Q1 2025 Vertex Pharmaceuticals Inc Earnings Call
Speaker Change: Good day and welcome to the Vertex Pharmaceuticals' first quarter 2025 earnings call. Good day and welcome to the Vertex Pharmaceuticals' first
Speaker Change: All participants will be in a listen only mode. Should you need assistance, please signal conference specialist by pressing the star key you followed by zero.
Speaker Change: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star than one on your touch-tone phone. And to withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Ms. Susie Lisa. Please go ahead, ma'am.
Susie Lisa: Good evening, all. My name is Susie Lisa, and as the Senior Vice President of Investor Relations, it is my pleasure to welcome you to our first quarter of 2025 Financial Results Conference call. On tonight's call, making prepared remarks, we have Dr. Rashma Kewalramani, Vertex's CEO and President, Stuart Arbuckle, Chief Operating Officer, Charlie Wagner, Chief Financial Officer, and Duncan McKechnie, SVP North America Commercial Operations, and come July 1, Chief Commercial Officer. Thank you.
Susie Lisa: We recommend that you access the webcast slides as you listen to this call. The call is being recorded and a replay will be available on our website. We will make forward-looking statements on this call that are subject to the risks and uncertainties discussed in detail in today's press release.
Susie Lisa: and in our filings with the Securities and Exchange Commission. These statements, including without limitation, those regarding Vertex's marketed medicines for cystic fibrosis, sickle cell disease, beta thalacemia, and moderate to severe acute pain, our pipeline, and Vertex's future financial performance are based on management's current assumptions. Actual outcomes and events could differ materially. I would also note that select financial results and guidance that we will review on the call this evening are presented on a non-GAAP basis.
Lisa's, I will now turn the call over to Reshma.
Reshma Kewalramani: Thanks, Susie. Good evening, all, and thank you for joining us on the call today.
Reshma Kewalramani: Continuing the momentum from 2024, we've kicked off 25 with another quarter of strong performance across the board We've kicked off 25 with another quarter of strong performance across the board
Reshma Kewalramani: Growing and diversifying revenue as we execute on multiple launches, accelerating programs in pivotal development, and advancing the R&D pipeline . . . .
Reshma Kewalramani: We continue to reach more patients with more products and delivered 2.77 billion in revenue in the first quarter, representing 3% growth versus Q1 2024.
Reshma Kewalramani: This year, we are keenly focused on commercialization, and we are pleased with the early launch dynamics and physician and patient feedback on a live trek, our fifth CF medicine, and your navics, the first oral, non opioid, from moderate to severe acute pain in more than two decades. [inaudible]
Reshma Kewalramani: Both of which were proved in the US in just the last few months. With these approvals and the continued global launch of Keshe Chevy, our gene-edited therapy for sickle cell disease in Betafal, Semia, we are significantly expanding the number of patients we serve. [inaudible]
Reshma Kewalramani: We are also sharply focused on advancing the four programs currently in pivotal development. Susceptrogene and diabetic peripheral neuropathy, The Myles Cell in type 1 diabetes. Susceptrogene. Susceptrogene.
Reshma Kewalramani: Innaxiplin, in APOL-1 mediated kidney disease, and POVI, in IgN neuropathy. Importantly, three of these phase three programs are on track to complete enrollment of the Interim Analysis cohort or the full study this year.
Reshma Kewalramani: And as we approached the one year anniversary of the acquisition of Alpine immune sciences, I wanted to highlight two big recent povitas of separated milestones. Now, let's take a closer look at the first one.
Reshma Kewalramani: First, we completed enrollment in the Interminalysis cohort in the Phase III, Renear Igan Trial. .
Reshma Kewalramani: And second, we reached agreement with the FDA to advance Povey to pivotal development in a second indication, primary member-ness nephropathy. This is a notable milestone as Povey continues to deliver on its promise as a pipeline in a product with best-in-class potential.
Reshma Kewalramani: The start of the POV member in the study will also mark our fifth program in pivotal development.
Reshma Kewalramani: Tonight, I'll limit my R&D comments on the pipeline programs with the most significant new information to share, specifically CF, Pain, Type 1 diabetes, and the kidney programs, starting with CF.
Reshma Kewalramani: Following our December US approval of a lift trek, we have gained MHRA approval in the UK and a positive CHMP opinion in the EU.
Reshma Kewalramani: As a result, we expect potential approval from the European Commission for a lift trek in the second half of this year, along with potential approvals in Canada, Australia and Switzerland [inaudible]
Reshma Kewalramani: These approvals are in addition to the European Commission's early April approval of Capturio for rare mutations.
Reshma Kewalramani: which followed similar approvals for tricaster rare mutations in the US and Canada late last year, adding hundreds of additional eligible patients in North America and thousands in Europe . [inaudible]
Reshma Kewalramani: These approvals are a direct result of the team's decades-long painstaking work to establish and verify the hypothesis that the three unique binding sites of our CFTR modulators results in overall protein stabilization and have the potential to transform the lives of nearly 95% of patients with CF. [inaudible]
Stuart will share more on the US lift trek launch shortly.
Reshma Kewalramani: Next on the horizon, for our CF Small Molecule Program, is the next gen, or NG3.0 CFTR regimen. With this program, we seek to reach our longstanding goal of bringing most, if not all, patients with CF to normal levels of CFTR function. The backbone of this NG3.0 combination is VX-828.
Reshma Kewalramani: the most efficacious CFTR corrector that we have ever studied in vitro.
Reshma Kewalramani: It is completing Phase One development and we remain on track to initiate a study with VX-828 in patients with CF before the end of this year. For the ongoing Phase One 2 study of VX-522, for the approximately 5,000 or so patients who cannot benefit from our CFTR modulators, we have recently implemented a temporary pause.
Reshma Kewalramani: to the study as we assess a tolerability issue. Given that this remains an active clinical trial, we won't be providing any additional details at this time so as to maintain study integrity. We will update you when we know more. [inaudible]
Moving next to the pain programs.
First.
Reshma Kewalramani: The Phase III study of Susetrogene in diabetic peripheral neuropathy, a chronic peripheral neuropathic pain condition that affects over 2 million Americans annually is well underway with ongoing enrollment and dosing. As a reminder, Susetrogene has fast-track designation for peripheral neuropathic pain and breakthrough designation for diabetic peripheral neuropathy. As a reminder, Susetrogene has fast-track designation for diabetic peripheral neuropathic pain and dosing.
Reshma Kewalramani: Next, I'm very pleased to share that the study of oral VX 993, another NAV 1.8 inhibitor, in acute pain post-bondionectomy, is on track to complete this quarter . . .
Reshma Kewalramani: and we expect to report results from this trial in the second half of this year. VX 993 has fast track designation for acute pain in both the oral and IV formulations. [inaudible]
Reshma Kewalramani: Lastly, we continue to make solid progress with additional nav 1.8 inhibitors beyond VX 993, as well as in our nav 1.7 pain signal inhibitor program that may be used alone or in combination with nav 1.8 inhibitors. We will continue to make a solid progress with our nav 1.8 inhibitor program that may be used alone or in combination with nav 1.8 inhibitors beyond VX 993.
Transitioning now to type on diabetes.
Reshma Kewalramani: Semi-Lacel remains on track to complete enrollment and dosing of its pivotal study, this quarter, positioning us for global regulatory submissions in 2026.
Reshma Kewalramani: if the data are supportive. Recall we expect about 60,000 severe type 1 diabetics who may potentially benefit from this first Zemile of Self-Semission.
Reshma Kewalramani: Based on the high unmet need in T1D and the transformative nature of this therapy, the Myles cell has multiple global regulatory designations.
Reshma Kewalramani: including Armatt and FastTrack in the US, Prime in the EU, and the Innovation Passport in the UK. In our other T1D work following the recent data from VX264 or the Celsplus Device Program, we have returned this approach to the research stage. Thank you very much.
Reshma Kewalramani: We continue to make preclinical progress on our other approaches to cloak the VX880 cells from the immune system. These cells have already demonstrated transformative efficacy.
Reshma Kewalramani: These approaches include alternative immunosuppressive regimens and gene editing to make hypoimmune isle itself, and we look forward to updating you as these programs advance. Thank you very much.
Reshma Kewalramani: Finally, a few updates on our kidney portfolio, which now has clinical stage programs in four renal diseases, IgA Nefropathy, AMKD, Membranus Nefropathy, and ADPKD, or Autosomal Dominant Polycystic Kidney Disease
Reshma Kewalramani: Starting with Povatassacept, a potential best in class, dual antagonist of the bath and April fine of kinds, which play a key role in the pathogenesis of B-cell mediated autoimmune diseases.
Reshma Kewalramani: First, in eigen, as mentioned earlier, I am very pleased to share that we have completed enrollment in the interim analysis cohort of the Rainier Phase III trial. Thank you very much.
Reshma Kewalramani: Once this cohort completes 36 weeks of treatment, we will conduct the internment analysis, and if positive it will support filing in the first half of 2026 for a potential accelerated approval in the US.
Reshma Kewalramani: In addition, our program to support the launch of POVY with a subcutaneous auto-injector for monthly at-home administration is well underway. Thank you very much.
Reshma Kewalramani: And for full approval, we're making strong progress towards our goal of enrolling the complete cohort of 480 patients in whom we will assess EGFR through week 104.
Reshma Kewalramani: Second, based on the positive results from the Ruby3Basket study, we have reached agreement with the FDA to advance POV to pivotal development in membranous nephropathy. Beginning in the second half of this year, we are planning to initiate a single Phase 2-3 adaptive study of POV versus standard of care with the primary endpoint of complete remission at week 72.
Reshma Kewalramani: Next, two highlights on an exoplan for APOL-1 mediated kidney disease, or AMKD. [inaudible]
Reshma Kewalramani: First, we remain on track to complete enrollment in the interim analysis cohort of the Amplitude Pivotal Trial this year. Amplitude is a study of primary AM Katie. That is to say, patients with two APOL-1 variants and no additional renal-related comorbidities.
Reshma Kewalramani: After completing enrollment, when this cohort reaches 48 weeks of treatment, we will conduct an internal analysis. If positive, we will be poised to file for potential accelerated approval in the US. We will conduct an internal analysis. If positive, we will conduct an internal analysis.
Reshma Kewalramani: Second, based on the positive proof of concept results of an exoplanet in primary AMKD, the momentum in the phase three study, and interest from the community, we recently initiated the amplified study. Amplified is a phase two proof of concept study of an exoplanet in patients with AMKD and other comorbidities. [inaudible]
Reshma Kewalramani: including type 2 diabetes. This study is enrolling in dosing patients. [inaudible]
Reshma Kewalramani: To close on our kidney pipeline, a few comments on VX 407 in autosomal dominant, polycystic kidney disease, or ADPKD.
Reshma Kewalramani: Vx407 is a first in class small molecule protein folding corrector that is designed to target the underlying cause of ADPKD by restoring PC1 protein function thereby reducing total kidney volume and preventing progression to kidney failure.
Reshma Kewalramani: As a reminder, by way of its mechanism of action, VX407 addresses up to 10% of ADP-KD patients. [inaudible]
Reshma Kewalramani: and as in CF, we will seek to expand the eligible patient population with serial innovation over time.
Reshma Kewalramani: We have completed the phase one trial of the X-407 and the PK safety are supportive of advancement. . . . . . . .
The Phase II proof-of-concept study is designed as a 52-week...
Reshma Kewalramani: Single Arm Study of 24 Patients that will evaluate the efficacy of Vx4-7 as measured by the height-adjusted total kidney volume. [inaudible]
Reshma Kewalramani: And we are on track to initiate this study in the second half of this year.
Speaker Change: For five years now, at the end of my remarks, I've turned a call over to Stuart. I'll do so for the final time tonight. Let me acknowledge and thank Stuart once again for the incredible run at Vertex and wish him the very best in retirement.
Speaker Change: With that, I'll now turn the call over to Stuart and Duncan for a commercial update.
Stuart Arbuckle: Thanks very much, Reshma. I'll focus my comments tonight on the CF franchise, including the launch of a lift trek and the continuing global launch of Cass Jevy, building on the foundation we established in 2024. Thank you very much.
Stuart Arbuckle: I'll then turn it over to Duncan to provide an update on the US launch of genetics in acute pain. Starting with CF, with our existing portfolio of CF medicines, Calidico, or Cambi, Simdico and Tricafter, we have continued to grow the number of eligible patients taking our CFTR modulators.
Stuart Arbuckle: As expected, we also continue to make regulatory and reimbursement progress that enables us to expand to younger patients. Calidico is now approved down to one month olds.
Stuart Arbuckle: Patients with rare mutations, tri-cafter recently secured US and EMA approvals to expand the label for additional mutations, which means that the triple combination is now approved for mutations present in nearly 95% of all CF patients in our core markets.
and patients in new geographies such as Brazil. [inaudible]
Stuart Arbuckle: In addition, as a result of better patient care, including the availability of our CFTR modulators, people with CF are now living longer than ever before. Now turning to the Alif Trek launch, our fifth CFTR modulator approved to treat the underlying cause of CF
Stuart Arbuckle: In phase three studies, when compared head-to-head with tri-cafter, a lift-track demonstrated non-inferiority on lung function, and further improvements in CFDR function, as measured by sweat chloride
Stuart Arbuckle: A lift trek was also approved by the FDA for an additional 31 mutations not covered by the tri-cafter label and offers the convenience of one's daily dosing
Stuart Arbuckle: Recall, too, that electric carries a meaningfully lower royalty burden for Vertex
Stuart Arbuckle: and extends our composition of matter-pattern protection from 2037 for Tricafta into 2039 for a lift trek. Thank you.
Stuart Arbuckle: We're pleased with the early US launch progress, and we're seeing uptake in all of the patient groups eligible for a lift trek. Those naive to CFTR modulators, or with newly approved rare mutations, where we have seen the fastest initial uptake. Patients who've discontinued one of our other CFTR modulators.
Stuart Arbuckle: and patients switching from tri-cafter who seek greater improvement in CFTR function and or the convenience of one's daily dosing. ElifTrek prescriptions are off to a strong start as patients and physicians familiarize themselves with the ElifTrek clinical data. ElifTrek prescriptions are off to a strong start as patients and physicians familiarize themselves with the ElifTrek clinical data.
including statistically significant lower-sweck chloride than Traycafter,
Stuart Arbuckle: The liver monitoring requirements when initiating therapy and the convenience of once daily dosing. [inaudible]
Stuart Arbuckle: We continue to expect the majority of patients in the US who are currently on CFTR modulator therapy will switch to a lift trek over time. We also look forward to launching a lift trek later this year in the UK and other countries pending ongoing regulatory approvals.
Stuart Arbuckle: Transitioning now to cast jevy, our transformative one-time treatment for patients with sickle cell disease and beta thalassemia. Since regulatory approvals in late 2023 and early 2024, the rollout of cast jevy is progressing as we expected and gathering momentum across all regions. [inaudible]
ATC Activations and Patient Initiations continue to increase. [inaudible]
Stuart Arbuckle: As we now have more than 65 authorized treatment centres, nearing our goal to activate approximately 75 total ATCs globally. We're also encouraged to see many ATCs have now collected cells from multiple patients. [inaudible]
Stuart Arbuckle: As to specifics on the other important marker of our progress, since launch approximately 90 patients have now had their first cell collections, meaning they have begun the patient treatment journey. [inaudible]
Stuart Arbuckle: Encouragingly, more than twice that number of patients has been referred by their physicians to ATCs to initiate the treatment process. And in Q1, eight patients completed their treatment journey and received their infusions of castyevy edited cells. [inaudible]
Stuart Arbuckle: With regard to access and reimbursement, we continue to make progress on the cast-gevy pay-off front. In the US, formal commercial coverage is either in place or provided through single case agreements. In the US, the US, the US, the US, the US, the US,
For Medicaid patients who represent about 45% of total patients, [inaudible]
Stuart Arbuckle: The majority of states have joined the CMMI Demonstration Project for Cell and Gene Therapy Access Model
Enabling fertility coverage for these patients.
Stuart Arbuckle: and providing an alternative, seamless approach for ATCs and states to the existing case-by-case coverage and state agreements.
Stuart Arbuckle: In Europe , we have now secured reimbursed access for both sickle cell disease and beta thalacymia patients in England, Wales, Denmark, Austria, and Luxembourg [inaudible]
Stuart Arbuckle: And in the Middle East, we have reimbursement in Bahrain, Saudi Arabia, and recently added coverage in the majority of Emirates in the UAE [inaudible]
Stuart Arbuckle: The interest in cast jevy continues to be incredibly high in the sickle cell disease and beta thalassemia, patient and physician communities globally, and uptake is accelerating as access and reimbursement is cured and familiarity with the process for collecting cells and infusing this truly transformative treatment grows.
Stuart Arbuckle: The impact of Castievi is best captured by the real-world feedback from patients.
Cairgivers, and Physicians,
Speaker Change: It's been inspiring to hear that cast-ever patients now feel able to live their lives in ways they never have before. Whether that means having the energy to play with their kids? [inaudible]
Speaker Change: Taking up snowboarding without fear that the cold might bring on a pain crisis or investing in their education and careers given expectations now for a longer and healthier life. It is a privilege to be part of their journey.
Speaker Change: I'll close my comments today by saying what a true honour it has been to serve patients, employees and shareholders as the Chief Commercial Officer and Chief Operating Officer at Vertex.
Speaker Change: The company has never been better positioned from a scientific, commercial, financial or people perspective [inaudible]
Speaker Change: and I look forward to following its continued success, including with Duncan as the new Chief Commercial Officer. I'll now hand over to Duncan to provide an update on the latest chapter in our commercial diversification, with the exciting launch of Genetics in moderate to severe acute pain.
Duncan McKechnie: Thank you, Stuart. It has been a privilege to know you for over 35 years and work with you at Vertex for the last 12.
I wish you every happiness in your retirement.
Speaker Change: We are seeing a strong reception for a novel, non-opioid option for the treatment of moderate to severe acute pain.
Speaker Change: We're pleased with the early launch, including broad retail pharmacy stocking, progress of reimbursement discussions and pay a coverage, P&T committee reviews, the breadth of usage to date and media coverage.
Speaker Change: To give you a sense of Genavix's progress thus far, I'll detail several key elements of our launch plan.
One, let me start with retail pharmacy stocking. [inaudible]
Speaker Change: which is crucial given the acute nature of pain. By mid-March, Genavix was available at approximately 33,000 pharmacy locations, including nearly every location for the three largest pharmacy chains in the country, as well as over a dozen regional chains nationwide. [inaudible]
Speaker Change: Two, I'm also happy to report that we've made rapid progress with payers.
Speaker Change: which is a testament to their appreciation for the Genavix clinical profile and the importance of a novel, non-opioid option in the treatment of acute pain.
Speaker Change: With commercial payers, our negotiations continue to progress favorably. We've recently reached a formal coverage agreement with one of the large national pharmacy benefit managers to make genetics available to their customers, collectively representing 22 million commercial lives. [inaudible]
Speaker Change: In Medicare, we continue to engage with Medicare plans to secure off-cycle coverage in 2025 and 2026 coverage in line with Medicare bid cycle timing. For Medicaid patients, 10 state Medicaid plans are now providing unrestricted access to genomics. For Medicaid patients, 10 state Medicaid plans are now providing unrestricted access to genomics. For Medicaid patients, 10 state Medicaid plans are now providing unrestricted access to genomics.
Speaker Change: meaning no prior authorization or step-edit requirements, and copays as low as three to five dollars as is common practice for Medicaid. We expect the coverage across commercial, Medicare and Medicaid payers will expand through 2025. We expect the coverage across commercial, Medicare and Medicaid payers will expand through 2025.
Speaker Change: 3. A key area of focus is hospital P and T committees. As a reminder, we are prioritising approximately 2,000 hospitals, many of which ladder up to 150 health care systems or integrated delivery networks. [inaudible]
Speaker Change: More than a third of these target healthcare systems have already taken steps to initiate P&T reviews of Genavix, and some have already added it onto their formulary
Speaker Change: 4. Turning to patients are patient support programs are working as designed
Speaker Change: to provide a smooth and positive patient experience so that eligible patients who are prescribed genetics for their acute pain get access to the medicine for an interim period while payer
Speaker Change: 5. Shifting to the policy landscape, we are encouraged by the continued momentum and interest by federal and state policy makers to provide equal access to non-opioids.
Speaker Change: The critical need for non opioid options was underscored by the presentation of new research at the American Academy of Pain Medicine in April .
Speaker Change: Our Health Economics Analysis indicates that replacing just 25% of current acute pain prescriptions for opioids with non-opiodes like genetics [inaudible]
Speaker Change: Could deliver annual cost savings of $4.5 billion to the healthcare system and could prevent up to 260,000 cases of opioid use disorder and approximately 9,000 overdose deaths over the next 15 years.
Speaker Change: With respect to state legislation, to date nearly 35 states have already either enacted or proposed legislation to support the use of non opioids. [inaudible]
Speaker Change: At the federal level, I'll highlight the No Pain Act, which in January began providing an add-on payment for non opiodes used in Medicare patients in the hospital outpatient or ambulatory surgery center settings [inaudible]
Speaker Change: We continue to expect genetics to be added near term to the list of medicines approved for this add-on payment.
Speaker Change: Lastly, an important indicator of our launch progress and a reflection of the unmet need in moderate to severe acute pain is that more than 20,000 prescriptions were successfully filled for genetics as of April the 18th.
Speaker Change: which is aligned with Genavix's broad label. We continue to execute on the opportunity to transform the treatment of pain while also creating another multi-billion dollar franchise for Vertex.
Speaker Change: To conclude, we are in a new era of commercial diversification at Vertex and we look forward to bringing our transformative therapies to more and more patients and to keeping you updated on our progress. [inaudible]
Speaker Change: I'll now turn the call over to Charlie to review the financials.
Charlie Wagner: Thanks, Duncan. Vertex's Q1 2025 results demonstrate our consistent strong performance in attractive growth profile. First quarter, 2025 total revenue increased 3% year-over-year to 2.77 billion. US revenue growth of 9% year-over-year was driven by ongoing patient demand, higher net realized pricing and the early launch of a lift trek.
Charlie Wagner: As expected, XUS revenue in the quarter declined and was down 5% year-on-year. [inaudible]
Charlie Wagner: Recall it outside the US, Q1 2024 benefited from increased channel inventory due to the majority of Russia shipments occurring early in that year. In Q1 2025, Russia revenue was negatively impacted by the availability of an illegal copy product. [inaudible]
Charlie Wagner: Excluding the impact of the revenue decline in Russia, XUS CF revenue growth would have increased in the low single digits. [inaudible]
Charlie Wagner: 14 million from cast Chevy and 10 million of collaboration revenue first quarter 'twenty twenty-five combined non-GAAP R&D acquired IP R&D and SG&A expenses were 1.23 billion, an increase of 21% compared to 1.02 billion in the first quarter of 'twenty 'twenty four the most significant increases in R&D and SG.
Charlie Wagner: <unk> expenses versus prior year were due to rapid advancement of our broad pipeline, including clinical trials for IGN pain and type one diabetes as well as the build out of commercial capabilities in pain first quarter 'twenty twenty-five non-GAAP acquired IP R&D expenses were 20 million compared to $77 million in the first quarter of 'twenty 'twenty four.
Charlie Wagner: First quarter 'twenty twenty-five non-GAAP operating income was 1.18 billion compared to 1.34 billion and non-GAAP operating income in the first quarter of 'twenty 'twenty four first quarter 'twenty twenty-five non-GAAP effective tax rate was 18.8% first quarter 'twenty 25, non-GAAP earnings per share were $4 and six.
Charlie Wagner: Cents compared to $4.76 in the first quarter of 'twenty 'twenty four primarily due to increased operating expenses as well as lower interest income we ended the quarter with 11.4 billion in cash and investments after deploying approximately $425 million to repurchase more than 930000 shares in the first quarter overall.
Charlie Wagner: All our priorities for cash deployment remain unchanged now switching to guidance given the strong start and clear line of sight to the balance of the year. We are raising the low end of our 20 twenty-five total revenue guidance from 11.75 billion to a revised range of 11.85 to 12 billion representing growth of approximately 8% at the midpoint.
Charlie Wagner: At current exchange rates.
Charlie Wagner: This outlook reflects our expectation for continued growth from our portfolio of CF medicines, including the ongoing launch of a lift truck in the U S. Followed by other regions. Later this year. We believe the illegal copy issue is isolated to Russia and is fully included in our outlook guidance. Also includes a continued ramp up and catch gebbie revenue as we treat more patients in.
Charlie Wagner: Geographies, where we have secured regulatory approval and reimbursement. In addition guidance reflects a revenue contribution from genetics, primarily in the second half of 2025 as a reminder, we expect volumes will ramp ahead of revenue due to financial assistance programs that are designed to provide eligible patients with immediate access while we work to secure broad.
Charlie Wagner: Sustainable payer coverage recently announced positive coverage decisions are included in our revenue guidance as a result of these positive trends and as implied in our guidance range, we expect growth to accelerate over the remainder of the year delivering another strong year for vertex in 2020 five for combined non-GAAP R&D occur.
Charlie Wagner: Wired IP R&D expenses and SG&A. There is no change to our guidance range of $4.9 billion to $5 billion for the full year 'twenty twenty-five consistent with prior guidance. This includes approximately $100 million in projected IP R&D charges. We will continue to invest the majority of our operating expenses into R&D given the momentum in our multiple.
Charlie Wagner: Mid and late stage clinical development programs with four and soon to be five phase III studies ongoing in multiple phase twos. The planned increase in commercial costs in 'twenty twenty-five supports our increasingly diversified commercial portfolio a full year of investments to support the launch of genetics and potential near term launches given our differentiated.
Charlie Wagner: Business model and focus on specialty markets, we can make these targeted investments, while maintaining attractive profitability and cash flow. We expect an immaterial cost impact from tariffs based on what we know today due to a lower exposure to China in a geographically diverse supply chain. Additionally, much of our intellectual property is either in the U S or the U K.
Charlie Wagner: <unk> of course, given the dynamic nature of the tariff situation, including the potential for sector specific tariffs. This outlook is subject to change and finally on guidance. There is no change to our expected full year 2025, non-GAAP effective tax rate in the range of 20.5% to 21.5% in.
Reshma Kewalramani: In closing vertex yet again delivered strong results in line with our expectations in Q1, 'twenty twenty-five growing and diversifying our revenue with the launch of two new products in the U S. A lift truck in genetics, continuing the global launch of cast gebbie, and making significant pipeline progress across the portfolio. In addition, we now have five programs.
Reshma Kewalramani: That are in phase III or soon will be in multiple additional programs with first in class <unk> best in class potential in the clinic and our early and mid stage pipeline. These and other anticipated milestones of continued progress in multiple disease areas are detailed on slide 17, we look forward to updating you on our progress on future calls before.
Charlie Wagner: Turning the call to Susie to begin the Q&A period, Let me also add my thanks, and congratulations to Stuart Stuart is a talented executive and team player who has contributed enormously to vertex. He's also a friend as Stuart passes the Baton we look forward to welcoming Duncan to the executive team and to future earnings calls I'll now ask Susie to begin the Q.
Reshma Kewalramani: Renee.
Reshma Kewalramani: Sure.
Reshma Kewalramani: Yes.
Reshma Kewalramani: Externally check can you get a statically.
Reshma Kewalramani: We will now begin the question and answer session.
Speaker Change: I ask a question you May press Star then one on your Touchtone phone.
Reshma Kewalramani: If you're using a speakerphone please pick up your handset before pressing the keys.
Reshma Kewalramani: If at any time. Your question has been addressed and you would like to withdraw. Your question. Please press Star then two and at this time, we'll pause momentarily to assemble our roster.
Speaker Change: And then in the first question will come from Geoff Meacham with Citibank. Please go ahead.
Reshma Kewalramani: Awesome.
Geoff Meacham: Afternoon, guys. Thanks for the question Ah Stewart, Congrats again on the retirement duck and looking forward to working together.
Geoff Meacham: I had a couple of quick ones one on a lift truck on the launch what's been the feedback on utilizing sweat chloride as a biomarker more in practice I wasn't sure if the.
Geoff Meacham: If the conversations that you guys are having with pulmonologists on switching from Tri CAFTA.
Geoff Meacham: This is more related to the dosing differential or the sweat chloride or maybe a combination.
Geoff Meacham: And then just on generics to get an update.
Geoff Meacham: Maybe give us a sense for how you're thinking about the chronic pain indications and the design of those studies I know you haven't had full FDA discussions, but as you look at the prior data you know maybe give us a sense for where you are with implementing maybe more novel strategies for that study. Thank you.
Reshma Kewalramani: First thing Hey, Jeff its ratio, let me start with the genetics in chronic pain work and then I'll turn it over to Stuart to talk left track.
Reshma Kewalramani: Really no new news to report to you Jeff We're on track to have our end of phase two meeting with the F. D. A.
Reshma Kewalramani: This summer.
Reshma Kewalramani: I really liked the study designs. The the team has come up with we've done a lot of work on innovating and optimizing the clinical trial designs and I do expect that we'll have an update for you. This summer separately, but on a related note. The D. P. M studied the diabetic peripheral neuropathy study with VX 548.
Reshma Kewalramani: Is well underway enrolment dosing in that study is going well Stuart Alif track, yet Jeff on a lift trek I would say sweat chloride is not.
Speaker Change: Routinely used in clinical practice to assess C. F T. All functional though it's well understood as a measure of C. F T a function, but it's not something that's being increasingly adopted in in clinical practice. Despite the the the ilife track data and in terms of what do people find compelling.
Speaker Change: [noise] about the Ilife correct profile I would say, it's really the sum of parts Geoff. So it's firstly the fact that it's demonstrated in large long robust clinical trials, but it's not in theory to try catheter, which as we all know sets a very high bar in terms of F. N. B one and then it is the improvement since the F T a function that people.
Speaker Change: The potential to access as measured by sweat chloride.
Speaker Change: Then reinforcing that improved potential efficacy, it's the additional 31 mutations in the Ilife Trek label.
Speaker Change: The FDA granted us versus the the Tricast a label and then lastly, but still very importantly for CF patients since the once a day versus the twice a day for Tri CAFTA. So I wouldn't say, it's one thing more than the others. It's really that combination of of benefits that I think people are finding attractive about the electric profile.
Speaker Change: The next question will come from Jessica Fye with J P. Morgan. Please go ahead.
Jessica Fye: Hey, guys. Good afternoon, thanks for taking my questions and congrats again.
Jessica Fye: First maybe for Charlie when you said you expect immaterial impact from tariffs just to confirm is that from the current tariffs or is that if biopharma specific tariffs are implemented and maybe just for our comfort can you give us a little more detail on for Texas manufacturing footprint, particularly for electric truck CAFTA and genetics and how you think about the company.
Jessica Fye: Potential exposure to tariffs if they are implemented and then just separately on the CF business can you recap how we should think about the impact of the Russia issue and just lapping last year's sales that included Russia is that impact largely contained to one Q.
Jessica Fye: Or is that also impacts Q2 and subsequent quarters can you just quantify what that headwind is thank you.
Jessica Fye: Charlie.
Jessica Fye: Yes, yes, I'm going to start with the with the C F impact lives.
Jessica Fye: The year's off to a great start and it's very much in line with our internal expectations. We commented in the fourth quarter about this isolated issue in Russia, and it's worked out exactly as we expected the impact in the first quarter is about $100 million and for the full year, it's $200 million total.
Jessica Fye: And so all of that is included in our current guidance, which as you know is 8% growth at the midpoint, which implies acceleration over the balance of the year. So we feel really good about where we're at and we can talk more about some of the drivers I'm going to move onto the second part of your question on tariffs.
Jessica Fye: Given how dynamic the situation is just I have to limit my comments to what we know today and so for tariffs that have been announced and are in effect. There is an immaterial impact to vertex we.
Jessica Fye: We have I think a very well balanced global supply chain, we have minimal exposure to China the.
Jessica Fye: The vast majority of our drug product manufacturing for CF is in the United States and most of our IP is concentrated in the U S and the U K. So for those reasons the impact is immaterial.
Jessica Fye: Again, there are all sorts of different tariff concepts that are being discussed including sector specific tariffs until we know more about what might be implemented I can't really size the impact for you.
Jessica Fye: Thank you.
Speaker Change: The next question will come from Selvey richer with Goldman Sachs. Please go ahead.
Speaker Change: Thank you. Good afternoon, just following up on Alex track could you just walk us through the early adopters are whether there is.
Speaker Change: There seems to be a significant portion coming from.
Speaker Change: A certain pool of patients and then on join attacks and with regard to the commercial payers here and can you speak to the nuances with regard to tiered and preferred versus non preferred status in your overall plan for positioning. Thank you.
Speaker Change: Sure thing Savi, let me split that question and ask Stuart to comment on a lift truck and the segments. We've talked about them on the kinds of patients and then I'll ask Duncan to give you a little bit more color and texture behind the journey <unk> launch in general, including where we are with Payors Stewart Yeah. So we are seeing uptake from.
Speaker Change: Our lift truck.
Speaker Change: All of the patient groups that we identified there are those that are newly eligible for CFT almost modulator people, who are sort of truly naive have never been on one previously which includes the Ram mutations that try catheter was approved for in the additional mutations that a lift truck was a fruitful.
Speaker Change: Perhaps not surprisingly we are seeing the fastest uptake as a percentage of the total pool in that group, but we are also seeing Ah patients who discontinued coming back to us the FTL modulate it now that a new auction like a lift truck is available and we are also seeing transitions primarily form tricast, there because that is where.
Speaker Change: The lions share of CF patients.
Speaker Change: And all of those transitions, we continue to expect the majority of patients will transition to electric over.
Speaker Change: Over time, so we're really seeing uptake in all three of those patient groups.
Speaker Change: The fastest perhaps not surprisingly in people who've never had a treatment option to treat the underlying cause of their disease before Duncan.
Speaker Change: So to provide you with a little bit of context of the overall launch of genetics today, we are incredibly pleased with the early progress.
Speaker Change: Early days, we're seeing tremendous receptivity to a novel non opioid option for the treatment of moderate to severe acute pain and over the last three months. We've made great progress in terms of broad retail pharmacy stocking advancing discussions with Payors initiating PMT Committee.
Speaker Change: Reviews, as well as broad usage of the product by physicians in multiple different pain.
Speaker Change: Pain settings and conditions in line with the label.
Speaker Change: To get to your question was specifically with regard to tears and preferred versus non preferred I would say, there's an enormous number of payers in the U S. With an enormous number of different plan designs and even within the same pay a different tiers can mean different things so what I would focus on.
Speaker Change: On all our goals in this area and that is to ensure that we have payer coverage in line with label.
Speaker Change: To ensure the bank coverage has a few restrictions as possible for physician prescribing and that we ensure the product is affordable for patient patients and we get to all of those outcomes, whilst ensuring of course, the optimizing the long term value for.
Speaker Change: For vertex and so in terms of the progress to date of the three big Pbms in the U S. We have one of those three big Pbms now covering genetics for a total of 94 million lives and I can tell you that the progress that we're making is in line with those overall goals to minimize restrictions.
Speaker Change: Physicians maximize access for patients and optimize long term value for vertex.
Speaker Change: The next question will come from <unk> Ahmad with Bank of America. Please go ahead.
Speaker Change: Hi, good afternoon, Thanks for taking my question.
Speaker Change: I wanted to ask one a couple of actually answer Nasdaq's you talk about.
Speaker Change: I mentioned that you've been seeing in the early innings of uptake.
Speaker Change: Just curious as to what the profile of the patients arent at Rd earliest on borders and where in the treatment regimen or these scripts being written.
Speaker Change: Written for patients on their way home from the hospital.
Speaker Change: Are they being written while in the hospital for use in the hospital or is there any other.
Speaker Change: It's an area that we're not thinking about and as you think about the second half of the year in terms of acceleration of recorded sales would you expect to start to see that already into Q or is most of that cannot be backend loaded towards the end of the year.
Speaker Change: Yeah.
Speaker Change: Alright.
Speaker Change: I ask you to comment on settings of care types of pain on the one hand, and then a comment on the.
The volume versus a revenue that we've talked about absolutely. So in terms of the.
Speaker Change: Settings of care that we're seeing at this point we.
Speaker Change: We're seeing genetics used in a surgery settings in non surgery settings.
Speaker Change: So for example, we're seeing it used in knee hip shoulder replacement for example, all the way through to ankle sprains fractured risks et cetera.
Speaker Change: So we're seeing broad uptake of generics in line with its broad indication.
Speaker Change: And it's being used by a broad range of physicians for example, orthopedic surgeons plastics general surgeons anesthesiologists and of course pain specialists and perhaps importantly, we're also seeing a repeat use by physicians and we're seeing very very positive.
Speaker Change: Feedback from physicians in terms of the clinical effects of genetics today.
Speaker Change: In terms of the recorded sales I think we've always said that we would see volume ramp in the first half of the year and then revenue in the latter part of the year as we secure payer coverage and can thus pair back some of our patient support programs.
Speaker Change: Okay.
The next question will come from Evan Seeger men with BMO capital markets. Please go ahead.
Evan Seeger: Hey, guys. Thank you so much for taking my question I really wanted to touch on the uptake of cast JV and really what are some of the key hurdles that are accelerating that are kind of preventing the acceleration of the uptake is that fertility issues of health system Trust trust issues involve an intensity the procedure. How can you really worked to overcome those so we can see really this product.
Speaker Change: Hit its maximum potential.
Stuart Arbuckle: I mean, let me ask Stewart to take that one yeah.
Stuart Arbuckle: Evan Thanks for the questions that we did see a acceleration in cash JV in the first quarter building on the foundation that.
Stuart Arbuckle: But we built in 2020 for the things that I think are leading to that the acceleration that we expect to continue as we work through the balance of 2025 is firstly, establishing authorized treatment centers, obviously, we need to have those so that patients can get treated.
Stuart Arbuckle: Securing access and reimbursement we've done that in large part here in the U S. In both commercial and government paid and increasingly we are securing a reimbursed access for sickle cell disease and beta thalassemia outside of the U S and we announced a number of those in my prepared remarks.
Stuart Arbuckle: We're also seeing our centers get more familiar with the treatment process. Clearly this is a very innovative medicine. This is a very innovative and new treatment process for them and their patients to consider and as they get more experience with the process. Then that's also encouraging them to treat more patients and I mentioned again in my <unk>.
Stuart Arbuckle: Prepared remarks that we've seen a number of our authorized treatment centers.
Stuart Arbuckle: Treated multiple patients now so I think all of those things.
Stuart Arbuckle: Contribute to the acceleration we saw in the first quarter and we expect that to continue through the balance of 2025 and beyond and it's that which gives me confidence that cash Debbie truly does have the potential to be a multibillion dollar product for vertex.
Michael Yee: The next question will come from Michael Yee with Jefferies. Please go ahead.
Michael Yee: Great. Thanks, two questions on ethane.
Speaker Change: I guess a lot of Wall Street is looking at third party data.
Michael Yee: Script data.
Michael Yee: Total.
Michael Yee: With what you guys are talking about but a lot of people are seeing it sort of decelerate week over week. So maybe could you just confirm or talk to what you see week over week and are you seeing an acceleration and don't pay too much attention. The data there and then on 99 three.
Michael Yee: Historically talked about.
Michael Yee: With David and Fred about how that could have significantly better exposure then susie. So could you just tell us about the data coming up in acute pain in the second half and how would you compare that to the acute pain data, we've already seen and figure out what to do with that.
Michael Yee: Yeah, Hey, Mike It's Ray I'll take your second question first on VX 993, and then I'll turn it over to Duncan.
Michael Yee: Tell you a little bit about dynamics the momentum the data, we see and help you sort of think through the commonly available IMS data am and the data that we see which also includes hospital on VX 993, So the big news from my prepared remarks on this one is the phase two trial.
Michael Yee: Oh and acute pain postbank connecting me, it's going to complete in the near term and I do expect to be able to share results with you in the second half of this year, what we're looking for in this program. It is a more potent molecule. It is a molecule where we can dose higher and so we're looking forward to.
Michael Yee: We're exploring the full dose range of 99 three.
Michael Yee: And what we're really looking for here is two things one is to have yet another safe and efficacious NAV, one eight inhibitor and we want that because we are looking for options and four NAV 1.7, which is making its.
Michael Yee: Wade pre clinically certainly our NAV one seven inhibitor when it makes its way into the clinic could be co formulated with <unk>, that's one possibility and a different possibilities that we have additional options like VX 993, So that's one.
Michael Yee: One thing we're looking for and second is of course, if it is possible to do better than <unk> on efficacy boy, we're going to be the ones, who do that and 993 is the first option behind journey <unk> to tell us that that's possible clearly that will require cross study comparisons and.
Michael Yee: The limits that come with that but I'm really happy to see this program move as fast as that half and to share results when available dumped.
Duncan McKechnie: Duncan can you say a few words about the momentum of the genetics scripts and add the data sources. Yeah. Thank you Mike for the question. So maybe just to step back briefly quickly our goals in 2025 are really focused on securing payer coverage for genetics.
Duncan McKechnie: As well as P N T.
Duncan McKechnie: Wins, whilst providing of course, a seamless experience for patients and as you've seen from our prepared remarks, we're incredibly encouraged by the progress, we're making with payers and in terms of P. N T coverage as well in terms of the prescription data I would make a couple of points firstly the latest two.
Duncan McKechnie: Co prescription data ending the week of April 25th So Friday April 25th is 25000 prescriptions.
Duncan McKechnie: But I suspect that in the data you're seeing youre seeing the IMS retail data, which does not include usage in hospitals.
Duncan McKechnie: Where we are seeing of course uptake so that the total number we're giving you includes both the retail data as well as our hospital usage I would say also that we are incredibly early in the launch and it is incredibly common to see variability week by week and prescription.
Duncan McKechnie: Number for example, actually last week's data shows the fastest growth in retail since genetics became available so.
Duncan McKechnie: So overall I think as the payer coverage improves and our formulary adoption increases in hospitals and as physicians get more experience with genetics will continue to see growth of the product. So overall, we're incredibly happy with the progress happy with the 25000 prescriptions to date and looking forward to seeing that.
Duncan McKechnie: These numbers grow over time.
Duncan McKechnie: Thank you.
Speaker Change: The next question will come from Lisa <unk> with Evercore ISI. Please go ahead.
Speaker Change: Hi, congratulations on the quarter and thanks for taking my question I was wondering if you could just provide a little more granularity at the follow up question to one of the earlier ones on <unk>.
Speaker Change: Hmm.
Speaker Change: In terms of the prescriptions, how many of those patients in our kind of fully paying patients what aircrafts to nuts, and how do you anticipate that evolving as the year goes on what should be our target gross to net say by the end of the year.
Speaker Change: And then one on type one diabetes, if you could just give us.
Speaker Change: A little bit of color on that.
Speaker Change: That product is M. S. L M. The 60 K patients.
Speaker Change: Who could who those patients are exactly I know, there's a certain blood type within that as well. Thank you.
Speaker Change: Okay.
Speaker Change: Yeah. Thanks, so much Lisa let me ask Charlie to comment on gross to net and I'll come back and tell you a little bit about as the Milo South.
Speaker Change: Keep in mind that we're only reporting out first quarter results here in the in the approval was only in the first quarter as well so.
Charlie Wagner: Gross to net is impacted by our patient assistance program, that's going to have a significant impact early in the launch while we worked to secure broad and sustainable access as we gain access to patient assistance programs will fall away and gross to net will start to normalize over the balance of the year, So I'm not going to get any more specific than that but as we.
Charlie Wagner: We exit 2025 and enter 2026, we should be approaching something that's a bit more normalized.
Charlie Wagner: And then Lisa on the as the myeloid cell program.
Charlie Wagner: You'll remember that this first program targets about 60000 people in the U S and.
Charlie Wagner: Canada and Europe that are the most severe of our type one diabetics. These are people who have very brittle diabetes high highs in terms of sugar and low lows and multiple S. H ease or symptomatic hypoglycaemic episodes. So this is the first filing that we're looking for the enrollment.
Charlie Wagner: Dosing should be done in the near term I am I said by the end of the quarter will set us up for that filing.
Charlie Wagner: Sometime next year that is for about 60000 patients. We're then looking to expand that not only in terms of.
Charlie Wagner: The patient numbers that can be served including immuno suppression, but also then moving to alternative immuno suppression and then of course, our gene edited programs and other programs to cloak ourselves. So that immuno suppression is not necessary. So that's sort of the traject.
Charlie Wagner: Tree that we're looking at first filings I expect we'll start next year and that's for about 60000 patients. Those are the most severe of Ikea wasn't he patients.
Charlie Wagner: Thanks.
Ellie Merle: The next question will come from Ellie Merle with UBS. Please go ahead.
Ellie Merle: Hey, guys. Thanks for taking my question.
Ellie Merle: Capex the retail pharmacy stocking you mentioned stocking now at around 30000 retail locations can you put this in the context I'll kick at the total number of retail locations do you hope to be stocked at and then in terms of the mix of scripts being felt in the retail versus the hospital setting how do you expect that to trend.
Ellie Merle: Over the course of the year.
Ellie Merle: And then just lastly, what's the average duration for the scrap that youre seeing for <unk> in terms of those that are being written so far thanks.
Ellie Merle: Sure thing Duncan I'm, all for you or for you.
Ellie Merle: Thank you for the question Ellie So let's take them in order in terms of retail pharmacy stocking.
Ellie Merle: It has always been a key part of our launch plan to ensure that genomics is easily available.
Ellie Merle: For patients obviously, they are being treated for acute pain and need to be able to get the medicine rapidly.
Ellie Merle: So at the point of retail stocking we were in about 95% of retail locations across the U S. Obviously that number varies day by day, depending on when genomics is being used in prescribed and comes out of the pharmacy store, but or.
Ellie Merle: We're all we're looking for broad coverage and thus easy access in retail for patients throughout the year.
Ellie Merle: In terms of the retail and hospital setting maybe to step back a little bit you remain may remember that in the acute pain market about 15% of patients are in the pure hospital setting about 35% of treatment days in discharge and about 50%.
Ellie Merle: Oh in retail and we always communicated that we expected to see the initial prescriptions for genomics focused heavily in the discharge setting as the hospital formularies get up to speed and that essentially is exactly what we are seeing that that trend will we think persist for the rest of the.
Speaker Change: Yeah and in terms of the average duration of a prescription in moderate to severe acute pain. It of course varies by setting of care as to whether someone's inpatient or whether they are outpatient or in the retail setting and also by type of medicine say, an opioid persistent and sage, but the average.
Bridge is about 14 days and essentially that is what we're seeing the prescription duration for genetics at this point.
Speaker Change: Chuck will take two more questions. Please.
Speaker Change: Yes, ma'am. The next question will come from David with finger with Leerink. Please go ahead.
Speaker Change: Yes, thanks, very much so I'm, just hoping to clarify.
David: Regarding the P. B M with 22 million lives are those within the 94 million figure or on top and are they unrestricted or restricted lives and then separately just a higher level question. Please rushmore ours vertex engaging with Washington liter.
David: Our ship to educate elected leadership about the importance of both proven medical science and biotechnology innovation to the United States. Thanks very much.
Duncan McKechnie: Yeah, Hey, David Thanks for the question, let me take the second question first and then I'll turn it over to Duncan to tell you a little bit more about.
David: The lives.
David: Covered.
David: We are and have been engaged with a D C as well as with state governments on all of our medicines CF cast Chevy genetics as well as the pipeline.
David: I found those meetings to be constructive and as far as our ability.
David: <unk> to ensure that the programs there are reviewed in a timely fashion that we get feedback from regulators and that we are able to speak with those providing coverage.
David: That has also continued its been business as usual.
David: And nothing.
David: Out of the ordinary for us.
David: Duncan over to you.
David: David Thank you for the question. So yes, the 22 million lives that youre, referring to all included in the total $94 million and in general those 22 million lives fall into our definition of unrestricted where we're looking for either no prior authorizations or no step.
David: Edits.
David: Yeah.
David: Last question Chuck.
Speaker Change: The last question will come from Gena Wang with Barclays. Please go ahead.
Gena Wang: Thank you for taking my questions PD, one regarding the VX 522.
Gena Wang: I know you cannot comment too much but for the temporary pause or was that due to the I.
Speaker Change: I don't know if you can give a little bit more color regarding what are the tolerability issue that raised.
Gena Wang: And then.
Gena Wang: Yep.
Speaker Change: That's the first question and then second question is regarding the Lf track. If we look at the first quarter revenue and when we compare to the other CF lunch in the past how do you see this compare to the past and the do you.
Speaker Change: The trend to pick up in the next few quarters.
Judah: Yeah, Judah let me take the question on 522.
Speaker Change: And then I'll ask Stuart to comment about the left truck launch obviously, we have the great benefit of having Stuart here, who has been involved in every single CF last night Youll have a.
Judah: You'll have good.
Judah: Line of sight on that.
Gena Wang: Don't have much more to add gena because VX 522 is an active program.
Gena Wang: And because we want to maintain study integrity I'll just leave it at the fact that the team is assessing a tolerability issue.
Gena Wang: And once we're able to say more we certainly will.
Stuart Arbuckle: And I'll turn it over to Stuart to tell you about our lift truck, yes, Gena I think it's a little bit difficult to compare a lift tret to other of our C. S. T. R. Modulator approvals for one main reason if you think about or can be when it was first approved it was approved for mutations which accounted for.
Stuart Arbuckle: Approximately 50% of CF patients who have previously all we had was kalydeco, which at the time I think was probably around 7% ish.
Stuart Arbuckle: A genotype for all CF patients and then if you think back to when Tricast. They came along try CAFTA took us from the sort of the 50% to the while its first approval to almost 90%. So there was such a lot of newly eligible patients who had never had a treatment to treat the underlying cause of their disease electric slightly different to that.
Stuart Arbuckle: There are additional mutations there are additional patients who are now eligible for a C. F. T O modulator with the approval of a lift correct I talked about the the 31 additional mutations here in the.
Stuart Arbuckle: The U S, but that's really hundreds of patients, whereas for all can be and try CAFTA we were talking about.
Stuart Arbuckle: If not tens of thousands of newly eligible patient. So I think it's really difficult to compare and contrast, the the approvals. This early on what I can tell you is we're seeing uptake in all the groups of patients that we anticipated naive patients those who are discontinued.
Stuart Arbuckle: And those who are already on a C. F T R modulator.
Stuart Arbuckle: And so we're very pleased with the launch of a lift right today and we look forward to keeping you updated overcoming quarters.
Stuart Arbuckle: Thank you that will conclude Chuck.
Speaker Change: Chuck if you could please related information.
Speaker Change: Yes, Ma'am. This concludes our question and answer session as well as our conference call for today. Thank you for attending today's presentation. A replay of today's event will be available. Shortly after the call concludes here by dialing one 870 734475 to nine or 141 to 31700.
Speaker Change: <unk> eight eight using replay access code 10196550. Thank you for your participation today you may now disconnect.
Speaker Change: [music].