JNJ

NEW BRUNSWICK, N.J., August 31, 2026--(BUSINESS WIRE)--Johnson & Johnson (NYSE: JNJ) will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, October 13th to review third-quarter results. Joaquin Duato, Chairman and Chief Executive Officer, Joseph J. Wolk, Executive Vice President and Chief Financial Officer and Ryan Koors, Vice President, Investor Relations will host the call. The question and answer portion of the call will also include additional members of Johnson & Johnson’s executive team. Investors and other interested parties can access the webcast/conference call in the following ways: The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes. By telephone: for both "listen-only" participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261. A replay of the conference call will be available until approximately 12:00 a.m. on October 27th. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13762207. The press release will be available at approximately 6:45 a.m. (Eastern Time) the morning of the conference call. Please refer to www.investor.jnj.com for a complete list of currently planned earnings webcast/conference calls. Please note the fourth-quarter date of Tuesday, January 26th, 2027. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. View source version on businesswire.com: https://www.businesswire.com/news/home/20260831627428/en/ Contacts Media contact: [email protected] Investor contact: [email protected]

Genmab A/S (NASDAQ:GMAB) boosted its full-year 2026 revenue guidance to a range of $4.325 billion to $4.525 billion, up from its previous outlook of $4.065 billion to $4.395 billion. The upward revision underscores the strong commercial momentum across the company's royalty streams and proprietary portfolio. For the first half of 2026, GMAB reported total revenue of $2,051 million, representing a 25% year-over-year growth. Royalty revenue increased 24% to $1,708 million, heavily supported by $8,171 million in net sales of DARZALEX by Johnson & Johnson. Meanwhile, global net sales of EPKINLY/TEPKINLY surged 48% to $312 million. Operating profit came in at $555 million, while adjusted operating profit rose 18% to $656 million. Following the robust print, Guggenheim analyst Michael Schmidt raised the firm’s price target on Genmab to $42 from $40 while maintaining a Buy rating on August 7. This brings up a key question: Does this guidance raise reflect a permanent, high-margin inflection for Genmab A/S (NASDAQ:GMAB)’s pipeline, or will rising operating expenses eventually weigh on its bottom line? Genmab's broad-based top-line expansion, driven equally by DARZALEX royalties and EPKINLY net sales, demonstrates a diversified, partner-plus-proprietary revenue model. This setup reduces reliance on any single product, securing predictable royalties that fund ongoing commercial rollouts. Furthermore, a Phase III PFS win for epcoritamab in B-cell malignancies strengthens its clinical proof, expanding label potential and long-term royalty streams across geographies. Additionally, Genmab's high cash conversion and strong balance sheet provide ample organic financing to fund late-stage programs without risking shareholder dilution. Conversely, leverage levels remain a consideration, limiting overall financial flexibility. Should interest or refinancing costs shift, capital allocation toward expensive confirmatory trials could face pressure. Margin compression also poses a near-term risk as adjusted operating expenses climbed 28% to $1,270 million in H1 2026 due to pipeline investments like Rina-S and petosemtamab. Lastly, competitive landscapes in key indications and regulatory hurdles surrounding overall survival data could slow peak adoption and shorten royalty durations for new assets. Hedge fund sentiment around Genmab has turned noticeably positive. According to Insider Monkey’s database, 30 hedge funds held positions in Genmab in Q1 2026, up from 24 funds in Q4 2025. Major institutional holders include Paradigm Biocapital Advisors with 13,133,131 shares valued at $360.77 million (representing a 65% increase in position) and Orbis Investment Management with 11,368,161 shares valued at $312.28 million. Investors should keep a close eye on whether Genmab A/S (NASDAQ:GMAB) can sustain its 20%+ royalty growth rate through the second half of 2026 without letting R&D and integration expenses erode operating margins. Additionally, key regulatory updates regarding epcoritamab's expanded indications and early pipeline updates for Rina-S will be vital in determining whether the stock can meet Wall Street's higher price targets. While we acknowledge the potential of GMAB as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Follow Insider Monkey on Google News.

The 2026 Q2 earnings cycle continues to wind down, with the reporting docket starting to get quiet. The period has been another one of positivity so far, with several companies, including Apple AAPL, EMCOR Group EME, and Johnson & Johnson JNJ, all reporting record-breaking results in one way or another. Apple’s results reflected its strongest June-quarter period ever, with quarterly revenue of $109.4 billion growing 16% year-over-year. Adjusted EPS came in at $2.02, growing an even stronger 29% from the year-ago period. It also reported double-digit revenue growth across iPhone, Mac, and Services, with similar gains in every geographic segment. Its installed base of active devices reached an all-time high across its major product categories, with its overall gross margin seeing a benefit from tariff refunds. As usual, the iPhone accounted for the mega-cap tech giant’s largest revenue source, with sales coming in at $54.3 billion and growing 21.6% year-over-year. Image Source: Zacks Investment Research Though iPhone reflects the greatest portion of sales, the Services category has quickly grown to be another big top line contributor over recent years, with quarterly sales of $30.7 billion reflecting a 12% YoY increase. Apple’s cash-generating abilities have always been a critical part of investor sentiment surrounding the stock, with it also reporting record operating cash flow for its June-quarter period. The strong cash-generating abilities have allowed shares to trade at a premium, with its dividend payouts pleasing investors looking to obtain top-tier tech exposure paired with paydays. EMCOR similarly posted a double-beat relative to our consensus expectations, with revenues of $5.2 billion reflecting a record and growing nearly 20% YoY. Adjusted EPS of $9.06 reflected a second-quarter-specific record, up 35% from the same period last year. The company didn’t just post records across headline figures, though, with remaining performance obligations (RPO) of $17.1 billion similarly reflecting an all-time high and surging 44% YoY. The favorable results were capped off with increased sales and earnings guidance, with the stock sporting a favorable Zacks Rank #1 (Strong Buy). Revenue has shown huge growth over recent years, with the record-high RPO in the release helping keep the overall trajectory bright. Image Source: Zacks Investment Research Johnson & Johnson shares have quietly delivered a huge gain in 2026 so far, up nearly 30%. The gain over the last month has similarly shown nice outperformance relative to the S&P 500, with the recent results leading to positive momentum post-earnings. Sales of $25.3 billion reflected a new quarterly record for the company, growing by a solid 6.6% year-over-year. It also increased both its current fiscal year sales and adjusted EPS guidance, with JNJ now on track to meet its 2026 target of more than $100 billion in annual revenue for the first time in its history. Image Source: Zacks Investment Research Bottom Line The 2026 Q2 earnings season continues to roll along, and results have been positive for many companies, including Apple AAPL, EMCOR Group EME, and Johnson & Johnson JNJ. Not all companies have seen great post-earnings reactions, but the overall earnings landscape remains one of strength. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Apple Inc. (AAPL) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report EMCOR Group, Inc. (EME) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Make better investment decisions with Simply Wall St's easy, visual tools that give you a competitive edge. Johnson & Johnson (JNJ) is back in focus after its stock moved higher following a 6.6% rise in second quarter sales and an improved outlook for 2026. See our latest analysis for Johnson & Johnson. The recent second quarter update and regulatory news around Johnson & Johnson's MONARCH QUEST 3 system have come alongside strong momentum, with a 30 day share price return of 9.88% and an 81.38% total shareholder return over three years. This suggests investors have increasingly rewarded its healthcare exposure and perceived resilience. If you are looking beyond Johnson & Johnson for other healthcare related ideas, this could be a good moment to scan a focused list of 42 healthcare AI stocks. After a sharp move that has already rewarded recent buyers, the question now is timing. Does it make more sense to add Johnson & Johnson at this level, or wait and hope for a cheaper entry before the next leg of the story is priced in? The latest fair value narrative on Johnson & Johnson points to a value of $246.46, which sits below the recent close around $273. This gap has caught the eye of investors weighing how much they are paying for a large, diversified healthcare business. Read the complete narrative. Curious what drives that $246.46 figure for Johnson & Johnson. The narrative leans heavily on steady revenue compounding, firm profit margins, and a future earnings multiple that assumes the market keeps paying up for that consistency. Result: Fair Value of $246.46 (OVERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, investors still need to watch for litigation outcomes and any setback in Johnson & Johnson's MedTech or pharmaceutical pipelines that could challenge this fair value story. Find out about the key risks to this Johnson & Johnson narrative. While the user generated fair value narrative suggests Johnson & Johnson is overvalued at around $273 versus $246.46, the SWS DCF model points in the opposite direction. It estimates a future cash flow value of $364.27, which frames the current $273.41 price as undervalued instead. This gap between a cash flow based value and the narrative fair value leaves investors with a practical question. Is the market underestimating Johnson & Johnson's ability to turn its $97.9b revenue and $21.0b net income into long run cash flows, or is the DCF model too generous about how durable that performance will be. Look into how the SWS DCF model arrives at its fair value. Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out Johnson & Johnson for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 52 high quality undervalued stocks. If you save a screener we even alert you when new companies match - so you never miss a potential opportunity. With Johnson & Johnson showing both optimism and caution in this story, now is a good time to review the data yourself and decide what really matters. To see how the potential upsides compare with the concerns, start by reviewing the 2 key rewards and 1 important warning sign. If you are weighing your next move after reviewing Johnson & Johnson, now is the time to scan other opportunities before the market prices them ahead of you. Spot potential future leaders early by reviewing screener containing 20 high quality undiscovered gems that pair solid fundamentals with room for greater market attention. Strengthen your income focus by scanning 12 dividend fortresses that aim to combine higher yields with resilient business profiles. Reduce portfolio stress by considering 78 resilient stocks with low risk scores that score well on financial stability and risk metrics. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include JNJ. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Shares of Liquidia Corporation LQDA have lost 15.4% since the company reported second-quarter results on Aug. 11. Liquidia reported second-quarter 2026 earnings of 74 cents per share, which beat the Zacks Consensus Estimate of 70 cents. The company reported a loss of 49 cents per share in the year-ago quarter. Total revenues surged to $171.7 million from $8.8 million a year ago and surpassed the Zacks Consensus Estimate of $165 million, driven by continued adoption of its lead drug, Yutrepia. Despite the earnings and revenue beats, investors appeared unimpressed, likely due to the relatively modest magnitude of the upside versus expectations. The recent weakness has added to LQDA’s underperformance over the past month. Shares have lost 3.5% during this period compared to a 4.5% gain for the industry. The stock has also lagged the broader sector and the S&P 500 Index. Image Source: Zacks Investment Research Against this backdrop, a closer examination of Liquidia’s key strengths and potential challenges could help investors determine whether the stock remains an attractive investment opportunity. Launched in June 2025, Yutrepia was approved by the FDA in May 2025 for the treatment of both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The drug is an inhaled dry-powder version of treprostinil made with the company’s proprietary PRINT technology, designed to deliver medicine deeper into the lungs through an easy-to-use inhaler and allow higher doses than other inhaled treprostinil treatments. Yutrepia net product sales reached $170.4 million in the second quarter, up from $6.5 million a year earlier, driven by higher Yutrepia volume. Product sales increased 31.0% sequentially. As of July 31, 2026, Liquidia had received approximately 5,900 unique prescriptions since launch and started more than 5,000 patients on therapy. More than 1,100 physicians had prescribed Yutrepia since its launch as of July 31, with more than 30% having written prescriptions for at least five patients. The prescription-to-start conversion rate remained above 85%. Strong Yutrepia sales helped drive the company's fourth consecutive profitable quarter, with net income reaching $74.7 million in the second quarter. Yutrepia appears to be gaining market share while expanding the inhaled prostacyclin market. Liquidia currently generates revenues from sales of Yutrepia inhalation powder, and through a profit-sharing arrangement with Sandoz under a promotion agreement originally signed in August 2018 and subsequently amended. The agreement allows Liquidia to share in the profits generated from sales of Sandoz's generic Treprostinil Injection in the United States. LQDA plans to explore Yutrepia in additional indications, including pulmonary hypertension associated with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, progressive pulmonary fibrosis and Raynaud’s phenomenon associated with systemic sclerosis. Liquidia is leveraging its expertise in respiratory and vascular diseases to advance a pipeline of novel therapies that could support long-term growth. A key pipeline asset is L606, an investigational liposomal formulation of treprostinil licensed from Pharmosa Biopharm, designed for twice-daily administration using a short-duration, next-generation nebulizer. It is also being evaluated in PAH and PH-ILD. The phase III Re-Spire study on L606 is currently enrolling. While Yutrepia is driving LQDA’s top-line growth, the company remains heavily dependent on the drug as its primary growth driver. LQDA’s relatively lean pipeline further increases this concentration risk. Liquidia is also involved in a patent dispute with United Therapeutics UTHR over Yutrepia’s use in PH-ILD. Management said an adverse ruling could result in a royalty or other injunctive/adjunctive relief. A decision could come at any time, so this is a binary risk that could affect Yutrepia economics or commercialization. Going by the price/sales ratio, LQDA shares currently trade at 6.89X forward sales, higher than the industry’s average of 1.94X but lower than its mean of 14.68X. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2026 earnings per share has moved south to $2.57 from $2.97 and that for 2027 EPS has declined to $4.38 from $4.81 in the past 60 days. Image Source: Zacks Investment Research Liquidia's products and pipeline candidates for PAH compete across several established and clinically validated treatment pathways. UTHR markets four medicines in the United States to treat PAH, namely Remodulin, an injectable formulation of treprostinil, Orenitram, an oral version of treprostinil, Tyvaso, an inhaled version of treprostinil, and Adcirca (tadalafil; under an in-license from Eli Lilly and Company) tablets. Remodulin is approved for both subcutaneous (SC) and intravenous (IV) use. Johnson & Johnson’s JNJ Uptravi (selexipag) is approved to treat PAH. JNJ has another PAH drug in its portfolio, named Opsumit. Despite Yutrepia’s strong launch, Liquidia’s investment case carries several risks. The company remains heavily dependent on Yutrepia, with a relatively lean pipeline, making any slowdown in prescriptions, reimbursement challenges or competitive pressure a significant threat to growth. The ongoing patent litigation with UTHR over Yutrepia’s PH-ILD indication is another major overhang. Competition from established PAH therapies could also limit Yutrepia’s market-share gains. While 2026 and 2027 EPS estimates have declined, rising R&D spending could pressure future profitability. Overall, LQDA’s high dependence on Yutrepia, litigation risk, competitive pressures, elevated valuation and rising costs create an unfavorable risk-reward profile. Hence, we advise current and prospective investors to avoid the stock for now. LQDA has a Zacks Rank #4 (Sell) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Liquidia Corporation (LQDA) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report United Therapeutics Corporation (UTHR) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Never miss an important update on your stock portfolio and cut through the noise. Over 7 million investors trust Simply Wall St to stay informed where it matters for FREE. Johnson & Johnson has delivered a 68.9% total return over the past 5 years, yet its valuation picture is split, with a Discounted Cash Flow (DCF) intrinsic value estimate pointing to upside while market multiples lean the other way. Over 5 years, Johnson & Johnson has returned 68.9%, which puts the recent share price near the upper end of its longer term journey. Pipeline progress in areas such as major depressive disorder therapies and new medical technologies like surgical robotics can support cash flow expectations, while large scale supply chain restructuring and related costs may weigh on how much of that cash ultimately reaches shareholders. The company scores 3 out of 6 on our valuation checks, which points to a mixed picture rather than a clear bargain or clear overvaluation. The stock's next move may depend on whether investors put more weight on the DCF driven intrinsic value estimate, which suggests Johnson & Johnson is trading at about a 28.1% discount, or on market multiples that currently point to a richer price. Find out why Johnson & Johnson's 53.7% return over the last year is lagging behind its peers. The Discounted Cash Flow (DCF) approach estimates what a stock is worth based on the cash it can return to shareholders over time. For Johnson & Johnson, the model starts with latest twelve month free cash flow of about $21.7b and assumes cash flows continue to grow rather than shrink. On that basis, the 2 Stage Free Cash Flow to Equity model points to an intrinsic value of about $364 per share. Compared with the current share price, this implies Johnson & Johnson screens as about 28.1% undervalued. The ongoing supply chain restructuring and related costs highlighted recently help explain why the market may be hesitant to fully reflect the DCF value in the price. On balance, the DCF work suggests Johnson & Johnson stock appears undervalued relative to the cash flows analysts expect it to produce. Our Discounted Cash Flow (DCF) analysis suggests Johnson & Johnson is undervalued by 28.1%. Track this in your watchlist or portfolio, or discover 51 more high quality undervalued stocks. Head to the Valuation section of our Company Report for more details on how we arrive at this Fair Value for Johnson & Johnson. The P/E ratio is a useful measure for Johnson & Johnson because earnings are a core yardstick for large, diversified healthcare businesses. Right now the stock trades on about 30.0x earnings, which is above the pharmaceuticals industry average of roughly 16.6x and below a peer group average near 48.8x. That leaves Johnson & Johnson priced at a premium to the broader industry even though it does not sit at the very top end of its peer set. Given that gap to the industry average P/E, the multiple indicates that Johnson & Johnson stock looks expensive on an earnings basis. Investors are paying more for each dollar of profit than they would for a typical pharmaceuticals stock, which suggests expectations for the business are relatively high compared with the sector overall. On this P/E measure, Johnson & Johnson currently screens as overvalued compared with the wider pharmaceuticals industry. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St Narratives pick up where this valuation split for Johnson & Johnson leaves off. They explain which assumptions on growth, margins and earnings would need to hold for the stock to be worth materially more or less than today. These narratives are available on Simply Wall St's Community page. Each narrative sets out a fair value as a thesis about Johnson & Johnson's business that you can track over time, rather than a one off snapshot. The community is split on Johnson & Johnson, with one camp seeing policy and product catalysts as support for the current setup while others focus more on premium pricing and defence. Bull case: roughly fairly valued Read the full Bull Case to see why Johnson & Johnson could be undervalued Bear case: 6% overvalued Read the full Bear Case to see why Johnson & Johnson could be overvalued Do you think there's more to the story for Johnson & Johnson? Head over to our Community to see what others are saying! For Johnson & Johnson, the Discounted Cash Flow (DCF) work points to intrinsic value above the current share price, while the earnings multiple suggests the stock is priced at a premium to sector peers. That split reflects a tension between what the company could generate in cash over time and what investors are currently willing to pay for its earnings. The mixed valuation checks keep the focus on one question: Does Johnson & Johnson convert its pipeline and restructuring efforts into durable cash flows that justify the premium P/E and close the discount, or is the current pricing already capturing most of that potential? This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include JNJ. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

It has been about a month since the last earnings report for Johnson & Johnson (JNJ). Shares have added about 4.8% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Johnson & Johnson due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its latest earnings report in order to get a better handle on the important catalysts. J&J’s second-quarter 2026 earnings came in at $2.90 per share, which beat the Zacks Consensus Estimate of $2.84. Earnings rose 4.7% from the year-ago period. Adjusted earnings exclude intangible amortization expense and special items. Including these items, reported earnings were $2.27 per share, down 0.9% year over year.Sales of $25.3 billion marginally beat the Zacks Consensus Estimate of $25.1 billion.Sales rose 6.6% from the year-ago quarter, reflecting an operational increase of 5.6% and a positive currency impact of 1.0%. Organically, excluding the impact of acquisitions/divestitures and currency, sales rose 5.7% on an operational basis. Stelara’s LOE negatively impacted total revenue growth by approximately 460 basis points. Excluding Stelara, sales grew in a double-digit range in the quarter.Second-quarter sales in the domestic market rose 7.3% to $14.53 billion. Excluding the impact of all acquisitions and divestitures on an adjusted operational basis, domestic sales rose 7.4% in the quarter.International sales rose 5.7% on a reported basis to $10.8 billion, reflecting an operational increase of 3.4% and a positive currency impact of 2.3%. Excluding the impact of all acquisitions and divestitures on an adjusted operational basis, international sales rose 3.5% in the quarter. Innovative Medicine sales rose 7.8% year over year to $16.38 billion. Operational sales increased 6.8%, while adjusted operational growth was 6.9%. U.S. sales advanced 8.9%, and international sales increased 6% on a reported basis. Innovative Medicines sales slightly beat the Zacks Consensus Estimate of $16.16 billion.Higher sales of key products such as Darzalex, Tremfya and Erleada due to strong market growth and share gains drove the segment’s growth. New drugs like Carvykti, Tecvayli, Talvey, Rybrevant and Spravato contributed significantly to growth. These gains were partly offset by lower sales of Stelara, Remicade, Imbruvica and Zytiga.Stelara’s LOE negatively impacted the Innovative Medicines segment’s growth by 760 basis points in the quarter.Oncology Worldwide oncology sales increased 17.3% to $7.41 billion. Darzalex rose 18.9% to $4.21 billion in the quarter, driven by continued share gains across all lines of therapy, particularly the front-line setting, as well as continued market growth. Sales beat the Zacks Consensus Estimate of $4.16 billion. Imbruvica sales declined 18.6% to $599 million. Rising competitive pressure in the United States due to new oral competition has been hurting Imbruvica's sales for the past few quarters. Imbruvica sales missed the Zacks Consensus Estimate of $630.0 million.Erleada sales increased 9.5% to $995 million, driven by share gains and market growth, partially offset by unfavorable patient mix and inventory dynamics. Erleada sales missed the Zacks Consensus Estimate of $1.06 billion.    Among the newer cancer drugs, Carvykti sales surged 49.4% to $657 million, driven by share gains and continued capacity expansion. Another new drug, Tecvayli’s sales jumped 56.5% year over year and 29.2% sequentially to $260 million, driven by launch uptake, share gains from continued expansion into the community setting and the launch of Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma.Talvey sales advanced 63.3% to $174 million, driven by continued expansion into the community setting. Rybrevant/Lazcluze sales climbed 60.8% to $289 million, driven by continued launch uptake in all regions, share gains and the rapid uptake of Rybrevant Faspro.J&J’s newly launched therapy, Inlexzo, delivered a strong second quarter, with sales more than doubling sequentially from the first quarter number of around $30 million. Sales comfortably exceeded consensus expectations, although J&J did not disclose the exact sales figure. The launch continued to gain momentum in the United States, supported by permanent J-code reimbursement, with one in three eligible patients now starting an Inlexzo regimen, up from one in four in the first quarter.ImmunologyWorldwide immunology sales declined 3.7% to $3.84 billion as biosimilar competition continued to put pressure on Stelara, whose sales fell 55.2% to $740 million. Increasing adoption of novel classes and unfavorable patient mix also hurt Stelara sales in the quarter. However, Stelara sales beat the Zacks Consensus Estimate of $654.0 million.Tremfya remained the key growth driver, with sales rising 72.5% to $2.05 billion, driven by share gains across all indications, particularly the IBD indications as well as continued market growth. Tremfya sales beat the Zacks Consensus Estimate of $1.85 billion.Remicade revenues decreased 25.8% to $338 million. Simponi and Simponi Aria sales declined 10.5% to $618 million.On the conference call, J&J said that it is seeing strong launches for its newly launched oral pill for plaque psoriasis, Icotyde, as well as new drug Imaavy for generalized myasthenia gravis.Neuroscience, PH and Other DrugsNeuroscience sales increased 14% to $2.34 billion. Spravato revenues grew 40.8% year over year and 24.8% on a sequential basis to $584 million driven by strong demand trends.Caplyta, added from last year’s acquisition of Intra-Cellular Therapies, generated $361 million, up 70.9% year over year backed by new patient starts and continuing patient growth following its FDA approval in adjunctive major depressive disorder. Caplyta new patient starts were up 122% year over year.Invega Sustenna/Xeplion/Invega Trinza/Trevicta sales rose 2.3% to $1.02 billion in the quarter. Pulmonary hypertension drug Uptravi recorded second-quarter 2026 sales of $494 million, up 3.8% year over year. Opsumit/Opsynvi sales increased 3.4% to $602 million.Xarelto sales rose 7.1% to $664 million. Sales of Prezista/Prezcobix/Rezolsta/Symtuza declined 6.3% to $372 million. MedTech sales increased 4.5% to $8.93 billion, including operational growth of 3.6%. However, MedTech segment sales slightly missed the Zacks Consensus Estimate of $8.96 billion.Excluding the impact of all acquisitions and divestitures, and currency, on an adjusted operational basis, worldwide sales rose 3.7%. In the MedTech segment, sales rose 3.9% in the United States and 3.2% outside of the United States on an operational basis. On the conference call J&J clarified that while its Cardiovascular sales slowed down in the second quarter due to weakness in Abiomed, its other three businesses, Surgery, Vision and Orthopedics accelerated in the quarter and performed above expectations. J&J claimed that overall procedure volumes were stable and there was no broad-based slowdown in medical procedure volumes across its MedTech business. J&J clarified that although some large U.S. hospitals have reported weaker volumes for certain elective procedures, those trends are not reflected in its own business. J&J also said that the expiration of Affordable Care Act (ACA) subsidies has not had any meaningful impact on procedure volumes so far and is unlikely to materially affect MedTech demand.Cardiovascular sales rose 4% to $2.40 billion. However, the growth was slower than prior trends due to competitive pressure in electrophysiology business and decline in Abiomed sales, partially offset by continued double-digit growth in Shockwave. Shockwave revenues rose 14.6% to $335 million. Electrophysiology sales increased 4.4% to $1.53 billion as procedure growth, commercial execution and contribution from new products was partially offset by competitive PFA pressures and negative impact from China inventory dynamics. Abiomed sales declined 2% to $440 million due to slow procedural volumes driven by usage patterns. Abiomed procedure volumes were hurt by uncertainty among physicians after a U.K. study questioned the benefit of using Impella devices in certain high-risk procedures. J&J believes this led to slower Impella usage as doctors reassessed patient selection for the device. J&J believes this is a temporary issue and is working with physicians to ensure the device is used in the right patients based on its existing clinical evidence. However, Abiomed sales in outside U.S. markets remained strong.Worldwide Surgery grew 3.9% to $2.65 billion as growth in wound closure and biosurgery offset the impact of competitive pressure in energy and endocutters and VBP issues in China. Worldwide orthopedics rose 4.9% to $2.42 billion, driven by new product launches and strong commercial execution. Worldwide Vision rose 6.0% to $1.45 billion, driven primarily by higher growth in contact lenses and Surgical Vision partially offset by competitive pressures in the United States in Surgical Vision. Backed by a strong second-quarter performance and uptake of new products, J&J raised its 2026 reported sales guidance to $100.8-$101.4 billion from $100.3-$101.3 billion. The sales projection indicates growth in the range of 7.0%-7.6% versus the prior expectation of 6.5%-7.5%. Operational sales growth is expected in the range of 6.5%-7.1% versus the prior expectation of 5.9%-6.9%.Adjusted operational sales (excluding currency impact, acquisitions/divestitures) growth is expected in the range of 6.2%-6.8% versus the prior expectation of 5.6%-6.6%.In 2026, the 53rd week is expected to provide a benefit of approximately 100 basis points. Operational sales growth is expected to improve in the second half of the year with fourth-quarter growth expected to be higher due to the benefit from the 53rd week.Adjusted earnings per share guidance was raised from a range of $11.45-$11.65 to $11.60-$11.75. Adjusted earnings per share growth is expected in the range of 7.5%-8.9% versus the prior expectation of 6.1%-8.1%.Adjusted pretax operating margin is expected to improve by approximately 75 basis points, higher than the prior expectation of 50 basis points.The company projects net interest expense to be between $250 million and $300 million, slightly lower than the prior expectation of $300 million to $400 million. The adjusted tax rate is expected to be approximately 17.0% to 18.0% (previous expectations: 17.5% to 18.5%).J&J expects its Innovative Medicine segment to remain a key growth driver in the second half of 2026. The growth is expected to be driven by its key products, such as Darzalex, Tremfya, Spravato, Carvykti and Erleada as well as increased contribution from new launches like Icotyde, Rybrevant, and Inlexzo which can offset the ongoing impact of Stelara biosimilar competition. J&J expects continued above-market growth through the remainder of 2026.Other than Stelara LOE impact, J&J expects generic impact for both Simponi and Opsumit to begin in 2026.J&J expects its MedTech business to perform better in the second half of the year than it did in the first half. However, it has lowered expectations for Abiomed, anticipating only modest growth through the remainder of 2026 instead of a sharper rebound. However, it emphasized that the business is not expected to decline, with growth likely to gradually improve as the year progresses. J&J expects a more meaningful acceleration in Abiomed's growth to occur after the release of the PROTECT IV study data in 2027.Overall, J&J expects MedTech growth to improve in the second half, driven by strength in Vision, Orthopedics, Surgery and better performance in Cardiovascular. In the past month, investors have witnessed a flat trend in estimates review. At this time, Johnson & Johnson has a average Growth Score of C, though it is lagging a bit on the Momentum Score front with a D. Charting a somewhat similar path, the stock was allocated a grade of C on the value side, putting it in the middle 20% for value investors. Overall, the stock has an aggregate VGM Score of C. If you aren't focused on one strategy, this score is the one you should be interested in. Johnson & Johnson has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Johnson & Johnson (JNJ) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

AbbVie's growth engine is firing on all cylinders, but on its latest earnings call, analysts focused on whether the company can defend its turf and execute on its next big pipeline bet. AbbVie (ABBV) is on a roll, with the stock up 29% in the past year and trading about 6% below its 52-week high. The company just posted a quarter of solid sales growth, beating expectations and raising its full-year guidance. But its latest call wasn't a victory lap. Instead, analysts focused sharply on whether this powerful momentum is built to last, probing the defensibility of its growth in the face of emerging competition and complex trials ahead. Is The SKYRIZI Moat Holding? The first test came on SKYRIZI, the immunology drug driving much of the company’s success with sales up 24% this quarter. The worry is straightforward: a new oral competitor has entered the psoriasis market, threatening to chip away at SKYRIZI’s dominance. For investors, this is a direct challenge to the durability of AbbVie’s primary growth engine. Management’s answer was direct and backed by data. They reported seeing “no degradation in any of our NBRx trends” since the competitor launched in March. In fact, they claimed that new prescription growth for SKYRIZI has actually accelerated. The company’s read is that the new drug is expanding the market for advanced therapies rather than stealing share. It was a confident, numbers-backed defense of their most important franchise. A Blind Spot In The Pipeline? The second challenge was more forward-looking, aimed at the next potential blockbuster franchise in hidradenitis suppurativa (HS), a chronic skin condition. AbbVie has two major assets, lutikizumab and RINVOQ, with crucial data coming soon. But one analyst highlighted a uniquely modern risk: the widespread use of GLP-1 weight-loss drugs. Because weight loss can reduce inflammation, the concern is that these drugs could “contribute to high placebo rates” in the trials, potentially masking the true benefit of AbbVie’s drugs and jeopardizing the studies. Management acknowledged the dynamic, explaining that the trials are large enough that any GLP-1 effect should appear in both the placebo and treatment groups, effectively canceling it out. The response was logical, but it left the risk on the table. Unlike the clear-cut defense of SKYRIZI, this answer underscored a real, external variable that could complicate a critical pipeline readout. Execution Now, Execution Next Ultimately, AbbVie’s management team successfully argued that its current commercial execution is holding strong against new competition. The stock's outperformance has been notable, and we recently looked at how ABBV stock moved away from its peer group. The call, however, shifted the focus from today's precision to tomorrow's pipeline. For investors who like the theme but not the single-stock risk, a broad healthcare ETF like XLV offers diversified exposure. The answer will come from the data. Management confirmed that results from the pivotal HS trials for both RINVOQ and lutikizumab are expected “later this year.” Investors should watch for any sign of elevated placebo rates in those HS trial results, as that will be the first real test of whether AbbVie’s pipeline execution is as solid as its current sales machine. Where One Stock's Open Questions Fit A Bigger Plan Every stock carries unresolved questions like these, and no earnings call settles all of them. Owning a sector fund spreads that risk across more names, but it is still one bet on one theme: when the theme wobbles, the whole basket wobbles with it. The Trefis High Quality (HQ) Portfolio takes the next step out. It holds about 30 businesses diversified across sectors, selected not on a theme but on quality itself: consistent cash generation, strong margins, and resilient balance sheets. No single unresolved debate, and no single industry, carries your result. It has a track record of outpacing a benchmark that combines the three major indices - the S&P 500, S&P Mid-cap, and Russell 2000. Track the debates on names you like, on top of a core built on quality rather than any one story.

Received FDA Breakthrough Therapy Designation for AAV2-hAQP1 and reported positive three-year data from Phase 1 AQUAx clinical trial evaluating AAV2-hAQP1 for the treatment of moderate to severe grade 2/3 radiation-induced xerostomia Completed the acquisition of all interests and rights to botaretigene sparoparvovec (bota-vec) for the treatment of X-linked retinitis pigmentosa (XLRP) from Johnson & Johnson* (J&J) for $25 million Strengthened balance sheet with $100 million equity financing concurrent with the bota-vec acquisition Secured up to $400 million strategic investment from Oberland Capital, with up to $375 million in non-dilutive capital to support development and commercialization of AAV2-hAQP1 and bota-vec Anticipate submission of global regulatory filings for approval of bota-vec in 2026 and potential BLA filing for AAV2-hAQP1 in mid-2027 LONDON and NEW YORK, Aug. 13, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced financial and operational results for the second quarter ended June 30, 2026, and provided a corporate update. “During the second quarter of 2026, we made tremendous progress towards transforming MeiraGTx into a commercial company,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “We acquired bota-vec from J&J and started working on the global filings for this product and establishing the market access and commercial infrastructure ahead of the potential first commercial launch in 2027. In addition, we made meaningful progress with our wholly owned AAV2-hAQP1 program for a significant unmet need, radiation induced xerostomia (RIX).  We were awarded Breakthrough Therapy Designation in March 2026 based on very strong 3-year data from our Phase 1 AQUAx clinical study (n=24), indicating strong durable responses in late-stage RIX patients. We completed enrollment in our pivotal Phase 2 AQUAx2 clinical study of AAV2-hAQP1 in RIX in the second quarter and are now working expeditiously to submit regulatory filings for bota-vec this year and preparing for AAV2-hAQP1 filings mid next year.” Dr. Forbes continued, “We are engaging high quality market access and commercial teams as we build our internal infrastructure to expedite potential launches of these first in class disease modifying therapies. We are particularly excited to be joined by two senior leaders previously with J&J, Penny Fleck as our Chief Development Officer, who has two decades of experience leading research and development at Takeda Pharmaceuticals, Johnson & Johnson Innovative Medicine, and ONL Therapeutics, including running the bota-vec program at J&J, and more recently, John Knighton as Executive Vice President of Global Manufacturing and Supply Chain. John has over 30 years of experience in biologic manufacturing and previously served as the Head of Cell & Gene Therapy API at Janssen Pharmaceuticals, Inc., supporting the successful launch of CARVYKTI®. Together, Penny and John provide extensive experience and expertise in achieving marketing approvals and successful commercial launches of many pharmaceutical products, and will be instrumental as we transition the Company into one that is well prepared for the potential launches of two products over the next two years.” Dr. Forbes added, “We also remain very excited about our Riboswitch platform. Following discussion with the FDA, we are finalizing the requirements for clinical development and progressing to first in human studies with our Ribo-Leptin program. We anticipate following this first clinical study of the Riboswitch technology with a second program in neuropathic pain which is supported by very strong animal data. In each case, a precise dose of the therapeutic gene product is produced in vivo based on an oral small molecule daily pill. We are eager to progress this powerful novel technology through clinical development to address conditions that cannot be readily addressed using any of the current therapeutic modalities available.” *Janssen Pharmaceuticals, Inc., a Johnson & Johnson company Second Quarter 2026 Highlights Botaretigene Sparoparvovec (bota-vec) for the Treatment of X-Linked Retinitis Pigmentosa (XLRP): In May 2026, MeiraGTx completed the acquisition of full rights and interests in bota-vec from J&J for a one-time $25 million upfront cash payment, with J&J eligible to receive a one-time regulatory and commercial milestone tied to U.S. approval and U.S. sales performance, plus potential mid-teens royalty on global net sales beginning in mid-2029. XLRP is a rare inherited retinal disease with early onset and progressive degeneration to complete blindness by the third decade of life, with no currently approved treatment options. There are more than 20,000 XLRP-RPGR patients in the U.S. and EU alone. The Phase 3 LUMEOS study was a global, randomized study (n=95) in which all patients were treated bilaterally. Data highlight the potential of bota-vec to improve vision, and the safety profile was as expected and manageable, with no new safety signals and an improved inflammatory profile relative to the Phase 1/2 study. As the commercial manufacturer of bota-vec, MeiraGTx has completed process performance qualification (PPQ) and holds a commercial license for its London, U.K. manufacturing facility and a commercial license for its QC facility in Shannon, Ireland. Bota-vec has been granted Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA), and in the EU has received Priority Medicines, or PRIME, advanced therapy medicinal product, or ATMP, and Orphan Drug Designations from the local regulatory authorities. AAV2-hAQP1 for the Treatment of Radiation-Induced Xerostomia: In March 2026, the FDA granted BTD to AAV2-hAQP1 for the treatment of grade 2 and grade 3 radiation-induced xerostomia, supported by three-year data from the 24-patient Phase 1 AQUAx study. In April 2026, MeiraGTx reported positive three-year data from its Phase 1 AQUAx clinical trial (n=24) evaluating AAV2-hAQP1 for the treatment of moderate to severe grade 2/3 radiation-induced xerostomia. Results demonstrated sustained, clinically meaningful improvements in both patient-reported outcomes and objective measures of salivary flow, with durable effects maintained from 12 months through 36 months post-treatment. AAV2-hAQP1 continued to be safe and well-tolerated at each dose tested. The results were presented on April 16, 2026 and a replay is available on the Investors page of the Company’s website at investors.meiragtx.com. The pivotal Phase 2 AQUAx2 study (NCT05926765), a randomized, double-blind, placebo-controlled study at 30 sites in the U.S., Canada, and the U.K. completed enrollment in the second quarter of 2026 and remains on track for a 12-month pivotal data readout in the second quarter of 2027, which, if positive, would support a BLA filing and potential approval targeted for the end of 2027, with U.S. launch in 2028. Up to $400 Million Strategic Investment from Oberland Capital: In June 2026, MeiraGTx entered into an agreement with Oberland Capital Management LLC (Oberland Capital) for an investment of up to $400 million, including up to $375 million in non-dilutive capital in exchange for low single-digit capped royalties on certain products and up to $25 million in equity investment. Following regulatory approval, Oberland Capital is entitled to receive low single-digit capped royalties on the net sales of each of AAV2-hAQP1 (RIX), bota-vec (XLRP), and AAV-AIPL1 (LCA4). Royalty payments are capped at a multiple of the amounts funded. The initial $135 million funded comprised $125 million in cash and a $10 million equity investment. Additional capital is available at the Company's option: $50 million tied to positive AAV2-hAQP1 data readouts in 2027 from the Phase 2 AQUAx2 study; $50 million tied to bota-vec regulatory approval in 2027; and $50 million tied to AAV2-hAQP1 regulatory approval in 2028. A further $100 million is available upon mutual agreement for new products or business development, and Oberland Capital has the right to purchase an additional $15 million in equity. The agreement includes flexible provisions for a potential change of control, including the Company’s ability to buy back the entire funded royalty note at any time by paying certain specified amounts. AAV-GAD for the Treatment of Parkinson’s Disease: FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to AAV-GAD for the treatment of Parkinson’s disease not adequately controlled with medication in 2025. This RMAT was awarded based on data demonstrating statistically significant efficacy in 2 double-blind sham-surgery controlled studies, a Phase 2 study (n=45), and a Phase 1/2 clinical bridging study (n=14) following the successful Phase 1 dose escalation study (n=14). This application also included the use of novel AI developed by our JV partner, Hologen, which demonstrated potential disease modification resulting from treatment. The Company is currently engaging with clinical trial sites globally and expects to initiate the Phase 3 study of AAV-GAD in the coming months. AAV-AIPL1 for LCA4: MeiraGTx entered into a strategic collaboration with Eli Lilly and Company (Lilly), granting Lilly worldwide exclusive rights to meduretgene parvec, or medu-vec (formerly referred to as AAV-AIPL1) for the treatment of Leber congenial amaurosis 4 (LCA4). Under the terms of the agreement, Lilly also received worldwide exclusive access rights to MeiraGTx’s innovative gene therapy technologies for use in ophthalmology with certain targets designated by Lilly, including novel intravitreal capsids developed in-house at MeiraGTx and bespoke promoters including AI-generated cell specific promoters. MeiraGTx also granted Lilly certain rights to its proprietary riboswitch technology for use in gene editing in the eye. MeiraGTx received an upfront payment of $75 million and is eligible to receive over $400 million in total milestone payments. MeiraGTx is also eligible to receive tiered royalties on licensed products. Riboswitch Gene Regulation Technology Platform for in vivo Delivery: The Company’s Riboswitch technology is a broadly applicable platform that provides a precise dose of any biologic therapeutic encoded by a transgene in response to a daily oral pill. We have demonstrated that the platform is gene agnostic and can be incorporated into any sequence delivered by lentivirus, AAV, CRISPR or LNPs providing a powerful mechanism for precisely controlling the level and timing of the production of biologic therapeutics in the body. This enables the native form of the therapeutic protein to be delivered by controlled in vivo production driven by a safe daily pill. This provides more physiological activity of the therapeutic compared to synthetic or stabilized injectable forms of the molecule, often providing improved efficacy and safety. MeiraGTx is advancing its first riboswitch program, native human leptin (Ribo-Leptin), toward the clinic in metabolic disease, and is in discussion with the FDA and is finalizing the package to open the Ribo-Leptin IND. The Company is also conducting IND-enabling studies for a second riboswitch-regulated program for neuropathic pain. Corporate and Leadership Updates In May 2026, MeiraGTx appointed Penny Fleck as Chief Development Officer. Ms. Fleck brings more than 20 years of experience from Johnson & Johnson and Takeda, leading development across numerous assets, including multiple global regulatory approvals. While Global Head of Specialty Ophthalmology at J&J, she worked closely with MeiraGTx on the development of bota-vec. In July 2026, MeiraGTx appointed John Knighton as Executive Vice President of Global Manufacturing and Supply Chain. Mr. Knighton brings more than 30 years of experience from J&J and GlaxoSmithKline. Most recently, John served as Vice President, Cell & Gene Therapy API Development at Janssen Pharmaceuticals, Inc. leading a diverse team of managers, scientists, and engineers who manufactured for the approval and successful commercialization of CARVYKTI® (a personalized CAR T-cell immunotherapy used to treat adult patients with relapsed or refractory multiple myeloma). As of June 30, 2026, MeiraGTx had cash and cash equivalents of approximately $143.2 million as well as $5.6 million in accounts receivables, $24.4 million in unbilled receivables and $14.3 million in tax incentive receivables. Together with the second purchase of $25.0 million of royalty notes and $10.0 million proceeds from the sale of the Company’s ordinary shares under the agreements with Oberland Capital in July 2026, and the additional $95.0 million upfront payment due from Hologen and associated reimbursements, the Company believes that it will have sufficient capital to fund operating expenses and capital expenditure requirements into the second half of 2028. This estimate does not include the $135.0 million in potential near-term cash consideration from Lilly upon achievement of certain development and regulatory approval milestones, or any subsequent tranches available under the royalty note purchase agreement with Oberland Capital. Financial Results Cash, cash equivalents and restricted cash were $145.4 million as of June 30, 2026, compared to $34.4 million as of June 30, 2025. Service revenue was $11.9 million for the three months ended June 30, 2026, compared to nil for the three months ended June 30, 2025. The increase of $11.9 million was due to revenue recognized for the contract manufacturing services provided to Lilly under the Lilly collaboration agreement and related agreements. Service revenue – related party was $104.9 million for the three months ended June 30, 2026, compared to $3.7 million for the three months ended June 30, 2025. The increase of $101.2 million was due to the release of deferred revenue from the termination of the original asset purchase agreement and supply agreement with J&J and the development and transition services provided to Reogen Limited (Reogen), formerly known as Hologen Neuro AI Limited, under the Hologen collaboration agreement and related agreements, which was partially offset by decreased activity of PPQ services under the original asset purchase agreement and related agreements with J&J as the work was substantially completed in the first half of 2025. License revenue – related party was $204.6 million for the three months ended June 30, 2026, compared to nil for the three months ended June 30, 2025. The increase of $204.6 million was due to revenue recognized for the licenses granted to Reogen for the AAV-GAD and AAV-BDNF programs and the AAV-GAD delivery device. Cost of service revenue was $1.4 million for the three months ended June 30, 2026 compared to nil for the three months ended June 30, 2025. The increase of $1.4 million was due to costs incurred during the three months ended June 30, 2026 in connection with contract manufacturing services provided to Lilly under the Lilly collaboration agreement and related agreements. Cost of service revenue – related party was $5.8 million for the three months ended June 30, 2026 compared to $2.7 million for the three months ended June 30, 2025. The increase of $3.1 million was due to costs incurred during the period related to the development and transition services provided to Reogen under the Hologen collaboration agreement and related agreements, partially offset by the decreased activity of PPQ services due to the termination of the original asset purchase agreement and related agreements with J&J during the second quarter of 2026. General and administrative expenses were $12.0 million for the three months ended June 30, 2026, compared to $12.3 million for the three months ended June 30, 2025. The decrease of $0.3 million was primarily due to decreases in legal fees and share-based compensation expense due to vesting in prior periods. These decreases were partially offset by increases in business development expenses and personnel costs. Research and development expenses were $57.8 million for the three months ended June 30, 2026, compared to $33.5 million for the three months ended June 30, 2025. The increase of $24.3 million was primarily due to the reacquisition of bota-vec from J&J under the asset purchase agreement. Costs related to the AAV2-hAQP1 clinical program increased due to the manufacturing of clinical trial batch material during the three months ended June 30, 2026 and higher clinical trial related spend. In addition, other research and development expenses increased due to employee and employee-related costs, facilities costs and other general research and development costs. These increases were partially offset by decreases in the Company’s AAV-GAD program due to a higher cost of clinical trial material batches being manufactured during the three months ended June 30, 2025. Manufacturing costs decreased due to higher manufacturing batch costs being allocated to the clinical programs during the three months ended June 30, 2026 and costs associated with the Company’s preclinical programs decreased primarily related to the gene regulation program due to the completion of certain preclinical studies in 2025. Foreign currency loss was $1.5 million for the three months ended June 30, 2026 compared to a gain of $8.6 million for the three months ended June 30, 2025. The change of $10.1 million was primarily due to the weakening of the U.S. dollar against the pound sterling and euro as it relates to the valuation of the Company’s intercompany payables and receivables. Interest income was $0.7 million for the three months ended June 30, 2026 compared to $0.4 million for the three months ended June 30, 2025. The increase of $0.3 million was due to higher cash balances in interest bearing accounts during 2026 offset by lower interest rates. Interest expense was $3.5 million for the three months ended June 30, 2026 compared to $3.0 million for the three months ended June 30, 2025. The increase of $0.5 million was primarily due to the transaction cost related to the issuance of the royalty note under the agreement with Oberland Capital, which is measured at fair value, and the write-off of unamortized deferred financing cost due to the termination of the Notes Purchase Agreement with Perceptive Credit Holdings III, LP, which is offset by a lower interest rate. Loss on derivative liability was $5.2 million for the three months ended June 30, 2026 compared to nil for the three months ended June 30, 2025. The increase of $5.2 million was due to the initial measurement of the derivative liability associated with the right granted under the securities purchase agreement with Oberland Capital. Loss on equity method investee was $71.9 million for the three months ended June 30, 2026, compared to nil for the three months ended June 30, 2025. The loss primarily reflects the Company’s proportionate share of Reogen’s expenses associated with the acquired in-process research and development assets relating to the AAV-GAD and AAV-BDNF programs and the AAV-GAD delivery device, as well as Reogen’s ongoing research and development activities. Income tax expense was $2.4 million for the three months ended June 30, 2026 compared to nil for the three months ended June 30, 2025. The increase of $2.4 million was primarily driven by taxable income generated from strategic collaboration and other non-recurring transactions, partially offset by valuation allowances and losses in jurisdictions where no tax benefit was recognized. Net income attributable to ordinary shareholders for the quarter ended June 30, 2026 was $160.7 million, or $1.76 basic and $1.71 diluted net income per ordinary share, compared to a net loss attributable to ordinary shareholders of $38.8 million, or $0.48 basic and diluted net loss per ordinary share for the quarter ended June 30, 2025. For more information related to our clinical trials, please visit www.clinicaltrials.gov About MeiraGTx MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical-stage genetic medicines company with a broad pipeline with four late-stage clinical programs. Each of these programs use local delivery of small doses resulting in disease modifying effects in both inherited and more common diseases, in the eye, radiation-induced xerostomia, and Parkinson’s disease. MeiraGTx uses its innovative technology in optimization of capsids, promoters and novel translational control elements to develop best in class, potent, safe viral vectors. MeiraGTx’s broad pipeline is supported by end-to-end in-house manufacturing. MeiraGTx has built the most comprehensive manufacturing capabilities in the industry, including two that are licensed for GMP viral vector production and a GMP QC facility with clinical and commercial licensure. In addition, MeiraGTx has developed a proprietary manufacturing platform process over 10 years based on more than 20 different viral vectors with leading yield and quality aspects and commercial readiness. Uniquely, MeiraGTx has developed a novel technology for in vivo delivery of any biologic therapeutic using oral small molecules. This transformative riboswitch gene regulation technology allows precise, dose-responsive control of gene expression by oral small molecules. MeiraGTx is focusing the riboswitch platform on the regulated in vivo delivery of metabolic peptides, including GLP-1, GIP, Glucagon, Amylin, PYY and Leptin, as well as cell therapy, CAR-T for liquid and solid tumors and autoimmune diseases, and additionally PNS targets addressing long term intractable pain. MeiraGTx has developed the technology to apply genetic medicine to common diseases, increasing efficacy, addressing novel targets, and expanding access in some of the largest disease areas where the unmet need remains high.For more information, please visit www.meiragtx.com Forward Looking StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our product candidate development and anticipated milestones regarding our pre-clinical and clinical data, reporting of such data and the timing of results of data and regulatory matters, statements regarding our collaborations and statements regarding our future obligations under the agreement with Oberland Capital, as well as statements that include the words “expect,” “will,” “intend,” “plan,” “believe,” “project,” “forecast,” “estimate,” “may,” “could,” “should,” “would,” “continue,” “anticipate,” “eligible” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, raise additional capital, repay our debt obligations, identify additional and develop existing product candidates, successfully execute strategic transactions or priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug or rare pediatric disease designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of pandemics, epidemics or outbreaks of infectious diseases on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Contacts Investors:[email protected] or Media:Jordyn TemperatoLifeSci [email protected]

LEGN surged 6% as Q2 revenue of $388M beat estimates and adjusted EPS of $0.16 doubled consensus, marking the company's first-ever profitable quarter. CARVYKTI net sales hit $657M, up 50%, with JNJ co-developer Janssen supporting management's target of over $5B in peak annual sales. Alan Bash, interim CEO following Ying Huang's departure, emphasized continuity as Wall Street's $52 consensus target sits well above current share prices. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Legend Biotech didn't make the cut. Grab the names FREE today. Shares of Legend Biotech (NASDAQ:LEGN) are climbing 6% to $21.88 Tuesday midday after the company reported Q2 2026 results that paired a solid revenue beat with the first quarter of company-wide profitability in its history. LEGN stock is still down 41% over the past year, so today's reaction reads as validation of Legend Biotech's CARVYKTI ramp. Legend Biotech disclosed the results in an SEC filing before the open and hosted its earnings call at 8:00 a.m. ET. The commercial trajectory of CARVYKTI, the CAR-T multiple myeloma therapy Legend co-develops with Johnson & Johnson (NYSE:JNJ) through its Janssen unit, continues to anchor the investment case here. The setup entering the report was heavy for Legend Biotech. LEGN stock had drifted lower through July, and short-dated positioning had grown cautious around the ongoing CEO transition, leaving room for a squeeze on any clean numbers. Legend Biotech posted total revenue of $387.5 million, up 52% year over year, topping the $362.81 million estimate. Legend Biotech's adjusted EPS came in at $0.16, more than double the roughly $0.07 analyst consensus. The revenue beat headlined the report, though the bigger surprise sat further down the income statement. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Legend Biotech didn't make the cut. Grab the names FREE today. Legend Biotech booked net income of $33.2 million versus a net loss of $125.4 million a year earlier, adjusted net income of $63.1 million, and operating income of $57.7 million. That marks the company's first quarter of company-wide profitability on both an IFRS and adjusted basis. A meaningful piece of the swing reflects foreign exchange dynamics for Legend Biotech. Unrealized FX losses fell to $0.6 million in Q2 2026 from $110.9 million a year earlier, cushioning the bottom line even as operating gains did most of the work. The balance sheet also strengthened. Legend Biotech ended the quarter with approximately $965 million in cash, cash equivalents and time deposits and no long-term debt, boosted by about $212 million of net proceeds from a June public offering. Legend Biotech's CARVYKTI net trade sales reached $657 million, up 50% year over year, with U.S. sales up 32% and ex-U.S. sales up 128%. The mix highlights international momentum outpacing the more mature U.S. launch. CARVYKTI is now available across 348 treatment sites and 19 markets, with Ireland the most recent launch for Legend Biotech. Management reiterated peak annual sales potential above $5 billion, keeping CARVYKTI the central pillar of the LEGN investment case. In the multiple myeloma CAR-T space, Bristol Myers Squibb (NYSE:BMY) markets Abecma, the other approved BCMA CAR-T therapy. Competitive positioning against Bristol Myers Squibb remains a key debate, since Legend Biotech is still a single-product commercial story tied largely to CARVYKTI. Legend Biotech reported first clinical proof-of-concept for LB2501, an investigational in vivo CD19/CD20 dual-targeting CAR-T therapy, showing a 100% overall response rate and 83.3% complete response rate at the higher dose level in relapsed or refractory B-cell non-Hodgkin lymphoma. A U.S. IND filing is planned by year-end. The LB2102 DLL3-targeted CAR-T program is licensed to Novartis (NYSE:NVS), giving Legend Biotech a partnered second shot on goal beyond the Johnson & Johnson collaboration. Novartis funding for LB2102 lets Legend Biotech concentrate spend on wholly-owned candidates like LB2501. Sector conditions remain supportive. The iShares Biotechnology ETF (NASDAQ:IBB) is up 18.5% year to date, keeping the backdrop friendly for biotech beats. The IBB ETF is a large-cap-concentrated biotechnology fund and unleveraged, so sector-concentration caution applies here. The leadership context matters with Legend Biotech. Alan Bash is the company's interim CEO following the departure of former CEO Ying Huang last month, and some analysts trimmed their Legend Biotech stock price targets around the transition even while maintaining confidence in CARVYKTI's growth curve. Bash stated in the release, "With meaningful commercial and clinical momentum and a strengthened balance sheet, we remain confident in our ability to advance innovation and progress toward company-wide profitability." The tone from Legend Biotech's management underscored a focus on continuity through the search for a permanent chief executive. Meanwhile, the Wall Street setup still leans constructive. The consensus analyst target on LEGN stock sits at $52.10, well above where shares trade today, with 5 strong buys, 6 buys, and 4 holds. That distribution can compress if analysts lower their ratings and/or price targets around Legend Biotech's CEO search. Traders can watch for whether LEGN stock holds today's gains into the close, and they can check for refreshed analyst notes on Wednesday as well as follow-up commentary from Johnson & Johnson on CARVYKTI's trajectory. This marks a first quarter of profitability, so investors may want to size their positions with Legend Biotech's single-product concentration and early-stage pipeline profile in mind. Act now: the analyst who called NVIDIA in 2010 just named his top 10 AI stocks — and Legend Biotech didn't make the cut. Grab the names FREE today. Contact [email protected] for any questions or corrections.