Latest news with #ReshmaKewalramani
Yahoo
09-05-2025
- Business
- Yahoo
Unpacking Q1 Earnings: Vertex Pharmaceuticals (NASDAQ:VRTX) In The Context Of Other Therapeutics Stocks
The end of the earnings season is always a good time to take a step back and see who shined (and who not so much). Let's take a look at how therapeutics stocks fared in Q1, starting with Vertex Pharmaceuticals (NASDAQ:VRTX). Over the next few years, therapeutic companies, which develop a wide variety of treatments for diseases and disorders, face strong tailwinds from advancements in precision medicine (including the use of AI to improve hit rates) and growing demand for treatments targeting rare diseases. However, headwinds such as rising scrutiny over drug pricing, regulatory unknowns, and competition from larger, more resourced pharmaceutical companies could weigh on growth. The 10 therapeutics stocks we track reported a mixed Q1. As a group, revenues beat analysts' consensus estimates by 1.2%. Amidst this news, share prices of the companies have had a rough stretch. On average, they are down 10.5% since the latest earnings results. Founded in 1989 with a mission to create medicines that treat the underlying causes of disease rather than just symptoms, Vertex Pharmaceuticals (NASDAQ:VRTX) develops and markets transformative medicines for serious diseases, with a focus on cystic fibrosis, sickle cell disease, and pain management. Vertex Pharmaceuticals reported revenues of $2.77 billion, up 3% year on year. This print fell short of analysts' expectations by 2.3%. Overall, it was a disappointing quarter for the company with a significant miss of analysts' EPS estimates and full-year revenue guidance slightly missing analysts' expectations. 'Vertex delivered a strong start to 2025 with notable execution across the business as we grow and diversify the revenue base, progress multiple launches and advance the R&D pipeline. We continued to expand our leadership in CF and build global momentum for CASGEVY, and we launched JOURNAVX in moderate-to-severe acute pain,' said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. Unsurprisingly, the stock is down 14.1% since reporting and currently trades at $429.37. Read our full report on Vertex Pharmaceuticals here, it's free. Founded by a mother seeking treatment for her daughter's pulmonary arterial hypertension, United Therapeutics (NASDAQ:UTHR) develops and commercializes medications for chronic lung diseases and other life-threatening conditions, with a focus on pulmonary hypertension treatments. United Therapeutics reported revenues of $794.4 million, up 17.2% year on year, outperforming analysts' expectations by 5.6%. The business had an exceptional quarter with an impressive beat of analysts' EPS estimates. The market seems content with the results as the stock is up 2.7% since reporting. It currently trades at $308. Is now the time to buy United Therapeutics? Access our full analysis of the earnings results here, it's free. Founded in 1991 as one of the pioneers in translating genetic discoveries into clinical applications, Myriad Genetics (NASDAQ:MYGN) develops genetic tests that assess disease risk, guide treatment decisions, and provide insights across oncology, women's health, and mental health. Myriad Genetics reported revenues of $195.9 million, down 3.1% year on year, falling short of analysts' expectations by 2.3%. It was a softer quarter as it posted full-year revenue guidance missing analysts' expectations. As expected, the stock is down 44.7% since the results and currently trades at $4.01. Read our full analysis of Myriad Genetics's results here. Rising to global prominence during the COVID-19 pandemic with one of the first effective vaccines, Moderna (NASDAQ:MRNA) develops messenger RNA (mRNA) medicines that direct the body's cells to produce proteins with therapeutic or preventive benefits for various diseases. Moderna reported revenues of $108 million, down 35.3% year on year. This result lagged analysts' expectations by 8.4%. It was a softer quarter as it also produced full-year revenue guidance missing analysts' expectations. Moderna had the weakest performance against analyst estimates, slowest revenue growth, and weakest full-year guidance update among its peers. The stock is down 14.5% since reporting and currently trades at $24.44. Read our full, actionable report on Moderna here, it's free. Born from a 2013 spinoff of Abbott Laboratories' pharmaceutical business, AbbVie (NYSE:ABBV) is a biopharmaceutical company that develops and markets medications for autoimmune diseases, cancer, neurological disorders, and other complex health conditions. AbbVie reported revenues of $13.34 billion, up 8.4% year on year. This number surpassed analysts' expectations by 3.3%. Overall, it was a very strong quarter as it also recorded an impressive beat of analysts' constant currency revenue estimates and a decent beat of analysts' EPS estimates. The stock is up 3% since reporting and currently trades at $185.99. Read our full, actionable report on AbbVie here, it's free. Thanks to the Fed's rate hikes in 2022 and 2023, inflation has been on a steady path downward, easing back toward that 2% sweet spot. Fortunately (miraculously to some), all this tightening didn't send the economy tumbling into a recession, so here we are, cautiously celebrating a soft landing. The cherry on top? Recent rate cuts (half a point in September 2024, a quarter in November) have propped up markets, especially after Trump's November win lit a fire under major indices and sent them to all-time highs. However, there's still plenty to ponder — tariffs, corporate tax cuts, and what 2025 might hold for the economy. Want to invest in winners with rock-solid fundamentals? Check out our Hidden Gem Stocks and add them to your watchlist. These companies are poised for growth regardless of the political or macroeconomic climate. Join Paid Stock Investor Research Help us make StockStory more helpful to investors like yourself. Join our paid user research session and receive a $50 Amazon gift card for your opinions. Sign up here.
Yahoo
06-05-2025
- Business
- Yahoo
Why Did Vertex Pharmaceuticals Stock Fall On Tuesday?
On Monday, Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) reported lower-than-expected first-quarter 2025 earnings. Vertex reported first-quarter adjusted earnings per share of $4.06, down from $4.76 a year ago, missing the consensus of $4.32. The cystic fibrosis-focused company reported sales of $2.77 billion, missing the consensus of $2.85 billion. Total revenue increased by 3%, primarily driven by the continued performance of Trikafta/Kaftrio and an early contribution from the U.S. launch of Alyftrek. In the U.S., total revenue increased 9% to $1.66 billion due to continued strong patient demand and higher net realized pricing. Outside the U.S., total revenue decreased 5% to $1.11 billion, as strong patient demand in established and newer markets was offset by the expected revenue decline in Russia, where Vertex is experiencing a violation of its intellectual property rights. Also Read: Vertex Discontinues Development Of Type 1 Diabetes Candidate After Disappointing Data 'Vertex delivered a strong start to 2025 with notable execution across the business as we grow and diversify the revenue base, progress multiple launches and advance the R&D pipeline. We continued to expand our leadership in CF and build global momentum for CASGEVY, and we launched JOURNAVX in moderate-to-severe acute pain,' said Reshma Kewalramani, CEO and President of Vertex. 'With multiple programs in pivotal development including povetacicept, which continues to make rapid progress in achieving its potential as a pipeline-in-a-product, and additional programs in early and mid-stage development, Vertex is poised to continue to deliver value for years to come.' Guidance: Vertex raised the low end of total revenue guidance by $100 million to $11.85 billion-$12 billion from $11.75 billion-$12 billion, compared to the consensus of $11.97 billion. The guidance also includes an immaterial cost impact from tariffs in 2025 based on currently known tariff rates and regulations. Vertex has temporarily paused the multiple ascending dose portion of the Phase 1/2 study of VX-522, a nebulized CFTR mRNA therapy, to assess a tolerability issue. William Blair writes, 'While the pause is unfortunate, we believe that the decision to pause the study rather than discontinue it suggests that, beyond the tolerability issue, management is encouraged by the data generated to date given it is open-label.' Analyst Myles Minter writes, 'While there was a slight miss on the top line leading to shares trading off 3% in the aftermarket, management raised the lower end of total revenue guidance, suggesting Street estimates may not have fully encompassed the previously disclosed impacts of an unauthorized Trikafta copy in Russia. We would be buyers on weakness here as the CF franchise still represents one of the most stable long-term growth franchises with a competitive moat in the biotech sector.'
Yahoo
05-05-2025
- Business
- Yahoo
Vertex Pharmaceuticals (NASDAQ:VRTX) Reports Sales Below Analyst Estimates In Q1 Earnings
Biotech company Vertex Pharmaceuticals (NASDAQ:VRTX) missed Wall Street's revenue expectations in Q1 CY2025 as sales rose 3% year on year to $2.77 billion. The company's full-year revenue guidance of $11.88 billion at the midpoint came in 0.9% below analysts' estimates. Its non-GAAP profit of $4.06 per share was 5.4% below analysts' consensus estimates. Is now the time to buy Vertex Pharmaceuticals? Find out in our full research report. Revenue: $2.77 billion vs analyst estimates of $2.83 billion (3% year-on-year growth, 2.3% miss) Adjusted EPS: $4.06 vs analyst expectations of $4.29 (5.4% miss) Adjusted Operating Income: $1.18 billion vs analyst estimates of $1.30 billion (42.7% margin, 9.1% miss) The company reconfirmed its revenue guidance for the full year of $11.88 billion at the midpoint Operating Margin: 22.7%, down from 42.4% in the same quarter last year Market Capitalization: $128.8 billion 'Vertex delivered a strong start to 2025 with notable execution across the business as we grow and diversify the revenue base, progress multiple launches and advance the R&D pipeline. We continued to expand our leadership in CF and build global momentum for CASGEVY, and we launched JOURNAVX in moderate-to-severe acute pain,' said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. Founded in 1989 with a mission to create medicines that treat the underlying causes of disease rather than just symptoms, Vertex Pharmaceuticals (NASDAQ:VRTX) develops and markets transformative medicines for serious diseases, with a focus on cystic fibrosis, sickle cell disease, and pain management. A company's long-term sales performance is one signal of its overall quality. Any business can experience short-term success, but top-performing ones enjoy sustained growth for years. Over the last five years, Vertex Pharmaceuticals grew its sales at an impressive 18.2% compounded annual growth rate. Its growth beat the average healthcare company and shows its offerings resonate with customers. We at StockStory place the most emphasis on long-term growth, but within healthcare, a half-decade historical view may miss recent innovations or disruptive industry trends. Vertex Pharmaceuticals's annualized revenue growth of 9.8% over the last two years is below its five-year trend, but we still think the results were respectable. This quarter, Vertex Pharmaceuticals's revenue grew by 3% year on year to $2.77 billion, falling short of Wall Street's estimates. Looking ahead, sell-side analysts expect revenue to grow 9.2% over the next 12 months, similar to its two-year rate. This projection is particularly noteworthy for a company of its scale and suggests the market sees success for its products and services. Unless you've been living under a rock, it should be obvious by now that generative AI is going to have a huge impact on how large corporations do business. While Nvidia and AMD are trading close to all-time highs, we prefer a lesser-known (but still profitable) stock benefiting from the rise of AI. Click here to access our free report one of our favorites growth stories. Adjusted operating margin is an important measure of profitability as it shows the portion of revenue left after accounting for all core expenses – everything from the cost of goods sold to advertising and wages. It's also useful for comparing profitability across companies because it excludes non-recurring expenses, interest on debt, and taxes. Vertex Pharmaceuticals has been a well-oiled machine over the last five years. It demonstrated elite profitability for a healthcare business, boasting an average adjusted operating margin of 40.1%. Looking at the trend in its profitability, Vertex Pharmaceuticals's adjusted operating margin decreased by 51.5 percentage points over the last five years. The company's two-year trajectory also shows it failed to get its profitability back to the peak as its margin fell by 44.3 percentage points. This performance was poor no matter how you look at it - it shows its expenses were rising and it couldn't pass those costs onto its customers. This quarter, Vertex Pharmaceuticals generated an adjusted operating profit margin of 42.7%, down 7 percentage points year on year. This contraction shows it was less efficient because its expenses grew faster than its revenue. We track the long-term change in earnings per share (EPS) for the same reason as long-term revenue growth. Compared to revenue, however, EPS highlights whether a company's growth is profitable. Sadly for Vertex Pharmaceuticals, its EPS declined by 15.6% annually over the last five years while its revenue grew by 18.2%. This tells us the company became less profitable on a per-share basis as it expanded due to non-fundamental factors such as interest expenses and taxes. We can take a deeper look into Vertex Pharmaceuticals's earnings to better understand the drivers of its performance. As we mentioned earlier, Vertex Pharmaceuticals's adjusted operating margin declined by 51.5 percentage points over the last five years. This was the most relevant factor (aside from the revenue impact) behind its lower earnings; taxes and interest expenses can also affect EPS but don't tell us as much about a company's fundamentals. In Q1, Vertex Pharmaceuticals reported EPS at $4.06, down from $4.76 in the same quarter last year. This print missed analysts' estimates. Over the next 12 months, Wall Street is optimistic. Analysts forecast Vertex Pharmaceuticals's full-year EPS of negative $0.41 will flip to positive $18.55. We struggled to find many positives in these results as its revenue, EPS, and adjusted operating income fell short of Wall Street's estimates. Overall, this quarter could have been better. The stock traded down 2.6% to $487 immediately after reporting. The latest quarter from Vertex Pharmaceuticals's wasn't that good. One earnings report doesn't define a company's quality, though, so let's explore whether the stock is a buy at the current price. The latest quarter does matter, but not nearly as much as longer-term fundamentals and valuation, when deciding if the stock is a buy. We cover that in our actionable full research report which you can read here, it's free. Sign in to access your portfolio
Business Wire
05-05-2025
- Business
- Business Wire
Vertex Reports First Quarter 2025 Financial Results
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the first quarter ended March 31, 2025, and raised the low end of its total revenue guidance range by $100 million, from $11.75 billion to $12 billion to a new range of $11.85 billion to $12 billion. 'Vertex delivered a strong start to 2025 with notable execution across the business as we grow and diversify the revenue base, progress multiple launches and advance the R&D pipeline. We continued to expand our leadership in CF and build global momentum for CASGEVY, and we launched JOURNAVX in moderate-to-severe acute pain,' said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. 'With multiple programs in pivotal development including povetacicept, which continues to make rapid progress in achieving its potential as a pipeline-in-a-product, and additional programs in early and mid-stage development, Vertex is poised to continue to deliver value for years to come.' First Quarter 2025 Results Total revenue increased 3% to $2.77 billion compared to the first quarter of 2024, primarily driven by the continued performance of TRIKAFTA ® /KAFTRIO ® and an early contribution from the U.S. launch of ALYFTREK. In the U.S., total revenue increased 9% to $1.66 billion due to continued strong patient demand and higher net realized pricing. Outside the U.S., total revenue decreased 5% to $1.11 billion as strong patient demand in both established and newer markets was offset by the expected revenue decline in Russia, where Vertex is experiencing violation of its intellectual property rights. Vertex has strong intellectual property protection for its medicines around the world and believes this violation in Russia is a limited and isolated matter. Combined GAAP and Non-GAAP R&D, Acquired IPR&D and SG&A expenses were $1.4 billion and $1.2 billion, respectively, compared to $1.2 billion and $1.0 billion, respectively, in the first quarter of 2024. The increases were primarily due to continued R&D investment in support of multiple mid- and late-stage clinical development programs and increased commercial investment to support the launch of JOURNAVX. Intangible asset impairment charge of $379.0 million associated with VX-264 (the 'cells plus device' program) in patients with type 1 diabetes, which will not be advancing further in clinical development, was included in GAAP operating income in the first quarter of 2025. GAAP effective tax rate was 11.5% compared to 14.0% for the first quarter of 2024. Non-GAAP effective tax rate was 18.8% compared to 17.4% for the first quarter of 2024. The difference between the GAAP and non-GAAP effective tax rates was primarily due to tax benefits related to stock-based compensation. GAAP net income was $646 million compared to $1.1 billion for the first quarter of 2024, as a result of increased operating expenses and the intangible asset impairment charge. Non-GAAP net income was $1.1 billion compared to $1.2 billion in the first quarter of 2024, as a result of increased operating expenses. Cash, cash equivalents and total marketable securities as of March 31, 2025, were $11.4 billion, compared to $11.2 billion as of December 31, 2024. The increase was primarily due to cash flows from operating activities, partially offset by repurchases of Vertex's common stock pursuant to its share repurchase program. Full Year 2025 Financial Guidance Vertex today raised the low end of its full-year 2025 revenue guidance range from $11.75 to $12 billion to $11.85 billion to $12 billion, which assumes continued growth in CF, including the launch of ALYFTREK; as well as continued uptake of CASGEVY in multiple regions; and early contributions from the launch of JOURNAVX. Vertex reiterated its guidance for both combined GAAP and Non-GAAP R&D, AIPR&D and SG&A expenses, which includes expectations for continued investment in multiple mid- and late-stage clinical development programs and commercial capabilities, and AIPR&D expenses of approximately $100 million. This guidance also includes an immaterial cost impact from tariffs in 2025 based on currently known tariff rates and regulations. Vertex's financial guidance is summarized below: Key Business Highlights Cystic Fibrosis (CF) Portfolio Marketed Products Vertex has worked for more than 20 years to discover and develop medicines to treat the underlying cause of CF. Vertex CFTR modulators can treat 95 percent of all people living with CF in markets with the highest prevalence and are approved for patients as young as one month old. ALYFTREK, the newest marketed CFTR modulator, is approved in the U.S. and the United Kingdom (U.K.) for the treatment of patients 6 years and older. Vertex anticipates the number of CF patients taking its medicines will continue to grow through new approvals and reimbursement, treatment of younger patients, increased survival, and expansion into additional geographies. Recent and anticipated progress includes: ALYFTREK, the once-daily, next-in-class combination CFTR modulator for the treatment of people with CF ages 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene, is now approved in the U.S. and the U.K. Vertex is working with the National Health Service (NHS) in the U.K. to secure coverage for eligible patients. In April, the European Medical Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ALYFTREK for the treatment of CF patients ages 6 years and older. European Commission approval is expected in the second half of 2025. Regulatory reviews are underway for ALYFTREK in Canada, Switzerland, Australia and New Zealand. Vertex secured European Commission approval for the label expansion of KAFTRIO in combination with ivacaftor for CF patients ages 2 years and older who have at least one non-class I mutation in the CFTR gene. With this approval, approximately 4,000 people in the European Union are newly eligible for a medicine that treats the underlying cause of their disease. Work to ensure access for all eligible patients is underway. CASGEVY for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT) CASGEVY is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT that has been shown to reduce or eliminate vaso-occlusive crises (VOCs) for patients with SCD and transfusion requirements for patients with TDT. CASGEVY is approved in the U.S., Great Britain, the EU, the Kingdom of Saudi Arabia (KSA), the Kingdom of Bahrain (Bahrain), Canada, Switzerland and the United Arab Emirates (UAE) for the treatment of both SCD and TDT. Recent highlights include: In Europe, Vertex secured a formal reimbursement agreement with NHS England for SCD patients to access CASGEVY, following the agreement reached in August 2024 for eligible TDT patients to access CASGEVY. Vertex recently entered into a similar agreement in Wales for both eligible SCD and TDT patients. Following a positive assessment, Vertex also finalized national reimbursement in Austria. In the Middle East, following regulatory approval in the UAE, Vertex secured reimbursement in the majority of emirates. Since launch through May 1st, Vertex has activated more than 65 authorized treatment centers (ATCs) globally and approximately 90 patients have had their first cell collection. Vertex recently filed a manufacturing license submission with the FDA and expects to begin manufacturing CASGEVY in Portsmouth, NH, in the second half of 2025. This submission is part of the planned ramp of CASGEVY manufacturing capacity as demand for the therapy increases. JOURNAVX (suzetrigine) for the treatment of moderate-to-severe acute pain JOURNAVX is a first-in-class, oral, selective, non-opioid NaV1.8 pain signal inhibitor, approved in the U.S. for the treatment of moderate-to-severe acute pain. Vertex continues to advance a portfolio of selective NaV1.8 and NaV1.7 pain signal inhibitors for stand-alone use or in combination, with potential to provide effective pain relief without the limitations of opioids and other available medicines. On January 30, 2025, the FDA approved JOURNAVX for the treatment of adults with moderate-to-severe acute pain, and it is now available and stocked at pharmacies across the U.S., including major national and regional retail pharmacy chains. Since JOURNAVX became available in early March through April 18th, more than 20,000 prescriptions have been written and filled across the hospital and retail settings in different acute pain conditions, consistent with JOURNAVX's broad label. As of May 1st, across commercial and government payers, approximately 94 million lives already have covered access to JOURNAVX, and approximately 42 million have unrestricted access (i.e., without the need for prior authorization or step edits). Vertex has reached a formal coverage agreement with a large national Pharmacy Benefit Manager (PBM) to make JOURNAVX available to their customers, representing approximately 22 million commercial lives. A total of ten state Medicaid plans are also providing unrestricted access to JOURNAVX and 20 more are currently evaluating their policies. More than 50 large healthcare systems have taken steps to initiate pharmacy and therapeutics (P&T) committee reviews of JOURNAVX, and some have already added it on formularies. Vertex recently initiated two Phase 4 studies in various moderate-to-severe acute pain conditions to provide additional data on the effectiveness and safety of JOURNAVX as part of real-world clinical practice, in both inpatient and outpatient settings. The Alternatives to Pain Act has been reintroduced in both the House and Senate of the new U.S. Congress, while nearly 35 U.S. states to date have passed or introduced new legislation in support of non-opioid options. Vertex also expects JOURNAVX to be added to the list of treatments eligible for an add-on payment under the NOPAIN Act, which became effective on January 1, 2025. Select Clinical-Stage R&D Pipeline Cystic Fibrosis Vertex is enrolling and dosing studies in younger age groups — a Phase 3 study of TRIKAFTA/KAFTRIO in 1- to 2-year-olds and a Phase 3 study of ALYFTREK in 2- to 5-year-olds — to expand the labels and enable earlier treatment of children with CF. Consistent with its commitment to serial innovation and bringing as many patients as possible to normal levels of CFTR function, Vertex continues to advance new oral small molecule combination therapies through preclinical and clinical development. Vertex expects to advance the once-daily, next-generation 3.0 VX-828 combination into a clinical trial in people with CF this year. Vertex has implemented a temporary pause to the multiple ascending dose (MAD) portion of the Phase 1/2 study of VX-522, a nebulized CFTR mRNA therapy, in order to assess a tolerability issue. Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia Vertex has completed enrollment of children 5 to 11 years of age with SCD or TDT in two global Phase 3 studies of CASGEVY. Vertex continues to advance preclinical assets for gentler conditioning for CASGEVY, which could broaden the eligible patient population. Acute Pain Vertex expects to complete the Phase 2 study for an oral formulation of VX-993 this quarter. VX-993 is a next-generation selective NaV1.8 pain signal inhibitor, for the treatment of moderate-to-severe acute pain following bunionectomy surgery. Vertex expects to report results from the Phase 2 study in the second half of 2025. VX-993 has Fast Track designation for moderate-to-severe acute pain. Vertex has completed the Phase 1 study of an intravenous formulation of VX-993 in healthy volunteers. The FDA has granted the intravenous formulation of VX-993 Fast Track designation for moderate-to-severe acute pain. Peripheral Neuropathic Pain (PNP) Vertex continues to enroll and dose patients with diabetic peripheral neuropathy (DPN) in a Phase 3 pivotal trial of suzetrigine. The FDA has granted suzetrigine Fast Track designation in PNP and Breakthrough Therapy designation in DPN. Vertex continues to enroll and dose patients in a Phase 2 study for the oral formulation of VX-993 for the treatment of DPN. Type 1 Diabetes (T1D) Vertex is evaluating stem cell-derived, fully differentiated islet cell therapies for patients suffering from T1D, with the goal of developing a potential one-time functional cure for this disease. Zimislecel (VX-880), fully differentiated islet cells with standard immunosuppression: Vertex continues to enroll and dose patients in the Phase 3 portion of the Phase 1/2/3 study of zimislecel in patients with T1D with severe hypoglycemic events and impaired awareness of hypoglycemia in the U.S., Canada, U.K., and EU. Vertex expects to complete enrollment and dosing of the pivotal study in the second quarter of 2025 and submit marketing applications to global regulators in 2026. Zimislecel has been granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration, Priority Medicines (PRIME) designation from the EMA, and has secured an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Vertex will present updated clinical data from the 12 participants who received the full dose of zimislecel as a single infusion with over one year of follow-up in the Phase 1/2 portion of the study in an oral presentation at the American Diabetes Association 85 th Scientific Sessions. Vertex will host an in-person investor event at the ADA conference on Friday, June 20, 2025 at 7:15 p.m. CT / 8:15 p.m. ET. The investor event will also be webcast live, and a link to the webcast can be accessed through Vertex's website at in the 'Investors' section. Additional approaches: Vertex previously announced that it has discontinued development of the VX-264 ('cells plus device' program), as the Phase 1/2 study did not meet its efficacy endpoint. Vertex is pursuing research-stage programs to evaluate additional approaches that could provide transformative benefit to people with T1D and reduce or eliminate the need for standard immunosuppressive regimens. These approaches include alternative immunosuppressives, gene editing, and novel immunoprotection to encapsulate the islet cells. IgA Nephropathy (IgAN), Primary Membranous Nephropathy (pMN) and Other B Cell-Mediated Diseases Vertex is developing povetacicept, a dual antagonist of the BAFF and APRIL cytokines, which play key roles in the pathogenesis of multiple B cell-mediated diseases. Pove represents a potentially best-in-class approach to treat IgAN and pMN and has pipeline-in-a-product potential. The global Phase 3 RAINIER trial of povetacicept in patients with IgAN has completed enrollment of the interim analysis cohort. The interim analysis will be conducted once this cohort reaches 36 weeks of treatment, with the potential to file for Accelerated Approval in the U.S. in the first half of 2026, if results are supportive. Studies to support the launch of povetacicept for home administration are underway. Based on positive results of povetacicept in primary membranous nephropathy (pMN) in the RUBY-3 study, Vertex has reached agreement with the FDA to advance povetacicept into pivotal development for this disease. Vertex will initiate a single, adaptive Phase 2/3 trial of povetacicept vs. standard-of-care this year. In the Phase 2 portion, both 80 mg and 240 mg of povetacicept will be assessed and the selected dose will advance to Phase 3, where the primary endpoint of complete clinical remission at 72 weeks of treatment will be evaluated. Vertex plans to present updated data from the IgAN and pMN cohorts of the RUBY-3 study at upcoming medical congresses. Vertex expects to share data and next steps from other RUBY-3 renal diseases and the hematologic conditions in the RUBY-4 study later this year. APOL1-Mediated Kidney Disease (AMKD) Vertex has discovered and advanced multiple oral, small molecule inhibitors of APOL1 function, pioneering a new class of medicines that targets the underlying genetic driver of this kidney disease. Vertex expects to complete enrollment in the interim analysis cohort of the Phase 3 portion of the AMPLITUDE trial of inaxaplin in the second half of 2025. Vertex will conduct the pre-planned interim analysis once this cohort has been treated for 48 weeks, with potential to file for accelerated approval in the U.S. if the results are supportive. Vertex continues to enroll and dose patients in the AMPLIFIED Phase 2 study of inaxaplin in people with AMKD and diabetes or other co-morbidities. Myotonic Dystrophy Type 1 (DM1) Vertex is evaluating multiple approaches that target the underlying cause of DM1. Vertex's lead approach, VX-670, is an oligonucleotide linked to a cyclic peptide, which holds the potential to address the underlying cause of DM1. Vertex continues to enroll and dose the MAD portion of the global Phase 1/2 clinical trial of VX-670 in people with DM1, which will assess both safety and efficacy. Autosomal Dominant Polycystic Kidney Disease (ADPKD) Vertex is developing small molecule correctors that restore function to the variant polycystin 1 (PC1) protein, with the goal of addressing the underlying cause of ADPKD. Vertex has completed the Phase 1 study of VX-407 in healthy volunteers. Vertex expects to advance VX-407 into a Phase 2 proof-of-concept study this year in patients with a subset of variants in the PKD1 gene, which encodes the PC1 protein, estimated to be up to ~30,000 (or ~10%) of the overall patient population. Non-GAAP Financial Measures In this press release, Vertex's financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, non-GAAP financial results and guidance exclude from Vertex's pre-tax income (i) stock-based compensation expense, (ii) intangible asset amortization expense, (iii) gains or losses related to the fair value of the company's strategic investments, (iv) increases or decreases in the fair value of contingent consideration, (v) acquisition-related costs, (vi) an intangible asset impairment charge, and (vii) other adjustments. The company's non-GAAP financial results also exclude from its provision for income taxes the estimated tax impact related to its non-GAAP adjustments to pre-tax income described above and certain discrete items. These results should not be viewed as a substitute for the company's GAAP results and are provided as a complement to results provided in accordance with GAAP. Management believes these non-GAAP financial measures help indicate underlying trends in the company's business, are important in comparing current results with prior period results and provide additional information regarding the company's financial position that the company believes is helpful to an understanding of its ongoing business. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally, to manage the company's business and to evaluate its performance. The company's calculation of non-GAAP financial measures likely differs from the calculations used by other companies. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial information. The company provides guidance regarding combined R&D, AIPR&D and SG&A expenses and effective tax rate on a non-GAAP basis. Unless otherwise noted, the guidance regarding combined R&D, AIPR&D and SG&A expenses does not include estimates associated with any potential future business development transactions, including collaborations, asset acquisitions and/or licensing of third-party intellectual property rights. The company does not provide guidance regarding its GAAP effective tax rate because it is unable to forecast with reasonable certainty the impact of excess tax benefits related to stock-based compensation and the possibility of certain discrete items, which could be material. Vertex Pharmaceuticals Incorporated Total Revenues (unaudited, in millions) Three Months Ended March 31, 2025 2024 TRIKAFTA/KAFTRIO $ 2,535.5 $ 2,483.6 ALYFTREK 53.9 — Other product revenues (1) 170.8 207.0 Product revenues, net 2,760.2 2,690.6 Other revenues 10.0 — Total revenues $ 2,770.2 $ 2,690.6 1: In the first quarter of 2025, "Other product revenues" included $14.2 million from CASGEVY, and an insignificant amount from JOURNAVX. In the first quarter of 2024, there were no revenues for these products. The remaining 'Other product revenues' are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products. Expand Vertex Pharmaceuticals Incorporated (unaudited, in millions, except percentages) Three Months Ended March 31, 2025 2024 GAAP cost of sales $ 363.0 $ 342.6 Stock-based compensation expense (2.6 ) (1.8 ) Intangible asset amortization expense (5.0 ) (5.0 ) Non-GAAP cost of sales $ 355.4 $ 335.8 GAAP research and development expenses $ 979.7 $ 789.1 Stock-based compensation expense (100.1 ) (119.4 ) Intangible asset amortization expense (0.6 ) — Non-GAAP research and development expenses $ 879.0 $ 669.7 Acquired in-process research and development expenses $ 19.8 $ 76.8 GAAP selling, general and administrative expenses $ 396.4 $ 342.7 Stock-based compensation expense (63.4 ) (70.7 ) Non-GAAP selling, general and administrative expenses $ 333.0 $ 272.0 Combined non-GAAP R&D, AIPR&D and SG&A expenses $ 1,231.8 $ 1,018.5 GAAP other expense, net $ (17.6 ) $ (31.2 ) Decrease in fair value of strategic investments 15.0 27.0 Non-GAAP other expense, net $ (2.6 ) $ (4.2 ) GAAP provision for income taxes $ 84.1 $ 179.5 Tax adjustments (2) 160.1 81.6 Non-GAAP provision for income taxes $ 244.2 $ 261.1 Expand GAAP effective tax rate 11.5 % 14.0 % Non-GAAP effective tax rate 18.8 % 17.4 % Expand Vertex Pharmaceuticals Incorporated Reconciliation of GAAP to Non-GAAP Financial Information (continued) (unaudited, in millions, except per share amounts) Three Months Ended March 31, 2025 2024 GAAP operating income $ 630.1 $ 1,139.5 Stock-based compensation expense 166.1 191.9 Intangible asset impairment charge 379.0 — Intangible asset amortization expense 5.6 5.0 Increase (decrease) in fair value of contingent consideration 2.2 (0.1 ) Non-GAAP operating income $ 1,183.0 $ 1,336.3 GAAP net income $ 646.3 $ 1,099.6 Stock-based compensation expense 166.1 191.9 Intangible asset impairment charge 379.0 — Intangible asset amortization expense 5.6 5.0 Decrease in fair value of strategic investments 15.0 27.0 Increase (decrease) in fair value of contingent consideration 2.2 (0.1 ) Total non-GAAP adjustments to pre-tax income 567.9 223.8 Tax adjustments (2) (160.1 ) (81.6 ) Non-GAAP net income $ 1,054.1 $ 1,241.8 Net income per diluted common share: GAAP $ 2.49 $ 4.21 Non-GAAP $ 4.06 $ 4.76 Shares used in diluted per share calculations: GAAP and Non-GAAP 259.5 261.1 2: In the first quarter of 2025 and 2024, 'Tax adjustments' included the estimated income taxes related to non-GAAP adjustments to the company's pre-tax income and excess tax benefits related to stock-based compensation. Expand Vertex Pharmaceuticals Incorporated Condensed Consolidated Balance Sheets (unaudited, in millions) March 31, 2025 December 31, 2024 Assets Cash, cash equivalents and marketable securities $ 6,201.2 $ 6,115.9 Accounts receivable, net 1,805.1 1,609.4 Inventories 1,359.7 1,205.4 Prepaid expenses and other current assets 642.8 665.7 Total current assets 10,008.8 9,596.4 Property and equipment, net 1,295.9 1,227.8 Goodwill and other intangible assets, net 1,529.2 1,913.9 Deferred tax assets 2,544.3 2,331.1 Operating lease assets 1,338.5 1,356.8 Long-term marketable securities 5,156.5 5,107.9 Other long-term assets 1,007.3 999.3 Total assets $ 22,880.5 $ 22,533.2 Liabilities and Shareholders' Equity Accounts payable and accrued expenses $ 3,396.8 $ 3,201.6 Other current liabilities 386.4 363.0 Total current liabilities 3,783.2 3,564.6 Long-term operating lease liabilities 1,537.7 1,544.4 Long-term finance lease liabilities 111.4 112.8 Other long-term liabilities 951.9 901.8 Shareholders' equity 16,496.3 16,409.6 Total liabilities and shareholders' equity $ 22,880.5 $ 22,533.2 Common shares outstanding 257.0 256.9 Expand About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, type 1 diabetes, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on LinkedIn, Facebook, Instagram, YouTube and Twitter/X. Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements that are subject to risks, uncertainties and other factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief, or current expectation of Vertex and members of the Vertex senior management team. Forward-looking statements are not purely historical and may be accompanied by words such as 'anticipates,' 'may,' 'forecasts,' 'expects,' 'intends,' 'plans,' 'potentially,' 'believes,' 'seeks,' 'estimates,' and other words and terms of similar meaning. Such statements include, without limitation, Dr. Kewalramani's statements in this press release, the information provided regarding future financial performance and operations, the section captioned 'Full Year 2025 Financial Guidance' and statements regarding (i) expectations for Vertex's continued growth in CF, including by increasing the number of CF patients taking its medicines through new approvals and reimbursements, treatment of younger patients, increased survival, and expansion into additional geographies, (ii) expectations regarding securing coverage for ALYFTREK in the U.K., (iii) expectations regarding approval of ALYFTREK in the E.U. in the second half of 2025, (iv) beliefs regarding the anticipated benefits and commercial launch progress of CASGEVY, and with respect to increasing and initiating manufacturing activities for CASGEVY in the second half of 2025, (v) expectations regarding the potential benefits of JOURNAVX for the treatment of moderate-to-severe acute pain, including regarding the efficacy and safety of JOURNAVX, beliefs that JOURNAVX has potential to provide effective pain relief without the limitations of opioids and other available medicines, expectations with respect to the commercial launch progress and that commercial coverage of JOURNAVX will continue to expand throughout 2025, and expectations that JOURNAVX will be included on the list of treatments that quality for add-on payment under the NOPAIN Act, (vi) expectations to expand the labels for TRIKAFTA/KAFTRIO and ALYFTREK and enable earlier treatment of children with CF, (vii) expectations to advance the VX-828 combination into people with CF this year, (viii) expectations for the VX-522 clinical trial, (ix) expectations regarding Vertex's SCD and TDT program, including with respect to gentler conditioning for CASGEVY broadening the eligible patient population, (x) plans with respect to the studies of the intravenous and oral formulation of VX-993 for the treatment of acute pain, including expectations to complete the Phase 2 study of the oral formulation of VX-993 in acute pain and expectations to report results from that study in the second half of 2025, (xi) expectations regarding the pivotal study evaluating zimislecel in T1D, including the expectations to complete enrollment and dosing during the fiscal quarter and submit marketing applications to global regulators in 2026, expectations to present updated data in upcoming medical conferences, and expectations and plans to pursue additional approaches to standard immunosuppression regimens, (xii) expectations with respect to povetacicept, including beliefs about its potential benefits and therapeutic scope, study designs, expectations regarding the Phase 3 RAINIER study, including plans to file for potential accelerated approval in the U.S. in the first half of 2026, beliefs with respect to the RUBY-3 basket study and plans to present updated data from this study at upcoming medical congresses, expectations and plans with respect to advancing povetacicept into pivotal development in pMN, beliefs with respect to the RUBY-4 basket study and expectations to share data and next steps later this year, (xiii) expectations regarding the AMPLITUDE trial in AMKD, including expectations to complete enrollment in the interim analysis cohort in the second half of 2025 and, assuming a positive interim analysis, apply for potential accelerated approval in the U.S., (xiv) expectations for the potential benefits and clinical status of VX-670 for the treatment in people with DM1, and (xv) expectations regarding the ADPKD program, including the potential benefits of VX-407 and expectations to advance VX-407 into a Phase 2 proof-of-concept study in 2025. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that the company's expectations regarding its 2025 full year revenues, expenses and effective tax rates may be incorrect (including because one or more of the company's assumptions underlying its expectations may not be realized), that we may be unable to successfully commercialize ALYFTREK as a treatment for CF or JOURNAVX as a treatment for acute pain, that external factors may have different or more significant impacts on the company's business or operations than the company currently expects, that data from preclinical testing or clinical trials, especially if based on a limited number of patients, may not be indicative of final results or available on anticipated timelines, that patient enrollment in the company's trials may be delayed, that the company may not realize the anticipated benefits from collaborations with third parties, that data from the company's development programs may not support registration or further development of its potential medicines in a timely manner, or at all, due to safety, efficacy or other reasons, and that anticipated commercial launches may be delayed, if they occur at all. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Vertex's business, particularly those risks listed under the heading 'Risk Factors' and the other cautionary factors discussed in Vertex's periodic reports filed with the SEC, including Vertex's annual report on Form 10-K and its quarterly reports on Form 10-Q and current reports on Form 8-K, all of which are filed with the Securities and Exchange Commission (SEC) and available through the company's website at and on the SEC's website at You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. Conference Call and Webcast The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (833) 630-2124 (U.S.) or +1(412) 317-0651 (International) and reference the 'Vertex Pharmaceuticals First Quarter 2025 Earnings Call.' The conference call will be webcast live and a link to the webcast can be accessed through Vertex's website at in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company's website. (VRTX-E)
Yahoo
10-02-2025
- Business
- Yahoo
Vertex Pharmaceuticals's (NASDAQ:VRTX) Q4 Sales Top Estimates
Biotech company Vertex Pharmaceuticals (NASDAQ:VRTX) reported Q4 CY2024 results exceeding the market's revenue expectations , with sales up 15.7% year on year to $2.91 billion. The company expects the full year's revenue to be around $11.88 billion, close to analysts' estimates. Its non-GAAP profit of $3.98 per share was 1% below analysts' consensus estimates. Is now the time to buy Vertex Pharmaceuticals? Find out in our full research report. Revenue: $2.91 billion vs analyst estimates of $2.78 billion (15.7% year-on-year growth, 4.9% beat) Adjusted EPS: $3.98 vs analyst expectations of $4.02 (1% miss) Adjusted Operating Income: $1.20 billion vs analyst estimates of $1.19 billion (41.2% margin, 0.8% beat) Management's revenue guidance for the upcoming financial year 2025 is $11.88 billion at the midpoint, in line with analyst expectations and implying 7.8% growth (vs 11.7% in FY2024) Operating Margin: 35.2%, down from 39.3% in the same quarter last year Market Capitalization: $120.9 billion '2024 marked a year of tremendous growth for Vertex and we anticipate 2025 will be another important year with the landmark JOURNAVX approval and launch for moderate-to-severe acute pain; the launch of our fifth CF medicine, ALYFTREK; the continuing global launch of CASGEVY; and multiple ongoing pivotal trials. We are excited to drive diversification of the revenue base, disease areas of focus, R&D pipeline, and geographies to continue to deliver long-term value to both patients and shareholders,' said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. Founded in 1989 to focus on a broad range of diseases, Vertex Pharmaceuticals (NASDAQ:VRTX) has since narrowed its focus and is now a biotechnology company known for its groundbreaking treatments for cystic fibrosis (CF), a genetic lung disease. Over the next few years, therapeutic companies, which develop a wide variety of treatments for diseases and disorders, face strong tailwinds from advancements in precision medicine (including the use of AI to improve hit rates) and growing demand for treatments targeting rare diseases. However, headwinds such as rising scrutiny over drug pricing, regulatory unknowns, and competition from larger, more resourced pharmaceutical companies could weigh on growth. A company's long-term sales performance signals its overall quality. Even a bad business can shine for one or two quarters, but a top-tier one grows for years. Luckily, Vertex Pharmaceuticals's sales grew at an excellent 21.5% compounded annual growth rate over the last five years. Its growth beat the average healthcare company and shows its offerings resonate with customers. Long-term growth is the most important, but within healthcare, a half-decade historical view may miss new innovations or demand cycles. Vertex Pharmaceuticals's annualized revenue growth of 11.1% over the last two years is below its five-year trend, but we still think the results were respectable. This quarter, Vertex Pharmaceuticals reported year-on-year revenue growth of 15.7%, and its $2.91 billion of revenue exceeded Wall Street's estimates by 4.9%. Looking ahead, sell-side analysts expect revenue to grow 6.5% over the next 12 months, a deceleration versus the last two years. We still think its growth trajectory is satisfactory given its scale and implies the market sees success for its products and services. Today's young investors likely haven't read the timeless lessons in Gorilla Game: Picking Winners In High Technology because it was written more than 20 years ago when Microsoft and Apple were first establishing their supremacy. But if we apply the same principles, then enterprise software stocks leveraging their own generative AI capabilities may well be the Gorillas of the future. So, in that spirit, we are excited to present our Special Free Report on a profitable, fast-growing enterprise software stock that is already riding the automation wave and looking to catch the generative AI next. Vertex Pharmaceuticals has been a well-oiled machine over the last five years. It demonstrated elite profitability for a healthcare business, boasting an average adjusted operating margin of 40.6%. Analyzing the trend in its profitability, Vertex Pharmaceuticals's adjusted operating margin decreased by 49.9 percentage points over the last five years. The company's two-year trajectory also shows it failed to get its profitability back to the peak as its margin fell by 47.4 percentage points. This performance was poor no matter how you look at it - it shows operating expenses were rising and it couldn't pass those costs onto its customers. In Q4, Vertex Pharmaceuticals generated an adjusted operating profit margin of 41.2%, down 4.6 percentage points year on year. This contraction shows it was recently less efficient because its expenses grew faster than its revenue. We track the long-term change in earnings per share (EPS) for the same reason as long-term revenue growth. Compared to revenue, however, EPS highlights whether a company's growth is profitable. Sadly for Vertex Pharmaceuticals, its EPS declined by 44% annually over the last five years while its revenue grew by 21.5%. This tells us the company became less profitable on a per-share basis as it expanded. Diving into the nuances of Vertex Pharmaceuticals's earnings can give us a better understanding of its performance. As we mentioned earlier, Vertex Pharmaceuticals's adjusted operating margin declined by 49.9 percentage points over the last five years. This was the most relevant factor (aside from the revenue impact) behind its lower earnings; taxes and interest expenses can also affect EPS but don't tell us as much about a company's fundamentals. In Q4, Vertex Pharmaceuticals reported EPS at $3.98, down from $4.20 in the same quarter last year. This print slightly missed analysts' estimates. Over the next 12 months, Wall Street expects Vertex Pharmaceuticals's full-year EPS of $0.29 to grow 6,298%. We enjoyed seeing Vertex Pharmaceuticals exceed analysts' revenue and adjusted operating income expectations this quarter. On the other hand, its EPS slightly missed and its full-year revenue guidance was in line. Overall, this quarter was decent. The stock remained flat at $472.04 immediately following the results. Should you buy the stock or not? We think that the latest quarter is just one piece of the longer-term business quality puzzle. Quality, when combined with valuation, can help determine if the stock is a buy. We cover that in our actionable full research report which you can read here, it's free. Sign in to access your portfolio
