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.

[Operator Instructions].

As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Ali Grande, Chief Financial Officer. Thank you, Ali. You may begin.

Alicia Grande — Vice President, Chief Financial Officer and Treasurer

Good morning, everyone. And thank you for joining our conference call to discuss Catalyst’s first quarter 2023 financial results and corporate highlights. Leading the call today is Patrick McEnany, Chairman and Chief Executive Officer. We are also joined by Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer; and Jeffry Del Carmen, our Chief Commercial Officer. Further, for the Q&A session, we will also have Dr. Gary Ingenito, 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&A session, we will make statements about our expected future results, which may be forward-looking statements for purposes of federal securities laws. These statements relate to our current expectations, estimates, and projections and are not guarantees of future performance. They involve risks, uncertainties, and assumptions that are difficult to predict and may prove not to be accurate. Actual results may vary from the expectations contained in our forward-looking statements. 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 2022 annual report on Form 10-K.

At this time, I will turn the floor over to Pat.

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

Thanks, Ali. And welcome everyone for first quarter 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 first quarter 2023 financial performance as shared in yesterday’s press release and I’ll now highlight several key points.

We achieved total revenues of $85.4 million during the quarter, representing 98% growth year-over-year. The exceptional performance reflects FIRDAPSE product net revenues of $57.5 million, achieving a net revenue increase of 34% year over year. Total revenues were bolstered by FYCOMPA net product revenues of $27.8 million for the approximately two months that we owned the US rights to the product during the 2023 first quarter.

Non-GAAP income for the first quarter was $46.8 million 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.

GAAP net income for the first quarter was $29.6 million or $0.28 per basic share and $0.26 per diluted share, which reflect the many other expenses, the expenses related to the amortization of the intangible assets associated with the acquisition of FYCOMPA and RUZURGI, which were approximately $6.5 million, the expenses related to the transition services agreement with Eisai for FYCOMPA were approximately $7 million for the two month period, and $2.9 million in non-cash stock based compensation.

We ended the quarter with a cash position of about $148 million.

The outstanding first quarter performance reinforces the belief in our strategy, and we reaffirm 2023 total revenue guidance of between $375 million to $385 million, representing a 75% to 80% increase in total revenue compared to 2022.

We expect operating expenses of $160 million to $170 million for the full year 2023, which includes amortization expenses of about $32 million for this year. This also includes the operating expenses directly related to FYCOMPA, which at this time we estimate to be $40 million to $45 million per year. Keep in mind that we are still fine-tuning our pro forma expenses to account for the FYCOMPA acquisition.

We’re also forecasting that non-GAAP net income for 2023 will be between $195 million to $205 million.

During the first quarter, we announced that we successfully completed the purchase of US rights to FYCOMPA on January 24, 2023. This marks an important milestone for Catalyst as we broadened our commercial product portfolio with the first and only non-competitive AMPA receptor antagonist for epilepsy, further augmenting the already strong revenue growth of FIRDAPSE.

Effective May 1, we onboarded the full US commercial team for the FYCOMPA brand, including marketing, promotion and medical support activities. I am pleased to report that the FYCOMPA 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 are 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 commercial capabilities, we are poised to fully benefit from our diversified portfolio to achieve targeted run rate synergies that 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 new use of FIRDAPSE. The Phase 3 registrational LEMS 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, DyDo Pharma, in the second quarter of 2024. Based upon an acceptance of the NDA to market the product in Japan, we also plan to accelerate our global growth expansion strategy for FIRDAPSE into other countries in Asia and South and Central America.

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 in 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.

Just last week, we received the minutes from our Type C meeting with the FDA regarding the supplemental NDA submission requirements for the application, seeking to expand the maximum daily dosage for FIRDAPSE from 80 to 100 milligrams. Based on the positive response from the meeting, we anticipate filing the SNDA, seeking approval of the change early in the third quarter of this year.

During this quarter, we 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.

Our mission, which has 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 that 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.

Looking ahead, we are well positioned for sustained growth with our two 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 executing our long term vision to drive sustainable growth and deliver value for all our various stakeholders.

I’ll now turn the call over to Jeff Del Carmen, our Chief Commercial Officer, who will provide an update on our commercial activities.

Jeff Del Carmen — Chief Commercial Officer

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 $85.4 million positions Catalyst well to achieve our combined 2023 revenue guidance of $375 million to $385 million.

First, let me start with FIRDAPSE performance. Q1 net sales of $57.5 million represents a 34% increased order over the same quarter last year, a direct result of a sustained cadence of new patient starts, high compliance, and consistent low discontinuation rates. Prescription approval rates were greater than 90% across all payors, government or private commercial insurers. Patients enrolled in Catalyst Pathways, including those who are covered by Medicare and accessing Foundation Assistance had an average co-pay 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 in 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 leader liaison will focus on the top 30 thoracic oncology centers to accelerate diagnosis of small cell lung cancer LEMs patients. Currently, greater than 80% of small lung cancer LEMS patients are undiagnosed. We continue to maintain a pipeline of approximately 450 diagnosed LEMS patients that are not yet on FIRDAPSE, which contributes 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.

During the first 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. The FYCOMPA sales team of 27 regional account managers and three area business directors were deployed into the field effective May 5.

Q1 net revenues for FYCOMPA were $27.8 million for the approximately two months that we owned the US rights to the product, which adds further confidence towards achieving our FYCOMPA full year 2023 net product revenue forecast of $130 million.

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 share of 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 FYCOMPA commercial business. We are highly focused on continued commercial execution, excellence and remain confident in our 2023 total revenue guidance of $375 million to $385 million.

I want to thank the entire team at Catalyst for their unwavering commitment to patients and look forward to a successful 2023.

I will now turn the call over to Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer, for an update on R&D activities.

Steven R. Miller — Chief Operating Officer and Chief Scientific Officer

Thanks, Jeff. Our clinical development and regulatory strategy for FIRDAPSE continues to focus on expanding access to all LEMs patients, enhancing the FIRDAPSE patent estate to maximize its commercial potential and integrating the newly acquired FYCOMPA product into Catalyst organization.

First, 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 the third quarter 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. 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 indicate daily dosage for FIRDAPSE.

Regarding our global expansion, our sub-licensee partner, DyDo 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 second quarter of 2024.

It is estimated that there are about 1,200 to 1,300 LEMS patients in Japan. Under our license agreement, the filing of the NDA in Japan is an important milestone for FIRDAPSE and Catalyst because it expands our territory, further advance our efforts to expand the global footprint of FIRDAPSE into other markets in Asia and in Central and South America.

As previously reported, we recently completed the acquisition of the US rights to FYCOMPA, or perampanel, which is the first and only approved AMPA receptor antagonist or inhibitor. Catalyst’s FYCOMPA integration efforts are progressing well, as Jeff reported, and we have completed the successful integration of the commercial teams. We are also well along with the process of integrating FYCOMPA’s manufacturing, quality and pharmacovigilance functions into our organization and anticipate beginning to distribute FYCOMPA in Catalyst trade dress by the fourth quarter 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 over-activation of AMPA receptors. Hyperactivity induced by seizures might also alter AMPA receptor function and duration of excitation. Hyperactivation of AMPA receptors is highly toxic and now epileptologists believe it adds to secondary [Technical Issues]. FYCOMPA, as an AMPA receptor antagonist, can act to reverse these effects and improve seizure control.

FYCOMPA is approved as an anti-seizure medication to treat partial onset seizures with or without secondary generalized seizures in people with epilepsy who are four years of age and older, and with other medications to treat primary generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older.

Moving on to our medical information function, Catalyst’s neuromuscular medical science liaisons, or MSLs, are actively reaching out to 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 and physician’s perceptions of wellbeing, and the patient’s ability to maintain functional ability. All of these domains are critical for the patient’s quality of life.

Catalyst has also onboarded the new FYCOMPA MSL team and their new director, all with prior epilepsy experience to support FYCOMPA. FYCOMPA is a mature product for which extensive published information and real-world data is available. The MSL team will bring this information to healthcare providers to treat epilepsy and also to address any questions that these physicians may have about using FYCOMPA. As previously reported, a recent publication identified a number of rare epilepsies that were shown to respond to FYCOMPA treatment.

As a service to the physician community, Catalyst provides support for the development of continuing medical education, or CME, programs that are part of the formal ongoing education of healthcare providers. Catalyst has, over the past three years, provided support for three CME programs for various aspects of the diagnosis, treatment and management of LEMS. Over this period of time, over 8,000 healthcare providers have utilized the CME program’s learning modules, and about 2,500 have taken the CME test in order to be granted CME credit toward the maintenance of their medical licenses.

Last quarter, we sponsored a new LEMS CME program that targeted oncologists that treat small cell lung cancer due to the correlation between this cancer and associated LEMS.

In just a few months, this recent program has already had 1,200 learners and 280 CME test takers. In short, through these programs, we have now reached far more healthcare providers than there are LEMS patients, and these programs’ successes may be one of the many contributing factors to the overall commercial 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 FYCOMPA in the first quarter, and we are continuing to identify additional assets for potential acquisition. 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 increasing numbers of rare epilepsies being identified and targeted therapies being developed for each. As a rare disease company, Catalyst’s acquisition of FYCOMPA is our entree into this expanding therapeutic area.

Catalyst is actively pursuing additional therapies that are commercial stage or very late stage products in development, including those that extend beyond epilepsy and neuromuscular rare disease.

At this time, I would like to turn the call over to Ali Grande, our CFO.

Alicia Grande — Vice President, Chief Financial Officer and Treasurer

Thanks, Steve. Results from Catalyst’s first quarter 2023 have set us on pace for another year of exceptional financial performance on strong execution. On the business development front, we were very busy as we closed the previously announced acquisition of the US rights to FYCOMPA for $160 million in cash, and integration efforts are underway. I remind you that FYCOMPA operations, including the results for the first quarter of 2023, include only a little over two months of activity since we acquired the product in late January.

Our total revenues for the first quarter of 2023 were $85.4 million, a 98% increase when compared to total revenues of $43.1 million for the first quarter of 2022. Product revenue net for the first quarter of 2023 for the FYCOMPA product acquired in late January 2023 was $27.8 million. Product revenue net for the first quarter of 2023 for our lead product, FIRDAPSE, was $67.5 million, a 34% increase year-over-year compared to $43 million for the first quarter of 2022.

Net income before income taxes for the first quarter of 2023 was $37.3 million, a 114% increase year-over-year compared to $17.5 million for the first quarter of 2022.

We reported GAAP net income for the first quarter of 2023 of $29.6 million, or $0.28 per basic and $0.26 per diluted share, an increase of 123% year-over-year compared to GAAP net income for the first quarter of 2022 of $13.2 million or $0.13 per basic and $0.12 per diluted share.

As a reminder, in the first quarter of the calendar year, like many companies in our industry, we are impacted by the reset of the patient deductibles. Further, in the first quarter we reported expenses related to our annual commitment to make charitable donations to 501(c)(3) foundations that fund LEMS patient support programs throughout the year.

Non-GAAP net income for the first quarter of 2023 was $46.8 million or $0.44 per basic and $0.41 per diluted share, which excludes from GAAP net income stock-based compensation expense of $2.9 million, depreciation of $69,000, amortization of intangible assets related to our acquisitions of RUZURGI and FYCOMPA of $6.5 million, and an income tax provision of $7.7 million. This compares to non-GAAP net income in the first quarter of 2022 of $19.4 million or $0.13 per basic and $0.12 per diluted share, which excludes from GAAP net income stock-based compensation of $1.9 million, depreciation of $34,000, and an income tax provision of $4.2 million. It also represents an approximately 141% increase of non-GAAP net income year-over-year.

In connection with the FYCOMPA acquisition, we recorded approximately $158 million in license and acquired intangibles that we expect to amortize on a straight-line basis over the next approximately five years. Amortization for intangibles acquired in connection with both the FYCOMPA product acquired in late January and the RUZURGI product acquired during July 2022 was approximately $6.5 million for the first quarter of 2023. We did not have any amortization in the comparable 2022 quarter as we had not acquired either product during the first quarter of 2022. We expect intangible related amortization for our acquired products to be approximately $8.5 million per quarter for the rest of 2023.

Our effective tax rate for the first quarter of 2023 on an annualized basis was 20.8% compared to 24.2% for the first quarter of 2022. For 2023, the difference to the statutory federal income tax rate of 21% was primarily driven by state income taxes and anticipated annual permanent differences, offset by the orphan drug tax credit claim. The effective tax rate is affected by many factors, including the number of stock options exercised in any given period, and is likely to fluctuate in future periods.

Cost of sales expenses were approximately $9.9 million in the first quarter of 2023 compared to $5.9 million in the first quarter of 2022 and consisted principally of royalties. As a reminder, royalties for FIRDAPSE increase by 3% when net product sales exceed $100 million in any calendar year, so we expect cost of sales to trend higher as the year progresses. Cost of sales for FYCOMPA in 2023 is exclusive of amortization of intangible assets.

Research and development expenses were $3.6 million in the first quarter of 2023, slightly down from the $3.4 million — slightly up from $3.4 million in the first quarter of 2022.

SG&A expenses for the first quarter of 2023 totaled $29.7 million compared to $16.4 million in Q1 2022. SG&A expenses decreased slightly as a percentage of total operating expenses to 60% for Q1 2023 compared to 64% for Q1 2022. The overall difference in SG&A expenses in the first quarter of 2023 was principally due to commercial expenses under the transition services agreement related to FYCOMPA acquired during January 2023 and our contributions during the first quarter of 2023 to the 501(c)(3) organizations, where the contributions would be used over the full year 2023 as previously noted.

As reported, we ended the quarter with cash and cash equivalents of $148 million. As a reminder, during January 2023, we used approximately $162 million of our available cash for the acquisition of the US rights for FYCOMPA. We believe our remaining funds continue to allow us the financial flexibility to fund our existing R&D programs as well as support our strategic initiatives of acquiring opportunities, leading to future growth and value creation.

More detailed information and analysis of our first quarter 2023 financial performance may be found in our quarterly report on Form 10-Q which was filed with the Securities and Exchange Commission yesterday, May 10, and can be found on our Investor Relations page on our website at www.catalystpharma.com.

And with that, I’ll turn the call over to Pat.

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

Thanks, Ali. In closing our prepared remarks, we are very optimistic about our path forward as we continue to strengthen our position as a leader within the neuroscience space. We are well positioned to drive sustainable growth with our sights set on further expansion that aligns with our core mission to deliver value to patients, healthcare providers and shareholders.

I am proud of our team’s accomplishments and I thank all of our employees for their dedication and ongoing commitment to the patient communities we serve.

At this time, I’d like to turn the call over to the operator to open the line for questions.

Question & Answers

Operator

Thank you. We will now be conducting a question-and-answer session.

[Operator instructions]

Thank you. Our first question is from Joon Lee with Truist Securities. Please proceed with your question.

Les Sulewski — Truist Securities — Analyst

Good morning. This is Les on for Joon. 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?

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

Did you say slide in the FIRDAPSE sales?

Les Sulewski — Truist Securities — Analyst

Quarter-over-quarter, sequentially, yes.

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

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

Jeff Del Carmen — Chief Commercial Officer

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 or their 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 copays and deductibles in January. So that always impacts us. 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, so you accrue the Medicare manufacturing rebates for all Medicare patients into Q1 and then gross to net will follow a little bit throughout the rest of the year. So, that’s why you see inflated gross to net in the first quarter.

And then — I already also talked about the re-authorization process, but during that re-authorization 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 first quarter.

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

Les, that’s typical, especially in the specialty pharmaceutical area where you’re dealing with one specialty distributor. And as Jeff pointed out, we gave away — because on bridge shipments, we can’t charge for that. That’s free of charge to patients that are waiting for re-authorizations, and that’s pretty typical in the business. And so, that delay can be anywhere from a week to three weeks, getting that re-authorization, in which you’re not only giving away free product, but you’re giving away the revenue, if you will.

And I think if you look back at us historically, with a few exceptions, you will see that Q4 versus Q1 is sort of flat. There are exceptions, like in Q1 of last year. We onboarded a number of the RUZURGI patients, so that was skewed. But otherwise, that’s pretty typical.

Jeff Del Carmen — Chief Commercial Officer

I’ll leave it with this, is once again, like we said throughout the call today, we confirm our forecast and guidance for FIRDAPSE, as well as FYCOMPA for 2023, given the strong performance with FIRDAPSE revenues in Q [Phonetic].

Les Sulewski — Truist Securities — Analyst

That’s very helpful. I understand the impacts and the industrywide, and I just wanted to get a sense if it’s the same for you or if there was something else. So, thank you for the explanation and detail.

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 lines?

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

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

Les Sulewski — Truist Securities — Analyst

Got it, okay. And then, if we normalize FYCOMPA sales for the full three months run rate, that would imply a very strong quarter, probably more so than what everyone on the Street expected, let’s say. Can you provide any color that you think drove that upside? And can we expect the remaining quarters to be similarly strong? If we do, like, a normalized run rate, something around $40 million per quarter, does that seem reasonable or is that a high number?

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

That’s a great question. And I’ll let Jeff take that as well.

Jeff Del Carmen — Chief Commercial Officer

Sure. 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’re taking about 40% from a size perspective, our number of field personnel versus what was previously used for FYCOMPA 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.

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

Let me add to that, Les. As Jeff pointed out in your earlier question, this is more of a retail product. And as a result, your rebates and your re-authorizations and things like that also are affected in the month of January, and so I don’t think you can merely take those two months and extrapolate for the full year. I think that would be a mistake. 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 we’re still very comfortable sitting with that $130 million for this year.

Jeff Del Carmen — Chief Commercial Officer

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

Les Sulewski — Truist Securities — Analyst

Guys, thank you for the color. Good luck on the progress. Thank you.

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

Great, thank you.

Operator

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

Joseph Catanzaro — Piper Sandler — Analyst

Hey, everybody. Thanks so much for taking my questions. Maybe first one from 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’ve sort of struck a collaboration with DyDo in Japan.

And then maybe related to DyDo, are there any milestones associated with the completion of their Phase 3 and then subsequent NDA filing? Thanks.

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

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

Jeff Del Carmen — Chief Commercial Officer

Hi, Joe. Thanks for the question. The cadence of new patient enrollments in Q1 exceeded forecasts, so we had a strong new patient enrollment 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 are tumors LEMS patients. Keep in mind that some patients come in with that tumor LEMS ICD-10 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 two 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 LEMS.

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

And, Joe, with regard to our global efforts, yes, the DyDo Pharma 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.

Joseph Catanzaro — Piper Sandler — Analyst

Okay, got it. That’s all helpful. Thanks for taking my questions.

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

Sure. Thanks, Joe.

Operator

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

Pete Stavropoulos — Cantor Fitzgerald — Analyst

Hi. This is Pete Stavropoulos on for Charles. Hi, Pat and team. Congratulations on all the progress for the quarter. First question is, there’s greater than 800 LEMS diagnosed patients 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?

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

I’ll turn that to Jeff, Pete.

Jeff Del Carmen — Chief Commercial Officer

Hey, Pete. 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 — what was your other question, Pete, about that — with the tumor LEMS patients, what we think we can get as far as penetration?

Pete Stavropoulos — Cantor Fitzgerald — Analyst

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

Jeff Del Carmen — Chief Commercial Officer

Okay, excellent. What I can say there is the unfortunate news for small cell lung cancer LEMS patients is that 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 towards.

Pete Stavropoulos — Cantor Fitzgerald — Analyst

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 dose to 100 milligrams?

Jeff Del Carmen — Chief Commercial Officer

Yes, right now there are 40% — 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 RUZURGI patients that were higher that patients will benefit from a higher dose, some of these patients felt. 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. So, when you have a cap of 80 milligrams, those patients that are at 60 milligrams or even 70 milligrams don’t want to go to 80 milligrams because that’s the max dose. So, now having 100 milligrams, that allows for some of these patients to also benefit from a higher dose if that’s what is necessary to help treat their disease.

Pete Stavropoulos — Cantor Fitzgerald — Analyst

All right, thank you. And one question, I guess, on FYCOMPA. What’s the potential for developing FYCOMPA in the 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 FYCOMPA can be utilized in?

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

There have already been seven 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 epilepsy and determine whether or not the patient responds well to that. But as I said, there’s already seven 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 rate 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 FYCOMPA.

Pete Stavropoulos — Cantor Fitzgerald — Analyst

Okay, thank you for taking our questions. And congratulations on the quarter once again.

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

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 McEnany for any closing comments.

Patrick J. McEnany — Co-Founder, Chairman, President and Chief Executive Officer

I’d like to thank everybody for joining us today. And we look forward to our next earnings call. Have a great day.

Operator

[Operator Closing Remarks]

AI Assistant

CATALYST PHARMACEUTICALS INC

Q1 2023

Earnings Transcript

Find Answers

Ask about any part of the document to get insights, explanations, or key details.