Earnings Call Transcript - ZVRA Q1 FY2025

Operator

Good afternoon, and thank you for joining ZEVRA's first quarter 2025 financial results and corporate update conference call. Today's call is being recorded and will be available via the investor relations section of the company's website later today. The host for today's call is Nicole Oshner, ZEVRA's vice president. Please go ahead.

Nicole Oschner, Head of Investor Relations

Thank you, and welcome to those who are joining us. Today, we will provide an overview of our recent accomplishments, followed by a review of first quarter financial results. I encourage you to read our financial results news release, which was distributed this afternoon and is available in the investor section of our website. Before we begin the call, please note that certain information shared today will include forward-looking statements. Actual results may differ materially from those stated or implied by any forward-looking statements due to risks and uncertainties associated with Severe's business. Forward-looking statements are not promises or guarantees and are inherently subject to risks, uncertainties, and other important factors that may lead actual results differing materially from projections made. These forward-looking statements should be evaluated together with the cautionary statements contained in the risk factors section in our most recently quarterly report on Form 10-Q, annual report on Form 10-K, and our other filings with the SEC. I am pleased to welcome Zevers Management Team members participating in today's call. Neal McFarlane, Zevers President and Chief Executive Officer, LeDwayne Clifton, our Chief Financial Officer, and Josh Schaefer, our Chief Commercial Officer. Our Chief Medical Officer, Adrian Cortell, will also be available for today's question-and-answer session. Now, it's my pleasure to turn the call over to Neil.

Neil F. McFarlane, CEO

Thank you, Nicole, and thank you for joining us this afternoon to review our strong progress and the ongoing execution of our four strategic pillars. Let me start with commercial excellence. We are delivering on our two commercial launches to bring innovative therapies to people living with rare diseases. We have exceeded our internal expectations for the MyPipa launch and have enrolled over one-third of those diagnosed with Neiman-Pick disease type C, or NPC, in the United States. With Alprova, for the treatment of certain urea cycle disorders, or UCDs, we refined our marketing efforts to further increase awareness and access for patients and providers. Moving on to pipeline and innovation, we are focused on where our capabilities have the greatest impact for patients as we progress our development programs. Our Phase 3 Discover trial of Soliprolol, our late-stage asset for the potential treatment of vascular Eilers-Danlos syndrome, or VEDS, which has received both orphan drug and breakthrough therapy designations, continues to progress with patient enrollments. Additionally, we continue assessing value-enhancing strategic alternatives for our Phase 3 Ready Asset, KP1077, for rare sleep disorders. These clinical-stage assets provide optionality and diversification to our portfolio. Turning to talent and culture, we have a passionate, highly motivated, experienced, and mission-driven team focused on our vision to bring life-changing therapies to people living with rare diseases. Our team's strong execution is being acknowledged. For example, we earned a spot on Fast Company's Top 10 Most Innovative Companies list in the Medicines, Therapeutics, and Pharmaceuticals category. This underpins all other pillars and allows us to responsibly invest in our long-term transformation through disciplined capital allocation while maintaining our position of financial strength. With the recent monetization of our Pediatric Rare Disease Priority Review Voucher, or PRV, we added $148.3 million of non-dilutive capital to our balance sheet, bolstering our financial strength. With this, we have ample resources and financial flexibility to execute on our strategic priorities independent from the capital markets. Driving a little deeper into our commercial programs. We are pleased with the early success in the my platform launch for the treatment of NPC, which is an ultra-rare neurodegenerative, progressive, and fatal disease. The launch is characterized by three unique patient cohorts. Those who are participants of our Expanded Access Program, or EAP, those who are diagnosed and may or may not be receiving treatment. And finally, those who are undiagnosed and living with NPC for whom we seek to accelerate diagnosis and treatment. We've received a total of 122 prescription enrollment forms from launch through March 31st, with 13 in the first quarter of 2025. Even in these early days of the launch, we have received prescription enrollment forms from all three patient cohorts, affirming the early impact of our commercial strategy. Notably, as we have previously reported, all active U.S. EAP participants have been enrolled to receive MyPlypha, and we have now closed the program, including locking the database and deactivating study centers ahead of our previously stated guidance. We are focused on providing MyPlypha to people living with NPC and have been educating prescribers and payers on the clinical benefit which demonstrates, in combination with Miglostat, a halting of disease progression through 12 months of treatment. Beyond the PIVOTAL trial, my PLIFA safety profile and the long-term treatment effect have been evaluated in open-label extension studies and through our multi-center EAP, with patients having as many as five to seven years of experience on treatment, which significantly differentiates MyPleipa and positions it as the cornerstone therapy. Josh will provide additional details related to our launch metrics later in today's call. Beyond the successful U.S. launch, our goal is to provide access to as many people living with NPC as possible by expanding the availability of MyPleipa outside of the U.S. We are diligently working towards expanding our regulatory submissions with an immediate focus on a Marketing Authorization Application, or MAA, in Europe in the second half of this year, where we estimate approximately 1,100 people are living with NPC. As a reminder, the European market is already well-established, with access to a marketed treatment for more than a decade. Further, we're expanding our global EAP, which has recently increased to approximately 85 NPC patients compared to the previously reported 70 to 80 patients. Our continued investment in MyPlyfa's global EAP, in combination with a more established market, could accelerate commercialization upon approval in Europe. Turning to Oprouva. From initial product availability in July of 2023 and including Zevra's promotion of Oprova in late January of 2024, through the end of the first quarter, 2025, we've received a total of 28 prescription enrollment forms with five prescription enrollment forms during the first quarter of this year. In November, we outlined a plan to refine our commercial strategy towards the adult and OTC-deficient populations, for whom Olpruva's portability and ease of administration may provide the greatest benefit. The enrollments received in the first quarter were all within this patient segment, suggesting early signs that this strategy is gaining traction. Before turning the call over to Josh, I'll share a few more updates on our clinical stage assets. Through our Phase 3 DISCOVER trial, soliprolol is being evaluated as a potential treatment of VEDS, a devastating connective tissue disorder caused by the Col3A1 gene mutation and characterized by spontaneous arterial aneurysms, hollow organ ruptures, and aortic dissections. In the U.S., approximately 7,500 people are living with VEDS, where the standard of care relies on reactive and invasive surgical interventions with no approved salipolol is also currently used off-label as a standard of care for VEDS in certain European countries. During the first quarter, we enrolled five additional subjects in the DISCOVER trial, bringing the total to 32. This is an event-driven trial, and the rate of enrollment is important. And we're implementing various strategies, including increasing our efforts to focus on providers and clinics specializing in genetically confirmed CALL-381 positive patients. We began receiving leads from a recently initiated genetic testing program, providing our team with a new group of confirmed VEDS patients for outreach. Importantly, we are optimistic in this strategy to drive enrollment and expect to see an increase in the enrollment rate in the upcoming quarters. Several updates related to the review of our extensive IP portfolio as we seek to extract value by determining where we continue to invest as well as where we choose to stop investing based on our strategic plan. I'm pleased to report that earlier this month, we've out-licensed intellectual property related to a pre-clinical pro-drug, an undisclosed party for a nominal upfront payment, potential future milestones, and mid-single-digit royalties on net sales. We will continue to optimize and curate our IP portfolio through a variety of avenues to realized value for the company and our shareholders. Additionally, regarding APIDAS, which was previously approved for the treatment of pain and has not been commercially available since 2023, we have made a strategic decision to formally withdraw the NDA. By limiting the regulatory activities associated with maintaining approval, we are further reducing costs. We are continuing Zebra's transformation into a patient-centric, commercial-stage rare disease therapeutics company. With our bolstered cash balance, we are well positioned to support our stated strategic priorities and execute on our long-term vision for the company by establishing myPipa as a cornerstone treatment for NPT globally, maximizing our commercial opportunity with Opruva, and supporting our growth through our development pipeline, including the ongoing phase three trial for solipolol. Continue to build on our track record of execution, positioning us to make future investments that are in alignment with our strategic plan. Let me turn the call over to Josh, who will give an update on our commercial products.

Josh Schafer, Other

Thank you, Neil, and good afternoon. Today, while discussing our commercial products, we will provide the following metrics, prescription enrollment forms for the quarter, the percent of covered lives, and net revenue. Beginning with MyPlypha, as Neil stated, the launch is progressing well and exceeding our expectations. With our EAP cohort fully enrolled, we're focused on reaching the diagnosed and undiagnosed cohort. Steady growth in the first quarter with 13 prescription enrollment forms, all representing individuals new to MyPlypha, which indicates a broadening of both the patient and prescriber base. This is a result of our ongoing efforts to raise awareness of NPC and to educate prescribers about MyPlypha's clinically differentiated profile. There are approximately 900 people living with NPC in the U.S., of which only 300 to 350 have been diagnosed. March 31st, we have received a total of 122 prescription enrollment forms, meaning that roughly one-third of the estimated individuals diagnosed with NPC in the U.S. have been enrolled to receive my Plyfa. As a reminder, a prescription enrollment form is a prescription submitted to our initiating the benefits investigation process to determine reimbursement and can lead to a 30-day paid dispense. Many payers have not yet formalized their formulary coverage or reimbursement policies, and our team has been actively engaging with payers to secure reimbursement. We have achieved 38% of covered lives, which is in line with our expectations at this stage of launch. We have been able to secure reimbursement authorization for many of our patients in clinical exception products, commonplace among rare disease products. We are very pleased with our team's ability to swiftly address payer challenges by presenting MyPlypha's robust and differentiated clinical data. NPC is a lysosomal storage disorder that is caused by progressive lipid buildup leading to cell death and ultimately organ dysfunction in the spleen, liver, and brain. The difficulty in diagnosing NPC patients centers around variability in age of disease onset and the heterogeneity of symptoms. As a result, the disease progression is measured by the only clinically validated tool, the four-domain NPC clinical severity scale, which evaluates four key domains deemed by NPC experts to be the most important, including ambulation, fine motor skills, speech, and importantly, swallow abilities. MyPlypha is the only product approved by the FDA based on the NPC clinical severity scale, and the data in our label demonstrate that MyPlypha, in combination with Miglistat halts disease progression through 12 months of treatment, as shown by a greater than two-point improvement in patients receiving MyPlypha and Miglistat compared to those receiving Miglistat alone. It is important to note that only a one-point improvement is needed to demonstrate a clinically meaningful difference with a well-tolerated safety profile. The only FDA-approved product for NPC with more than five years of clinical data in its label and with more than 270 NPC patients who have participated in our pivotal trial, our open label extension study, or our EAP. In our view, these data, in addition to its well-tolerated safety profile, establishes MyPlypha as the cornerstone of therapy for NPC. In a long body of evidence, we recently issued a publication discussing mechanistic insights into MyPlypha's mediated effects on lysosome function in NPC in the Journal of Molecular Genetics and Metabolism. The elucidation of MyPlypha's differentiated mechanism of action marks a critical step in understanding its interactions with NPC at a cellular level. These insights substantiate how MyPlypha addresses the underlying pathology of NPC and supports the long-term benefit observed in our clinical trial. We unveiled numerous initiatives to reach the MPC patient cohorts, namely those who are diagnosed and may or may not be receiving treatment, as well as the undiagnosed population. We utilize claims data to identify existing patients, and we are employing targeting techniques to identify new and undiagnosed patients based on related symptoms and conditions. In addition, our targeted media campaign to build awareness and educate about early signs and symptoms of NPC is proving to be successful. We have expanded to a national scale, reaching households across the U.S. Our team is amplifying the reach of these news segments through branded geotargeting efforts in the corresponding regions. And these news segments are increasing awareness of NPC and the availability of treatment options and are primarily designed to resonate with individuals who have been diagnosed but are not yet receiving treatment. We also launched our Disease State Awareness Campaign, Learn NPC, Read Between the Signs, on rare disease data this past February, and it's driving disease recognition and early diagnosis. Treatment of NPC is multifaceted, and our program provides education and genetic testing options for individuals with suspected lysosomal storage disorders. We have already seen the impact of this initiative with new patients who were not previously diagnosed with NPC being identified, enabling us to facilitate earlier diagnosis and offer MyPlypha as a treatment option. In summary, we are encouraged by the early results of our efforts to engage the diverse patient cohorts, and we're looking forward to sharing our ongoing progress and future success with the program. for the treatment of certain UCDs. UCDs are a group of rare inherited metabolic disorders resulting from a defect in one of the six enzymes or two transporters in the urea cycle, causing an accumulation of ammonia known as hyperanonymia, which can be toxic and lead to neurocognitive damage or even death. As we have discussed in prior quarters, we have moderated our expectations for the pace of the launch, given the unique dynamics of the UCD commercial landscape. From initial product availability in July of 2023, and including Zebra's promotion of Alprova from January 2024 to the end of this first quarter, 28 total prescription enrollment forms for Alprova have been received, including five in this first quarter of 2025. Prescription enrollment forms may also include our 30-day free trial program. As Neil highlighted, we have refined our marketing strategy to more specifically target the adult patient seeking more independence, as well as the OTC-deficient and carrier population, who may receive greater benefit from the portability and countering fewer reimbursement obstacles, suggesting that this positioning resonates with prescribers. Given that patients with this disease typically only see their physician one to two times a year, we anticipate that the impact of our refined marketing strategy will require additional quarters to gain further traction. We remain committed to patient access and focus on delivering comprehensive patient services through our in-house program, Amplify Assist. Case managers who support both MyPlaifa and ElPruva are demonstrating early impact through their ability to assist with reimbursement hurdles. Concurrently, our market access team continues to engage with payers to identify opportunities for ElPruva to improve its formulary position. Regular communication with payers and have increased covered lives to 78%. We're forwarding to sharing additional updates in the coming quarter. We'll call to LeDwayne, who will present the financial results for the first quarter of 2025.

LaDuane Clifton, CFO

Thank you, Josh, and good afternoon, everyone. In addition to the financial details included in today's call, we encourage you to refer to Zebra's quarterly report on Form 10-Q for more detailed information, which we intend to file shortly. In the first quarter of 2025, we reported net revenue of $20.4 million, comprised of 17.1 from MyPIFA revenue, 0.1 from Oprova revenue, 2.3 in net reimbursements from the French EAP for Aramakamal, and 0.9 from royalties and other reimbursements under the Astaris license. For our commercial products, MyPlyfa and Opruva, we recognize revenue when shipments are received by the specialty pharmacy. Our operating expense for the first quarter was $22.8 million, dollars, which was a decrease of 0.6 compared to the same quarter a year ago. R&D expenses were 3.3 for Q1 2025, which was a decrease of 9 compared to Q1 2024, due primarily to a decrease in third-party costs upon completion of the KP 1077 Phase II trial, combined with a decrease in personnel-related costs. SG&A expenses were 19.5 for Q1 2025, which was an increase of 9.6. Period-over-period increase in SG&A expenses was primarily related to an increase in personnel-related costs, professional fees, and other expenses associated with our commercial, medical, and launch activities. Net loss for the first quarter of 2025 was $3.1 million, or $0.06 per basic and diluted share, compared to $16.6 million, or $0.40 per basic and diluted share for the same quarter a year ago. As of March 31, 2025, total cash, cash equivalents, and investments were $68.7 million, which was a decrease of $6.8 compared to December 31, 2024. Combined with the net proceeds of $148.3 from the sale of the PRV received just after the end of the quarter on April 1, cash, cash equivalents, and investments would be $217 million. Total debt was approximately $60. As mentioned earlier, adding the non-dilutive capital from the PRV sale has further enhanced our financial flexibility to support our strategic priorities, which includes executing on the commercial launches of MyPlyfa and Opruva and supporting our ongoing phase three trial for Soliprolol. We currently have ample resources to execute on our strategic priorities independent from the capital markets. Our financial results for Q1 2025 reflect the solid momentum in building a leading rare disease therapeutics company, and we are pleased with the opportunities we have in 2025 and beyond to drive value creation through disciplined investments where we can win. Now, I'll turn the call back to Neil for his closing remarks.

Neil F. McFarlane, CEO

2025 is off to a terrific start for Zebra. The launch of MyPlyfa is exceeding expectations. Our course corrections and marketing strategy for Opruva are gaining traction, and we're advancing our development pipeline. Today, driven by our sustained execution, we believe we're well positioned for future growth and see Zebra as a promising commercial stage rare disease therapeutics company with a clear plan to drive shareholder value. Our vision for the future is bright, and we have many opportunities to serve the needs of patients and caregivers as we execute on our mission. Thank you for joining the call, and we'll now open the call for questions. Operator?

Operator

Thank you. At this time, if you would like to ask a question, please press star 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. Once again, that is star one to ask a question. We will go first to Sumat Kulkarni at Canaccord.

Sumat Kulkarni, Analyst — Canaccord

Good afternoon. It's nice to see the progress, and thanks for taking our questions. I have a couple. So first, relative to the 122 patient enrollment forms, could you give us any details on the number of patients that are actually on my platform right now and what the split of reimbursed patients might be?

Neil F. McFarlane, CEO

Thanks, Sumat. And just before I answer that question, I want to let everybody know that we're taking the call from multiple locations, so that may necessitate a slight delay in responding as we get the folks who are going to be answering the question. I'll hand that question directly off to Josh in regards to the strong performance we've seen with my plifus so far.

Josh Schafer, Other

Yeah, thanks, Simant. So as noted, we have seen 122 or received 122 enrollments since the launch through the end of the first quarter. We do not report on how many of those are actively on drug, but I can say that the majority of them are on drug. And those who are not yet are going through a process of benefits investigation and are in some stage of pending. Some might be receiving what we call quick start, which is free drug while we investigate the benefits and then intend to convert those patients to paid. And then there may be others that are just in some various stage of benefits investigation.

Sumat Kulkarni, Analyst — Canaccord

Got it. And one more before I hop into the queue. You mentioned denials of reimbursement at early stages in rare disease launches are to be expected. That's understandable. But could you give us any sense of what the top reason might be for the denial of MyPlypha?

Josh Schafer, Other

Absolutely. And those are two different data points. The 38% of covered lives is looking at the total number of patients out there, excuse me, the total number of people out there with insurance. 38% of those total covered lives who are receiving commercial insurance, federal insurance, VA. And then any challenges that we're finding right now, we haven't seen some initial denials, and that's totally to be expected with a rare disease product. And that is typical of products that have to go through some sort of prior authorization before they can get approved. We've been able to get coverage for almost all of our patients either through direct formulary status or through some sort of medical exception process, which might require a physician writing a letter of medical necessity, but we've had great success in getting that covered. And that's largely due to the demonstrated differentiation that MyPlypha has, with it being the only drug that's demonstrated the halting of disease progression through 12 months. It's got five to seven years of patient experience with more than 270 patients treated. And we have the only clinically validated endpoint for NPC, which is the Neiman-Tick Clinical Severity Scale.

Neil F. McFarlane, CEO

Thank you. Yeah. Suma, maybe I'll just bring to the forefront. Josh laid it out beautifully. Our differentiation in the clinical profile is what's really driving the strong performance. The feedback from physicians and so far how we've been able to address the market access challenges that come up with every product that's in the specialty space is really demonstrating the strength of That's really what's driving a lot of our performance today.

Operator

Once again, if you would like to ask a question, please press star 1 on your telephone keypad now. We'll go next to Jason Butler with Citizens.

Jason Butler, Analyst — Citizens

Hi, thanks for taking the questions, and congrats on the quarter. A couple for me on my play. First of all, how much visibility do you have into whether patients are coming from that undiagnosed bucket versus diagnosed but not on a therapy right now? And just how should we think about bringing those patients on board, the cadence you can bring those patients on board throughout the year? And then second question, just qualitatively, can you speak to how inventory levels end of the quarter versus the end of 2024?

Neil F. McFarlane, CEO

Jason, thanks for the question. I'll try to quarterback this a little bit. I'll ask Josh to talk a little bit specifically in regards to the three cohorts that we talked about and the visibility. And then I'll ask him to hand it off to LeDwayne, which, again, may take a quick second to talk about inventory levels and our targets and where we are today.

Josh Schafer, Other

Jason, as we've mentioned, there are three distinct cohorts that we think about. The total prevalence for NPC is roughly 900 patients, 600 of which or so that are undiagnosed, living with the disease and don't even yet know it. and there are about 300 to 350 that are diagnosed and either receiving some sort of treatment or just sort of, you know, waiting and watching. Of that subset, we had 83 patients who were in our expanded access program, and those patients have all been enrolled to receive MI-PLYFA. We reported at the end of the fourth quarter 109 patients, and that included those EAP patients plus a combination of diagnosed and undiagnosed. We continue to see a number of the second, the two cohorts, the diagnosed and undiagnosed patients coming in as a direct response to the initiatives that we've rolled out to bring more awareness to the disease and also to my plight for the treatment option. If you can call off mute.

LaDuane Clifton, CFO

Sure, thank you. And so, Jason, with regard to inventory, these are the early days of the launch, and we seek to support patients and remain very nimble. So we're managing that closely using a target days on hand. When we reported out in Q4, we explained that we had reached it and stocked at that target level, and we are maintaining that as we come into the end of Q1 as well.

Josh Schafer, Other

Great. Thanks for taking the questions.

Operator

We'll go next to Eddie Hickman with Guggenheim.

Eddie Hickman, Analyst — Guggenheim

Hey, good afternoon. Thanks for taking my questions, and congrats on this progress so far. Any qualitative metrics on refill rates or patient retention or average net price that you can give us that might be helpful for modeling the durability and treatment effects or trajectory going into the second half of the year? Should we expect this cadence of de novo patients of maybe around three to four per month to continue throughout 2025? And, you know, what are the challenges in continuing to penetrate those non-EAP patients?

Josh Schafer, Other

Yeah. Yeah. So I can give you a little bit of color to say that of those patients that have come in and for whom we've received enrollments and who are receiving active drug, the vast majority of them have received refills and are continuing to stay on drug. You know, certainly as we continue through the launch, we would expect to see that maybe diminish a little bit. But it really, you know, if you reflect back to our EAP, We had patients who stayed on drug for as long as five to seven years, and so that really speaks to the clinical benefit of MyPlypha as well as the durability of response, and we would expect to see that commercially as well. Well, your other questions were around net price, and again, what we're seeing in commercial is something very similar to the distribution of doses that we saw in the EAP, with the vast majority of patients receiving one or two of the higher doses, so that can give you kind of a sense of what the WAC price is and give you a sense of how that's trending as well.

Neil F. McFarlane, CEO

Yeah, Eddie, before, maybe you have a follow-up question here, but before we move forward, you know, when we actually launched the program back in September, we talked about the fact that we were utilizing the average dosing of our EAP patients, which, you know, the clinical trial leaned more to younger, lighter weight patients. And then our expanded access program really brought more adult patients in, too. So R and the average pricing that we had reported out based on the weight distribution of our 83 patients has really kind of continued the same. So that guidance that we provided is guidance that I would continue to have you move forward with.

Eddie Hickman, Analyst — Guggenheim

Thanks. And then I was curious sort of about the cadence of those new patients starts throughout the year. Should we continue to sort of think about 12 to 13 per quarter, or will that diminish or grow throughout the year?

Neil F. McFarlane, CEO

Thanks again for the question. I think it's difficult for us. We're not going to provide guidance. We're going to continue to be disciplined in what we do around the metrics that Josh talked about and new patient enrollment forms, as well as market access, and then revenue to be able to pull through. What I would say to you, though, is that as we went through the three cohorts and accelerating the expanded access programs and continuing to get them really rapidly enrolled, which we had originally think would take us 12 months. We got it done in just a quarter and a little bit. We're now in the process of getting to these two other cohorts, the diagnosed patients who have not been on therapy, as well as those patients who are not yet been diagnosed. We've seen all three of those cohorts in Q1, and we expect that we'll continue to see all three of those cohorts can, well, not the EAP, those are done, but the other two cohorts, those patients who are diagnosed and undiagnosed continue as the strength of the product and the benefits, you know, lead to getting patients on therapy. So I can't give you guidance in terms of where the cadence is going to be, but I can tell you that the strong performance today is based on

Operator

our data. That's right. Thank you so much. Again, if you would like to ask a question, Please press star 1 on your telephone keypad. We will go next to Lachlan Hanbury-Brown with William Blair.

Lachlan Hanbury-Brown, Analyst — William Blair

Hey, guys. Thanks for taking the questions, and congrats on the progress. I wanted to ask on the coverage, you know, you said 38% of lives are covered. Can you just elaborate on what that coverage looks like, what the requirements are? Did you contract for that? And maybe how much of an impact does having that coverage make in terms of the time to get a patient from sort of prescription enrollment form to actually on drug because I assume it still requires a prior authorization and then if I could just clarify as well on the EAP patients you said that they'd all been enrolled just to clarify is that are they all receiving drug through the commercial channel now or are some of them still through sort of in the you know benefits

Josh Schafer, Other

investigation stage great well I'll take your first question around what the 38 percent of covered lives means. So again, most commercial plans and federal plans will evaluate a drug based on its clinical merits. And some plans will not by policy evaluate a product until it's been on the market for six months, and some it might be as long as 12 months. And so the 38% of covered lives means that those plans, roughly 75 to 100 plans out there covering several hundreds of millions of lives, have reviewed Mike Plypha and have made it available to their patients. And that represents about 38% of the total lives out there that have insurance. That does not mean that only 38% of our patients will receive drug or be able to get drug reimbursed. That just means that there's a direct route through a formulary status or position. All plans have a medical exception pathway, and we've been very successful in getting our patients reimbursed through a medical exception pathway. We expect that 38% to increase as more plans evaluate my PLIFA going forward, and we will continue to see that number increase, and we will continue to have patients reimbursed

Neil F. McFarlane, CEO

either through direct formulary exception. On an answer on your question, you asked if all of the patient enrollment forms have been put onto a commercial product. And that's a process way, as well as others, to get patients through a form to a paid version, if you will, or commercial product. That timeline is not immediate. Some of them are within 24 hours. They can get through the process. And others take time to work through this peer-to-peer medical exception, so on and so forth, process of getting specialty pharmacy products through. What I'm very proud of is the team has actually worked diligently to be able to ensure that when a prescription form comes in, we do everything that we can to make sure that patient and their family receive the product as soon as possible while we're going through the benefits investigation process. And they're actually rapidly working through this really large number, again, 122 enrollment forms, a dramatic number of forms and really strong performance, and getting through that process. Some are going to take 30 days. Some are going to take 24 hours. Some are going to take 30 days. Some are going to take much longer than that. So I would say that right now our team is doing a great job, and you see that based on the revenue numbers that we've got in just our first full quarter post-launch of converting those patients.

Lachlan Hanbury-Brown, Analyst — William Blair

Thanks.

Operator

We'll return now to Simant Kalarni at Canaccord.

Sumat Kulkarni, Analyst — Canaccord

Thanks for the follow-up. This is on Celeprolol, which seems to be flying under the radar a little bit. You said you have 32 patients enrolled. It's an event-driven trial where you're increasing efforts to drive enrollment. If I remember right, this is a 150-patient trial. It looks like the last update on clinicaltrials.gov came about a year ago. So given that the phase three trial for a competitor, Enzastarin, has been suspended for some time now, what does that mean in terms of your ability to give us a timeline on when enrollment might be complete?

Neil F. McFarlane, CEO

So your numbers are absolutely accurate, Sumat. You talked about an N of 150 patients and a two-to-one randomization. I think it's important to just take a quick step back. We inherited this trial after it had actually paused enrollment for some time. with a large number, as we've said publicly previously, of screenings that were ready to go into the trial. We kicked that off in Q3 with our first patients being re-enrolled and re-dosed in the trial. And then we've been actually investing in getting through the screening of the previous patients, but also now targeting how we're going to be able to drive future enrollment. We talked about our ability to go to call 3A1 patient centers and physicians to be able to find more readily diagnosed patients who are more keen to be able to go into the trial. And we also talked about some genetic testing that we're also doing as part of our screening, so we get more patients who are already diagnosed have the genetic defect, and we can then offer them the opportunity to be in the trial. Those activities, we feel very confident, will continue to drive and now accelerate enrollment of the trial, but it's really only been two quarters since we got the trial up and going. The learnings as we've walked through, and now we've got these five additional patients, 32 patients enrolled to date, and there's a high unmet need and no approved therapy, as you know, but we're working through with these clinics and testing centers now to really ramp it. So, you know, in a nutshell, I can't tell you exactly when we will finalize it, but the strategies are starting to pay off in terms of our commitment to moving forward. Got it. Thanks.

Operator

And that will conclude the Q&A session. I will now turn the program back over to Neil McFarlane for any additional or closing remarks.

Neil F. McFarlane, CEO

Thanks, Operator, and thanks, everybody, for joining our call today. We look forward to keeping your praise of future progress and look to see you in Q2.

Operator

Thank you, sir. This does conclude today's program. We thank you for your participation. You may disconnect at any time.