This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk01: Greetings and welcome to the Catalyst Pharmaceuticals first quarter 2024 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Cobb, Chief Financial Officer. Thank you, sir. You may begin.
spk02: Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's first quarter 2024 financial results and business highlights. Richard Daley, President and CEO, will be leading the call today, and Jeffrey Del Carmen, our Chief Commercial Officer, and I will also be presenting. Additionally, Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, will be available for the Q&A. Before we begin, I would like to remind you that in our remarks this morning and in the Q&A session, we will make statements about expected future results, which may be forward-looking statements for purposes of federal securities laws. These statements relate to our current expectations, estimates, and projections and are not guarantees of future performance. They involve risks, uncertainties and assumptions that are difficult to predict and may not prove to be accurate. Actual results may vary from the expectations contained in our forward-looking statements. These forward-looking statements should be considered only in conjunction with the detailed information contained in our SEC filings, including the risk factors described in our 2023 annual report on Form 10-K filed with the SEC on February 28th, 2024, and in our first quarter 2024 quarterly report on Form 10-Q, which was filed yesterday with the SEC. At this time, I'll turn the call over to Rich. Thanks, Mike.
spk03: Welcome to the Catalyst Q1 2024 financial results call. Today we will discuss our excellent performance in the first quarter, as well as our continued focus on execution, provide an update on clinical and regulatory milestones, delve into our portfolio diversification approach, and finally provide insight into our continued delivery on financial discipline. In Q124, we delivered another quarter of strong performance with total revenues of $98.5 million. This performance, along with our January equity raise, enhanced our substantial cash position which totaled $310.4 million as of March 31st, 2024. During the quarter, our agility and focus on execution enabled our team to respond to opportunities in the market and drive continued growth in FERDAPs, successfully launch a GAMRI, and deliver on consistent performance for FICOMPA. I want to congratulate our team for continuing to meet the challenging targets we set for them. We are poised for promising growth as demonstrated by the significant milestones achieved. Ferdaps continues to deliver strong, double-digit growth, a tremendous testament to our ability to drive the sustained success of the brand for more than five years. Additionally, we successfully launched the gamry for Duchenne's muscular dystrophy, or DMD, on March 13th. While just over two weeks of launch performance are included in our Q1 financials, We are very excited by Agamri's performance and potential when reviewing Agamri's uptake trends. Based on physician and patient response, we are experiencing a great deal of momentum, and this speaks to the tremendous market conditioning we did prior to the launch, as well as our ability to successfully integrate Agamri into our Catalyst Pathways patient services infrastructure. Although it's early in the launch, we believe IGAMRI is positioned for a significant step up in Q2 and beyond. Jeff will provide further details about product performance during his discussion. Let's transition to product development and regulatory. For IGAMRI, we are preparing to launch our previously reported long-term registry study of IGAMRI, which we have rebranded as the Summit study. This study aims to gather long-term patient safety and quality of life data, offering a deeper understanding of the product's potential long-term benefits for patients. We recognize that a fundamental challenge in the traditional steroid use in treating DMD is in the safety impact for the long-term use of these steroids. Long-term effects can cause doctors and patients to, number one, delay initiation of steroids, number two, dose too low to accrue the therapeutic benefits of steroids, and number three, discontinue steroid use too early. We have initiated the summit study designed in accordance with FDA guidance for the use of real-world data to evaluate the long-term safety and quality of life benefits of the gamma-ray. The IGAMRI profile may offer patients and physicians the opportunity to start therapy sooner, optimize the effective dose, and stay on therapy longer, with the goal of potentially improving the care of patients with DMD. Moving on to Ferdaps, we are eagerly awaiting the June 4, 2024, PDUFA date of our supplemental new drug application seeking to increase the Ferdaps maximum daily dose from 80 milligrams to 100 milligrams. If our SNDA is approved, we believe that it creates the potential to provide increased therapeutic flexibility for patients and the physicians who treat them. Internationally, we continue to work with our partner in Japan, Daito Pharma, as they await word from Japanese regulatory authorities on the Ferdaps Japan NDA that they filed late last year and with a decision expected around the end of Q3, beginning of Q4 this year. Next, regarding business development and portfolio diversification. We are working on three fronts to increase our BD opportunities. First, expanding our portfolio. We are aggressively exploring opportunities to expand our portfolio in this orphan CNS and orphan adjacent spaces. We are taking a comprehensive approach to decision-making, ensuring alignment with our overarching strategy for optimal success and our long-term vision. Second, we are working to expand our partnerships. We are actively pursuing opportunities to expand the partnerships for FRDAPs in the APAC region beyond Japan and looking to enter agreements in LAT-TAB. There is a recognized need for LEMS treatment options like FRDAPs in both regions. Additionally, we are pursuing partnerships for Agamri with ex-US partners in North America. Third, we are exploring opportunities to diversify and expand the use of our existing products through lifecycle management. Our teams are fully immersed in developing an Agamri lifecycle plan, seeking to open up new avenues for growth for this product, and we expect to provide an update on this project during the second half of this year. Our accomplishments in the first quarter reflect our strong performance with steady product revenue contributions and a promising product launch, further adding to our financial strength and driving our growth. We are grateful to our team for delivering excellent results this quarter, which gives us further confidence as we reaffirm our full year 2024 total revenue guidance in the range of $455 million to $475 million. Mike will provide additional details on our financial performance during his discussion today. Since the outset of 2024, we have surged forward with formidable momentum, laying down solid groundwork to drive short- and long-term value. We remain excited about the journey ahead. I'll now turn over the call to Jeff DelCarmen, who will provide an overview of our commercial performance. Jeff?
spk09: Thanks, Rich, and good morning, everyone. Fueled by the successful execution of our strategic growth initiatives across our entire commercial portfolio, we are exceedingly pleased with our first quarter 2024 performance. As Rich mentioned, Catalyst had an excellent start to 2024, driven by the combination of sustained organic growth of FERDAPs, stable revenues from FICOMPA, and the strong initial commercial launch of Agamri. Q1 total net product revenues of $98.4 million positions Catalyst well to achieve our 2024 full-year total revenue guidance. First, let me start with FERDAPs. Q1 2024 net sales were 66.8 million, representing a 16% increase over the same quarter last year, in line with our forecasted growth projections a direct result of a sustained cadence of new patient starts, high compliance, and consistent low discontinuation rates. Net new patients in Q1 2024 were the highest total since Q1 2022. We believe that these facts demonstrate that our underlying Ferdapp's business is solid. Prescription approval rates were greater than 90% across all payers, government, or private commercial insurers. As expected, net product revenues in the first quarter reflected the typical Q1 seasonality and the reset of deductibles and copays at the beginning of the year. In addition, some new patient and refill prescription adjudications were temporarily impacted by the Change Healthcare cyberattack, particularly in February. Given the intensely symptomatic nature of LEMS, we exercised Catalyst's no-patient-left-behind approach and provided five days of free drug to any FERDAPS patient who could not fill their prescription. It is our mission to ensure continuity of care for the patients we serve, and we believe that what we did supports that commitment. I am also glad to report that at the end of the day, we subsequently received reimbursement for all the five-day bridge prescriptions provided. The FRDF's refill rate was temporarily affected in February, but we saw a rapid rebound in filled prescriptions in March back to historic norms. Our strategic growth initiatives will continue to drive organic growth moving forward. We maintain a pipeline of approximately 500 LEMS patients in various stages of their diagnostic journey that are not yet on Ferdows. Tracking these LEMS patients is a prime reason for our ability to consistently deliver 15% to 20% annual growth. as half our new patient enrollments typically come from this group. Furthermore, LEMS education programs targeting healthcare providers have already resulted in consistently higher voltage-gated calcium channel antibody testing rates, which will shorten the diagnostic journey for LEMS patients and lead to more patients being eligible for treatment with VirDaps. Now let me provide an update on Phycompa. We achieved solid Q1 net revenues of 30.4 million, further fortifying our revenue diversification. We expect continued stable net revenues for the rest of 2024. Further, all epilepsy regional account managers have been trained on FRDFs and LEMs, and moving forward, these RAMs will conduct secondary calls with healthcare providers that account for the 45% overlap in FICOMPA and Ferdaps physician call points, further increasing Ferdaps' share of voice and the ability to identify new LEMS patients. Let's turn to a GAMRI. We successfully commercially launched a GAMRI on March 13th. Early indicators of new patient enrollments show strong interest, exceeding initial expectations. This is primarily due to penetration of both the EMFLAZA and the prednisone patient segments. Payer approval rates are greater than 90%, averaging less than 30 days to approval. Based on our experience with FERDAPs, we expect this to improve over time. Further, to date, 63% of the DMD Centers of Excellence have enrolled at least one patient on a GAMRI. Since most of the prescriptions for DMD patients are written by doctors who practice in these centers of excellence, we believe this is a very positive sign for the acceptance of a GAMRI. In summary, we believe that we are making meaningful progress on sustained organic growth for FERDFs, continuing to generate stable net revenues for FICOMPA, and exceeding our expectations for our revenues for a GAMRI. We are highly focused on continued commercial execution excellence and leveraging our strategies to maximize our demonstrated capabilities. I want to thank the entire team at Catalyst for their unwavering commitment to patience and look forward to continuing with a successful 2024. I will now turn the call back over to Mike.
spk02: Thank you, Jeff. As Virch noted, Our performance during the first quarter of 2024 has set us on pace for another strong year, driven by our solid financial performance, financial discipline, and strong execution. We remain steadfast in our commitment to driving growth, leveraging strategic partnerships, and expanding our portfolio to capitalize on emerging opportunities throughout the year. We intend to continue our commitment to growth through strategic partnerships and portfolio expansion in 2024. To support this objective, in January 2024, Catalyst sold 10 million shares of its authorized but unissued common stock to raise net proceeds of approximately $140.7 million for the purposes of funding potential future acquisitions and for general corporate purposes. Our total revenues for the first quarter of 2024 were $98.5 million, an approximate 15% increase when compared to total revenues of $85.4 million for the first quarter of 2023. Product revenue net for our lead product, FerdApps, was $66.8 million, a 16% increase year-over-year compared to $57.5 million in Q1 2023. Product revenue net for the first quarter of 2024 for PICOMPA increased to $30.4 million compared to $27.8 million for the portion of the first quarter of 2023 in which we recognized revenue following our acquisition of the product rights in late January of 2023. As a reminder, we anticipate that 2024 revenue for FICOMPO will be affected by differences in variable consideration compared to 2023 when revenues were booked under a size cost arrangements with distributors and government agencies. Effective January 1st of this year, these costs are tied to arrangements between the company and those distributors and agencies which are higher. Finally, we launched the GAMRI in mid-March, and for the short time during the first quarter that the product was commercially available, product revenue net was $1.2 million. In the first quarter of the calendar year, like many companies in our industry, we are impacted by the reset of patient insurance deductibles. Further, in the first quarter of 2024, we reported expenses related to our annual commitment to make charitable contributions to foundations that fund LEMS patient support programs throughout the year. Cost of sales was approximately $12.5 million in the first quarter of 2024, compared to $9.9 million in the first quarter of 2023, and consisted principally of royalties. As a reminder, royalties for Ferd apps increased by 3% when net product sales exceed $100 million in any calendar year. As a result, we expect cost of sales to trend higher as this year progresses. Additionally, I would like to note that a GAMRI also carries a royalty in the range of low double digits to mid 20%, depending on sales achievements within a calendar year. Further details on our royalty obligations for GAMRI are reported in our Q124, Form 10-Q. Research and development expense was $2.6 million in the first quarter of 2024, slightly down from $3.6 million in the first quarter of 2023. At this point, as noted in the 2024 guidance we provided earlier this year, we believe that R&D expense for 2024 will be similar to 2022. SG&A expenses for the first quarter of 2024 totaled $46.9 million, compared to $29.7 million in Q1 2023. SG&A expenses moderately increased as a percentage of total operating expenses to 66% for Q1 2024 compared to 60% for Q1 2023. The overall difference in SG&A expenses in the first quarter of 2024 was principally due to the incremental selling and marketing expenses to support the launch of the GAMRI and operating expenses for FICOMPA being present for a full quarter in Q1 2024 when compared to approximately two-thirds of Q1, 2023, as well as the non-cash stock-based compensation charges of $3.9 million relating to the retirement of the company's former CEO and CFO based on the terms of their respective separation agreements with the company. Our effective tax rate for the first quarter of 2024 was 20% compared to 20.8% for the first quarter of 2023. Although lower in the first quarter of 2024, We still expect our annualized effective tax rate to be slightly higher than the annual effective tax rate in full year 2023 of 24.4%. For 2024, the difference to the statutory federal income tax rate of 21% was primarily driven by state income taxes and anticipated annual permanent differences. Effective tax rate is affected by many factors, including the number of stock options exercised in any given period and is likely to fluctuate in future periods. Net income before income taxes for the first quarter of 2024 was $29.1 million, a 22% decrease year over year compared to $37.3 million for the first quarter of 2023. We reported gap net income for the first quarter of 2024 of $23.3 million or 20 cents per basic and 19 cents per diluted share. A decrease of 21% year over year compared to GAAP net income for the first quarter of 2023 of $29.6 million or 28 cents per basic and 26 cents per diluted share. The decrease in both net income before income taxes and GAAP net income reflects a full quarter of operating expenses pertaining to FICOMPA, as well as substantial incremental operating expenses to prepare for the launch of a GAMRI. It also includes one-time non-cash stock-based compensation expense that I mentioned earlier. Non-GAAP net income for the first quarter of 2024 was $46.8 million, or 40 cents per basic, and 38 cents per diluted share. which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FICOMPA, Agamri, and Resurgy of $9.3 million, stock-based compensation expense of $8.2 million, the income tax provision of $5.8 million, and depreciation of $86,000. This compares to non-GAAP net income in the first quarter of 2023 of $46.8 million, or 44 cents per basic, and 41 cents per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of Thycompa and Resurgy of $6.5 million, stock-based compensation expense of $2.9 million, the income tax provision of $7.7 million, and depreciation of $69,000. As previously reported, we ended the first quarter of 2024 with cash and cash equivalents of $310.4 million compared to $137.6 million at December 31st, 2023. The increase in cash of $172.8 million was largely driven by our January 2024 capital raise, which added approximately $140.7 million in net cash proceeds. The remaining increase in cash is driven primarily by $31.9 million in cash generated from business operations. We believe our current funds continue to allow us the financial flexibility to fund our existing R&D programs, meet our potential contractual obligations, and support our strategic initiatives, business development, and portfolio expansion efforts, leading to long-term growth and value creation. More detailed information and analysis of our first quarter 2024 financial performance may be found in our quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission yesterday, May 8th, and can be found in our investor relations page on our website at www.catalystpharma.com. And with that, I will turn the call back over to Rich.
spk03: Thanks, Mike. At Catalyst, our mission is resolute. to pioneer first-in-class innovative medicines for patients with rare and difficult to treat diseases. With an expanding portfolio of commercial products and a track record of operational excellence, we are primed for ongoing success in delivering transformative therapies to the market. We look forward to providing updates on our continued progress. At this time, we'll turn the call back over to the operator, and we look forward to answering your questions. Thank you.
spk01: Thank you. We will now be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. And you may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we pull for questions. Thank you. Our first question comes from the line of June Lee with Truist Securities. Please proceed with your question.
spk04: Hi, this is Jeremy. I'm for June. Thanks for taking our questions. Can you just share any specific doc or patient feedback on the GOMRA experience? And then any further updates on your BD plans? How far along are you in that search? And is there a specific therapeutic area you're targeting, such as epilepsy? Thanks.
spk03: Thanks for the question. Jeff, do you want to handle the first part?
spk09: Sure. It's a little early to get some specific feedback about physicians and the efficacy that their patients are seeing with a gamma ray. What we can tell you is the physicians and the patients are extremely happy with the process to get on a gamma ray and to get drug. So that's first and foremost. But we do anticipate feedback about their patients here shortly. Great.
spk03: And that's the second part of the question. So we are aggressively pursuing opportunities, as we mentioned on the call, in the orphan space and what we call the orphan adjacent. So we believe our infrastructure is one that really supports patient care. So when you think about what we did in the quarter and really making sure that our patients had uninterrupted care, I think it really speaks to the strategic advantage we have as a company. So we believe that our infrastructure supports essentially any orphan opportunity and so we are out aggressively seeking opportunities across the orphan space we believe what we're seeing our success our continued success our ongoing success with ford apps and our burgeoning success with the gamory really supports that so we are looking uh pretty far and wide uh on the in the orphan space um so we're i would i would say we're pretty uh essentially agnostic because we believe that our infrastructure would support just about any orphan opportunity.
spk04: Thank you. Thanks.
spk01: And our next question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
spk05: Hey, good morning, Rich and team. Thanks for taking the question and congratulations on a nice quarter. start the year, I had a couple of them, one on Agamri, one on Ferdaps, and then one on BD. So on Agamri, you mentioned new patient enrollments, very good to hear. Can you give us some color on where you're taking patients from? Is it more mFLAZA or is it more prednisone and any color on that? as well as the pacing of information from the new summit study. Thanks.
spk03: Great. So, Charles, great. Thanks for the questions. And, Jeff, do you want to handle the first part of the question, and we'll have Steve handle the second part?
spk09: Sure. Good morning, Charles. When we look at the enrollments that we're getting so far for a GAMRI, 47% of our new enrollments are from patients that we're currently on in Plaza. of our patients were coming from patients that were on prednisone. And there are just a handful or a smaller percentage that were naive patients to any corticosteroid.
spk03: And then, Charles, your second question, I believe you said the pacing of information from the summit study. Is that correct? Yes. Yes. Steve, do you want to handle that?
spk00: Sure. Thank you, Rich, and thank you, Charles. The summit study is scheduled to be a five-year study. We anticipate doing analyses approximately once a year, but it would depend on the nature and significance of findings that we observe during the course of the study. At the very least, the information will be published and made available to the medical information staff, and at the most, it will be submitted to the FDA under the FDA's guidance for real-world data and its use for updating product labeling.
spk05: Okay, that's helpful. And then quickly, Ferdaps, yeah, looking forward to the PDUFA date, possible dose expansion. Could you remind us of, you know, call it, roughly what percentage of patients are at maximum dose and how that decision, if it is positive to expand dosing, might impact demand for Ferdaps? Thank you.
spk09: So Charles, currently 40% of Ferdaps patients, active Ferdaps patients, are on a daily dose of 80 milligrams, which is the maximum. there are another 4% of patients that are on a dose greater than 80 milligrams, which they work directly with the specialty pharmacy to get that approved. So we do think that there's a significant upside there for patients to find their optimal dose. And over time, we expect the average daily dose, which is currently at around 61 milligrams a day, to go up to approximately 65 milligrams or 66 milligrams. That is over time. We expect for maybe the following 12 months post-expansion of the label to get to that average daily dose increase. Got it.
spk05: Final question, BD. Going back to the prior question, it seems like you're busy with a gamma relaunch, I guess. You know, despite the interest in additional assets, is there a goal for doing that in 24 or is that really dependent on the opportunity set? Thanks.
spk03: That's a great question, Charles. You know, we continue under Preeti's leadership to consider a number of opportunities. I would say Primary is to get GAMRI off the launch pad, which I think we're doing a great job getting it off the launch pad. But we want to be sure we have the right opportunity. We want to build on the CNS franchise. We want to continue to look and see where the opportunities are in the marketplace and do the right deal at the right time. And we want to be sure that we take advantage of those opportunities that come our way. I think we can do additional deals, but you know, the timing and the right deal has to be right for us. So we're going to play it smart to benefit the patients, take advantage of the talent in the organization, and obviously benefit the shareholders.
spk05: Got it. Thanks, Rich, for the added color. That's helpful.
spk03: Thanks, Charles. Thank you.
spk01: And our next question comes from the line of Jason Gerberry with Bank of America. Please proceed with your question.
spk06: Hey guys, thanks for taking my question. Um, uh, one BD question for me, and then one, a gamery question just on, on BD front. I'm just curious, um, if there's a general profile range in terms of size of deal on stage development that you look at, um, would you be willing to bring in an asset that wouldn't deliver sales and profit in the short term and how for naps litigation outcomes sort of shape your, your MNA aperture? And then on a GAMRI, maybe a little surprise just to hear, you know, lifecycle management discussion this early in the launch. Is this something that you update in the second half that could be beneficial within, you know, the IP window of a GAMRI or the regulatory exclusivity window of a GAMRI or something that's kind of a longer term IP extending approach? If you can comment on that, that'd be great. Thanks.
spk03: Thank you. Thanks for the questions. So on the BD size and opportunity, so we would look for things at this point in our company's lifecycle for things that are immediately accretive or nearly immediately accretive. We would want to take advantage of the balance sheet that Mike talked about in the call. So when we think about size and opportunity, We would want to be really thoughtful. We'd want to look at things that could add to the company's balance sheet immediately. So I think we would stay within ourselves, if you will. I don't want to commit to a size at this point in time. I think we would, again, assess, but really looking at those things that are very close to market or are on market. And again, to continue to build the breadth of our capabilities so that we can continue to build and look at larger opportunities in the future. As a buy and build company, that's what we want to do. We want to build our presence in the market. On how the FRDAPS litigation colors our thought on that, right now, Steve can speak to the timing of that. We assume that we're going to have a significant runway with FirdApps and FirdApps sales, and so we have an opportunity to build our portfolio, and we're going to take full advantage of that as we can do that for the time being. Regarding lifecycle management, we believe now is the time to be looking at opportunities for Agamri to build a portfolio of applications for the product in rare and orphan conditions that require a steroid. We want to be that steroid of choice. And in the companies I've worked in in the past, typically companies wait too long to think about those things. And so to your point about is it going to be something that's applicable within the window of IP for a GAMRI, that's exactly the point. That's what we're trying to do is make sure that we can get the studies done, identify those opportunities, get the studies done, and then take advantage of it and create value for patients and create value for shareholders as well. Is that helpful, Jason?
spk08: Yeah, thank you. Thanks.
spk01: Our next question comes from the line of Samantha Semenko with Citi. Please proceed with your question.
spk08: Good morning. This is Eric on for Sam. Thanks for taking our questions. What do you think is driving the high percentage of patients switching from prednisone in your early launch, and how do you see that evolving as this progresses?
spk09: Thanks for your question. We do think that the conversion from prednisone over to a gamma ray is basically because of the safety profile. And many of these patients have been on prednisone for a significant amount of time and have seen or experienced those side effects. and they're looking to, they transitioned over to GAMRI to benefit from the more positive safety profile. So over time, we do expect this mix to be about what it is today, which is very encouraging. Initially during planning and forecasting, we expected the initial launch to be primarily from the ENFLASA patients or those patients that we're used to being on a branded corticosteroid. We are encouraged by this because we're now opened up to the entire corticosteroid market for boys living with DMD, and that's what we're seeing and that's what we expect moving forward.
spk05: Thank you.
spk01: Our next question comes from the line of Joe Cannanzaro with Piper Sandler. Please proceed with your question.
spk07: Hey, everybody. Thanks so much for taking my questions. I have a few on Montgomery. If I recall correctly, I think you had said there were about 28 patients in the EAP program. I'm wondering if you could just sort of speak to what percent of those patients have been able to transition to commercial reimbursed drugs. And then maybe if you could also sort of speak to the current cadence of intake forms, maybe how the current rate compares to your pre-launch experience where you indicated, you know, there was a sort of indication of significant pent-up demand. So wondering if current cadence of intake forms sort of continues to point to that pent-up demand. Thanks, and I have maybe one follow-up.
spk03: Sure. Jeff, do you want to take that?
spk09: Sure, so I can point to first about the cadence of the enrollments. We started accepting pre-commercial launch enrollments in December, and we saw significant pent-up demand. We also knew at that time that there were the centers of excellence that were waiting for an announcement of the official commercial launch date. So they were holding some enrollments until that announcement. Post-announcement, we started really seeing volume increase that validated our confidence in the launch. And since the commercial launch, we continue to see steady enrollments that are steady at a high level, higher than what we had forecasted, which is very encouraging. And Joe, can you remind me of your first question about AMRE?
spk07: About the EAP patients, sort of what percent have been able to transition to commercial reimbursed drugs?
spk09: Correct. Of the 28, over half of those patients are on reimbursed shipments right now, and the rest are still in process.
spk07: Okay, great. And then maybe my follow-up, still on Montgomery, you guys had mentioned a step-up in 2Q that you're expecting. Maybe you could just help contextualize that a little bit, how much of that will be driven by patients already on drugs seeing a full three months of treatment versus expectations around new patient starts. Thanks again for taking my question.
spk03: Sure. So just to start off, as Jeff mentioned, you know, we saw this nice curve of patients enrolling prior to launch and physicians were waiting. And then with the announcement of the launch, we did see an increased enrollment, which was great. So we expect this rollover to happen. And as Jeff mentioned in his comments, it takes about, currently taking about four weeks to convert these patients from enrollment to reimbursed. So that's going to roll over into the second quarter. So we're really excited about that. And, you know, these physicians waiting. for the launch, obviously now we're going to see that impact in the second quarter. But Jeff, do you want to take the rest of it?
spk09: Well said and well stated, Rich. And just to add on to that, we do expect the current positive payer landscape to improve even more over time. So that four weeks that Rich mentioned, we expect that to reduce. Within six months, we do potentially see it to about one to two weeks. from time of complete enrollment to reimbursed shipment. That's our expectation. And then the other part is balanced by a significant volume of enrollments that we continue to see. So on both ends is why we have confidence in that step up in Q2.
spk07: Okay, great. Thanks again.
spk09: Thank you.
spk01: Thank you. As a reminder, if you would like to ask a question, please press star one on your telephone keypad. One moment, please, while we pull for questions. Thank you. We have reached the end of our question and answer session. And with that, this concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Disclaimer