Q1 2025 Catalyst Pharmaceuticals Inc Earnings Call
Good day, everyone, and welcome to today's Catalyst Pharmaceuticals First Quarter 2025 Financial Results Conference Call.
At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the star and one keys on your telephone keypad.
Please note this call is being recorded and that I will be standing by, should you need any assistance?
Speaker Change: It is now my pleasure to turn today's program over to Mike Kalb, CFO . Please begin.
Mike Kalb: Good morning everyone and thank you for joining our conference call to discuss Catalyst's first quarter 2025 financial results and business highlights
Richard Daly: Leading the call today is Richard Daly, Catalysts, President and Chief Executive Officer Professor.
Speaker Change: We are also joined by Jeff DelCarman, our Chief Commercial Officer [inaudible]
Speaker Change: Further for the Q&A session, Dr. Steve Miller, our chief operating officer and chief scientific officer will be available for questions.
. . . .
Speaker Change: 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. Thank you very much.
Speaker Change: These statements relate to our current expectations, estimates and projections, and are not guarantees of future performance.
Dr. Prasad, Dr. Prasad, Dr. Prasad, Dr. Prasad,
Speaker Change: The involve risks, uncertainties and assumptions that are difficult to predict and may not prove to be accurate.
Speaker Change: Actual results may vary from the expectations contained in our forward-looking statements.
Speaker Change: 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 recent 2024 annual report on Form 10K filed with the SEC on February 26th, 2025.
Speaker Change: and our first quarter, 2025 Quarterly Report on Form 10-2, which was filed yesterday, May 7, 2025 with the SEC.
At this time, I'll turn the call over to Rich. Rich?
Thanks, Mike.
Good morning everyone and thanks for joining us
Speaker Change: Catalyst delivered an outstanding start to 2025 with continued excellent execution, strong demand for our rare disease therapies, and continued progress on key strategic priorities.
Speaker Change: These results highlight our sustained momentum and growing impact in the patient communities we serve.
Speaker Change: Total net revenues grew 43.6% year-over-year to $141.4 million with meaningful contributions from each of our products.
Speaker Change: These results highlight the strength of our portfolio and the effectiveness of our commercial execution.
Speaker Change: With a strong cash position of $580.7 million and disciplined operational management, we've positioned to drive long-term growth while advancing our strategic priorities.
Speaker Change: Let's turn to the specifics of our commercial performance, beginning with Ferdamps.
Speaker Change: Prasad continues to demonstrate outstanding performance, maintaining its position as the only evidence-based approved product in the U.S. for the lever to eat in myestinic syndrome, or LEMS.
Speaker Change: In the first quarter of 2025, the brand delivered another strong quarter of organic growth generating revenue of $83.7 million and increase of 25.3% year-over-year .
Speaker Change: Performance was driven by a continued adoption among newly diagnosed patients and a modest tailwind from normalized prescription activity following temporary disruptions related to the Change Healthcare Cybersecurity Inc. in quarter-1, 2024 .
Speaker Change: Michael discussed the impact of Jane Charles Cybersecurity Incident in more detail in his remarks.
Speaker Change: In addition, since the 100 milligram label expansion for furtaps approved in May 2024, we've seen an increase in the average daily dose of furtaps
Speaker Change: The 100-milligram enhancement offers provided greater flexibility to individualize therapy based on patient needs.
Speaker Change: We expect the average daily dose to increase in the near term.
Speaker Change: As we have stated in the past, approximately half of all limbs and diagnoses are associated with cancer, in particular small cell lung cancer and cancer.
Speaker Change: We continue to work with the National Comprehensive Cancer Network to improve the understanding of the relationship between LEMs and Cancer.
Speaker Change: The role of VGCC testing and the benefits of treating LEMS-associated cancer patients with
Speaker Change: These initiatives reflect our strategic approach to ascending Ferdaps's market leadership and position of the brand for durable long-term growth.
Speaker Change: This continued performance reinforces our confidence in delivering Fort Apsis 2025 net product revenue forecast of between $350,000,000 and $360,000,000.
Now turning to a gamma ray.
Speaker Change: Montgomery delivered a solid performance in Q1 2025, marking its first full year of commercial availability following a March 13th, 2024 U.S. launch.
Speaker Change: sustained organic uptake and increased confidence in the gamma rays potential as a differentiated cortical steroid treatment for Dishan's muscular dystrophy, or DMD.
Speaker Change: A Gary continues to source patients from branded and generic competitors in a balanced manner as it has since launched
And the patient retention rate remains robust. [inaudible]
Speaker Change: We believe these are indications of the market sensing a gamma's potential benefits.
Speaker Change: Prescriber engagement continues to build, supported by the full deployment of our dedicated again Refield team in April of 2025.
Speaker Change: These early commercial indicators position a gallery for broader market reach as a foundational complementary corticosteroid therapy within the evolving DMD treatment landscape.
Speaker Change: This momentum continues to support our full year 2025 net revenue forecast for a hundred million and one hundred and ten million dollars.
Speaker Change: On the clinical front, we're advancing to summit study, our five-year real-world evidence-based study evaluating long-term outcomes in DMD patients treated with a gambling.
Speaker Change: During the first quarter of 2025, the Semen study advanced with the activation of additional sites and continued progress in patient enrollment
Speaker Change: We hope that the results of the summer study will provide long-term real-world evidence of the benefits of the treatment of the gamery.
and Final Fight Compa.
Speaker Change: By compa delivered solid results in this quarter, driven by steady demand and discipline execution to maximize near-term value ahead of the anticipated generic entry on or after May 23, 2025.
Speaker Change: Net product revenue for the period was $35.6 million, representing a year over year growth of 17.1% driven by sustained performance.
Speaker Change: Strong patient preference and the product's well-established clinical role in seizure control.
Speaker Change: As we approach the end of exclusivity, we remain focused on ensuring continuity of care and managing the brand's value through well-planned transition
Speaker Change: As discussed previously, we expect a measured revenue decline post-pat next-free. Our teams are fully prepared and executing against the defined strategy to manage this evolution effectively.
Speaker Change: We believe that Phycopper remains on track to deliver on our 2025 bull year net product revenue forecast of between 90 and 95 million dollars as we continue to maximize near term value.
Speaker Change: In parallel, where you remain committed to expanding access to our rare disease therapies in markets outside the US .
Speaker Change: In January , our sub-licency, Dytopharma successfully launched Ferdaps in Japan, making it the first approved treatment for LEMS.
Speaker Change: This important milestone expands access for an estimated 1,200 LEMS patients and addresses an important unmet need in the Japanese rare disease patient community.
Speaker Change: In Canada, our sub-licency, Chi Pharmaceuticals, which also markets furtips in Canada, is advancing regulatory plans for a gamery.
Dr. Prasad, Dr. Prasad, Dr. Prasad, Dr. Prasad
Speaker Change: April of 2025, Health Canada accepted the New Drug Submission under Priority Review, with potential of approval by year end.
Speaker Change: If approved, a gallery would be the first authorized treatment for DMD in Canada addressing a patient population of more than 800 individuals and making a meaningful advance in the care of this underserved DMD community.
Speaker Change: While these license agreements are not expected to contribute materially to revenue, they are aligned with our broader mission to advance health equity by expanding access to our therapies for underserved patient populations.
Speaker Change: In January , we reached a favorable settlement with Teva, restricting US generic entry until February 25th, 2035, subject to certain conditions.
Speaker Change: Litigation with the two remaining first-fiflers remains ongoing, and remain confident in our strength, in the strength of our intellectual property portfolio .
Speaker Change: However, there could be no assurances that we will prevail in this litigation
Speaker Change: Business Development continues to be a core growth lever for Catalyst. We remain disciplined in our approach, prioritizing opportunities with strategic synergy, clinical differentiation, and the potential to drive long-term value.
Speaker Change: With a robust pipeline of evaluations underway, we believe that we are well positioned to execute transactions that further enhance our leadership in rare disease.
Speaker Change: As we advance through 2025, we remain firmly focused on executing our strategic priorities in sustaining operational excellence with a strong foundation, a high performing team, and a clear path to value creation.
Speaker Change: We believe that we are well positioned to deliver durable growth while continuing to elevate care for patients living with rare diseases.
Speaker Change: We are reaffirming our full-year total product revenue guidance of between $545 million to $565 million
Speaker Change: We believe Catalyst is well positioned to create a meaningful value for patients, healthcare providers and our stakeholders.
Speaker Change: With that, I'll now turn the call up to Jeff Del Carmen, our Chief Commercial Officer Officer.
Speaker Change: Thanks, Rich. Good morning, everyone. Q1 marked another record quarter for our commercial organization, reflecting strong execution across the portfolio, and continued demand for our innovative therapies.
Speaker Change: Is Rich mentioned, Catalyst had an excellent start to 2025, driven by the combination of sustained or scantic growth of fur daps, stable revenues from Phycompa, and the steady adoption of a gamery.
Speaker Change: Q1 Total Net Revenues of 141.4 million, Positions Catalysts Well To Achieve Our Combined 2025 Total Revenue Guidance of 545 million, and 565 million.
Speaker Change: Also, I am pleased to report that we successfully completed the commercial field team restructuring, establishing dedicated sales teams for a gamery and furtops.
Speaker Change: This realignment strengthens our focus within each therapeutic area and sets a strong foundation for future growth.
Let me walk through Key Performance Highlights by Product. [inaudible]
First, I'll start with Third Apps Performance.
Q1 Ferdaps, Net Product Revenue of 83.7 million.
Speaker Change: represents a 25.3% increase quarter over the same quarter last year. A direct result of strong new patient starts in a low annual discontinuation rate of approximately 15%.
Speaker Change: The prescription approval rates were greater than 90% across all payers, government or private commercial
Speaker Change: We continue to see strong leading indicators in April , furthering our confidence in achieving FedEx full-year net product revenue guidance of $355 million and $360 million in 2025.
Speaker Change: As we look ahead, our strategic growth initiatives remain a key driver for organic growth.
Speaker Change: We continue to maintain a pipeline of greater than 500 potential lens patients in various stages of their diagnostic journey, who have not yet started treatment with furtaps, representing roughly 50% of our new patient enrollments each quarter.
Speaker Change: Furthermore, we are particularly excited about the opportunity in Cancer Associated Lens, where we are expanding our focus to the community oncology channel, which manages the Missourity of Cancer Care in the U.S.
We are confident that potential BGCC antibody screening arrangements
Speaker Change: with GPOs in the second half of 2025. We'll help accelerate LEMS diagnosis rates in the approximately 90% of small cell lung cancer LEMS patients who are currently undiagnosed. [inaudible]
Next, I would like to discuss a canary.
Speaker Change: We are proud of the continued early market momentum of a gamery and its growing presence in the market as a breakthrough treatment for DMD, as evidenced by Q1 Net Product Revenue of 22 million.
Speaker Change: Since the commercial launch of a Gamri in March 2024, 93% of the top 45 DMD centers of excellence and 224 unique healthcare providers have submitted an enrollment form for a Gamri.
Speaker Change: We continue to see transitions to a gamery from both corticosteroid segments, 44% from prednisone, and 44% from influenza.
Speaker Change: Approximately 85% of shipments are successfully reimbursed, which is aligned with our forecast.
Speaker Change: In addition, our dedicated Gamery Salesforce is actively executing targeted educational initiatives to reinforce a Gamery's potential for differentiated value, driving durable patient uptake, and strengthening our competitive position.
Speaker Change: Gamaries Net Product Revenue for 2025 is expected to be between 100 million and 110 million, reflecting its continued market adoption and commercial momentum.
Speaker Change: Lastly, I would like to provide a brief overview of FICOMPA.
Speaker Change: By compa delivered solid Q1 net product revenues, a 35.6 million, further fortifying our revenue diversification.
Speaker Change: Looking ahead, we are closely managing the upcoming Phycompa Laws of Exclusivity. [inaudible]
Speaker Change: While we anticipate revenue impact in the second half, we have mitigation plans in place to appropriately minimize brand erosion.
Speaker Change: We remain confident in our full year 2025 net product revenue forecast for FICOMPA of between 90 million and 95 million.
Speaker Change: To summarize, our commercial organization continues to execute with precision, supported by a strong field force and focus strategies across our portfolio.
Speaker Change: Following a strong first quarter and sustained momentum across the business, we are confident in reaffirming our whole year 2025 total revenue guidance.
Speaker Change: We believe that we are well positioned to seize the growth opportunities ahead and we remain focused on driving operational excellence, enhancing patient access.
and scaling our commercial impact across our entire product portfolio.
I will now turn the call back over to Mike [inaudible]
Mike Kalb: Thanks, Jeff. Our performance during the first quarter of 2025 has set us on pace for another strong year.
Mike Kalb: driven by our solid financial performance, financial discipline, and strong execution.
Mike Kalb: with the continued success from the launch of a gallery in mid-march of 2024.
Mike Kalb: Along with the continued performance of Ferdaps and Fekampa, we have set the groundwork for what promises to be yet another strong year in 2025 and we were here for our our 2025 full year total revenue guidance that we provided in February .
Thank you.
Mike Kalb: We remain steadfast in our commitment to driving growth, leveraging strategic arrangements and expanding our portfolio to capitalize on emerging opportunities throughout the year.
Dr. Prasad, Dr. Prasad, Dr. Prasad, Dr. Prasad,
Mike Kalb: Our total revenues for the first quarter of 2025 were $141.4 million, a 43.6% increase when compared to total revenues of $98.5 million for the first quarter of 2024.
Mike Kalb: Product revenue met for our lead product, Ferdaps, was $83.7 million, a 25.3% increase year-over-year compared to $66.8 million in Q1 2024.
Mike Kalb: Primarily driven by an increase in sales volumes, a portion of which is attributed to the government.
to a delay in patient claims to certain non-Medicare payers.
Mike Kalb: In certain states, resulting from the Change Healthcare Cybersecurity Incident that occurred in the first quarter of 2024 and was resolved in the second quarter of 2024
Mike Kalb: The first quarter of 2025 also reflects a small amount of revenue, improvements to sub-licenses outside of the U.S.
Dr. Prasad, Dr. Prasad, Dr. Prasad, Dr. Prasad,
Mike Kalb: Product Revenue Net for the first quarter of 2025 for a gallery was $22 million, compared to $1.2 million in the first quarter of 2024. As mentioned earlier, a gallery was made commercially available in mid-March 2024.
The results underscore continued growth and an increase in prescribe or engagement.
Mike Kalb: Product Revenue Net for the first quarter of 2025 for Ficompo, was $35.6 million, compared to $30.4 million in the first quarter of 2024, which included a reduction in variable consideration or gross tenet.
resulting from a decrease in wholesale distribution fees in 2025.
Mike Kalb: We expect that product revenue net for FICOMPO will likely decrease once the patent protection expires, which occurs on May 23rd, 2025 for the tablets and on December 15th, 2025 for the oral suspension.
Mike Kalb: Net income before income taxes for the first quarter of 2025 was $71.3 million. A 145% increase year-over-year compared to $29.1 million for the first quarter of 2024.
Mike Kalb: We reported gap net income for the first quarter of 2025.
of $56.7 million.
or 47 cents per basic and 45 cents per diluted share. [inaudible]
An increase of 144% year-over-year
Mike Kalb: Compared to gap net income for the first quarter of 2024.
Mike Kalb: of $23.3 million or 20 cents per basic and 19 cents per diluted share.
Thank you.
Speaker Change: As a reminder in the first quarter of the calendar year, like many companies in our industry, we are impacted by the reset of patient insurance deductibles
Dr. Prasad, Dr. Prasad, Dr. Prasad, Dr. Prasad
Speaker Change: Cost of sales expense was approximately $17.9 million in the first quarter of 2025 compared to $12.5 million in the first quarter of 2024 and consistent principle of royalties.
Speaker Change: The Gamri Roathies paid to the product license or increased by 2% when a Gamri's net product revenue exceeds $100 million in any calendar year.
Speaker Change: The company is also required to make a $12.5 million milestone payment once the Gamary's net product revenue reaches $100 million.
Speaker Change: which will be capitalized once achieved and amortized as part of cost of goods sold over the remaining estimated useful life of the intangible asset.
Speaker Change: non-GAAP Net Income for the first quarter of 2025 was $86.6 million or 71 cents per basic.
and 68 cents per diluted share. [inaudible]
Speaker Change: which excludes from gap net income, amortization of intangible assets related to our acquisitions of Ficompa, a gallery and resurgie of $9.3 million.
Speaker Change: Stock-based compensation expense of $5.9 million, the income tax provision of $14.5 million, and depreciation of $115,000.
Speaker Change: that this compares to non-GAAP net income in the first quarter of 2024 of $46.8 million or 40 cents per basic and 38 cents per diluted share.
Speaker Change: which excludes from gap net income amortization of intangible assets related to our acquisitions of FACOMPA, Gamery, and Resurge, you have $9.3 million.
Speaker Change: Stock-based compensation, expense of $8.2 million, the income tax provision of $5.8 million, and depreciation of $86,000.
Speaker Change: Our effective tax rate for the first quarter of 2025 was 20.4% compared to 20% for the first quarter of 2024.
Speaker Change: We expect the 2025 annualized effective tax rate to be relatively consistent with the 2024 annual rate of 24.2%.
Speaker Change: For the first quarter of 2025, the difference to the statutory federal income tax rate of 21 percent was primarily driven by state income taxes, fluctuations in the value of investments and anticipated annual permanent differences.
Speaker Change: The effective tax rate is affected by many factors, including the number of stock options exercised in any given period and is likely to fluctuate in future periods.
Speaker Change: Further, we are required to pay royalties based on net product revenue to the product license or for FICOMPA following the loss of exclusivity which will occur later this month for tablets and in December 2025 for the oral suspension.
Speaker Change: The royalty rates are higher if there is no generic entry following loss of patent exclusivity than they are once generics enter the market.
Speaker Change: As a reminder, royalties for fur daps increased by 3% when that product sells exceed $100 million in any calendar year.
Speaker Change: As a result, we expect cost of sales to trend higher as the air progresses. Additionally, I would like to note that a camera also carries a royalty in the range of low double digit to mid-twenty
depending on sales achievements with any calendar year. [inaudible]
Speaker Change: Further details on our royalty obligations for a Gamary are disclosed in our Q-1 2025 form 10Q and are expended upon within the MDNA section.
Speaker Change: Research and Development Expense was $3.9 million in the first quarter of 2025 up from $2.6 million in the first quarter of 2024.
Speaker Change: During the three months ended March 31st, 2025, research and development expenses consisted of costs for company sponsored research and development activities.
Speaker Change: Support for a selected investigator, sponsor to research, and support for our commercial activities.
The company anticipates full year 2025 research and development expenses
Speaker Change: to range between $15 million and $20 million, excluding the impact of any additional acquisitions, reflecting investments in the summit study, and the start of initiatives to investigate the potential for a gallery's label to be expanded in the future.
Speaker Change: S.GNA expenses for the first quarter of 2025 totaled $46.9 million flat as compared to $46.9 million in Q1, 2024.
However, at this point, SGNA expenses.
Speaker Change: are expected to increase modestly over the remainder of the year. Reflecting personnel additions during 2024 and the strategic alignment of dedicated commercial teams supporting Ferdapsin and the Garmory which became effective in the start of the 2025 second quarter.
Speaker Change: As reported, we ended the first quarter of 2025 with cash and cash equivalents of $580.7 million compared to $517.6 million at December 31, 2024.
Speaker Change: The increase in cash of $63.1 million was largely driven by $60 million in cash generated from operations of our business.
Speaker Change: 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 efforts, leading to long-term growth and value creation.
Speaker Change: More detailed information and analysis of our first quarter 2025 financial performance may be found in our quarterly report.
Speaker Change: on Form 10Q, which was filed with the Securities and Exchange Commission yesterday, May 7th, and can be found in our Investor Relations page on our website at www.catalystforma.com
Speaker Change: And with that, I'll turn the call back over to Rich. Rich?
Thanks Mike.
Speaker Change: As you heard throughout today's call, Catalyst enters the remainder of 2025 with strong momentum, strategic focus, and a clear commitment to delivering value across the rare disease portfolio .
Speaker Change: We're executing with discipline, advancing initiatives that support near-term performance, taking steps to create long-term value and growth.
Speaker Change: The quarters results reflect the strength of our execution, the resilience of our model, and the depth of the talent across the organization of the organization.
Speaker Change: I want to thank our employees, partners, and stakeholders for their continued dedication.
Speaker Change: As we look ahead, I'm confident in our ability to drive meaningful impact and sustain value.
Speaker Change: Thank you for joining us today. I'll now turn the call back over to the operator for questions.
Thank you.
Thank you.
Speaker Change: At this time, if you would like to ask a question, please press the star and one keys on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2.
Once again, that is star 1 to ask a question.
Operator: And our first question will come from Joon Lee with truest securities. Please go ahead.
Speaker Change: Congrats on the quarter and the beat. This is awesome on for June . Thank you for taking the question just a couple from us.
Speaker Change: So for an episode of 25% growth from last year, how much of that would you say is strength in this quarter versus weakness in last year's 1-2 due to the change healthcare impact?
Speaker Change: And then as a follow-up to remind us of what proportion of psychoma patients are on the tablet formulation versus the oral suspension formulation. Thank you
Speaker Change: Thanks for the question. As we alluded to, there was some shift in the business due to the change healthcare. I'm going to turn it to Jeff to address the question and then Jeff will also address the fight-compa question as well. Sure, regarding the strength of the business, we always say 15-20% growth is what.
Speaker Change: We saw strong enrolments, low discontinuation rates, and we continue to see great leading indicators in April , too. Yeah, so just to really put a bow on that, if you were to back out the effect of change healthcare, you'd still be in that 15 to 20% range, that right? Absolutely. Is that clear?
Very clear, thank you, and then just on the omni [inaudible]
Speaker Change: The proportion of bi-compatations that are on the tablets, the oral suspension formulation.
Scent of Tablet for Semenkow.
It's probably about... I'm sorry. Okay.
Yes.
It's about 15, I'm sorry, it's about 98% [inaudible]
Speaker Change: Owner Normal Owner Microsoft Office Word Microsoft, Incitement Title Microsoft, Incident Title Microsoft, Incident Title Microsoft Word Document MSWordDoc Word.Document.8
Thank you, very helpful.
Thank you.
Samantha Semenukau: Our next question will come from Samantha Semenkow with City. Please go ahead.
Speaker Change: Hello, this is Benjamin Paluchon for SAM. Thanks for taking the questions. How is the uptake of third apps among small cell lung cancer patients trending? Are you seeing an impact from your patient screen efforts in this population? And how should we think about growth from small cell lung cancer versus idiopathic patients over the next several quarters?
Speaker Change: Thanks for the question, Benjamin. I'm going to turn it over to Jeff. So our current mix for all our limbs patients, certainly on furtats, about 20 to 25 percent.
R Cancer Associated Lens Patients. [inaudible]
Speaker Change: Our goal for this year is to really focus on our BGCC antibody screening arrangements with each of those in community oncologists.
Speaker Change: Transition, Onto Therapy, so that's our goal. In the long term, we expect that 20 to 25% to grow to, you know, potentially 30 to 35%.
Thank you.
Thank you. Thank you.
Thank you. Okay. Great. Thank you.
Speaker Change: Our next question will come from Joel Beatty with Beard. Please go ahead.
Thank you. Thank you.
Speaker Change: Hey, you got to come out some of the quarter and thanks for taking the questions. The first one is on business development activities and in the past you've put a lot of focus on that. I guess we're currently in a lot of people are describing as a rapidly changing macro environment. What are your current thoughts on business development and are there any recent impacts on that? Yeah.
Speaker Change: Thanks for the question, Joel. So we remain focused on our strategy, which is looking at immediately creative or nearly immediately creative opportunities.
Speaker Change: So the dynamics in the market are metting fold as you point out. We see this as a really beneficial opportunity for us.
Speaker Change: We continue to see in balance at about 80% so the opportunities that come to us are...
Speaker Change: or the opportunities we're assessing, 80% of them are coming to us, DeNovo, so we like that.
Speaker Change: The capital markets, while they're in turmoil, we think present an opportunity for us which we like as well. And then because of our strategy, looking at opportunities that are near the finish line and going commercial. That's all.
Speaker Change: We think this remains relatively unaffected by the regulatory environment and changes in the regulatory environment so we see this again as beneficial for us in the strategy that we have. So while it's unsettling, I think in general for our strategy, I think it reinforces our strategy so we feel good about where we stand as a company in the strategy that we have.
Speaker Change: Great, that's helpful to hear, then, as a follow-up on fur dabs
Speaker Change: For cancer-associated limbs, any anecdotes or things that you've seen working at a smaller scale perhaps that helps give you confidence in the strategy that you're taking to increase the diagnosis rates of the antibody and see that lead to treatment. Thank you.
Speaker Change: So when you say smaller scale, can you clarify? Thank you.
Speaker Change: It's just something that you've maybe been able to kind of...
Speaker Change: Test and certain locations, I'm trying to get into the antibody test. Are we still kind of early in these efforts, but you know, but just anything right this is a maybe another way to ask is that you've had a lot of success and non-cancer associated loans marketing, but this is a different approach. So what kind of gives you confidence that you can be successful in this setting as well.
Speaker Change: Great, okay, so let me start and then I'll turn it over to Jeff. So I think what you're asking is have we in our dialogue with the oncology community, have we seen interest in this? And the answer is a definite yes.
Speaker Change: We're talking to these larger groups, you know there's been a consolidation of these oncology practices in larger groups and our dialogue with these oncology groups we're seeing a definite interest in is because they realize that as Jeff has alluded to in previous discussions 90% of the patients with small cell lung cancer
Speaker Change: Associated Lams are not getting treated and so they see the dynamic, they see the unmet clinical and medical need and so when we talk to them about it and the ability to diagnose and then thus treat with a definitive treatment, there is a definite interest but Jeff, you're closer to the subject, you want to address it? Absolutely, there have been significant ad boards that have been done with these thought
Speaker Change: over the last year or two years. So, like Rich mentioned, significant interest among these key opinion leaders.
Speaker Change: and also our goal is to help provide frictionless testing for these patients.
Speaker Change: So that these 90% of patients that are undiagnosed can't get tested and hopefully diagnosed in those discussions these physicians again they see the unmet need for these small cell lung cancer patients
So, there's significant interest out there in the oncology community
You all have been helpful.
Speaker Change: I just want to correct one thing. I believe I've been spoke before when the question came up about the split between solid tablets is actually 85% so I apologize. So it's 85% are tablets and 15% is oral solution on site compa, so my apologies to the group.
Thank you.
Charles Duncan: Our next question will come from Charles Duncan with Cantor Fitzgerald. Please go ahead.
Charles Duncan: A morning rachian team, first of all, congratulations on the first quarter of performance. Secondly, thanks for taking our question.
Speaker Change: or I guess the new to brand or new patients starts come from that pool. I'm wondering if you could give us some color on, you know, how you're setting that guidance if I, if I look at color to 15% growth.
Speaker Change: That thus far this year, that's that's closing in on 390, not 360. So I'm wondering what what is the source of your conservativeism with regard to fur-damps?
Speaker Change: Yeah, Yeah, I mean in terms of new patient adds or persistence or growth in average daily dosing.
Speaker Change: We eat.
Speaker Change: Where do you where do you stand on what the most important trigger areas.
Speaker Change: Okay, adjusting I'll take that yeah, Hey, Charles good morning, as far as what I can talk about are the leading indicators for us in our core business.
Speaker Change: And we've seen it over the last 15 quarters now that 15% growth and like you mentioned, the 500 patients or so that our pipeline of patients that are somewhere in their diagnostic journey for lens.
Speaker Change: We have significant resources or sources to find continue to backfill the patients after they get on therapy to find new lean. So that we always have about 500 or discontinuation rates remained low at 15%.
Speaker Change: Over time, we see what our trend is for our net new patients each month any given quarter. So that's what helps inform us about where our growth is in our confidence. So this is our six year out. So we kind of understand where the trend is and where we're headed so thats what gives us confidence hopefully that helps.
Speaker Change: Charles I don't know if there is any a follow up question that you can asset can point me in the direction that you want me to go.
Charles Duncan: No I think that's good I understand the confidence, but I definitely think it's conservative my perspective, maybe we'll move on to <unk> com.
Charles Duncan: And that is you mentioned measured revenue declined and that makes sense for for an epilepsy.
Charles Duncan: Indication.
Charles Duncan: You said that this year you have measures in place.
Charles Duncan: Could those measures also apply to next year I know youre not guiding to next year, but.
Charles Duncan: Is it inherent in the use of my comp that use may continue for those for those patients into next year.
Charles Duncan: Charles there tends to be a stickiness for lack of better terms for.
Charles Duncan: For anti seizure medications.
Charles Duncan: There there is an opportunity there for patients two or two <unk>.
Charles Duncan: <unk> brand erosion over time.
Charles Duncan: We haven't given guidance as you mentioned for next year.
Charles Duncan: But yes, I mean, there is an opportunity to minimize brand erosion continuing into next year I think the challenge with that Charles is dead.
Charles Duncan: This six month exclusivity period ends at the end of this year and then we.
Charles Duncan: While we don't know what we would expect additional generics to enter the market and at that point, while we Havent gears, Jeff has alluded to we haven't given guidance for 2026.
Charles Duncan: No the way that.
Charles Duncan: Prices inversely proportional to the number of players in the generic market. So I think it just becomes tougher to control.
Charles Duncan: Okay last question on Biz Dev.
Charles Duncan: Helpful color.
Charles Duncan: So far but in terms of the market.
Charles Duncan: The environment it does seem like it favors your approach.
Charles Duncan: Your cash position I'm wondering if you have specific goals for this year to get a transaction done or is it something you don't want to commit to at this point.
Charles Duncan: I would I wouldn't say, we have a specific goal to get a transaction done we have a specific goal to get the right transaction done or REIT transactions done.
Charles Duncan: I think we've been very very good as a company in bringing in the appropriate assets and we want to continue that trend.
Charles Duncan: We want to make sure we bring in the right assets.
Charles Duncan: We've looked at a lot of opportunities.
Charles Duncan: And for a number of reasons, they don't fit us and they don't make sense for us.
Charles Duncan: It would be.
Charles Duncan: Unfortunate for us to bring in an opportunity that didnt fit us culturally financially structurally and so all of those things have to fit and we are I think a very discriminating buyer of assets.
Charles Duncan: Acquirer of assets and we want to continue that because we think that's beneficial for shareholders.
Charles Duncan: Fisher for us as a company and so.
Charles Duncan: I'm not trying to parse words, but we have a goal to do the right deal.
Speaker Change: Okay. Thanks for taking all my questions.
Charles Duncan: Thanks for your support too as well.
Charles Duncan: Thank you.
Speaker Change: Our next question will come from Rohit <unk> with Oppenheimer. Please go ahead.
Ron: Hi, This is Ron on for Leland good Phil Thanks for taking the question and congrats on another really strong quarter.
Ron: Just one for me on a gallery as you see the stomach study progress what aspects of the <unk> profile do you think will resonate most with prescribers.
Ron: Especially those who have yet to incorporate it into their own practice. Thank you.
Ron: Thanks, Gary.
Speaker Change: We have Gary engineered our Chief Medical Officer online Gary do you want to take that question.
Speaker Change: Thank you rich, yes, Rob I think that the.
Speaker Change: The demonstration of bone health bone density.
Speaker Change: And the effects on cardiac.
Speaker Change: We'll be some of the key findings.
Speaker Change: That confirm the differentiation of the Gambari, which we see based upon our.
Speaker Change: Preliminary data and we will do it again in the long term with the real world evidence.
Speaker Change: Got it and just a follow up.
Speaker Change: Have you sort of plan to quantify that.
Speaker Change: Summit.
Speaker Change: So in sum that we will be looking at fracture rates.
Speaker Change: Loan age.
Speaker Change: Bone density.
Speaker Change: And development or prevention.
Speaker Change: Cardiomyopathy.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Thanks, Ron.
Speaker Change: Our next question will come from Jason <unk> with Bank of America. Please go ahead.
Speaker Change: Oh, Hey, guys.
Speaker Change: Sorry, I joined late and missed everything so far on the call. So apologies. If this has been addressed but just can you remind me with the strength of the third quarter. Just wondering if theres any pull forward at all I'm just trying to think through the quarterly progression of sales and <unk>.
Speaker Change: Furthermore, if you can speak to.
Speaker Change: Whether you are starting to see.
Speaker Change: <unk> performance of the small cell lung adoption on the LM side there. Thanks.
Jason: Jason Thanks so.
Speaker Change: We'll turn that first part of the question over to Mike and then we'll turn the second part of the question over to Jeff, Yes, Hey, Jason. Thanks for the question. Thanks for the support.
Jason: On <unk> Q1, and we did note it.
Jeff: I would look at it as let's start with we've said consistently 15% to 20% growth and we maintain that notwithstanding the strong growth in Q1. Some of the Q1 'twenty five compared to Q1 'twenty four is actually the Q1 2000 and for change healthcare cyber security incident and that impact timing into into Q2.
Jeff: So if you back that out Jason just to clarify if you back out what happened in 2020 Q1 'twenty four we are still in the range of a growth of about 15% to 20%.
Jeff: Is that helpful.
Jeff: Yes.
Jeff: Great and then.
Speaker Change: You just asked the second question. So we're all clear on where we stand for your second question.
Jeff: Yes.
Jeff: How <unk> may have been impacted at all sort of the momentum you're seeing on the small cell lung.
Jeff: <unk> pick up.
Jeff: Relative to I guess baseline our year on year comp.
Jason: Sure. So Jason let me get you the baseline where we're at it's about 20% to 25% of our current <unk> patients are cancer associated lens patients. Our main focus this year is too.
Jason: Get BGC antibody screening arrangements in place with community Oncologists Gpo's.
Jason: And where we expect to see growth in the percentage of our patients to be cancer associated lens.
Jason: <unk> will be in 2026 and beyond so that's where we expect that.
Jason: The opportunity to be realized more so again this year, we're hopeful that we can help those 90% of patients that are currently on diagnosis small cell lung cancer lung patients that are diagnosed we want to help them get tested and diagnosed.
Jason: Got it okay. Thanks, so much.
Jason: Thanks, Jason.
Jason: Thank you.
Speaker Change: Our last question will come from Sudan, Logins with Stephens. Please go ahead.
Speaker Change: So Dan please make sure that youre not muted.
Speaker Change: Yeah.
Speaker Change: I am sorry, congrats on the call. This VL exposure didn't look Nathan.
Speaker Change: I had a quick question on ADEPS.
Speaker Change: Given the high.
Speaker Change: Percentage of the undiagnosed lens patients.
Speaker Change: Can you please give us color in terms of the.
Speaker Change: Proportion of.
Speaker Change: The penetration that you have so far on Fedex.
Speaker Change: And what will contribute.
Speaker Change: The percent penetration to increase given that you have initiative to increase diagnosis.
Speaker Change: Thanks for the question. So we've said.
Speaker Change: Recently.
Speaker Change: J P. Morgan Conference. We said, we believe that size of the market is about $1 $2 billion.
Speaker Change: In today's prices and no price increases et cetera. If you just look at our sales last year about 300.
Speaker Change: And that.
Speaker Change: That would mean, we have about a 25% market penetration across the board. So we believe there is significant upside in this market for us and this consistent growth that Jeff alluded to the 15% to 20% we've experienced.
Speaker Change: For some time, we believe that we can sustain that.
Speaker Change: And given this cancer associated lumps initiatives and continuing to push on the idiopathic side, our non cancer associated lens. We believe that there is a significant opportunity to continue to grow this market and we're really excited about it Jeff any comments.
Jeff: So like Rich mentioned I mean significant opportunity on both are in both segments of the lens prevalence.
Jeff: We expect to see more opportunity to help the small cell lung cancer lens patients moving forward.
Jeff: Right now the idiopathic lens the penetration is strong however, there is still plenty of opportunity.
Jeff: The 500, or so pipeline patients those patients that are somewhere in their diagnostic journey. The vast majority of those patients are idiopathic lantus patients. So we have plenty of opportunity to help them in the short term as well so both segments significant opportunity remaining.
Speaker Change: Thanks, Alex appreciate it any other questions. Thank you.
Jeff: No questions from my side. Thank you very much. Thank you. Thank you.
Speaker Change: Ladies and gentlemen, this does conclude today's program and we appreciate your participation.
Jeff: May disconnect at any time.
Jeff: Okay.
Jeff: [music].
Jeff: Okay.
Jeff: [music].