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| Statement |
|---|
| We're happy to see that we're both expanding and deepening the prescriber base as we progress in our launch |
| It has been immensely gratifying to see a growing number of US patients benefit from VYJUVEK as our commercial launch progresses |
| In terms of market research, our current EU General Manager, Laurent, has already been talking to physicians and centers of excellence who have really strong registries, so we feel really good about the identified patient population |
| We're seeing really good demand on name patient sales from a handful of countries |
| With that being said, and given our projected revenue trajectory in 2024, and our current strong balance sheet, we are well capitalized and positioned for these growth drivers, and we look forward to reporting our progress over the next several quarters |
| With a great launch underway and growing revenue to contribute to our already strong balance sheet, we believe we are well positioned to create value for our shareholders and deliver our mission for patients now and in the future |
| The efficacy profile is very strong |
| We are excited about our success to date and more excited still by the years to come as we work to change the treatment paradigm for every patient with DEB |
| And now, as of mid-February, we've secured reimbursement approvals for 228 patients and have positive coverage policies in place for over 93% of commercial and Medicaid patients |
| Altogether, these successes point to a strong long-term growth strategy for VYJUVEK in the US |
| Our success in 2023 allowed us to deliver another year of significant value creation for our shareholders and perhaps more importantly, set us down a path for continued growth in the years to come |
| With respect to the J-code, the reason I mentioned that comment, look, J-code is a great tailwind for the company long term |
| Thanks to a breakthrough year in 2023 and growing VYJUVEK revenue, we are positioned better than ever to deliver on that vision |
| With strong financial resources and FDA-approved redosable gene therapy platform and two commercial-scale GMP manufacturing facilities, we're uniquely positioned to develop and bring to market highly differentiated gene therapies for many rare and serious diseases |
| And outside of the centers of excellence, our field team has had tremendous success educating regional, adult, and pediatric dermatologists and community physicians as evidenced by the continued influx of community prescriptions |
| And with that, it's a powerful tailwind behind us |
| Once the initial scheduling and setup is complete, which again takes a certain amount of time, what we're seeing is strong adherence, given that VYJUVEK is designed to be integrated into existing wound care routines and demonstrated efficacy |
| And accordingly, we also continue to see strong patient compliance to once weekly treatment while on drug, holding at 96% in the fourth quarter |
| So we feel pretty positive on 407 |
| And we are very excited actually about 408 |
| Christine brings decades of commercial experience to Krystal, including a strong record of leading US rare disease sales themes at Travere, Reata, and Shire |
| We're encouraged to see the broadening of VYJUVEK prescriber base as awareness of our product grows through both our direct promotion efforts and organically through patient groups and the medical community |
| Outside of the United States, we benefit from patient registries, which give us a high degree of confidence in the global market opportunity |
| Gross margins were 93% for the quarter, in line with our previous guidance of margins north of 90% at launch and expected to improve to over 95% after a few years |
| So again, 408 is an exciting program for us |
| The pace of enrollment in CORAL-1 is improving as clinicians grow more familiar with inhaled KB407 |
| 707 is also exciting |
| And of course our lung program, also again we are excited |
| We believe this increase is a reflection of the growing familiarity among prescribers with VYJUVEK, and we expect this positive trend to continue as patient outcomes on VYJUVEK become more widely known |
| People seem very happy with the drug, people seem very happy with the home dosing |
| Statement |
|---|
| Actual results could materially differ from these forward-looking statements, as any -- and such risk can material and adversely affect the business, results of operations, and trading price of Krystal's common stock |
| But our view right now, and this could be different, since VYJUVEK has the ability to treat larger wounds, we doubt if patients would go through the inconvenience of having to graft over and over and again in the same location and takes a certain bit of time |
| With the permanent J-code now assigned, the trajectory for access and reimbursement approvals is only looking better |
| On the opportunity, look, there was some confusion when we first reported |
| A lot of home dosing in Europe is handled by the hospital, so a lot of the logistical complications you see in the US, like getting home dosing in place, finding patients are not as big issues in Europe |
| But that said, look, definitely the holiday period was a bit slow |
| Although this is a long-term tailwind and sets us up for sustained broad access in the US, I will note that the revenue in the month of January was temporarily impacted as commercial and Medicaid coverage plans, including those that were previously covering VYJUVEK under a temporary J-code, were updated to the now-issued permanent J-code |
| This also has implications for the launch |
| I just was simply pointing out that in January, as our specialty pharmacy was transitioning people from -- into the official J-code from a prior J-code, you should expect a few weeks of a revenue hit to the story in the interim |
| Compliance is high because of this, we see patients unwilling to even go to a local physician to get it done on a weekly basis |
| A lot of it has to do with single case agreements and with access getting behind us, we expect the trend to only decrease and get to a steady state of two to three weeks in the second half of this year |
| So trying to correlate the shape of the launch curve to prevalence is simply erroneous |
| We expect compliance to continue to be high in 2024, but as wounds start to heal, one has to think about maybe a handful of patients slowing down, either taking a pause and restarting, or going from four to maybe two to two vials a month, but it's not immediate |
| Two questions from us |
| These forward-looking statements involve risks and uncertainties, any of which are beyond Krystal's control |
| And we might have seen some in the past |
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