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spk03: Hello, and welcome to the Catalyst Pharmaceuticals third quarter 2021 earnings call and webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Ali Grandi, CFO. Please go ahead.
spk01: Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's Third Quarter, 2021 Financial Results and Corporate Highlights. Leading the call today, we have Patrick McEnany, Chairman and Chief Executive Officer. We are also joined by Dr. Steven Miller, Chief Operating Officer and Chief Scientific Officer, and Jeffrey Del Carmen, Chief Commercial Officer. For the Q&A session, we'll also have Dr. Gary Ingenito, 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. These statements relate to our current expectations, estimates, and projections and are not guarantees of future performance. They involve risk, uncertainties, and assumptions that are difficult to predict and may prove not to be accurate, especially in light of the effects of COVID-19. Actual results may vary. Before-looking statements should be considered only in conjunction with the detailed information containing our SEC filings, including the risk factors described in our 2020 Annual Report No. Form 10-K. At this time, I'd like to turn the call over to Patrick.
spk05: Thanks, Allie. Good morning, everyone, and thank you for joining us today for Catalyst's third quarter results and update call. I'm very pleased to report that we delivered record FERDAPS revenue results for the third quarter ending September 30th. We generated net FERDAPS revenues of $35.9 million, an increase of 23% versus the third quarter of 2020. Burnout revenues for the nine-month period were $99.7 million as compared to $87.9 million for the nine months last year, which represents a 13% increase year over year. At this time, I anticipate continued organic growth through the end of this year and for the foreseeable future. Net income before income taxes for Q3 2021 was $14.1 million, a 20 percent increase when compared to $11.7 million for the third quarter of last year. We reported GAAP net income of $10.3 million for the third quarter of this year, or 10 cents per basic and diluted share. We entered the quarter with $174.8 million in cash and short-term investments, further supporting our long-term growth strategy to diversify through reinvestments in our business or external growth opportunities. These results also highlight the strength of our commercial capabilities and resilience as we continue to execute throughout the current environment. Allie will have more to provide during her financial presentation. Our share purchase program continues with 949,746 shares purchased in the open market during the third quarter. And since inception in March of this year, through the end of the third quarter, we have purchased 1,749,746 shares at an average price of $5.15 per share. Notwithstanding our success in treating many Lynch patients, As of now, we have only reached about 25% of the estimated 3,000 U.S. LEMS patients. We remain confident of the progress of our commercial team is making in evolving the market for the PERDAPS brand. We continue to make substantial investments in PERDAPS, focusing on expanding reach to targeted healthcare specialists, most recently to oncologists and general neurologists. providing resources to help shorten the diagnostic journey for LIMS patients, and support through patient and healthcare provider education programs. Our focus on commercial execution excellence remains a top priority to us, as well as to the patients we serve. Jeff will provide additional information on our commercial progress shortly. Importantly, we've made substantial advancements related to Ferdapp's exclusivity and commercial potential in the U.S. Most notable was the receipt of a positive decision from the 11th Circuit Court of Appeals supporting the orphan drug exclusivity for Ferdapp's tablets, 10 milligram, for treating limbs patients in the U.S. We are currently extremely pleased with the court's decision While there is a 45-day period for which an in-block hearing request can be submitted to the court related to the court's decision, we remain confident in our position and look forward to when we can fully recognize our exclusivity. Our priority has always been and will continue to be on addressing patients' needs first. We are well prepared to do everything we can to ensure that all LIMS patients will have uninterrupted access to amifapidine for treating their condition. We also continue to make important progress in bolstering our intellectual property for PRDAPs. Currently, two patents have been issued that extend the life of our intellectual property portfolio to 2034, both of which are listed in the Archbook. We have additional patents pending to further strengthen the IP portfolio, adding to our commitment to protect the innovation and the product's commercial potential. As we continue to execute our commercial-related initiatives, we are taking a very targeted approach towards our clinical development programs. We are working on expanding the label for FerdEvs as we plan to see U.S. approval to include pediatric limbs patients. which we believe numbers are 10 to 15 children. This program further underscores our continued commitment to providing an important treatment option for LIMS patients of all ages. We're also continuing our efforts to expand the global footprint for PROTEPs beyond the U.S., Canada, and Japan. Steve will have more to add shortly regarding activities outside the U.S. In addition, having objectively and thoroughly evaluated the clinical development timeline, regulatory path, and commercial viability for MuskMG, we have elected to end the program and concentrate our R&D efforts in other areas. We believe having a more focused approach towards our development programs will drive the greatest value for the company and enable us to better utilize our resources to pursue value-creating opportunities to expand our focus beyond FNFs. During the quarter, we made considerable progress in our efforts to build a more diversified portfolio that aligns our growth strategy and priorities, including the potential to expand the breadth and depth of our pipeline. With a robust process in place during the third quarter of 2021, we engage in extensive due diligence activities on a potential acquisition that fit our strategic objectives. However, after a thorough and extensive assessment of the acquisition candidate, we elected not to further pursue this opportunity. Coupled with our strong balance sheet, we are in an excellent position to take advantage of opportunities that meet our specified criteria and commitment to pursue rare disease opportunities and are very encouraged about projects that are currently under review. Our quarterly achievements demonstrate continued performance excellence, supported by several key strategic decisions that have positioned Catalyst firmly for the future. In saying that, we are excited about the path ahead as we continue to execute across all priorities to drive sustainable growth for the long term. Finally, there are a couple of other points worth noting. First, we achieved these results during a period when Catalyst and most of our peers were affected to some degree by the Delta variant of COVID-19. As this variant is abating, we are beginning to see a more normalized pattern of practices with healthcare providers and patients. Lastly, while addressing the COVID-19 effects, I want to reiterate that as we have previously stated, our supply chain is rock solid with qualified redundancies throughout our supply chain. Now I will turn the call over to Jeff DelCarmen, our Chief Commercial Officer, who will provide further highlights of our commercial execution for the quarter.
spk06: Jeff DelCarmen Thanks, Pat, and good morning, everyone. As Pat mentioned, Q3 net Ferdap sales were $35.9 million, which represents 23.1% growth quarter versus the same quarter last year, 6.7% growth versus Q2 2021. We are extremely proud of the continued strong performance by the entire Catalyst organization. Strong net revenue in Q3 was driven primarily by steady new patient enrollments, continued favorable reimbursement dynamics, and stable discontinuation rates. While we continue to see some sporadic COVID-19-related slowdowns in new patient starts due to delays at the point of care between diagnostic testing and initiation of treatment, Q3 new patient enrollments were still 26% higher this quarter versus the same quarter last year and slightly higher than Q2 2021. Our strong patient persistency resulted in continued low 90-day discontinuation rates of less than 15%. In October, net new patients were the highest monthly total in 2021, a result of consistent, naive deferred APPS new enrollments, adult LEMS patients restarting deferred APPS, and low discontinuation rates. We are proud that around 800 adult LEMS patients have received the FERDAPS prescription since launch. However, Catalyst is focused on the significant remaining opportunity to help all adult LEMS patients. We are confident that our continued heavy investment in patient resources will shorten the diagnostic journey for LEMS patients and enable Catalyst to serve the significant number of remaining LEMS patients sooner. approximately 3,000 unique undiagnosed potential patients have opted in to receive useful information regarding LEMS, an increase of nearly 1,000 since our last earnings call. Furthermore, we continue to meet key milestones in the development and execution of our oncology LEMS strategy. Approximately 50% of LEMS patients are thought to be tumor LEMS patients, with the vast majority having small cell lung cancer. Therefore, we believe that oncology is a key element of our future growth. After completing a thorough assessment of the market, conducting ad boards with oncology thought leaders and ongoing market research, we are excited to launch our non-personal promotion to thoracic oncologists in Q4. Engagement with this segment of the market has resulted in early positive indicators that the strategy put into motion will yield more patients with a proper diagnosis of LEMS, and accelerate the opportunity to receive treatment for this disease. We continue to partner with key professional societies like AA and EM, which provide continuing education for all levels of neuromuscular healthcare providers. We had the opportunity at the recent annual meeting to engage with their constituency and educate clinicians about LEMS in new and innovative ways, helping to identify atypical LEMS adult patients. Through healthcare provider education, we expect more patients will benefit from a correct and timely LEMS diagnosis. Our LEMS, I'm sorry, our Catalyst Pathways patient services team remains dedicated to supporting the needs of adult LEMS patients, caregivers, and healthcare professionals, as well as providing educational resources regarding LEMS and FERVAPs In addition, Catalyst Pathways has numerous types of financial assistance programs to help patients with their out-of-pocket costs. Patients enrolled in Catalyst Pathways, including those who are covered by Medicare and accessing foundation assistance, have an average copay of less than $2 a month. Prescription approval rates remain over 90% across all payers, government, or private commercial insurers. Catalyst Pathways patient services team also connects patients to community and advocacy resources, such as patient support groups. In closing, we are pleased with our performance in Q3 and are excited about the significant opportunity ahead to help all adult LENS patients. We are confident that the strategies and tactics we have put in place will deliver sustained growth in Q4 and beyond. I want to thank the entire team at Catalyst for their unwavering commitment to the LENS community. 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.
spk04: Thanks for the commercial update, Jeff. I'll now provide an update on our clinical pipeline and product development efforts. We continue to make important progress with our development programs for FERDEPs, including advancing our plans for developing a long-acting formulation of amethylampronine phosphate in order to provide an improved dosing experience that is a more convenient option for patients and provides enhanced consistency in its therapeutic effect. Plans are underway to initiate an additional pharmacokinetic study in the first quarter of 2022 to study the drug release and absorbance characteristics of the most recent long-acting candidate formulations. Our design efforts have been guided by input from patient and physician panels regarding the desired performance characteristics of a long-acting version of FERDEPs. We believe the target characteristics of our long-acting formulation of amifampradine phosphate will address the needs of the LEMS patient community as we continue to execute on our plans to advance this development program. In alignment with our commitment to provide a treatment for all LEMS patients, we are now preparing a supplementary NDA submission package for the treatment of pediatric LEMS with FERDEPs. We anticipate filing this supplement with the FDA in the first quarter of 2022. Catalyst has all the required data, including all necessary safety data, to file a complete submission for this label expansion. The preparation of this supplement is a high priority for Catalyst as we remain committed to advancing our efforts to expand the use of FURDAP so that we may be able to provide all LEMS patients with an approved treatment option. Now I would like to provide an update on the MUSK-MG program. As previously announced, Catalyst submitted plans, including a protocol, for a new clinical trial for the symptomatic treatment of MUSK at Mycenae Gravis, or MUSK-MG, to the agency for their review and comment. Having received the agency's comments, we convened an advisory board meeting during the third quarter consisting of key opinion leaders and experts for input and options for the MUSK-MG development program. some physicians that had experience using Ferdaps to treat MUSK-MG in our most recent trial. After an in-depth evaluation of the feasibility and measurability of study endpoints for this indication, as well as the input from the agency and advisors that was received, we have concluded that the universal use of Ferdaps as a first-line therapy for MUSK-MG is unlikely, and therefore we have decided to put off further development plans at this time. However, for those patients that currently receive FURDAPs to treat their MUSK-MG symptoms, we will continue to support them through investigator-initiated programs in accordance with agency regulations. We continue to make valuable progress in increasing healthcare provider awareness of LEMS through our medical affairs programs. An accredited continuing medical education, or CME, course about LEMS is now available through Medscape. To date, over 4,600 mostly healthcare provider learners have viewed the course, and as of this October, 1,338 licensed healthcare providers have taken the CMU test. Our medical science liaisons also recently completed hosting several neuromuscular medicine fellows from various academic medical centers for another Catalyst-sponsored hands-on training session on LEMS given by neuromuscular experts earlier this month. Previous sessions, like this one, have received strong positive feedback on their ability to raise awareness among fellows of the diagnostic challenges with LEMS. Now I would like to provide an update on our ongoing global expansion initiative. As we previously announced in June, we partnered with Daito Pharma for the development and commercialization of FURDEPs for the treatment of Lambert-Eaton Myosinic Syndrome in Japan. Daito has made great strides initiating development activities, including consulting with the Japanese Pharmaceuticals and Medical Devices Agency to confirm clinical study parameters and requirements to obtain regulatory approval. As a result of their efforts, DITO is preparing their clinical trial notification and anticipate the small-scale Phase III clinical trial will be initiated in 2022. Catalyst continues to support DITO in preparing for the clinical activities by supplying clinical trial materials as well as collaborating with DITO in its efforts to obtain required documentation for the Japanese regulatory authorities. We have made significant progress on developing an intellectual property estate to extend the market exclusivity for FERDEPs. As of the third quarter 2021, we have two patents listed for FERDEPs in the FDA's Orange Book, which extends the IP portfolio to 2034. We have several other pending patents related to the use of FERDEPs filed with the US Patent and Trademark Office and anticipate that they may issue later this year or in early 2022. In addition to the US, FERDEPs currently has data exclusivity in Canada out to 2028, And in Japan, we expect FERDAPs will be granted 10 years of market exclusivity upon approval in that market. We will continue to seek opportunities to enhance the portfolio estate to further protect the market exclusivity for FERDAPs and to expand the FERDAPs market geographically. During this quarter, we advanced our objectives to expand our portfolio of rare disease treatments beyond FERDAPs. As Pat mentioned, we continue to actively evaluate new products or other kinds of transactions to expand both Catalyst product offerings and or our research and development pipeline. Our teams are actively and vigorously engaging in the process as we look for worthwhile prospects where we can utilize our expertise, resources, and know-how to expand our programs and drive growth. With a very efficient approach in place, we are enthusiastic about the path ahead and confident in our ability to identify the right opportunities to maximize our capabilities and resources. I will now turn the call over to Allie Grandy, our Chief Financial Officer, to review our financial results.
spk01: Thanks, Steve. We are very pleased with our financial results for the third quarter. As reported, we ended the quarter with cash and investments of $174.8 million and no funded debt. We believe this allows us the financial flexibility to advance our programs and support our strategic initiative of acquiring earlier stage opportunities and innovative technologies to enable growth and value creation. Total net revenues for the third quarter of 2021 were 36 million, a 22.6 increase when compared to total revenues of 29.3 million for Q3 20. DESPITE THE CONTINUED CHALLENGES OF COVID-19, TOTAL FURTHER PRODUCT REVENUE NET WAS $35.9 MILLION FOR THE THIRD QUARTER OF 2021, A 23% INCREASE OVER NET PRODUCT REVENUE OF $29.2 MILLION FOR THE THIRD QUARTER IN 2020. NET INCOME BEFORE INCOME TAXES FOR Q3 2021 14 MILLION AND APPROXIMATELY 20% INCREASE WHEN COMPARED TO 11.7 MILLION FOR Q3 2020. WE REPORTED GAP NET INCOME OF 10.3 MILLION FOR Q3 2021 FOR 10 CENTS PER BASIC AND DILUTED SHARE. FOR Q3 2020, WE REPORTED GAP NET INCOME OF 43.3 MILLION OR 42 CENTS PER BASIC AND 41 CENTS PER DILUTED SHARE. However, these figures are not comparative as the third quarter of 2020 benefited from the reporting of a one-time non-cash deferred tax asset of approximately $31.6 million upon reversal of the related valuation allowance. Our effective tax rate in the third quarter of 2021 on an annualized basis was 24.3% as compared to 2.8% in the third quarter of 2020. While in 2020, we benefited from the use of our federal net operating losses, in 2021 and future periods, we expect that we will benefit from the use of our deferred tax assets, primarily relating to state NOLs and the orphan drug tax credit, although those are subject to certain limitations, resulting in a more normalized tax rate. Because of the significant effect of the one-time reporting of our deferred tax asset in the third quarter of 2020 compared to the third quarter of 2021, we believe that the non-GAAP measures we presented in yesterday's press release provide a more useful comparison of our resource of operations for the third quarter of 2021 versus the third quarter of 2020. Non-GAAP net income for Q3 21 WAS 15.6 MILLION, OR 15 CENTS FOR BASIC, AND 14 CENTS FOR DILUTED SHARE, WHICH EXCLUDES FROM GAP NET INCOME SUB-BASE COMPENSATION EXPENSE OF 1.5 MILLION, DEPRECIATION OF 31,000, AND THE INCOME TAX PROVISION OF 3.7 MILLION. THIS COMPARES TO NON-GAP NET INCOME FOR Q3 2020 OF 13.2 MILLION, OR 13 CENTS PER BASIC, AND 12 CENTS PER DEBIT SHARE, WHICH EXCLUDES FROM GAP NET INCOME, STOCK-BASED COMPENSATION OF 1.5 MILLION, DEPRECIATION OF 30,000, AND AN INCOME TAX BENEFIT OF 31.6 MILLION. THE ABOVE REPRESENTS AN ALMOST 18% INCREASE OF NON-GAAP INCOME YEAR-OVER-YEAR FOR THE THIRD QUARTER. RESEARCH AND DEVELOPMENT EXPENSES WERE 4.5 MILLION THE THIRD QUARTER OF 2021 COMPARED TO 3.7 MILLION FOR THE THIRD QUARTER OF 2020. AND THE EXPENSES REMAIN CONSISTENT AT 20% AND 21% OF TOTAL OVERRATING COSTS FOR THE THIRD QUARTER OF 2021 AND THE THIRD QUARTER OF 2020, I'M SORRY, RESPECTED. WE EXPECT THAT RESEARCH AND DEVELOPMENT EXPENSES WILL CONTINUE TO BE SUBSTANTIAL IN 2021 AND BEYOND as we advance the developments of a law-enacting formulation program for FERDEPs and continue our expanded access programs. In addition, we expect R&D will also increase in future periods if we successfully execute on our strategic initiatives to acquire or in-license innovative technology platforms and or earlier stage programs in other therapeutic areas outside of neuromuscular disease. STNA expenses. FOR THE THIRD QUARTER OF 2021 TOTAL 12.2 MILLION COMPARED TO 10 MILLION IN THE THIRD QUARTER OF 2020. SG&A EXPENSES DECREASED SLIGHTLY AS THE PERCENTAGE OF TOTAL OPERATING EXPENSES TO 55% FOR THE THIRD QUARTER IN 2021 COMPARED TO 57% FOR THE THIRD QUARTER OF 2020. WE EXPECT THAT SG&A EXPENSES WILL CONTINUE TO BE SUBSTANTIAL IN 2021 as we continue our efforts to increase revenues from furloughs and take steps to further expand our business. More detailed information and analysis may be found in the company's quarterly report on Form 10-Q, which was filed with the Securities and Exchange Commission yesterday, November 9, and can be found on the investor relations page of our website at www.catalystpharma.com. And with that, I'll turn the call over to Pat.
spk05: Thanks, Allie. Catalyst continued to demonstrate resilience and strong execution in the third quarter of the year, providing a very strong foundation for the company as we make progress in our business development activities and look to build a portfolio of rare disease marketed products and or other clinical programs. Finally, I'd like to thank all of our employees have each demonstrated a dedication of making a positive impact on patients' lives. This would not happen without their passion and commitment to serving the LIMS community. This ends our prepared remarks. We will now open the call for questions.
spk03: Thank you. We'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate the line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. One moment, please, while we poll for questions. Our first question today is coming from Charles Duncan from Cancer Postural. Your line is now live.
spk08: Yeah, hey, good morning, Pat and team. Congratulations on a nice quarter of performance. Thanks for taking our questions. I had one on commercial, one on pipeline, and one on strategy. Perhaps I'll start with the commercial. Regarding Ferdinand's growth drivers in 22, not really asking for guidance here, but it might be nice to know whether or not you'd be comfortable providing guidance in 22 later in a few weeks, maybe with the start of 22. But more importantly, when you think about the growth drivers for 22, what is the key factor that you're focused on? Is it increasing awareness, or is it increasing breadth or depth of prescribers?
spk05: Yeah, so your first question, Charles, is as far as giving guidance, as we go through the process of developing our budget for next year and our forecast, and hopefully looking at this pandemic from the rear view mirror. I think perhaps early in Q1, we might feel comfortable in giving guidance, I think. So that's our hope and desire is that we can give some revenue guidance at the beginning of the year, the new year. With regard to the key growth factors, I'll let Jeff address that.
spk06: Thanks, Charles, for the question. We see a significant opportunity in 2022 to grow. Specifically, when we look at the diagnosed patients that are out there already for LEMS that are not yet on FURDAPs, we have a robust pipeline of these leads. And many of these physicians are telling us at this point that they're just waiting for these patients to come in and visit before they prescribe. So we have that. That's one. Other things, we take a look at the oncology and the tumor lens patients. We're applying significant resources there to educate HCPs as well as patients on tumor lens, the disease, and potential treatments. So we already are seeing growth right now. I'll give you a quick specific here. In 2021, our new enrollments, 22% of the new enrollments are tumor lens patients. That's a growth of 10% from 2019, and 2019 is only 12%. So we're seeing growth with the limited resources that we've applied there thus far, and we know all the work that we've done to date this year will generate new patient opportunities, oncology or tumor lens patients next year. The other part is, you take a look at the other 3,000 patients that are out there, A significant portion of these patients are either undiagnosed or misdiagnosed. So we've applied resources there to help educate patients, caregivers, and physicians about LEMS and treatments that are available. And we will shorten that patient journey, and that will open up the opportunities for these patients to be served sooner. So that's where we see the significant growth coming in 2022.
spk08: Very good. Appreciate that added color, Jeff. Regarding the pipeline question that I had, I'm actually intrigued with several of the pipeline initiatives. But I wanted to focus on the pediatric filing that you mentioned. You know, it seems to make a lot of sense, although you said it's a very, very, very low incidence and prevalence for pediatric patients with LEMS. I guess I'm wondering if you anticipate being able to provide some PK data or other supportive evidence for that filing. And then is it possible that pediatric LEMS is actually underdiagnosed? And where would the source of pediatric LEMS be from? Could it be for small cell lung cancer patients that are pediatric, which I'm sure is very few? Or what is the source of pediatric LEMS? Genetics?
spk04: Charles, I'll let Steve Miller answer that question. Well, thanks for the question, Charles. First, let me speak to the origin of pediatric limbs. It is autoimmune, like the limbs for adults. It is essentially the same disease. As you probably know, all autoimmune conditions typically occur later in life, although they can occur in pediatric patients, but it is relatively low frequency, and that is the origin of why the numbers are relatively small. It is possible that there is some undiagnosed cases that are out there, but the reality is that the number of patients is relatively small. At this point in time, we believe there may be perhaps 10 to 15 pediatric LEMS patients that are known currently. There may be others out there as well, and as we move our commercial efforts into the pediatric LEMS space upon approval, we may be able to find those patients. The most important thing is that in spite of the fact that it's just a few patients, it's very important for us to ensure that we can make sure that every single LEMS patient, regardless of who they are, what age they are, or where they are, is able to get an approved therapy for their disease.
spk08: Okay, that's very helpful. Appreciate the focus on delivering for patients. Last question is strategy-based. I'm not sure if you're going to be able to answer this, but I'll give it a shot anyway. So you said that you're happy with the 11th Court of Appeals designation in terms of orphan, possible en banc hearings. What's your sense of being able to say with a definitive statement on the outcome of that And regarding legal interactions with wannabe competitors, if you will, how would clarity on the outcome, especially a win with that, putting it to bed, change your perspectives on investment in Firdevs Marketing, the pipeline of potential and licensing?
spk05: So, Charles, as we previously stated, the... The FDA and Jacobus had 45 days from the opinion to seek an inbound hearing or rehearing of the opinion. And that date is approximately November 15th. And the statistics bear out that less than 5 percent of the requests actually ever get re-heard. And so, we don't know what other strategies may be incorporated by the other side, if you will. But that would be the first step. And of course, the FDA, as we understand it, would require actually the approval of the Solicitor General's Office to even make that request. So we don't know what the next steps will be. We believe even if a request is submitted, that it's likely based on the results of the three-judge panel and the opinion which was strongly worded, we think that it's very unlikely that a rehearing would be granted. And so, of course, the other option is cert in applying requests to the Supreme Court for a hearing, and less than 2% of cases that are sent to the Supreme Court are actually heard by the Supreme Court. So, we are, from a commercial perspective, and a patient advocacy perspective, we're ready at any point for what what the decision of the court may be, ultimately, and the overturning, if you will, of the FDA approval for Resurgy. And what the results of that would be in terms of transitioning, a warm transition of patients to amifampidine.
spk08: Okay, that answers my question. We'll look forward to some visibility on that and appreciate the focus on, like I said, serving the patients. Thanks for taking my questions.
spk03: Thank you, Charles. Thank you. Next question today is coming from Scott Henry from Roth Capital. Your line is now live.
spk09: Thank you, and good morning. Pat, sort of a follow-up to the appellate court question. Obviously, we can look at the organic process growth of FirdApps and chart that out over the next couple years. But if Resurgy is pulled off the market, can you talk about how that would change the outlook, sort of what could be the incremental upside to the revenue line if that event were to occur? Thank you.
spk05: Scott, that's a great question. You know, we're reluctant really to talk much about that. You know, it's really the concern would be, the first concern would be a smooth transition where no patient ever misses a dose of their drug. That's our biggest concern. And I think that we're prepared for that. I know we're prepared for that. You know, we previously have stated when asked how many patients are on Resurgy. We, of course, don't have access to that information, but based on the number of patients that we lost when Resurgy was approved and likely some growth, we've said that we believe that there's somewhere between 100 to 125 patients that are currently receiving Resurgy. We know a number of those patients are at higher doses than what our average dose patient is, which is on average about 60 milligrams for an adult patient. So, you know, I think those are the only metrics that we can talk about at this point. And, you know, perhaps in giving guidance, if we do so early next year, we can be a bit more specific than we can right now.
spk09: Okay. Thank you, Pat. And if you were to pick up those patients, would that be sort of a step increase, or would you expect them to come in gradually or kind of overnight, just trying to think about that?
spk05: I think, you know, we're seeing some patient migration actually right now to a lesser degree, but I would expect that it would be a fairly large bolus over time. 830 to 60-day period of time.
spk09: Okay, great. Thank you for taking that question. Just a small follow-up for Allie, a couple model questions. First, the tax rate was 27% in third quarter. What should we think about as the ongoing tax rate? I would expect it to be perhaps close to 22%, 23%. And then... Even though R&D is expected to be substantial, should we expect that to trend down, you know, given some of the programs that are not getting resources currently?
spk01: So, first, to address your tax question, we expect our future rates be more of a normalized rate. So we expect it to be a federal statutory rate of 21%, plus approximately from 2% to 4%. On your R&D questions, while you are correct that some of our programs are winding down, we do expect to have some R&D expenses from our future programs that we might pick up in the future based on our growth strategy.
spk05: Scott, I'll add to that. Thank you, Ellie. That, you know, for modeling purposes, I don't think you're going to see R&D expenses go down. They'll probably accelerate some as we bring in new projects and opportunities, which we expect in 22. So I don't think that that number is going to decline.
spk01: Yes, we also continue to have expenses from our expanded access programs, including, and we'll have some expenses from our continuing, or we expect to have expenses from our continuing NUSK-NG patients that we'll continue to supply.
spk09: Okay, great. Thank you for taking the questions.
spk03: Thank you. Our next question is coming from Joe Catanzaro from Piper Stanley. Your line is now live.
spk02: Hey, guys, thanks so much for taking my question. Maybe just one quick one from me. I was just wondering, maybe over the last year or so of your team's BD diligence, what have you found the most challenging? Has it been asset quality, deal terms, or something else? And what specifically led you not to pursue that one asset that you alluded to? Thanks.
spk05: Yeah, good question, Joe. Thank you. The issue really came down to when we brought in subject matter experts and our team was able to do a deeper dive, the issue really was about valuation more than anything. The number that in looking at public disclosures, when we dug in a little bit, we just couldn't get comfortable with with the devaluation of the transaction. And we did spend a lot of time and effort, and so we were certainly quite invested in the project. And so I think it took a lot of discipline on our part to walk away. It was unfortunate. But I think the biggest challenge has been until we Until we opened up to other therapeutic areas, the biggest challenge was trying to find something in neuro. And as you know, we recently decided that we're going to look outside of neuro and everything, any therapeutic area outside of oncology. And so that's opened up quite a vast opportunities for us that we're looking at. So, and I think that valuations, as you look at products and or companies that might have some innovative technology, those valuations have come down a bit, as you guys know, since the beginning of this year. And so, I think it's, at the time, it was pretty much a seller's market. I think it's a little more balanced at this point And I think that companies who are in need for additional capital are looking around at what their strategic options may be to just doing another financing.
spk02: Okay, got it. That's very helpful. Thanks for taking my question.
spk03: Thanks, Joe. Thank you. Our next question is coming from June Lee from Truist. Your line is now live.
spk07: Good morning. This is Les for June, and thank you for taking my questions. I have two. First, on the small trial in Japan with your partner, Dido, can we just kind of get an idea of what the study design looks like and timelines? And then second, what have been your challenges of getting the diagnosed patient population onto FairDocs? Thank you.
spk04: Well, thanks for the question, June. We're not going to go into any detail about the study design because of confidentiality reasons with Dido. I can tell you that it's smaller than the studies that we ran in the United States, as we had previously discussed publicly, and it should be a relatively short period of time to recruit and complete the study, shorter than we spent on studies in the United States.
spk05: Could you repeat the second part of your question, please?
spk07: Sure. I just wanted to get an idea of what have been your challenges in reaching the diagnosed LEMS population and putting them on FredEx.
spk06: You know, I'll take that answer. And it's really not the challenge of reaching these patients because we know the patients and who is treating these patients who these physicians, and many times it's just the logistics behind it. There was a backlog in patient visits, you know, because of the Delta variant and other reasons. So the physicians, what they're telling our field force is that as soon as that patient comes back in, they will then put that patient on FERVAPs, if appropriate. So we feel like there is a backlog, pent-up demand that will happen once these patients can get back in there. But we are extremely proud of our growth that we've had, and we see this as being incremental growth moving forward. Does that address your question?
spk07: It does. Thank you.
spk03: Thank you. We reach the end of our question and answer session. I'd like to turn the floor back over to management for any further closing comments.
spk05: Thanks, everyone, for joining our call today. We look forward to our next corporate update. Have a great day.
spk03: Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.
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