Q2 2025 Catalyst Pharmaceuticals Inc Earnings Call

Greetings, and welcome to a catalyst Pharmaceuticals second quarter, 2025 Financial results conference call.

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 during the conference, please press. Start and zero on your telephone keypad.

As a reminder, this conference is being recorded.

I would now like to turn the conference over to the Chief Financial Officer. Mike kelb. Please go ahead sir.

Thank you. Good morning everyone and thank you for joining our conference call to discuss catalyst's second quarter 2025 Financial results and business highlights.

Richard Daly, president and CEO will lead the call today. And Jeffrey Del Carmen our chief commercial officer and I will also present

Additionally, Dr. Stephen Miller, our chief operating officer and chief scientific officer, and Dr. Will Andrews our chief medical officer will be available for the Q&A.

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 before looking statements for purposes of federal Securities laws.

These statements reflect our current expectations, as estimates and projections, and do not guarantee future performance.

They involve risks uncertainties and assumptions that are difficult to predict and may not prove to be accurate.

Actual results May Vary from the expectations contained, in our forward-looking statements.

These forward-looking statements should be considered only in conjunction with our detailed information contained in our SEC filings, including the risk factors described in our 2024 Annual Report on Form 10-K filed with the SEC on February 26th, 2025.

At this time, I'll turn the call over to rich rich.

Thanks, Mike. Good morning, everyone, and thank you for joining us.

Catalyst delivered another record-setting quarter in Q2 2025, with total revenue reaching $146.6 million, an increase of 19.4% year-over-year.

For the first half of 2025, total revenue, grew 30.2%, to 288 million, reflecting, strong execution, and sustained demand for our differentiated portfolio.

We needed the second quarter of 2025 with the cash position of 652.8 million reinforcing our abilities to invest strategically for long-term growth.

Based on strong leading indicators, we remain confident in our trajectory and believe that we are on track to achieve our full-year 2025 revenue guidance of $545 million to $565 million.

Our outstanding progress is underpinned by the balanced performance of our commercial portfolio, which continues to deliver consistent growth and a positive impact on patients.

Let's dive deeper and start with F.

For apps generated net product, revenue of 84.8 million in Q2 2025 a growth of 7.5 million versus Q2 2024.

As we discussed in our q1 2025 earnings call last year's second quarter results, reflect the timing impact of the February 2024, change Healthcare cyber security breach on our year-over-year growth rate.

The temporary impact of the change Health Care security breach, which shifted volume from q1. 2024 to Q2 2024 was fully resolved by the end of June 2024.

As a result, we believe that comparing fruit apps, first, half 2025 performance to the same period in 2024 provides the most accurate view of the franchises continued strength.

Importantly, the underlying demand remains strong consistent and durable here to date. F says delivered 168.6 million in net product Revenue, representing a 16.9% increase, over the first half of 2024 in 2025, our sales of fur apps have returned to their expected Cadence and we reaffirm our full year. 2025 product, net product Revenue, guidance of 355 million to 36060 million

we are confident that FS remains well, positioned for sustained, organic growth supported by consistently High prescription, approval rates, a robust pool of patients, progressing through their diagnostic Journey,

This strong and visible demand, underscores underscores the durability of our franchise and reinforces our leadership and addressing the needs of the limbs patient community.

To unlock the next phase of growth for fur apps. We are actively advancing a focused expansion strategy, centered on education of hcp's supported by the recent updated. Nccn guidelines.

Since we believe that potentially 90% of cancer Associated LMS, patients, remain undiagnosed. We see a meaningful opportunity to expand our reach in this high potential underserved population.

We expect momentum to build in the months ahead setting a stage for a sustained growth in 2026 and Beyond.

Jeff will cover the specifics in his section of the call.

While Fred apps continues to perform. Well, we're equally encouraged by the accelerating adoption and performance of a gamery.

Gamry continues to outperform, expectations generating 27.4 million in net product, Revenue in Q2 2025.

A new post-launch high and a 213% increase year-over-year from Q2 2024.

First half net, revenues reached 49.4 million up, 398% from the prior year, driven by Steady conversion from both PA Zone and in Plaza, a strong 90% patient retention rate and growing adoption across the duchin centers of excellence.

The Gams commercial execution is tracking well with strong patient retention and increasing prescriber engagement.

Further supported by our full deployment of our dedicated field team.

Continued transitions from both branded and generic therapies along with growing market receptivity and payer alignment reinforce our confidence in meeting our full year outlook.

Backed by focused commercial strategy. Again, me is well positioned to continue momentum

We are reaffirming yams full year 2025, net product Revenue, guidance of 100 million to 110 million.

Let's switch to FICO.

25 with revenue of 34.3 million reflecting a year-over-year, decrease of 6%.

First half 2025 Revenue, reached 70 million up 4.5% from the same period last year.

We anticipate the impact of generic competition going forward, and our full-year net product revenue guidance of $90 million to $95 million for Faba remains unchanged.

We recently strengthened our corporate and board leadership.

I'd like to formally welcome Dr. Will Andrews as our new chief medical officer. We'll join Catalyst on June 2nd 2025, we'll bring deep pharmaceutical. Expertise in rare diseases, spending clinical development medical Affairs, Business Development and portfolio strategy.

His leadership will ensure a scientific rigor and operational excellence, as we continue to differentiate a game within the duchin, treatment landscape and further solidify our position in the limbs community.

Will's role in leading our medical function is foundational to ensuring the long-term success of our portfolio.

For the Gamery, Will is leading the Summit study, which aims to generate real-world evidence and support the appropriate use of the Gamery.

To date. The study has initiated 19 sites with patient enrollment progressing.

As the study progresses, we will provide updates when the interim data becomes available.

In parallel will is overseeing the execution of our Phase. 1. Study comparing a game pre-done into Plaza Court to determine a potential switching algorithms.

Additionally, we are working to assess the immunosuppressive effects of a gamry that could help us Define the life cycle management potential for of a gamry.

Initial results are expected by the end of 2025 to early 2026.

Will's expertise in insights are also also enhanced our strategic perspective as we advance growth initiatives, aligned with our long-term vision.

This past Monday. We announced that Dr. Dan Curran joined our board of directors.

We are pleased to welcome Dr. Curran to our board of directors, he brings deep experience in rare disease, and a strong track record in business development and strategic growth.

Is experienced advancing transformative therapies, and building value across the development, Continuum aligned, well with our mission and growth strategy.

On the business development and IP fronts. We remain. Highly disciplined. In employing, our business development strategy, actively evaluating a broad range of opportunities that align both strategically and financially with our long-range plan.

Our commitment to Value driven growth is unwavering and we are confident in our that our focused and deliberate approach will position us to capitalize on the right opportunities. In parallel, we are advancing on our initiatives to protect and enhance the long-term value of our portfolio.

We are still awaiting a trial data on in our ongoing patent litigation for fur apps with our remaining first filers, but anticipated to be in Q4 2025 or q1 2026.

We expect more clarity on this issue on or after our Markman hearing which is scheduled for October 7th, 2025.

We remain committed to updating our performance related to environmental social and governance reporting in June. We published our 2024 ESG report underscoring, our commitment to sustainable, growth and responsible innovation,

This report is available on Catalyst website.

In summary, we are entering the second half of 2025 with strong momentum. We have clearly defined growth drivers and a focused strategy to deliver long-term value and impact for patients.

With that, I'll turn it over to Jeff who provide additional insights into our commercial performance.

Thanks Rich. Q2 marked another record setting quarter for our commercial organization. Underscoring continued strong execution across the portfolio and sustained demand, and for a differentiated Therapies.

As Rich noted Catalyst, delivered sustained, organic growth from third apps, strong revenues from by compa and accelerating adoption of a gamry.

Q2 net product revenue of $146.5 million puts us firmly on track to meet our 2025 guidance, reflecting the strength of our Neuroscience business.

Bird apps Remains the only evidence-based FDA approved treatment for Lambert. Eaten my aesthetic syndrome.

The brand continues to perform well across both neurology and our emerging oncology segments.

Bird apps continues, its strong, multi-quarter growth trajectory driven by durable demand and consistent execution.

Prescription approval rates remained above 90%, across both, government and Commercial, payers and discontinuation rates, were in line with expectations.

These indicators, reflect strong, patient, adherence, and reinforce the foundation for sustained performance.

Leading indicators including steady growth in new patient starts and refill. Volume through July continued. To Trend, positively reinforcing our confidence in achieving full year 2025 FS Revenue guidance.

We continue to advance our patient identification efforts and continue to have a pool of over 500 lens patients in active diagnostic stages.

These patients consistently account for approximately half of new starts each quarter, giving us confidence in driving sustained, organic growth.

To further, unlock the next phase of growth. Third apps. We are actively advancing a focused expansion strategy, centered on hcp education which is supported by the recently updated. Nccn guidelines for small cell lung, cancer, broadening access to vgcc, antibody testing.

Streamlining, the diagnostic Journey.

And accelerating adoption across oncology and neurology settings.

By improving diagnosis, particularly in small cell, lung cancer patients.

And increasing recognition of patients, often misdiagnosed with Mastin gravis.

We hope to meaningfully expand, the addressable population and tries to stay in growth within what we believe is a more than 1 billion dollar addressable Market opportunity.

As we advance these priorities, we are implementing a 3-step program of targeted initiatives designed to enhance diagnostic access in clinical recognition across key market segments.

First.

We are deploying a frictionless testing model, that makes it easier for Physicians and particularly oncologists.

To order vgcc antibody screening directly within their practices.

Eliminating referral delays and helping to significantly reduce time to diagnosis.

These efforts, represent progress in advancing important diagnostic initiatives, to help improve lm's, patient outcomes, and accelerate the adoption of fur apps.

Second.

We are pleased to share that ahead of schedule. The nccn published updated guidelines for small cell, lung cancer on July 25th.

Which now include bgcc antibody testing and recommend that amaan should be considered as a treatment for cancer patients with limbs.

This Milestone strengthens our ability to expand access accelerate diagnosis and help drive further apps adoption in oncology.

Most importantly, it represents meaningful progress in improving care for cancer. Patients, living with lens.

Our third step involves forging, strategic Partnerships with leading oncology practices to update care Pathways which are generally structured plans. That outline the steps and interventions required for patient care, ensuring standardized and efficient treatment for specific conditions.

We plan to execute comprehensive education and promotion programs.

to ensure broad understanding and integration of the Care pathways

Due to the early updating of the nccn guidelines. We are accelerating our investment in educating hcps on the new guidelines and working to incorporate Diagnostic and treatment recommendations into the care. Pathways in targeted large group oncology practices.

Since we believe that potentially, 90% of cancer Associated lens, patients, remain undiagnosed.

We see a meaningful opportunity to expand our reach in this high potential underserved population.

We expect momentum to build in the months ahead setting the stage for sustained growth in 2026 and Beyond.

Turning to a gamery.

A gamery continues to demonstrate strong early Market momentum as a differentiated treatment for duchan muscular dropi.

In Q2 2025, net product revenue was $27.4 million.

Continues to expand.

Key centers.

Date 93% of the top 45. DMC centers of excellence.

And 231 unique Healthcare Providers, have submitted enrollment forms.

in Q2 approximately 43% of patients, transition from prednisone in 42% from enlaza,

Underscoring, a gamer's broad clinical relevance across standard treatment segments.

Reimbursement, success remains high at approximately 85% consistent with our expectations.

Our commercial and Medical Teams. Continue to drive targeted. Provider education, and payer engagement supporting durable, uptake and sustained Market expansion.

By compa delivered, Q2 2025, net product, revenue of 34.3 million reflecting continued demand. Despite the first generic approval for tablets following a loss of exclusivity in late May

As previously noted, we do expect Revenue erosion from generic competition to impact by competent performance. In the second half of the year and Beyond

That said, based on a strong first half performance in the execution of our mitigation strategies, we are reaffirming our full year 2025 fmpa, Revenue guidance.

In summary, our commercial and Medical Teams continue to execute with discipline and focus.

Delivering strong portfolio performance.

While advancing the next wave of our growth led by firdapse is expansion into Unity.

We believe that we are well positioned to seize the growth opportunities ahead.

And we remain focused on driving commercial execution, excellence.

enhancing patient access and scaling our commercial impact across our entire

product portfolio.

I want to thank the entire team at Catalyst for their unwavering commitment to the patients. We serve and look forward to a successful second half of 2025.

With that, I'll turn the call back over to Mike.

Thank you, Jeff. Our performance, during the second quarter of 2025 has kept us on Pace for another strong year.

Driven by our solid financial performance, Financial discipline and strong execution.

With the continued success of our Flagship product fur apps as well as a strong growth of a gamry which we launched in mid-march of 2024 and the solid performance of a compa which currently has only 1 generic competitor for the tablets following the patent expiry in May of 2025, we have set the groundwork for what promises to be yet another unparalleled year in 2025.

We are reaffirming our 2025 full year total revenue guidance as initially provided in February and reaffirmed in May.

We remain steadfast in our commitment to driving growth and expanding our portfolio to capitalize on emerging opportunities throughout the year.

Our total revenues for the second quarter of 2025, were 146.6 million and approximate 19.4% increase. When compared to Total revenues of 122.7 million for the second quarter of 2024 product Revenue net for our lead product for apps was 84.8 million. A 9.7% increase year-over-year compared to 77.4 million.

As a reminder, the second quarter of 2024 benefited from the change Healthcare cyber security incident that occurred in the first quarter of 2024, which is evidenced by the fact that our growth in that product, Revenue preferred apps for the first half of 2025. Compared to the first half of 2024, was 16.9%

Product Revenue, net for the second quarter of 2025 for ficoa was 34.3 Million compared to 3 6. 5 2 4,

Revenue, net, in the second quarter of 2025 for gamry was 27.4 Million as compared to 8.7 million in the second quarter of 2024, representing a year-over-year increase of approximately 213%,

Of 2024.

we reported gaap net income for the second quarter of 2025 of 52.1 million or 41 cents per diluted share,

Gaap net income increased by 27.7% year-over-year compared to gaap. Net income for the second quarter of 2024 of 40.8 million or 33 cents per diluted. Share non-gaap net income for the second quarter of 2025 was 86.4 million or 68 cents per diluted share.

Which excludes from gaap net, income amortization of intangible assets related to our our Acquisitions of fmpa.

Again and resurgent, 9.3 million.

Stock-based compensation expenses of $7.6 million.

Income tax provision of $17.2 million, and depreciation of $100,000.

that this compares to non-gaap net income, for the second quarter of 2024 of 69.6 million or 56 cents per diluted share,

Which excludes from gaap. Net income amortization of intentful assets related to our Acquisitions of FICO a Gamay, and resurgent 9.3 million

f***. These compensation, expense of 4.4 million, the income tax provision of 15.0, million dollars and depreciation of $100,000.

our year-to-date effective income tax rate, through the first half of 2025, was 22.6% compared to 24.5%, through the first half of 2024,

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.

if sales expense was approximately 20.6 million in the second quarter of 2025,

Compared to 15.4 million in the second quarter of 2024, this consisted principally of royalties.

As a reminder, a gamry royalties paid to the product license, or equal 5% of net sales up to $100 million.

7% of net sales in excess of $100 million and up to Millions.

With additional increases as net sales, increase Beyond dollars.

The company is also required to make a 12.5 million sales-based Milestone payment once again, Gams net product Revenue reaches, 100 million,

That this Milestone payment when earned will be capitalized in the advertised over the estimated remaining useful life of the asset.

Research and development. Expenses were 4.4 million in the second quarter of 2025 up, 46% from 3.0 million in the second quarter of 2024.

R&D spending in the second quarter of 2025, was comprised mainly of costs to support our ongoing gamry studies.

Selling General and administrative or sgna expenses for the second quarter of 2025 totaled. 45.9 million compared to 40.7 million in the second quarter of 2024,

The increase in sgna expenses for the second quarter of 2025.

Is primarily driven by increased Personnel costs including the implementation of 2 dedicated sales forces for third absent, a gamry, which became effective on April 1st 2025.

As reported at June 30th 2025. We had cash and cash equivalents of 652.8 million compared to 517.6% 2024.

The increase in cash of 135.2 million was primarily driven by 131.3 million and cash generated from operations of the business.

Underscoring, our continued focus on profit optimization and strong cash flow generation.

We believe our current funds along with our anticipated continued generation of cash from operations.

Continue to provide us with 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.

More detailed information and Analysis of our second quarter, 2025 financial performance, may be found in our quarterly report on form, 10 Q which was filed with the Securities and Exchange Commission. Yesterday, August 6th, 2025 and can be found on the investor relations page on our website.

At this time, I will turn the call back over to Rich.

Thanks Mike, as we look ahead Catalyst remains focused on and confident in our ability to drive S sustained growth and long-term value. We are executing a clear strategy rooted in a strong commercial Foundation, our focus and execution will continue to drive our performance and enable us to deliver on our commitments while making a meaningful difference for patients.

Our teams are energized by the opportunities ahead, and we remain committed to delivering differentiated therapies with operational excellence and responsible growth.

Thank you to our Catalyst teams for their, unwavering dedication to patients and to all of you for your continued support.

We look forward to continuing to execute our growth initiatives as we advance into the second half of 2025.

I'll now turn the call back over to the operator. Thank you.

Thank you, sir.

Ladies and gentlemen.

I'll be conducting.

If you would like to ask a question, please press star, then 1.

Confirmation tone will indicate your line is in the question queue? You may press star and then 2. If you would like to remove your question from the queue,

Again, if you would like to ask a question, please press star and then 1 now.

First question that we have comes from Samantha Samano of City Bank, please go ahead.

Hi, good morning, and thanks very much for taking the questions, a couple first on F apps. Um, can you speak more about your strategy for educating oncologists on the lens opportunity and I'm curious. Uh, what metrics are you using to track the success of the campaign and then, as you continue to focus on the oncology opportunity. When do you expect that segment of the business to begin representing? A greater proportion of revenues versus historical experience. I believe in the past you said it's about 28 to 25% of revenues come from oncology patients. Thank you.

Thanks Samantha. Appreciate the question. I'm going to turn that to Jeff. Jeff. Do you want to take on sure. Hi Sam. Good to hear from you.

You know, as we noted in in the script, I think the our approach to oncology in the addressable Market there for cancer Associated limbs. The first thing we really wanted to do was, you know, increase the the, uh, provide frictionless testing for these patients. And we were able to make that happen where oncologists and and all ages could order our no-cost, vgcc antibody tests within their office. So that a that shortened the uh the the time to uh the D diagnostic.

Secondly, the nccn guideline changes.

So you heard that in July 25th that those changes happen. So those were the first 2 steps,

And now we're working on working with the group practices and uh, trying to uh, put together some arrangements with them to Pro, uh, for screening. So that's the third step. How are we going to educate? These Physicians? We're focused on digital marketing and media.

We're also doing congresses and conferences.

And uh, publication plan working with our medical team on that.

To do abstracts as well. So those are the the things that we're doing to help. Educate Physicians about this uh, important opportunity to um, diagnose LMS patients, how we're going to track? It is through increased, vgcc antibody testing from oncologists, we're also tracking it. Like you said, we anticipate an increase over time of our mix of patients that are cancer associated with patients.

The this year, our primary goal is to increase screening for cancer Associated lens patients. 90% of these patients are undiagnosed. So if we can help these patients get diagnosed, then we anticipate a larger address for Market that we should start seeing, uh, a an increase in that percentage in 2026 and Beyond. So that's, that's how we're, uh, looking at this Sam.

Penis zone or for Med Plaza to a Gamay. I'm wondering how do you plan to leverage this data as you commercialize the Grammy I or is it for additional uh studies that you're planning? Just any context you could share. That would be very helpful. Thank you.

Thanks Sam. Um, I'm going to turn that over to will Andrews our chief medical officer. Um, obviously, we're looking at the we'll be looking for the data and I think a lot of that will determine how we leverage it. So obviously this study is ongoing. So I think it becomes a little challenging to, to answer your question directly, but will do you want to take that? Yeah. Thank you Rich, and hello Sam. Um, the study, uh, is an exploratory trial and we are looking forward to seeing data uh later this year in the early into 2026 and uh that data will describe uh, be be descriptive and we'll help indicate. Um, whether we need to do future studies to further delineate, uh potential switching Etc.

Understood. Thanks very much for the question.

Thank you Sam. Thank you.

Congrats on the quarter and thanks for taking the questions. This is awesome on for June just a couple from us.

And and then as a follow-up on further apps just help us think about this growth over the next few quarters. Should we still be expecting a mid teens growth rate on a year-to-year basis? Thank you.

Sasha, I think again, it's Jeff's gonna answer that question. So, thanks for the question, Jeff. Thanks for the question. You know, like you said, we we deployed dedicated sales forces for both a gamry and third apps in April. So, beginning in the second quarter, what we've seen is still too early to tell, but you, you know, based on performance, you can see that there are increased engagements, um, that have taken place. We we we're also deeper relationships now Within These accounts and um, also more frequent interactions with many of the healthcare provided uh, providers in our targeted positions.

We're also seeing it from our leading indicators, you know, as I mentioned on the call, you know, and with fur apps. We're we're exceeding or meeting and exceeding, um, the enrollments thus far in in July. So very strong and we're also have a strong pipeline there, uh, with a game, too. You know, we've seen the 231 unique positions that have enrolled.

Since launch. So that also increased from the second quarter. So very, um, very uh, satisfied with with the results thus far, and we'll continue to track that moving forward, as far as performance for fur apps and and what you should expect. We reiterated guidance, uh, for the balance of this year and also, like, I just mentioned the strong leading indicators. So, um, we, we do believe, um, in, in our business, in the foundation of our business, preferred apps. So we expect continued,

Thank you.

The next question we have comes from Jason Jason, Gary of Bank of America, please go ahead.

Hey guys, thanks for taking my questions. Um, a couple for me just

uh given all that's going on with 11s in the um uh I guess non-ambulatory group of patients and some of the um, commentary earlier in the year around queuing, I'm just kind of wondering how that

Impacts the quarterly kinetics of game rate, uptake if at all.

Uh, and then with third apps, uh, wondering if you just maybe comment on sort of the the time lag, uh, for uh, the nccn recommendation to have more of a, an impactful commercial impact. Thanks,

Jason, thanks so much.

Um so we from a commercial perspective we'll take the 11th question we'll turn it over to Jeff and if there are more of a clinical uh we'll have will jump in on that but uh Jeff you want to take that 1 first? Thanks for the question Jason and with a gamery. Um, and steroids specifically, they are the foundation.

Treatment for these boys living with DMT. So, the impact of the unfortunate news about the 11th, um, really hasn't impacted much the use of steroids, and we do strongly believe that a Gamry is a choice.

we see the the new additions to the nccn guidelines, as critical to help us for for levitus

For DMD. Oh yes, I'm sorry in the second question was nccn. Yes, on on 11th is I, I would add medically that. I, I agree with Jeff from the prospective of that being an entirely different modality of treatment. Um, and as Jeff said, it's unfortunate as to what's happened, but we still see. Of course, uh, corticosteroids and the Monet, as foundational treatment for these, uh, kids that is unaffected, We Believe by what's happened with 11 is um, to answer your second question on the nccn guidelines. We see that as critical to helping educate oncologists clinical oncologists on the disease and and very importantly on how to better diagnose the disease and that Ami am. Aiden is a critical um option for them in the treatment.

They have uh well the way we see the Cadence working out Jeff and the team have done a really good job of getting this frictionless testing in there, which we believed was the first step so that position can order the the test and the report will come to their office prior to this the patient had to actually go to a remote site, get a test and then get the test results themselves.

So that's the first step and guideline really is the bridge to care Pathways within the practice. So as we get this out there and it was just released obviously last week we get this out there, the opportunity again is to work through those oncology practices, get the nccn guidelines embedded as the standard and nccn is the true standard within oncology, get that embedded. And then be begin talking to the uh, to the the group practices about how they want to use it. And how we can be supportive. And then, as Jeff mentioned earlier, on an earlier question, those educational efforts, working hand in hand with the gpo's and then beyond the gpo's as well. Become important, Jeff.

Thanks, Rich and and Jason your question. When do we expect this to to hit commercial? Uh, an increase?

Um, some of the revenue, you know, the way we look at this again is increased screening this year and then next year with more patients.

thankfully being diagnosed the addressable marketing increases and then that can help uh, with the um,

Uh, treatment with fur apps. So, we expect that to take place, probably in the second half of next year. And, and Beyond is, when we start seeing converting some of these diagnosed patients onto FedEx therapy.

Hopefully, that helps.

Yep, thank you.

Thanks Jason.

Thank you. Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then 1.

The next question we have comes from Leland Gel of Oppenheimer. Ian Cole, please go ahead.

Oh, great. Good morning and thanks for taking our questions. Um, just, uh, 1 from us, uh, just on, on Opex. Um, maybe for for Michael just wondering, you know, given the, um, realignment in the sales for, uh, for dapps and a gamry affected, a few months ago, just wondering how you see, um, sbna expense rolling forward. It looks like it was pretty flat-ish from q1 to Q2. Just wondering, if, if we should see a bit of a bump, um, you know, any increase into, uh, the second half. Thank you.

Thanks. So I went to hope all as well. Um,

So we, as you know, we did not quantify sgna guidance. We, we did, uh, talk qualitatively at the, at the beginning of the year, some of the folks that we had hired were were in, uh, obviously a little before April 1. So I think the flat is, is, is a little bit to what we'd expect, but to your point with the acceleration of the nccn guidelines, I do think that we will uh, we will see a little bit of an uptick in the second half.

Okay. Great. Thanks for taking the question.

Thanks.

Thank you.

The next question we have comes from Luke.

Bed, please go ahead.

Hey guys, thanks for taking the question. Uh, 2 from me, first on the change Health disruption. I was wondering if you could share your thoughts on whether all the Loose Ends have been closed here or if there's potential for any future anomalies.

And then second, um,

Recently, language from the administration on farms and tariffs has obviously been constantly evolving. I see the first apps are manufactured in the U.S. and Canada. And I think you've had a process underway to consider the addition of third-party manufacturers for a Gamry. I guess, has there been any recent evolution in thinking around the manufacturing strategy?

Um, so the change Healthcare uh, issue. Uh the disruption we saw there really was, as we mentioned in the, in the script really was a pull sort of a push into the second quarter of 2024.

um, we we believe and we see it the the the natural Cadence of of furth apps

Returning post June of 2024.

And now we believe that effect is washed through the system. So we're very confident about that because we can see uh because of our Specialty Pharmacy relationship uh we can see what's happening there at a very granular level. You may remember uh in our second first quarter call in May last year, we mentioned that, we saw it the day, it began to happen so we were able to take rapid action so having that Specialty Pharmacy is a real benefit for us.

On the Tariff side, you are correct. When you think about the volume of sales, uh, based on our guidance, about 66% of sales, come from furred apps as it relates to our guidance for the year. And we've we feel really well protected there. And you are also correct on working with third-party manufacturers for a gamer and transitioning that to the us. And we were working on that. Well before this current Administration came in into play. So we're we're confident we'll be able to do that in the, in the near term. But uh, it's it's still going to take a while to actually validate the plant, but we feel really good about the opportunity to, uh, Shield that from, uh, tariffs as well.

Well, in the mid to long term, because of the ability to move it to the U.S.

Great. Thank you.

Thanks.

Thank you.

The next question we have comes from Jennifer Kim of council. Please go ahead.

Hi, good morning, thanks for taking my questions. Um, maybe to start with for that. Are there? Any are, is there any color you can give around the average dose? You've reached for the quarter and maybe expectations, um, on that growth for the rest of the year. And then anything, you can say about this continuation rates for the quarter.

Jeff, do you want to take that? Sure. Thanks Rich. And uh, yes. The uh, first I'll answer the, the discontinuation rates discontinuation rates were, um, below 20%, the annual discontinuation rate, uh, 20% for third apps. So, um, hopefully, were you asking about, um, Jennifer, were you asking about F specifically on discontinuation?

Yeah.

Less than 20% annual discontinuation.

And what was your first question again? Dose the dose. So since the label expansion in June of last year, we have seen significant increase to the average daily dose. Um, approximately about 4 milligrams, which is what we have expected.

so we we, um, the the dose is performing according to what we had uh,

Question on CY compa, um, I think right now Teva is. Is the only generic for the oral tablet? That's launched. I just want to clarify. Do they have

Uh, 100 day exclusivity and I asked because I wonder whether guidance could prove to be on on the conservative side for that product.

So, uh, Teva is the only player in the space. Uh, right now for a generic they have 180 days. Exclusivity, um,

as to whether or not the guidance is

too conservative. Um, so far, as we mentioned in the call, we've booked 70 million dollars in sales. Our, um, guidance is 90 to 95, however, we think that there's an opportunity to be cautious here, because, uh, this is a significant risk. Um, if, uh, there is another generic player that could come into the market,

And they have we have not seen them yet. Uh and so we're

thinking, what we believe is a prudent position for the balance of the

And we will expect generic additional generic competitors by mid December and as you know, Jennifer sometimes they can load the channel into November and so that could affect our xfactory sales. So we believe this is a prudent approach to, uh, the forecast.

Okay, that's helpful. All right, thanks guys.

Sure, thank you.

Thank you.

Ladies and Gentlemen, Just a final reminder, if you would like to ask a question, please press star and then 1 now.

The next question we have comes from Sudan, Logan Chan of Stevens Inc, please go ahead.

Grow in this space, and then secondly, what is your current stance on the near-term strategic initiatives to offset fee? Are there any ongoing discussions with potential partners regarding a commercial-stage asset or a late-stage pipeline asset?

I think appropriate to turn that to Jeff for the first part. Yes, we done. Uh, just uh, like similar to a levitus, you know, the way we look at this is, um, a gamry and steroids are the foundation of treatment. Um, trans Lana does not, um, impact that at all. So we we just continue to feel strongly about a gamer's potential moving forward because we do believe it is the best and differentiated steroid out there, for boys, living with DMD. And as far as well. I'm sorry. See that, could you just repeat your question? I lost you for a second. Repeat. Second question.

Yeah so the second 1 was just a your current stance on the near term strategic initiatives to offset the fight comp eloe. If there's any ongoing discussions with the other commercial stage asset or late stage pipeline that said that you're kind of leaning towards in this uh marketing environment or um you know how you're viewing that going forward.

Thanks for clarifying. Um, so uh, on our business development front, as we look to offset, we think of our business into 2 elements, right? The business development front bringing in new assets. We are incredibly busy. We believe this is probably 1 of the best buying environments we've seen in the last 15 or 20 years. And our team is uh, assessing multi

Multiple opportunities at any point in time. Um, and as mentioned on previous calls, we continue to see 80% of the opportunities, uh, coming to us inbound. So,

Other companies will approach us or other parties will approach us about opportunities. So a really excited about building, continuing to build a portfolio.

In addition to that a second pillar of our business is life cycle management and when we talk about the opportunity, uh around a gamry looking for opportunities to better understand the molecule and how it might play in the orphan and rare space, we continue to do that work. And on the commercial front in diversifying, our opportunities with fur apps, we believe the oncology play uh and the dedicated sales force can continue to work to offset uh the loss of Phi comp.

I appreciate that. Thank you.

Thank you.

Thank you.

Ladies and gentlemen.

Brings an end to all question and answer session. Thank you for joining today's conference. You may now disconnect your lines.