Q4 2023 Catalyst Pharmaceuticals Inc Earnings Call

Participants

Michael Kalb; CFO & EVP; Catalyst Pharmaceuticals, Inc.

Richard Daly; CEO & Director; Catalyst Pharmaceuticals, Inc.

Jeffrey Del Carmen; EVP & Chief Commercial Officer; Catalyst Pharmaceuticals, Inc.

Steven Miller; EVP, COO & Chief Scientific Officer; Catalyst Pharmaceuticals, Inc.

Charles Duncan; Analyst; Cantor Fitzgerald & Co.

Joon Lee; Analyst; Truist Securities, Inc.

Joe Catanzaro; Analyst; Piper Sandler & Co.

Leland Gershell; Analyst; Oppenheimer & Co. Inc.

Presentation

Operator

Hello, and welcome to the Catalyst Pharmaceuticals, Inc. fourth quarter and full year 2023 financial results conference call and webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. Our question and answer session will follow the formal presentation. Here may be placed in the question queue at any time by pressing star one on your telephone keypad. We ask you please ask one question and one follow-up then return to the queue. As a reminder, this conference is being recorded. It is now my pleasure to turn the call over to CFO, Mike Kalb, please go ahead.

Michael Kalb

Thank you.
Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's Fourth Quarter and Full Year 2023 financial results and business highlights leaving the call today is Richard Daly, CEO. We are also joined by Dr. Steven Miller, our Chief Operating Officer and Chief Scientific Officer, and Jeffrey Del Carmen, our Chief Commercial Officer, further for the Q&A session. Dr. Gary Ingenito, or our Chief Medical and Regulatory Officer, will be available for questions.
Before we begin, I would like to remind you that in our remarks this morning and in the Q&A session, we will make statements about expected future results, which may be forward-looking statements for purposes of federal securities laws. If these statements relate to our current expectations, estimates and projections and are not guarantees of future performance. They involve risks, uncertainties and assumptions that are difficult to predict and may prove not to be accurate and 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 2023 Annual Report on Form 10 K.
At this time, I'll turn the call over to Rich.

Richard Daly

Thanks, Mike, and welcome, everyone, to the call first, I'd like to say that our entire team is proud of the work that we do on behalf of the orphan and rare disease communities that we serve. And we're especially excited to be speaking you to today on Rare Disease Day 2023 was an outstanding year for Catalytica. We are proud of all that the team has achieved. We are pleased to highlight the progress we have made during this transformational year that we just completed, and we are proud to provide insight into the year ahead. But before the team size into this, I'd like to offer some high-level comments. We operate our business around four key pillars. First, commercial execution with Supreme focus on patient care and access. Second, portfolio expansion to business development, third lifecycle management and partnerships, and finally, financial discipline. Our discussion today will provide you with updates on each of these areas.
2023 was a transformational year for catalysts, but start with our first pillar, our commercial execution, the core Firdapse business remains strong, evidenced by our sustained organic growth and continue to reach more patients in this market by working diligently to increase awareness of Firdapse and the disease, it treats lamps to further enhance our business.
In 2023, we expanded our commercial portfolio with our acquisition of Compo seamless integration of aficamten franchise into our company has yielded promising results. We're pleased with the progress the product's performance, this addition in which it enriches our portfolio by enhancing income diversity fostering stable revenue streams and fortifying our balance sheet in preparation for future acquisitions.
Our second pillar portfolio expansion, in addition to five copper in the third quarter of 2023 we licensed the North American rights to again raise our US NDA filed asset for Duchenne's muscular dystrophy Academy was approved in the fourth quarter, and we remain on track for the launch of The Gallery before the end of the first quarter 2024. We're excited to have this innovative product in our portfolio. More importantly, we know through our outreach to patients, caregivers and providers that the Duchenne community is excited as well. We are well prepared prepared for the successful launch of a gallery, providing further revenue growth and diversification while addressing a significant unmet need for improved therapeutic options for patients. Future potential for Gambro represents an opportunity for incremental growth that can continue to propel the company forward. We are committed to our buy and build strategy and our results bear testament to its success. In 2023 alone, we allocated approximately $300 million toward acquiring assets without debt, bolstering the company's commercial position. Furthermore, our recent common stock offering, combined with our robust balance sheet, underscores our ability to persistently pursue strategic investments aimed at expanding our TAM and diversifying our portfolio Jeff will provide an overview of our performance in 2023 with respect to commercializing Firdapse and Fycompa and our plans for our portfolio in 2024, including Gary and his section this morning for pillar number three, lifecycle management and partnerships. We await the FDA's decision on the expansion of the Firdapse label to include 100 milligram dosing which is expected in the second quarter of 2024. We believe this has the potential to provide an important option for patients who live with limbs. We are also making great strides in our ex-US partnerships. Japanese regulatory authorities have accepted diagnose NDA for Firdapse, and we expect a decision on their application later this year. This also bodes well for our expanding it for expanding our ex U.S. opportunities as the Japanese NDA acceptance triggers the expansion of our territorial rights for Firdapse in certain A-Pac and Latin markets.
Finally, pillar number four we are well known for our financial discipline and we plan to continue to deliver the rigor you have come to expect. Mike will go into great detail in his section of the call now to our 2023 results. We delivered outstanding performance in 2023, exceeding our guidance for the year, delivering record total revenues, both organically and through expansion of our product portfolio. These results continue to drive our momentum as we move through 2024. Our full year total revenue for 2023 were $398.2 million, an 85.9% increase year over year compared to $214.2 million in 2022. Additionally, we achieved record fourth quarter total revenues of $110.6 million, representing an 82% increase compared to $60.8 million in Q4 of 2022 we achieved our results by delivering [20%], 21% revenue growth for the full year of 2023. For Firdapse, a sales of $258.4 million and delivering $138.1 million in sales for flat comp. We are proud of these results, and we thank our team for delivering such a strong performance.
Looking ahead to 2024, our full year 2024 guidance reflects our confidence outlook, projecting a sustained growth and strategic advancements in line with our long-term objectives. We believe that 2024 will provide opportunities for continued growth of our portfolio. And we are forecasting full year total net revenues of between $455 million and $475 million, representing a 14% to 19% increase in our total net revenues compared to 2023. Provide you with more color on each of these pillars. I'll turn the presentation over to the team. Let's begin with Jeff Del Carmen, our Chief Commercial Officer. Jeff?

Jeffrey Del Carmen

Thanks, Rich, and good morning, everyone. First, I wanted to numerator each day and all the people touched by rare diseases. We are pleased with the outstanding performance delivered in 2023, highlighted by full year combined total revenues of $398.2 million, exceeding the upper end of guidance of $395 million. This remarkable performance was fueled by Firdapse, reaching an all-time high of $258.4 million and the consistent strong contribution from copper, which generated $138.1 million in net revenues.
Let's start by reviewing our advancements with Firdapse, the only evidence-based FDA approved treatment for Lambert, Eaton Myasthenic Syndrome. In the fourth quarter, net revenues amounted to $69.8 million, showcasing a remarkable year on year growth, 15%. Moreover, the overall net revenues at 2023 displayed a robust 20.8% growth compared to the previous year, propelled by consistent initiation of new patients in an annual low discontinuation rate trending below 20%, consistent with previous years and internal expectations. Prescription approval rates exceeded 90% for all types of payers, including government and private commercial insurers. Patients enrolled in Catalyst Pathways, including those with Medicare coverage, accessing third party Foundation assistance experienced an average monthly co-pay of less than $2. We are confident in the continued Firdapse organic growth in 2024 will be between 15% and 20% building upon the momentum from 2023. This growth will primarily be fueled by several key factors. Firstly, the conversion of a portion of the 500 identified lens patients to Firdapse treatment will play a significant role. Additionally, the anticipated approval of the 100 milligram expanded label in June 2024 should help contribute to this growth trajectory, providing patients the opportunity for a higher daily dose when appropriate.
Furthermore, the expansion of educational programs targeting small cell lung cancer to lens health care providers is poised to accelerate lens diagnosis rates.
Lastly, our efforts to broaden the addressable lens market through increased VGCC. antibody testing will further bolster growth prospects. As a reminder, we shared an abstract at the World Conference on Lung Cancer in September, which projected that the prevalence of lands in the United States is at least 3,600 data suggests it could potentially reach 5,400 individuals. This figure marks a notable rise from the previously estimated prevalence of 3,000. Our estimate stems from a thorough analysis of real-world data, particularly emphasizing the prevalence of lens diagnosis among patients with small cell lung cancer. Presently, we gauge that over 80% of small cell lung cancer lens patients remain undiagnosed, indicating a substantial growth opportunity.
Now I'd like to share some key updates regarding our progress with by complex the commercialization of Kampo has surpassed our initial expectations in May 2023. We seamlessly integrated by Kampo into our product offerings as a strategic and highly accretive product. We actively engage with health care providers. Their key opinion leaders, expanded our outreach to establish vital partnership partnerships with patient advocacy groups to increase awareness and further our mission and fostered valuable relationships that have played a significant role and buy tons of success. By comparison, net revenues have exceeded the anticipated full year estimate of $130 million, reaching a total product revenue of $138.1 million, surpassing expectations by 6%. This achievement was propelled by robust end to the year with revenues for Q4 2023 reaching $39.3 million. We forecast 2024 by comp and net revenues will be approximately $130 million to $135 million based on changes in gross to net when products transition to companies with a smaller portfolio like we experienced with by copper, you typically encounter higher fees from service providers such as wholesalers let's turn to a gallery of promising novel anti-inflammatory corticosteroid aimed at addressing a significant gap in treatment for the estimated 11,000 to 13,000 boys living with Duchenne muscular dystrophy or DMD. As previously disclosed, we are on track for a commercial launch in the first quarter of 2024 Gamunex will be integrated into our neuromuscular franchise, capitalizing on the team's proven capabilities, commercial expertise and experience. We have finalized the recruitment of 10 commercial personnel to bolster the impending launch, primarily focusing on marketing and patient services. Our existing neuro muscular sales force comprising 16 regional account managers and two area business directors will assume responsibility for both Firdapse and a gambling. Furthermore, again, Marie will benefit from the support of our top notch Catalyst Pathways program, ensuring that all eligible patients have access to the product. Based on the feedback from our constituents and analysis of the DMD market, the wholesale acquisition cost of a January will be at a slight discount to Emflaza. We will implement the same financial programs as we have for Firdapse with a goal to ensure the average out-of-pocket cost per patient will be less than $2 per month. More details on the commercial launch will be available in the coming weeks. We began accepting precommercial launch new patient enrollments on December 1, 2023, based on the volume of new patient enrollments and observed pent-up demand. Our 2024 net revenue guidance for Camry is between $25 million and $30 million.
In conclusion, we are extremely proud of our achievements in 2023 and maintained strong confidence in meeting our targets for 2024 as we prepare for the launch of a gallery, we will leverage our established commercial proficiency. I express sincere appreciation to the entire Catalyst team for their unwavering dedication to patients, and I eagerly look forward to a prosperous 2024 ahead.
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 for Integer.

Steven Miller

I would first like to discuss our development efforts to increase the indicated maximum dose of Firdapse. As previously reported in October of [2023], the FDA accepted for review the company's supplemental new drug application to increase the indicated maximum 80 milligram daily dosage of Firdapse to [100] milligrams for the treatment of Liberty Myasthenic Syndrome or lapse catalyst continues to anticipate approval of the application on or about June 4, 2023, just the produce have actually been granted by the FDA. About 40% of patients are on the current indicated maximum dose of 80 milligrams per day, and their physicians would like the option to increase the daily dosage above 80 milligrams per day based upon disease progression catalyst believes that this expansion of the Firdapse label, if approved, would address an important opportunity for patients and their health care providers and may lead to about a 5% to 10% increase in the prescribed average daily dose of Firdapse over time.
In 2023, we focused on expanding our intellectual property portfolio for Firdapse, resulting in the granting of two additional patents for Firdapse. These patents were issued at 2023 and 2024, bringing the total number of patents protecting Firdapse to nine. This further strengthens our intellectual property estate for Firdapse, which has patent protection to [2037]. Catalyst's expansion to global markets is continuing to progress. Our partner in Japan, Daido pharma achieved a notable milestone in December of 2023, having successfully submitted their NDA for Firdapse to the Japanese PMDA. We anticipate a priority review cycle time of nine months and if approved, a potential launch in early 2025 with 10 years of market exclusivity in Japan after approval.
Next, I'll move on to our newest approved product in January for the treatment of Duchenne muscular dystrophy or DMD and January was approved October 26th of last year and was granted new chemical entity exclusivity and orphan drug exclusivity. Conferring market exclusivity to October 2027 and 2030, respectively, that this FDA granted exclusivity is augmented by six Orange Book-listed patents that provide protection to [2040]. Again, as part of our ongoing effort to maximize Vanish and this will continue to seek opportunities to strengthen again this patent protection and explore new indications for labeling.
In summary, over Morila and clinical studies has shown efficacy for treatment of DMD patients while holding the potential for a reduction in the burden of steroid associated side effects compared on steroids. This includes the potential for notable benefits for bone health growth and behavioral outcomes based on preliminary data out of the estimated 11,000 to 13,000 DMD patients in the U.S., roughly 90% have undergone corticosteroid treatment at some stage. Presently, it is estimated that about 70% of DMD patients currently under treatment receive steroids. Steroids serve as the cornerstone of DMD therapy, highlighting the pressing demand for a more tolerable steroid option short term safety and efficacy of a more alone was demonstrated in a 24 week randomized, double-blind, placebo and active controlled study, and it is well tolerated and was associated with maintenance of muscle strength and function to determine what specific safety benefits again we may have, if any, relative to other approved corticosteroids catalysts is investing in a registry to study the long-term safety and quality of life at males with DMD that are treated with. Again, as this data is collected and analyzed, catalysts will periodically seek to update the gamma prescribing information with the latest information regarding the safety of the drug based upon FDA guidance. Documents for real-world data, education and information on new and unique products is the focus of Catalyst medical science liaisons for our pump based on our critical support to the medical community by providing information that is in the public domain to the medical community in order to educate them on these rare disease states and on the academic research that may have been published about these medications. This assist health care providers in selecting the best treatment for their patients, more alone has generated a high level of interest within the health care community. Neuromuscular MSL team is doing with the DMD medical community since the gamblers approval in October of last year. These There are numerous publications of the Marlins pharmacology and effect in DMD patient population. I'll not now turn the call over to Mike Kalb, our chief financial officer.

Michael Kalb

Thank you, Steve. Capital's Fourth Quarter and Full Year 2023 financial performance resulted in another record breaking year, driven by exceptional execution by all facets of our business. In addition to our outstanding results, the Company has successfully closed two transactions in 2023, the acquisition of the U.S. rights to pay copper and a North American license for gaming. Both transactions provide the company with additional opportunity to continue to create incremental net positive cash flow through disciplined execution.
I'd like to take a moment to reiterate some of the key accounting implications and accounting treatment of the Gambro transaction as a result of the FDA approval of January on October 26th, 2023, we made a $36 million milestone payment to Centerra in the fourth quarter of 2023, which was capitalized on the balance sheet as an intangible asset and will be amortized on a straight-line basis over its estimated useful life of 10.5 years. I would like to reinforce that based on the timing of the January approval, amortization expense was prorated in the fourth quarter of 2023. Catalyst also made a strategic equity investment in center, which was recorded with an initial fair value of $13.5 million and will be mark to market value on a quarterly basis using the observable market price.
Now on to 2023 results. Our total net revenue for 2023 sorry, for 2023 was $398.2 million or 95.9% increase when compared to total net revenue of $214.2 million for 2022. Product revenue met for 2023 for Firdapse was $258.4 million, a 20.8% increase percent increase year over year compared to $213.9 million or 22 product revenue. Net profit comparable was $138.1 million for '23. As mentioned in our press release, 2024 or five comp and net product revenue will be adversely affected by gross-to-net adjustments in 2023. Our gross-to-net for Viacom was booked under sized arrangements with distributors and government agencies. However, starting in 2024 or all such costs are tied to arrangements between us and those distributors and government agencies. Since our costs under these arrangements are likely to be higher than the size costs. We expect to be impacted by an increase in gross to net deductions for Fycompa, thereby causing a corresponding decrease in PI comp and net product revenue. As Jeff mentioned, this typical for smaller companies with smaller product portfolios.
Net income before income taxes for '23 was $94.5 million, a 9.7% decrease year over year compared to $104.7 million for '22. Net income for 2023 was adversely impacted by the $81.5 million charge for in-process R&D resulting from the Gambro license acquisition, we reported US GAAP net income for 2023 of $71.4 million, or $0.67 per basic share and $0.53 per diluted share a decrease of 14% year over year compared to GAAP net income for '22 of $83.1 million, or $0.8 per basic and $0.75 per diluted share. The decrease in net income is attributed to the one-time gain related IPR&D expense recorded during the third quarter of '23.
Non-gaap net income for '23 was $223.2 million or $2.10 per basic and $1.96 per diluted share, which excludes the IPR&D expense. The income tax provision of $23.1 million, amortization of intangible assets related to our acquisitions of resurging five comp in January of $32.6 million. Stock-based compensation expense of $14.3 million and depreciation expense of $316,000 from GAAP net income. This compares to non-GAAP net income for 2022 of $113.9 million or $1.10 per basic and $1.2 per diluted share, which excludes from GAAP net income. The income tax provision of $21.6 million, stock-based compensation of $7.9 million, amortization expense of research, the intangible assets of $1.1 million and depreciation expense of $141,000. The above represents an approximate 96% increase of non-GAAP net income year over year. Without consideration for potential M&A activity, we expect amortization expense for acquired licenses and intangible assets to be approximately $9.3 million, beginning with the first quarter of 2024 and continuing until the depletion of the intangibles related to PHI copper in 2027. Our effective tax rate for 2023 was 24.4%. We anticipate our effective tax rate to increase slightly for 2024. Our tax rate is affected by many factors and therefore may fluctuate. Quarterly cost of sales were approximately $52 million in 2023 compared to $34.4 million in '22 and consisted principally of royalties. As a reminder, royalties for Firdapse paid to our licensor for that product. It increased by 3% once net product sales exceed $100 million in any calendar year research and development expenses were $93.2 million in 2023. This compares to $19.8 million in 2022. As previously mentioned, the driver behind the increase in research and development expenses relates to the one-time. Again, we IPR&D expense during the third quarter of '23 relative to normal course of business. Absent another acquisition, we expect R&D costs in 2024 to trend.
Similarly to R&D costs in 2022, SG&A expenses for 2023 totaled $133.7 million compared to $57.1 million in '22. The increase in SG&A year over year is principally due to expenses related to the integration of copper, including commercial expenses incurred under the transaction service agreement and an increase in headcount, principally in sales and marketing, as well as certain increases in corporate headcount required to support the Company's growth during the fourth quarter of '23, the company incurred significant selling and marketing expenses for the preparation of the game we launch.
With regard to the first quarter of 2024, we anticipate a significant increase in 2024 SG&A expenses compared to Q1 of 2023 due to the upcoming January launch and the company's support of three commercial products compared to in Q1 '23.
Further, I would like to note that consistent with prior years as a result of US GAAP requirements, the Company expects an increase in SG&A expense in the first quarter of 2024 as compared to other quarters due to its five o. one c. three donations. As reported, we ended 2023 with cash and cash equivalents of $137.6 million compared to $298.4 million at December 31, '22. The decrease in cash of $160.8 million was largely driven by approximately $293.3 million in payments in connection with acquisitions, including equity securities, which was offset by net positive cash flows generated from operations of $141.4 million.
On a related note, I would like to mention that on January ninth, 2024, the Company issued $10 million shares of common stock for total net cash proceeds of approximately $140.1 million, which is intended to fund the potential acquisition of new product candidates as well as for general corporate purposes. We believe our current funds continue to allow us the financial flexibility to fund our existing R&D programs, meet our potential contractual obligations and support our strategic initiatives, business development and portfolio expansion expansion efforts, leading to long-term growth and value creation. More detailed information analysis of Fourth Quarter and Full Year 2023 financial performance may be found in our annual report on Form 10 K, which was filed with the Securities and Exchange Commission yesterday, February 28th, and can be found on the Investor Relations page of our website at w. w. w. dot Cabelas pharma.com. And with that, I'll turn the call back over to Rich.

Richard Daly

Thanks, Mike. I'd like to thank the leadership team and all our employees at catalyst for the effort they put forth to deliver such outstanding results in 2023. We're off to a strong start in '24 with continued momentum to sustain our long-term durable growth. We continue to be committed to excellent execution. We are focused on increasing the scope and scale of our business through our disciplined approach in identifying derisked innovative therapies that address critical unmet medical needs in the rare orphan neuro and adjacent rare orphan therapeutic areas. We also hope to increase our geographic footprint through ex U.S. partnerships. In short, we are prepared to invest in opportunities that add value to Catalyst, further grow portfolio and provide improved care for patients. Our team and excuse me, our team is dedicated to improving the lives of more patients by working on key lifecycle management projects that have the potential to expand the use of the products we offer. We believe our financial rigor, strength of our financial results and our cash flow position us to advance our critical initiatives.
In summary, we are focused on our strategic priorities for 2024 number one, continue to deliver double digit growth for our portfolio in order to successfully launch and commercialize again, right? Number three, expansion of our product portfolio and our geographic partnerships in the CNS, orphan and orphan adjacent therapeutic spaces. And we look forward to providing you with updates on our progress at this time, I will turn it back turn the call back over to our operator. Kevin?

Question and Answer Session

Operator

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 one on your telephone. As a reminder, we ask you please ask one question one follow-up to return to the queue, and that’s star one to be placed in the question queue.
Our first question is coming from Charles Duncan from Cantor Fitzgerald.
Your line is now open.

Charles Duncan

Yes, good morning, Rich and team. Congratulations on a transformative year, and I appreciate the guidance going forward. Had a quick question on Firdapse with regard to that label expansion. Steve did a great job helping us understand, you know, the percentage of patients really that are looking for a higher dose, but I'm wondering what is the driver of that? What would there be anticipated in short term efficacy or long term durability?

Steven Miller

Charles, we believe that it will be long term durability. There's really two driving forces behind the first is disease progression as these patients age. And so they gradually very gradually need a higher dose.
The other thing also is that there are a handful of fast metabolizers out there who have higher weights that also need a higher dose. And so we'll be able to support those patients if and when the FDA approves this 100 milligram maximum daily dose.

Charles Duncan

Got it. And then was jumping over to Gary. One quick question and for Jeff or others on the team. I guess I'm wondering if you could provide a little bit more color on the registry. I think you mentioned that you would be starting that and some anticipated size and timing. Any updates from that that you anticipate that could drive awareness of the more loans, our value proposition versus other standard of care, thanks.

Steven Miller

Charles, the registry and the size is going to depend on how many patients I agreed to join the registry.
It is voluntary. We anticipate that a significant number of patients will join the registry and the track for as long as shape and the patient registry in terms of duration, it will be carried on for many years as we collect data for long term safety evaluation of again, Gary do you want to make any commentary about the number of sites and excuse me, number of sites as well?

Charles Duncan

So we will be looking at all of the sites that potentially enroll a commercial or to have commercial again, moderate patients and evaluate them for their ability to collect data rigorously in the registry. So at the present time, we haven't said a specific number. But we'll again, as Steve said, look at how many patients are prescribed, what the locations are in order to determine the site and patient numbers.

Michael Kalb

But I'd say just a sense of it's a pretty broad, but we're looking at a pretty broad-based approach that would that be safe to say?

Charles Duncan

Yes, right.
Okay.

Michael Kalb

So we'll follow that health plans, things become clear, Charles,

Charles Duncan

Got it. thanks, Rich, for the added here.

Operator

Thank you. Your next question is coming from Joon Lee from Truist Securities. Your line is open.

Joon Lee

Great. Congrats on another strong quarter and thanks for taking the questions and really impressed that you are able to provide guidance on Admin Re, which has yet to launch. I can only imagine that you must be getting a lot of inbound interest to be able to provide guidance. Is this why you think just some additional sales force will be sufficient to launch into a 10,000 plus DMD patient space? And will it be more word-of-mouth awareness? Or do you have any DTC efforts in mind? Quick follow-up.

Jeffrey Del Carmen

Sure.
So thanks for the question, Joon. We with our DMD. It's a very defined market. There are only primarily 250 prescribers that prescribe a 95% of the cortical steroids for boys living with DMD. And those 250 prescribers are housed in about 90 to 100 centers of excellence. So it's a focused call point that our team has the capacity, the team that was selling of Firdapse had the capacity to handle and handle effectively. And these are very experienced and tenured people. So we're very confident in that structure.
Now as far as the pent-up demand that you had mentioned. And it sounds like, as I mentioned on the call, we've been accepting pre-commercial launch enrollments since December and based on those enrollments and the number of enrollments that we've seen and also the the other stakeholders that have talked about their interest in going on in January. We do believe we're confident in the number that we provided so that's one thing.
As far as DTC., we have nonpersonal promotion along with our sales force efforts to help provide education on January as well as DMD. That will be focused on not only the physicians but also to other stakeholders like patients and caregivers.

Joon Lee

Great. Thanks for the color. And on the continued strength of your Firdapse franchise, you mentioned conversion of 500 additional lung patients you've identified and the anticipated approval of the higher 100 milligram dose. But then how does a small cell lung cancer lens patients factor into that guidance, is that really in the guidance? Or is there more upside or help us navigate that, that component of the population? Thank you.

Jeffrey Del Carmen

So June, a great question about that and it is factored into small cell lung cancer lens opportunity is factored in into the growth potential, but we also see it as upside from there, too. And like I mentioned, about 80% of these small cell lung cancer lung patients are unfortunately undiagnosed at this point. So our efforts to accelerate that diagnosis, the diagnosis for these patients will increase the addressable market over time, which will help with our growth.

Joon Lee

Great. Congrats again on the strong quarter.
Thank you.

Jeffrey Del Carmen

Thank You.
Thanks very much to thank you.

Operator

next question is coming from Joe Catanzaro from Piper Sandler. Your line is open.

Joe Catanzaro

Yes, hi, guys. Appreciate you taking my question and congrats on all the great progress here. So Steve, I think you mentioned the percent of patients that are on the current maximum dose of Firdapse. But I think you previously said that you would expect even patients some on lower doses to be taken to higher doses. I'm wondering if that's still your expectation and if that sort of factored into the Firdapse guidance for 2024.
Thanks.
And I have one quick follow-up.

Steven Miller

I'll let Jeff address the factored into the guidance. But with regard to your question about patients being on doses below 80 milligrams a day as there are patients on that, the norm being a neuromuscular physician community is somewhat conservative. It's a go-slow of start low and go slow on mentality with regards to medical industry. Many of them like to lose ground also headspace in terms of the dose that patients are receiving so that if the patient gets worse, they can increase the dose with the increase in the daily maximum dosage, we would expect some of those conservative physicians who have been concerned about the overall efficacy of, say, a 60 milligram dose that a patient may have been receiving maybe more likely to increase the dose, knowing that they still have more room to further increase the dose for those patients.
So that that is you're correct that some of those patients at below 80 milligrams may increases adjusted you want to address factored into.

Jeffrey Del Carmen

Sure, Joe. Before I get into that question, just wanted to reiterate the percentages that 40% of our patients are currently on 80 milligrams, then there's an incremental 3% of patients are on greater than 80 milligrams currently on overtime, we do expect the average daily dose to increase and that increase that gradual increase is factored in on to the forecast. But keep in mind with the due for date for this June arm, it's overtime. So it's just the impact from June and through December of this year.

Joe Catanzaro

Okay, thanks. That's helpful. And then maybe my follow-up question on sort of future Cadence business development and maybe one for you, Rich. As we as we look back at sort of our historical approach to business development? How are you thinking about some potential opportunities moving forward?

Steven Miller

Great question. So obviously, we feel that our balance sheet is prime right now. And we're really confident and pretty and her team are continuing to look, we have a very wide aperture. So we consider ourselves an orphan company, obviously in the CNS space. So that would include epilepsy as well. And we're looking at those opportunities that are not only just in CNS because we believe our infrastructure is one that supports getting the patient on and keeping the patient on that's critical. We see that as a foundational element of who we are as a company, we believe that infrastructure is trans is transferable to other orphan states outside of CNS, metabolic, cardiovascular, et cetera. So our aperture is quite wide. We believe our opportunities are very, very broad. So we continue to scan the landscape. We have a number of opportunities that we're evaluating at a very deep level and we're continuing there. And we're, I would say, appropriately aggressive in our search for new opportunities that we believe fit with who we are and our ability to serve the patient community.

Joe Catanzaro

Okay, great. Thanks again and appreciate you taking the question.
Thank you.

Jeffrey Del Carmen

Thank you.

Operator

Our next question is coming from, we will go from Oppenheimer.
Your line is lower now.

Leland Gershell

Yes, good morning, everyone, and thanks for taking my questions and great to see the sun Clayton from scammers and as well as overall.
Just a few questions from me.
Actions by Compass looks like now with the guidance, let's say we've been more flattish year on year and 24, then I think previously, the Company indicated maybe sort of a mid to high-single digits growth. Just wondering and any dynamics there we should be aware of.
And then second, also, ones like copper. Is there any update with respect to IP exclusivity?
I think a base case. We have this potential D-2 all sort of Spring of 25 and then Central to that extended to 26. Just wondering if there's any update on the IP that.
Thank you.

Jeffrey Del Carmen

Currently lines.
So Mike will take the first part and Steve will take the second part Sure.

Michael Kalb

Good morning, Leo, and thanks for the question on Onfi copper, as we mentioned in the press release as well as on the call from our our arrangements now with wholesalers and distributors and government agencies are through us as opposed to for 2023. They were through a site and as is common for companies of our size, smaller companies, smaller product portfolios, those those rates are are going to be slightly higher.

Steven Miller

OffHighway with with regard to the intellectual property, we have completed our work appearing drug substance houses and apartments and the expiration date of May of 2025 is the we'll see we execute them and have exclusivity for that patent for them for a composition of matter. However, we are still evaluating whether or not to enforce the polymorph patents. And we hope to conclude that evaluation in the near future.

Jeffrey Del Carmen

And I just want to make a final comment about by cabo. One of the reasons why we like this asset losses for the financial opportunity. We believe that this compound has life significant life beyond its patent expiry because of the stickiness of epilepsy drugs of patients with epilepsy do not like to change drugs even post patent expiry. So there is a great a willingness for the patient to continue on their branded medication receive is. So there's a significant opportunity for this compound post expiration to continue to deliver good return for the Company. And that was baked into our calculus when we bought the product. So we continue to see this as a very good opportunity to serve patients and to build the balance sheet and again, help us to build our portfolio as we go forward. So we see this as a really good smart financial play and a good play for patients as well.

Leland Gershell

I think that's very helpful. And then just one question on Firdapse, if I may, I think the mention of about 500 remaining diagnosed but untreated patients. If I if I have that correctly, just wondering if you could point a ticking of hurdles and they may face in converting those untreated but diagnosed patients. So there are plenty.

Richard Daly

So we lend on a 50% about 50% of our new enrollments each month or any given quarter come from these leads. These patients that are diagnosed but never have been treated with Firdapse. We use a variety of sources to continually backfill those patients so as one patient gets converted on to on Firdapse, we find new leads to backfill those patients. So we always tried to maintain those 500 or so patient leads as far as hurdles to get on a lot of times, it's just it's a matter of these patients waiting to get into see their physicians, whether it's a three month or six month timeframe that they're waiting to get in, and that's primarily it. There are some patients within these 500 that have been on the or a patient lead for over a year. But most of these, the newer leads can be converted within 30 days. That's how we see it. But again, we backfill those patients converted with new leads over time.

Michael Kalb

I think we've learned it's all part of what we would call it. You know, this is the patient journey, and it's really dependent upon the physician and the patient and where they come in and how aggressive they want to be with their own therapy. And so once we identify them, we keep calling on the physician and working with the physician to expedite therapy if it's appropriate, but it really comes down the physician. But once we identify the physician has the patient, we can then begin to help the physicians understand the disease state and then the patient journey and how we how Firdapse can help that patient.

Leland Gershell

Appreciate the added color.
Thank you.

Michael Kalb

Thank you.

Operator

Thank you.
We've reached the end of our question and answer session.
And ladies and gentlemen, that does conclude today's teleconference and webcast. We do thank you for your participation.
You may have a nice day.