Q4 2022 Catalyst Pharmaceuticals Inc Earnings Call
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Speaker 3: As a reminder, this conference is being recorded. It is now my pleasure to introduce one of your hosts, Ali Grande, Chief Financial Officer. Please go ahead.
Speaker 4: Good morning, everyone, and thank you for joining our conference call to discuss catalyst fourth quarter and full year 2022 financial results and corporate highlights.
Speaker 5: Leading the call today is Patrick McEnany, Chairman and Chief Executive Officer. We are also joined by Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer, and Jeffery L. Carman, our Chief Commercial Officer.
Speaker 6: 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 our expected future results.
Speaker 7: which made it forward looking statements for purposes of federal security's laws.
Speaker 8: These statements relate to our current expectations, estimates, and projections, and are not guarantees of future performance.
Speaker 9: They involve risks, uncertainties, and assumptions that are difficult to predict and may prove not to be accurate.
Speaker 10: Actual results may vary from the expectations containing our four looking statements.
Speaker 11: before looking statements should be considered in conjunction with the
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Speaker 14: I time TR never that.
Speaker 15: The good it can here.
Speaker 16: 2022 Financial Resource and Corporate Highlights.
Speaker 17: Leading the call today is Patrick McAnany, Chairman and Chief Executive Officer.
Speaker 18: We're also joined by Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer and Jeffrey the Apartment, our Chief Commercial Officer.
Speaker 19: Further, for the Q&A session, we will also have Dr. Gary Ingenito, our Chief Medical and Regulatory Officer.
Speaker 20: 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.
Speaker 21: These statements relate to our current expectations, estimates, and projections, and are not guarantees of future performance.
Speaker 22: They involve risks, uncertainties, and assumptions that are difficult to predict and may prove not for the average.
Speaker 23: 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 22 annual report and Form 10-K .
Speaker 24: At this time, I will turn the poll over to Pat.
Speaker 25: Thanks, Allie, and welcome everyone to our fourth quarter in full year 2022 results conference call solid Despite Pantsboro cherry drunk
Speaker 26: I'm pleased today to highlight the progress we've made across our business throughout 2022 and now into the start of 2023.
Speaker 27: As we did in yesterday's press release, let me highlight several key points.
Speaker 28: 2022 is 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.
Speaker 29: The robust results capped an important year of transformation as we successfully executed our strategic initiatives across all segments of the business.
Speaker 30: This included attaining a favorable resolution of the PAP litigation relating to the Risurgi along with the U.S. rights underscoring the strength of the FERDAP's intellectual property portfolio.
Speaker 31: the receipt of a positive US court decision supporting FURDAP's orphan drug exclusivity.
Speaker 32: the approval of an expanded pediatric medication for pert apps.
and the recent acquisition of Ficomple.
With our sights set on further expansion, these accomplishments add a considerable strength to our neuroscience presence and confidence that we can accelerate the company's long-term growth strategy. Thank you.
Important to note, FERDAPs continues its strong performance and remains the cornerstone of our success.
We are pleased with the strong demand and growth for FERDAPs 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 Med 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 of 2022, or 80 cents per basic share and 75 cents per diluted share, a 110% increase compared to $39 million, or 38 cents per share basic.
and 37 cents 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.
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Our full year 2022 total net revenue for $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 cent per diluted share in 2021.
Further, non-GAF met 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.
were 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 four year 2023 total net revenues of between $375 million and $385 million, representing a 75 to 80% increase in total net reviews 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 by COPPA 2023 net revenues to be approximately $130 million.
having closed the acquisition of FlyCompler in late January of this year.
Additionally, we continue to expect that PICAPA will be accretive to our EBITDA and UPS 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. rights to PICAPA from A-Side Company Limited.
We are extremely pleased to have delivered on this important objective for 2022. PYCOMPA not only broadens our commercial product portfolio with the first and only non-competitive AMPA receptor antagonist for epilepsy, but also adds a growing revenue base, further augmenting our already strong revenue and earnings growth.
of curdips. More importantly, the addition of Playcompo serves as a complementary growth driver and a 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 PICOMPA U.S. leadership and expect to complete the full transition of PICOMPA activities by mid-year 2023. And we look forward to the future onboarding.
into the Cata Los family, many of the ASI employees who have been responsible for the success of the Piscampa 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. So that's that first secret
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 orphan drug market exclusivity. Additionally, we were granted three new patents.
and ended the year with six FDA orange booklisted patents that go out to 2037, which we believe supports the product's long-term durability.
We remain confident about the strength of FERDAP'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 cut mitigation other than to say that we intend to vigorously defend and prosecute any infringers of our intellectual property rights related to production.
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 and Fortune's 2022 Top 100 Small Companies, and being honored as BIO Florida'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 biopharmaceutical 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 Del Carmen, our Chief Commercial Officer, who will provide an update on our commercial activities. Thanks, Pat, and good morning, everyone. 2022 was a very successful year for Catalyst, as well as the LENS community.
First, we are very proud to announce that over 1,000 unique patients have now received the FURDAP enrollment from launch to date, which is a tremendous milestone for LEM patients in the United States.
We are very pleased with the full year FERDAS net sales of $214 million, representing a 52% increase year over year, driven by consecutive quarterly FERDAS net product sales growth.
In Q4, net FERDAP 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 Ferdapp business is solid.
Operational excellence chose new patient starts.
maintain favorable prescription approval rates of greater than 90% across all payers, government or private commercial insurers,
continued high compliance of 90% and lower discontinuations.
Nieve new enrollments in 2022, not including LEM patients that transition from Resergy to FURDAS. Nieve new enrollments in 2022, not including LEM patients that transition from Resergy
We're 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, in accessing foundation assistance.
have an average copay of less than $2 per month.
As Pat mentioned, we have forecast FERDAC net revenues of $245 million to $255 million.
in 2023.
We are confident that our strategic growth initiatives will drive organic growth moving forward.
LEM's 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 LEM patients and lead to more patients being eligible for treatment with Burt abs.
Additionally, we will increase the share of voice of thoracic oncologists through the newly hired oncology thought leader, Leadon.
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.
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 lance patients.
that are not yet on FERDAS, which contribute around 50% of new patient enrollment 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 Phi-Comple, 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.
By COPPA net revenues for 2023, our forecast would be $130 million for approximately 11 months of sales.
Catalyst will capitalize on proven commercial capabilities to enhance the growth potential of phytoplof and established 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 statistical Gothenburg- park luck.
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.
Panelists is committed to continue collaboration with the rare disease and LEMs advocacy and new partnerships with epilepsy advocacy groups. We will continue to ensure access to FERDAS for LEMs and FICOMPA for appropriate epilepsy patients through established assistance programs.
In closing, we are very optimistic about the organic growth potential for FERDAS and thrilled with the addition of a best-in-class epilepsy franchise.
demonstrated operational excellence positions 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 Fertac'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. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer for an update on R&D activities.
the entire team a catalyst for their unwavering commitment to patients and look forward to a successful 2023. I will now turn the call over to Dr. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer for an update on R&D activities. Thanks, Jeff.
Our clinical development and regulatory strategy for FERDAPs continues to focus on expanding access to all LEMs patients, enhancing the FERDAPs patent to stake to maximize its commercial potential and to integrate the newly acquired phytoploproduct 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...
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 doses to 100 milligrams to optimize therapy and this planned supplement if approved will help those patients.
The previously acquired Resurgue Rights gave us access to safety and efficacy data for those patients treated at 100 mg 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 mg daily dose of Japardax.
And we believe that the combined dataset constitutes an acceptable basis for seeking a 100mg maximum indicated daily dose of preferred ops. 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 Floridaps to treat pediatric lens patients.
During the first quarter of 2022, we filed this supplemental MBA and it was approved by the FDA on September 29, 2022.
With the approval of this supplemental NDA, all pediatric patients aged 6 and above and all adults now have access to Prodaps 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 LEN patients have access to products.
Regarding our global expansion, our sub-licency partner, Daito Pharma in Japan, has completed enrollment in their HURDAPS Phase III 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 we predict a RECAP in the next Especially in the case of Delaware pipeline, we are
only approved amphoreceptor antagonist or inhibitor. Amphoreceptors 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 amphoreceptors.
Hyperactivity induced by seizures might also alter AMPA receptor function and duration of excitation. Hyperactivation of AMPA receptors is highly neurotoxic, adding to secondary damage induced by seizures and electrogenesis. Like HAPPA, as an AMPA receptor antagonist, can actually reverse these effects and improve seizure control.
Bi-copter 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 reviewed from a group of European neurologists treating rare epilepsy working under the framework of the Network for Therapy in Rare Epilepsies reported in the widely respected journal Epilepsia how Ficopa was capable of significantly reducing seizures in patients with epilepsy that resulted from specific genetic mutations.
Of the 137 patients treated with parempanel, 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 of 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 FERDAS by those patients. Oncologists that already treat LEMs in their practices have found that FERD...
These efforts will help broaden the use of fur ducts to treat lambs across additional medical specialties including oncology.
With the acquisition of Phycopha, Catalyst also plans to add up to six additional MSLs in the U.S. to support the Phycopha product. Phycopha 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 to treat epilepsy and to also address any questions and concerns that these physicians may have about using phycophil to treat epilepsy patients. As a service to the physician community, CataList provides support for the development of continuing medical education or CME programs that are part of the formal...
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 Ferdex, and on March 1st of this year, Catalyst initiated legal proceedings against all of them to protect and enforce our intellectual property rights.
look at statements. Regarding Ficopa, there are two patents listed in the FDA's orange book for the Ficopa 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, and which contends that it should be June 8, 2026.
Due to the approximately 13 additional months it took the DEA to determine that Viscompa 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 23, 2025.
which Cadalyst could still challenge if we feel it is appropriate to do so. The other Orange Book listed patent claims the commercial personal form of Parabola for Ficompa, and this patent expires on July 1, 2026. Cadalyst is evaluating whether or not to enforce this patent at this time, and upon completion of that evaluation will inform the investment community on our plans regarding this patent.
Moving on to business development, Pat described a significant portfolio expansion of the acquisition of phycopha 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...
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 Elisa Grano. Thank you. We are very pleased with our financial results for the fourth quarter and full year 2022 and remain steady in our performance. We reported gap net income for 2022.
83.1 million or 80 cents per basic and 75 cents per annual share. A 110% increase year over year compared to the gap net income of 39.5 million or 30 cents per basic and 37 cents per annual share. Full net revenue for 2022, principal use for product approach revenue net.
for 2042 is due to an increase in staff 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 was for the end of 2022.
Non-gab net income for 2022 was $113.99 for $1.10 per basic and $1.02 per direct share.
which excludes from GAAP net income of $83.1 million, subgrade compensation expense of $7.9 million, depreciation of $141,000, commoditization of $1.1 million, and an income test provision of $21.6 million.
This compares to non-GAAP net income for 2021 of $58.9 million for $0.57 per basic and $0.55 per dilute share, which excludes from GAAP net income of $39.5 million, sub-base compensation expense of $6.1 million, depreciation of $192,000.
million for 2022 increase when compared to 21.9 million for 2021.
For both years, 2022 and 2021, custom sales was approximately 16% of product revenue net and consistent principally of royalties due to our further license. Research and development expenses were $19.28 million in 2022 compared to $16.9 million in 2021. Over the past year, virtual reality has improved the value of independent software systems
in the third quarter of 2022 upset by an overall decrease in RMB expenses. RMB expenses decreased the 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 but don't seeosis in the potential future.
and amortization of intangibles, a foreign connection with the research year precision. Doing the right of course is consistent.
The set percentage of total operating expenses as GNA expenses decreased to 52% for 2022 compared to 56% for 2021. As reported, we end 2022 with cash on equivalent 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 FICOMPA without any diluted finance.
We believe our strong cash sufficient continues to allow us the financial flexibility to execute on our current programs and to this initiative.
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 bank.
More detailed information and analysis of fourth quarter and third year 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 15, and can be found on the investor relations page of our website.
at www.caldisfarma.com. And with that, I will turn the call over to Pat. Thanks, Ali.
We entered 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.
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.
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. The 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.
while we call for questions.
Our first question comes from Joe, from Joe Kinzaro with Piper Sendler. Hey guys, thanks for taking the questions and congrats on the nice quarter. Maybe just two quick ones for me.
around FURDAPs. So you said there's about a thousand 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 LEM opportunity. And then a follow-up Steve, I think you said there are some patients already on the 100 mg dose.
and then I'll turn it over to Steve. Sure. 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 the new patients are diagnosed. So while there's about 25% penetration, like I mentioned, very optimistic and confident about the continued growth for sustainability.
Steve, you want to take the answer? Another great question. Joe, we haven't actually publicly discussed the number of patients on the 100-milligrown dose because it requires the physician to work independently a catalyst to get authorization to move it to that dose. It's not that it...
a very large number, but there's some patients who are on the 100 milligrams 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. Okay. Got it. That's helpful. Thanks for taking my questions. Thank you.
Thank you. Our next question comes from Charles Duncan with Kent or Fitzgerald. Hi, this is Pete Stebroblison for Charles. Hi, patent team. Congratulations on all the progress for the quarter. I just have a couple of questions that relates to Viacompa. The first is, can you discuss your strategy for reinvigorating the brand?
And how can or will Catalyst leverage the company's current infrastructure for the Phi Kappa franchise? Great, thank you. Jeff, do you want to take that? Agreed. Invigorating the branch? Sure. You know, I think first and foremost, our priorities to fully integrate the epilepsy franchise
FICOMPA, the ones that are prescribing new to brand. There are about 6,700 targets that we'll be focusing all of 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...
our business approach during our next conference call, during Scalding Bay.
And as Jeff pointed out, there's about a 45% overlap between the call points for FURHAPS and PICAPA. 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 Phi Kappa and Perdaps will actually carry both products.
Great. Thanks. Sorry. I just 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...
particularly the state case of bicopa.
particularly the state use of the company.
All right, thanks. The second question I have is, you know, what's the potential for developing Pricompa in rare epilepsy indications? 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 – Ok.
the Program and the full opportunity to 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 that where Ficopa could be successfully used as a treatment over your diseases.
One thing I also want to add to that, Clotopa has a very broad label for the treatment of epilepsy 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 phytophan. All right, thank you. Thank you for taking our questions. Thank you. Thank you. Our next question comes from John Lee with Tris Securities.
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? Les, thanks for the question. I'll turn that over to Steve.
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.
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 HCC tests done. And then you saw that number carry through 2022. And then you saw the increase in the number of HCC tests done in 2021. And then you saw the increase in the number of HCC tests done in 2021.
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... And as you know in March, experimental research with the ALARD credit christian technologies US association of supervised remotely- reluctant clinicians work to monitor
gets diagnosed that there's a peri-meoplastic panel that's done, which includes the BGCC antibodies. So that's our approach, and more of a top-down approach. That is helpful, thank you for that. Perhaps with SEVA, 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...
What does the higher dose impact your pricing strategy? 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 of
to convince the FDA to let us apply for an increased maximum daily dosage of Bredaps.
Unless with regard to pricing, you know, remember it is dose related and our typical patient is on about six, 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 three hundred and seventy five thousand dollars. So, you know, you could extrapolate from there with regard to
is around $375,000. So, you know, you could extrapolate from there with regard to, you know, what the price you might be.
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 DITO enter the market in Japan and what's the strategy for the periphery countries? Thank you.
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. They're collecting data on completion and collection of all that data.
The next step is to file the MDA in Japan, which I mentioned will be in 2024. As an orphan drug, the typical review cycle time in Japan for an orphan drug MDA 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, providing of course their MBA is acceptable for the DAPA's authorities. Thank you. Thank you. Our next question comes from Scott Henry with Ross Capital Partners.
the average that they should be approved toward the end of 2024, provided of course their MBA is acceptable for the Daphnis authorities. Thank you. Thank you. Our next question comes from Scott Henry with Ross Capital Partners.
Thank you and good morning and congratulations on the strong year. Couple questions. Thank you Scott. 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?
Dave, you want to take that question? Sure. 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.
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.
Scott, I'll turn that over to Jeff. 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 healthcare 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.
Okay, thank you. And then FICOMPA, I believe $130 million in revenues in 2023 guidance. As far as trajectory, should we just kind of allocate that over 11 months or is there any trends we should expect there?
Well, we're in the process of a transition, Scott. And we expect the full integration to be completed by midyear. And so I would expect that the runway will.
by quarter sequentially increase over 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 ten years and Got a very established base
and we're looking to get the integration completed and then grow the product. Okay, thanks for that color. It's going to impact if I break out.
and we're looking to get the integration completed and then grow the product. Okay, thanks for that color. In impact, if I break out the Ficompa,
revenue from your overall guidance. You get to 245 to 255 if I did my math correctly.
for FERD apps. 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. For FERD apps you're talking about Scott? Correct.
Yeah, I think that the trend will be typical as it has been. Remember last.
Last year's first quarter was impacted with the resolution of the Eleventh Circuit Court when the approval for Resergy pediatric indication was overturned. A number of the Resergy patients, you're in Q1 of last year,
transition to FERDEP. So it's probably going to be a difficult comparison for the first quarter.
But, you know, as Jeff pointed out, we continue to enroll new patients in CataLose 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 of quarterly, sequentially up each quarter.
Okay, great. And then just finally just a couple.
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 be, you know, will you start to pay taxes at this point? That tax asset, how much more cover do you have there? Your first question, Scott, was about, um,
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 2018 bills is somewhere between 4 and 5%. So it's-
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 Fertabst and Pyshompa.
Allie, maybe you can address the tax issue? Yeah, regarding the tax issue, as we mentioned, our effective tax rate for 2022 is 21%. However, we fully utilize our federal net operating law system to provide a better understanding of the tax rate.
operating losses, so we do expect a more normalized 23 to 25 percent rate in future periods. Yeah, I would say that starting midyear last year, Scott, we were guiding the state of the last 3,000UAECC
that we anticipated a more normalized 25% tax rate going forward. And that's going to vary according to, you know, based on some of the state taxes that we pay. And also, you know, auction exercises can affect that as well.
which for 2022 really is a better rate, but we can anticipate that will be the same for future years. Okay, great. Thank you for taking the question.
to really set a rate, but we can anticipate that will be the same for future years. Okay, great. Thank you for taking the question. Thank you, Scott.
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 McNaney for closing comments. Thanks everyone for joining our call. We look forward to our next corporate update and have a great day. Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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