Catalyst Pharmaceuticals Q1 2023 Earnings Call Transcript

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Provided by Quartr
May 11, 2023

There are 8 speakers on the call.

Operator

Greetings, and welcome to the Catalyst Pharmaceuticals First Quarter 2023 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. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ali Grande, Chief Financial Officer.

Operator

Thank you, Ali. You may begin.

Speaker 1

Good morning, everyone, and thank you for joining our conference call to discuss Catalyst First Quarter I'm joined by Doctor. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer and Jeffrey Del Carmen, our Chief Commercial Officer. Further, for the Q and A session, we'll have Doctor. Gary Ingenido, our Chief Medical and Regulatory Officer. Before we begin, I would like to remind you that in our remarks this morning and in the Q and A session, we will make statements about expected future results, which may be forward looking statements for purposes of federal securities laws.

Speaker 1

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 prove not 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 20 22 and I'll report on Form 10 ks. At this time, I'll turn the call over to Todd.

Speaker 2

Thanks, Ali, and welcome, everyone, to our Q1 2023 results conference call. We started 2023 strong as we made meaningful progress across all our functional areas. I'm very pleased to report on our record breaking Q1 2023 financial performance as shared in yesterday's press release, And I will now highlight several key points. We achieved total revenues of $85,400,000 during the quarter, representing 98% growth year over year. The exceptional performance reflects Firdapse Product net revenues of $57,500,000 achieving a net revenue increase of 34% year over year.

Speaker 2

Total revenues were bolstered by Fycompa and net product revenues of $27,800,000 for the approximately 2 months that we own the U. S. Rents for the product during the 2023 Q1. Non GAAP income for the Q1 was $46,800,000 or $0.44 per basic share and $0.41 per diluted share. This excludes from GAAP net income, non cash stock based compensation, depreciation, amortization of intangible assets and our income tax provision.

Speaker 2

GAAP net income for the Q1 was $29,600,000 or $0.28 per basic share and $0.26 per diluted share, which reflect among other expenses, the expenses related to the amortization of the intangible assets Associated with the acquisition of Fycompa and Resurgi, which were approximately $6,500,000 The expenses related to the transition services agreement with Eisai for VYCOMPA were approximately $7,000,000 for the 2 month period and $2,900,000 in non cash stock based compensation. We ended the quarter with a cash position of about $148,000,000 The outstanding Q1 performance reinforces the belief in our strategy and we reaffirm 2023 total revenue guidance of between $375,000,000 to $385,000,000 representing a 75% to 80% increase in total revenue compared to 20 22. We Exact operating expenses of $160,000,000 to $170,000,000 for the full year 2020 3, which includes amortization expenses of about $32,000,000 for this year. This also includes the operating expenses directly related to FICAPA, which at this time we estimate to be $40,000,000 to $45,000,000 per year. Keep in mind that we are still fine tuning our pro form a expenses to account for the Fi We are also forecasting that non GAAP net income for 2023 will be between $195,000,000 to $205,000,000 During the Q1, we announced that we successfully completed the purchase of U.

Speaker 2

S. Rights to FICOPPA by January 24, 2023. This marks an important milestone for Catalyst as we broadened our commercial product portfolio with the 1st and only noncompetitive amply receptor antagonist for epilepsy, further augmenting the already strong revenue growth of Firdapse. Effective May 1, we onboarded the full U. S.

Speaker 2

Commercial team for the FICOPPA brand, including marketing, promotion and medical support activities. I'm pleased to report That the Fycopha Commercial Medical Affairs integration is for the most part completed and our newly established franchise teams are actively field engaged as of this week. We're excited to welcome our new Fycompa team members who bring a wealth of passion, experience and expertise in the epilepsy field to the Catalyst family. Building upon our exceptional We are poised to fully benefit from our diversified portfolio to achieve targeted run rate synergies to position Catalyst to benefit from this long term revenue and income opportunity. Moving on to our clinical business, we are making meaningful progress focused on expanding the use of Firdapse.

Speaker 2

The Phase 3 registrational limb study in Japan is progressing on plan. We anticipate study completion By the end of 2023 and assuming success in that study, we anticipate an NDA submission to the Japanese regulatory agency by our partner Daidou Pharma in the Q2 of 2024. Based upon an acceptance of the NDA to market the product in Japan, we also plan to accelerate our global growth Initiatives are already underway to identify potential partnership opportunities in these territories as part of our longer term strategic Growth plans. Along with our global expansion plans, we are also planning to seek an increase from the FDA And the maximum daily dose of Firdapse from 80 milligrams per day to 100 milligrams per day. As we know, there are quite a number of Firdapse patients that could benefit from being treated with 100 milligrams per day.

Speaker 2

Just last week, we received the minutes from our Type And the maximum daily dosage for Firdapse from 80 to 100 milligram. Based on the positive response from the meeting, We anticipate filing the sNDA seeking approval of the change early in Q3 of this year. During this quarter, we've gained significant ground in identifying acquisition opportunities towards building a diversified rare disease portfolio. Our key priority on the strategy front remains to smartly continue to broaden and diversify our product portfolio through collaborative global partnerships, acquisition of commercial stage assets and or acquisitions of companies that own those type of assets. Our company is fully resourced and there is capacity from multiple perspectives to add in Tuck in rare disease programs with a preference towards neurology, commercial or late stage assets.

Speaker 2

Our mission, which has been driven, our strategy since inception, is to improve the lives of those who suffer from rare and difficult to treat diseases. This commitment to providing these patients with safe and effective medicine, while enabling affordability and accessibility, remains core to our values. With that in mind, we are proud to share that earlier this month, We released our inaugural ESG report, highlighting our commitment and progress on environmental, social and governance initiatives did benefit our patients, people and communities. We look forward to advancing our ESG journey as we continue building our strong and sustainable foundation. Without question, we achieved meaningful results as we successfully executed across multiple initiatives, while delivering an exceptional financial performance that exceeded expectations.

Speaker 2

Looking ahead, we are well positioned for sustained growth with our 2 branded products and a sound strategy for our company's future, supported by our recent achievements. Coupled with our expanding capabilities and prudent approach to capital allocation, we will continue I'll now turn the call over to Jeff Del Carmen, our Chief Commercial Officer, who will provide an update on our commercial activities.

Speaker 3

Thanks, Pat, and good morning, everyone. As Pat mentioned, Catalyst had an excellent start to 2023, driven by the combination of strong Firdapse net revenues and compelling revenues from Fycompa. The record Q1 total net revenues of $85,400,000 positions Catalyst well to achieve our combined 2023 revenue guidance of $375,000,000 to $385,000,000 First, let me start with Firdapse performance. Q1 net sales of $57,500,000 represents a 34% increase order over the same quarter last year, a direct result of a sustained cadence of new patient starts, high compliance and consistent low discontinuation rate. Prescription approval rates were greater than 90% across all payers, government or private commercial insurers.

Speaker 3

Patients enrolled in Catalyst Pathways, including those who are covered by Medicare and accessing foundation assistance, at an average copay of less than $2 per month. Our strategic growth initiatives will continue to drive organic growth moving forward. LEMS education programs targeting healthcare providers have already resulted And a significant increase in voltage gated calcium channel antibody tests, which will shorten the diagnostic journey for LEMS patients and lead to more patients being eligible for treatment with Firdapse. Additionally, the recently hired oncology thought of small cell lung cancer LEMS patients. Currently, greater than 80% of small cell lung cancer LEMS patients are undiagnosed.

Speaker 3

We continue to maintain a pipeline of approximately 450 Diagnose LEMS patients that are not yet on Firdapse, which contribute around 50% of new patient enrollments each quarter. Now let me provide an update on Fycompa. We have established a new commercial Fycompa franchise business that is highly synergistic with our Firdapse business. The integration has gone exceptionally well, a credit to the entire organization and our commercial capability to execute flawlessly without interruption to the Firdapse business. The Fycompa sales force and marketing team are fully staffed with 34 highly experienced personnel with a deep understanding of Fycompa and a passion to help patients living with epilepsy.

Speaker 3

During the 1st week of May, we successfully held our Fycompa launch meeting in which our Fycompa commercial team was trained and certified. On conclusion of our Fycompa franchise launch meeting, the entire Fycompa team and our corporate leadership were all energized about future growth opportunities. A Ficompa sales team of 27 regional account managers and 3 area business directors were deployed into the field effective May 5. Q1 net revenues for Fycompa were $27,800,000 for the approximately 2 months that we own the U. S.

Speaker 3

Right to the product, which adds further confidence towards achieving our VYCOMPA full year 2023 net product revenue forecast of 130,000,000 Adding Fycompa to our portfolio is an ideal strategic fit for our existing commercial infrastructure With a 45% overlap in Fycompa and Firdapse physician call points and an increased We share a voice that will benefit both franchises in driving growth. In summary, We are making meaningful progress on sustained organic growth for Firdapse as well as the successful execution of the launch of our VYKOPPA commercial business. We are highly focused on continued commercial execution, Excellent and remain confident in our 2023 total revenue guidance of 375,000,000 to $385,000,000 I want to thank the entire Chemic Catalyst for their unwavering commitment to patients and look forward to a successful 2023. I will now turn the call over to Doctor. Stephen Miller, Our Chief Operating Officer and Chief Scientific Officer for an update on R and D activities.

Speaker 4

Thanks, Jeff. Our clinical development and regulatory strategy for Firdapse continues to focus on expanding access to all LEMS patients, enhancing the Firdapse Patent to state to maximize its commercial potential and integrating the newly acquired Fycompa product into Catalyst organization. 1st, I would like to discuss our development efforts to increase the indicated maximum dose of Firdapse from 80 milligrams per day to 100 milligrams. As announced earlier this week, the agency has responded that they accept our approach for the filing of a supplemental NDA that we expect The sNDA submission to be submitted early in Q3 of this year. Currently, there are a number of LEMS patients who are already being treated at a 100 milligram daily dosage of Firdapse after their physician worked with the pharmacy and insurance providers to justify the higher dose.

Speaker 4

Other patients on the current indicated maximum dose of 80 milligrams per day and their physicians have expressed a need to increase the patient's daily dosage to 100 milligrams to optimize therapy and this planned supplement if approved will help those patients. We believe that our data set constitutes an acceptable basis for seeking a 100 milligram maximum indicated daily dosage for Firdapse. Regarding our global expansion, our sub licensee partner, Daito Pharma, in Japan has completed enrollment in their Firdapse Phase 3 Clinical trial, which is required to seek approval for the Japanese market and the safety follow-up phase of that study is ongoing. We continue to anticipate completion of that trial by the end of the year and filing of a Japanese NDA submission in the Q2 of 2024. It is estimated that there are about 1200 to 1300 LEMS patients in Japan.

Speaker 4

Under our license agreement, the filing of the NDA in Pan is an important milestone for Firdapse and Catalyst because it expands our territory, further advance our efforts to expand the global footprint Firdapse into other markets in Asia and in Central and South America. As previously reported, We recently completed the acquisition of the U. S. Rights to Fycompa or pyrapinal, which is the 1st and only approved apa receptor antagonist or inhibitor. Catalyst Fycompa integration efforts are progressing well as Jeff reported, and we have completed the successful integration of the commercial teams.

Speaker 4

We are also well along with the process of integrating Fycopha's manufacturing, quality and pharmacovigilance functions into our organization and anticipate beginning to distribute Fycompa in catalyst trade dress by the Q4 of this year. AMPA receptors enable fast excitatory synaptic Transmission throughout the central nervous system. Epileptologists believe that seizure generation and spreading can be dependent on overactivation of aporeceptors. Hyperactivity induced by seizures might also alter aporeceptor function and duration of excitation. Hyperactivation of aporeceptors is FYCOMPA as an AMPA receptor antagonist can act to reverse these effects and improve seizure control.

Speaker 4

Lycopa is approved as an anti seizure medication to treat partial onset seizures with or without secondary generalized seizures in people with epilepsy Moving on to our medical information function, Catalyst Neuromuscular Medical Science Liaisons or MSLs are actively reaching out Oncology healthcare providers to build relationships and provide education about the importance of testing their patients for LEMS in order to expand the use of Firdapse by those patients. Oncologists that already treat LEMS in their practices have found that patients treated with Firdapse maintained muscle strength, improving the patient's Catalyst has also onboarded the new FYCOMPA MSL team and their new director, all with prior epilepsy experience to support FYCOMPA. Lycopa is a mature product for which extensive published information and real world data is available. The MSL team will bring this information As previously reported, a recent publication identified a number of rare epilepsies that were shown to respond to Fycopha treatment. As a service to the physician community, Catalyst provides support for the development of continuing medical education or CME programs that are part from the formal ongoing education of healthcare providers.

Speaker 4

Catalyst has, over the past 3 years, provided support for 3 CME programs for various have utilized the CME programs learning modules and about 2,500 have taken the CME test in order to be granted CME credit for the maintenance of their medical licenses. Last quarter, we responded we sponsored a new LEMS CME program that targeted oncologists that and 280 CME testings. In short, through these programs, we have now reached success of Firdapse for the treatment of LEMS. Catalyst will continue to support the creation of new CME programs for both Firdapse and now for Fycompa in the future. Moving on to business development, Pat described our significant portfolio expansion with the acquisition of quarter, and we are continuing to identify additional assets for potential acquisition.

Speaker 4

It is also important to point out how The Fycompa acquisition fits into our broader business development strategy. As the specific biochemical origins of epilepsy Are increasingly being elucidated, the field of epilepsy treatment is evolving into a precision medicine approach with Precinct numbers of rare epilepsies being identified and targeted therapies being developed for each. As a rare disease company, Catalyst acquisition VYCOMPA is our entree into this expanding therapeutic area. Catalyst is actively pursuing additional therapies that are commercial stage or very late stage products development, including those that extend beyond epilepsy and neuromuscular rare disease. At this time, I would like to turn the call over to Allie Grande, our CFO.

Speaker 1

Thanks, Steve. Results from Catalyst Q1 2023 have set us on pace for another year of exceptional financial performance and strong On the business development front, we were very busy as we closed the previously announced acquisition of the U. S. Rights to Faicompa for for $160,000,000 in cash and integration efforts are underway. I remind you that FiCompa operations Included in the results for the Q1 of 2023 include only a little over 2 months of activities since we acquired the product in late January.

Speaker 1

Our total revenues for the Q1 of 2023 were $85,400,000 a 98% increase when compared to total revenues of $43,100,000 for the Q1 of 2022. Product revenue net for the Q1 of 2023 For the phycompa product acquired in LATAM, we expect to amortize on a straight line basis over the next approximately 5 years. Amortization for intangibles acquired in connection with both the Fiscompa products acquired in late January 2023 and their Resurgi products acquired during July 2022 was approximately $6,500,000 for the Q1 of 2023. We did not have any amortization in the comparable 2022 quarter as we had not acquired either products during the Q1 of 2022. We expect intangible related amortization for our acquired products to be approximately $8,500,000 per quarter for the rest of 2023.

Speaker 1

Our effective tax rate for the Q1 of 2023 on an annualized basis was 20.8% compared to 24.2% for the Q1 of 2022. For 2023, the difference to statutory federal income tax rate of 21% was primarily driven by Yes, that's it, that's great. It's affected by many factors, including the number of stock option pesticides in any given period and is likely to fluctuate in future periods. Cost of sale expenses were approximately $9,900,000 in the Q1 of 2023 compared to $5,900,000 in the Q1 of 2022 and consisted principally of royalties. As a reminder, royalties for Firdapse increased by 3 When net product sales exceed $100,000,000 in any calendar year, so we expect cost of sales to trend higher as the year progresses.

Speaker 1

Cost of sales for Fi Compa in 2023 is exclusive of amortization of intangible assets. Research and development expenses were $3,600,000 in the Q1 of 2023, slightly down from $3,400,000 in the slightly up from $2,400,000 in the Q1 of 2022. SG and A expenses for the Q1 of 20 23 totaled $29,700,000 compared to $16,400,000 in Q1 2022. SG and A expenses decreased slightly as a percentage of total operating expenses to 60% for Depends in SG and A expenses in the Q1 of 'twenty three was principally due to commercial expenses under the transition services agreement related to Fi Compa The 5,000,001,000,000 organizations where the contributions will be used over the full year 2023, as previously noted. As reported, we ended the quarter with cash and cash equivalents of $148,000,000 As a reminder, during January 2023, we used approximately $162,000,000 of our available cash for the acquisition of the U.

Speaker 1

S. Rights for a 5th company. We believe our remaining funds continue to allow us the financial flexibility to on our existing R and D programs as well as support our specific initiative of acquiring opportunities leading to future growth and value creation. More detailed information analysis of our Q1 2023 financial performance may be found in our quarterly report on Form 10Q, which was filed with the Securities and Exchange Commission yesterday, May 10, and can be found on our and the Investor Relations page on our website at www.atalystpharma.com. And with that, I'll turn the call over to Pat.

Speaker 2

Thanks, Ali. In closing our prepared remarks, we are very optimistic about our path forward as we continue with our sights set on further expansion that aligns with our core mission to deliver value to patients, healthcare providers and shareholders. I'm proud of our team's accomplishments, and I thank all of our Thank you, and good morning everyone. At this time, I'd like to turn the call over to the operator To open the line for questions.

Operator

Thank you. We will now be conducting a question and answer One moment please while we poll for questions. Thank you. Our first question is from Joon Lee with Truist Securities. Please proceed with your question.

Speaker 5

Good morning. This is Les on for June. Thank you for taking my questions. First, I'll start on Firdapse. Can you talk about any seasonal trends that you might have seen and Any other impacts that drove the quarter over quarter slide in the Firdapse sales?

Speaker 2

Could you say slide in the Firdapse, yes?

Speaker 5

Quarter over quarter sequentially, yes.

Speaker 2

Yes. So Jeff, do you want to take that question?

Speaker 3

Sure. What we saw in Q1, we're very pleased with The net revenue results in Q1, the typical seasonal factors impacted the quarter, such as What patients try to do in December to ensure that they have medication over the holidays, they try to pull forward their Prescriptions are the shipment into December, so that impacts January a little bit as well as some of these patients want to get their drug before Some of their benefits are reset like co pays and deductibles in January. So that always impacts, it's not just for Firdapse, but it's for the industry in general. That's what happens in Q1. Also for gross to net, the accrual percentage is always higher.

Speaker 3

So you accrue the Medicare manufacturing rebates for all Medicare patients into Q1 and then gross to net will fall a little bit throughout the rest of the year. So that's why you see inflated gross to net in the Q1. And then and I I already also talked about the reauthorization process, but during that reauthorization process that for the most part happens in January, We provide bridge shipments for these patients so that they don't have an interruption in any of their medication. So those are the seasonal factors that we have as well as again like I mentioned all the other products in the industry get impacted with for the most part in the Q1.

Speaker 2

Yes, that's typical, especially In the specialty pharmaceutical area, where you're dealing with 1 specialty distributor. And as Jeff pointed out, there we gave away because on the bridge shipments, we can't charge for that. That's free of charge to patients that are waiting for reauthorizations. And that's pretty typical in the business. And so that delay can be anywhere from a week to 3 weeks getting that reauthorization in which you're not only giving away free You're giving away the revenue, if you will.

Speaker 2

So and I think if you look back at us Historically, with a few exceptions, you will see that Q4 versus Q1 It's sort of flat. There are exceptions like in Q1 of last year, we onboarded a The Resurgi patients, so that was skewed. So but otherwise that's pretty typical.

Speaker 3

And I'll leave it with this is Once again, like we've said throughout the call today, we confirm our forecast and guidance for Firdapse as well as FITCOMP before 2023, given the strong performance with Firdapse revenues in Q.

Speaker 5

That's very helpful. I understand the impacts in the And I just wanted to get a sense if it's the same for you or if there is something else. So just thank you for the explanation Regarding just, I guess, you touched on the guidance. Has there been a shift in the mix of the guidance? Or is that still the same as you provided last Quarter for the separate product line?

Speaker 2

Yes. Right now, there's no change in the mix. The proportion is the same as we talked about last time, Les.

Speaker 5

Got it. Okay. And then if we normalize Fi Compa sales for the Full 3 months run rate, that would imply a very strong quarter. I mean, probably more so than what everyone on the street expected, I'd say. Can you provide any color that you think drove that upside?

Speaker 5

And can we expect the remaining quarters to be similarly strong? I mean, if we do like a normalized run rate, Something around $40,000,000 per quarter. Is that seem reasonable or is that a high number?

Speaker 2

Yes, that's a great question and I'll let Jeff take that as well.

Speaker 3

Sure. So One quick thing is with any integration, you have to allow for a transition period. What we're doing is we feel like we're going to be Much more efficient with our sales force where we are taking about 40% from a size perspective or a number of field personnel versus what was previously used for Ficompa and larger territories. But with that, we want to allow for that transition period to take hold and that's why we're very confident in the flat 2023 versus 2022.

Speaker 2

Let me add to that, Les. As Jeff pointed out in your earlier question, this is more of a retail product. And as a Tail Products and as a result, your rebates and your reauthorizations and things like that also are affected in the month of January. And so I don't think you can merely take those 2 months And extrapolate for the full year. I think that would be a mistake.

Speaker 2

And I think that right now for the moment, And if that changes, we'll certainly provide an update on the guidance. But I think that we're still very comfortable sitting with Yes, 130 for this year.

Speaker 3

Correct. And we are very confident that we can demonstrate growth in 2024 with Viconla.

Speaker 2

Great. Thank you.

Operator

Thank you. Our next question is from Joe Catanzaro with Piper Sandler. Please proceed with your question.

Speaker 6

Hey, everybody. Thanks so much for taking my questions. Maybe first one for me. Just wondering if you could comment on the cadence of new patient enrollments in the quarter and The split you're seeing between non tumor LEMS and tumor LEMS and whether that dynamic is changing in any way with some of your efforts In oncology. And then with regards to your comments on further global expansion opportunities, wondering if we should think about that in the same way you sort of Structural collaboration with Daido in Japan and then maybe related to Daido, are there any milestones associated with the completion of their Phase 3 and then subsequent NDA filing?

Speaker 6

Thanks.

Speaker 2

Sure. Jeff, do you want to take the first question?

Speaker 3

Hi, Joe. Thanks for the question. The cadence of new patient enrollments in Q1 exceeded forecast. So we had a strong new patient enrollments There in Q1 and we continue to see that strong cadence here thus far in Q2. As far as the mix goes, we saw we estimate about a 25% of our new enrollments in Q1 Our Tumor LEMS case.

Speaker 3

Keep in mind that some patients come in with that Tumor LEMS ICD-ten code, But there are some patients that come in that are LEMS patients and then over so we have to make an assumption. So over the next 2 years as they get their scans, They will be diagnosed with it. So based on all those factors, we're estimating that we're about 25% Mix of our total enrollments are tumor lens.

Speaker 2

And Joe, with regard to our global efforts, The Daidopharma transaction for Japan serves as a really good model for other territories in Asia and South and Central America. And with regard to milestones, there is an undisclosed Milestone based on filing and acceptance by PMDA.

Operator

Thank you. Our next question is from Charles Duncan with Cantor Fitzgerald. Please proceed with your question.

Speaker 7

This is Pete Stavropoulos on for Charles. Hi, Pat Congratulations on all the progress for the quarter. First question is that there's greater than 800 LEMS diagnosed That are being treated with Firdapse. But wondering what you can say or what that number suggests in terms of penetration Into the total LEMS opportunity? And are there any specifics you can give into penetration as a result of the oncology outreach efforts?

Speaker 2

I'll turn that over to Jeff, Pete.

Speaker 3

Hey, Pete. So what we're seeing right now is about a 25% penetration of current patients that are still living and diagnosed with LEMS. So that's what we're seeing. It's about a 25% Penetration. As far as your what was your other question, Pete, about that and with the tumor And patients, what we think we can get as far as penetration?

Speaker 7

Yes. So I was asking, what do you think the oncology efforts, Our outreach efforts has been impacting.

Speaker 3

Okay, excellent. And what I can say there is the unfortunate news for Small cell lung cancer patients that 80 greater than 80% of these patients are undiagnosed. And so it's up to us to help these patients get diagnosed so that they can get benefit from the treatment with Firdapse. And so we've seen an uptick recently, just a slight uptick in 25% or so into The percent of our new enrollments that are small cell lung cancer LEMS patients, but we're hopeful that we can get to about 30 Of the mix will be the tumor LEMS patients. So that's what all our efforts are geared toward.

Speaker 7

Okay. And of the patients on Firdapse, can you provide any the proportion of or any color about patients Who would like to go from 80 milligrams and be up those to 100 milligrams?

Speaker 3

Yes. Right now, there are So 40% of our current patients are on 80 milligrams or higher. We know that LEMS is a progressive disease And also from hearing from patients and physicians and from former Resurgi patients that were higher that patients will benefit from a Higher dose some of these patients fill. So we feel like there will be that's a huge benefit again to these LEMS patients. Also, we do see some physicians that and patients that don't want to go to the max dose.

Speaker 3

So when you have a cap of 80, those patients that are at 60 or even 70 milligrams don't want to go to 80 milligrams if that's the max dose. So now having 100, that allows for some of these patients to also benefit from a higher dose if that's what is necessary to help treat

Speaker 7

All right. Thank you. And one question, I guess, on Fykampa. So it's What's the potential for developing pikampoa in rare epilepsy indications? And if I heard you correctly, you mentioned earlier in the call that epilepsy is Evolving into a precision medicine approach, are there any specific epilepsies you believe Vycampa can be utilized in?

Speaker 4

There have already been 7 different rare epilepsies that were identified in a recently published paper that we did a press release on not too long ago. With regard to other rare epilepsies that may develop, the current label for Fycompa actually contains a fairly broad description of clinical characteristics of epilepsies that can be treated with the drug. If a specific rare epilepsy Presents with those clinical characteristics, a physician would be able to prescribe Fycompa on label for that rare And determine whether or not the patient responds well to that. But as I said, there's already 7 that have been identified. Because of the relative maturity of this product, we do not anticipate Doing any formal clinical trials to update the label to specifically call out specific rare epilepsies, but Our team of MSLs will continue to provide any information that is relevant for the treatment of rare epilepsies to the physician community with SICOMPA.

Speaker 7

Okay. Thank you for taking our questions and congratulations on the quarter once again.

Speaker 2

Thank you, Pete.

Operator

Thank you. There are no further questions at this time. I would like to hand the floor back over to Patrick Mechenaini for any closing comments.

Speaker 2

Yes. I'd like to thank everybody for joining us today, and we look forward to our next earnings call. Have a great day.

Operator

This concludes today's conference. You may disconnect your lines at this time.

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