly shape of a drag, so they have these in their labo, they have to degree these wounds, open the bones.
Speaker Change: Strip Minister of the Docs, so there is additional burden to these patients. So once that means there's apples and oranges where it's asked, it's home minister easy to compare and label to label, we don't consider this as a competition. It's different. So, I'll.
Speaker Change: Now, I mean, a second question with the Vasko. We are absolutely excited about our Vasko poster. It's going to be a poster talk
Speaker Change: Many of the positions are, I mean, it's novel because we can administer cytokines to rattles of the lungs in a safe, effective manner. We've already demonstrated that. I mean, safety from all the biggest concerns is over from that burden. [inaudible]
Speaker Change: You know, in December , we presented the data in 11 patients in NMCCL, and at that time, we had data cut of November , now we have additional, I mean...
Speaker Change: Three or four months data on the same patients that we presented, so you will see, you know, revised numbers on efficacy, safety, as well as you will see images of the scans where you social thinking of the tumor. So there's very, very excited about the post tense.
Debjit Chattopadhyay: Here next question for today is from Debjit Chattopadhyay, with Guggenheim Securities Debjit Chattopadhyay,
Debjit Chattopadhyay: Good morning and thank you for taking the questions. I have a couple, so number one, could you elaborate on the subpoena with respect to the genetic testing and does that impact prior revenue recognition or future implications? Thank you very much.
Debjit Chattopadhyay: and the second question, just to clarify, the 83% compliance rate that is being reported.
Speaker Change: That includes the patients who are, let's say, one week on, one week off, right? I mean, you're 83% assumes that there is going to be partial compliance, at least in the patient who are on therapy for the longest.
Speaker Change: And one last follow-up, in the patients who are still being treated or managed at the community centers who you still don't have on therapy, did we assume that off the bat these are minor patients and compliance to start off is going to be on the lower end of what you currently have versus the most severe RDA patients, thank you.
Speaker Change: Look, early on, irrespective of whether you're R Deb or D Deb in the community or a COE, your compliance is pretty good.
Speaker Change: where the lying TVA is one of the reasons for patients talking on drugs in the biggest reason is all wounds are healed. And all wounds are healed, happens faster in a dominant patient, much faster than in a recessive patient.
Speaker Change: and then in terms of comeback times, dominant patients take a bit longer on the repeat than the ardent patients who are much more sensitive, much more focused on their wounds. But I'll try
Speaker Change: Besides one being, you know, and then there's a spectrum, right? There's a severe, there's a moderate, there's a mild, but the nature of getting on being so lowly on, the compliance is no different between possessive and dominant for an extended period.
Speaker Change: Here next question for today is from Yigal Nochomovitz with Citigroup
Yigal Natomovitz: Hi, Krishnan team. I had a question on the Japan market with the upcoming approval there. Can you just discuss how the Japan market will contribute to the global revenue picture for Vagabect?
Speaker Change: And do you have any numbers in terms of the identified patients there in Japan based on genetic testing as well as the overall prevalence compared to Europe and the United States?
Yigal Natomovitz: Thanks, yeah, you should look the overall prevalence and I'm giving a number that to be off 10% is about 500 north of 200, 225 something that range or fully identify you.
Speaker Change: We just had the inspection which went pretty well. So it's a pretty attractive market and pricing that's been, no, I wouldn't say comparable to the U.S. but...
Speaker Change: You know, somewhere between US and Europe prides, it's where it's a pan-price ends if we do a good job of making a strong value proposition and if you look at some of the other companies in the right disease, market Japan's been very attractive compared to us. [inaudible]
Speaker Change: Some European countries and so we look forward to launching in Japan.
Speaker Change: Hopefully by the end of this year it will not really next year.
Speaker Change: And you mentioned you just had the inspection, what was the outcome of that?
Speaker Change: I mean, this was, we had both the clinical and the CMC infection because we did study, we did have Japanese particular study, and obviously our manufacturing facility at Enchorus was infected [inaudible]
Speaker Change: For the drug? Yeah, look, without get because we don't have the official answer here, I mean, I can broadly say the inspection went well, there were no, maybe if I don't find anything. Let me help you.
Speaker Change: Thank you. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.