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DATE

May 6, 2026, 4:30 p.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Neil F. McFarlane
  • Chief Commercial Officer — Joshua M. Schafer
  • Chief Financial Officer — Justin Renz

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TAKEAWAYS

  • Total Net Revenue -- $36.2 million, representing a 78% increase year over year.
  • MyPlifer Net Sales (U.S.) -- $24.6 million, supported by 170 total prescription enrollment forms, of which 9 were received in the first quarter.
  • Expanded Access Program (EAP) -- $10.2 million in net reimbursements and 122 patients enrolled across multiple territories, with France contributing a stable patient base and roughly $10 million net per year post-stabilization; new markets are contributing incremental growth.
  • Portfolio Optimization -- Divestiture of the SDX portfolio to CommAv Therapeutics for $50 million, with $40.5 million received in Q1 and $4.5 million in April; one-time gain recorded at $43.3 million, partially offset by a $10 million debt extinguishment expense.
  • Debt Status -- All debt retired in Q1; company is now debt-free with an annual interest savings of approximately $8 million.
  • Net Income -- $37.9 million, or $0.62 per basic share and $0.60 per diluted share; excluding one-time items, estimated net income is $11.5 million, or $0.18 per diluted share.
  • Operating Expenses -- $25.2 million, up $2.4 million year over year; R&D at $4.4 million (+$1.1 million) and SG&A at $20.8 million (+$1.2 million).
  • Cash Position -- $236.8 million in cash, cash equivalents, and investments as of March 31; decrease of $2.1 million from year-end, mainly due to debt payoff.
  • Market Access -- MyPlifer has 69% coverage of U.S. lives through formulary access, with others reached via medical exception pathways.
  • Clinical Guidelines & Practice Adoption -- MyPlifer added to updated NPC clinical practice guidelines, reinforcing genetic testing and the NPC severity scale as key endpoints, supporting "combination therapy" and early treatment.
  • Intellectual Property -- MyPlifer received orphan drug designation, granting U.S. marketing exclusivity through 2031; a patent term extension is under review with the U.S. Patent Office.
  • Commercial Initiatives -- Company implemented AI-driven targeting models and provider collaborations for genetic testing to identify undiagnosed NPC patients and expand prescriber base to the community level.
  • Payer Dynamics -- No change in net price except for normal gross-to-net variability; robust patient service programs facilitate access and reimbursement navigation.
  • Late-Stage Pipeline -- Phase III DISCOVER trial for saliprolol (VEDS) enrolled 62 patients (10 in Q1), with 2 of 28 events required for interim analysis; U.S. commercialization planned, additional FDA meeting scheduled for 2H 2026 to discuss development acceleration.
  • EMA Review -- Marketing authorization application for aramcholamol under active EMA review; company responded within the permitted window to the 120-day list of questions.

SUMMARY

Zevra Therapeutics (ZVRA +6.03%) reported substantial momentum driven by strong commercial uptake of MyPlifer, expanded international platforms, and a fortified balance sheet following portfolio rationalization and debt retirement. The company achieved inclusion in updated clinical guidelines for NPC, advancing its value proposition in prescriber adoption and payer engagement. Its expanded access programs and ongoing EMA review signal active pursuit of European market penetration, while U.S. market access remains supported by both coverage expansion and the deployment of targeted commercial and diagnostic efforts.

  • The commercial strategy placed particular emphasis on early detection via innovative AI and genetic collaborations, which is leading to a wider distribution of prescribers, including those in community-based practices previously unaware of their NPC patient base.
  • Executives highlighted sustained demand and real-world evidence demonstrating MyPlifer’s durable benefit profile, supporting continuous penetration into the diagnosed patient pool.
  • Leadership expects further EAP and commercial growth as additional European and ex-European markets come online, and variability in EAP enrollments is anticipated until patient cohorts stabilize in new geographies.
  • Management described the orphan designation and pending patent extension as key levers for potential exclusivity beyond 2031, potentially strengthening the franchise.
  • Progress in the saliprolol VEDS program is tied to event-driven interim analysis and continued patient enrollment, with further FDA interactions scheduled to discuss expedited development pathways.
  • Financial flexibility is reinforced by a cash-rich, debt-free position following monetization of non-core assets, with management stating, "We remain well positioned with the financial capacity to execute on our strategic priorities independent of the capital markets."

INDUSTRY GLOSSARY

  • Expanded Access Program (EAP): A regulatory mechanism enabling use of unapproved therapeutics for patients with serious diseases outside of clinical trials, often prior to formal commercial launch.
  • Formulary Access: Inclusion of a drug on an insurer’s list of covered medications, determining prescribing and reimbursement pathways for providers and patients.
  • Gross-to-Net: The difference between a drug’s gross sales at list price and the revenue retained after rebates, discounts, chargebacks, and deductions; often fluctuates quarterly.

Full Conference Call Transcript

Neil F. McFarlane: Thank you. And welcome to everyone joining our quarterly call this afternoon. We are building a durable rare disease company grounded in disciplined execution, financial strength and a commitment to patients. We continue to advance our strategic plan, delivering strong performance and positioning ourselves for long-term growth. We made substantial progress in establishing MyPlifer as a foundational treatment for Niemann-Pick disease type C, or NPC, in the U.S. by delivering meaningful clinical impact to patients and pursuing multiple pathways to expand patient access globally. We are also advancing our late-stage asset, ciliprole, through a Phase III study for the treatment of vascular Ehlers-Danlos syndrome, or VEDS, and executing several approaches to accelerate its development.

To sharpen our focus on high-impact activities and remove operational distractions, we optimized the portfolio by divesting non-core assets with the sale of the FDX portfolio to CommAv Therapeutics for $50 million and concurrently resolved the legal dispute. Our balance sheet is strong, with a cash position of $236.8 million and no outstanding debt, providing financial flexibility to drive growth. In the first quarter, total net revenue was $36.2 million, which is a 78% increase over Q1 2025. We have now reached a total of 170 prescription enrollment forms for MyPlifer from launch through March 31, nine of which were received in the first quarter.

Recall, the estimated prevalence of NPC patients in the U.S. is approximately 900, of whom 300 to 350 are currently diagnosed. Thus, we have successfully reached roughly half of this patient population and continue to have traction with newly diagnosed patients. This is a significant early launch achievement and remains consistent with the meaningful opportunity ahead for continued growth. As a reminder, we have established a solid patent position for MyPlifer. It received orphan drug designation in the U.S., enabling marketing exclusivity through 2031. Consistent with our strategy to maximize the potential growth drivers for our business, we are pursuing a patent term extension through the U.S. Patent Office and await their decision, which could provide coverage beyond 2031.

Through our Global Expanded Access Program, or EAP, we are able to deliver a much-needed treatment to patients with NPC in certain European countries and select territories outside of Europe, including the U.K. As of the end of the quarter, we have a total of 122 patients enrolled in the EAP across geographies. Our global EAP is comprised of multiple access programs, including compassionate use and named patient reimbursement. Within each, we expect variability in enrollment and reimbursement over the first few years until the patient base has stabilized, consistent with our experience in the French EAP program. In Europe, there are an estimated 1,100 individuals with NPC.

Diagnosis rates exceed those in the U.S., largely because the earlier approval of miglustat established physician awareness and enabled patient identification. To support the geographic expansion, with a potential approval of aramcholamol in Europe, we have a marketing authorization application under review by the European Medicines Agency, or EMA. We submitted our responses to the EMA's 120-day list of questions within the 90-day clock stop period and are progressing along the standard review process to make aramafamol available to the European NPC community. As a reminder, we have also received orphan medicinal product designation in Europe for the treatment of NPC.

Turning to our late-stage pipeline, our Phase III DISCOVER trial is evaluating saliprolol for the treatment of VEDS, a rare inherited connective tissue disorder caused by COL3A1 gene mutations that weaken the walls of blood vessels and hollow organs, and can cause arterial rupture or dissection, among other complications. Approximately 90% of patients experience an event by the age of 40. There are roughly 7,500 individuals living with VEDS in the U.S. Filippool is a selective adrenoceptor modulator that works by inducing vascular dilation and smooth muscle relaxation, and thereby reducing mechanical stress on tissues of the arterial wall and hollow organs. Currently, there are no approved therapies for VEDS.

Our commercialization strategy for saliprolol is focused exclusively in the U.S.; there is a clear opportunity to fill an unmet need. While not approved in Europe for VEDS, saliprolol is the primary off-label treatment in several European countries. This use is supported by the results of several studies, including long-term European cohorts. We have enrolled a total of 62 patients in the DISCOVER trial, with 10 patients enrolled in the first quarter. This is an event-driven study, and we have two confirmed events out of the 28 events required to trigger the interim analysis.

We continue to implement activities aimed at driving enrollment, including building a network of genetic testing centers to improve diagnosis, as well as strengthening connections with key specialists who manage these patients. In parallel, following the FDA Type C meeting we had in the first quarter, we are preparing for a follow-up meeting in the second half of the year to explore pathways to accelerate its clinical development. In summary, we have a clear vision to become a leading rare disease therapeutics company, and we are motivated by the momentum and the opportunity that this phase of growth brings. I will now turn the call over to Josh to review our commercial performance in more detail. Josh?

Joshua M. Schafer: Thank you, Neil, and good afternoon. Before reviewing the quarterly progress with MyPlisa, I will provide a quick background on NPC. NPC is a rare lysosomal storage disorder caused by mutations in genes that impair intracellular cholesterol and lipid trafficking, leading to the abnormal lipid accumulation in the brain, liver, spleen, and other organs. The onset and course of disease are heterogeneous, ranging from infancy to adulthood, with progressive neurodegeneration that can vary in both speed of onset and clinical presentation. The extensive data generated for MyPlife in NPC has shown long-term meaningful patient outcomes through the most expansive clinical development program in NPC to date.

We have more than five years of data across more than 270 NPC patients worldwide through clinical studies, including our pivotal trial, open-label extension study, global EAP, and pediatric sub-study, all demonstrating MyPlifer's efficacy and safety. Notably, MyPlifer in combination with miglustat is the first and only disease-modifying therapy shown to halt disease progression at 12 months in a randomized controlled trial based on the validated NPC Clinical Severity Scale. The onset of benefit is rapid, with improvements noted at the first clinical evaluation time point of 12 weeks, and has durable efficacy with treatment effects sustained for over five years.

We are pleased to announce that MyPlayFo was added to the NPC clinical practice guidelines, which were recently published in the Journal of Inherited Metabolic Disease, marking the first update to the guidelines since initial publication in 2018. These guidelines discuss the heterogeneity of the disease and reinforce that the NPC Clinical Severity Scale and genetic testing are the most reliable clinical endpoints in confirmation of diagnosis. The guidelines also point out, consistent with our messaging, that early detection is critical to delay disease progression. MyPlifer's mechanistic and clinical differentiation is resonating with prescribers and patients and is driving adoption.

As Neil shared, we have received a total of 170 prescription enrollment forms since launch, with nine enrollment forms coming in Q1. Our commercial strategy is focused on three key priorities: accelerating time to diagnosis and treatment, driving demand, and facilitating access to MyPiper. NPC remains significantly underdiagnosed and often diagnosed late due to heterogeneous symptoms. To enable earlier diagnosis, we have focused on education and engagement within the medical community through a strong presence at medical conferences where we regularly present data, and through our ongoing disease awareness campaign called Learn NPC, Read Between the Signs.

Additionally, we have built a custom AI-driven targeting model to find likely NPC patients and have collaborations with providers of genetic testing to accelerate their diagnosis. As a result, we continue to see new enrollments from previously diagnosed as well as newly diagnosed patients. We are also finding patients and seeing demand for MyPath increase outside of the centers of excellence. Our prescriber base is expanding to include community-based prescribers, which we believe reflects the success of our targeting and education efforts. Many of these new prescribers did not know that they had NPC patients in their practice and were previously unfamiliar with the disease and treatment options.

We help facilitate medical education efforts through various initiatives such as the recently launched Expert Connect, which connects HCPs unfamiliar with NPC to experts who can address questions regarding disease state and available treatment options. Our patient mix has grown to include adults and children equally. These trends give us confidence in the estimated prevalence of 900 people in the U.S. living with NPC. We remain focused on reaching as many patients as possible and expanding the total addressable market. From a market access standpoint, we have stable coverage of 69% and continue to achieve reimbursement through the medical exception pathway.

Payer engagement continues to be focused on emphasizing robust clinical safety and efficacy data and the extensive real-world evidence seen in clinical practice that supports MyPlifer's value. We believe we are differentiating MyPlifer through its clinical benefit, support services, and broad patient access. Independent market research suggests MyPlaza is the preferred NPC therapy most trusted by clinicians and shown to improve balance, swallowing, cognition, and speech, and reduce falls. We receive heartwarming letters from families noting how positively impacted they have been by MyPlayfa and the support of our Amplify Assist patient services program. Together, this feedback reflects the impact of our commercial activities and sets the stage for continued growth.

With that, I will turn the call over to Justin to review our financial results.

Justin Renz: Thank you, Josh. In addition to the financial details included in today's call, we encourage you to refer to our quarterly report on Form 10-Q for more detailed information, which we intend to file shortly. As Neil mentioned, in Q1 2026 we generated net revenue of $36.2 million, which was an increase in total net revenue of $15.8 million compared to $20.4 million in Q1 2025. This is comprised of $24.6 million from MyPlifer net sales in the United States, $300 thousand from OLPUVA, $10.2 million in net reimbursements from the global EAP for aramcholamol, and $1.1 million in royalty revenue.

It is worth noting that we had one less shipment week of MyPLYFA in the U.S. due to the first quarter delivery calendar, and as a result, channel inventory fell below the low end of our targeted range. Turning to recent business transactions, in March, we executed an agreement with CAMAi Therapeutics for the sale of the SDX portfolio for $50 million, monetizing assets that were not central to our core investment thesis. Per our contractual obligations, Aquestive Therapeutics received 10%, or $5 million, of gross proceeds. In the first quarter, we received $40.5 million of the $45 million in net proceeds. We received a final payment of $4.5 million in April.

In connection with this transaction, we reviewed our capital allocation strategy and retired our debt early, saving on average approximately $8 million a year in future interest expense. We are now debt free, strategically positioned for growth, supported by a clean balance sheet. These one-time transactions impacted our first quarter financials. Accordingly, we recorded a one-time gain of approximately $43.3 million, partially offset by an approximately $10 million expense associated with the early extinguishment of debt, which is noted in the other income and expense section of our financial statements. Pivoting back to normal operations, during Q1 2026 our operating expenses were $25.2 million, which was an increase of $2.4 million compared to the same quarter a year ago.

R&D expense was $4.4 million for Q1 2026, which was an increase of $1.1 million compared to Q1 2025, due primarily to increases in third-party costs and professional fees. SG&A expense was $20.8 million for Q1 2026, which was an increase of $1.2 million compared to Q1 2025, primarily due to an increase in professional fees, partially offset by a decrease in third-party spending. We utilized the vast majority of our usable net operating loss carryforwards, and as a result of the multiple one-time transactions that we recorded in the first quarter, we incurred an estimated tax provision of $6.9 million.

Net income for Q1 2026 was $37.9 million, or $0.62 per basic and $0.60 per diluted share, compared to a net loss of $3.1 million, or $0.06 per basic and diluted share, for the same quarter a year ago. Excluding the one-time transactions as well as the related tax provision, for clear comparability across periods the estimated quarterly net income reported would be $11.5 million, or $0.18 per diluted share. As of March 31, 2026, total cash, cash equivalents, and investments were $236.8 million, which was a decrease of $2.1 million compared to December 31, 2025.

As mentioned earlier, this decrease is attributable to deleveraging driven by our debt payoff, partially offset by the non-dilutive capital proceeds from the sale of the SDX portfolio and supported by our operating income. Collectively, these factors have further fortified our balance sheet. We remain well positioned with the financial capacity to execute on our strategic priorities independent of the capital markets. And now I will turn the call back to Neil for his closing remarks. Neil?

Neil F. McFarlane: Thanks, Justin. Our corporate profile has evolved significantly with the execution against the strategic pillars we introduced a little over a year ago. We are delivering strong commercial execution while thoughtfully monetizing the assets that are not core to our business. We relocated our corporate headquarters to Boston, a hub of biotech innovation, and we strengthened our leadership by attracting seasoned professionals to our executive management team and board of directors, bringing valuable experience and perspective. These efforts, combined with prudent financial stewardship, are positioning us to deliver on our vision. As we advance through 2026, we are anchored by a clinically meaningful commercial product with multiple opportunities for global growth, a late-stage pipeline, and a strong financial position.

Our collective team at Zevra Therapeutics, Inc. is energized by the numerous opportunities we have to expand our impact for people living with rare diseases. Operator? Please open the line for questions.

Operator: Thank you. And our first question today comes from Kristen Kluska with Cantor Fitzgerald. Your line is now open.

Analyst: This is Iain on Kristen's line. Congrats on the quarter updates here, and thank you for taking our questions. First, now that MyPIFA has been added to the NPC clinical practice guidelines, we are just wondering what this means for physician adoption. Are these doctors now formally advised to consider MYCFR when treating these patients?

Neil F. McFarlane: Thank you for the question. We are really pleased that, as we have been previously communicating, these guidelines were in process and really came out quite fast after the introduction of new products that were approved in the U.S. It really reinforces the NPC severity scale as the tool that shows disease progression, the genetic testing as a key endpoint and diagnostic tool, and the complexity of the disease. When we think about the heterogeneity of both infantile versions and adult versions of the disease, it is really important to detect early in order to be able to delay progression. But really importantly, the combination therapy being considered for NPC was one of the major takeaways.

I will ask Josh to talk a little bit about some of the impacts that we see and, quite frankly, hurdles that are lowered with these guidelines that have been published.

Joshua M. Schafer: Yes. Thanks, Neil. Just to add to what Neil said, we are also really pleased that the guidelines addressed the need for early detection and that early treatment helps delay progression. It also went on to talk about the importance of using combination therapy in patients who have been diagnosed with NPC. This is really important because these are the opinions of a select group of key opinion leaders that we are now able to use and communicate and help build confidence and consistency in the way that some HCPs who might not be as familiar with NPC can now use this as a consistent guide for their treatment.

Analyst: Thank you for that color. And then second, do you have a sense of the proportion of the patients that are identified through the genetic testing that you are conducting and the AI-driven predictive model that ultimately convert onto the drug? I guess, and just related to that, I was wondering what feedback you hear from the physicians that are managing these patients in terms of how they are reacting to these data-driven identification approaches that you are using? Thank you so much.

Neil F. McFarlane: Wonderful question, and thanks for outlining our commercial strategy really clearly for us. Let me ask Josh to touch on some of the key priorities we are executing against and some of the feedback that we are getting.

Joshua M. Schafer: Yes. We mentioned in the prepared remarks, we have three key priorities from a commercial perspective. The first is to accelerate the time to diagnosis and treatment, and we are seeing that through our disease awareness campaign, as well as some of the collaborations with the genetic testing companies. Our second priority is to really drive demand, and you are seeing that in the enrollments that we have been able to get over the past quarter and more. And then facilitate access, with 69% of covered lives currently able to access MyPlifer and the others we are able to do through medical exception pathways.

So we feel really confident in our line of sight for more patients given what we are seeing today, which is a nice mix of newly diagnosed as well as previously diagnosed patients.

Operator: Thank you. And our next question comes from Kambi Ziyazi with BTIG. Your line is now open.

Analyst: Hi, team. EAP revenue growth was quite robust. Is France driving that growth or other countries? And how should we think about geographic composition of the EAP as a leading indicator where commercial demand may concentrate post EU approval?

Neil F. McFarlane: Thank you for the question. Welcome to the analyst coverage. As we reported, 122 patients enrolled in Q1 2026. This really encompasses multiple access programs we have and multiple territories. In Europe, we have had outstanding, for quite some time, our French EAP experience, which we have previously guided and consistently receive about $10 million net per year now that our patient base has stabilized in that territory. And that was per year. Today, we have new markets that are coming on, and that variability in ordering pattern and the rates of new enrollments, and the reality is that we have both compassionate use as well as named patient reimbursement ability that we continuously guide towards. It is early.

We have new distributors. We are really pleased, though, with our new distributors and actually all of our distributors and how fast they are able to be able to get the named patient requests for individual patients and then drive that. We are really [inaudible] with the continued inbound in these markets. And our goal is to really expand access to as many markets as we can while still focusing on our key territories in the U.S. and expanding the diagnosis and treatment, along with our global expansion, i.e., Europe and the EMA as well.

Analyst: Any quantitative milestones or leading indicators you are tracking internally around your bespoke AI-driven patient identification and genetic testing efforts and identifying newly diagnosed NPC patients?

Neil F. McFarlane: Let me ask Josh to work on some of those strategies that are starting to really give us confidence in the TAM.

Joshua M. Schafer: Yes. And we monitor and measure a number of [inaudible] internally, but we are measuring how many patients we find that are newly diagnosed. We are looking at how many new prescribers we are able to bring into the mix as well. And then other interesting dynamics. They may have been on the [inaudible] look to really understand as much as we can about these patients. This program is working extremely well. And [inaudible] who we know are diagnosed with NPC clinicians in accelerating their diagnosis and [inaudible] treatment.

Neil F. McFarlane: Heterogeneity of the disease, the patient journey [inaudible] of rare diseases it is, you know, one patient, you know, one patient. We are talking [inaudible] been developed over many, many years and has been really [inaudible] child based. We saw that it was about 50% of the patients that were [inaudible]. Now that means that we have to continue to learn how we can then make the tools and continue to evolve NPC. So this is early in our launch.

Sumant Satchidanand Kulkarni: Good afternoon. What does your competitive intelligence tell you about your share versus the competitor [inaudible] in the [inaudible]? And do you know of any cases where payers are allowing [inaudible]?

Neil F. McFarlane: Thanks, Sumant. We will take one question at a time here. To double click on this a little, you are correct that [inaudible] because of the complexity of the disease as well as [inaudible]. And we are actually seeing success in getting those patients [inaudible] able to get them covered from a commercial perspective. These guidelines, I think, are going to continue to [inaudible]. We believe that bodes really well for us, our label disease modification, halting the progression of the disease, and the durable effects that we see.

Joshua M. Schafer: A little bit more in practice, clinicians want to be able to treat patients with as many different angles as possible. And so we have seen treatment guidelines. The patients that we are treating now, some of them very likely [inaudible] marketplace. And so we can see coverage is continuing to get that through direct formulary. We are able to get coverage even for combination [inaudible].

Sumant Satchidanand Kulkarni: On seliprolol, we know you plan to meet with the FDA again in the second half of the year to move faster to bring this product to VEDS patients.

Neil F. McFarlane: Last call, we had a Type C meeting in Q1, and the conversation is constructive, also informative. We are now, you know, this is the early part of 2026, and quite frankly, it is too early for us [inaudible]. One, to continue to boost enrollment activities and the other [inaudible].

Operator: Our next question comes from Lynn with Guggenheim Securities. Your line is now open.

Analyst: Apologies if this has already been asked. I am jumping between a few calls. Do you have any update from the 120-day—day 120—on the updated CHMP opinion? Thanks.

Neil F. McFarlane: Within the responses that are there, I will not get into the specifics. I would continue to say is that since we have not actually seen any new questions that we did not see that we were able to then provide. So the substantial [inaudible]. As a reminder, it is the totality of the data is over [inaudible]. We have an open-label extension study that has five years of data, our EAP and [inaudible] path, and we look forward to our next engagement with the European regulators.

Operator: Thank you.

Analyst: Our next question—thanks for taking the question.

Jason Nicholas Butler: And again, speaking to the HCP community here, how heterogeneous are they? Diagnosis is delayed, and then channel inventory was below the lower end of the preferred range at the end of the quarter—any additional context?

Neil F. McFarlane: Thank you, Jason. Let me start with the “when you know one patient, you know one patient.” One patient may present with a primary symptom that is epilepsy. Another may present with other challenges. And because of that, as Josh talked about, the predictive modeling, claims data, all the things that we are doing, we are performing how we go at [inaudible] and try to continue to expand. And as I mentioned, we have talked about the prevalence of the non 300 to 350 and the 900—we are somewhere [inaudible] patient population. So let me ask Josh to talk a little bit about some of the characteristics [inaudible] of newly diagnosed patients?

Joshua M. Schafer: Yes. Just to bring an example, there was a case of a toddler who had an enlarged spleen, and that is what we are seeing. On the other end of the spectrum, there was an adult who had been misdiagnosed with MS for years, and then underwent genetic testing and confirmed that it was NPC. So it really runs the gamut, but there are some similarities and some patterns that we are able to really identify, and we are continuing to educate physicians. We have a strong presence at medical conferences. We publish a lot of—

Neil F. McFarlane: And Jason, let me hand off to Justin to keep him going here this evening on the [inaudible] in the U.S. than typical. End of our targeted range. And so [inaudible] we do expect this to fall back within our targeted range by the end of the second quarter.

Operator: Next question will come from Brandon Folkes with H.C. Wainwright.

Brandon Richard Folkes: Maybe just two from me. Any color on the time from submitting an enrollment form to getting on product and how that is trending at this stage of the launch? And then secondly, is there a difference in net revenue realized per patient if it goes through a medical exception versus a patient whose insurance falls into the 69% of covered lives currently? Thank you.

Neil F. McFarlane: Thanks, Brandon. Let me ask Josh to talk a little bit about the enrollment numbers that we are seeing now.

Joshua M. Schafer: Yes. I think your question was really around the time from when an enrollment comes in and then once a patient receives therapy, and it is varied. It is largely dependent on the payer type, whether it is government or whether it is commercial. We are seeing in Q1 we had a number of patients who went through a reauthorization process, which is very typical at the beginning of the year, as patients might either change plans or plans might change their policies. And so that had an impact on the first quarter, and we are working through those reauthorizations.

So it is a little difficult to give you what the average or the standard is just because of the reauthorizations that took place in the first quarter.

Brandon Richard Folkes: Your second question might have to—this is about, I guess, like, you know, what is the priority to grow the 69% of covered lives given your market? And, think, strong. Revenue per patient that goes through insurance versus—

Neil F. McFarlane: And I will ask Josh to opine. But the 69% of covered lives allows for you to be on a formulary. It does not necessarily have a preferred position on the formulary, and it does speed up the process. A lot of our education that has gone to payers so far has really allowed us to be able to educate on the clinical benefits with the medical directors of the plan and achieve what we believe is a really good covered life plan. The important component of the question I think you just asked, which is maybe getting into potential for gross-to-net as well: we do not contract currently today.

So it is standard government discounts along with distribution margins and the like. So the net price has not really changed except for the variability in gross-to-net on a quarter-over-quarter basis.

Joshua M. Schafer: Yes, and I think you are asking a very salient question around the 69% and our intent to grow that. We absolutely do, and we are making steady progress in that area, largely by talking about the clinical differentiation of MyPlifa. The guidelines certainly will help those discussions as well. But as you point out, it really does not impact overall ability for a patient to receive MyPlypha because every plan has a medical exception pathway. What it does is it reduces a little bit of the time; it reduces some of the burden. We have very robust patient services resources that we provide to help patients and offices navigate this.

And so our goal is to make MyQuaifa as accessible to patients as possible, and we do that both through increasing the covered lives but also providing these patient services.

Brandon Richard Folkes: Great. Thank you very much. And congrats again on all the success.

Analyst: Thank you.

Operator: Thank you. This concludes the Q&A portion of today's call. I will now turn the call back to Neil for any additional or closing remarks.

Neil F. McFarlane: Thank you for joining our call today. We look forward to keeping you apprised of our future progress. Have a wonderful evening.

Analyst: Thank you.

Operator: This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.