Latest news with #biosimilar
Yahoo
17-07-2025
- Business
- Yahoo
Harrow Enters into Commercialization Agreement with Samsung Bioepis for Ophthalmology Biosimilars Portfolio in the United States
Harrow to assume full commercial responsibility for BYOOVIZ® and OPUVIZ™ by the end of 2025 NASHVILLE, July 17, 2025--(BUSINESS WIRE)--Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced that it has entered into a definitive agreement with Samsung Bioepis Co. Ltd. (hereafter "Samsung Bioepis") to secure the exclusive U.S. commercial rights to the ophthalmology biosimilar portfolio of Samsung Bioepis — BYOOVIZ® (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTISi (ranibizumab), and OPUVIZ™ (aflibercept-yszy), an FDA-approved biosimilar referencing EYLEAii (aflibercept) — two of the most widely used anti-VEGF therapies for retinal diseases. BYOOVIZ has been commercialized by Biogen in the U.S. since its initial launch in June 2022. In October 2024, Biogen notified Samsung Bioepis of their decision to terminate the 2019 Development and Commercialization Agreement within the U.S. and Canada. Samsung Bioepis has been closely working with Biogen on the transfer of commercialization rights for BYOOVIZ and OPUVIZ back to Samsung Bioepis in these regions. Harrow will assume full responsibility for commercialization of BYOOVIZ in the U.S. upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis. The transition is expected to be completed by the end of 2025. This strategic acquisition enhances Harrow's position as the leading full-spectrum ophthalmic pharmaceuticals provider in the U.S., expands its pipeline with high-value biosimilars for sight‑threatening retinal diseases, and reinforces its commitment to delivering value-oriented innovation to the U.S. eyecare market. "This transformational acquisition marks a pivotal moment for Harrow and reinforces our commitment to delivering innovation, accessibility, and value to the U.S. ophthalmology community," said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. "We are excited to leverage our growing commercial presence within the retina specialist community, built over the past year, and partner with Samsung Bioepis, globally recognized for its scientific excellence in biologics and biosimilars. These ophthalmic assets are among the most highly regarded in the market, and we are looking forward to bringing these products to U.S. physicians and patients." Transaction Highlights Acquired Rights: Harrow gains exclusive U.S. commercial rights to Samsung Bioepis' portfolio of ophthalmic biosimilars, including BYOOVIZ® ("bio-viss") and OPUVIZ™ ("op-u-vis"): BYOOVIZ (ranibizumab-nuna) 0.05mL injection, the first FDA-approved LUCENTIS biosimilar indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). OPUVIZ (aflibercept-yszy) 0.05mL injection, an FDA-approved EYLEA biosimilar indicated for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). Market Opportunity: The retinal disease treatment market represents a $9 billion opportunityiii in the U.S., with biosimilars expected to expand patient access and affordability. Execution-Ready Platform: Harrow will leverage its established commercial infrastructure and national reach to accelerate the market impact of these biosimilars. Harrow is committed to reshaping the Wet AMD treatment landscape by offering an FDA-approved, on-label, and affordable alternative to existing anti-VEGF therapies. The market is dominated by EYLEA, LUCENTIS, VABYSMO, and compounded Avastin, which continues to be used off-label due to its low cost, despite not being formulated or approved for ocular administration. Current anti-VEGF therapies are among the most expensive drug categories covered under Medicare Part B, with annual spending in the U.S. exceeding $4.2 billioniv. Harrow's acquisition of these products has the potential to substantially lower the financial burden on Medicare and commercial plans, while improving access and affordability for patients. About BYOOVIZ (ranibizumab-nuna) BYOOVIZ (ranibizumab-nuna) injection, for intravitreal (ranibizumab-nuna) is biosimilar to LUCENTIS (ranibizumab injection).BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:Neovascular (Wet) Age-Related Macular Degeneration (AMD)Macular Edema Following Retinal Vein Occlusion (RVO)Myopic Choroidal Neovascularization (mCNV) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the in intraocular pressure (IOP) have been noted both pre- and post-intravitreal is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP. Please see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE. About OPUVIZ (aflibercept-yszy) OPUVIZ (aflibercept-yszy) injection, for intravitreal (aflibercept-yszy) is biosimilar to EYLEA (aflibercept).OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of patients with:Neovascular (Wet) Age-Related Macular Degeneration (AMD)Macular Edema Following Retinal Vein Occlusion (RVO)Diabetic Macular Edema (DME)Diabetic Retinopathy (DR) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. Please see Prescribing Information for OPUVIZ (aflibercept-yszy) HERE. About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the North American market. Harrow helps eyecare professionals preserve the gift of sight by making its portfolio of pharmaceutical products accessible and affordable to millions of patients each year. For more information about Harrow, please visit Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks, including litigation matters, and other uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. i Lucentis is a trademark of Genentech, Inc. ii Eylea is a trademark of Regeneron Pharmaceuticals, Inc. iii Company annual reports & Biopharma AVASTIN estimates iv View source version on Contacts Investors:Mike Biega, VP of Investor Relations and Communicationsmbiega@ 617-913-8890Media: Silvana Guerci-Lena, Powers & 508-808-8993
Globe and Mail
16-07-2025
- Business
- Globe and Mail
Johnson & Johnson (JNJ) Q2 2025 Earnings Call Transcript
DATE Wednesday, July 16, 2025 at 8:30 a.m. ET CALL PARTICIPANTS Chairman and Chief Executive Officer — Joaquin Duato Chief Financial Officer — Joe Wolk Chief Financial Officer (transition/introduction) — Darren Snellgrove Executive Vice President, Worldwide Chairman, Innovative Medicine — Jennifer Taubert Executive Vice President, Innovative Medicine, Research and Development — John Reed Executive Vice President, Worldwide Chairman, MedTech — Tim Schmid Need a quote from one of our analysts? Email pr@ RISKS STELARRA Biosimilar Competition: Jennifer Taubert said, "the immunology space is highly competitive." Darren Snellgrove noted that a 43.2% decline in STELARRA sales in Q2 2025 was "driven by the impact of biosimilar competition and Part D redesign, which is in line with our expectations." Operating Margin and Segment Margin Pressure: Adjusted net earnings and EPS decreased by 2.1% and 1.8%, respectively, compared to Q2 2024, due to interest from the Intracellular acquisition and gross profit erosion from STELARRA. MedTech Margin Decline: MedTech segment adjusted margin dropped from 25.7% to 22.2%, attributed to "macroeconomic factors in cost of products sold, as well as other income." Orthopedics Decline: Orthopedics segment sales fell 1.6% due to "competitive pressures, the transformation program, and China VBP." TAKEAWAYS Worldwide Sales: $23.7 billion, growing 4.6% operationally, despite an approximate 7.1% sales headwind from STELARRA. Innovative Medicine Sales: $15.2 billion, a 3.8% operational increase despite an 11.7% headwind from STELARRA, with US growth of 7.6% and a 1.6% decline outside the US. Notable Brand Growth: Double-digit revenue growth in thirteen innovative medicine brands, including DARZALEX grew 21.5%, CARVICTI (over 100%) operational sales growth, TECVAYLI operational sales growth was 22.4%, TALVEY (+54.3%), ERLEADA operational sales growth was 21%. RYBREVANT plus LUMAKRAS (over 100%), and SPRAVATO grew 53%. TREMFYA Performance: Sales increased 30.1%, supported by uptake in new inflammatory bowel disease indications, positioning it for at least $10 billion in annual peak year sales. MedTech Performance: $8.5 billion in sales, 6.1% operational growth, driven by 8% US growth and 4.1% outside the US, with strong contributions from cardiovascular, surgery, and vision. Cardiovascular Momentum: Cardiovascular posted over 22% operational sales growth, led by new products from Abiomed, Shockwave, and growth in electrophysiology (9.8%). Margin Performance: Innovative medicine margin (adjusted) fell to 42.7% (from 44.6%), MedTech margin fell to 22.2% (from 25.7%), with cost pressures linked to product mix, acquisitions, and macro factors. Adjusted Earnings: Adjusted net earnings were $6.7 billion; adjusted diluted EPS was $2.77, both declining compared to Q2 2024 due to higher interest expense and gross profit erosion in STELARRA. Guidance Updates: Raised full-year sales guidance by $2 billion and Adjusted EPS guidance raised by $0.25 to a new range of $10.80-$10.90; operational sales growth now targeted between 4.5%-5%, with reported sales growth of 5.1%-5.6% after FX adjustments. Free Cash Flow/Capital Structure: Free cash flow through the first half exceeded $6 billion; cash and marketable securities at $19 billion, debt at $51 billion, net debt $32 billion, including Intracellular acquisition funding. Tax Rate Guidance: Effective tax rate (GAAP) expected to be 17%-17.5%, with a statutory GILTI rate step-up to 12.6% in 2026, resulting in an approximate 1% increase in the global effective tax rate in 2026. Pipeline and Regulatory Milestones: Notable expected approvals and filings in 2025 include TAR-200 for bladder cancer, subcutaneous RYBREVANT, TREMFYA in ulcerative colitis, and ICHTHYOKINRA in psoriasis, as well as new product launches in MedTech and Vision. SUMMARY Johnson & Johnson (NYSE:JNJ) highlighted 4.6% operational sales growth and $23.7 billion in quarterly sales, with over $15 billion in quarterly innovative medicine revenue accomplished for the first time despite large STELARRA headwinds. The innovative medicine segment demonstrated resilience through double-digit growth in thirteen brands, significant oncology and immunology expansion, and continued strategic execution in neuroscience bolstered by acquisitions such as Intracellular Therapies. MedTech outpaced recent quarters, with particular momentum in cardiovascular and new surgical technologies, while operating segment margins experienced pressure from product mix and external cost factors. Guidance for both full-year sales and earnings per share was raised, reflecting strong business fundamentals, expected approval catalysts, and favorable foreign currency impacts, with free cash flow and capital position supporting ongoing R&D investment. Joaquin Duato said, "No other healthcare company has grown through the loss of exclusivity of a multibillion-dollar product in the first year. In our case, STELARRA, and yet, that is exactly what we are doing and for the second quarter in a row." Jennifer Taubert said, "if you take a look at the 90% of our business that is not STELARRA, we actually had extraordinarily robust growth of 15.5%." The CFO confirmed, "we remain confident and reiterate our operating margin guide for the full year." despite current margin headwinds and outlined ongoing efficiency and expense initiatives to address pressures. The company expects continued MedTech acceleration, with newly launched products anticipated to drive higher growth in the second half of 2025. INDUSTRY GLOSSARY Loss of Exclusivity (LOE): The expiration of patent protection for a branded drug, allowing for generic or biosimilar competition and revenue erosion. Biosimilar: A biologic medical product highly similar to an approved original ("reference") biological product, but manufactured by a different company once original patents expire. GILTI: Global Intangible Low-Taxed Income, a US tax provision affecting multinational companies' foreign earnings. CAR T therapy: A type of cellular immunotherapy where patient's T cells are engineered to attack cancer cells. PFA: Pulsed Field Ablation, a non-thermal cardiac ablation technique for treating atrial fibrillation. IPR&D: In-Process Research and Development expense, referring to R&D costs related to product development projects acquired in a business combination. VBP (Volume-Based Procurement): China's price-reduction policy for medical products, where bulk purchasing results in aggressive unit price cuts. Full Conference Call Transcript Joaquin Duato, our chairman and CEO, will discuss our business performance and key catalysts. I will then review the second quarter's sales and P&L results. Joe Wolk, our CFO, will then close by sharing an overview of our cash position and guidance update for 2025. Jennifer Taubert, Executive Vice President Worldwide Chairman, Innovative Medicine. John Reed, Executive Vice President, Innovative Medicine, Research and Development, and Tim Schmid, Executive Vice President, Worldwide Chairman, MedTech, will be joining us for Q&A. To ensure we provide enough time to address your questions, we anticipate the webcast will last approximately sixty minutes. With that, I will now turn the call over to Joaquin. Joaquin Duato: Thank you, Darren. And hello, everyone. I'm excited to talk about our very strong second quarter. Today's results showcase the strength of our uniquely diversified business as the only major healthcare company operating in both the MedTech and innovative medicine sectors. In the second quarter, we delivered operational sales growth of 4.6% across our business. In innovative medicine, we reported 3.8% operational sales growth, delivering more than $15 billion in quarterly sales for the first time. No other healthcare company has grown through the loss of exclusivity of a multibillion-dollar product in the first year. In our case, STELARRA, and yet, that is exactly what we are doing and for the second quarter in a row. Our performance was driven by double-digit growth across thirteen brands, including DARZALEX, CARVICTI, TECVAYLI, TALVEY, as well as RYBREVANT and PLUVITTO, and SPRAVATO. Delivering 6.1% operational sales growth, with particularly strong momentum in cardiovascular, surgery, and vision. Based on our strong performance in the quarter, we are pleased to raise our full-year sales guidance by $2 billion and EPS guidance by $0.25 from $10.60 to $10.85. Results like these are a direct result of our deep and resilient portfolio. It's what makes Johnson & Johnson unique. Today, we will focus on the remarkable ways we are driving innovation and creating value for patients and shareholders. We'll highlight the depth of our portfolio and pipeline, focusing on six areas of unmet need and where we are delivering significant growth: oncology, immunology, neuroscience, cardiovascular, surgery, and vision. These are spaces where we are moving the conversation from treatment to cure and where we are extending and improving lives in meaningful ways. Let's start with innovative medicine and oncology to illuminate where we have a bold vision for cancer. Our leading products for the treatment of blood cancers and solid tumors are built on cutting-edge scientific platforms that are transforming outcomes for patients. With more than ten products in the market, across twenty-six approved indications, and over twenty-five treatments in late-stage development, we expect to become the number one oncology company by 2030 with sales of more than $50 billion. And when you look at our quarterly results in oncology, with operational sales growth of 22.3%, you can see that we are well on our way to achieving that. I'll draw your attention to three key areas of Q2 progress. First is multiple myeloma, where we have treatments in every line of therapy. Approximately 80% of myeloma patients today receive a Johnson & Johnson medicine at some point in their treatment journey. And in Q2, we presented several important sets of data. They include new five-year data showing a single treatment of our CAR T therapy CARVICTI has the potential to deliver long-term remission. We also presented the first data from our investigational trispecific antibody, which showed an unprecedented 100% overall response rate in heavily pretreated patients. With results like this, we are closer than ever to our ambition of curing multiple myeloma. Second is lung cancer, where our chemotherapy-free combination of RYBREVANT plus LUMAKRAS has a projected overall survival of at least a year over the current standard of care in frontline non-small cell lung cancer with EGFR gene mutations. Intent to prescribe continues to grow among healthcare professionals, which you can see in our strong quarterly sales. This is a life-changing advancement for patients and one we are building on with a pipeline of novel therapies. And third is bladder cancer, where we are excited to share that we have received FDA priority review for TAR-200, a first-of-its-kind drug-releasing system. We anticipate launching TAR-200 for high-risk, non-muscle invasive bladder cancer later this year with a transformational product that harnesses our unique expertise in both innovative medicine and MedTech. We expect TAR-200 to generate at least $5 billion in annual peak year sales. In immunology, we have a 25-year legacy of redefining the standard of care, and we are just getting started. With six products in the market across fourteen approved indications and many treatments in late-stage development, we are expanding treatment options for patients and restoring health for millions of people around the world. From REMICADE and SIMPONI to STELARRA and TREMFYA, we are now exploring targeted oral peptides and future combinations. The growth potential of our immunology portfolio and pipeline continues to be significant. In immunology, I will draw your attention to two key areas of Q2 progress. First, TREMFYA, which has recently expanded into inflammatory bowel disease. TREMFYA grew 30% in the quarter. With strong uptake in Crohn's disease and ulcerative colitis, we expect TREMFYA to generate at least $10 billion annually in peak year sales. We also made important progress in our pipeline in Q2 and expect to file ICHTHYOKINRA with the FDA in the third quarter as the first targeted oral peptide to selectively block the IL-23 receptor with similar efficacy to a biologic. As a once-a-day pill, this molecule has the potential to set a new standard in the treatment of plaque psoriasis, and we look forward to sharing more in the coming months. In neuroscience, we are building on a 70-year legacy and expect to be the number one company by the end of the decade. We are pushing boundaries in diseases like schizophrenia, depression, and Alzheimer's, which together affect one in eight people worldwide. In Q2, SPRAVATO grew 53%, delivering sustained double-digit growth and demonstrating the power of this medicine for patients living with difficult-to-treat depression. We also completed the acquisition of Intracellular Therapies this quarter. Intracellular's CAPLYTA is approved to treat adults with schizophrenia and bipolar depression, and we are excited about the anticipated major depressive disorder approval later this year. With the addition of CAPLYTA, we now have five neuroscience products in the market across six approved indications and eight treatments in late-stage development. CAPLYTA adds to Johnson & Johnson's robust lineup of therapies with $5 billion-plus potential in peak year sales and further solidifies sales growth above analyst expectations through the rest of the decade. Turning to MedTech and in cardiovascular specifically, we are leaders in heart recovery, circulatory restoration, and electrophysiology. Cardiovascular has some of the largest unmet needs in healthcare and is one of the fastest-growing spaces in MedTech. In Q2, we delivered over 22% operational sales growth over the quarter, driven by new product performance in Abiomed, Shockwave, and strength in mapping in electrophysiology. Today, we are a leader in four of the largest and highest-growth MedTech segments within cardiovascular intervention, impacting more than one million patients each year. Now let me highlight three areas of important progress from Q2. First is electrophysiology, which delivered close to 10% operational sales growth over the quarter, driven by new product performance and strength in mapping. We have now completed more than 10,000 VARIPULSE cases globally, with a reported neurovascular event rate of less than 0.5%, consistent with published rates across other PFA platforms. Second, we continue to advance a suite of cardiovascular solutions to expand our market leadership, including our dual-energy ThermoCool SmartTouch SF catheter, where we performed our first cases in Europe this quarter. It also includes Omnipulse, where we presented strong early data that will expand our portfolio of tools for safe and streamlined ablation procedures. Third is Shockwave's unique intravascular lithotripsy technology, or IVL, which has transformed the treatment of atherosclerotic cardiovascular disease and is driving significant growth. Shockwave is expected to be our $13 billion MedTech platform by the end of the year, a position that is further strengthened by a compelling body of evidence on the benefits of this technology. This includes data showing an IVL-first approach can achieve excellent outcomes in female patients with complex calcified coronary artery disease. In surgery, we have spent 140 years advancing the standard of care, and today, our surgical technologies are used in most operating rooms around the world. Q2 highlights include the introduction of the Ethicon 4000 surgical stapler, the newest advancement in our surgical portfolio. Featuring advanced stapling technology and reloads, the Ethicon 4000 minimizes surgical leaks and bleeding, which are common and costly surgical complications for patients and hospitals. This advanced stapling technology will be harnessed for future use exclusively on the Ottava robotic surgery system. And as mentioned on our earnings call in April, Ottava completed its first clinical cases with gastric bypass surgeries performed in Houston. In our conversations with surgeons who have spent time on Ottava, they tell us that they are eager for the system's sophisticated architecture, design features like Twinmotion, the surgeon, and trusted Ethicon advanced instrumentation only available in Ottava and the future connection to our open digital ecosystem Polyphonic. We plan to submit for an FDA de novo approval next year. And finally, Vision, where we have a deep legacy in developing transformational innovation. With quarterly growth of 4.6% across the business and 8.9% in Surgical Vision, the portfolio has a robust growth trajectory driven by our Acuvue OASYS MAX 1-Day family of contact lenses and our TECNIS Eyhance and TECNIS Synergy intraocular lenses. And with the Q2 release of the first disposable multifocal lenses for people with astigmatism, we have high expectations. You know, few other healthcare companies can talk about their impact across many high-growth areas as Johnson & Johnson. And none spanning both innovative medicine and MedTech. These six examples are only a cross-section of our cutting-edge portfolio. The depth and breadth is who we are at Johnson & Johnson. It's how we grow through a major loss of exclusivity, how we have reinvented ourselves time and time again, and how we will deliver strong financial performance through the end of the decade and beyond. The bottom line is this: Johnson & Johnson's relentless focus on innovation yields results. Quarter after quarter, year after year. I will now turn the call back over to Darren. Darren Snellgrove: Thank you, Joaquin. Moving to our financial results. Unless otherwise stated, the percentages quoted represent operational results and therefore exclude the impact of currency translation. Starting with Q2 2025 sales results. Worldwide sales were $23.7 billion for the quarter. Sales increased 4.6% despite an approximate 710 basis point headwind from STELARRA. Growth in the US was 7.8% and 0.6% outside of the US. Worldwide growth was positively impacted by 160 basis points primarily due to the Intracellular and Shockwave acquisitions. Turning now to earnings. For the quarter, net earnings were $5.5 billion with diluted earnings per share of $2.29 versus diluted earnings per share of $1.93 a year ago. Adjusted net earnings for the quarter were $6.7 billion with adjusted diluted earnings per share of $2.77, representing a decrease of 2.1% and 1.8% respectively, compared to the second quarter of 2024. The decrease is driven by interest associated with incremental debt from the Intracellular acquisition and GP erosion from STELARRA. I will now comment on business sales performance in the quarter, with a focus on the six areas Joaquin discussed that will drive significant growth for the enterprise. Beginning with innovative medicine, where our results demonstrate the depth of our expertise in oncology, immunology, and neuroscience. Worldwide sales of $15.2 billion increased 3.8% despite an approximate 1170 basis point headwind from STELARRA, demonstrating the strength of our key brands and new launches. Growth in the US was 7.6% and minus 1.6% outside the US. Growth outside of the US was negatively impacted by STELARRA biosimilars and the COVID-19 vaccine. Acquisitions and divestitures had a net positive impact of 140 basis points on worldwide growth due to the Intracellular acquisition. In oncology, starting with myeloma, DARZALEX growth was 21.5%, primarily driven by continued strong share gains of approximately 4.1 points across all lines of therapy, with close to 8 points in the frontline setting as well as market growth. CARVICTI achieved sales of $439 million with growth of over 100%, driven by share gains and capacity expansion. This reflects continued strong sequential growth of 17.9% as we expand outside of the US. TECVAYLI and TALVEY growth was 22.4% and 54.3%, respectively, bolstered by continued expansion into the community setting. Patient demand remains strong despite continued adoption of longer dosing intervals. In prostate cancer, ERLEADA delivered strong growth of 21%, with continued share gains and market growth. In lung cancer, RYBREVANT plus LUMAKRAS delivered sales of $179 million and growth over 100%, with sequential growth of 26.5% driven by continued strong launch uptake. We continue to see share gains in both first and second lines of therapy. Within immunology, TREMFYA delivered growth of 30.1%, primarily driven by share gains with continued strong uptake across recently launched IBD indications and overall market growth. STELARRA declined by 43.2%, driven by the impact of biosimilar competition and Part D redesign, which is in line with our expectations. In neuroscience, SPRAVATO growth of 53% was driven by continued strong demand from physicians and patients. Long-acting injectables declined by 6.3% due to the impact of Part D redesign and unfavorable patient mix. I'll now turn your attention to MedTech. Worldwide sales of $8.5 billion increased 6.1%, with growth of 8% in the US and 4.1% outside the US, driven by strong performance in three focus areas: cardiovascular, surgery, and vision. Acquisitions and divestitures had a net positive impact primarily due to Shockwave. In cardiovascular, electrophysiology delivered growth of 9.8% versus prior year, driven by strength in competitive mapping, new product performance, and procedure growth. Abiomed delivered growth of 16.9% with continued strong adoption of Impella technology, and Shockwave delivered strong double-digit growth with the recent introduction of the Javelin and E8 catheters. As a reminder, the acquisition benefit of Shockwave was lapped at the end of May. Surgery grew 1.8% despite divestitures negatively impacting results by approximately 60 basis points. Performance was primarily driven by technology penetration and wound closure, the strength of the portfolio, and biosurgery. Growth was partially offset by competitive pressures in energy and the negative impact of China VBP across the portfolio. In vision, contact lenses and other ocular products grew 2.9%, driven by strategic price actions and strong performance in the Acuvue OASYS 1-Day family of contact lenses, including the recent launch of OASYS MAX 1-Day multifocal for astigmatism. Surgical vision growth of 8.9% continues to be driven by strong performance in TECNIS Eyhance, TECNIS Synergy, and iHANCE. The orthopedics business declined by 1.6%, driven by competitive pressures, the transformation program, and China VBP. Now turning to our consolidated statement of earnings for the second quarter of 2025. I'd like to highlight a few noteworthy items that have changed compared to the same quarter a year ago. Cost of products sold deleveraged by 150 basis points, driven by product mix and amortization related to the Intracellular, as well as MedTech macroeconomic factors and VBP in China. Selling, marketing, and administrative expenses improved 50 basis points, driven by corporate expense rationalization, partially offset by increased investment in recent acquisitions. In research and development expenses leveraged by 50 basis points, primarily driven by portfolio rationalization and expense phasing in MedTech. We continued our strong investment in research and development, with $3.5 billion or approximately 15% of sales in Q2. Interest income and expense was a net expense of $48 million as compared to $125 million of income in the second quarter of 2024, primarily driven by lower rates of interest earned on cash balances and a higher average debt balance associated with the Intracellular acquisition. Other income and expense was a net expense of $0.1 billion compared to an expense of $0.7 billion in the prior year, primarily driven by lower talc litigation expense in 2025 and the $0.4 billion loss on the sale of the retained stake in Cambrex as recorded in 2024. Regarding taxes in the quarter, our effective tax rate was 14.7% compared to 18.5% in the same period last year. I encourage you to review our upcoming 10-Q for details on changes in taxes. Lastly, I'll direct your attention to the box section of the slide, we have also provided the company's income before tax, net earnings, and earnings per share adjusted to exclude the impact of intangible amortization expense and special items. Now let's look at adjusted income before tax by segment for the quarter. In support of our efforts to increase financial transparency, you will again find GAAP to non-GAAP reconciliations by segment in the supplemental schedules of our press release. Innovative medicine margin declined from 44.6% to 42.7%, primarily driven by negative mix in cost of products sold related to STELARRA. MedTech margin declined from 25.7% to 22.2%, driven by macroeconomic factors in cost of products sold, as well as other income. This concludes the sales and earnings portion of the call. And I will now turn the call over to John. John Reed: Thank you, Darren, and glad to see your first earnings call is off to a good start. I look forward to you leveraging your recent experience leading the innovative medicine finance team to benefit Johnson & Johnson's investor relations function. Hello, everyone. Thank you for joining us today. As already highlighted, we delivered a very strong second quarter exceeding expectations on both the top and bottom line. While our currently marketed products and platforms drove this quarter's performance, the progress across our pipeline in the first half of the year heightens our conviction to achieve and I'd be willing to bet likely beat the upper end of the growth targets we conveyed at our 2023 enterprise business review. As previously mentioned by Joaquin and Darren, the innovative medicine business continues to grow through STELARRA's loss of exclusivity driven by our end-market portfolio. We continue to advance our pipeline attaining significant clinical and regulatory milestones that will help drive sustained and accelerating growth through the back half of the decade. In MedTech, while we still have work to do, we saw improvement over first-quarter results. Driven by strong performance in the cardiovascular portfolio, surgical vision, and wound closure in surgery. We remain focused on higher-growth markets, enhancing competitiveness to gain market share, and executing against our transformation initiatives to improve margins. Let's get into some of the financial commentary starting with our cash position. Free cash flow through the first half of 2025 exceeded $6 billion, which accounts for elevated tax payments related to the final annual TCJA toll tax payment when compared to the first half of 2024. We ended the second quarter with $19 billion of cash and marketable securities and $51 billion of debt for a net debt position of $32 billion. These figures include the debt raised for the $14.5 billion Intracellular acquisition, which closed on April 2nd. Regarding talc litigation, we expect the Daubert hearing to commence this fall and look forward to the court reexamining the junk science the mass tort plaintiff's bar has funded to promote baseless talc claims against Johnson & Johnson. Turning to our full-year guidance for 2025. Driven by the strength of our first-half performance, we are increasing our operational sales guidance for the full year by approximately $900 million. We are now expecting operational sales growth for the full year to be in the range of 4.5% to 5%, with a midpoint of $92.9 billion or 4.8%, representing a full point better when compared to prior guidance. Excluding the impact from acquisitions and divestitures, our adjusted operational sales growth is now expected to be in the range of 3.2% to 3.7% compared to 2024. As you know, we don't speculate on future currency movements. Last quarter, we utilized the euro spot rate relative to the US dollar of 1.11. The US dollar has weakened across all major currencies since April. Last week, the euro spot rate relative to the US dollar was 1.17. We estimate an incremental positive foreign currency impact of $1.1 billion versus previous guidance. As such, we now expect reported sales growth between 5.1% to 5.6% with a midpoint of $93.4 billion or 5.4%. Currently, our guidance does not include the impact of the most favored nation concepts. With respect to MFN, we share the administration's goal that American patients should pay less by addressing the real drivers of higher US costs, including middlemen driving up prices, and foreign markets not paying their fair share. Turning to other notable items on the P&L. At the beginning of the year, we guided to an approximate 300 basis points improvement in operating margin. Despite what you may have calculated on a year-to-date basis, we remain confident and reiterate our operating margin guide for the full year. This is due to efficiency programs designed for margin improvement as well as nonrecurring one-time IPR&D charges that occurred in the second half of 2024. This expected improvement also takes into consideration the dilution from the Intracellular transaction as well as what we know today about the impact of tariffs on our business. During our first-quarter conference call, we anticipated an impact from tariffs in 2025 to be approximately $400 million. Based on the current tariff landscape, we now anticipate exclusively related to our MedTech business. We will look to reinvest the differential to continue to accelerate our pipeline and further power the launch of our new products. Those on the market with new indications and those with near-term anticipated approvals. We continue to monitor what the future year's impact could be from tariffs on our business. For net interest expense, we now project between $0 and $100 million, an improvement from the previous guidance, primarily driven by higher interest earned on cash balances. Our effective tax rate is now expected to be in the range of 17% to 17.5% for the full year, with the increase largely due to an adjustment to the company's global tax reserves. We are pleased that the One Big Beautiful Bill Act provides certainty for our previously announced $55 billion commitment to invest here in the United States. This includes provisions such as permanent expensing for domestic R&D spend, permanent bonus depreciation, and 100% expensing of qualified production property, including our newly planned facility in North Carolina. We also welcome the improvements that were made to the international tax system. For your modeling, it is worth noting that the tax rate on foreign earnings known as GILTI is increasing by approximately 2% from a statutory rate of 10.5% to 12.6%. This will result in an approximate 1% increase to our global effective tax rate in 2026. Turning to earnings per share. We are pleased to increase our reported adjusted earnings per share estimate by $0.25 to $10.85 or 8.7% at the midpoint. For a range of $10.80 to $10.90, which is a combination of operational improvement and the favorable foreign currency dynamics I referenced earlier. Embedded in that is $0.08 of adjusted operational earnings per share, increasing our guidance to $10.68 or 7% at the midpoint. I'll now provide some qualitative considerations on phasing for your models. We continue to expect both innovative medicine and MedTech operational sales growth to be higher in the second half of the year versus the first half. Regarding innovative medicine, we maintain the assumption that STELARRA's biosimilar competition will accelerate throughout the year with erosion similar to HUMIRA's in year two. Turning to MedTech, we anticipate an acceleration in growth to be driven by the increased adoption of newly launched products in cardiovascular, surgery, and vision. We continue to expect normalized procedure volumes and typical seasonality patterns throughout the remainder of the year. Beyond our financial commitments and what Joaquin has already referenced, we are excited for the expected pipeline progress in the remainder of 2025. In innovative medicine, this includes expected approvals in TAR-200, in non-muscle invasive bladder cancer, subcutaneous RYBREVANT for non-small cell lung cancer in the US, TREMFYA subcutaneous induction for ulcerative colitis, and CAPLYTA for adjunctive major depressive disorder. Anticipated filings for approval include ICHTHYOKINRA in psoriasis and TREMFYA in psoriatic arthritis. As far as data readouts, we are planning for RYBREVANT, head and neck cancer, and ICHTHYOKINRA in ulcerative colitis as well as head-to-head data versus STELARA in psoriasis. In MedTech, we continue to make progress with our clinical trials for our Ottava robotic surgical system. In our cardiovascular portfolio, we are planning regulatory submission for dual-energy ThermoCool SmartTouch SF catheter for cardiac arrhythmia in the US. An Impella ECP submission in heart recovery as well as Javelin and Shockwave E8 launches in circulatory restoration. In orthopedics, we will be launching a tune revision hinge, a new plating system called Volt in the US. We will also be launching the Ethicon 4000 stapler with 3D reloads in surgery and the Acuvue OASYS MAX in vision for astigmatism. In summary, I trust you agree the results delivered in the first half are evidence that our portfolio has the breadth and depth that enables us to attain growth. Even in the face of a major LOE, where very few, if any, other companies could. The clinical advancements provide a robust base for accelerated top-line growth, not just for the remainder of this year, but for the back half of the decade. We're confident that the strength of our business model enables Johnson & Johnson to navigate a dynamic external environment delivering on our financial commitments. This is directly attributable to the hard work and dedication of our 138,000 colleagues who focus daily on advancing our pipeline, increasing market share, and progressing breakthrough treatments to patients that create long-term value for our shareholders. Thank you. And with that, we are happy to take your questions. Kevin, will you please provide instructions for those seeking to participate in the Q&A? Operator: Certainly. We'll obviously be conducting a question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad. Our first question is coming from Chris Schott from JPMorgan. Your line is now live. Chris Schott: Great. Thanks so much for the question. Johnson & Johnson also reported a very strong top-line beat despite the STELARRA LOE. And I am just interested, Joe, in any color you might hire up in terms of the drivers of upside to the guidance for the year as we think about much of this is the innovative business versus MedTech. Any particular franchises in those businesses that's driving guidance raise? Thank you. Joe Wolk: Yeah. Good morning, Chris, and thank you very much for the question. I would say it's both are contributing in terms of the strong performance. And in fact, I would say this is a great opportunity for Jennifer and Tim to address some of the strength that we saw in our second-quarter results. As you saw, and credit to Jennifer and her team achieving the first $15 billion quarter, despite $1.2 billion of year-on-year erosion in the quarter from STELARRA. I don't think any other company can do that. And then, Tim, a notable improvement from what we reported in Q1. That gives us a lot of enthusiasm for the balance of this year where we, as you heard in my earlier comments, we expect both businesses to actually continue that momentum and grow better in the second half than the first half. But when I turn it over to Jennifer and Tim, to give you some insights from their perspective? Jennifer Taubert: Thank you so much, Joe, and good morning, everybody. And, Joe, you stole my thunder on the over $15 billion in our first $15 billion quarter. You know, importantly, if you take a look at the 90% of our business that is not STELARRA, we actually had extraordinarily robust growth of 15.5% growth really demonstrating the strength across our portfolio. We had thirteen brands that were growing double digits, and as we take a look at those, the vast majority of those are not only our growth drivers for today and tomorrow but are also key growth drivers out through the end of the decade. So a few of the notable drivers there. So first in oncology, DARZALEX continues to perform very well. CARVICTI performed well. ERLEADA and we're really pleased with the launch uptakes thus far on RYBREVANT plus LUMAKRAS in non-small cell lung cancer. In immunology, TREMFYA is off to a great start in ulcerative colitis and also Crohn's disease. And across neuroscience, both SPRAVATO and CAPLYTA both had really, really strong performance for the quarter. So as I mentioned, brands with double-digit growth. I won't go into all of those, but really, really strong across the base of our business. And we're really excited throughout the rest of this year because we've got a number of additional catalysts that are coming through with additional approvals and such. Tim? Tim Schmid: Thank you, Jennifer. And, Chris, to your question, I mean, for MedTech, we were happy with our Q2 operational growth of 6.1%. This is a 4.4% sequential improvement over the first quarter. I think you know the primary contributor is certainly cardiovascular, and we are by far and away now one of the largest and certainly the fastest-growing MedTech company in cardiovascular, not Schmid: ...in terms of the size of the business but also in terms of the growth rate. We are seeing significant traction with our new product launches, and the integration of Shockwave and Abiomed is progressing well, contributing to our strong performance. Additionally, our surgical and vision businesses are also showing robust growth, driven by the adoption of our innovative technologies and strategic pricing actions. We are confident that the momentum we have built in the first half of the year will continue into the second half, supported by our strong pipeline and ongoing investments in R&D. Overall, we are very pleased with the progress we are making across our MedTech portfolio and are excited about the opportunities ahead. Thank you for your question, Chris. Operator: Thank you. Our next question comes from Larry Biegelsen from Wells Fargo. Your line is open. Larry Biegelsen: Good morning. Thanks for taking the question. I wanted to ask about the competitive landscape in the immunology space, particularly with the biosimilar competition for STELARRA. How are you positioning your portfolio to address this challenge, and what are your expectations for market share retention in the coming quarters? Jennifer Taubert: Good morning, Larry, and thank you for the question. As you know, the immunology space is highly competitive, and we have been preparing for the biosimilar competition for STELARRA for some time. Our strategy has been to focus on our differentiated portfolio and pipeline, which includes TREMFYA, SIMPONI, and our upcoming launches. TREMFYA, in particular, has been performing exceptionally well, with strong uptake in new indications such as ulcerative colitis and Crohn's disease. We are also advancing our pipeline with promising candidates like ICHTHYOKINRA, which we believe will set a new standard in the treatment of plaque psoriasis. Our goal is to maintain our leadership position in immunology by continuing to deliver innovative solutions that meet the needs of patients and healthcare providers. We are confident in our ability to navigate the competitive landscape and drive growth in this important therapeutic area. Thank you for your question, Larry. Operator: Thank you. Our next question comes from Terence Flynn from Morgan Stanley. Your line is open. Where to invest $1,000 right now When our analyst team has a stock tip, it can pay to listen. After all, Stock Advisor's total average return is 1,060%* — a market-crushing outperformance compared to 179% for the S&P 500. They just revealed what they believe are the 10 best stocks for investors to buy right now, available when you join Stock Advisor. *Stock Advisor returns as of July 14, 2025 This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. Parts of this article were created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. 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Yahoo
11-07-2025
- Business
- Yahoo
Lupin and Zentiva in licence and supply deal for Certolizumab Pegol
Zentiva Group has entered into a licence and supply agreement with pharmaceutical company Lupin for the commercialisation of the latter's biosimilar Certolizumab Pegol, a tumour necrosis factor alpha (TNFα) inhibitor medicine, across several markets. The partnership will enhance the availability of the affordable biosimilar on a global scale. Zentiva will manage commercial activities primarily within Europe and CIS markets, excluding the US and Canada. Meanwhile, Lupin will focus on product development, manufacturing, supply of the medicine within the agreed territories and commercial efforts in the remaining regions, including Canada and the US. The collaboration involves investment from both companies. Lupin will receive $10m upon execution of the agreement and could earn up to $50m based on developmental and regulatory milestones. Profits generated within their respective markets will be shared between Zentiva and Lupin. The biosimilar is a recombinant humanised antibody Fab' fragment targeting TNFα, conjugated to a 40kDa polyethylene glycol. Zentiva CEO Steffen Saltofte stated: "Ensuring accessibility to high-quality and affordable healthcare is at Zentiva's core. Our collaboration agreement with Lupin signifies another step forward in our biosimilars and growth strategies. 'Lupin's advanced development and manufacturing capabilities, coupled with our significant market knowledge and presence, mean we can deliver high-quality biosimilar solutions for our customers and their patients, aligning with our purpose of providing health and wellbeing for all generations." The biosimilar is indicated for conditions including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis without X-ray evidence (non-radiographic), moderate-to-severe plaque psoriasis and Crohn's disease. Lupin president of corporate development Fabrice Egros stated: 'Our global development and commercialisation partnership with Zentiva, with its pan-European focus, enables Lupin to commercialise this unique biosimilar in its core markets and through Zentiva in Europe. 'This partnership underscores our dedication to improving the quality of life for individuals living with chronic conditions and ensuring accessibility and affordability of transformative therapies worldwide.' In March 2025, Lupin entered a licensing and supply agreement with SteinCares to commercialise its biosimilar ranibizumab in Latin American markets excluding Argentina and Mexico. "Lupin and Zentiva in licence and supply deal for Certolizumab Pegol" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Forbes
10-07-2025
- Business
- Forbes
The Culprit Impeding Drug Competition Is Not Who The Feds Expected
"There's little point in pouring hundreds of millions of dollars into creating a biosimilar if PBMs ... More will refuse to cover it," writes Pipes." The Federal Trade Commission and U.S. Department of Justice recently kicked off a series of listening sessions to examine barriers to competition in the drug industry. The title of the first session—"Anticompetitive Conduct by Pharmaceutical Companies"—made it seem that regulators would chiefly investigate biotech firms. Yet by the end, panelists had refocused the spotlight onto pharmacy benefit managers—and provided striking evidence that PBMs, not biotech companies, deserve most of the blame for the anticompetitive practices that lead to high drug prices. If the FTC and DOJ heed the panelists' warnings and crack down on this misbehavior, it could tangibly reduce drug costs for patients. PBMs decide which medicines are included on insurers' formularies, or lists of covered drugs. That gatekeeping authority gives PBMs the power to negotiate prices with manufacturers and secure rebates. PBMs claim to use those rebates to reduce costs for patients. But the rebate structure actually gives them a strong incentive to prefer higher-priced drugs—even when cheaper and equally effective alternatives are available. That's because their earnings are generally determined as a percentage of a drug's list price. A 2024 House Oversight Committee report identified more than 1,000 instances in which PBMs favored higher-cost medicines over less expensive equivalents. In 300 of those examples, PBMs' preferred medicines cost patients at least $500 more than an alternative they excluded from their formularies. Formulary decisions like these lead to larger rebates and fees for PBMs—while the costs pile up for patients. According to a 2023 analysis, PBMs collect more than 40 cents of every dollar spent on brand-name medicines by commercial health plans. PBMs' perverse incentives go beyond the financial. As the FTC's and DOJ's panelists explained, PBMs' behavior stifles competition and innovation in the drug industry by crushing the development of generic and biosimilar drugs. Biosimilars, which are clinically similar versions of existing "biologic" drugs grown from living cell cultures, typically debut at prices that are more than 40% lower than the brand-name version's launch price. In some cases, biosimilars launch at prices that are 81% lower. But even after a year on the market, the average biosimilar commands just under 20% market share for its therapeutic line. PBMs frequently exclude these lower-cost—and thus lower-rebate—biosimilars from formularies or lock them behind prior authorization and "fail-first" requirements. In cases when PBMs do include biosimilars in their formularies, they're often artificially pricey "private-label" drugs affiliated with the PBMs themselves. Juliana Reed, the executive director of the nonprofit Biosimilars Forum, highlighted a particularly egregious example involving the blockbuster autoimmune drug Humira, which has 10 biosimilar competitors—that collectively account for less than 10% of U.S. market share. As James Gelfand—president and CEO of the ERISA Industry Committee, an organization representing large employer health plans—stated, "[t]his manipulation undercuts biosimilar sustainability." It dramatically limits biosimilar manufacturers' ability to establish themselves in the market and earn a return on their products. In fact, it's creating what the FTC and DOJ panelists termed a "biosimilar void"—a dramatic collapse in new biosimilar development. According to a recent IQVIA study, 118 biologic drugs will lose patent protection in the next decade. But biotech companies are currently developing biosimilar competitors for just 12 of them. There's little point in pouring hundreds of millions of dollars into creating a biosimilar if PBMs will refuse to cover it. Manufacturers of traditional chemically synthesized generic drugs face many of the same hurdles. The House Oversight Committee report found that "[n]ew generic drugs are experiencing historically slow adoption by patients directly resulting from PBM coverage decisions." The FTC and DOJ may not have recognized just how severely PBMs have undermined competition across the drug market. But it's not too late to solve the problem. The three largest PBMs—Caremark, Express Scripts, and OptumRx—are each integrated with a major pharmacy and together control nearly 80% of U.S. prescriptions. The nation's six largest PBMs account for almost 95% of all prescriptions dispensed. If any industry deserves to face antitrust scrutiny, it's this one. Putting a stop to PBMs' anticompetitive practices would be far more fruitful than imposing new price controls or other regulations on manufacturers. Policymakers should also consider requiring PBMs to pass negotiated rebates directly to patients, so beneficiaries see real savings at the pharmacy counter. The recent listening session has given our leaders an actionable path to reform of the market for prescription drugs. Fix PBMs, and concerns about drug prices will resolve themselves.
Yahoo
10-07-2025
- Business
- Yahoo
Alvotech Appoints Linda Jónsdóttir as Chief Financial Officer
Linda Jónsdóttir REYKJAVIK, ICELAND (July 10, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the appointment of Linda Jónsdóttir as Chief Financial Officer (CFO). Linda is a highly experienced international executive with a strong background in finance and corporate leadership. She has held senior roles across a range of industries, including banking, food technology, transportation, and healthcare. Linda will be based in Iceland. Joel Morales, who has served as CFO of Alvotech since 2020, based in the U.S., has decided to step down to spend more time in the U.S. and prioritize time with his family. He will continue supporting Alvotech in an advisory capacity, to ensure a smooth transition. Linda held senior roles for 15 years at Marel, a global leader in food processing technology, including Director of Treasury and Investor Relations, Chief Financial Officer and Chief Operating Officer, until stepping down in 2024. She has also served on various boards, including in banking, private equity funds, and at the Icelandic Chamber of Commerce. 'We are delighted to welcome Linda to the Alvotech executive team. She brings a wealth of experience to this position, with a strong record of senior leadership and financial expertise. I am confident that she will hit the ground running, supporting our continued growth and evolution,' said Robert Wessman. 'I would also like to thank Joel for his valuable contribution. During his tenure we experienced an amazing transformation, as Alvotech transitioned from being privately held and R&D focused, to a public, profitable and fully integrated global commercial biosimilars company that is poised to become a leader in the industry.' "It's a great pleasure to join Alvotech, which is a unique company domestically as well as an emerging leader in its field internationally. It's been thrilling to watch Alvotech's rapid growth, and its prospects are equally exciting. I look forward to working with an exceptional team, building on this strong foundation and history of achievement," said Linda Jónsdóttir. 'It has been an honor to be a part of the Alvotech team. I would like to thank all of my colleagues and Robert especially for a wonderful journey. We have accomplished much together, and I'm confident that Alvotech is well positioned for future growth and success. I look forward to supporting the team in the weeks ahead to ensure a smooth transition and prepare for presenting our Q2 results in August. I will of course remain a proud shareholder in Alvotech,' said Joel Morales. About AlvotechAlvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech's commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy's (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, X and YouTube. Alvotech Forward Looking StatementsCertain statements in this communication may be considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech's expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as 'may', 'should', 'expect', 'intend', 'will', 'estimate', 'anticipate', 'believe', 'predict', 'potential', 'aim' or 'continue', or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech's estimates of expenses and profitability; (6) Alvotech's ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech's partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech's ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech's current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech's ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech's ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech's products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company's business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled 'Risk Factors' and 'Cautionary Note Regarding Forward-Looking Statements' in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONSBenedikt Stefansson, Attachment Linda JónsdóttirSign in to access your portfolio
