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spk05: Greetings and welcome to the Catalyst Pharmaceuticals fourth quarter and full year 2022 financial results conference call. At this time, all participants are in a loose and lonely mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce one of your hosts, Allie Grundy, Chief Financial Officer. Please go ahead.
spk01: Good morning, everyone, and thank you for joining our conference call to discuss Catalina's fourth quarter and full year 2022 financial resource and corporate highlights. Leading the call today is Patrick McEnany, Chairman and Chief Executive Officer. We're also joined by Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, and Jeffrey DelCarmen, 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 the following comments and in the Q&A session, we will make statements about expected future results, which may be forward-looking statements for purposes of federal securities laws. The 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 containing our forward-looking statements. These forward-looking statements should be considered only in conjunction with the detailed information containing our SEC filings, including the risk factors described in our 2022 annual report At this time, I will turn the call over to Pat.
spk02: Thanks, Allie, and welcome everyone to our fourth quarter and full year 2022 results conference call. I'm pleased today to highlight the progress we've made across our business throughout 2022 and now into the start of 2023. As we did in yesterday's press release, let me highlight several key points. 2022 was a pivotal year for Catalyst as we delivered exceptional financial performance, exceeding our 2022 total net revenue guidance projections driven by consecutive quarterly revenue growth and fiscal discipline. The robust results capped an important year of transformation as we successfully executed our strategic initiatives across all segments of the business, This included attaining a favorable resolution of the patent litigation relating to the resurgi along with the U.S. rights underscoring the strength of the FERDAPS intellectual property portfolio, the receipt of a positive U.S. court decision supporting FERDAPS orphan drug exclusivity, the approval of an expanded pediatric indication for FERDAPS, and the recent acquisition of Phi Kappa. With our sights set on further expansion, these accomplishments added considerable strength to our neuroscience presence and confidence that we can accelerate the company's long-term growth strategy. Important to note, Ferdapps continues its strong performance and remains the cornerstone of our success. We are pleased with the strong demand and growth for Ferdapps. as we continue to see very positive trends across a number of our key performance indicators, which Jeff will address shortly. Our full year 2022 total revenues were $214 million, representing a 52% year-over-year increase compared to $141 million in total revenue for 2021. Fourth quarter total net revenues were $61 million, a 59% increase compared to $38 million in 2021. We reported GAAP net income of $83 million for the full year of 2022, or $0.80 per basic share and $0.75 per diluted share, a 110% increase compared to $39 million for $0.38 per share basic and $0.37 per share diluted. In 2021, further, non-GAAP net income for the full year 2022 was $114 million, or $1.10 per basic and $1.02 per diluted share, a 93% increase compared to $59 million. Please hold while we reconnect our speakers.
spk03: Let's go back two paragraphs. Okay.
spk02: Our full year 2022 total net revenue were $214 million representing a 52% year-over-year increase compared to $141 million in total net revenue for 2021. Fourth quarter total net revenues were $61 million a 59% increase compared to $38 million in 2021. We reported gap net income of $83 million for the full year 2022, or 80 cents per basic share and 75 cents per diluted share, a 110% increase compared to $39 million, or 38 cents per basic share and 37 cents per diluted share in 2021. Further, non-GAAP net income for the full year 2022 was $114 million or $1.10 per basic share and $1.02 per diluted share, a 93% increase compared to $59 million or 57 cents per basic share and 55 cents per diluted share for the full year 2021. Additionally, we ended 2022 with $298 million in cash and cash equivalent. It's another year of expected growth in front of us. We have recently provided the market with our forecast of full year 2023 total net revenues of between $375 million and $385 million, representing a 75% to 80% increase in total net revenue compared to 2022. We have also forecasted FERDAP's 2023 net revenues to be between $245 million and $255 million. And based on 11 months of sales projections, we expect Phi Kappa 2023 net revenues to be approximately $130 million, having closed the acquisition of Phi Kappa in late January of this year. Additionally, we continue to expect that Phi Kappa will be accretive to our EBITDA and EPS for this year. Allie will provide further financial highlights and details during her remarks. During the current quarter, our focused and diligent process to pursue value-added transaction opportunities has come to fruition with the successful acquisition of U.S.-wide supply compa from A-side Company Limited. We are extremely pleased to have delivered on this important objective for 2022. PICOMPA not only broadens our commercial product portfolio with the first and only noncompetitive AMPA receptor antagonist for epilepsy, but also adds a growing revenue base, further augmenting our already strong revenue and earnings growth of ProDEPs. More importantly, the addition of PICOMPA serves as a complementary growth driver and the strategic market adjacency within neuroscience that establishes a potential gateway to expand into rare epileptic diseases. We are already working closely and collaboratively with the eight-site Phi Kappa U.S. leadership and expect to complete the full transaction of Phi Kappa, transition of Phi Kappa activities by mid-year 2023. And we look forward to the future onboarding into the Catalyst family, many of the ASI employees who have been responsible for the success of PICOMPA Epilepsy Program to date. During this quarter, although we did not enter into any new contracts to acquire additional products, we continue to make significant strides in our efforts to identify acquisition opportunities that align with our overarching growth strategy to build a diversified patient-centric portfolio. Our key priority on the strategy and business development front remains our intention to broaden and diversify our product portfolio through collaborative partnerships and acquisitions of commercial stage assets and or companies. Currently, we are in advanced stages of due diligence on several commercial stage products and or companies and strongly believe that a transformational expansion of our portfolio that offers the potential to further implement our near and long-term growth strategy could occur in 2023. We remain optimistic about FERDEP's long-term growth prospects. During 2022, we made significant advancements related to FERDEP's intellectual property estate. which included the affirmation of its Orkin drug market exclusivity. Additionally, we were granted three new patents and ended the year with six FDA Orange Book listed patents that go out to 2037, which we believe supports the product's long-term durability. We remain confident about the strength of FURDAP's intellectual property estate supported by the successful outcomes achieved in 2022. That said, we are limited to what we can say at this point about ongoing patent litigation, other than to say that we intend to vigorously defend and prosecute any infringers of our intellectual property rights related to PRDEPs. We will, of course, provide regular updates in our disclosures filed with the SEC, which will be available on the company's website. Having ended the year with several significant achievements that aided the company's growth, we are pleased to be recognized for these accomplishments. These included being recognized as one of Forbes' 2023 America's Best Small Companies for the second consecutive year, Inclusion in Fortune's 2022 Top 100 Small Companies, and being honored as BioFlorida's 2022 Company of the Year, as well as being added to the S&P Small Cap 600 Index. These recognitions represent the culmination of our Catalyst Team's patient-centric attitude, work ethic, and commitment to excellence. In closing, the Catalyst Team's accomplishments underscore the significant advancements in our evolution to becoming a leading, innovative, rare disease by a pharmaceutical company. We expect these achievements coupled with our expanded capabilities and disciplined approach to capital allocation to drive sustainable growth and enhance value as part of our long-term vision. I'll now turn the call over to Jeff Delcarm and our Chief Commercial Officer who will provide an update on our commercial activities.
spk04: Thanks, Pat, and good morning, everyone. 2022 was a very successful year for Catalyst, as well as the LEMS community. First, we are very proud to announce that over 1,000 unique patients have now received the Ferdaps enrollment from launch to date, which is a tremendous milestone for LEMS patients in the United States. We are very pleased with the full year Ferdaps net sales of 214 million, representing a 52% increase year over year. driven by consecutive quarterly Firdaus net product sales growth. In Q4, net Firdaus sales were 61 million, a 6% growth quarter over quarter. These achievements demonstrate the strength of our commercial strategy and capabilities, giving confidence for continued organic growth. The foundation of the Firdaus business is solid. Operational excellence drove new patient starts, Maintained favorable prescription approval rates of greater than 90% across all payers, government or private commercial insurers. Continued high compliance of 90% and lower discontinuations. 90 new enrollments in 2022, not including LEMS patients that transitioned from Nosurgy to Ferdaps, were 25% greater year over year. while the annual discontinuation rate was 15%. The Q4 discontinuation rate was only 2.8%. Patients enrolled in catalyst pathways, including those who are covered by Medicare and accessing Foundation assistance, have an average co-pay of less than $2 per month. As Pat mentioned, we have forecast FERDAP net revenue of 245 million to 255 million in 2023. We are confident that our strategic growth initiative will drive organic growth moving forward. LEMS education programs targeting healthcare providers, patients, and caregivers have led to 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 VRNAPs. Additionally, we will increase the share of voice of thoracic oncologists through the newly hired oncology thought leader liaisons, small cell lung cancer lens focused educational programs available on a variety of platforms, as well as greater lung cancer conference participation. Also, we are working on strategic partnerships with institutions to help more small cell lung cancer patients get screened and diagnosed. We consistently identify a steady stream of approximately 450 diagnosed, primarily non-tumor lens patients that are not yet on Ferdows, which contribute around 50% of new patient enrollments each quarter. Thus far in Q1, net new patients are tracking to match or exceed Q4, driven by consistent new patient enrollments and low discontinuation rates. The commercial organization is excited about the addition of Phycompo, which serves as a complementary growth driver in strategic market adjacency within neuroscience that establishes a potential gateway for catalysts to expand into rare epileptic disease. Phycompa net revenues for 2023 are forecast to be $130 million for approximately 11 months of sales. Catalysts will capitalize on proven commercial capabilities to enhance the growth potential of Phycompa and establish first-in-class commercial stage epilepsy assets. We are making great progress hiring marketing sales and sales leadership for our epilepsy franchise with an effective Catalyst start date of May 1st. The vast majority of the epilepsy franchise will be staffed from ASI employees currently dedicated to phycompa. We were proud to participate in the ringing of the NASDAQ closing bell on February 28, 2023, in recognition of International Rare Disease Day to help shed light on the important unmet need for rare diseases in partnership with leading advocacy groups. Catalyst is committed to continued collaboration with the Rare Disease and LEMS Advocacy and new partnerships with epilepsy advocacy groups. We will continue to ensure access to Ferdaps for LEMS and Phytompa for appropriate epilepsy patients through established assistance programs. In closing, we are very optimistic about the organic growth potential for Ferdaps and thrilled with the addition of a best-in-class epilepsy franchise. Demonstrated operational excellence physicians' catalyst well to deliver the forecast combined net revenues of $375 million to $385 million in 2023 and leverage the 45% overlap in FICOMPA and FURDAP's physician call points. 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.
spk03: Thanks, Jeff. Our clinical development and regulatory strategy for FURDEPs continues to focus on expanding access to all LEMS patients, enhancing the FURDEPs patent estate to maximize its commercial potential, and to integrate the newly acquired phycophy product into catalyst systems. First, I would like to discuss our development efforts to increase the indicated maximum dose of FODAPs from 80 milligrams per day to 100 milligrams per day. We anticipate meeting with the FDA to outline our strategy in the second quarter and assuming a positive outcome of that meeting, plan to file a supplemental NDA in the third quarter of this year seeking to increase the indicated maximum daily dosage of FODAPs to 100 milligrams per day. A number of lens patients are already being treated at 100 milligrams per daily dosage of Ferdaps 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 indicated daily dosage to 100 milligrams to optimize therapy, and this planned supplement, if approved, will help those patients. The previously acquired ResurgiRights gave us access to safety and efficacy data for those patients treated at 100 milligram daily dose. And that data has been incorporated into our strategy along with our own data, including safety data for patients treated at a 100 milligram daily dose of deferred EPS. And we believe that the combined data set constitutes an acceptable basis for seeking a 100 milligram maximum indicated daily dose of deferred EPS. The investment community will be regularly updated on this project as it progresses. I would next like to comment on our previously approved supplemental new drug application for Ferdaps to treat pediatric LEMS patients. During the first quarter of 2022, we filed this supplemental NDA and it was approved by the FDA on September 29th, 2022. With the approval of this supplemental NDA, all pediatric patients age six and above and all adults now have access to Ferdaps as an FDA approved product for LEMS in the United States. The pediatric LEMS patient population is a very small patient group, estimated to be less than 30 patients in the United States. But this supplement highlights our commitment to ensure that all LEMS patients have access to Ferdaps. Regarding our global expansion, our sub-licensing partner, Dido Pharma in Japan, has completed enrollment in their Ferdaps Phase 3 clinical trial, which is required to seek approval for the Japanese market and the safety follow-up phase of that study to collect safety data in a Japanese patient population is ongoing. We continue to anticipate completion of that trial by the end of the year, and assuming the trial is successful, a Japanese NDA submission in 2024. It is estimated there are about 1,200 to 1,300 LEMS patients in Japan. Moving on to our recent business development success, we completed the acquisition of the U.S. rights to Phycopa from iSight in January of this year. Ficopla or perampanel is the first and only approved aporeceptor antagonist or inhibitor. Aporeceptors enable fast excitatory synaptic transmission throughout the central nervous system and are indispensable for learning, memory, and synaptic plasticity. 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 exaltation. Hyperactivation of aporeceptors is highly neurotoxic, adding to secondary damage induced by seizures and electrogensis. Lycopa, as an aporeceptor antagonist, can actually reverse these effects and improve seizure control. Lycopene is approved as a unique anti-seizure medication to treat partial onset seizures with or without secondarily generalized seizures in people with epilepsy who are four years of age and older, and with other medications to treat generalized tonic-clonic seizures in people with epilepsy who are 12 years of age and older. A recently published case review from a group of European neurologists treating rare epilepsies working under the framework of the Network for Therapy in Rare Epilepsies reported that in the widely respected journal Epilepsia, how Ficomple was capable of significantly reducing seizures in patients with epilepsies that resulted from specific genetic mutations. Of the 137 patients treated with parabenome, 60 patients, or 43.5%, sustained over 75% reduction in seizure frequency, and includes 38 patients, or 27.5%, with a greater than 90% reduction in seizure frequency. High efficacy was consistently observed and reported in seven different rare genetic epilepsies. Moving on to our medical information function, Catalyst Neuromuscular Medical Sales Liaisons, or MSLs, are actively reaching out to thoracic oncologists to build relationships and provide education about the importance of testing their patients for LEMS in order to expand the use of FERDEPs by those patients. Oncologists that already treat LEMS in their practices have found that FERDEPs maintain muscle strength improve the patient's and physician's perception of well-being, and the patient's ability to maintain functional mobility. All of these domains are critical in the minds of an oncologist, and they understand that quality of life and functional mobility are important for a better treatment outcome. These efforts will help broaden the use of FURDEPs to treat limbs across additional medical specialties, including oncology. With the acquisition of FICAPA, Catalyst also plans to add up to six additional MSLs in the U.S. to support the Phycopa product. Phycopa is a mature product that has extensive published knowledge base within the medical community that treats epilepsy. This MSL team will be responsible for continuing to spread this knowledge among physicians that treat epilepsy and to also address any questions and concerns that these physicians may have about using Phycopa to treat epilepsy patients. 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 educational positions. A new LEMS Medscape CME case-based virtual symposium will launch next week entitled The Dysfunction in the Neuromuscular Junction and the Emphasis on Cancer-Associated LEMS. Part of Catalyst's efforts to develop new therapies for rare disease patients include the development, maintenance, and enforcement of patents. Ferdaps is protected by six patents listed in the FDA's approved drug products with therapeutic equivalents, the so-called Orange Book, and is also protected by other granted and pending patents. Three companies have filed generic drug applications for Ferdaps, and on March 1st of this year, Catalyst initiated legal proceedings against all of them to protect and enforce our intellectual property rights. Catalyst remains confident on the strength and enforceability of our patents. As these cases proceed, Catalyst will provide regular updates to the investment community, but please understand, like all litigation, our comments and updates will need to be limited to information in the public court records with no additional forward-looking statements. Regarding FICAPA, there are two patents listed in the FDA's orange book for the FICAPA suspension and tablet products. The first of these is a composition of matter and primary indication patent. Prior to our acquisition of this asset, the Patent and Trademark Office determined that an extended expiration date of May 23, 2025. Subsequent to that, a redetermination of the expiration date was requested, that is still pending, and which contends that it should be June 8, 2026, due to the approximately 13 additional months it took the DEA to determine that Phycompa should be Schedule III, which the agency and PTO omitted from their prior expiration date calculations. There is no assurance this latest request will succeed, and if it does not, the final expiration date will be May 23rd, 2025, which Catalyst could still challenge if we feel it is appropriate to do so. The other orange book listed patent claims the commercial personal form of Parapenil for Phycompa And this patent expires on July 1, 2026. Catalyst is evaluating whether or not to enforce this patent at this time. And upon completion of that evaluation, we'll inform the investment community on our plans regarding this patent. Moving on to business development. Pat described our significant portfolio expansion with the acquisition of Phi Kappa this quarter. And we are continuing to identify additional assets for potential acquisition. It is also important to point out strategy. As the specific biochemical origins of epilepsy are increasingly being elucidated, the medical field of epilepsy treatment is evolving into more of a precision medicine approach with increasing numbers of rare epilepsies being identified and with specific therapies being developed for each. As a rare disease company, catalyst acquisition of phycophen is our entree. into an expanding rare disease field in a way that self-funds the commercial infrastructure that will support the acquisition and marketing of additional new rare epilepsy assets. At this time, I would now like to turn the call over to Alicia Grant. Thank you.
spk01: We are very pleased with our financial results for the fourth quarter and full year 2022 and remain steady in our performance. We reported GAAP net income for 2022 83.1 million or 80 cents per basic and 75 cents for the share. A 110% increase year over year compared to gap net income of 39.5 million or 30 cents per basic and 37 cents for the share. Total net revenue for 2022 principally from further revenue net was $214.2 million, a 52% increase year-over-year when compared to total net revenue of $140.8 million for 2021. For the year 2022, our effective tax rate was 21% compared to 25% for the year 2021. The decrease in the effective tax rate for 2022 is due to an increase in stock option exercises during the year due to an increase in our stock price. We expect that our effective tax rate will fluctuate in future periods and may be higher in future periods than it was for the year 2022. Non-GAAP net income for 2022 was $113.9 million for $1.10 per basic and $1.02 per direct share. which excludes from GAAP net income of $83.1 million, sub-grace compensation expense of $7.9 million, depreciation of $141,000, amortization of $1.1 million, and an income tax provision of $21.6 million. This compares to non-GAAP net income for 2021 of $58.9 million, or $0.57 per basis, and $0.55 per diluted share. which excludes from GAAP net income of $39.5 million, the base compensation expense of $6.1 million, depreciation of $192,000, and an income tax provision of $13.2 million. The above represents an approximately 93% year-over-year increase of non-GAAP net income. Cost of sales of $34.4 million for 2022 increased when compared to $21.9 million for 2021. For both years, 2022 and 2021, cost of sales was approximately 16% of product revenue net and consisted principally of royalties due to our further licenses. Research and development expenses were $19.8 million in 2022 compared to $16.9 million in 2021. The increase of $2.9 million in R&D was principally related to the acquisition of $4.1 million of researching inventory, fully recorded to expense in the third quarter of 2022, offset by an overall decrease in R&D expenses. R&D expenses decreased as a percentage of total operating expenses to 18% for 2022 from 19% for 2021. SG&A expenses for 2022 total $58.2 million compared to $49.6 million for 2021. The increase of $8.6 million when compared to the prior year is due to, among other changes, increases in compensation and benefit expenses as we continue to grow our business, additional charitable contributions to fellow 123 organizations supporting UNM stations, and amortization of intangibles acquired in connection with the research acquisition during July of 2022. With a percentage of total operating expenses, SG&A expenses decreased to 52% for 2022 compared to 56% for 2021. As reported, we ended 2022 with cash and equivalents of $298 million. Our continued revenue growth and prudent expense management allowed us in late January 2023 to use approximately $162 million of our cash to acquire Compa without any diluted financing. We believe our strong cash position continues to allow us the financial flexibility to execute on our current programs and strategic initiatives. Catalyst is aware of the Silicon Valley bank situation. The company does not hold any deposits or securities at such banks or any other regional banks. More detailed information and analysis of fourth quarter and three years 2022 financial performance may be found in our annual report on Form 10-K, which was filed with the Securities and Exchange Commission yesterday, March 15th, and can be found on the investor relations page of our website at www.catalystpharma.com. And with that, I will turn the call over to Pat.
spk02: Thanks, Allie. We enter 2023 focused on growing and diversifying our revenues, strengthening our position within the neuroscience space with our sights set on further expansion and serving our patient communities. We have all the elements in place for another strong year. We are well positioned to drive sustainable growth that aligns with our core mission to deliver value to our patients, healthcare providers, and shareholders. Finally, I thank all of our employees for their continued dedication and commitment to positively impacting patients' lives. At this time, I'd like to turn the call over to the operators to open the line for questions.
spk05: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. This confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. we can ask the participants who are in the question queue to please speak up so we can have a better understanding of your audio. Please hold while we poll for questions. Our first question comes from Joe Canzero with Piper Sandler.
spk09: Hey guys, thanks for taking the questions and congrats on the nice quarter. Maybe just two quick ones for me. around for depth. So you said there's about 1,000 unique patients since launch, and that's obviously over a period of about four years. But wondering what you could say that number suggests about the penetration into what you see as the total LEMS opportunity. And then a follow-up, Steve, I think you said there are some patients already on the 100-mig dose. Can you say what percent you think that is? And then what are your expectations around what percent of patients currently on 80-migs that would step up to 100 megs if that label is updated in the future. Thanks.
spk02: Jeff, do you want to take the first question, please? And then I'll turn it over to Steve. Sure.
spk04: Hi, Joe. The question about penetration of the total population, we feel the penetration is around 25% right now. Significant opportunity remaining because if you look at the total population of about 3,000 patients, And unfortunately, some of these patients pass away and then new patients are diagnosed. So, you know, while there's about 25% penetration, like I mentioned, very optimistic and confident about the continued growth sustainability.
spk02: Steve, do you want to take the 100 milligram?
spk03: Yeah. Joe, we haven't actually publicly disclosed the number of patients on the 100 milligram dose. because it requires the physician to work independently of catalysts to get authorization to move to that dose. It's not a very large number, but there's some patients who are on the 100 milligram daily dose. With regard to the number of 80 milligram patients, I really don't want to speculate on that. All I can say to you is that about 40% of the patients are on 80. We believe a portion will move to 100. and there are some patients on 60 who may move to 80 as well.
spk09: Okay, got it. That's helpful. Thanks for taking my question.
spk03: Thank you.
spk05: Thank you. Our next question comes from Charles Duncan with Kentor Fitzgerald.
spk07: Hi, this is Pete Stavropoulosan for Charles. Hi, patent team. Congratulations on all the progress for the quarter. I just have a couple of questions that relates to FICAMPA. You know, the first is, you know, can you discuss your strategy for reinvigorating the brand? And, you know, how can or will Catalyst leverage the company's current infrastructure for the FICAMPA franchise?
spk02: Great. Thank you. Jeff, do you want to take that? Reinvigorating the brand?
spk04: Sure. You know, I think first and foremost, our priority is to fully integrate the epilepsy franchise or the FICOMPA personnel. That's what we hope to do by mid-year. When we take over the sales and marketing May 1st, we are going to focus on applying resources to the physicians that are currently prescribing FICOMPA, the ones that are prescribing new to brands. There are about 6,700 targets that we'll be focusing all our resources towards, and that's how we've staffed our field force. So hopefully that gives you a little bit of a peek behind how we're going to do this. We'll be more prepared to share our business approach during our next conference call, earnings call in May.
spk02: Yeah, and as Jeff had pointed out, there's about a 45% overlap between the call points for per-daps and pi-compa. And we don't want to confuse things out of the gate, but when the transition is completed, we expect in the second half of the year that basically the reps for pi-compa and per-daps will actually carry both products.
spk03: Great. Thanks. Sorry. I want to add one comment about the medical sales liaisons as well. I mentioned during the earlier part of the call that we are adding up to six medical sales liaisons who will be doing a lot of efforts to educate the physician community on Ficompa, particularly the safe use of Ficompa.
spk07: All right, thanks. The second question I have is, you know, what's the potential for developing Ficompa in rare epilepsy indications?
spk02: Yeah, we are not, this is Pat. Thanks for the question. We're really not prepared to talk about that at this point. You know, we're right now just getting our arms around the program and the full opportunity to look at rare epilepsies. There was a paper published recently which Steve referred to in epilepsy, which is available online, I suggest. that you take a look at that. But I think we'll have a lot more to say when we have our first quarter call in May with regard to the other opportunities where Phi Kappa can be successfully used as a treatment of rare diseases.
spk03: One thing I also want to add to that, Phi Kappa has a very broad label for the treatment of epilepsies, and many of the rare epilepsies fall into that category. In other words, the patients exhibit the epilepsy characteristics that are consistent with the product label. So our MSL team will be educating the physicians on which specific types of genetic epilepsies that fall within the product label can be successfully treated with phycopen.
spk07: All right. Thank you. Thank you for taking our questions.
spk02: Thank you.
spk05: Thank you. Our next question comes from John Lee with Tris Securities.
spk06: Good morning. This is Les for June. Thank you for taking my questions. First question is for Jeff. Could you quantify how many antibody tests were provided and utilized by physicians, perhaps in 4Q, and how has that trended? And then specifically in the small lung cancer patient population, and what drivers would push for that additional testing?
spk02: Les, thanks for the question. I'll turn that over to Steve.
spk03: We haven't actually provided any specific numbers of patients who are treated with the antibody test. However, it is increasing significantly. We have visibility to how the test is being utilized. We buy that data from the test providers, and it has been increasing significantly.
spk04: And I'll add to that too, what we did see starting in the fourth quarter of 2021, you did see a significant increase in the number of VGCC tests done. And then you saw that number carry through 2022. So, you know, we're seeing consistent high levels of the VGCC tests that are done when compared to previous years. As far as the small cell patients, Our approach is to be working with the top small cell academic institutions or institutions and to put that in the protocol so that when a small cell lung cancer patient gets diagnosed that there's apparently a plastic panel that's done, which includes the BGCC antibodies. So that's our approach, more of a top-down approach.
spk06: That is helpful. Thank you for that. Perhaps with Steve, it appears the reasoning on the 100 milligram dose is primarily from patient feedback. Other than safety, what data do you plan to present to the regulators? And essentially, what does the higher dose impact your pricing strategy?
spk03: I'll let Jeff and Pat address anything about pricing. But With regard to the strategy, I'll just remind you that when Resurgi was on the market before the FDA removed it, it was approved for up to 100 milligrams. And so we will be using all the data that is in the Resurgi MDA as part of the basis of our supplemental MDA to increase the strength or to increase the maximum daily dose perhaps to 100 milligrams. And as I previously mentioned on the call, we also have a number of patients who are on the 100 milligram strength or taking 100 milligrams of Ferdaps per day, and all of that safety data will also be included. And again, as I said, all of that data as a whole, we believe constitutes a sufficient body of evidence to convince the FDA to let us apply for an increased maximum daily dosage of Ferdaps.
spk02: Unless, with regard to pricing, Remember, it is dose-related, and our typical adult patient is on about 60 milligrams per day, more or less. And our net price after gross to net discounts and rebates and what have you for that patient is around $375,000. So you could extrapolate from there with regard to... you know what the pricing might be.
spk06: Great. That's very helpful. And the last one for the team, I guess on the regulatory process in Japan, just kind of go over that if you could. And if all goes well, how soon can Daito enter the market in Japan and what's the strategy for the periphery countries? Thank you.
spk03: Well, I'm limited by what I can say because our partners don't disclose a lot to the public markets. I'll just generally go over the process that happens in Japan. As I said during the call, they're collecting safety data from their ongoing safety follow-up phase. Upon completion and collection of all that data, the next step is to file the NDA in Japan, which I mentioned will be in 2024. As an orphan drug, the typical review cycle time in Japan for an orphan drug NDA is about six to eight months, so I would anticipate that if their cycle time is on the average, that they should be approved toward the end of 2024, provided, of course, their NDA is acceptable for the Japanese authorities.
spk06: Thank you.
spk05: Thank you. Our next question comes from Scott Henry with Ross Capital Partners.
spk08: Thank you and good morning and congratulations on the strong year. A couple of questions. And I know you don't want to disclose a lot, but with regards to the three patent filings, do you know if there's a, or is there a first filer among those three?
spk02: Steve, you want to take that question? Sure.
spk03: The short answer to your question is yes, that's public information. It's on the FDA's website. The answer is that all three of them are first filers. In other words, they're all tied for first.
spk08: Okay, great. Thank you for that clarification. A couple other questions. With the shift from the 80 milligram to the 100 milligram dose, would you expect to see some revenue creep upward per patient? I mean, often higher doses... generates higher revenue per patient. Just want to make sure that is correct.
spk02: Scott, I'll turn that over to Jeff.
spk04: Yes, Scott. So we do anticipate the average daily dose will increase for our patients. I've mentioned it before. Our average daily dose is about 61 milligrams right now. And we do have feedback from health care providers and patients asking for, you know, that they feel they would benefit, the patient would benefit from being able to go above 80 if that was within the label. So with that, we anticipate our average daily dose to creep up over time significantly.
spk08: Okay, thank you. And then FICOMPA, I believe $130 million in revenues in 2023 guidance. As far as trajectory here, Should we just kind of allocate that over 11 months, or is there any trends we should expect there?
spk02: Well, we're in the process of a transition, Scott. And, you know, we expect the full integration to be completed by mid-year. And so I would expect that the runway will – by quarter sequentially increase over the course of this year, the first year of our ownership. Remember, it's a pretty mature product, been in the market for nine to 10 years and got a very established base. And we're looking to get the integration completed and then grow the product.
spk08: Okay, thanks for that color. And then, Pat, if I break out the FICOMPA revenue from your overall guidance, you get to 245 to 255, if I did my math correctly, for FURDAPs. Q4 was $60 million, and it sounds like Q1 is better than Q4, so it seems like... I guess the question is, would you say you're perhaps being conservative or are you expecting more of a flattening? It sounds like it's just being conservative.
spk02: For Ferdaps, you're talking about Scott? Correct. Yeah, I think that, you know, I think the trend will be typical as it has been. Remember last year's first quarter was impacted with the – with the resolution of the 11th Circuit Court when the approval for Resurgy pediatric indication was overturned. And a number of the Resurgy patients during Q1 of last year transitioned to Ferdep. So it's probably gonna be a difficult comparison for the first quarter. But as Jeff pointed out, we continue to enroll new patients in catalyst pathways that are naive to either product. And just continuation rates are down, and we want to continue to see that. And so we think that, you know, we're going to have a typical year quarterly, sequentially up each quarter.
spk08: Okay, great. And then just finally, just a couple, you know, clerical questions. First, the cash is significant. I guess I don't want to get in the business of predicting interest rates, but it sounds like you're probably generating around 4% on that for the interest income line. Is that a reasonable assumption? And staying on the income statement as well, as far as taxes, will you start to pay taxes at this point, that tax asset, how much more cover do you have there?
spk02: Your first question, Scott, was about where we've invested our remaining cash. And it's, you know, we've been very conservative and typically been in 90-day T-bills. And, you know, you're right. It's what a difference a year makes. You know, this time last year, we were getting about seven basis points on our investable cash. Today, I would say our blended yield right now in our 90-day team bills is somewhere between 4% and 5%. So you're right, it's going to be hard to predict going forward. But, you know, I think we're in a pretty good spot right now because, I do believe that we're going to generate a lot of cash this year, again, with Ferdaps and FICOMPA. Allie, maybe you can address the tax issue.
spk01: Yeah, regarding the tax issue, as we mentioned, our effective tax rate with 2022 is 21%. However, we fully utilize our federal funds. net operating losses, so we do expect a more normalized 23% to 25% rate in future periods. Yeah, I would say that starting mid-year last year, Scott, we were guiding that we anticipated a more normalized 25% tax rate going forward.
spk02: And that's going to vary according to, you know, based on, you know, some of the state taxes that we pay. And also, you know, option exercises can affect that as well.
spk01: Which for 2022 really is a better rate, but we can anticipate that will be the same for future years.
spk08: Okay, great. Thank you for taking the question.
spk02: Thank you, Scott.
spk05: Thank you. It appears we have no further questions at this time. With that, I would now like to turn the floor back over to Patrick McNanny for closing comments.
spk02: Thanks, everyone, for joining our call. We look forward to our next corporate update, and have a great day. Thank you.
spk05: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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