Q1 2025 BeiGene Ltd Earnings Call
Jorge Soto Angel Doc Charlie Miller In cobweb. Come March 28, 2020 Go to透明TV.com or trigger a notification from any App Store or Google Play Store.
Speaker Change: Welcome to Beijing, Q1, 2025 earnings call webcast.
Speaker Change: All lines have been placed on mute to prevent any background noise.
Speaker Change: After the Speakers' remarks, there will be a question and answer session.
Speaker Change: At this time I would like to turn the call over to the company.
Speaker Change: Hello, and welcome thanks for joining us today, and Dan dollar head of Investor Relations at Beijing.
Speaker Change: Before we begin please note that you can find additional materials, including a replay of today's webcast and presentation on the Investor Relations section of our website IR Dot Beijing Dot com.
Speaker Change: I'd like to remind all participants that during this call. We may make forward looking statements regarding among other things the companys future prospects business strategy actual results may differ materially from those indicated in the forward looking statements as a result of various factors, including those risks discussed.
Speaker Change: Most recent periodic report filed with the SEC.
Speaker Change: Please also carefully review the forward looking statements disclaimer slide deck that accompanies this presentation.
Speaker Change: Reconciliations between GAAP and non-GAAP financial measures discussed on this call are provided in the appendix to our presentation, which is posted to our Investor Relations website, along with our earnings release.
Speaker Change: All information in this presentation is as of the date of the presentation and we undertake no duty to update such information unless required by law.
Speaker Change: Now turning to today's call as outlined on slide three.
John Oyler: John Oyler, our co founder Chairman and CEO, who will provide a business update Sheldon who's our president and Chief operating officer will provide an update on our global commercial progress.
Speaker Change: <unk>, our general manager of North America, we will provide an update on the U S commercial performance of <unk>.
Speaker Change: <unk>, our global head of R&D, who will discuss our R&D and pipeline progress and Aaron Rosenberg, Our CFO will review, the first quarter financial results and financial guidance.
Speaker Change: We will then open the call to your questions.
Speaker Change: Pass the call over to John John.
Speaker Change: Thank you Dan and welcome everyone to our Q1 earnings call.
Speaker Change: Last quarter's call I spoke about three priorities for 2025.
Speaker Change: The first was solidifying and deepening our hematology franchise leadership.
Speaker Change: <unk> was advancing our prolific pipeline of internally developed assets and the third was driving superior financial performance I'm excited to share with you. How we delivered on these priorities through the first quarter.
Speaker Change: Beijing is the only company with an internally discovered and wholly owned portfolio of potentially best in class molecules across all three foundational mechanisms and CLO.
Speaker Change: We believe our relentless focus on cereal innovation in CLO uniquely positions us to address the full scope of unmet patient need across all lines of therapy and subpopulations.
Speaker Change: <unk> is the best in class PTK inhibitor that serves as the backbone of our franchise in the U S. Brookins as the leader in new patient starts for both frontline and relapse refractory CLO and across all of its approved indications for <unk>.
Speaker Change: This is the broadest label of any <unk>.
Speaker Change: And for the first time Brookins has surpassed both ibrutinib and to calibrate nib and overall U S quarterly revenue and continues to outpace <unk> competitors and year over year growth.
Speaker Change: This leadership follows the science and the data.
Speaker Change: And it reflects brookins is clear clinical differentiation.
Speaker Change: <unk> is the only be teekay to exhibit complete and sustained inhibition and its the only be PKI to demonstrate superior efficacy and safety in a head to head trial against Ibrutinib.
Speaker Change: And anchored by its best in class clinical data broke Enzo has now treated over 200000 patients globally.
Speaker Change: So in row, our potentially best in class Bcl two inhibitor continues to advance rapidly through late stage clinical development, we've completed enrollment in our phase III celestial trial of <unk> plus Zanu in treatment naive CLO and we progressed two additional phase III trials as lie.
Speaker Change: I will review.
Speaker Change: Importantly, we have reached our first registrational milestone for Sone room, with our regulatory filings submitted in China, and we plan to submit our first global filing in the second half of this year.
Speaker Change: These filings Mark the beginning of <unk> evolution, and a potential game changing therapy across multiple b cell malignancies.
Speaker Change: We are the leading next generation of innovation and <unk> with our first in class PTK Seatac program, which is now dosed over 600 patients and continues to progress rapidly.
Speaker Change: We have reached an agreement with the FDA on the phase III dose and we've already initiated our first phase III trial with plans to initiate another phase III trial against <unk> brute NIM in the second half of the year.
Speaker Change: We continue to expect data from our potentially pivotal phase II trial next year and pending positive results intend to complete global regulatory submissions.
Speaker Change: Outside of heme, we continue to advance one of the broadest solid tumor pipelines in the industry. Our CDK four inhibitor continues to advance rapidly with over 300 patients enrolled including over 100 in just the past two months.
Speaker Change: <unk> <unk> program, a key area of enthusiasm has completed seven monotherapy cohorts with promising signs of clinical activity.
Speaker Change: We enrolled the first patients in both of our clotting six CD three by specific program for gynecological and other solid tumors and our second generation Bcl two for metastatic breast cancer.
Speaker Change: And our <unk> inhibitor also entered the clinic in early Q1, marking another milestone in our targeted lung cancer therapy portfolio.
Speaker Change: This year, we anticipate more than 10 proof of concept readouts across our solid tumor pipeline.
Speaker Change: Each representing a potential near term value inflection point.
Speaker Change: These assets feature differentiated potentially first <unk> best in class profiles and have the potential to deliver transformational impact for both patients and shareholders.
Speaker Change: Our internal clinical development team of 3700, plus continues to demonstrate time cost and quality advantages that are driving higher ROI for each R&D dollar spent and we're routinely seeing proof of these advantages and programs.
Speaker Change: And competitive settings, like <unk> or Bcl, two and our CDK <unk> inhibitor just to name a few.
Speaker Change: Moving to financial performance, we achieved a major milestone in Q1 GAAP profitability for the first time.
Speaker Change: Darren will provide more detail later in the call, but these strong quarterly results place us on solid footing to deliver on our full year financial guidance.
Speaker Change: I'd like to close by sharing a few reflections on the external landscape as our industry continues to navigate in an increasingly challenging and complex global environment.
Speaker Change: I believe our unique model positions us exceptionally well to succeed in spite of today's challenges.
Over the past 15 years, we've built an organization from scratch that is technology enabled time and cost advantaged and now vertically integrated.
Speaker Change: It was built not only to survive but to thrive in a world with pricing pressure.
Speaker Change: In today's macro environment, our global manufacturing footprint and regional resilient supply chain are essential to ensuring product availability and operational continuity.
Speaker Change: This has been a foundational principle of our operations across the U S Europe, China and other key markets. We've realize this vision with action, including most recently at $800 million investment in our Hopewell, New Jersey manufacturing facility, which opened in 2024.
Speaker Change: With the landscape around trade policies and tariffs will continue to evolve our commitment to regional manufacturing helps us mitigate potential risks and maintain reliable supply.
Speaker Change: Finally, I am pleased to announce that the shareholders have approved our re domicile in Switzerland from the Cayman Islands as well as our name change to be one medicines, reflecting our continued evolution into a globally diversified oncology leader and our deepening ties to the world class with.
Speaker Change: Tech ecosystem.
Speaker Change: And with that I'll pass it over to <unk> to provide a global commercial update.
Speaker Change: Thank you John our global development strategy and the boat tried design have results to in the.
Speaker Change: The broadest label in a widespread coverage for <unk>.
Speaker Change: Got shaved a significant global reach shorter period of time.
Now traded almost one 7 million.
Speaker Change: As a patient we saw synergies.
Speaker Change: Mr Partnership bump foundational assets.
Speaker Change: Well positioned to deliver meaningful benefits to patients worldwide.
Speaker Change: <unk> built the commercial infrastructure to successfully launch and scale across more than 80 markets.
Speaker Change: Strong foundation also positions us to fully leverage our global network to support internal clinic development and to drive the successful commercialization of our pipeline.
Speaker Change: In the first quarter Global says $1 1 billion.
Speaker Change: We are growing 49% from Q1 2004.
Speaker Change: U S. Our largest market grew 60%.
Speaker Change: Strong <unk> demand.
Speaker Change: As Matt will discuss later.
Speaker Change: In addition, <unk> was approved for frontline.
Speaker Change: You said in the U S during the quarter.
Speaker Change: China says grew by 26% compared to the prior year period.
Speaker Change: Which Stephen Bra, and our proteins are sustaining our market leadership positions.
Speaker Change: <unk> expanded our not yet camrys in frontline gastric on the Frontlines small cell lung cancer.
Speaker Change: Imaging collaboration products also continued the strong momentum in the first quarter Euro.
Speaker Change: Europe.
Speaker Change: We experienced a 75% gross.
Speaker Change: As we continue our launch <unk> weighted.
Speaker Change: Weighted received reimbursement as a follow up Kevin brought new spend and earlier this week.
Speaker Change: Europe.
Speaker Change: <unk> approval, followed keven bra in frontline extensive stage small cell lung cancer.
Speaker Change: We're encouraged by the growth perspective of the region for 2025.
Speaker Change: <unk> also reward SaaS totaled.
Speaker Change: $32 million in the <unk>.
Speaker Change: First quarter.
Speaker Change: Growing 146% compared to the prior year. This was primarily driven by expansion in our new launches in ashy peg downturn Mena regions, including notable progress in South Korea, Japan, Mexico and Brazil.
Speaker Change: While we're still in the early stage of commercialization in our rest of the world market.
Speaker Change: We expect them to be strong consistent contributor to our future revenue growth and haphazard realize our mission to reach many more patients with improved access and affordability.
Speaker Change: I'll now pass the presentation over to Matt.
Matt: Who provided that U S commercial update.
Matt: Thanks, Dr. Luke.
Speaker Change: Moving to our Kansas U S performance.
Speaker Change: Q1 U S per Kansas sales reached $563 million, representing growth of 60% versus the prior year and establishing <unk> as the market leader by revenue in the large and growing U S. D teekay market, which grew 11% year over year.
Speaker Change: This is an important milestone was reached just two years after our CLO launch.
Speaker Change: And while this strong performance underscores for Kansas continued momentum.
Speaker Change: Q1 revenue reflects the typical seasonality seen across all products in the PTK class as previously discussed on the Q4 update.
Speaker Change: Ken just Q1 net revenue and net revenue growth was driven primarily by strong underlying demand as you can see on this slide.
Speaker Change: Year over year demand growth was 54% when compared to the first quarter of 2024, and 6% sequentially when compared to the fourth quarter.
Speaker Change: This steady trend of demand growth reflects our leadership in terms of new patient starts where we are the leader across all lines of therapy in indications, including both frontline and relapsed refractory CLO. This.
Speaker Change: This momentum combined with the growing base of existing patients underscores a solid foundation for ongoing growth.
Speaker Change: We're confident in the underlying business fundamentals and well positioned for strong performance in the second quarter.
Speaker Change: And the rest of 2025.
Speaker Change: Significant growth opportunities remain within the frontline CLO market or treatment success requires steam responses impressive and sustain in PFS and a strong safety profile.
Speaker Change: All areas in which <unk> has consistently demonstrated proven advantages.
Speaker Change: Nearly half of all newly diagnosed CML patients have one or more high risk features including <unk> mutated ghd.
Speaker Change: Deletion, 11, Q and TT 53, Felicia 17, P and even more have high risk co morbidities such as Afib.
Speaker Change: In this population other PTK inhibitors and current fixed duration treatments are associated with poor outcomes.
Speaker Change: And the Alpine trial, where kenseth became only be teekay to demonstrate superiority over ibrutinib in a head to head trial.
Speaker Change: And in the high risk T. P 53, deletion 17 P population subset of Alpine for Kansas PFS at $42. Five months median follow up was 59% versus Ibrutinib PFS of 32% and.
Speaker Change: An impressive 27% higher.
Speaker Change: For <unk> as the best in class option for all patients regardless of mutation where significant comorbidities.
Speaker Change: Given the challenges with current fixed duration regiments, and Kansas Best in class profile, we see additional opportunity perfect returns a monotherapy to continue to take market share from these treatment options.
Speaker Change: And beyond expansion of PTK mono therapy.
Speaker Change: Believe that becomes a plus <unk> has the opportunity to deliver on the promise of fixed duration and expand its role in the treatment paradigm.
Speaker Change: Similarly, our BT Casey that has the potential to surpass other existing treatment options and fulfill the unmet needs of patients with cielo.
Speaker Change: On that note now over to your line.
Speaker Change: Since Matt I would like to take a few minutes to highlight key aspects of our portfolio starting with our hematology franchise.
Speaker Change: Our <unk> franchise is evolving quickly while relentlessly pursuing the best in class treatment options from frontline until late <unk> and.
Speaker Change: <unk> continues and the fixed duration treatments, we believe that to let events thats demo kit. The fundamental question of whether a potential Madison is better than the existing best in trim options must be ounces.
Speaker Change: Clinical trial needs to be designed accordingly.
Speaker Change: Candice you can see that our Pos Charles including Alpine and our current phase III trial is for Sorel, and our BTC deck, which al will review today.
Speaker Change: Well it turns out was designed from inception to provide 24, 7% inhibition with <unk> disease relevant compartments.
Speaker Change: To address efficacy challenges of inputs and this led to a phase III that tree, although you're putting them in a direct comparison restaurant battery sale.
Speaker Change: The mall is in Kansas that activity has resulted in poor tolerability and clinical settings.
Speaker Change: Similarly, <unk> exhibits higher potency and selectivity comparisons in that class.
Speaker Change: Also I mean potential advantages in efficacy and the safety that is supported by clinical data with a shorter half life and no drug accumulation soil may allow for more patient funded <unk> laundry.
Speaker Change: This serves as a key differentiator for <unk>.
We believe that the vast majority of <unk> patients, where only one single hospital visits for solar ramp up of <unk>.
Speaker Change: <unk> is the most advanced the PDK to agree that contain the clinic.
Speaker Change: Whereas preclinical properties, indicating safety and efficacy benefits for patients. It is a novel mechanism of action offers distinct advantages over traditional you can get there is by overcoming and preventing the emergent resistant mutations or disruptions careful functions.
Speaker Change: Next I would like to discuss that fits duration treatment landscape.
Speaker Change: Significantly enhancing our leadership in Seattle.
Speaker Change: To establish a compounding set stimulation therapy must achieve a higher efficacy.
Speaker Change: Safety standards in terms of efficacy and must it extend the PFS, allowing patients to expense at Jennie O. Jacques holiday visceral caused deep responses, enabling doctors to feel confident that the best called relapses minimum when just engineers.
Speaker Change: Which is measured by <unk>.
Speaker Change: Furthermore, it should not present additional clinical meaning for safety concerns during the Timna periods all potential best in class fish duration combination of Azania was <unk> has demonstrated a deep almaty right.
Speaker Change: In class F under sustained PFS.
Speaker Change: Acceptable safety profiles.
Speaker Change: Well progressing rapidly with the development of this fixed duration combination therapy in line with our standard practice to slash Osteal lung trial was designed to demonstrate the PFS utility of plaza over the concert best and Italian fixed duration treatment deal in humanized failure.
Speaker Change: This child completing enrollments in February was just 14 months, marking a significant milestone for the <unk> and the showcasing strong interest from patients and conventions and our clinical execution capabilities.
Speaker Change: In addition to trim a nice CIL, while also advancing the development of solar photographs of factory cell patients through our celestial COC study, which combines always CD 20. This is a show hatched with <unk> designed to demonstrate the superiority of <unk> and S class.
Speaker Change: Paul mantle cell lymphoma phase II trial has been initiated to evaluate the true may in fact of two yourselves. So combined with continuous Daniel in the relapsed refractory setting.
This trial will also serve as a confirmatory trial for so that showed 202, a single arm phase II study of solar monotherapy in relapsed refractory mantle cell lymphoma post <unk>, which with potential fall globally bauxite approval in the second half of this year. If the results are positive.
Speaker Change: Moving on to our <unk> that we presented a compelling body efficacy and the safety data in a heavily pretreated population. The ash as you can see here on this slide.
Speaker Change: The evolution of our data together with junk mail feedback gave us confidence to initiate a hatchet hedgehop phase III study against them for the visit it.
Speaker Change: The detail of the trial designs, it's showing this slide.
Speaker Change: The first patient is expected to be enrolled in the second half of this year, we have mats ways FD and obtain agreement on all of those phase III and sale I'm very excited to announce that our first phase III study for the <unk> cadence <unk> versus physicians choice in relapsed refractory <unk> patients.
Speaker Change: First patient in this week.
Speaker Change: We have also started a multi cobalt platform study two combined BD Casey that was internal and external assets like Sorel Donahue on the CD 20 advisers fix this combinations have the potential to expand the treatment options for patients with B cell malignancies.
Speaker Change: Our solid tumor portfolio has evolved over the last two years was 19, Neil molecules in that kind of across three major tumor types lung breast and colon cancers in the Gi cancers.
Speaker Change: To fund our portfolio to focus on targeted therapy, utilizing various modalities, including adcs the greatest in the Maldives specifics to deliver highly efficacious treatment for our patients our commitment to industry, leading speed is evidenced by our fastest path strategy, which continues to drive the wrap.
Speaker Change: Development of this molecule.
Speaker Change: Our actual highlights several key pipeline value inflection points.
Speaker Change: The presentation adjusts for some of our significant late stage milestones.
Speaker Change: And we had a successful phase II readout for <unk> in relapsed or refractory CIL and achieved the expedited NDA submission in China.
Speaker Change: Completing the process.
Speaker Change: 711 weeks, while the data cutoff to the NDA acceptance.
Speaker Change: Dissipate, our global filing relapsed refractory mantle cell lymphoma in the second half of this year additional phase III pivotal trials for both <unk> and our <unk> will be initiated later this year.
Speaker Change: Turning to our early stage pipeline, we have several POC catalysts expected throughout the year.
Speaker Change: By the more details regarding our innovative scientific advancements in the portfolio progression during our R&D day on June 20, <unk> with that I'd like to pass it over to Adam.
Adam: Thanks, a lot we had a strong start to the year with first quarter 2025 revenue of $1 1 billion compared to $752 million in Q1, 2024 revenue growth was 49% with meaningful contributions across all of our key brands. These topline results are consistent with our communicated guidance.
Speaker Change: <unk> and set us up well for the balance of 2025.
Speaker Change: This quarter demonstrates our dual mandate inaction as we are driving significant topline growth with material operating leverage to support long term business sustainability.
Speaker Change: As a result of this focus we delivered positive GAAP operating profit and net income for the quarter you can see the year over year improvement in GAAP, and non-GAAP operating profit measures of $272 million and $286 million respectively.
Speaker Change: And as a result of our value focused investment philosophy, we achieved a third consecutive quarter of positive operating cash flow. This is notable as the first quarter has a seasonally high use of working capital.
Speaker Change: When looking at our operating cash generation performance compared to Q1, 2024, we improved by $353 million.
Speaker Change: Sales of Brookins, it totaled $792 million in Q1, representing 62% growth as compared to Q1 2020 for growth continues to be primarily driven by demand from our leading new patient share in the United States, coupled with year over year increase volume following a full year of use from patients who began treatment in 2024.
Speaker Change: This is layered on top of the stable base of patients who remain on therapy from prior years, given perkins's long duration of therapy.
Speaker Change: Growth contributions were seen across all geographies, including Europe, China and rest of world markets <unk> sales of $171 million resulted in an 18% revenue growth when compared to Q1 2024.
Speaker Change: Driven primarily by our leading market position in China. We're in the early stages of our commercial expansion in other markets.
Speaker Change: Amgen in licensed products were key contributors to performance coming in at $114 million and grew 58% year over year and finally, we are also seeing year over year growth contribution from collaborations revenue given our global royalties for <unk> Delta.
Speaker Change: Now moving to the GAAP income statement.
Speaker Change: Product gross margin increased nearly two percentage points to 85% this quarter compared to 83% in Q1 2024. This was largely due to favorable mix and cost of sales productivity for both <unk> and brookins them.
Speaker Change: Operating expenses totaled $941 million, representing growth of 6% as compared to Q1 2024 growth was seen in both SG&A and R&D as we continue to invest with discipline to support our commercial businesses and our robust pipeline note that Q1 2024 included $35 million of business development expenses.
Speaker Change: Which should be considered when interpreting the period over period change taken together our focus on topline growth with meaningful operating leverage led to our achievement of GAAP profitability for the quarter.
Speaker Change: Our non-GAAP P&L includes adjustments for typical items with a full reconciliation provided in the appendix focusing on the bottom line non-GAAP net income totaled $136 million in Q1, 2025, an increase of $282 million versus prior year. This equates to non-GAAP earnings of $1 20.
Speaker Change: Two for Aes.
Speaker Change: Switching to guidance, our full year 2025 guidance remains unchanged, we project revenue to be between $4 9 billion to $5 3 billion movement in exchange rates, while volatile at the start of 2025 have largely offset and current rates are contemplated in this affirmed range our GAAP gross margin.
Speaker Change: Percentage is projected to be in the mid 80 percentile range benefiting from mix and production efficiencies.
Speaker Change: Operating expenses on a GAAP basis are anticipated to be between four 1% and $4 4 billion non-GAAP operating expenses are expected to track with our GAAP guidance with reconciling items remaining unchanged from existing practice.
Speaker Change: As we have demonstrated in the first quarter of 2025, we are committed to achieving full year GAAP operating income breakeven and generating positive cash flow from operations for the full year <unk>.
Speaker Change: Recognizing uncertainty remains our guidance includes our estimates of the impact of announced tariffs to our 2025 results. We do not expect the tariff impact associated with our partnered products. Our exposure has been mitigated by our significant investments in partnerships to build a truly global production network, including our commitment to manufacturing in the United States for <unk>.
Speaker Change: U S supply of Brookins, Zimbra and the commercialization of our pipeline assets. This includes our 42 acre Hopewell, New Jersey campus, which is currently being qualified for biologics production and can be expanded to other modalities as needed to support our advancing pipeline.
Dan Dollar: We will continue to take action to build supply chain resiliency to ensure patients around the world have uninterrupted access to our critically important lifesaving medicines and with that I will turn the call back to Dan.
Dan Dollar: Thanks, Aaron we are now ready for Q&A I ask participants to limit themselves to one or two questions to ensure we have time to hear from as many attendees as possible. Operator, we are ready for the first question.
Speaker Change: Thank you if you would like to ask a question. Please use the raise hand icon, which can be found at the bottom of the webinar application.
Speaker Change: When you all cooldown. Please meet on mute your line and ask your question.
Speaker Change: We will now take a minute to the queue to assemble.
Speaker Change: Our first question comes from Andrew Berens Leerink partners. Please mute your line and ask your question.
Andrew Berens: Hi, Thanks, and congrats on all the progress.
Speaker Change: Kind of question on the CDK four program can you just remind us how 43 95 differs from pfizer's of turmoil.
Speaker Change: It's early but where do you see the CDK four agents being used in HR positive breast cancer in terms of lines of therapy and potential combination partners and then maybe another question on <unk>.
Speaker Change: Just wondering if you have any appetite to develop the driver beyond oncology.
Speaker Change: Think of the potential role in autoimmune diseases and is this something that you would consider doing yourself or with a partner potentially.
Speaker Change: Yup sensible question for the CDK four.
Speaker Change: Our molecule was designs benchmark handguns to defy the tomo Sutcliffe should be more potent as was most of that step.
Speaker Change: Right now we're still in the process of a dose escalation, we're actually moving this program very aggressively.
Speaker Change: The last one month, so it's already happening rose the last couple of months well ahead in the order of 100 patients.
Speaker Change: We still plan to move this forward into the phase III trials aggressively.
Speaker Change: The counter thinking around this <unk> initiating a phase III trial in the second line settings in combination with search.
Speaker Change: So that's our plan in addition to that we're also contemplating the play in the audio lines.
Speaker Change: As for your question relates to the bookings outside of oncology, we have Adrian.
Speaker Change: Which is in membranous nephropathy, which is once you mentioned about an eye indication.
Speaker Change: Okay. Thank you and do you have an oral served in your portfolio.
Speaker Change: Closed.
Speaker Change: We did not have <unk>.
Speaker Change: Okay. Thank you.
Speaker Change: Our next question comes from Yaron Werber Cowen <unk> Company. Please Amit your line and ask you a question right. Thanks, so much and congrats on a lot of pipeline progress.
Speaker Change: <unk>.
Speaker Change: Maybe for Matt or Aaron any.
Speaker Change: Can you give us a sense bookings during Q1 and any sense, how much was the weakness in the costs related to the part D. Redesign and then <unk> is there any way you can split out sales in the U S. Europe.
Speaker Change: Sort of rest of the world in China.
Speaker Change: Thank you.
Speaker Change: So we go into <unk> sure sure. This is Eric Thanks for the question, Eric I mean, I would start without speaking to the broader industry, obviously part D resigned.
Speaker Change: Some impact.
Speaker Change: As it relates to pricing, we've talked about a relatively stable pricing environment for our company.
Speaker Change: This is coming from a couple of factors of course with the redesign.
Speaker Change: As we look at our business, we do see some Q1 favorability driven by the redesign in part as a result of the elimination of the manufacturer liability for the coverage gap as you know that would largely be experienced earlier in the year.
Speaker Change: Patients work through the Donut hole and then obviously manufacturers had the liability associated with that coverage gap.
Speaker Change: For us with the redesign we do benefit as we've spoken about from the specified small manufacturer designation, which layers in our manufacturing liability.
Speaker Change: Over a five year period, so on balance as you think about Q1 and get a little bit of favorability given the lapping of the pricing in the base from 2024.
Speaker Change: And that's offset to a degree by the manufacturer liability on the part D redesign for us which will be consistent over the balance of this year. So.
Speaker Change: Other than that not anything maybe I'll, just add a little bit of commentary about Q1 related to seasonality I think that kind of goes hand in hand, with the Medicare part D piece, and then I'll gladly.
Speaker Change: Dress the U S <unk> component of the question as well.
Speaker Change: We talked about some things back in the fourth quarter related to what we anticipated in Q1 on seasonality.
Speaker Change: There is a typical customer inventory build in the fourth quarter with a drawdown that we see in the first quarter, we disclose about a $30 million buying and then we also.
Speaker Change: Have noted one less shipping week in first quarter of this year then that for other.
Speaker Change: Other typical quarters.
Speaker Change: So really in the first quarter, we typically see a slight drop in new starts due to changes in patients in showrooms and out of pocket resets and other factors. So this first quarter. It was really no different than that on the <unk> piece. We don't report separate breakouts for that but we're very encouraged with the progress thats been made onto Debra.
Speaker Change: In the U S, where we're very pleased to receive our frontline esophageal approval that was our third approval in the U S. Within a year coming after a second line <unk> in frontline gastric.
Speaker Change: And of course, we were also very pleased to see listing and the NCC guidelines and also more recently our alternative dosing Q2 W. In Q4, the revenue came in line.
Speaker Change: As well so.
Speaker Change: What we now see as the initial experiences patient starts all in line with with launch expectations and we will see the second quarter really be the starting point for it to them or in the U S. Now that all those other factors come into line.
Speaker Change: If I could just move to just follow up on bookings the secret.
Speaker Change: Approval now in EMEA.
Speaker Change: So it is a big deal how much inventory can they do can they supply the U S market as well or is there a chance that they will have capacity to or.
Speaker Change: Or it sounds like Youre talking to another manufacturer for the U S.
Speaker Change: Yes, so thanks for the question.
Speaker Change: We are pleased with our approval for our second source of API from our Swiss supplier as you mentioned and we are working to continue to broaden out our supply chain resiliency with securing sourcing from another supplier in.
Speaker Change: In Spain.
Speaker Change: So that's a portion of our API usage, we've taken assertive action to ensure we have significant stockpiles both for regular run demand, but as well to have additional security as it relates to our API stockpile.
Speaker Change: We're confident in our position in that regard.
Speaker Change: Thank you.
Speaker Change: Next question comes from Jessica Fye at J P. Morgan Please Amit your line and ask your question.
Jessica Fye: Hey, guys. Good morning, Thanks for taking my question.
Speaker Change: On the CDK four programs and firm.
Dan Dollar: Thanks, Dan.
Speaker Change: She did it could come during your R&D day in late June and can you maybe set the stage a little bit or.
Speaker Change: What kind of data youll share I E.
Speaker Change: And a follow up to get a look at durability here or should we be expecting.
Speaker Change: More safety and response rates and then.
Speaker Change: Also related to that program can you just remind us where you are in terms of starting our enrolling <unk> naive cohort with that molecule.
Speaker Change: Bob just a sense for the question in some for the.
Speaker Change: For the data disclosure at R&D day will be many folks on the dose escalation cohorts with certainly including the efficacy data in addition to the safety PK.
Speaker Change: However, as you noticed this program a little bit about quickly as trade just in the last two months, we enrolled over 100 patients. So the derivative side of that as you can imagine can will be limited.
Speaker Change: And chunk for.
Speaker Change: This molecule is.
Speaker Change: The second part of your question was about.
Speaker Change: CDK four and CDK four six naive treatment settings, we actually have a lot of patients already in that setting. So we begin to accumulate data in those settings. So what are they waiting for that data to help us to make the decision in the frontline.
Speaker Change: And will we see any of that at R&D day.
Speaker Change: That's too early to be disposed settlement meeting.
Speaker Change: Okay. Thank you.
Speaker Change: Our next question comes from Reni Benjamin of citizens. Please mute your line and ask your question.
Reni Benjamin: Hey, good morning, everyone and thanks for taking the questions and congratulations on all the progress.
Reni Benjamin: As you look at the 10 proof of concept Readouts. This year can you maybe highlight maybe the.
Reni Benjamin: The top ones that you think could really drive.
Reni Benjamin: Your excitement as you as you move forward and then separately. The mangrove trial. You mentioned has an interim analysis of the phase III trial can you just provide an overview and just what your.
Reni Benjamin: Expectations are from that interim analysis. Thanks.
Reni Benjamin: Sense of a question I got this question a lot.
Reni Benjamin: Where do I start there are so many really exciting programs.
Reni Benjamin: Further the progress that you anticipate in most markets and sort of last year, which should expansive data. This year I wouldn't say, which one is my favorite.
Reni Benjamin: Like them all.
Reni Benjamin: In some further member of study is that you Benjamin study so.
Reni Benjamin: We were waiting eagerly waiting for the events to happen.
Reni Benjamin: So we hope that's what happened in the second half of this year.
Reni Benjamin: Okay.
Reni Benjamin: Thank you.
Speaker Change: Our next question comes from Michael Schmidt Guggenheim Partners. Please on mute your line and ask your question.
Michael Schmidt: Hey, good morning, Thanks for taking our questions I just had a follow up on the first line mantle cell lymphoma opportunity for Cooper.
Michael Schmidt: <unk> based on mangrove could you just help us understand the size of that opportunity and do you plan on submitting regulatory filings based on this interim data out here in the second half.
Michael Schmidt: And then a question just longer term on the C&I market.
Michael Schmidt: Yes.
Michael Schmidt: Is your view on how broke into his position longer term with the printed NIM first line data reading out here later this year from Lilly what gives you confidence in.
Michael Schmidt: <unk>.
Michael Schmidt: Best in class.
Michael Schmidt: Market precision long term and CMO. Thanks, so much.
Speaker Change: Yes ill harvest stock, probably ask Matt to comment on commercial side of it and some for the first nine mango study I just want to remind everybody about the study design. This is we're using a chemo free regimen, which shares if it tops mab plus zani, putting them. The control arm is beyond this is a little bit different.
Speaker Change: The <unk> study, which is adding a column top of BR. We do believe this providing a really probably a preferred option ultimately the choice successful through the patients which is chemo free.
Speaker Change: So this one thing was to highlight the bumps limestone piece the treatment duration will be bound along so if it's successful. It does further expand our marketing mental cell, but they don't want to ask matts comments, how big the market is.
Speaker Change: Moving on to your comment or your question around the <unk> side of the <unk> study in the frontline as against the VR that's their.
Speaker Change: First study the second study was eroding about one set of patients which is in the.
Speaker Change: Q&A, but it's a mixed population will also with the second line in the later line.
Speaker Change: A competitor that is important to them. So we don't we do not believe this presents sooner.
Speaker Change: Threats to our book in South because the competitor is Norfolk Wilkinson.
Speaker Change: Yes, and I'll just briefly.
Speaker Change: Comment on the mantle cell and then what was the <unk> related element of the question, we clearly see a reasonable size opportunity in <unk>.
Speaker Change: Mantle cell.
Speaker Change: And in fact.
Speaker Change: Continue to see opportunities for the <unk> class.
Speaker Change: In that segment.
Speaker Change: And also continue to have strong share position there with regard to <unk> in the future outlook.
Speaker Change: For for the class and for Kinder, but we fully expect to continue to maintain and expand market share.
Speaker Change: With our PTK therapy.
Speaker Change: Based on the peer to Readouts recently, we think it's really unlikely to see significant shifts to earlier lines of therapy.
Speaker Change: We think that we've heard the competitor makes similar with ARX <unk>.
Speaker Change: Regarding sequencing.
Speaker Change: And really believe that continuous PTK therapy is going to continue to be the best option in those earlier lines of therapy.
Speaker Change: We also see that utilization is in line with that and then they appear to us really being utilized in those later lines of therapy.
Speaker Change: Thank you.
Speaker Change: Our next question comes from <unk> Chen with Goldman Sachs. Please mute your line and ask your question.
Speaker Change: Hey, good morning, and thank you for taking my questions two questions one on <unk>.
Speaker Change: And the other one on expenses. So how do you see the potential impact of power plants can inspire in negotiation this year and now with the new price can be effective in 2027 and also for your IRA.
Speaker Change: Hey.
Speaker Change: What it's going to be your base case scenario.
Speaker Change: In terms of expenses, we actually see.
Speaker Change: A major wave of proof of concept data coming from the solid tumor pipeline, we believe theyre going to be a lot more.
Speaker Change: Trial has been initiated and a lot more potentially pivotal studies initiatives. So how should we see the trend of the R&D spending in the first quarter is download a better quarter over quarter.
Speaker Change: But do you still have the flexibility and spending given you have the target.
Speaker Change: Profit.
Speaker Change: And this year potentially beyond 2025.
Speaker Change: Yes, I guess I'll just start out with.
Speaker Change: With IRR and your question related to Californians, we won't see Cal.
Speaker Change: <unk> IRI implications until 2026.
Speaker Change: We may see some indirect marketplace.
Speaker Change: Todd impact regardless of that price negotiation status, and we think that thats going to be manageable.
Speaker Change: Obviously with respect to <unk>, we don't see it as a credible substituted for cancer due to the safety and efficacy, particularly given our alpine trial, showing head to head superiority and also the non cardiac toxicity profile for them, but we.
Speaker Change: We see substantial.
Speaker Change: Differentiation there.
Speaker Change: Of course.
Speaker Change: Later, well with California, we see less cardiac issues than <unk>, but also questionable efficacy across multiple studies.
Speaker Change: And clearly the best thing that is of course subject to corporate Kansas. So we continue to be pleased with our leadership position in new starts in relapsed refractory and frontline.
Speaker Change: And are the most prescribed across B cell malignancies, we think that.
Speaker Change: Continued strong market performance will be critical as we head into that.
Speaker Change: The IRR type of thing.
Speaker Change: Great. Thank you and with respect to our R&D investment as you see in our 2025 guidance, we are investing significantly.
Speaker Change: To rapidly advance our pipeline.
Speaker Change: You did reference our dual mandate of driving being a growth company, but doing in a sustainably sustainable way and you see that in our operating results not just this quarter, but in the preceding quarters as well. So we will continue to operate against that dual mandate of growth with margin expansion and we're committed to developing the pipeline I think what we've talked.
Speaker Change: About historically is <unk>.
Speaker Change: Having a strong title topline.
Speaker Change: Topline with disciplined investment still allows us to invest with growth against that emerging pipeline and we always speak to the fact that we have a significant investment already and we have a.
Speaker Change: Pipeline that has had a portfolio of late stage investments you think about the Denver are you think about broken do you think about our ticket program. Those were significant investments those are rolling over and as we and they are being replaced by our investments and are currently at stage pipeline and great opportunities in front of us with Sandro.
Speaker Change: It's on our O&M to greater and that provides opportunity also with respect to our early stage program, but we have talked about how BD is in our DNA. We're fortunate to have such a robust pipeline for.
Speaker Change: <unk> talked about how many favorites. We do have that provides a lot of optionality for us. These are all fully owned assets.
Speaker Change: So we're obviously theres no shortage of interest in our pipeline. We're open for the Optionality that affords, but given our strong balance sheet and our capital discipline, we're not obligated to do anything so we're really in a strong position as it relates to advancing the pipeline and do and creating the maximizing value for our shareholders.
Speaker Change: Yes.
Speaker Change: Thank you.
Speaker Change: Our next question comes from Kelly She at Jefferies. Please Amit your line and ask your question.
Speaker Change: Hi, Good morning. This is clearer on for Kelly. Thanks for taking my question and congrats on the progress for the quarter.
Speaker Change: So for the phase <unk> data readout for surround Clarkson refractory mantle cell lymphoma in the second half of the year and the <unk>.
Speaker Change: Casey that phase two data in 2026.
Speaker Change: Clarify what are the endpoints you and congratulate your agents you're looking at potentially support the registration.
Speaker Change: Also for the following of signs of Clarkson, China, maybe walk us through what kind of the typical timeline there. Thank you.
Speaker Change: Yeah.
Speaker Change: Yeah, I'll kind of a sense of a question for <unk>.
Speaker Change: Both saw as less become Casey that those are typical single arm monotherapy phase two studies.
Speaker Change: <unk> on the deal this was of course potential accelerated approval.
Speaker Change: In some mothballed.
Speaker Change: So class stuff out and we have already received a policy with needle from the CD New best initiative on the <unk> sites, we're anticipating potential approval and probably the first half of next year.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Yeah.
Speaker Change: Our next question comes from Gregory <unk> RBC capital, please meet to align and ask your question.
Gregory: Great Hey, good morning, John and team Congrats on the progress and thanks for taking my question.
Gregory: Just just on the quest for serial innovation, and just around DLL and and on the BT cases feedback I'm. Just curious if you could comment on on that relative positioning <unk>.
Gregory: <unk> active to routine PTK as in the longer term one what gives you confidence that $106 73 may have the ability to beat curtailment in a head to head.
Gregory: Study and secondly, certainly with discussion around maybe some some risks about using integrators earlier and treatment lines and treatment settings. Im just curious about potential mechanism of resistance, how that could preclude other treatment options. Just curious on your view with respect to that sequencing. Thanks, so much.
Gregory: Yes. Thanks for the question relates to our covenants, our beating Caitlin Greater I can tell you what that's increasing by day with more data coming this really give us assurance. This jump is three months supposed to do to ensure they fully completed the grades PTK protein.
Gregory: Even patients sustained clinical benefits.
Gregory: What is the additional data coming in and also our feedback from the Kols really gives us confidence to start this had to have hedge hall.
Gregory: That's total.
Gregory: This trial will be initiated in the second half of this year.
Gregory: In terms of utilizing the beauty category late in the audio line as industrial second question Web Gagnon data on that we're opening a cohort in the <unk> naive patient population to test it out.
Gregory: This is Stefan ml difference in Malaysia versus traditional beauty King bedroom, it's been an HSA, which one is better than the Watson are like six months, so with under the scientific dismantle the personnel is great. So we have the option of both.
Gregory: Traditional beauty gained picture as was upbeat deeply integrated pipeline. In addition to that I just wanted to finalize with.
Gregory: Or is there also potentially passing cost bcl two.
Gregory: That gave us a lot of different options and play in this space, which we think is very important when you really want to provide the best option for patients not just in the Bronx line, but also in the later months.
Speaker Change: That's great. Thank you very much and if I may an earlier question on the Teekay and PMN I'm, just curious how youre thinking about the ini portfolio certainly with the Iraq or is that an area that you want to expand upon as you think.
<unk>.
Speaker Change: Internal and external development, Thanks again guys.
Speaker Change: Central a question I didn't spend fund to discuss our portfolio during the call.
Speaker Change: This is actually very exciting portfolio Copay June.
Speaker Change: I actually have a dozen of the preclinical program, which is what they are operating in a space again, while utilizing our Friday depend methodically trying to create the best in class molecule, that's less dependent of closing cost monitors relate to the Iraq volume Hector IRA for the greater Las Super.
Speaker Change: Excited about this molecule so far the early data we have seen with this molecule again suggest and has the best in class potential ways. Its PK.
Speaker Change: There's some level over the degradation. We believe we can achieve complete target aberration at very low dose level and then we're also.
Speaker Change: Is eagerly anticipating our data.
Speaker Change: Tissue PD, which should come in the second half of this year.
Speaker Change: Well as I mentioned, we also have other portfolio, which we are really began to developing and hopefully a USD modest views coming from our pipeline in the next couple of years.
Speaker Change: Thank you.
Sean London: Our next question comes from Sean London at Morgan Stanley. Please.
Speaker Change: Please mute your line and ask your question.
Sean London: Good morning, everyone.
Speaker Change: Bureau World.
Speaker Change: Some are single benchmarking question to start if you look at the revenue reported by being quite sure.
Speaker Change: How would you size the opportunity trends sirona clients against that given potential beta site issues.
Speaker Change: Broadening.
Speaker Change: Improving efficacy and what other combination opportunities that might be.
Speaker Change: Yes.
Speaker Change: <unk>.
Speaker Change: And all that.
Speaker Change: Like the BK I fields.
Speaker Change: <unk> also have competition in the visa Sofia that truly decimated two molecules along with that.
Speaker Change: <unk>, yes.
Speaker Change: Okay.
Speaker Change: We actually I'm very excited about the portfolio.
Speaker Change: <unk> of our son's Cox.
Speaker Change: Multiple events and also more selective right now we're seeing that in a different indication waste response rate with duration of response. This is why it gave us the confidence to start and more than just the one after that trial. The first trial, we mentioned, which was an hour. So thats just one well at a finishing enrollment.
Speaker Change: This is a C S measurement versus the bolt on we are very excited about the second trial as well, which is in the relapsed refractory setting <unk> testing.
Speaker Change: Central costs, lecithin that causing the CD funding combination study, but this is truly a head to head trial weight body weight those two Charles can really establish.
Speaker Change: Is that potentially the best in class Bcl two this is critical.
Speaker Change: To that I just mentioned, we're also exploring the indications, which the net cost hasn't really had a success that's including multiple myeloma.
Speaker Change: Winter not talk about that trial for a while now, but it's moving along very nicely.
Speaker Change: Great and with more data later this year.
Speaker Change: I'll hand over to Matt Yeah, I can just offer some commentary on that.
Speaker Change: The market opportunity and we currently see the opportunity for a bcl two nice TV 20, that'd be about of about a quarter.
Speaker Change: That frontline opportunity in CLO and <unk>.
Speaker Change: We have set a number of times that we think that there's really three necessary components for for success and in particular with fixed duration that steep response.
Speaker Change: Undetectable Mardi long PSS.
Speaker Change: And strong safety and more recently, we've seen some of this exploration Reggie.
Speaker Change: Regiments fell of heat that that high bar.
Speaker Change: For some of the reasons that lies outlined we're very confident that there'll be opportunities with zahnow and sango to meet that high bar.
Speaker Change: And then ultimately leading to some expansion of the use of a <unk> and <unk> and in.
Speaker Change: In that setting so that that's a possibility and then clearly we see <unk> and <unk> as being the real driver for the expansion in that setting.
Speaker Change: Thank you and one more quick one if I may are more on the commercial side, but historically when you do benchmarking against bookings of revenue against peers.
Speaker Change: Across Europe, you seem sort of underweight, if you like that I'm just wondering if you could momentum. It appears in this quarter do you think you've got the investment about right in terms of salespeople to really grow that European revenue or you just sort of map that Matt.
Speaker Change: That out for me a little bit would be awesome.
Speaker Change: Yes European business.
Speaker Change: Growing nicely and you have seen.
Speaker Change: <unk> growth was 75%.
Speaker Change: Bookings.
Speaker Change: Syed and increasingly and we also.
Speaker Change: Increasingly we have more new patient share sofar for cancer.
Speaker Change: And in terms of <unk> and we get.
Speaker Change: New product launched in Germany in Austria span and also some other countries like Switzerland and Norway.
Speaker Change: I'll also got reimbursement and eight grossman countries kv, increasing and.
Speaker Change: The launch activity is on track.
Speaker Change: In the rest of the world.
Speaker Change: And you can say.
Speaker Change: <unk>, obviously these two girls so 146%.
Speaker Change: The amount of Cabo we have also launched routines.
Speaker Change: <unk> Japan.
Speaker Change: And also.
Speaker Change: Recently, we also got approval of Cuban bra in multiple countries in Brazil.
Speaker Change: In South Korea, and reimbursement to Australia reimbursement and also we see significant progressing to Rainbow.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: Our final question comes from ecosystem with its from Citigroup. Please mute your line and ask your question.
Speaker Change: Hi, great. Thank you very much I had a few questions.
Speaker Change: On Zen Sondra, plus their new pricing I know, it's early but I'd like to get your early thoughts if youre expecting that to be price neutral with brookins, though with the idea to take more share with a better profile or possibly a premium and then you talked a lot about supply chain resiliency and you mentioned the the sourcing of.
Speaker Change: <unk>, API, and Switzerland, and Spain, obviously, you have the fill and finish in the United States I'm wondering if there's some long range plan to Additionally introduces an API supply within the United States and then finally.
Speaker Change: John you talked a lot about resiliency I am curious about geographic Brazilian cities, specifically with respect to R&D.
Speaker Change: The re domicile in Switzerland, do you expect to move more of the core R&D outside of China to Switzerland, as well as as well as U S. Thank you very much.
Speaker Change: So thanks for the question. So I'll take the first couple and then hand it over to John.
Speaker Change: It's way too early to talk pricing with respect to our pipeline assets. All say is we're really confident.
Speaker Change: In the profiles that these assets, having front of them and we will price them accordingly relative to the value that they're creating issues.
Speaker Change: With respect to supply chain resiliency, yes, we're very we're very enthused by the efforts we've taken in the past to ensure that we have supply and resilience for patients all around the world. Obviously, we are monitoring all the activity that's happening.
Speaker Change: In the environment and we'll be sure that we take measures to proactively ensure that supply for U S patients, but really importantly patients everywhere around the world.
Speaker Change: Okay.
Speaker Change: Yes, we are.
Speaker Change: As you mentioned, we're excited about things from a global perspective, and I think the organization is always in this global expansion last quarter I think you've heard us talk about.
Speaker Change: Opening operations in South Africa for example.
Speaker Change: Today, the management team is sitting here in our San Carlos.
Speaker Change: Office on our in center.
Speaker Change: We are excited to be interviewed recruiting people here for the R&D perspective, too. So I just think it's inevitable.
Speaker Change: Expansion process as we try to work globally had a grade one and.
Speaker Change: Yeah.
Speaker Change: From a research from a clinical ad.
Speaker Change: Great medicines to patients for cyber thank.
Speaker Change: Thank you.
Speaker Change: Thanks.
Speaker Change: There are no further questions I will turn the call over to Jon Wheeler for closing remarks.
Jon Wheeler: Thanks, So much I think our first quarter execution across the key priority is really sets a strong foundation for 2025, and I'm really looking forward to sharing more updates and milestones with all of you throughout the year. So thanks, so much for joining us today and taking your time and energy.
Jon Wheeler: And for the very thoughtful process and how can a wonderful day.