Q1 2025 Theravance Biopharma Inc Earnings Call
Moving to slide four and beginning on the left hand side you Pal re delivered solid results in the first quarter with net sales, increasing 6% to just over $58 million.
This performance was driven by a similar increase in demand as well as favorable pricing and channel mix.
Building on the strong momentum we experienced in 2024 hospital doses increased 48% year on year.
We are steadily advancing cypress trial, consistent with our objective of enrolling the right patients at high performing sites and are pleased to be nearing the completion of the planned enrollment into the open label portion of the study.
Shifting to the randomized withdrawal portion of the study we are laser focused on ensuring that we optimize those factors that are within our control, including study power and patient experience.
Based on our current projections, we anticipate enrolling the final patient into the open label portion of the study by late summer with topline data available approximately six months later.
Our overarching objective remains to deliver the highest quality result possible in order to bring this once daily selective norepinephrine reuptake inhibitor to a rare disease population of roughly 40000 U S patients with MSA, the desperately need new options.
<unk> to address their symptoms of NIH as well as thousands more around the world.
And finally, our positive outlook for trilogy, and our strong financial position remain unchanged on April 30, GSK reported another strong quarter for trilogy with global net sales up 14%, placing us comfortably on pace to achieve the higher 50 million.
Milestone from royalty pharma in 2025, we ended the quarter with $131 million in cash and remain committed to returning excess capital to shareholders.
Rhonda: Now I'll turn the presentation over to Rhonda to cover your <unk> performance in the quarter Rhonda.
Rick: Thanks, Rick.
Speaker Change: Let's turn to slide six you'll.
Rhonda: You'll see that the fair of Anson the interest commercial partnership turned in another strong quarter <unk> performance.
Rhonda: Overall net sales increased 6%, which is driven primarily by demand growth as well as pricing and channel mix improvements since the first half of 2024.
Rhonda: As we've communicated our first quarter has historically been impacted by seasonality not only for you Perry that across other maintenance COPD products.
Rhonda: If demand and overall net sales continue to improve throughout the year.
Rhonda: On slide seven.
Jason: Jason to the importance of the community Channel African volume our.
Rhonda: Our hospital performance continues to be a key strategic differentiator and contributor to <unk> growth.
Rhonda: We achieved record high volume in the quarter with approximately 316000 units pull through the hospital channel, which was up 48% year over year.
Rhonda: This was our strongest quarter launch to date in the hospital setting and demonstrates the impact of our focus on continued success in securing formulary wins and therapeutic interchange protocols.
Rhonda: The strong hospital performance remains critical to the overall brand strategy, specifically in transitioning our growing number of <unk> hospital patients the community maintenance cure.
Rhonda: Moving to slide eight.
Speaker Change: There continues to be significant future potential with <unk>.
Speaker Change: Recent market research conducted with Beatrice supports additional demand growth along with the sizable remaining addressable patient population.
Speaker Change: Our joint brand strategies continue to increase both the adoption of concomitant use with Lama LABA therapies as well as switches teu powering from handheld only regimens.
Speaker Change: Patients may have difficulty receiving the full benefit of those medications and could be better served with once daily Neb utilization.
Speaker Change: We're also encouraged by our success in improving fulfillment and are confident that we can expect continued progress across adherents persistency and overall claim approvals.
Speaker Change: <unk> remains a foundational durable and highly profitable asset.
Speaker Change: It continues to demonstrate strong brand momentum across both the hospital and community channels.
Speaker Change: Sales up 6% in the most recent quarter and expanding margins.
Speaker Change: The potential for a $25 million near term milestone extended IP protection through 2039 in the U S.
Speaker Change: And future royalties and milestones from China, We believe <unk> is well positioned to deliver long term sustainable value to their advanced and our shareholders.
Speaker Change: At this point I'll turn things over to <unk> for a quick update oncology disease.
I'll: Thanks, Rhonda I'll begin on slide 10, where I'll discuss our potential third milestones for trilogy in Q1, which is typically the lowest quarter of the year GSK reported $854 million in sales up 14% year over year.
I'll: This puts us on track to achieve the $50 million milestone this year, which is tied to achieving $3 4 billion in annual sales.
I'll: The brand continues to experience strong growth as evidenced by the quarter and recent all time highs in script volume.
I'll: As a result, we remain confident in achieving the higher end milestones totaling $150 million in 2025, and 2026 with consensus estimates materially exceeding the sales threshold to achieve these milestones.
I'll: Of note consensus estimates are about 2025, and 2026 have increased by approximately 100 million since our last earnings call in February.
I'll: Reflecting continued confidence in the brand's growth trajectory.
I'll: Turning briefly to slide 11, where we continue to see substantial long term value of metrology royalties.
I'll: As a reminder, these royalties return to us in 2029.
I'll: While it's still several years away that data is steadily approaching now just four years out.
I'll: The combination of a shortened time horizon and continued strong brand performance gives us greater clarity and confidence in the future value of these royalties.
Andre: With that I'll pass it to Andre to provide an ample oxiclean update on you.
Andre: Thanks Aviv.
Speaker Change: Again, my covering our phase III <unk> study on slide 13, we continue to focus on quality as we advance towards completion of enrollment and the Cypress study.
Speaker Change: Our efforts remain centered on ensuring the right patients are enrolled at the right sites with close collaboration across our network of leading academic institutions and MSA centers of excellence.
Speaker Change: <unk> for their high touch approach to patient engagement.
Speaker Change: This disciplined data driven approach supports our overarching goal of generating high quality data to maximize the likelihood of a successful outcome and one that reflects the therapeutic potential of <unk>. We are now nearing the end of the open label period of the study unexpected enrolled the last patient by late summer.
Speaker Change: Based on our expectations around achieving database lock and finalizing our initial analysis, we expect to share top line results of approximately six months after we complete enrollment.
Speaker Change: Drawing your attention to the bottom of the slide is the Cypress study is comprised of two phases. A 12 week open label period, followed by an eight week randomized withdrawal periods. We have included an enrichment strategy. During the open label period in order to identify patients benefiting from <unk> and to optimize the population and <unk>.
Speaker Change: In the randomized withdrawal portion of the study.
Speaker Change: This randomized withdrawal phase is critical it's the components that evaluates the sustained efficacy of <unk> and will deliver the data needed for regulatory submission.
Speaker Change: We believe our thoughtful and rigorous execution intended to deliver a sufficient number of patients through the randomized withdrawal period positions us well to advance our robust data package that if positive would ultimately support a new treatment option for patients with MSA a community urgently in need of effective therapies.
Speaker Change: On slide 14, I'll provide a quick update on our activities and recent and upcoming medical conferences.
Speaker Change: We had a highly productive American Academy of Neurology meeting last month, where we presented important new analysis of our prior phase III program.
Speaker Change: Findings from these nozzles supported <unk> highly selective mechanism of action and its pharmacodynamic effects over time.
Speaker Change: Resulting in durable target engagement and a physiological effect outstanding blood pressure.
Speaker Change: In addition, an office in 24 hour ambulatory blood pressure findings show that umbrella oxygen did not exacerbate supine hypertension, and 70 169 potentially a meaningful differentiator in this population.
Speaker Change: And this weekend. We are also excited to participate in the international MSA Congress in Boston at this conference. We are presenting analysis based on a pre specified MSA sub population from study 117, as well as an analysis highlighting the high symptoms and quality of life burden Moh places on these patients.
Speaker Change: Finally, turning now to the bottom of the slide I want to highlight that we are making excellent progress on key module of the NDA in parallel with the ongoing study we already have a substantial body of work complete this which enables us to compile and offer significant portions of the NDA ahead of the slide for three days.
Speaker Change: This proactive approach positions us to move quickly and efficiently towards an expedited regulatory submission should cypress be positive.
Speaker Change: At the time of filing we also intend to request a priority review to accelerate the potential path to approval.
Speaker Change: Now I'd like to turn the call back to <unk> to cover our financial performance and outlook disease.
Speaker Change: Thanks, Sonya beginning with the quarterly results slides 16, and 17 cover the detailed financials on.
Speaker Change: On slide 18, I'll highlight our quarterly performance, which was generally in line with expectations.
Speaker Change: Starting with collaboration revenue, we reported $15 4 million up 6% year over year.
Speaker Change: Importantly, <unk> brand level cash profitability grew at a faster rate than collaboration revenue, reflecting our disciplined approach to investment and focus on margin expansion.
Speaker Change: Operating expenses, excluding share based comp increased to $25 million this quarter.
Speaker Change: On the R&D side growth was driven by increased Cyprus patient enrollment and incremental NDA and regulatory activities.
Speaker Change: SG&A growth was primarily due to incremental prelaunch commercial and medical affairs related initiatives ramp blocks.
Speaker Change: These increases were as expected as we near full enrollment for the Cypress study and move closer to the data readout and NDA filing next year.
Speaker Change: As a reminder of the NDA and regulatory activities reflect onetime incremental spending to facilitate the completion of a majority of the NDA prior to data readout.
Speaker Change: Share based comp expense decreased 7% year over year, driven by ongoing cost cutting initiatives.
Speaker Change: Lastly, we ended the quarter with $131 million in cash and no debt.
Speaker Change: The increase to cash in the quarter reflects the receipt of the $50 million trilogy milestone payment from royalty pharma, which was received in February.
Speaker Change: On slide 19, I will cover our 2025 financial guidance.
Speaker Change: Following a detailed review of potential tariff measures announced by the current administration, we do not anticipate any material impact to our ongoing operations at this time.
Speaker Change: Accordingly, we are reaffirming all financial guidance metrics.
Speaker Change: Looking ahead to the remainder of the year for R&D, we anticipate a decline in clinical trial costs in the second half.
Speaker Change: The study moves to completion, partially offset by continued incremental spending to complete the majority of the NDA ahead of the Cypress data readout for.
Speaker Change: For SG&A, we are anticipating relatively flat or slightly lower expenses for the remainder of the year with continued spending on prelaunch commercial and medical affairs activities for <unk>.
Speaker Change: Recurring non-GAAP loss and cash burn excluding the impact of any potential milestone, we expect both metrics to improve throughout the year, especially in the second half driven primarily by continued growth in <unk> net sales and slightly lower cost.
Speaker Change: However, we do expect a one time tax payment in Q2 related to the receipt of the $50 million trilogy milestone.
Speaker Change: We'll reflect a one time increase the cash burn in Q2 relative to Q1.
Speaker Change: Excluding this payment, we expect cash burn to improve sequentially throughout the year.
Speaker Change: Note that this one time tax payment in Q2 will not affect the P&L given that we ever have already accrued for this expense in prior periods.
Speaker Change: Finally, and more broadly regarding potential tariff implications at this time, we do not expect any material impact to our value drivers.
Speaker Change: <unk> milestones and royalties are based on net sales rather than Cogs, which is where tariffs would apply from an accounting perspective, So our trilogy economics would be unaffected.
Speaker Change: <unk> also remains well positioned with U S based manufacturing and an efficient cost structure.
Speaker Change: <unk> given that the product is not yet approved we have time to respond to any future policy trade policy or trade developments.
Speaker Change: That said the broader situation remains fluid.
Speaker Change: Settlement reflects what we know today and could change if there are material shifts in policy or action from the administration.
Speaker Change: Given the lack of formal guidance on the evolving policy landscape, we won't be providing additional specifics until there's more clarity.
Speaker Change: With that I'll pass it back to Rick to conclude Rick.
Speaker Change: Thanks for fees to wrap up on slide 20, we continue to execute our strategy with focus and remain well positioned to deliver value across the portfolio.
Speaker Change: As <unk> indicated we ended the quarter in a strong financial position with $131 million in cash and no debt.
Speaker Change: The opportunity to earn up to $150 million of additional trilogy milestones and 25 and 2026 as well as significant royalties, which return in 2029 and extend through the mid Thirty's.
Speaker Change: <unk> remains a core growth driver and we're focused on improving its financial contribution of fair events, while advancing towards key economic milestones. We're on track to achieve one time $25 million U S. Milestone good sales reached $250 million in the calendar year as well as a seven.
Speaker Change: $5 million milestone should <unk> received approval in China.
Speaker Change: Finally, <unk> presents a truly transformational opportunity for our company the.
Speaker Change: Cypress Phase III study is now entering its final stretch.
Speaker Change: We expect to complete enrollment in the open label portion by late summer and to deliver top line data from the randomized withdrawal portion about six months later.
Speaker Change: Guided by our clinical results to date and constructive ongoing dialogue with the MSA community our confidence in <unk> commercial prospects continue to grow.
Speaker Change: Meanwhile, we continue to lay the groundwork for an expedited NDA submission and broadened awareness through disease state education and targeted stakeholder engagement.
Speaker Change: We look forward to sharing Cypress results soon and are now ready to take your questions operator.
Speaker Change: Thank you.
Speaker Change: Once again, if you would like to ask a question you may do so by passing the star key followed by the digit one on your Touchtone phone.
Speaker Change: As listening via the webcast. Please mute audio on your webcast advisory for asking a question over the phone.
Speaker Change: If you are using a speaker phone for todays call. Please make sure.
Speaker Change: Your mute function is turned off to allow your signal to reach our equipment again Thats star one if you'd like to ask some questions and we'll pause for a moment and assemble the roster.
Speaker Change: We'll have our first question from Marc Frahm from TD Cowen.
Speaker Change: Your line is open.
Marc Frahm: Hi, Thanks for taking the question maybe.
Marc Frahm: One kind of on a.
Marc Frahm: On April <unk> and then.
Marc Frahm: Follow up on.
Marc Frahm: On the commercial performance of Rhonda.
Marc Frahm: To start on the <unk>.
Marc Frahm: Appreciate your comments that you have some time before.
Marc Frahm: NDA has even filed let alone let alone launching the product in the U S. You had some time to maybe adjust to whatever policies may come out.
Marc Frahm: Can you just give us a status update like where the current plan for and manufacturing is in terms of locations and then and where the IP resides is that in Ireland or warehouse.
Marc Frahm: <unk> already been placed in the United States.
Marc Frahm: Yes.
Marc Frahm: Thanks Mark.
Speaker Change: For the question, yes, the IP for <unk> currently is in is in Ireland.
Marc Frahm: Manufacturing of the API is.
Marc Frahm: Is outside the United States.
Marc Frahm: Taiwan so.
Marc Frahm: We will.
Marc Frahm: Obviously, we've got a lot of time to adjust.
Marc Frahm: What.
Marc Frahm: Where supplies are et cetera, but we feel pretty good about where we are right now and the flexibility that we've got.
Marc Frahm: Okay.
Marc Frahm: And then.
Marc Frahm: Rhonda.
Marc Frahm: Slide you presented in the performance of <unk>.
Marc Frahm: Your team the hospital team.
Marc Frahm: Tremendous in terms of the growth that we're seeing there over the past year.
Marc Frahm: What efforts are.
Marc Frahm: You kind of tweaking over time to maybe try to increase the rate at which those hot.
Marc Frahm: Hospital.
Marc Frahm: Prescriptions.
Marc Frahm: Turning to filled chronic prescriptions once the patient leaves.
Marc Frahm: Yes.
Speaker Change: Thanks Mark.
Marc Frahm: Got you appreciate the work and results the team is delivering.
Marc Frahm: The importance and the critical nature of that transition of care patient given the increasing volume of hospital patient is obviously the whole purpose of why we are focused and that site of care and in partnership with the interest at the local geographies. The teams are working.
Marc Frahm: Very closely not only in recognizing where patients are leaving the hospital with a script in hand to ensuring that they're getting the support to patient fulfillment programs getting that patient to the right tests element.
Marc Frahm: Site, and then ensuring that follow up with what the maintenance cure.
Marc Frahm: Is a handoff and very very close partnership that's occurring at the local level.
Marc Frahm: But I guess any case as you are.
Marc Frahm: As youre doing that handoff any refinements that are happening here because it does seem that it's been a few quarters of the.
Marc Frahm: Real strength in the hospital.
Marc Frahm: I appreciate it takes time to translate into the broader franchise, but it does seem to be.
Marc Frahm: Maybe not completely translated.
Marc Frahm: Yeah.
Marc Frahm: Oh definitely where we're seeing it translate juicy and have very clear understanding of the best practices, that's occurring in those local geographies.
Marc Frahm: As you can imagine with sales team members when theirs.
Marc Frahm: A known entity and what's working and an award winning territories, there's others that want to employ those strategies.
Marc Frahm: So I would say our hospital.
Marc Frahm: Transition of care voucher program.
Marc Frahm: It really plays a critical role in ensuring that not only in the health care provider has high confidence of making the right decision for ensuring that patient leaves with respect in hand, but that they will move very quickly and easily turn into their fifth element and onto maintenance care. So it's a matter of ensuring that where those territories.
Marc Frahm: We're having great success that the teams are very clear on what works and those individual situations.
Marc Frahm: Okay. Thank you.
Marc Frahm: Thank you.
Speaker Change: Our next question comes from the line Julian Harrison from BTG.
Speaker Change: Your line is open.
Speaker Change: Hi, This is ray on for Julien. Thank you for taking our question just a couple for US first on <unk> have you received any feedback yet from payers on umbrella occitane and NIH or is that something that will likely occur after topline data from cypress.
Speaker Change: And on that point what endpoints.
Speaker Change: Payers to be most receptive to.
Speaker Change: Okay.
Speaker Change: Ron do you want to take a.
Speaker Change: Quick shot at that and then I'll follow up.
Speaker Change: Yes. Thanks Ram for the question as you would likely anticipate we have started engagement with with payers to ensure not only they have an appreciation of the of the significant need and the burden of this disease has on patients so that they fully appreciate.
Speaker Change: What role a therapy like ample occitane can serve in this patient population.
Speaker Change: And we're working very closely to ensure that education on the endpoint and likely scenarios of data.
Speaker Change: Hi.
Speaker Change: But from from the study readout itself.
Speaker Change: The messaging and the reaction and questioning and additional educational support that they may need and a poster paywall situation that they are armed with the right data.
Speaker Change: Sales and support so we're definitely very active in that space now, but obviously, we've got a bit of time to ensure that we have that segment and critical element and access setup.
Speaker Change: Got it thank you I think clearly.
Rhonda: Just to complement what yes, what rhonda.
Speaker Change: Is that.
Rhonda: For <unk> the team the.
Rhonda: The breadth of the composite score in terms of the overall well being.
Rhonda: Of the of the patient and their ability to function et cetera. These are this is very meaningful and thus all the composite broad composite score as well as the elements of the composite this has not been demonstrated before so it can be a significant.
Rhonda: A significant advantage.
Rhonda: Really for us and obviously, a significant benefit for patients as well as caregivers given the nature of the components of the composite score.
Speaker Change: Got it thank you and if I could ask one on <unk> could you provide us with an update on the paragraph four filings.
Rhonda: The settlement has been reached for all parties.
Speaker Change: Yes, sure we've settle.
Speaker Change: We've settled with five of the eight filers, we have three outstanding litigants.
Speaker Change: No other update other than outside of that.
Speaker Change: Got it thank you.
Speaker Change: Okay.
Speaker Change: Thank you. It appears we have no further questions on the phone.
Speaker Change: I would like to turn the conference back to Mr. William.
Speaker Change: Go ahead Sir.
Speaker Change: Yes. Thank you very much operator, and thank you for joining us today and the questions that you've asked and we look forward to keeping you updated.
Speaker Change: Through the course of through the course of the year as we approach a very exciting period for the company. Thank you.
Speaker Change: This concludes today's conference call. We thank you for your participation you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: Yeah.
Speaker Change: [music].
Speaker Change: Sure.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Thank you.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Yes.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: [music].
Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Right.
Speaker Change: Yes.
Speaker Change: Sure.
Speaker Change: Sure.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Thanks.
Speaker Change: Okay.
Speaker Change: Great.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Thank you.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Thanks.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Thanks.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Thanks.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Hi.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Thanks.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Sure.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Hi.
Speaker Change: [music].
Speaker Change: Thanks.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Sure.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Sure.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Hello, ladies ladies and gentlemen, good afternoon.
Speaker Change: Like to welcome everyone to the fair advantaged Biopharma first quarter 2025 conference call.
Speaker Change: During the presentation, all participants will be in a listen only mode.
Speaker Change: <unk> session will follow the company's formal remarks.
Speaker Change: That's question <unk>.
Speaker Change: The Star key followed by the digital one AGA phone again that is star one to ask a question.
Speaker Change: If listening via webcast. Please mute audio on your webcast advisory for asking a question over the phone.
Speaker Change: I will repeat these instructions after management completes their prepared remarks also today's conference is being recorded.
Speaker Change: And now I would like to turn the call over to Rick Winningham, Chief Executive Officer. Please go ahead Sir.
Speaker Change: Good afternoon, and welcome to <unk> Biopharma first quarter 2025 earnings results Conference call.
Speaker Change: On slide two you will find our forward looking statements disclaimer, which cover a certain risk factors, which could cause actual results to differ materially from any forward looking statements we might make in today's call and which are described further in our filings with the SEC.
Speaker Change: Moving to slide three I'm joined today by Rhonda, Florida, Chief business Officer and.
Speaker Change: Jim Miller head of development and as these swaps Chief Financial Officer.
Speaker Change: Moving to slide four and beginning on the left hand side <unk> delivered solid results in the first quarter with net sales, increasing 6% to just over $58 million.
Speaker Change: This performance was driven by a similar increase in demand as well as favorable pricing and channel mix.
Speaker Change: Building on the strong momentum we experienced in 2024 hospital doses increased 48% year on year.
Speaker Change: We are steadily advancing cypress trial, consistent with our objective of enrolling the right patients at high performing sites and are pleased to be nearing the completion of the planned enrollment into the open label portion of the study.
Speaker Change: Shifting to the randomized withdrawal portion of the study we are laser focused on ensuring that we optimize those factors that are within our control, including study power and patient experience.
Speaker Change: Based on our current projections, we anticipate enrolling the final patient into the open label portion of the study by late summer with topline data available approximately six months later.
Speaker Change: Our overarching objective remains to deliver the highest quality result possible in order to bring this once daily selective norepinephrine reuptake inhibitor to a rare disease population of roughly 40000 U S patients with MSA, who desperately need new options.
Speaker Change: <unk> to address their symptoms of NIH as well as thousands more around the world.
And finally, our positive outlook for trilogy, and our strong financial position remain unchanged.
Speaker Change: April 30th GSK reported another strong quarter for trilogy, with global net sales up 14%, placing us comfortably on pace to achieve the higher 50 million dollar milestone from royalty pharma in 2025, we ended the quarter with $131 million in cash.
Speaker Change: And remain committed to returning excess capital to shareholders.
Speaker Change: Now I'll turn the presentation over to Rhonda to cover your <unk> performance in the quarter Rhonda.
Rhonda: Thanks, Rick.
Rhonda: If you turn to slide six you.
Rhonda: You'll see that the fair of Anson Beatrice commercial partnership turned in another strong quarter of <unk> performance.
Rhonda: Overall net sales increased 6%, which is driven primarily by demand growth as well as pricing and channel mix improvements since the first half of 2024.
Rhonda: As we've communicated the first quarter has historically been impacted by seasonality not only for <unk>, but across other maintenance COPD products.
Rhonda: If demand and overall net sales to continue to improve throughout the year.
Rhonda: On slide seven.
Rhonda: In addition to the importance of the community Channel African volume.
Rhonda: Our hospital performance continues to be a key strategic differentiator and contributor to <unk> growth.
Rhonda: We achieved record high volume in the quarter with approximately 316000 units pull through the hospital channel, which was up 48% year over year.
Rhonda: This was our strongest quarter launch to date in the hospital setting and demonstrates the impact of our focus and continued success in securing formulary wins and therapeutic interchange protocols.
Rhonda: The strong hospital performance remains critical to the overall brand strategy, specifically in transitioning our growing number of <unk> hospital patients to community maintenance cure.
Rhonda: Moving to slide eight.
Rhonda: There continues to be significant future potential with <unk>.
Rhonda: Recent market research conducted with Beatrice supports additional demand growth along with the sizable remaining addressable patient population.
Rhonda: Our joint brand strategies continue to increase both the adoption of concomitant use with Lama LABA therapies.
Rhonda: As well as switches Teu powering from handheld only regimens.
Rhonda: Where patients may have difficulty receiving the full benefit of those medications and could be better served with once daily Neb utilization.
Rhonda: We're also encouraged by our success in improving fulfillment and are confident that we can expect continued progress across adherents persistency and overall claim approvals.
Rhonda: <unk> remains a foundational durable and highly profitable asset.
Rhonda: It continues to demonstrate strong brand momentum across both the hospital and community channels with sales up 6% in the most recent quarter and expanding margins.
Rhonda: With the potential for a $25 million near term milestone extended IP protection through 2039 in the U S.
Rhonda: And future royalties and milestones from China, We believe <unk> is well positioned to deliver long term sustainable value to their advanced and our shareholders at.
Rhonda: At this point I will turn things over to <unk> for a quick update ontology disease.
Speaker Change: Thanks, Rhonda I'll begin on slide 10, where I'll discuss our potential third milestones for trilogy in Q1, which is typically the lowest quarter of the year GSK reported $854 million in sales up 14% year over year.
Speaker Change: This puts us on track to achieve the $50 million milestone this year, which is tied to achieving $3 4 billion in annual sales.
Speaker Change: The brand continues to experience strong growth as evidenced by the quarter and recent all time highs in script volume.
Speaker Change: As a result, we remain confident in achieving the higher end milestones totaling $150 million in 2025, and 2026 with consensus estimates materially exceeding the sales threshold to achieve these milestones.
Speaker Change: Of note consensus estimates are about 2025, and 2026 have increased by approximately 100 million since our last earnings call in February.
Speaker Change: Reflecting continued confidence in the brand's growth trajectory.
Speaker Change: Turning briefly to slide 11, where we continue to see substantial long term value of metrology royalties as.
Speaker Change: As a reminder, these royalties return to us in 2029.
Speaker Change: While it's still several years away that data is steadily approaching now just four years out.
Speaker Change: The combination of a shortened time horizon and continued strong brand performance gives us greater clarity and confidence in the future value of these royalties.
Andre: With that I'll pass it to Andre to provide an ample oxiclean update on here.
Speaker Change: I'll begin by covering our phase III <unk> study on slide 13, we continue to focus on quality as we advance towards completion of enrollment and the Cypress study.
Speaker Change: Our efforts remain centered on ensuring the right patients are enrolled at the right sites with close collaboration across our network of leading academic institutions and MSA centers of excellence.
Speaker Change: <unk> for their high touch approach to patient engagement.
Speaker Change: This disciplined data driven approach supports our overarching goal of generating high quality data to maximize the likelihood of a successful outcome.
Speaker Change: That reflects the therapeutic potential of <unk> we.
Speaker Change: We are now nearing the end of the open label period of the study unexpected enrolled the last patient by late summer.
Speaker Change: Based on our expectations around achieving database lock and finalizing our initial analysis, we expect to share top line results of approximately six months after we complete enrollment.
Speaker Change: Drawing your attention to the bottom of the slide is the Cypress study is comprised of two phases.
Speaker Change: 12 week open label period, followed by an eight week randomized withdrawal periods. We have included an enrichment strategy. During the open label period in order to identify patients benefiting from <unk> and to optimize the population enrolled in the randomized withdrawal portion of the study.
Speaker Change: This randomized withdrawal phase is critical it's the components that evaluates the sustained efficacy of <unk> and was delivered the data needed for regulatory submission.
Speaker Change: We believe our thoughtful and rigorous execution intended to deliver a sufficient number of patients through the randomized withdrawal period positions us well to advance our robust data package that if positive would ultimately support a new treatment option for patients with MSA a community urgently in need of effective therapies.
Speaker Change: On slide 14, I'll provide a quick update on our activities and recent and upcoming medical conferences first we had a highly productive American Academy of Neurology meeting last month, where we presented important new analysis of our prior phase III program findings from these analyses supported <unk> highly selective mechanism of <unk>.
Speaker Change: And it's firm of dynamic effects over time.
Speaker Change: Not an enjoyable target engagement and a physiological effect outstanding blood pressure in.
Speaker Change: In addition, an office in 24 hour ambulatory blood pressure findings show that <unk> did not exacerbate supine hypertension, and 70 169 potentially a meaningful differentiator in this population.
Speaker Change: And this weekend. We are also excited to participate in the international MSA Congress in Boston at this conference. We are presenting analysis based on a pre specified MSA sub population from study 117, as well as an analysis highlighting the highest symptoms and quality of life burden <unk> places on these patients.
Speaker Change: Finally, turning now to the bottom of the slide I want to highlight that we are making excellent progress on key modules of the NDA in parallel with the ongoing study.
Speaker Change: I already have a substantial body of work completions, which enables us to compile and order a significant portions of the NDA ahead of the slide for three days.
Speaker Change: This proactive approach positions us to move quickly and efficiently towards an expedited regulatory submission should cypress be positive.
Speaker Change: At the time of filing we also intend to request a priority review to accelerate the potential path to approval.
Speaker Change: Now I'd like to turn the call back to <unk> to cover our financial performance and outlook.
Speaker Change: Thanks, Tanya beginning with the quarterly results Slide 16, and 17 cover the detailed financials on slide 18, I will highlight our quarterly performance, which was generally in line with expectations.
Speaker Change: Starting with collaboration revenue, we reported $15 4 million up 6% year over year.
Speaker Change: Importantly, <unk> brand level cash profitability grew at a faster rate than collaboration revenue, reflecting our disciplined approach to investment and focus on margin expansion.
Operating expenses, excluding share based comp increased to $25 million this quarter.
Speaker Change: On the R&D side growth was driven by increased Cyprus patient enrollment and incremental NDA and regulatory activity.
Speaker Change: SG&A growth was primarily due to incremental prelaunch commercial and medical affairs related initiatives ramp blocks.
Speaker Change: These increases were as expected as we near full enrollment for the Cypress study and move closer to the data readout and NDA filing next year.
Speaker Change: As a reminder of the NDA and regulatory activities reflect onetime incremental spending to facilitate the completion of a majority of the NDA prior to data readout.
Speaker Change: Share based comp expense decreased 7% year over year, driven by ongoing cost cutting initiatives.
Speaker Change: Lastly, we ended the quarter with $131 million in cash and no debt to.
Speaker Change: To increase the cash in the quarter reflects the receipt of the $50 million trilogy milestone payment from royalty pharma, which was received in February.
Speaker Change: On slide 19, I'll cover our 2025 financial guidance.
Speaker Change: Following a detailed review of potential tariff measures announced by the current administration, we do not anticipate any material impact to our ongoing operations at this time.
Speaker Change: Accordingly, we are reaffirming all financial guidance metrics.
Speaker Change: Looking ahead to the remainder of the year for R&D, we anticipate a decline in clinical trial costs in the second half.
Speaker Change: The study moves to completion, partially offset by continued incremental spending to complete the majority of the NDA ahead of the Cypress data readout for.
Speaker Change: For SG&A, we're anticipating relatively flat or slightly lower expenses for the remainder of the year with continued spending on prelaunch commercial and medical affairs activities for <unk>.
Speaker Change: Recurring non-GAAP loss and cash burn excluding the impact of any potential milestone, we expect both metrics to improve throughout the year, especially in the second half driven primarily by continued growth in <unk> net sales and slightly lower cost.
Speaker Change: However, we do expect a onetime tax payment in Q2 related to the receipt of the $50 million trilogy milestone.
Speaker Change: We'll reflect a one time increase the cash burn in Q2 relative to Q1.
Excluding this payment, we expect cash burn to improve sequentially throughout the year.
Speaker Change: Note that this one time tax payment in Q2 will not affect the P&L given that we have heard have already accrued for this expense in prior periods.
Speaker Change: Finally, and more broadly regarding potential tariff implications at this time, we do not expect any material impact to our value drivers.
Speaker Change: <unk> milestones and royalties are based on net sales rather than Cogs, which is where tariffs would apply from an accounting perspective, So our trilogy economics would be unaffected.
Speaker Change: <unk> also remains well positioned with U S based manufacturing and an efficient cost structure.
Speaker Change: <unk> given that the product is not yet approved we have time to respond to any future policy trade policy or trade developments.
Speaker Change: That said the broader situation remains fluid.
Speaker Change: Settlement reflects what we know today and could change if there are material shifts in policy or action from the administration.
Speaker Change: Given the lack of formal guidance on the evolving policy landscape, we won't be providing additional specifics until there's more clarity.
Rick Winningham: With that I'll pass it back to Rick to conclude Rick.
Rick Winningham: Thanks to Steve to wrap up on slide 20, we continue to execute our strategy with focus and remain well positioned to deliver value across the portfolio.
Speaker Change: As <unk> indicated we ended the quarter in a strong financial position with $131 million in cash and no debt.
Speaker Change: Have the opportunity to earn up to $150 million of additional trilogy milestones in 2005, and 2026 as well as significant royalties, which return in 2029 and extend through the mid Thirty's.
Speaker Change: <unk> remains a core growth driver and we're focused on improving its financial contribution of fair events, while advancing towards key economic milestones. We're on track to achieve one time $25 million U S. Milestone good sales reached $250 million in the calendar year as well as a seven.
Speaker Change: $5 million milestone should <unk> received approval in China.
Speaker Change: Finally, ample occitane presents a truly transformational opportunity for our company.
Speaker Change: Cypress Phase III study is now entering its final stretch.
Speaker Change: We expect to complete enrollment in the open label portion by late summer and to deliver top line data from the randomized withdrawal portion about six months later.
Speaker Change: Guided by our clinical results to date and constructive ongoing dialogue with the MSA community our confidence in <unk> commercial prospects continue to grow.
Speaker Change: Meanwhile, we continue to lay the groundwork for an expedited NDA submission is broadened awareness through disease state education and targeted stakeholder engagement.
Speaker Change: We look forward to sharing cypress results soon.
Speaker Change: Now ready to take your questions operator.
Speaker Change: Thank you.
Speaker Change: Once again, if you would like to ask a question you may do so by passing the star key followed by the digit one on your Touchtone phone.
Speaker Change: If you're listening via the webcast. Please mute audio on your webcast advisory for asking a question over the phone.
Speaker Change: If you are using a speaker phone for todays call. Please make sure. Your mute function is turned off to allow your signal to reach our equipment again Thats star one if you'd like to ask some questions and we will pause for a moment and assemble the roster.
Speaker Change: We will have our first question from Marc Frahm from TD Cowen.
Speaker Change: Your line is open.
Marc Frahm: Hi, Thanks for taking my questions maybe.
Speaker Change: <unk>.
Speaker Change: On <unk> and then.
Speaker Change: Follow up on that.
Speaker Change: On the commercial performance of Rhonda.
Speaker Change: On the <unk> I appreciate your comments that you have some time before.
Speaker Change: NDA has even filed let alone let alone launching the product in the U S. You had some time to maybe adjust to whatever policies may come out.
Speaker Change: Yeah.
Speaker Change: Just give us a status update like where the current plan for manufacturing is in terms of locations and then and where the IP resides is that in Ireland or has that.
Speaker Change: Already been placed in the United States.
Speaker Change: Yes.
Speaker Change: Thanks, Marc for the question, yes, the IP for <unk> currently is in is in Ireland.
Speaker Change: The manufacturing of the API as.
Speaker Change: Is outside the United States.
Speaker Change: <unk> so.
Speaker Change: We will.
Speaker Change: Obviously, we've got a lot of time to adjust.
Speaker Change: What.
Speaker Change: Where supplies are et cetera, but we feel pretty good about where we are right now and the flexibility that we've got.
Speaker Change: Okay. That's helpful and then.
Speaker Change: Rhonda.
Speaker Change: Slide you presented in the performance of.
Your team the hospital team.
It seems tremendous in terms of the growth that we're seeing there over the past year.
Speaker Change: What efforts are.
Speaker Change: Are you kind of tweaking over time to maybe try to increase the rate at which those.
Speaker Change: Hospital.
Speaker Change: Prescriptions.
Speaker Change: Turning to filled chronic prescriptions once the patient leaves.
Speaker Change: Yes.
Speaker Change: Thanks Mark.
Speaker Change: Got you appreciate the work and results the team is delivering.
Speaker Change: <unk>.
Speaker Change: The importance and the critical nature of that transition of care patient given the increasing volume of hospital patients is obviously the whole purpose of why we are focused and that site of care and in partnership with the interest at the local geographies. The teams are working very.
Speaker Change: Mostly not only in recognizing where patients are leaving the hospital with a script in hand to ensuring that they're getting the support to patient.
Speaker Change: Ailment programs getting that patient to the right test element.
Speaker Change: Site, and then ensuring the follow up with with the maintenance care. So it is a handoff and very very close partnership that's occurring at the local level.
Speaker Change: But I guess any case.
Speaker Change: <unk>.
Speaker Change: As youre doing that handoff any refinements that are happening here because it does seem that has been a few quarters of this year.
Speaker Change: Strength in the hospital.
Speaker Change: I appreciate it takes time to translate into the broader franchise, but it does seem to be.
Speaker Change: Not completely translated.
Speaker Change: Okay.
Speaker Change: Oh definitely where we're seeing it translate to see and have very clear understanding of the best practices that's occurring in those local geographies.
Speaker Change: And as you can imagine with sales team members when theirs.
Speaker Change: A known entity and what's working and an award winning territories. There is others that want to employ those strategies.
Speaker Change: I would say our hospital.
Speaker Change: Transition of care voucher program.
Speaker Change: Really plays a critical role in ensuring that not only in the health care provider has high confidence of making the right decision for ensuring that patient leaves with a struct in hand, but that they will move very quickly and easily.
Speaker Change: Through their fifth element and onto maintenance care. So it's a matter of ensuring that where those territories are having great success that the teams are very clear on what works and those individual situations.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line.
Speaker Change: Julian Harrison from BTG.
Speaker Change: Your line is open.
Speaker Change: Hi, This is ray on for Julien. Thank you for taking our question just a couple for US first on <unk> have you received any feedback yet from payers on <unk>.
Speaker Change: Or is that something that will likely occur after topline data from cypress.
Speaker Change: And on that point, what endpoints do you expect payers to be most receptive to.
Speaker Change: Okay.
Ron: Ron do you want to take a quick shot at that.
Speaker Change: Follow up.
Speaker Change: Yes. Thanks Ram for the question as you would likely anticipate we have started engagement with with Payors.
Speaker Change: Sure not only they have an appreciation of the of the significant need and the burden of this disease has on patients. So that they fully appreciate what role a therapy like ample occitane can serve in this patient population and we're working very closely to ensure.
Speaker Change: That education on the endpoint and likely scenarios of data.
Speaker Change: And put from from the study readout itself.
Speaker Change: The messaging and the reaction and questioning and additional educational support that they may need and a poster paywall situation that they are armed with the right details and support so we're definitely very active in that space now, but obviously, we've got a bit of time to ensure that we have that.
Speaker Change: And critical element and access setup.
Speaker Change: Got it thank you I think clearly.
Speaker Change: Yeah, just to complement what yes, what rhonda.
Speaker Change: Saying that no.
Speaker Change: For <unk> team.
Speaker Change: The breadth of the composite score in terms of the overall well being.
Speaker Change: The patient and their ability to function et cetera. These are this is very meaningful.
Speaker Change: All the composite broad composite score as well as the elements of the composite this has not been demonstrated before so it can be a significant.
Speaker Change: A significant advantage really for us and obviously a significant benefit for patients as well as caregivers given the nature of the components of the composite score.
Speaker Change: Got it thank you and if I could ask one on <unk> could you provide us with an update on the paragraph four filings.
Speaker Change: Have settlement has been reached for all parties.
Speaker Change: Yes, sure we've settle.
Speaker Change: We have settled with five of the eight filers, we have three outstanding litigants.
Speaker Change: No other update other than outside of that.
Speaker Change: Got it thank you.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: It appears we have no further questions on the phone I would now like to turn the conference back to Mr. William.
William: Go ahead Sir.
William: Yes. Thank you very much operator, and thank you for joining us today and the questions that you've asked we look forward to keeping you updated.
William: Through the course of through the course of the year as we approach a very exciting period for the company. Thank you.
William: This concludes today's conference call. We thank you for your participation you may now disconnect.