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Investor releaseQuarter not tagged2026-09-01JAZZ Rises on Updated OS Results From Gastric Cancer Study
Zacks
JAZZ Rises on Updated OS Results From Gastric Cancer Study
Jazz Pharmaceuticals JAZZ announced second interim top-line overall survival (OS) results from the phase III HERIZON-GEA-01 study, which evaluated different combination regimens involving its marketed drug, Ziihera (zanidatamab) as a first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The HERIZON-GEA-01 study evaluated two regimens — Ziihera plus chemotherapy and Ziihera combined with BeOne Medicines’ (formerly BeiGene) PD-1 inhibitor Tevimbra plus chemotherapy — against the current standard of care (SoC) treatment, trastuzumab plus chemotherapy, in the given population. The second interim analysis has now demonstrated that the two-drug regimen of Ziihera plus chemotherapy led to a statistically significant and clinically meaningful improvement in OS versus trastuzumab plus chemotherapy (SoC), strengthening the clinical profile of Ziihera in first-line HER2-positive GEA. Importantly, the OS hazard ratio improved from the first interim analysis, indicating a stronger survival benefit with longer follow-up. The latest results represent an important update to the first interim analysis. In the first interim analysis reported in November 2025, the results had only shown a strong trend toward statistical significance. Management also reported that with longer follow-up, Ziihera plus Tevimbra and chemotherapy resulted in an improvement in the OS hazard ratio compared with the first interim analysis. Jazz said the updated findings further demonstrate a statistically significant, clinically meaningful and durable OS benefit for the three-drug regimen. Shares of Jazz were up 2.5% yesterday following the announcement of the updated OS results. The stock has rallied 47.5% so far this year, compared with the industry’s increase of 9.7%. Image Source: Zacks Investment Research The updated OS results follow the FDA’s recent label expansion of Ziihera as the first-line treatment of adults with HER2-positive unresectable locally advanced or metastatic GEA. Under the expanded indication, Ziihera can be used in combination with chemotherapy, with or without Tevimbra, in this patient population. The approval significantly expands the addressable market for Ziihera beyond its existing use in previously treated HER2-positive biliary tract cancer (BTC). The expanded indication represents a much larger commercial opportunity than Zi…Read full documentShow less
Jazz Pharmaceuticals JAZZ announced second interim top-line overall survival (OS) results from the phase III HERIZON-GEA-01 study, which evaluated different combination regimens involving its marketed drug, Ziihera (zanidatamab) as a first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The HERIZON-GEA-01 study evaluated two regimens — Ziihera plus chemotherapy and Ziihera combined with BeOne Medicines’ (formerly BeiGene) PD-1 inhibitor Tevimbra plus chemotherapy — against the current standard of care (SoC) treatment, trastuzumab plus chemotherapy, in the given population. The second interim analysis has now demonstrated that the two-drug regimen of Ziihera plus chemotherapy led to a statistically significant and clinically meaningful improvement in OS versus trastuzumab plus chemotherapy (SoC), strengthening the clinical profile of Ziihera in first-line HER2-positive GEA. Importantly, the OS hazard ratio improved from the first interim analysis, indicating a stronger survival benefit with longer follow-up. The latest results represent an important update to the first interim analysis. In the first interim analysis reported in November 2025, the results had only shown a strong trend toward statistical significance. Management also reported that with longer follow-up, Ziihera plus Tevimbra and chemotherapy resulted in an improvement in the OS hazard ratio compared with the first interim analysis. Jazz said the updated findings further demonstrate a statistically significant, clinically meaningful and durable OS benefit for the three-drug regimen. Shares of Jazz were up 2.5% yesterday following the announcement of the updated OS results. The stock has rallied 47.5% so far this year, compared with the industry’s increase of 9.7%. Image Source: Zacks Investment Research The updated OS results follow the FDA’s recent label expansion of Ziihera as the first-line treatment of adults with HER2-positive unresectable locally advanced or metastatic GEA. Under the expanded indication, Ziihera can be used in combination with chemotherapy, with or without Tevimbra, in this patient population. The approval significantly expands the addressable market for Ziihera beyond its existing use in previously treated HER2-positive biliary tract cancer (BTC). The expanded indication represents a much larger commercial opportunity than Ziihera’s existing BTC indication. GEA encompasses stomach, gastroesophageal junction and esophageal cancers and is the fifth most common cancer globally. Approximately 20% of GEA patients have HER2-positive disease, a subgroup associated with particularly poor outcomes in advanced and metastatic settings. In metastatic disease, the five-year survival rate remains below 10%, highlighting the need for more effective treatment options. The latest findings could help Jazz establish Ziihera-based regimens as an important treatment option in the first-line setting and support the company's efforts to position Ziihera as the preferred HER2-targeted backbone therapy. Jazz plans to present the updated results at a medical meeting in the fourth quarter of 2026 and submit the same to regulatory authorities worldwide. With its approval across HER2-positive disease regardless of PD-L1 status, Ziihera could address a broader patient population than regimens that require PD-L1 expression. Ziihera was added to JAZZ’s portfolio as part of a 2022 licensing agreement with Zymeworks ZYME. Per the agreement, JAZZ has exclusive rights to develop and market Ziihera in all territories except Asia-Pacific territories (where the drug has been licensed to BeOne Medicines). Zymeworks is eligible to receive tiered royalties on sales of the drug. JAZZ is developing the drug in separate late-stage studies across first-line BTC and metastatic breast cancer. Ziihera is being evaluated across multiple clinical studies for the treatment of HER2-positive solid tumors. Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Repligen RGEN and Anika Therapeutics ANIK, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 10.5% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 117.2% year to date. Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%. 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 Jazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Anika Therapeutics Inc. (ANIK) : Free Stock Analysis Report Zymeworks Inc. (ZYME) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-11TBPH Meets Q2 Earnings Estimates, to be Acquired by Zymeworks
Zacks
TBPH Meets Q2 Earnings Estimates, to be Acquired by Zymeworks
Theravance Biopharma TBPH reported second-quarter 2026 adjusted earnings of 19 cents per share, matching the Zacks Consensus Estimate. In the year-ago quarter, the company had incurred an adjusted loss of 8 cents per share. Total revenues in the quarter were $20.7 million, marginally beating the Zacks Consensus Estimate of $20 million. In the absence of any licensing and milestone revenues, total revenues declined nearly 21% year over year. Year to date, shares of Theravance have lost 9.6% compared with the industry’s 1.2% decline. Image Source: Zacks Investment Research Theravance’s top line consisted solely of collaboration revenues from partner Viatris VTRS tied to Yupelri (revefenacin) sales in the United States and rose 11% year over year, driven by continued net sales growth of Yupelri and improved operating leverage. Theravance and VTRS have collaborated on the development and commercialization of Yupelri, which is approved in the United States for the maintenance treatment of patients with chronic obstructive pulmonary disease. Viatris and Theravance share U.S. profits and losses associated with the commercialization of Yupelri. While Viatris gets 65% of the profits, Theravance receives 35%. Viatris' collaboration revenues include Theravance’s 35% share of Yupelri net sales, as well as its proportionate amount of the total shared costs incurred by the two companies. Research and development expenses (excluding share-based compensation) totaled $4.2 million, down 56.4% from the year-ago quarter’s level, driven by cost savings from the restructuring announced in March and the ongoing wind-down of the CYPRESS study on its lead candidate, ampreloxetine. Selling, general and administrative expenses (excluding share-based compensation) declined 28.7% year over year to $10.6 million due to cost-cutting initiatives from the restructuring announced in March. As of June 30, 2026, Theravance had cash, cash equivalents and marketable securities worth $387.7 million compared with $394.7 million as of March 31, 2026. In late June, Theravance entered into an agreement with Zymeworks Inc. ZYME under which the latter will acquire TBPH in an all-cash transaction valued at approximately $929 million. The acquisition is expected to close in the second half of this year. The deal followed a strategic review initiated after Theravance's growth outlook deteriorated signifi…Read full documentShow less
Theravance Biopharma TBPH reported second-quarter 2026 adjusted earnings of 19 cents per share, matching the Zacks Consensus Estimate. In the year-ago quarter, the company had incurred an adjusted loss of 8 cents per share. Total revenues in the quarter were $20.7 million, marginally beating the Zacks Consensus Estimate of $20 million. In the absence of any licensing and milestone revenues, total revenues declined nearly 21% year over year. Year to date, shares of Theravance have lost 9.6% compared with the industry’s 1.2% decline. Image Source: Zacks Investment Research Theravance’s top line consisted solely of collaboration revenues from partner Viatris VTRS tied to Yupelri (revefenacin) sales in the United States and rose 11% year over year, driven by continued net sales growth of Yupelri and improved operating leverage. Theravance and VTRS have collaborated on the development and commercialization of Yupelri, which is approved in the United States for the maintenance treatment of patients with chronic obstructive pulmonary disease. Viatris and Theravance share U.S. profits and losses associated with the commercialization of Yupelri. While Viatris gets 65% of the profits, Theravance receives 35%. Viatris' collaboration revenues include Theravance’s 35% share of Yupelri net sales, as well as its proportionate amount of the total shared costs incurred by the two companies. Research and development expenses (excluding share-based compensation) totaled $4.2 million, down 56.4% from the year-ago quarter’s level, driven by cost savings from the restructuring announced in March and the ongoing wind-down of the CYPRESS study on its lead candidate, ampreloxetine. Selling, general and administrative expenses (excluding share-based compensation) declined 28.7% year over year to $10.6 million due to cost-cutting initiatives from the restructuring announced in March. As of June 30, 2026, Theravance had cash, cash equivalents and marketable securities worth $387.7 million compared with $394.7 million as of March 31, 2026. In late June, Theravance entered into an agreement with Zymeworks Inc. ZYME under which the latter will acquire TBPH in an all-cash transaction valued at approximately $929 million. The acquisition is expected to close in the second half of this year. The deal followed a strategic review initiated after Theravance's growth outlook deteriorated significantly. The company’s long-term growth strategy was centered on its lead candidate, ampreloxetine, a norepinephrine reuptake inhibitor being developed for symptomatic neurogenic orthostatic hypotension in patients with multiple system atrophy. However, in early March, the pivotal phase III CYPRESS study failed to meet its primary and secondary endpoints. Consequently, TBPH discontinued the ampreloxetine program. Following the setback, the company launched a broad strategic review, explored value-maximizing alternatives, including a potential sale and implemented a major organizational restructuring to reduce costs. Per management, the Zymeworks acquisition is the most value-maximizing option for Theravance shareholders after evaluating all available strategic alternatives. Theravance is currently undergoing a major organizational restructuring aimed at optimizing its cost structure and sharpening its focus on its commercial product, Yupelri. The restructuring is expected to cut operating costs by approximately 60% relative to the company’s 2025 operating costs of $111.1 million. Combined with continued sales of Yupelri, these savings are projected to drive approximately $60-$70 million in annualized cash flow beginning in the second half of 2026. Theravance Biopharma, Inc. price-consensus-eps-surprise-chart | Theravance Biopharma, Inc. Quote Theravance currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Theravance currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Theravance Biopharma, Inc. price-consensus-eps-surprise-chart | Theravance Biopharma, Inc. Quote Theravance Biopharma, Inc. price-consensus-eps-surprise-chart | Theravance Biopharma, Inc. Quote 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 Theravance Biopharma, Inc. (TBPH) : Free Stock Analysis Report Zymeworks Inc. (ZYME) : Free Stock Analysis Report Viatris Inc. (VTRS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-06Zymeworks Provides Corporate Update and Reports Second Quarter 2026 Financial Results
GlobeNewswire
Zymeworks Provides Corporate Update and Reports Second Quarter 2026 Financial Results
August 25, 2026 U.S. PDUFA target action date for zanidatamab has potential to unlock a $250 million U.S. approval milestone and up to $190 million in potential additional global regulatory milestones Acquisition of Theravance Biopharma, Inc. expected to close in 2H 2026, adding durable commercial cash flows and expanding Zymeworks' diversified revenue base Continued advancement of R&D pipeline across wholly-owned and partnered programs Repurchased $49.4 million of common shares as of August 4, 2026 under the newly authorized 2026 share repurchase program Strong balance sheet with $322.5 million in cash, cash equivalents and marketable securities as of June 30, 2026 VANCOUVER, British Columbia, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, today reported financial results for the second quarter ended June 30, 2026 and provided a summary of recent business highlights. In light of the previously announced proposed acquisition of Theravance Biopharma, the Company has elected not to host a second quarter earnings conference call after release of its financial results. “The first half of 2026 has been a transformative period for Zymeworks, demonstrating the continued evolution of our business into a diversified, revenue-generating biotechnology business. While scientific innovation remains our foundation, we believe long-term value is created not only through discovering new medicines, but also through disciplined capital allocation, creative business development and thoughtful partnership structures that maximize the impact of that innovation for patients and shareholders,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “The second half of 2026 has the potential to continue creating meaningful value for both patients and shareholders. Subject to regulatory approval and customary closing conditions, the August U.S. PDUFA target action date for zanidatamab and the planned closing of the Theravance Biopharma acquisition, respectively, would immediately strengthen our revenue base and cash flow outlook. This includes a $250 million approval milestone for zanidatamab in the U.S. with up to $190 million in additional potential global regulatory milestones. These diverse ro…Read full documentShow less
August 25, 2026 U.S. PDUFA target action date for zanidatamab has potential to unlock a $250 million U.S. approval milestone and up to $190 million in potential additional global regulatory milestones Acquisition of Theravance Biopharma, Inc. expected to close in 2H 2026, adding durable commercial cash flows and expanding Zymeworks' diversified revenue base Continued advancement of R&D pipeline across wholly-owned and partnered programs Repurchased $49.4 million of common shares as of August 4, 2026 under the newly authorized 2026 share repurchase program Strong balance sheet with $322.5 million in cash, cash equivalents and marketable securities as of June 30, 2026 VANCOUVER, British Columbia, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, today reported financial results for the second quarter ended June 30, 2026 and provided a summary of recent business highlights. In light of the previously announced proposed acquisition of Theravance Biopharma, the Company has elected not to host a second quarter earnings conference call after release of its financial results. “The first half of 2026 has been a transformative period for Zymeworks, demonstrating the continued evolution of our business into a diversified, revenue-generating biotechnology business. While scientific innovation remains our foundation, we believe long-term value is created not only through discovering new medicines, but also through disciplined capital allocation, creative business development and thoughtful partnership structures that maximize the impact of that innovation for patients and shareholders,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “The second half of 2026 has the potential to continue creating meaningful value for both patients and shareholders. Subject to regulatory approval and customary closing conditions, the August U.S. PDUFA target action date for zanidatamab and the planned closing of the Theravance Biopharma acquisition, respectively, would immediately strengthen our revenue base and cash flow outlook. This includes a $250 million approval milestone for zanidatamab in the U.S. with up to $190 million in additional potential global regulatory milestones. These diverse royalty and milestone cash flows improve our ability to sustain long-term investment in our wholly-owned R&D pipeline, pursue additional strategic acquisitions and partnerships, and continue returning capital to shareholders through our share repurchase program. We believe this disciplined approach to compounding capital and innovation is what will differentiate Zymeworks over the long term.” Business HighlightsPositioning Zymeworks for Multiple Value-Creating Catalysts in 2H 2026 Advancing Partnerships Toward Key Regulatory and Commercial Inflection Points Zanidatamab The top-line results from the second interim overall survival analysis for the HERIZON-GEA-01 trial doublet regimen are expected in the third quarter of 2026. The FDA granted Breakthrough Therapy Designation (BTD) for zanidatamab (Ziihera®), for the treatment of adults with previously treated, locally advanced, unresectable, or metastatic HER2-positive colorectal cancer. The EmpowHER-303 trial is expected to complete patient enrollment in mid-2027 with top-line data expected by the end of 2027 or early 2028. Results from Phase 3 HERIZON-GEA-01 published in The New England Journal of Medicine; Additional subgroup analyses presented in an oral presentation at the 2026 ASCO Annual Meeting showing improved clinical outcomes with zanidatamab-containing combinations regardless of PD-L1 expression, including in PD-L1-negative patients. August 25, 2026 U.S. PDUFA target action date for zanidatamab for the treatment of patients with first-line (1L) HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). Potential $250 million milestone upon approval in the U.S., the first of up to a total of $440 million potential global regulatory milestones for zanidatamab in 1L HER2+ GEA. Zymeworks will continue to receive royalties on Ziihera® sales, with royalty revenues expected to increase following U.S. and global regulatory approvals for GEA. Our royalty revenue from Jazz Pharmaceuticals (Jazz) and BeOne Medicines was $1.8 million in the three months ended June 30, 2026, driven primarily by net product sales of Ziihera by Jazz in the United States. Pasritamig Johnson and Johnson Innovative Medicine (J&J) expect to present Phase 1b clinical data for pasritamig, a first-in-class bispecific antibody against KLK2, in combination with JNJ-9401 in patients with advanced prostate cancer who have progressed after multiple lines of therapy, during the second half of 2026. J&J increased the planned enrollment for its Phase 3 trial of pasritamig (JNJ-78278343) in combination with best supportive care in patients with late-line metastatic castration-resistant prostate cancer (mCRPC), from approximately 663 to 1,203 participants. The study is actively recruiting across 172 sites globally and is evaluating overall survival versus placebo, with median overall survival as the primary endpoint. The anticipated primary completion date is now estimated as December 2027, compared with the previously estimated May 2028 date (NCT07164443). Leveraging Partnerships and External Innovation The Company is advancing strategic initiatives to maximize the value of its proprietary Pan-RAS antibody-drug conjugate (ADC) platform, including evaluating the formation of a separate, dedicated entity with third-party capital participation. The Company expects to use third-party capital to advance multiple product candidates from the platform into clinical studies while retaining an equity interest and future economic participation, including potential royalties, subject to completion of a transaction. The Company has engaged MTS Healthcare to evaluate strategic partnering opportunities to fund further development for ZW191 with the objective of maximizing long-term value. The Company continues its evaluation of additional business development opportunities consistent with its capital allocation strategy. Expanding Revenue Diversification Proposed acquisition of Theravance Biopharma expected to be accretive to earnings and generate positive cash flow upon closing in 2H 2026. YUPELRI® U.S. profit share and ex-U.S. royalties expected to generate ~$60 million annualized cash flow at current run-rates, with continued expected growth. Proposed acquisition to add diversified assets beyond YUPELRI®, including additional royalty interests, milestone payments, an early-stage I&I portfolio, and $2.5 billion in Irish tax attributes, further strengthening both potential near-term cash flow generation and long-term development optionality. Transaction financed primarily by $350 million non-recourse note secured solely by U.S. YUPELRI® profit share from OMERS Life Sciences, and Theravance Biopharma’s expected net cash balance of $360 million at closing, with Zymeworks contributing the remainder of the purchase price in cash at closing. Zymeworks expects to receive $100 million in TRELEGY ELLIPTA® milestones in Q1 2027, assuming milestone conditions are met, in 2026, offsetting cash outlay. The anticipated closing of the acquisition is expected to support Zymeworks' transition to a diversified, revenue-generating business. Consistent with this evolution, the Company no longer intends to provide cash runway guidance, and expects to increasingly focus on providing guidance on operating performance and long-term growth. Advancing a Differentiated ADC Pipeline In June 2026, we presented new clinical data from the dose-escalation portion of the ongoing Phase 1 study evaluating ZW191, a folate receptor alpha-targeting antibody-drug conjugate, at the European Society for Medical Oncology Gynaecological Cancers Congress 2026. Among response-evaluable platinum-resistant ovarian cancer patients, ZW191 demonstrated a cORR of 78.6% in patients with FRα-positive tumors and 47.4% in patients with FRα-negative tumors across all dose levels. These findings demonstrate meaningful anti-tumor activity across both FRα-positive and FRα-negative tumors as well as in the overall population. We continue to recruit patients in an ongoing Phase 1b study of ZW251, a GPC3-targeting antibody-drug conjugate, for the treatment of patients with hepatocellular carcinoma, squamous non-small cell lung cancer and germ cell tumors. Maintaining Financial Flexibility Cash Resources: Zymeworks reported $322.5 million in cash, cash equivalents and marketable securities as of June 30, 2026 Share Repurchase Program: In May 2026, the Board of Directors authorized a 2026 share repurchase program under which the Company may repurchase up to $125.0 million of its outstanding common stock, par value $0.00001 per share. As of August 4, 2026, the Company has utilized approximately $49.4 million of this current approved repurchase program to acquire 1,971,454 shares at an average price of $25.04 per share (exclusive of commission expense and estimated excise tax). Since initiating its share repurchase program in August 2024, the Company has cumulatively utilized $213.6 million to reacquire 10,571,316 shares at an average price of $20.21 per share (exclusive of commission expense and estimated excise tax). As of August 4, 2026, the Company had approximately 71.0 million common shares outstanding. Operating Expense Discipline: The Company expects significant near-term milestones, including the anticipated closing of the Theravance Biopharma acquisition and the upcoming August 25, 2026 PDUFA date for zanidatamab in GEA, each of which has the potential to immediately expand the Company's revenue and cash flow profile, subject to customary closing conditions and regulatory approval, respectively. The Company continues to expect disciplined investment across research and development and general and administrative activities through the anticipated closing of the Theravance Biopharma acquisition. The Company's previously communicated operating expense framework was established prior to entering into the definitive acquisition agreement, and therefore does not reflect the expected operating profile of the combined organization. Subject to the successful completion of the transaction, the Company expects to provide an updated financial outlook following closing that reflects the combined business. Financial Results for the Quarter Ended June 30, 2026 The key financial highlights for our 2026 second quarter results are as follows: Revenue – Total revenue was $4.6 million in 2Q-2026, compared to $48.7 million for the same period in 2025. The decrease was driven mainly by absence of significant non-recurring collaboration revenue recognized in 2026, as well as continued declines in development support and drug supply revenue from Jazz. Revenue in the current‑year period reflects ongoing collaboration activity and increased royalty revenue, which is expected to grow over time as commercial sales of Ziihera® increase. Research and Development (R&D) Expenses – R&D expenses were $27.4 million in 2Q-2026, compared to $34.4 million for the same period in 2025, primarily reflecting reduced spending on later‑stage and discontinued programs, as well as an overall decrease in spending for earlier‑stage programs and research platforms. R&D expenses in 2Q-2026 were 20% lower than in 2Q-2025, consistent with our planned reduction in R&D expenses in 2026. General and Administrative (G&A) Expenses – G&A expenses were $19.3 million in 2Q-2026, compared to $15.0 million for the same period in 2025. The increase was primarily driven by higher non-cash stock-based compensation expense. This increase was partially offset by decrease in software amortization and software subscription expenses. Other Income, net – Net other expense was $3.1 million in 2Q-2026, compared to net other income of $2.8 million for the same period in 2025. The change was driven primarily by $6.6 million of interest expense related to the royalty-backed note financing arrangement with Royalty Pharma executed in March 2026. Net Loss – Net loss was $45.0 million in 2Q-2026, compared to a net income of $2.3 million for the same period in 2025. The change in 2026 was primarily due to a decrease in revenue, driven by the non-recurring clinical milestones earned in 2Q-2025 and interest expense related to the royalty-backed note financing arrangement with Royalty Pharma. This was partially offset by decrease in total operating expenses. Liquidity – As of June 30, 2026, we had $322.5 million of cash resources consisting of cash, cash equivalents and marketable securities, comprised of $179.4 million in cash and cash equivalents and $143.1 million in marketable securities. In light of the Company's expected transition to a revenue-generating business supported by multiple anticipated recurring cash flow streams, the Company no longer intends to provide cash runway guidance. Going forward, the Company expects to focus its financial outlook on metrics that more appropriately reflect the operating performance and growth of the business. About Zymeworks Inc. Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company’s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates, such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the development of innovative medicines. Zymeworks engineered and developed Ziihera, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology and has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zymeworks is rapidly advancing a robust pipeline of product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutics. These capabilities have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X. Non-GAAP Financial InformationZymeworks believes that the presentation of non-GAAP financial information provides important supplemental information to management and investors regarding financial and business trends relating to the Company’s financial condition and results of operations. Reconciliations of non-GAAP financial measures to the most directly comparable financial results as determined in accordance with GAAP are included at the end of this press release following the accompanying financial data. For further information regarding why Zymeworks believes that these non-GAAP measures provide useful information to investors and some of the limitations associated with the use of these measures, please refer to the “Explanation of Non-GAAP Financial Information” section at the end of this press release. Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities and the anticipated benefits thereof, including shareholder returns and the anticipated manner of such returns; implementation of its long-term strategy to maximize value creation; the anticipated benefits of its collaboration agreements, including Zymeworks’ ability to receive any future milestone payments and royalties thereunder; Zymeworks' ability to complete the proposed transaction with Theravance Biopharma; future growth of YUPELRI® sales and future royalty payments; contingent milestone payments due to Theravance Biopharma from the sale of Theravance Biopharma’s TRELEGY ELLIPTA® royalty interests; Zymeworks’ ability to execute the share repurchase program, in whole or in part; expected timing and amount of repurchases; the potential addressable market of zanidatamab and other product candidates; the timing of and results of interactions with regulators; Zymeworks’ and its partners’ clinical development of product candidates; the expected contributions of personnel to Zymeworks’ clinical development, strategic goals and long-term shareholder value for patients and shareholders; the timing and status of ongoing and future studies and the related data; potential safety profile and therapeutic effects of zanidatamab and Zymeworks’ other product candidates; the potential of ZW191 to be a best-in-class therapy; the commercial potential of technology platforms and product candidates; Zymeworks’ ability to satisfy potential regulatory and commercial milestones with existing and future partners; anticipated continued receipt of revenue from existing and future partners; Zymeworks’ ability to generate royalty revenue from Ziihera; Zymeworks’ ability to execute new collaborations and partnerships; Zymeworks’ early-stage pipeline; anticipated sufficiency of existing cash resources, when combined with the assumed receipt of certain anticipated regulatory milestone payments related to the potential approvals of Ziihera in GEA in the U.S., Europe, Japan, and China, and assuming the full execution of the $125.0 million share repurchase program, to fund Zymeworks’ planned operations beyond 2028 based on current operating plans; expected financial performance and future financial position, including anticipated adjusted gross operating expense (non-GAAP), adjusted research and development expense (non-GAAP) and adjusted general and administrative expense (non-GAAP) for the three-year period ending December 31, 2028, excluding any potential acquisition-related expenses or new partnerships and collaborations; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, “preserve”, “intend”, “could”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks and Theravance Biopharma may not be able to successfully execute the acquisition; uncertainties regarding the commercial success of YUPELRI® and TRELEGY ELLIPTA®; the anticipated benefits of the acquisition may not be realized or will not be realized within the expected time period; TRELEGY ELLIPTA® may not achieve anticipated sales resulting in sales milestones not being met; Zymeworks may not be able to successfully execute the share repurchase program; the anticipated benefits of the share repurchase program may not be realized; Zymeworks may not achieve milestones or receive additional payments or royalties under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab may not be successfully commercialized; Zymeworks’ business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ evolution of its business strategy may not deliver meaningful shareholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue-generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; data providing early validation of our antibody drug conjugate platform and next generation pipeline programs may not be replicated in future studies; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; the inability of Zymeworks to identify and consummate a strategic acquisition; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedarplus.ca). Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. ZYMEWORKS INC. Consolidated Statements of Loss and Comprehensive Loss (In thousands except share and per share data) ZYMEWORKS INC.Selected Consolidated Balance Sheet Data(In thousands) Explanation of Non-GAAP Financial Information In addition to reporting financial information in accordance with U.S. generally accepted accounting principles (GAAP) in this press release, we have elected to present selected non-GAAP, or adjusted, financial measures on a forward-looking basis. Zymeworks believes that estimated adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense, which are non-GAAP financial measures, may be helpful to investors because they provide consistency and comparability with financial performance across periods. These non-GAAP financial measures are not defined by GAAP and should not be considered as alternatives to operating expenses, research and development expenses, and general and administrative expenses or any other indicators of Zymeworks’ performance required to be reported under GAAP. In addition, other companies, including companies in Zymeworks’ industry, may calculate similarly titled non-GAAP or adjusted measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense as financial measures. Investors and others are encouraged to review Zymeworks’ financial information in its entirety and not rely on a single financial measure. As defined by Zymeworks, adjusted gross operating expense represents the aggregate of adjusted research and development expense and adjusted general and administrative expense, each of which excludes stock-based compensation expense for equity- and liability-classified equity instruments. Zymeworks excludes stock-based compensation expense, which is a non-cash expense, because Zymeworks believes that excluding this item provides meaningful supplemental information regarding operational performance. A reconciliation of historical adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense to the most directly comparable GAAP measures is set forth below. A reconciliation of anticipated adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense to the most directly comparable GAAP measures is not available without unreasonable effort due to the uncertainty of expenses that may be incurred in the future, and we are also unable to predict the probable significance of such adjusted measures. Accordingly, in reliance on the exception provided by Item 10(e)(1)(i)(B) of Regulation S-K, we have not provided a reconciliation for the adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense guidance provided in this press release. GAAP to Non-GAAP Reconciliations(In thousands)(unaudited) Contacts: Investor Inquiries:Shrinal InamdarVice President, Investor Relations(604) 678-1388 [email protected] Media Inquiries: Diana PapoveVice President, Corporate Communications(604) 678-1388 [email protected] A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/787f573b-920d-41e6-b487-e6d8add0c85c
Investor releaseQuarter not tagged2026-08-03Jazz Pharmaceuticals Q2 Earnings Call Highlights
MarketBeat
Jazz Pharmaceuticals Q2 Earnings Call Highlights
Interested in Jazz Pharmaceuticals PLC? Here are five stocks we like better. Jazz Pharmaceuticals reported record second-quarter revenue of $1.21 billion, up 16% year over year, and raised its 2026 revenue outlook to $4.60 billion–$4.75 billion. Growth was led by sleep and epilepsy products: XYWAV sales rose 13% to $471 million, Epidiolex sales increased 16% to $292 million, and Jazz now expects double-digit full-year XYWAV growth. Oncology momentum continued, with portfolio sales up 32%; Jazz is awaiting an FDA decision by Aug. 25 on zanidatamab for first-line HER2-positive metastatic GEA and remains confident in approval. Zymeworks Offers Hope for More than Just Long-Term Investors Jazz Pharmaceuticals (NASDAQ:JAZZ) reported second-quarter 2026 revenue of $1.21 billion, up 16% from a year earlier, as growth across its sleep, epilepsy and oncology portfolios drove record quarterly sales. The company raised its full-year revenue outlook and said it is preparing for a potential August approval and launch of zanidatamab in first-line HER2-positive metastatic gastroesophageal adenocarcinoma, or GEA. President and Chief Executive Officer Renee Gala said the company’s first-half performance reflected demand for its commercial medicines, coordinated execution across its portfolio and progress on long-term growth initiatives. Jazz now expects 2026 total revenue of $4.60 billion to $4.75 billion. → Lost in Space: Why Aerospace Valuations Are Plummeting Right Now Top Marijuana Stocks: Plenty of Investment Opportunities Abound (You're not Late to the Game) “The momentum we’ve built in the first half of the year provides us with confidence to raise our full-year revenue guidance,” Gala said. XYWAV, Jazz’s low-sodium oxybate therapy for narcolepsy and idiopathic hypersomnia, generated $471 million in second-quarter net product sales, an increase of 13% year over year. Chief Commercial Officer Sam Pearce said the medicine added approximately 525 net patients during the quarter, bringing total active patients to about 17,125, up more than 12% from a year earlier. → MarketBeat Week in Review – 07/27- 07/31 Of the quarterly patient additions, approximately 200 were in narcolepsy and 325 were in idiopathic hypersomnia, according to Pearce. He said demand remained strong and that high-sodium generic oxybate products had so far had limited effect on the franchise. Chief Financ…Read full documentShow less
Interested in Jazz Pharmaceuticals PLC? Here are five stocks we like better. Jazz Pharmaceuticals reported record second-quarter revenue of $1.21 billion, up 16% year over year, and raised its 2026 revenue outlook to $4.60 billion–$4.75 billion. Growth was led by sleep and epilepsy products: XYWAV sales rose 13% to $471 million, Epidiolex sales increased 16% to $292 million, and Jazz now expects double-digit full-year XYWAV growth. Oncology momentum continued, with portfolio sales up 32%; Jazz is awaiting an FDA decision by Aug. 25 on zanidatamab for first-line HER2-positive metastatic GEA and remains confident in approval. Zymeworks Offers Hope for More than Just Long-Term Investors Jazz Pharmaceuticals (NASDAQ:JAZZ) reported second-quarter 2026 revenue of $1.21 billion, up 16% from a year earlier, as growth across its sleep, epilepsy and oncology portfolios drove record quarterly sales. The company raised its full-year revenue outlook and said it is preparing for a potential August approval and launch of zanidatamab in first-line HER2-positive metastatic gastroesophageal adenocarcinoma, or GEA. President and Chief Executive Officer Renee Gala said the company’s first-half performance reflected demand for its commercial medicines, coordinated execution across its portfolio and progress on long-term growth initiatives. Jazz now expects 2026 total revenue of $4.60 billion to $4.75 billion. → Lost in Space: Why Aerospace Valuations Are Plummeting Right Now Top Marijuana Stocks: Plenty of Investment Opportunities Abound (You're not Late to the Game) “The momentum we’ve built in the first half of the year provides us with confidence to raise our full-year revenue guidance,” Gala said. XYWAV, Jazz’s low-sodium oxybate therapy for narcolepsy and idiopathic hypersomnia, generated $471 million in second-quarter net product sales, an increase of 13% year over year. Chief Commercial Officer Sam Pearce said the medicine added approximately 525 net patients during the quarter, bringing total active patients to about 17,125, up more than 12% from a year earlier. → MarketBeat Week in Review – 07/27- 07/31 Of the quarterly patient additions, approximately 200 were in narcolepsy and 325 were in idiopathic hypersomnia, according to Pearce. He said demand remained strong and that high-sodium generic oxybate products had so far had limited effect on the franchise. Chief Financial Officer Phil Johnson said Jazz now expects double-digit XYWAV growth for the full year, compared with its prior expectation for results ranging from flat to mid-single-digit growth. The revised outlook reflects slower-than-anticipated uptake of high-sodium generics, he said. → GE HealthCare Stock Climbs on Vital Diagnostics Demand Jazz raised its rare sleep revenue outlook to a range of $2.025 billion to $2.125 billion for 2026. The company said it continues to invest in digital outreach, media spending and patient-support programs for XYWAV. Epidiolex reported net product sales of $292 million, up 16% year over year. Pearce attributed the increase primarily to underlying demand in pediatric and adult settings, including continued growth in long-term care. He said there were no significant unusual U.S. inventory movements during the quarter, though Johnson noted that comparisons with the prior-year period benefited from one-time ex-U.S. pricing adjustments and foreign-exchange effects. Jazz has submitted a new drug application to the Food and Drug Administration for a capsule formulation of Epidiolex for its currently approved indications: Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex. The company also plans new studies in adult Lennox-Gastaut syndrome, developmental and epileptic encephalopathies, and juvenile myoclonic epilepsy. Jazz’s oncology portfolio grew 32% year over year in the quarter. Zepzelca generated $106 million in net product sales, up 42%, while Modeyso contributed $48 million and Ziihera recorded $15 million. Pearce said Zepzelca’s growth was driven by adoption in the first-line maintenance setting for metastatic small cell lung cancer, which offset a declining second-line business. Jazz estimates that first-line maintenance now accounts for 30% to 40% of overall U.S. Zepzelca sales. Robert Iannone, Global Head of R&D and Chief Medical Officer, said Jazz plans to submit a labeling supplement to remove Zepzelca’s second-line indication during the third quarter, based on results from the LAGOON trial and discussions with the FDA. The first-line maintenance indication will not be affected. Modeyso, launched in August 2025, had treated more than 600 patients through the end of the second quarter, according to Pearce. Jazz expects the overall-survival interim analysis for its Phase III ACTION trial of Modeyso to occur in the first half of 2027. Ziihera, Jazz’s zanidatamab product, has achieved more than 50% of the addressable U.S. market in second-line biliary tract cancer since launch, Pearce said. The company is awaiting an FDA decision by its Aug. 25 Prescription Drug User Fee Act date for zanidatamab in first-line HER2-positive metastatic GEA. Iannone said Jazz had been “productively engaged” with the FDA and remained highly confident in approval on or before the PDUFA date. He also said the company expects results from a second interim overall-survival analysis of zanidatamab plus chemotherapy in the third quarter. Jazz cited published Phase III HERIZON-GEA-01 results showing median overall survival of 26.4 months for zanidatamab plus tislelizumab and chemotherapy, more than seven months longer than the trastuzumab control arm. The company said it has submitted the data to oncology pathways and the National Comprehensive Cancer Network for potential guideline consideration. Johnson said non-GAAP adjusted gross margin declined slightly year over year because Zepzelca and Modeyso carry third-party royalties. Non-GAAP adjusted selling, general and administrative expenses and research and development expenses each rose 11%, reflecting commercial investments, clinical trial costs and zanidatamab-related spending. Jazz reported non-GAAP adjusted earnings per share of $5.71 for the quarter, including $0.94 in in-process research-and-development charges. Operating cash flow totaled $824 million for the first half of 2026, and the company paid off its 2026 convertible notes during the second quarter. The company modestly increased its SG&A expense guidance to support investment in XYWAV, Epidiolex, its rare-disease strategy and business-development activities. Gala said Jazz expects to announce one or more business-development deals in 2026, spanning opportunities from preclinical programs to commercial or near-commercial assets. Jazz recently entered a preclinical collaboration with AbCellera focused on discovering multispecific antibodies using a T-cell engager platform. Gala said the agreement complements Jazz’s oncology capabilities and its refined rare-disease strategy. Jazz Pharmaceuticals plc is a global biopharmaceutical company focused on developing and commercializing therapies in neuroscience and oncology. The company's research and development efforts target unmet medical needs in sleep disorders, hematologic malignancies, rare neurological conditions and solid tumors. Jazz's product portfolio includes therapies for narcolepsy, hepatic veno-occlusive disease, acute myeloid leukemia and other serious disorders. Flagship products from Jazz Pharmaceuticals include Xyrem® (sodium oxybate) and Xywav® (calcium, magnesium, potassium, and sodium oxybates) for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Jazz Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
Investor releaseQuarter not tagged2026-07-16Zymeworks to Report Second Quarter 2026 Financial Results on August 6, 2026
GlobeNewswire
Zymeworks to Report Second Quarter 2026 Financial Results on August 6, 2026
VANCOUVER, British Columbia, July 16, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced that management will report its second quarter 2026 financial results after market close on August 6, 2026. In light of the previously announced proposed acquisition of Theravance Biopharma, Zymeworks has elected not to host a second quarter earnings conference call after release of its financial results. We look forward to providing an update following the expected closing of the proposed acquisition of Theravance Biopharma, sharing greater visibility into the combined business and its strategic priorities. About Zymeworks Inc. Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks’ asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates, such as pasritamig. In addition, Zymeworks is building a portfolio of healthcare assets that can generate strong cash flows, while supporting the development of innovative medicines. Zymeworks engineered and developed Ziihera, a HER2-targeted bispecific antibody using Zymeworks’ proprietary Azymetric™ technology and has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zymeworks is rapidly advancing a robust pipeline of product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Zymeworks’ complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutics. These capabilities have been further leveraged through strategic partne…Read full documentShow less
VANCOUVER, British Columbia, July 16, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced that management will report its second quarter 2026 financial results after market close on August 6, 2026. In light of the previously announced proposed acquisition of Theravance Biopharma, Zymeworks has elected not to host a second quarter earnings conference call after release of its financial results. We look forward to providing an update following the expected closing of the proposed acquisition of Theravance Biopharma, sharing greater visibility into the combined business and its strategic priorities. About Zymeworks Inc. Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks’ asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates, such as pasritamig. In addition, Zymeworks is building a portfolio of healthcare assets that can generate strong cash flows, while supporting the development of innovative medicines. Zymeworks engineered and developed Ziihera, a HER2-targeted bispecific antibody using Zymeworks’ proprietary Azymetric™ technology and has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zymeworks is rapidly advancing a robust pipeline of product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Zymeworks’ complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutics. These capabilities have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X. Contacts: Investor Inquiries:Shrinal InamdarVice President, Investor Relations(604) [email protected] Media Inquiries:Diana PapoveVice President, Corporate Communications(604) [email protected]
Investor releaseQuarter not tagged2026-05-11Here's What Analysts Are Forecasting For Zymeworks Inc. (NASDAQ:ZYME) After Its First-Quarter Results
Simply Wall St.
Here's What Analysts Are Forecasting For Zymeworks Inc. (NASDAQ:ZYME) After Its First-Quarter Results
It's shaping up to be a tough period for Zymeworks Inc. (NASDAQ:ZYME), which a week ago released some disappointing quarterly results that could have a notable impact on how the market views the stock. It was not a great statutory result, with revenues coming in 93% lower than the analysts predicted. Unsurprisingly, earnings also fell seriously short of forecasts, turning into a per-share loss of US$0.59. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. We thought readers would find it interesting to see the analysts latest (statutory) post-earnings forecasts for next year. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Taking into account the latest results, the most recent consensus for Zymeworks from eleven analysts is for revenues of US$299.8m in 2026. If met, it would imply a sizeable 269% increase on its revenue over the past 12 months. Earnings are expected to improve, with Zymeworks forecast to report a statutory profit of US$1.03 per share. Yet prior to the latest earnings, the analysts had been anticipated revenues of US$298.3m and earnings per share (EPS) of US$1.20 in 2026. The analysts seem to have become more bearish following the latest results. While there were no changes to revenue forecasts, there was a substantial drop in EPS estimates. See our latest analysis for Zymeworks It might be a surprise to learn that the consensus price target was broadly unchanged at US$40.15, with the analysts clearly implying that the forecast decline in earnings is not expected to have much of an impact on valuation. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. There are some variant perceptions on Zymeworks, with the most bullish analyst valuing it at US$58.00 and the most bearish at US$31.00 per share. This is a fairly broad spread of estimates, suggesting that analysts are forecasting a wide range of possible outcomes for the business. Taking a look at the bigger picture now, one of the ways…Read full documentShow less
It's shaping up to be a tough period for Zymeworks Inc. (NASDAQ:ZYME), which a week ago released some disappointing quarterly results that could have a notable impact on how the market views the stock. It was not a great statutory result, with revenues coming in 93% lower than the analysts predicted. Unsurprisingly, earnings also fell seriously short of forecasts, turning into a per-share loss of US$0.59. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. We thought readers would find it interesting to see the analysts latest (statutory) post-earnings forecasts for next year. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Taking into account the latest results, the most recent consensus for Zymeworks from eleven analysts is for revenues of US$299.8m in 2026. If met, it would imply a sizeable 269% increase on its revenue over the past 12 months. Earnings are expected to improve, with Zymeworks forecast to report a statutory profit of US$1.03 per share. Yet prior to the latest earnings, the analysts had been anticipated revenues of US$298.3m and earnings per share (EPS) of US$1.20 in 2026. The analysts seem to have become more bearish following the latest results. While there were no changes to revenue forecasts, there was a substantial drop in EPS estimates. See our latest analysis for Zymeworks It might be a surprise to learn that the consensus price target was broadly unchanged at US$40.15, with the analysts clearly implying that the forecast decline in earnings is not expected to have much of an impact on valuation. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. There are some variant perceptions on Zymeworks, with the most bullish analyst valuing it at US$58.00 and the most bearish at US$31.00 per share. This is a fairly broad spread of estimates, suggesting that analysts are forecasting a wide range of possible outcomes for the business. Taking a look at the bigger picture now, one of the ways we can understand these forecasts is to see how they compare to both past performance and industry growth estimates. It's clear from the latest estimates that Zymeworks' rate of growth is expected to accelerate meaningfully, with the forecast 5x annualised revenue growth to the end of 2026 noticeably faster than its historical growth of 5.3% p.a. over the past five years. Compare this with other companies in the same industry, which are forecast to grow their revenue 22% annually. It seems obvious that, while the growth outlook is brighter than the recent past, the analysts also expect Zymeworks to grow faster than the wider industry. The most important thing to take away is that the analysts downgraded their earnings per share estimates, showing that there has been a clear decline in sentiment following these results. Fortunately, they also reconfirmed their revenue numbers, suggesting that it's tracking in line with expectations. Additionally, our data suggests that revenue is expected to grow faster than the wider industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates. Keeping that in mind, we still think that the longer term trajectory of the business is much more important for investors to consider. We have estimates - from multiple Zymeworks analysts - going out to 2028, and you can see them free on our platform here. Another thing to consider is whether management and directors have been buying or selling stock recently. We provide an overview of all open market stock trades for the last twelve months on our platform, here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.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.
Investor releaseQuarter not tagged2026-05-09A Look At Zymeworks (ZYME) Valuation After Earnings Miss And Key FDA And Capital Return Updates
Simply Wall St.
A Look At Zymeworks (ZYME) Valuation After Earnings Miss And Key FDA And Capital Return Updates
Get insights on thousands of stocks from the global community of over 7 million individual investors at Simply Wall St. Zymeworks (ZYME) just posted a wider quarterly loss and lower than expected revenue, while also highlighting upcoming FDA and pipeline milestones that could shape how you think about the stock over the next year. See our latest analysis for Zymeworks. The earnings miss helped drive a 1 day share price return of 3.66% decline and a 7 day share price return of 3.41% decline, yet the 90 day share price return of 17.08% and 1 year total shareholder return of very large suggest momentum has been building over a longer stretch. If this kind of earnings driven move has your attention, it could be a good moment to look at other biotech ideas powered by AI through the 35 healthcare AI stocks. With shares up 17.08% over 90 days and a very large 1 year total return, yet still trading below some estimated value markers, the real question is whether Zymeworks is still mispriced or if the market is already accounting for future growth. The most followed narrative pegs Zymeworks' fair value at $40.08 versus a last close of $26.60, framing the stock as materially discounted on that view. Read the complete narrative. Curious what has to happen for that gap to close? The narrative leans on fast improving earnings, richer margins, and a premium future profit multiple. The exact mix of growth, dilution and discount rate assumptions might surprise you. Result: Fair Value of $40.08 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this depends on partners meeting clinical and regulatory milestones on schedule, and on early stage pipeline assets avoiding setbacks that could disrupt expected royalty streams. Find out about the key risks to this Zymeworks narrative. With that optimism in mind, do not just rely on headlines or a single narrative; move quickly, review the details, and see what stands out in the 3 key rewards If Zymeworks is on your radar, do not stop there. Broaden your watchlist with other ideas that match your goals and risk comfort. Target quality at a discount by scanning for companies flagged as potential bargains using the 51 high quality undervalued stocks. Protect your downside by focusing on businesses with stronger finances through the solid balance sheet and fundamentals stocks scree…Read full documentShow less
Get insights on thousands of stocks from the global community of over 7 million individual investors at Simply Wall St. Zymeworks (ZYME) just posted a wider quarterly loss and lower than expected revenue, while also highlighting upcoming FDA and pipeline milestones that could shape how you think about the stock over the next year. See our latest analysis for Zymeworks. The earnings miss helped drive a 1 day share price return of 3.66% decline and a 7 day share price return of 3.41% decline, yet the 90 day share price return of 17.08% and 1 year total shareholder return of very large suggest momentum has been building over a longer stretch. If this kind of earnings driven move has your attention, it could be a good moment to look at other biotech ideas powered by AI through the 35 healthcare AI stocks. With shares up 17.08% over 90 days and a very large 1 year total return, yet still trading below some estimated value markers, the real question is whether Zymeworks is still mispriced or if the market is already accounting for future growth. The most followed narrative pegs Zymeworks' fair value at $40.08 versus a last close of $26.60, framing the stock as materially discounted on that view. Read the complete narrative. Curious what has to happen for that gap to close? The narrative leans on fast improving earnings, richer margins, and a premium future profit multiple. The exact mix of growth, dilution and discount rate assumptions might surprise you. Result: Fair Value of $40.08 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this depends on partners meeting clinical and regulatory milestones on schedule, and on early stage pipeline assets avoiding setbacks that could disrupt expected royalty streams. Find out about the key risks to this Zymeworks narrative. With that optimism in mind, do not just rely on headlines or a single narrative; move quickly, review the details, and see what stands out in the 3 key rewards If Zymeworks is on your radar, do not stop there. Broaden your watchlist with other ideas that match your goals and risk comfort. Target quality at a discount by scanning for companies flagged as potential bargains using the 51 high quality undervalued stocks. Protect your downside by focusing on businesses with stronger finances through the solid balance sheet and fundamentals stocks screener (44 results). Get ahead of the crowd by searching for lesser known opportunities in the screener containing 23 high quality undiscovered gems. 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 ZYME. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-05-09Zymeworks Q1 Earnings Call Highlights
MarketBeat
Zymeworks Q1 Earnings Call Highlights
Interested in Zymeworks Inc.? Here are five stocks we like better. Zanidatamab is approaching key regulatory milestones, including a U.S. PDUFA date of Aug. 25, 2026, and a China sBLA filing completion, which could unlock $250 million from Jazz and $50 million from BeOne in milestone payments. Zymeworks posted a wider Q1 net loss of $44.2 million as revenue fell to $2.4 million from $27.1 million a year earlier, mainly because prior-year milestone payments did not repeat. Despite that, the company ended the quarter with $403.8 million in cash resources and said it expects funding beyond 2028, even assuming full share buybacks. The company highlighted progress in its pipeline, including encouraging AACR data for ZW191 in ovarian and endometrial cancers and new preclinical pan-RAS ADC candidates. Zymeworks also pushed the expected IND for ZW1528 to 2027 while keeping ZW209 on track as a possible 2026 IND. Zymeworks Offers Hope for More than Just Long-Term Investors Zymeworks (NASDAQ:ZYME) reported a wider first-quarter loss as revenue declined from year-earlier milestone payments, while management highlighted regulatory catalysts for zanidatamab, progress across its antibody-drug conjugate pipeline and continued share repurchases. Chair and CEO Ken Galbraith said the company sees the Aug. 25, 2026, PDUFA date for zanidatamab in first-line HER2-positive gastroesophageal adenocarcinoma, or GEA, in the U.S. and the completion of an sBLA filing in China as “an important inflection point” for the company. Zanidatamab is partnered with Jazz Pharmaceuticals and BeOne. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Galbraith said potential approvals could trigger near-term milestone payments of $250 million from Jazz upon U.S. approval in GEA and $50 million from BeOne upon approval in China. He said Zymeworks also expects potential royalties from commercialization, while zanidatamab continues to be studied in additional settings, including breast cancer. CFO Kristin Stafford said total revenue was $2.4 million for the quarter ended March 31, 2026, compared with $27.1 million in the same period of 2025. The decline was driven mainly by non-recurring clinical milestones achieved in 2025 and lower development support and drug supply revenue. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Operating expenses totaled $49.5 million, down from…Read full documentShow less
Interested in Zymeworks Inc.? Here are five stocks we like better. Zanidatamab is approaching key regulatory milestones, including a U.S. PDUFA date of Aug. 25, 2026, and a China sBLA filing completion, which could unlock $250 million from Jazz and $50 million from BeOne in milestone payments. Zymeworks posted a wider Q1 net loss of $44.2 million as revenue fell to $2.4 million from $27.1 million a year earlier, mainly because prior-year milestone payments did not repeat. Despite that, the company ended the quarter with $403.8 million in cash resources and said it expects funding beyond 2028, even assuming full share buybacks. The company highlighted progress in its pipeline, including encouraging AACR data for ZW191 in ovarian and endometrial cancers and new preclinical pan-RAS ADC candidates. Zymeworks also pushed the expected IND for ZW1528 to 2027 while keeping ZW209 on track as a possible 2026 IND. Zymeworks Offers Hope for More than Just Long-Term Investors Zymeworks (NASDAQ:ZYME) reported a wider first-quarter loss as revenue declined from year-earlier milestone payments, while management highlighted regulatory catalysts for zanidatamab, progress across its antibody-drug conjugate pipeline and continued share repurchases. Chair and CEO Ken Galbraith said the company sees the Aug. 25, 2026, PDUFA date for zanidatamab in first-line HER2-positive gastroesophageal adenocarcinoma, or GEA, in the U.S. and the completion of an sBLA filing in China as “an important inflection point” for the company. Zanidatamab is partnered with Jazz Pharmaceuticals and BeOne. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Galbraith said potential approvals could trigger near-term milestone payments of $250 million from Jazz upon U.S. approval in GEA and $50 million from BeOne upon approval in China. He said Zymeworks also expects potential royalties from commercialization, while zanidatamab continues to be studied in additional settings, including breast cancer. CFO Kristin Stafford said total revenue was $2.4 million for the quarter ended March 31, 2026, compared with $27.1 million in the same period of 2025. The decline was driven mainly by non-recurring clinical milestones achieved in 2025 and lower development support and drug supply revenue. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Operating expenses totaled $49.5 million, down from $52.7 million a year earlier. Stafford said lower research and development expenses reflected reduced activity on later-stage and discontinued programs, partly offset by higher investment in early-stage clinical and preclinical programs and leadership transition costs. General and administrative expenses decreased due to lower professional fees, consulting and information technology-related costs, partly offset by higher salaries and benefits. Zymeworks reported a net loss of $44.2 million, compared with a net loss of $22.6 million in the prior-year period. Stafford attributed the year-over-year change primarily to the lower revenue from the absence of the 2025 milestones. → Years in the Making, AMD’s Upside Movement Has Just Begun The company ended the quarter with $403.8 million in cash resources, including cash equivalents and marketable securities, up from $270.6 million at Dec. 31, 2025. Stafford said that, based on current plans and assuming full execution of the company’s $125 million share repurchase program, Zymeworks expects existing cash resources plus anticipated regulatory milestone payments of $440 million tied to potential approvals of Ziihera in GEA in the U.S., Europe, Japan and China to fund planned operations beyond 2028. Stafford said that as of May 6, Zymeworks had used approximately $95.8 million of its approved $125 million repurchase program to acquire 3,930,734 shares at an average price of $24.37 per share, excluding commission expense and estimated excise tax. The company had approximately 73 million common shares outstanding as of that date. Galbraith said that since initiating its share repurchase program in 2024, Zymeworks has retired approximately 8.3 million shares through roughly $155.8 million in capital deployment at a weighted average repurchase price of about $18.70 per share. He said that represented more than 10% of common shares outstanding. Chief Scientific Officer Paul Moore said Zymeworks presented six posters, an oral presentation for ZW191 and two invited talks at the American Association for Cancer Research annual meeting. He focused on the company’s newly disclosed pan-RAS ADC platform, which includes three preclinical candidates using proprietary payloads. Moore said Zymeworks generated and screened more than 117 novel pan-RAS inhibitors derived from in-house scaffold work. He said the company prioritized ADC-suitable properties including efficacy in xenograft models, pharmacokinetics, bystander activity and tolerability. The company’s disclosed pan-RAS ADC candidates include: ZW439, a Claudin 18.2-targeting pan-RAS inhibitor ADC for RAS-mutated pancreatic cancer. ZW427, a Ly6E-targeting ADC for RAS-mutated cancers including colorectal, pancreatic and non-small cell lung cancer. ZW418, a biparatopic PTK7-targeting ADC for non-small cell lung cancer. Moore said the lead payload candidate, evaluated in a Ly6E pan-RAS ADC, showed no observed body weight loss, skin toxicity or gastrointestinal toxicity in non-human primates at doses up to 120 mg/kg, the maximum dose tested. He said a single dose in a mouse xenograft model produced sustained accumulation of the RAS payload in tumors compared with normal organs and durable RAS pathway inhibition in tumors out to 14 days. During the question-and-answer session, Moore said the pan-RAS ADCs are positioned to enter IND-enabling work, though the timing of clinical entry will depend in part on internal development priorities and potential partnerships. Chief Medical Officer Sabeen Mekan said ZW191 showed antitumor activity in data presented at AACR across ovarian and endometrial cancers. In ovarian cancer, she said tumor regression of at least 30% was observed in 68% of patients, with some degree of tumor shrinkage in 85%. Disease control was achieved in 94%, with an overall response rate of 56% across dose levels. In the clinically relevant 6.4 mg/kg to 9.6 mg/kg dose range, Mekan said disease control was observed in all ovarian cancer patients, with a confirmed overall response rate of 61%. She described the ovarian cohort as heavily pretreated, with all patients resistant to prior platinum therapy and most previously exposed to PARP inhibitors. In relapsed or refractory endometrial cancer, Mekan said tumor regression of at least 30% was observed in 50% of patients, and 70% had some degree of tumor shrinkage. Disease control was 80%, with an overall response rate of 40% across dose levels. At the 6.4 mg/kg to 9.6 mg/kg range, the overall response rate rose to 57%, with disease control in 86% of patients. Mekan said activity was seen regardless of folate receptor alpha expression level, including in low or negative tumors. She said safety findings mainly consisted of manageable cytopenias and gastrointestinal events, with no unexpected or new safety signals observed with longer follow-up. A roughly 60-patient dose optimization cohort is fully enrolled, and the company plans to present additional folate receptor alpha expression analyses at ESMO Gynae in June. Mekan said Zymeworks updated the ongoing ZW251 phase 1 trial to explore additional tumor types beyond hepatocellular carcinoma, including squamous non-small cell lung cancer and germ cell tumors, based on GPC3 expression. She said the trial continues to recruit on schedule, with clinical data expected at a future medical meeting when appropriate. Galbraith also said the company now expects an IND in 2027 for ZW1528, compared with its prior expectation of 2026. He said Zymeworks is taking more time to evaluate IL-33 biology and refine the clinical development strategy as recent clinical data in the field are presented. Galbraith said the core preclinical package, including GLP toxicology, is largely complete. Galbraith said ZW209 remains IND-ready and is still maintained as a potential IND in 2026. He added that Zymeworks continues to evaluate partnerships, collaborations and acquisitions while maintaining a disciplined capital allocation framework. Zymeworks Inc is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics. The company specializes in engineered antibody and protein therapeutics designed to address a range of unmet medical needs in oncology and other serious diseases. Through its proprietary platforms, Zymeworks aims to create novel bispecific and multispecific molecules that can simultaneously engage multiple targets and recruit immune effector functions to enhance potency and specificity. At the core of Zymeworks' innovation is its Azymetric™ bispecific antibody platform, which enables the design of asymmetrical bispecific antibodies with controlled assembly and high stability. The article "Zymeworks Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.
Investor releaseQuarter not tagged2026-05-08Zymeworks Provides Corporate Update and Reports First Quarter 2026 Financial Results
GlobeNewswire
Zymeworks Provides Corporate Update and Reports First Quarter 2026 Financial Results
Jazz announced U.S. FDA acceptance with Priority Review of Supplemental Biologics License Application (sBLA) for zanidatamab in first-line HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA); PDUFA target action date of August 25, 2026 China’s NMPA has accepted the sBLA for zanidatamab; the U.S. FDA has granted Breakthrough Therapy Designation to zanidatamab in combination with fluoropyrimidine- and platinum-based chemotherapy (±) TEVIMBRA, for this indication. Presented new data from our Phase 1 trial of ZW191 at AACR, continuing to support best-in-class potential in ovarian and endometrial cancers Presented on emerging RAS inhibitor antibody-drug conjugate platform at AACR $95.8 million utilized for share repurchases as of May 6, 2026 under the current authorized share repurchase program Reported $403.8 million in cash, cash equivalents and marketable securities as of March 31, 2026 Conference call with management today at 4:30 p.m. Eastern Time (ET) VANCOUVER, British Columbia, May 07, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, today reported financial results for the first quarter March 31, 2026 and provided a summary of recent business highlights. “Having a U.S. PDUFA date established under priority review by the FDA for zanidatamab for the treatment of first-line HER2-positive advanced GEA, represents a significant regulatory and strategic milestone for Zymeworks. Zanidatamab's progress across additional clinical indications continues to highlight the value of our strategy to accumulate long-term cash flows from differentiated assets, whether generated internally or externally, with meaningful clinical and commercial potential. Pending global approvals in GEA, we expect zanidatamab to contribute significant milestone payments and to generate long-term, high-quality royalty revenues,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “Over the past quarter, we have further strengthened our leadership team with the addition of individuals bringing extensive experience in strategic capital allocation, investment execution, and deal-making, enhancing our ability to identify and maximize value for our emerging royalty and R&D p…Read full documentShow less
Jazz announced U.S. FDA acceptance with Priority Review of Supplemental Biologics License Application (sBLA) for zanidatamab in first-line HER2-positive unresectable locally advanced or metastatic gastroesophageal adenocarcinoma (GEA); PDUFA target action date of August 25, 2026 China’s NMPA has accepted the sBLA for zanidatamab; the U.S. FDA has granted Breakthrough Therapy Designation to zanidatamab in combination with fluoropyrimidine- and platinum-based chemotherapy (±) TEVIMBRA, for this indication. Presented new data from our Phase 1 trial of ZW191 at AACR, continuing to support best-in-class potential in ovarian and endometrial cancers Presented on emerging RAS inhibitor antibody-drug conjugate platform at AACR $95.8 million utilized for share repurchases as of May 6, 2026 under the current authorized share repurchase program Reported $403.8 million in cash, cash equivalents and marketable securities as of March 31, 2026 Conference call with management today at 4:30 p.m. Eastern Time (ET) VANCOUVER, British Columbia, May 07, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, today reported financial results for the first quarter March 31, 2026 and provided a summary of recent business highlights. “Having a U.S. PDUFA date established under priority review by the FDA for zanidatamab for the treatment of first-line HER2-positive advanced GEA, represents a significant regulatory and strategic milestone for Zymeworks. Zanidatamab's progress across additional clinical indications continues to highlight the value of our strategy to accumulate long-term cash flows from differentiated assets, whether generated internally or externally, with meaningful clinical and commercial potential. Pending global approvals in GEA, we expect zanidatamab to contribute significant milestone payments and to generate long-term, high-quality royalty revenues,” said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. “Over the past quarter, we have further strengthened our leadership team with the addition of individuals bringing extensive experience in strategic capital allocation, investment execution, and deal-making, enhancing our ability to identify and maximize value for our emerging royalty and R&D portfolios. We look forward to the potential of bringing an important new therapy to patients.” Recent Developments Wholly-Owned Programs In April 2026, we shared new preclinical and clinical data at the American Association for Cancer Research (AACR) Annual Meeting. Presentations included new preclinical combination insights from ZW191, as well as additional clinical data from Part 1 of our Phase 1 trial of ZW191: In Part 1 of our Phase 1 trial of ZW191 in platinum resistant ovarian cancer (PROC) patients, ZW191 demonstrated a confirmed objective response rate of 56% across all dose levels, with tumor regression observed in 68% of patients and disease control achieved in 94%. Notably, ZW191 demonstrated compelling efficacy in the 6.4-9.6 mg/kg dose range regardless of FRα expression, with confirmed objective response rates of 61% observed in both ovarian and 57% in endometrial cancers, with disease control observed in 100% of patients, and no new safety signals. These findings highlight the potential for ZW191 to benefit a broad patient population, including those with low or heterogeneous target expression. In March 2026, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW191, for the treatment of patients with advanced or metastatic PROC. Part 2 of our Phase 1 study evaluating both 6.4 mg/kg and 9.6 mg/kg dose regimens in PROC is fully-enrolled with 60 total patients and remains ongoing. ZW191’s differentiated clinical profile in nonclinical studies, including favorable tolerability, bodes well for combination strategies including chemotherapy, targeted therapies, and immunotherapies that are mechanistically supported by preclinical studies. At AACR, we also presented preclinical data from our emerging RAS inhibitor antibody-drug conjugate (ADC) platform and three novel candidates designed to target treatment of RAS mutated cancers: A pan-RASi ADC platform with high anti-tumor activity against RAS-driven cancers ZW418, a biparatopic PTK7-targeting ADC incorporating a novel pan-RAS inhibitor payload for the treatment of non-small cell lung cancer (NSCLC) ZW427, a Ly6E-targeting ADC bearing a novel pan-RAS inhibitor payload for the treatment of RAS mutated cancers including colorectal, pancreatic, and NSCLC ZW439, a novel CLDN18.2-targeting pan-RAS inhibitor ADC for the treatment of RAS mutated pancreatic cancer “At AACR, our team presented three posters highlighting novel preclinical RAS-targeting ADC candidates, demonstrating the breadth of our capabilities in antibody engineering, linker chemistry, and the development of new proprietary payloads. These programs reflect a modular, highly tunable platform designed to address historically challenging targets. In parallel, updated Phase 1 data for ZW191 continue to reinforce the differentiated profile we have seen to date, with breadth and durability of responses, along with activity across varying levels of FRα expression, that we believe position ZW191 as a potential best-in-class therapy,” stated Adam Schayowitz, Ph.D., MBA., Head of R&D at Zymeworks. “Taken together, these data reflect the strength and scalability of our ADC platform and open up a range of future opportunities for both our ADC platforms and product candidates.” Partnered Programs Zanidatamab In April 2026, the U.S. FDA accepted our partner Jazz’s sBLA filing for Ziihera® (zanidatamab-hrii) combinations for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or GEA for priority review with a PDUFA date of August 25, 2026. Pending approval, Jazz expects to commercially launch zanidatamab in the U.S. in this indication. Zymeworks is entitled to receive a $250.0 million milestone payment from Jazz related to approval of Ziihera in GEA in the United States. In April 2026, BeOne announced that the U.S. FDA has granted Priority Review to a sBLA for TEVIMBRA® (tislelizumab) in combination with Ziihera and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma. In April 2026, BeOne also received acceptance for the filing of the sBLA for zanidatamab by the Center for Drug Evaluation of the China National Medical Products Administration (NMPA) to seek approval for zanidatamab for the first-line treatment for HER2+ locally advanced or metastatic GEA, including cancers of the stomach, gastroesophageal junction, and esophagus. BeOne has also received filing acceptance for an sBLA for tislelizumab by the CDE in China based on the HERIZON-GEA-01 data. Zymeworks is entitled to receive a $15.0 million milestone payment from BeOne related to approval of Ziihera in GEA in China. In April 2026, Jazz presented three posters and an oral presentation at AACR exploring zanidatamab’s utility across HER2-expressing solid tumors beyond biliary tract cancer and GEA. Jazz also announced that they will present multiple presentations on zanidatamab at the American Society of Clinical Oncology Annual Meeting, including a rapid oral presentation of PD-L1 subgroup data from HERIZON-GEA-01 evaluating zanidatamab combinations, and additional analyses of tolerability, biomarker response and real-world treatment patterns in first-line HER2+ GEA. The second interim overall survival analysis for the HERIZON-GEA-01 trial is expected in mid-2026. Our royalty revenue from Jazz and BeOne was $1.6 million in the three months ended March 31, 2026, driven primarily by net product sales of Ziihera by Jazz. Business Updates We recently announced leadership appointments and transitions to align with the evolution of our corporate strategy, including the following changes: Ms. Kristin Stafford appointed as Executive Vice President, Chief Financial Officer, effective April 1, 2026. Dr. Adam Schayowitz, Ph.D., MBA appointed as Executive Vice President, Head of R&D, effective April 9, 2026. Mr. Scott Platshon appointed as Executive Vice President, Chief Business Officer, effective April 9, 2026. Mr. Paul R. Schneider appointed as Executive Vice President, General Counsel, effective May 13, 2026. Share Repurchase Program In November 2025, the Board of Directors authorized a share repurchase program providing the ability to repurchase up to $125.0 million in common stock. As of May 6, 2026, the Company has utilized approximately $95.8 million of this approved repurchase program to acquire 3,930,734 shares at an average price of $24.37 per share (exclusive of commission expense and estimated excise tax). As of May 6, 2026, the Company had approximately 73.0 million common shares outstanding. Financial Outlook Operating Expense Discipline: The Company today is reiterating its previously provided guidance on adjusted gross operating expense (non-GAAP), which combines adjusted research and development (R&D) expense (non-GAAP) and adjusted general and administrative (G&A) expense (non-GAAP) (excluding stock compensation expense), reflecting a disciplined framework of approximately $300.0 million in aggregate adjusted gross operating expenditures (non-GAAP) over a three-year period ending December 31, 2028. The Company is also reiterating that it expects a greater proportion of adjusted gross operating expense (non-GAAP) to be incurred in 2026 and decline in 2027 and 2028, reflecting a deliberate and measured investment across R&D and G&A aligned with clearly defined strategic priorities. This outlook reflects current expectations, underscores the Company’s continued focus on cost discipline and capital allocation rigor, and does not include any potential acquisition-related expenses or new partnerships and collaborations. The Company’s GAAP gross operating expenses in 2025 were $198.5 million and the Company currently expects adjusted gross operating expenses (non-GAAP) in 2026 to be approximately 20% lower than adjusted gross operating expenses (non-GAAP) in 2025 of $170.5 million, excluding the impact of any acquisition-related expenses or new partnerships and collaborations. Financial Results for the Quarter Ended March 31, 2026 The key financial highlights for our 2026 first quarter results are as follows: Revenue – Total revenue was $2.4 million in 1Q-2026, compared to $27.1 million for the same period in 2025. The decrease was driven mainly by the achievement of non-recurring clinical milestone payments in 2025, as well as continued declines in development support and drug supply revenue from Jazz . Revenue in the current‑year period reflects ongoing collaboration activity and increased royalty revenue, which is expected to grow over time as commercial sales of Ziihera increase. Research and Development (R&D) Expenses – R&D expenses were $34.5 million in 1Q-2026, compared to $35.7 million for the same period in 2025, primarily reflecting a shift in program mix, as reduced spending on later‑stage and discontinued programs exceeded increased investment in early‑stage clinical studies and preclinical pipeline activities. General and Administrative (G&A) Expenses – G&A expenses were $15.1 million in 1Q-2026, compared to $17.0 million for the same period in 2025. The decrease was primarily driven by lower professional fees, consulting, and information technology‑related costs reflecting the absence of prior-year non-recurring initiatives and post-implementation cost reductions, partially offset by higher salaries and benefits reflecting previously disclosed leadership transitions. Other Income, net – Other income was $0.8 million in 1Q-2026, compared to $3.5 million for the same period in 2025. The change was driven primarily by $2.1 million of interest expense related to the royalty-backed note financing arrangement with Royalty Pharma executed in March 2026 and lower interest income. Net Loss – Net loss was $44.2 million in 1Q-2026, compared to a net loss of $22.6 million for the same period in 2025. The change in 2026 was primarily due to a decrease in revenue, driven by the non-recurring clinical milestones earned in 1Q-2025. Liquidity – As of March 31, 2026, we had $403.8 million of cash resources consisting of cash, cash equivalents and marketable securities, comprised of $244.3 million in cash and cash equivalents and $159.6 million in marketable securities. Based on current operating plans, and assuming full execution of the $125.0 million share repurchase plan, we expect our existing cash resources as of March 31, 2026, when combined with anticipated regulatory milestone payments of $440.0 million related to the potential approvals of Ziihera in GEA in the U.S., Europe, Japan, and China, to fund our planned operations beyond 2028. This anticipated cash runway does not take into account any contribution from additional future milestone payments or royalties related to Ziihera, other current licensed product candidates or contributions from future partnerships and collaborations. About Zymeworks Inc. Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. The Company’s asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates, such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the development of innovative medicines. Zymeworks engineered and developed Ziihera, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology and has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zymeworks is rapidly advancing a robust pipeline of product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutics. These capabilities have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X. Non-GAAP Financial Information Zymeworks believes that the presentation of non-GAAP financial information provides important supplemental information to management and investors regarding financial and business trends relating to the Company’s financial condition and results of operations. Reconciliations of non-GAAP financial measures to the most directly comparable financial results as determined in accordance with GAAP are included at the end of this press release following the accompanying financial data. For further information regarding why Zymeworks believes that these non-GAAP measures provide useful information to investors and some of the limitations associated with the use of these measures, please refer to the “Explanation of Non-GAAP Financial Information” section at the end of this press release. Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ expectations regarding implementation of its strategic priorities and the anticipated benefits thereof, including shareholder returns and the anticipated manner of such returns; implementation of its long-term strategy to maximize value creation; the anticipated benefits of its collaboration agreements, including Zymeworks’ ability to receive any future milestone payments and royalties thereunder; Zymeworks’ ability to execute the share repurchase program, in whole or in part; expected timing and amount of repurchases; the potential addressable market of zanidatamab and other product candidates; the timing of and results of interactions with regulators; Zymeworks’ and its partners’ clinical development of product candidates; the expected contributions of personnel to Zymeworks’ clinical development, strategic goals and long-term shareholder value for patients and shareholders; the timing and status of ongoing and future studies and the related data; potential safety profile and therapeutic effects of zanidatamab and Zymeworks’ other product candidates; the potential of ZW191 to be a best-in-class therapy; the commercial potential of technology platforms and product candidates; Zymeworks’ ability to satisfy potential regulatory and commercial milestones with existing and future partners; anticipated continued receipt of revenue from existing and future partners; Zymeworks’ ability to generate royalty revenue from Ziihera; Zymeworks’ ability to execute new collaborations and partnerships; Zymeworks’ early-stage pipeline; anticipated sufficiency of existing cash resources, when combined with the assumed receipt of certain anticipated regulatory milestone payments related to the potential approvals of Ziihera in GEA in the U.S., Europe, Japan, and China, and assuming the full execution of the $125.0 million share repurchase program, to fund Zymeworks’ planned operations beyond 2028 based on current operating plans; expected financial performance and future financial position, including anticipated adjusted gross operating expense (non-GAAP), adjusted research and development expense (non-GAAP) and adjusted general and administrative expense (non-GAAP) for the three-year period ending December 31, 2028, excluding any potential acquisition-related expenses or new partnerships and collaborations; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, “preserve”, “intend”, “could”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not be able to successfully execute the share repurchase program; the anticipated benefits of the share repurchase program may not be realized; Zymeworks may not achieve milestones or receive additional payments or royalties under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab may not be successfully commercialized; Zymeworks’ business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ evolution of its business strategy may not deliver meaningful shareholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue-generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; data providing early validation of our antibody drug conjugate platform and next generation pipeline programs may not be replicated in future studies; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; the inability of Zymeworks to identify and consummate a strategic acquisition; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedarplus.ca). Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. ZYMEWORKS INC. Consolidated Statements of Loss and Comprehensive Loss (In thousands except share and per share data) ZYMEWORKS INC. Selected Consolidated Balance Sheet Data (In thousands) Explanation of Non-GAAP Financial Information In addition to reporting financial information in accordance with U.S. generally accepted accounting principles (GAAP) in this press release, we have elected to present selected non-GAAP, or adjusted, financial measures on a forward-looking basis. Zymeworks believes that estimated adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense, which are non-GAAP financial measures, may be helpful to investors because they provide consistency and comparability with financial performance across periods. These non-GAAP financial measures are not defined by GAAP and should not be considered as alternatives to operating expenses, research and development expenses, and general and administrative expenses or any other indicators of Zymeworks’ performance required to be reported under GAAP. In addition, other companies, including companies in Zymeworks’ industry, may calculate similarly titled non-GAAP or adjusted measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense as financial measures. Investors and others are encouraged to review Zymeworks’ financial information in its entirety and not rely on a single financial measure. As defined by Zymeworks, adjusted gross operating expense represents the aggregate of adjusted research and development expense and adjusted general and administrative expense, each of which excludes stock-based compensation expense for equity- and liability-classified equity instruments. Zymeworks excludes stock-based compensation expense, which is a non-cash expense, because Zymeworks believes that excluding this item provides meaningful supplemental information regarding operational performance. A reconciliation of historical adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense to the most directly comparable GAAP measures is set forth below. A reconciliation of anticipated adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense to the most directly comparable GAAP measures is not available without unreasonable effort due to the uncertainty of expenses that may be incurred in the future, and we are also unable to predict the probable significance of such adjusted measures. Accordingly, in reliance on the exception provided by Item 10(e)(1)(i)(B) of Regulation S-K, we have not provided a reconciliation for the adjusted gross operating expense, adjusted research and development expense, and adjusted general and administrative expense guidance provided in this press release. GAAP to Non-GAAP Reconciliations (In thousands) (unaudited) GAAP to Non-GAAP Reconciliations (In thousands) (unaudited) (continued) Contacts: Investor Inquiries: Shrinal Inamdar Vice President, Investor Relations (604) 678-1388 [email protected] Media Inquiries: Diana Papove Vice President, Corporate Communications (604) 678-1388 [email protected]
Investor releaseQuarter not tagged2026-05-07Royalty Pharma Q1 Earnings Call Highlights
MarketBeat
Royalty Pharma Q1 Earnings Call Highlights
Royalty Pharma reported a “strong start” to 2026 with 10% growth in portfolio receipts and 13% growth in royalty receipts, deployed more than $0.5 billion of capital (with $1.25 billion announced), repurchased 1 million shares for $50 million, raised the dividend 7%, and raised full‑year 2026 guidance to $3.325–$3.45 billion. The company struck material deals and saw major portfolio catalysts, including a $250 million funding for Zymeworks’ Ziihera royalty (peak sales modeled >$2 billion) and a $500 million synthetic royalty investment in Revolution Medicines’ daraxonrasib after trial data showed a near doubling of overall survival, driving expectations for substantial peak royalties. Balance-sheet strength and strategic positioning underpin growth: cash of $586 million, investment‑grade debt of $9.2 billion with leverage ~2.9x and an undrawn $1.8 billion revolver (Fitch upgrade to BBB), while the firm is expanding into R&D co‑funding (first‑quarter deals with J&J and Teva ~ $1 billion) to capture a large biopharma R&D opportunity. Interested in Royalty Pharma PLC? Here are five stocks we like better. How Royalty Pharma Prints Cash Without Biotech's Biggest Risks Royalty Pharma (NASDAQ:RPRX) reported what executives described as a “strong start” to 2026, driven by double-digit growth in cash receipts, active capital deployment and a series of clinical and regulatory developments across its portfolio, according to management’s remarks on the company’s first-quarter earnings call. Chief Executive Officer and Chairman Pablo Legorreta said the company delivered “10% growth in portfolio receipts” and “13% growth in royalty receipts,” which he characterized as Royalty Pharma’s recurring cash flows. Legorreta added that performance was supported by the “strength of our diversified portfolio,” and said the company maintained “returns on invested capital of around 14% and returns on invested equity of around 20%.” → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries 1 Trial, 2 Franchises: Zenas Stock Climbs on Landmark Data Legorreta also highlighted capital deployment during the quarter, citing “$1.25 billion of announced transactions on three attractive therapies,” with capital deployed “in excess of $0.5 billion dollars.” He said Royalty Pharma repurchased 1 million shares for $50 million and increased its dividend by 7% during the quarter. C…Read full documentShow less
Royalty Pharma reported a “strong start” to 2026 with 10% growth in portfolio receipts and 13% growth in royalty receipts, deployed more than $0.5 billion of capital (with $1.25 billion announced), repurchased 1 million shares for $50 million, raised the dividend 7%, and raised full‑year 2026 guidance to $3.325–$3.45 billion. The company struck material deals and saw major portfolio catalysts, including a $250 million funding for Zymeworks’ Ziihera royalty (peak sales modeled >$2 billion) and a $500 million synthetic royalty investment in Revolution Medicines’ daraxonrasib after trial data showed a near doubling of overall survival, driving expectations for substantial peak royalties. Balance-sheet strength and strategic positioning underpin growth: cash of $586 million, investment‑grade debt of $9.2 billion with leverage ~2.9x and an undrawn $1.8 billion revolver (Fitch upgrade to BBB), while the firm is expanding into R&D co‑funding (first‑quarter deals with J&J and Teva ~ $1 billion) to capture a large biopharma R&D opportunity. Interested in Royalty Pharma PLC? Here are five stocks we like better. How Royalty Pharma Prints Cash Without Biotech's Biggest Risks Royalty Pharma (NASDAQ:RPRX) reported what executives described as a “strong start” to 2026, driven by double-digit growth in cash receipts, active capital deployment and a series of clinical and regulatory developments across its portfolio, according to management’s remarks on the company’s first-quarter earnings call. Chief Executive Officer and Chairman Pablo Legorreta said the company delivered “10% growth in portfolio receipts” and “13% growth in royalty receipts,” which he characterized as Royalty Pharma’s recurring cash flows. Legorreta added that performance was supported by the “strength of our diversified portfolio,” and said the company maintained “returns on invested capital of around 14% and returns on invested equity of around 20%.” → 3 Emerging Markets ETFs to Maximize Exposure to High-Potential Countries 1 Trial, 2 Franchises: Zenas Stock Climbs on Landmark Data Legorreta also highlighted capital deployment during the quarter, citing “$1.25 billion of announced transactions on three attractive therapies,” with capital deployed “in excess of $0.5 billion dollars.” He said Royalty Pharma repurchased 1 million shares for $50 million and increased its dividend by 7% during the quarter. Chief Financial Officer Terry Coyne said royalty receipts grew 13% in the quarter and portfolio receipts grew 10% “considering a sizable year-over-year decline in milestones and other contractual receipts.” He noted operating and professional costs were 3.9% of portfolio receipts in the quarter, which he attributed to cash savings from the company’s internalization transaction completed last May. → The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches 4 Healthcare Stocks With Massive Gains—and More to Come Coyne reported net interest paid of $167 million, reflecting the company’s “semi-annual timing” of interest payments. Portfolio cash flow—defined as adjusted EBITDA less net interest paid—was $722 million for the quarter, and Coyne said net margin of “around 78%” demonstrated the business’s cash conversion. Marshall Urist, executive vice president and head of research and investments, detailed a strategic funding agreement signed in March with Zymeworks. Under the deal, Royalty Pharma provided $250 million upfront in exchange for 30% of Zymeworks’ royalty on Jazz and BeOne’s Ziihera, which Urist said translates into a “low-to-mid single-digit royalty” for Royalty Pharma. → Tyson Foods' Total Returns: Tasty Treats for Income Investors? Urist said Ziihera, a HER2-targeted bispecific antibody, is FDA-approved for metastatic biliary tract cancer and was recently submitted for approval in gastric cancer. He called the gastric cancer pivotal study results “impressive,” citing a “five to seven-month or nearly 40% overall survival advantage” over existing therapies. Urist said consensus models include Ziihera peak sales of “greater than $2 billion,” and the company expects the transaction to generate “an unlevered IRR in the low double digits.” Urist also discussed Revolution Medicines’ daraxonrasib, pointing to “unprecedented results” from the RASolute phase III trial in second-line pancreatic cancer. He said daraxonrasib “nearly doubled overall survival from just under seven months with chemotherapy to over 13 months.” Revolution Medicines plans to submit for approval to global regulators, including the FDA, he said. As a reminder of Royalty Pharma’s exposure, Urist said the company agreed in 2025 to provide up to $2 billion in long-term funding to Revolution Medicines. With the new data, Royalty Pharma has invested $500 million for a synthetic royalty starting at 4.55% on sales up to $2 billion with tiering beyond that. Based on consensus peak annual sales of “greater than $10 billion,” Urist said Royalty Pharma expects peak potential annual royalties of approximately $180 million on the currently funded amount, and “up to $340 million” if Revolution Medicines draws an additional $750 million tranche. Urist highlighted multiple portfolio catalysts and updates discussed during the quarter and after quarter end, including positive top-line results for MYQORZO in non-obstructive hypertrophic cardiomyopathy, positive results for Zenas’ obexelimab in IgG4-related disease, positive phase II results for Biogen’s litifilimab in cutaneous lupus, FDA approval of Denali’s Avlayah in Hunter syndrome, and Nuvalent’s filing of neladalkib in ALK-positive non-small cell lung cancer. He also noted Teva’s announced acquisition of Emalex for up to $900 million, with a planned second-half regulatory submission for ecopipam in Tourette’s syndrome, and reiterated Royalty Pharma’s tiered royalty terms on ecopipam. Chris Hite, now Chairman, Partnering and Investments, centered his remarks on Royalty Pharma’s view of “a major opportunity” in R&D co-funding with global biopharma companies. He said the company estimates “over $1 trillion of cumulative projected R&D spend” by global biopharma over the next five years, and described co-funding arrangements as a way for biopharma to “share risk at scale,” enhance ROI, expand R&D capacity and diversify pipelines. Hite said demand for co-funding increased after “more clarity around contract R&D accounting treatment,” and cited first-quarter deals with J&J and Teva totaling $1 billion in announced value. He also said the number of global biopharma companies using the funding modality has “doubled since 2020.” In response to a question about how the portfolio mix might evolve, Hite said Royalty Pharma has invested in development-stage products since 2012 and is “expanding the opportunity” through large-pharma co-funding. He referenced an appendix slide indicating roughly 85% of capital at work is in approved products, roughly 10% in development-stage products, and about 3% of development-stage capital has already had positive pivotal results. Coyne said the company is raising full-year 2026 guidance. Royalty Pharma now expects portfolio receipts of $3.325 billion to $3.45 billion, up from $3.275 billion to $3.425 billion previously. The updated outlook assumes royalty receipts growth of around 4% to 8% and incorporates headwinds including Promacta loss of exclusivity, the launch of a U.S. biosimilar for Tysabri, and “the potential impact of IRA,” Coyne said. He also said the company expects milestones and other contractual receipts to decrease from $128 million in 2025 to approximately $60 million in 2026. For the second quarter, Royalty Pharma guided to portfolio receipts of $740 million to $760 million, citing the seasonal impact of upward-tiering royalties that reset to a lower rate in the first quarter and flow through to Royalty Pharma’s receipts with a one-quarter lag. On the balance sheet, Coyne reported cash and equivalents of $586 million at the end of March 2026, investment-grade debt outstanding of $9.2 billion with a weighted average duration of around 12 years, and leverage of 2.9x total debt to adjusted EBITDA (2.7x net). Coyne noted Fitch upgraded the company’s credit rating to BBB from BBB- and said the company’s $1.8 billion revolver was undrawn. In Q&A, Coyne told analysts Royalty Pharma had “quite low leverage right now” and “a lot of financial flexibility” if deal flow increases. Coyne also provided an update on the company’s arbitration with Vertex, saying that based on the arbitration panel’s schedule, Royalty Pharma now expects the dispute to be resolved “by around the middle of 2027.” In response to an analyst question on the delay, Coyne said the timing change was “simply based on the availability of the arbitration panel.” On MYQORZO, Urist said the company did not assume success in the non-obstructive hypertrophic cardiomyopathy trial when it made its investment thesis, which was “premised on the obstructive” indication. He said adding non-obstructive to the label “can only be helpful” and represents upside relative to original estimates, and later added the broader label should be “a tailwind” as Cytokinetics launches aficamten. Asked about consolidation among smaller royalty players, Legorreta said it could reduce competition and argued Royalty Pharma has advantages including scale, an efficient tax structure, and access to capital at a lower cost. On China, Hite pointed to last year’s transaction with BeOne and said the company is monitoring out-licensing activity from China to Western multinationals. He also said Ken Sun, former head of Asia at Morgan Stanley, is starting soon and will help “catalyze” the effort. Legorreta addressed how the company uses data and artificial intelligence, saying Royalty Pharma has invested in data for “many years, decades” and cited claims data for 200 million Americans and electronic medical records for 44 million Americans with nine years of longitudinal data. He said the company uses data to improve investment decisions and to share insights with partners, which in some cases “has led to…better terms on transactions.” He also highlighted the recent hire of Lucas Glass as head of AI, saying Glass will work on implementing AI across the business, including automating diligence processes and strengthening evaluation capabilities. Legorreta closed by reiterating confidence in Royalty Pharma’s positioning, citing leadership in the expanding biopharma royalty market, a platform to invest in transformative products, expectations for “strong low volatility” growth through 2030 and beyond, and a track record of attractive returns. Royalty Pharma plc is a specialty finance company that acquires biopharmaceutical royalty interests and provides non-dilutive financing to drug developers and rights holders. The firm purchases future royalty streams, milestone-contingent payments and other revenue rights linked to approved and late-stage pharmaceutical and biotechnology products. By paying upfront consideration for these rights, Royalty Pharma seeks to generate long-term cash flows tied to the commercial performance of a diversified portfolio of medicines. The company's transaction structures include outright royalty purchases, structured financings and milestone arrangements tailored to the needs of innovator companies, academic institutions and investors. The article "Royalty Pharma Q1 Earnings Call Highlights" was originally published by MarketBeat.
TranscriptFY2026 Q12026-05-07FY2026 Q1 earnings call transcript
Earnings source - 129 paragraphs
FY2026 Q1 earnings call transcript
Good day, thank you for standing by. Welcome to Zymeworks' First Quarter 2026 Results Conference Call. At this time, all participants are in listen-only mode. After the speakers' presentation, there will be a question-and-answer session. To ask a question during your session, you will need to press star one one on your telephone. You will hear an automated message advising that your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Shrinal Inamdar, VP of Investor Relations.
Thank you, operator. Good afternoon, everyone. Thank you for joining our first quarter 2026 results conference call. As usual, I'd like to remind you that we'll be making a number of forward-looking statements during this call, including, without limitation, those forward-looking statements identified in our slides and the accompanying oral commentary. These forward-looking statements are based upon our current expectations and various assumptions and are subject to the risks and uncertainties, including those associated with companies in our industry and at our stage of development. For a discussion of these risks and uncertainties, we refer you to our latest SEC filings as found on our website and as filed with the SEC. In a moment, I'll hand over the call to Ken Galbraith, our Chair and CEO, who will provide an overview of recent business updates.
Ken will then hand the call over to Kristin Stafford, our Chief Financial Officer, to discuss our cash position and financial results for the first quarter 2026. Dr. Paul Moore will then provide a brief summary of new preclinical data disclosed at AACR on our pan-RAS ADCs. Following this, Dr. Sabeen Mekan, our SVP and Chief Medical Officer, will provide progress updates on both the phase I clinical trial of ZW191 and ZW251. At the end of the call, Ken, Kristin, Sabeen, and Paul will be joined for a Q&A session with Scott Platshon, our Chief Business Officer, and Adam Schayowitz, Head of R&D. As a reminder, the audio and slides from this call will also be available on Zymeworks' website later today. I'll now hand the call over to Ken.
Thank you, Shrinal, and good afternoon, everyone. We're pleased to be reporting on further progress this quarter on both our wholly-owned and partnered assets. The PDUFA date of August 25th, 2026 for zanidatamab in first-line GEA in the U.S., together with the completion of an sBLA filing in China for first-line GEA, marks an important inflection point and near-term foundational value-driving opportunity for Zymeworks. These regulatory milestones provide increasing visibility toward commercialization in first-line HER2-positive GEA and accompany continued clinical development in additional settings such as breast cancer, helping to establish a clear baseline for zanidatamab's value. If you didn't get a chance to tune in, we'd urge you to listen in to Jazz's disclosures within their earnings call earlier this week on preparedness and launch activities for GEA in anticipation of an FDA approval later this year on or before the PDUFA date.
With our partners Jazz and BeOne bringing established commercial capabilities, we believe zanidatamab is well-positioned to translate potential approvals and label extensions into meaningful uptake, significant milestone payments, and durable royalty revenues. This includes near-term milestone payments of $250 million upon approval in the U.S. for GEA from Jazz and $50 million upon approval in China for GEA from BeOne. Importantly, this momentum also illustrates the broader strength of our business model. Recent data presented at the American Association for Cancer Research annual meeting, alongside this continued regulatory progress for zanidatamab, reinforce the strategic advantage of integrating our R&D portfolio with royalty participation within a single organization. We will continue to be intentional about maintaining a portion of our R&D portfolio unencumbered, preserving optionality for future transactions and aiming to capture upside beyond structured royalty streams.
Advances across our ADC portfolio at AACR, including the presentation of three new preclinical RAS-targeting ADC candidates featuring proprietary payloads, as well as encouraging phase I data for ZW191, highlight the scalability of our platform and its ability to generate multiple potential future value drivers. Taken together, we believe this integrated model, anchored by near-term catalysts such as potential global approvals for zanidatamab and supported by a productive and innovative pipeline that provides future optionality for our emerging royalty portfolio, positions us to deliver durable compounding returns for shareholders over time. Over the past quarter, we've also strengthened our leadership team with the addition of Kristin and the full-time appointments of Scott and Adam, who bring deep experience in strategic capital allocation, investment, and deal making. Also pleased to announce the appointment today of Mr. Paul Schneider, who joins us as General Counsel from Pfizer.
All of these appointments enhance our ability to systematically identify, structure, and execute opportunities that align with our long-term value creation framework. With that, I'd like to hand the call over to Kristin, who will provide an overview of our financial highlights for the first quarter of 2026.
Thank you, Ken. Having now spent my first month at Zymeworks, what stands out for me is the potential for us to build a novel strategy of royalty aggregation and growth, one that's differentiated by the integration of our productive R&D engine with a quality portfolio of royalty interests. My focus as I step into this role is to ensure we execute with discipline, particularly in how we allocate capital, prioritize programs, and pursue external opportunities. That includes maintaining a high bar for investment, strengthening operational rigor, and leveraging our integrated model to drive both near-term visibility and long-term compounding value. I'm excited to join the team to build on this momentum and to position Zymeworks as a leader in this emerging model.
As part of this, we're evaluating ways to potentially evolve our financial reporting in order to provide better visibility into returns on invested capital and the performance of both our R&D and royalty portfolios. We intend to build on the OpEx framework we introduced last quarter, adding greater transparency around how that investment translates into key value drivers for shareholders. I'll now talk through the financial results for the first quarter of 2026. Total revenue was $2.4 million for the three months ended March 31st, 2026, compared to $27.1 million for 2025. The decrease was driven mainly by the achievement of non-recurring clinical milestones in 2025, as well as continued declines in development support and drug supply revenue from GEV.
Revenue in the current year period reflects ongoing collaboration activity and increased royalty revenue, which is expected to grow over time as commercial sales of the Ziihera increase. Overall operating expenses were $49.5 million for the three months ended March 31st, 2026, compared to $52.7 million for 2025. The decrease in research and development expenses was primarily driven by lower third-party program costs following reduced activity on later-stage and discontinued programs, partially offset by increased investment in early-stage clinical and preclinical programs, as well as increased unallocated costs related to leadership transition. The decrease in general and administrative expenses was primarily driven by lower professional fees, consulting, and information technology-related costs, partially offset by higher salaries and benefits reflecting the previously disclosed leadership transitions.
Net loss was $44.2 million for the three months ended March 31st, 2026, compared to a net loss of $22.6 million in 2025. The change in 2026 was primarily due to a decrease in revenue, driven by the non-recurring clinical milestones earned in the first quarter of 2025. Despite the year-over-year change in earnings, we ended the quarter with a strong cash position, providing flexibility to fund operations and execute on our capital allocation strategy. Turning to capital allocation, we have made progress on our share repurchase program, which reflects our commitment to disciplined capital allocation and enhancing long-term shareholder return.
As of May 6, 2026, the company has utilized approximately $95.8 million of the approved $125 million repurchase program to acquire 3,930,734 shares at an average price of $24.37 per share, exclusive of commission expense and estimated excise tax. As of May 6, 2026, the company had approximately 73 million common shares outstanding. As of March 31, 2026, we had $403.8 million of cash resources, consisting of cash equivalents, and marketable securities, compared to $270.6 million as of December 31st, 2025.
Based on our current operating plans and assuming full execution of the $125 million share repurchase plan, we expect our existing cash resources as of March 31st, 2026, when combined with anticipated regulatory milestone payments of $440 million related to the potential approvals of Ziihera and GEA in the U.S., Europe, Japan, and China to fund our planned operations beyond 2028. This anticipated cash runway does not take into account any contribution from additional future milestone payments or royalties related to Ziihera or other current licensed product candidates or contributions from future partnerships and collaborations. For additional details on our quarterly results, I encourage you to review our earnings release and other SEC filings available on our website at www.zymeworks.com. I will now pass the call over to Paul, who will provide a summary of our preclinical presentations at AACR.
Thank you, Kristin. Well, it certainly has been another busy AACR for Zymeworks, with six poster presentations, an oral presentation for ZW191, and two invited talks from our research leadership team, one covering multispecifics and the other ADCs. For the call today, I wanted to focus on the pan-RAS ADC platform that we unveiled at AACR, which has attracted a lot of attention over the last few weeks. You may recall at our R&D day at the end of 2024, we first outlined our plans to pursue novel payloads, it is particularly satisfying to now see that intention translated into clear execution. Against that backdrop, the decision to focus on RAS payloads reflects both the strength of the screening outcomes and the quality of the candidates identified. It marks a meaningful step forward in delivering on the strategic direction originally outlined.
As you're aware, we have also been encouraged by the continued translation of our proprietary TOPO1i payload, purpose-built for ADCs from the preclinical setting into the clinic, which Sabeen will talk about in a few minutes. Based on that foundation, our focus has been on what comes next. As we think about the next generation of ADCs, we've been intentionally addressing certain core aspects, deploying additional mechanisms of action through payload selection, enhancing efficacy, overcoming resistance, and further improving safety. These priorities have guided our investment in both novel targets and novel payloads, particularly as resistance can emerge through multiple mechanisms, including target evolution or following sequential ADC treatments. In parallel, RAS inhibitors have generated significant interest given recent developments in the field.
Toxicity remains a key limitation. We believe an ADC-based approach offers a compelling way to address this by improving targeting and enabling more sustained tumor exposure with the potential to enhance efficacy while reducing systemic side effects. This profile may also better support combination strategies. To explore this, we generated and functionally screened more than 117 novel pan-RAS inhibitors derived from our scaffold work in-house. Our thesis for our total payload, our selection criteria extended beyond potency alone. We prioritized molecules with properties best suited for an ADC modality, as shown in this slide, supported potent efficacy in xenograft models, favorable pharmacokinetics, meaningful bystander activity, and a tolerability profile in non-human primates that are collectively supportive of further development.
From a safety perspective, our lead payload candidate, evaluated in the context of a Ly6E pan-RAS ADC, demonstrated encouraging results in non-human primates, with no observed body weight loss, skin toxicity, or GI tox at doses up to 120 mgs/kg, representing the maximum dose tested. The data set on this slide also highlights the ability of an ADC approach to sustain tumor-targeted inhibition of the RAS pathway over an extended period, and how it differentiates both in distribution and biological effect to a pan-RAS small molecule inhibitor delivered orally. Following a single dose of RAS ADC in a mouse xenograft model, we observed sustained accumulation of the RAS payload in the tumor at levels higher relative to that observed in normal organs.
This differential exposure is also reflected in the durable RAS pathway inhibition as measured via DUSP6 levels in the tumor out to 14 days, with again, clear differentiation between tumor and normal tissue. In contrast, while a small molecule pan-RAS inhibitor delivered orally achieves RAS pathway inhibition, the magnitude of inhibition in tumors overlaps with that observed in normal tissues such as skin, liver, and colon. Consistent with the broader distribution and uptake pattern of the small molecule, as shown in the top right relative to the tumor-targeted design of the pan-RAS ADC. Again, for the pan-RAS ADC, what we see is a more selective inhibition of the RAS pathway in tumor relative to skin, in contrast to the small molecule that shows activity across both skin and GI, aligning with the tox profile observed clinically for pan-RAS inhibitors.
Taken together, we believe that this differentiation underscores the potential for ADCs to fundamentally reshape how RAS-targeted therapies can be deployed in patients. As far as the mechanism goes, we have not divulged full details, but it is a RAS(ON) inhibitor. Our focus so far has been on the functional behavior of the molecules and how the overall design translates into pathway modulation and tolerability. At AACR, we presented also on the application of this platform across three different therapeutic candidates. We chose our targets with intent to reach deeply into cancers where RAS mutations drive disease at scale, including non-small cell lung cancer, pancreatic cancer, and colorectal cancer, ensuring both relevance and impact. All candidates incorporate the bystander active pan-RAS payload at DAR 8.
While on the antibody side, we will leverage our antibody engineering expertise to optimize internalization, tumor penetration, and kinetic properties that ultimately determine whether this modality delivers on its promise to provide target-driven tumor-selective RAS inhibition. The candidates, as you can see here, include ZW439, a Claudin 18.2 targeting pan-RAS inhibitor ADC for the treatment of RAS-mutated pancreatic cancer. ZW427, a Ly6E targeting antibody drug conjugate bearing a novel pan-RAS inhibitor payload for the treatment of RAS-mutated cancers including colorectal, pancreatic, and non-small cell lung cancer. ZW418, a biparatopic PTK7 targeting ADC incorporating the same RAS inhibitor payload for the treatment of non-small cell lung cancer. The data we've seen so far across the three candidates targeting PTK7, Ly6E, and Claudin 18.2 respectively that we share at the AACR reinforces both the design of the payload and the broader principles underpinning our ADC platform.
I'll leave it there for now and happy to go into more detail during the Q&A session. Sabeen, I will now hand over to you to run through the updates on our clinical development program for ZW191 and ZW251.
Thank you, Paul. At the data presented at AACR, we observed strong antitumor activity for ZW191 across both ovarian and endometrial cancers. Starting with ovarian cancer, we observed tumor regression of at least 30% in 68% of patients, and importantly, some degree of tumor shrinkage in 85% of patients. Disease control was achieved in 94% of patients with an overall response rate of 56% across all those levels. When we look at the clinically relevant dose range of 6.4-9.6 mg/kg, disease control was observed in all patients with a confirmed ORR of 61%. It is important to underscore that this ovarian cohort represents a particularly challenging population who was heavily pretreated. All of these patients were resistant to prior platinum therapy.
Majority had prior PARP inhibitor exposure. There was no limit to the number of prior lines of therapy. This makes cross-trial comparisons difficult and in our view, highlights the strength of the antitumor activity of ZW191. In relapsed or refractory endometrial cancer, we observed tumor regression of at least 30% in 50% of patients, with 70% experiencing some degree of tumor shrinkage. Disease control was achieved in 80% of patients with an overall response rate of 40% across all those levels. At 6.4-9.6 mg/kg dose range, ORR increased to 57% with disease control in 86% of patients. Across both tumor types, responses were observed starting at 3.2 mg/kg dose. Importantly, activity was seen regardless of FRα expression level, including in low or negative tumors.
Median follow-up time was approximately seven months, with a number of patients still on treatment supporting the durability of signals we have discussed. Turning to safety, ZW191 is being evaluated at meaningfully higher doses than some other programs in this space. Regardless, we're pleased with the safety profile we're observing at these doses, which mainly consist of cytopenias and GI events, at low rates that are very manageable and types of events that are in line with the TOPO1i ADC class. Importantly, no unexpected or new safety signals were observed with longer follow-up. These 6.4 and 9.6 mg/kg doses are being further evaluated in a larger data set in dose optimization. As previously reported, this approximately 60-patient cohort is fully enrolled, and the results should assist in defining the optimum dose to move forward into subsequent clinical studies.
Given the consistency of efficacy across the active dose range, we believe we have the flexibility to optimize dose to further refine tolerability without compromising activity. We also believe the profile remains compatible with combination approaches with appropriate dose selection and monitoring. At AACR, we presented a poster on preclinical combinations with ZW191. In non-clinical studies, ZW191 demonstrates activity across all levels of FRα expression and shows promising combination potential with standard of care therapies supported by a favorable tolerability profile. These data provide an important translational foundation for the clinical observations of activity in low and negative FRα-expressing tumors and support the breadth of activity we're beginning to see emerge in the clinic. In addition, the combination data reinforce the potential to position ZW191 in earlier lines of treatment. We believe these combinations should be feasible with appropriate dose selection and monitoring.
Overall, we view these data as supporting a compelling and increasingly well-defined benefit risk profile for ZW191. We look forward to the opportunity to present additional updates on our phase I study at future medical meetings, including at ESMO Gynae in Denmark during June, where we will be presenting efficacy analysis by folate receptor alpha expression levels from the phase I study. I also want to touch briefly on the protocol updates for our ongoing trial for ZW251. As we think about expansion opportunities beyond our initial indication for hepatocellular carcinoma, GPC3 expression provides a compelling biological rationale across multiple tumor types. Across published data sets, we see GPC3 expression in approximately 86% of hepatocellular carcinoma, and more broadly in a range of 60%-100%, depending upon the tumor subtype, staining methodology, and patient population.
Notably, in squamous non-small cell lung cancer, GPC3 expression has been observed in roughly 60% of tumors, which supports the inclusion of squamous non-small cell lung cancer as a relevant population for further exploration. We're also exploring germ cell tumors, where high GPC3 expression has been reported, particularly in non-germinative subtypes such as yolk sac tumors and choriocarcinoma. While pediatric germ cell tumors are relatively rare, expanding into adult germ cell tumors meaningfully broadens the addressable population and introduces more heterogeneous mixed histologies. Importantly, in these mixed tumor settings, the bystander effect associated with our ADC may be particularly relevant as it has the potential to address both GPC3 positive and adjacent antigen-lower negative tumor cells within the same lesion. In our phase I study, we're assessing GPC3 expression retrospectively from available tumor samples.
This approach allows us to better understand the distribution of GPC3 expression across tumor sites without restricting enrollment and helps inform future patient selection strategies. Overall, we believe the addition of these tumors positions us to efficiently map GPC3 expression across tumor types and identify those settings where the biology and mechanism of action are best aligned. Our phase I dose-escalation study continues to recruit on schedule, and we look forward to having the opportunity to share the clinical data at the appropriate time at a future medical meeting. I'll now hand the call back to Ken to provide for closing remarks.
Thank you very much, Sabeen. Looking ahead at the potential catalyst for 2026, we remain on track to deliver on the majority of these objectives and continue to see opportunities for a steady cadence of data and pipeline progress. As I mentioned earlier, with the near-term U.S. PDUFA date set for zanidatamab and the sBLA submission in China, Zymeworks has a greater visibility to near-term milestone payments from Jazz and BeOne and more meaningful royalty revenues upon potential launches in the U.S. and China. We also continue to follow progress from our collaboration partner, J&J Innovative Medicine, with respect to their broad clinical development program for pasritamig, a novel KLK2 T-cell engager for prostate cancer patients. I do wanna highlight that we are now guiding to an IND in 2027 for ZW1528 compared to our prior expectation of 2026.
As we've continued to evaluate the IL-33 biology across the competitive landscape, we see an opportunity to further deepen our understanding and refine the clinical development strategy as recent clinical data outcomes are disclosed at upcoming medical meetings. Given the novelty of the target, we believe taking this additional time positions us to enter the clinic with a more focused and differentiated plan. However, the core preclinical package, including GLP toxicology, is largely complete and compelling. More broadly, we're also evaluating how partnerships and collaborations can support the advancement of our R&D pipeline. As we think about capital allocation execution, we do see opportunities to bring in external partners, where in doing so, we can enhance speed, scale, or probability of success. We remain very encouraged by the progress of ZW209, as well as the broader TriTCE portfolio behind it.
ZW209 is IND ready and still maintained as a potential IND in 2026, which we believe should provide confidence in both the maturity of the program and its underlying safety profile. We have multiple additional targets in development within the TriTCE platform, we continue to view this as a key driver of long-term value. We've demonstrated our ability to repeatedly extract high-quality assets from a single platform. Our Azymetric platform enabled the development of zanidatamab, supported partner programs such as pasritamig, continues to drive our wholly-owned pipeline, including our TOPO1i ADC programs built on optimized antibodies and our RAS-targeting ADC candidates, as well as our multi-specific antibody product candidates behind ZW209 and ZW1528. Importantly, we believe this capability is transferable beyond our internally generated R&D pipeline.
We have the ability to supplement and scale our existing capabilities through acquisitions, rapidly apply our technologies, and efficiently advance novel candidates into the clinic, as we've consistently demonstrated. We've been very active in external processes to assess potential acquisitions and feel well-funded to do so with the proceeds of the Royalty Pharma note and the upcoming expected GEA approval milestones and enhanced royalty income from zanidatamab. We are also remaining disciplined in our approach to acquisitions to ensure we find the right opportunities for our long-term strategic objectives and the right price. At the same time, our capital allocation framework remains disciplined and highly focused on per-share value creation.
Since initiating our share repurchase program in 2024, we've retired approximately 8.3 million shares through the deployment of roughly $155.8 million in capital for a weighted average repurchase price of approximately $18.70 per share. This represents over 10% of our common shares outstanding. Notably, our average repurchase cost remains at a meaningful discount to today's share price, reinforcing our view that these buybacks have represented an attractive and accretive use of capital on behalf of shareholders. Over time, repurchases are designed to continue to reduce our share count while increasing each remaining shareholder's participation in the future economics of the business. We believe these repurchases have represented an attractive use of capital, given the disconnect we've seen between our market valuation and the long-term value of our commercial royalty interests and development pipeline.
This balanced approach of pairing growing and durable royalty revenues with opportunistic share repurchases and a disciplined investment is designed to enhance intrinsic value per share and support increasing total shareholder return over time. With key leadership appointments recently completed, we're well-positioned to execute with focus and discipline. We look forward to advancing our strategic priorities and providing clear updates on our progress in the quarters ahead. Overall, while we are being thoughtful in how we sequence and advance programs, we remain confident in the depth of the pipeline and the opportunities it presents. With those closing remarks, I'd like to thank everyone for listening, and I'll turn the call over to the operator to begin the question and answer session. Operator?
Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please do limit yourself to one question. Please stand by while we compile the Q&A roster. Our first call is from Eva Fortea with Wells Fargo. Your line is open.
Hi, good afternoon. Congrats on the progress and thanks for taking our questions. A couple from us. First, how should we be thinking about cadence of data for some of your internal pipeline programs in the next 12 months? The second question is on the pan-RAS ADCs. Can you provide some color on timing to reach the clinic and whether you plan to pursue the early clinical stages of development yourselves? Thanks.
No, thanks for that question, Eva. I'll just maybe take the first one, and then I'll pass the second one for Paul to answer, and then happy for Adam to add to Paul's comments as well. You know, I think we've tried to provide, you know, as much guidance as we can on the cadence of data. Obviously, we presented some additional updates on ZW191 at AACR and also just had an abstract accepted for ESMO Gynae in June in Copenhagen. I think we'll continue to have a cadence of, you know, as we understand our data, then we'll be able to present that always in a peer-reviewed format, as I think we've talked about, 'cause we think that's the best practice.
I think you should expect that at oncology meetings throughout the course of 2026 that you will see some additional progress on both clinical and pre-clinical programs in our oncology portfolio. Until we provide guidance about accepted abstracts, just as we're doing now with ESMO Gynae conference coming up next month, then that'll be the only forward guidance we'll provide. I'll turn over to Paul to see if you'd like to answer that second question.
Yeah. I think your second question, Eva, was on the timing of the RAS ADCs and when they could be in the clinic. I think what we shared at AACR is, you know, the strength of our conviction in the choice of the targets and choice of the payload and the mechanism. There are certain IND-enabling activities that you still need to do, the manufacturing, and you'll be ready for the phase I. But we're well-positioned from here to enter into that phase. I think, you know, as Ken alluded to, and maybe Adam can also expand upon, you know, our balance of what we can push internally through as well as through partnerships is something very much, you know, at the front of our mind. That will also be a factor in driving, you know, when they enter the clinic. Certainly they are well-positioned where they are to enter into the IND-enabling stage and be ready, you know, shortly for clinical testing.
Very helpful. Thanks.
Thanks, Paul. Anything you want to add, Adam, or are you okay with that?
No, I think that's well said, right? We've got a lot of belief in these compounds. It's super exciting coming out of AACR and, you know, we're moving them forward as quickly as we can. As soon as we have a real definitive date, we'll share with you guys.
Great. Thank you.
Thank you for your question. Our next question comes from Charles Zhu with LifeSci Capital. Your line is open.
Hello. Can you all hear me all right?
Yes, Charles.
All right, perfect. No technical difficulties this afternoon. Great. Thank you very much for taking our questions, and congrats on all the progress. two quick ones from me, if you don't mind. One, it sounds like you had amended the protocol for ZW251 to include additional tumor types. I guess, as you head towards initial clinical data for that particular asset, you know, how important or not would it be to include some of those other tumor types beyond liver cancer as part of that initial clinical data package? Second question, it sounds like the IND filing for ZW1528, your IL-33, IL-4 receptor alpha bispecific, has been pushed out a little bit. It sounds like you're waiting to understand or see a little bit more about the IL-33 biology.
Could you perhaps, I presume you're talking about the AstraZeneca compound. Could you help us understand, you know, what you're looking for in the full data? Maybe also remind us, on your asset, are you able to block both oxidized and reduced forms of IL-33? Thank you.
Great, great question, Charles. Maybe we'll take your second one first. I'll just make a comment, and then I'll pass it to Paul for more of a technical question, then we can go back to the ZW251 with Sabeen. I mean, obviously we saw some data results last year with respect to IL-33 antibodies and other programs that were not successful, and I think we tried to understand, as clinical data was presented at medical congresses, what that meant and why. Obviously this year, as you mentioned, we've seen a top-line data release of a positive phase III study outcomes in IL-33 in a patient population similar to what we would like to study. Haven't seen the detailed data yet presented at medical congress.
I think we'd like the opportunity to understand that data, when it's presented, and hopefully that's soon, and make sure we understand that and discuss that with our clinicians who are helping us with our planning around the clinical development program we have in mind for ZW1528. I think that, you know, hopefully it's a prudent thing to do to make sure we understand the differences between some of the negative studies and this, what's seen as a positive study before we dive into the clinic. Maybe I'll turn that last technical question over to Paul Moore, and then Sabeen can follow up on ZW251.
Thanks, Charles. Your question was about the blocking of IL-33, the oxidized and the reduced form. you know, we've obviously been characterizing that, understand that, and we feel that we do have the potential to block both pathways. We're still dissecting that more on the mechanism, clearly, you know, we have a very potent IL-33 blocker, it works very well also in the context of the bispecific. There's biology also associated with binding, you know, having the IL-33 binder in a bispecific format with the IL-4 that we are very excited about and we think really differentiates our approach to others. But to your point, we feel that we can, on the IL-33 side, we will be able to block, you know, both forms.
Thank you very much for your question.
Oh, sorry. I'm sorry. Sabeen, do you want to add to that?
Sure.
Go ahead, yeah.
To your question regarding ZW251 of inclusion of additional tumor types for squamous non-small cell lung cancer and germ cell tumors, I think I can explain our rationale behind it. If previously, as we entered into the clinic with ZW251, we chose hepatocellular carcinoma as our lead tumor type due to the high unmet need in this tumor type and also the high levels of expression for GPC3 in this tumor and very little expression in normal tissue. As we've gotten over time more comfortable with our ADCs, and particularly with our folate receptor alpha ADC, where we saw activity in lower levels of expression for the target, we became more comfortable in other tumor types as well. Also over time, there's very little data with regards to expression of GPC3 in other tumor types.
We've been able to go through the literature and also including our data for GPC3 expression in squamous non-small cell lung cancer and germ cell tumors, where we feel very comfortable in including these tumors in our study. It's fairly common for those escalation studies to include multiple solid tumor study or tumors, which is what we're doing at this stage.
Got it. Thank you very much for taking our questions. Congrats on everything.
Thanks, Charles.
Thank you. Our next question is from John Miller with Evercore.
Hi, guys. Thanks so much for taking my question, and congrats on all the progress. I'd like to ask my question on the novel pan-RAS ADCs. In particular, in the criteria you had for selecting the pan-RAS payload that you ended up choosing. Looks like you looked at a number of different molecules here across a variety of different characteristics. It's notable that most other second-gen or next-wave pan-RASs have prioritized high potency, and it doesn't seem like that was your priority next other thing. I'd love to get a little bit more granularity in what you were selecting for in the payload and why you didn't think that pushing potency as far as it could go was the key to success in the next-gen space.
Thanks, Paul. Do you wanna take that?
Yep. Yeah. Thanks, John. Maybe I should clarify that there. You know, it may be that the messaging was that we've looked at payloads that work well as ADCs and emphasize their compatibility as ADCs, and that may have signaled that we weren't so focused on potency. We definitely had a potency bar that we wanted to achieve, and I think you can actually see it in the data that we share today, you know, in the comparison with the same target with a TOPO1i ADC compared to our RAS ADC. We actually have, you know, greater potency. There was definitely a bar of potency that we wanted, and we wanted in the context of an ADC to meet a bar that we felt was necessary.
We also feel because it's a payload potency, there's other attributes that need to be also factored in when we're looking at that. That includes things like bystander activity that we think can also be important, and then also the pharmacokinetic properties, and then also just the balance of tolerability as well. I think what we've done is we've really hit the A, a great place where we've got very good potency, activity in xenograft models in the 1 mg/kg range, whereas the tolerability in non-human primates is 120 mg/kg. That's just, you know, really a very impressive window that we've found. We You know, that taken together is giving us a lot of excitement on this platform.
The fact that we can then plug and play it and apply it to different targets really opens up, you know, scope across different tumor indications. There we can really drive the selectivity of the payload to the tumor through our mechanism, which is not what you can do with the small molecules.
Makes sense. Thanks so much. Maybe to follow up on that NHP comment that you made on the tolerability, can you translate those dose levels that you were talking about? I assume those are ADC dose levels. Can you translate that to the relative level of payload compared to some of the non-ADC based pan-RASs out there?
Yeah. non-pan-RAS. Sorry, say that again, Jonathan. Just ask me that question again. Sorry.
I think you're citing NHP safety data talking about the full dose of the ADC you're giving, which makes sense.
Yes. Yeah.
We're used to looking at tox profiles for other pan-RASs outside of the context of an ADC, those are just naked molecules. Can you give us a sense of the relative amount of payload, you're delivering pre-clinically so I can think about the tolerability profile?
I mean, maybe I don't know if the DAR helps you, but these are DAR 8 antibodies or ADCs. That can help you factor that in. Again, I think we're very much focused on showing the difference in the distribution and the tolerability profile of our ADC. That's what we've really been focused on. Those experiments I showed you, where we're comparing distribution in the tumor versus normal tissue, we think is the key here. That we think this allows us to go very high in dose, and still maintain tolerability. That's really been our focus as opposed to trying to compare against, you know, relative amount of moles or comparison to the small molecules themselves.
That makes perfect sense.
Yep.
Yeah. Thank you so much.
Thanks, sir.
Thank you. Our next question is from Yigal Nochomovitz, my apologies, from Citigroup. Your line is open.
Yeah. Hi. Thanks. Congrats on all the progress. I just had two questions. Jazz had commented on their earnings call regarding some MFN pricing headwinds associated with the ex-U.S. launch of Ziihera. I'm just wondering if you could comment on that with respect to your royalty base for your ex-U.S. royalty stream for Ziihera and how that factored into your thinking about underwriting the $250 million note with Royalty Pharma. With regard to the second interim for overall survival for HERIZON-GEA, which is coming in the middle of the year, I'm just wondering if that is going to be included in the label or that would be a post-approval update. If you could comment on, you know, what the threshold is for that second interim. Thank you.
Thanks, Yigal, for the questions. I think, one, I don't think we wanna comment further than Jazz's observation about Ziihera, you know, having maybe some more pricing pressure outside the U.S. than inside the U.S. I don't think that's unexpected for Ziihera or any pharmaceutical in today's market. Obviously, the way we've modeled out Ziihera, and I think obviously the way that maybe Royalty Pharma has modeled out Ziihera, you know, would have taken into account some of those pricing pressures that may be more significant outside the U.S. market than inside the U.S. market. I don't think that's something that's unexpected.
Again, we'll, you know, have to wait and see with the GEA launch, how that goes, obviously, there's a tremendous clinical benefit that we've seen already with our second-line biliary tract cancer opportunity with Ziihera when you look at the data, and you've obviously seen the clinical data for GEA. There's no doubt we're providing a tremendous clinical benefit for the patient based on our clinical data, compared to the current standard of care, I think that's reflected in pricing reimbursement mechanism. Secondly, beyond that, other than the fact that, you know, Jazz continues to guide that the, you know, next interim analysis will be by mid-year, I don't think we're able to comment further on the regulatory strategy that might be related to that data set.
Thank you.
Yeah, sorry.
Thank you for your question. Our next question comes from Mayank Mamtani with B. Riley Securities. Your line is open.
Hi, this is Paulo on for Mayank. Thank you for taking our questions. Just to touch on the FRα, like, what's the specific durability or subpopulation edge that distinguishes it from the competitors enough to drive a deal? On the RAS, like, you know, to expand on the internal versus the partnership balance, can you speak specifically on the partnership funnel post-AACR? Has the data driven any incremental inbound interest? If so, which one of the three molecules is leading those discussions? Thank you for taking our questions.
No, thanks. I'll cover the second part of your question first, then I'll ask Sabeen to comment on maybe our thoughts around where we think ZW191 might be differentiated from some of the other ADCs in development and therefore the positioning of that. I think, you know, it's fair to say we, you know, we, you know, are open to and have active conversations around our R&D portfolio up and down the portfolio from the furthest clinical asset that's advanced, like ZW191, right to some of the earliest opportunities that we might be working on inside the company.
I think we're open to having those discussions and looking for ways that we can attract partners to share capital, share risk, move more quickly to keep up the competition and also find a way to manage the breadth of the R&D pipeline that we find ourselves with right now, which is, you know, vast and continues to grow, and we need to make sure that we manage our ongoing investments in that, in that R&D portfolio.
I think we have a range of discussions ongoing. I don't think we'll talk further or provide guidance about that until we have completed transactions, and then happy then to talk about the transactions that have been completed and the rationale for it and what we think it brings to us and what we might do next beyond that. You'll just have to wait for announcements of transactions around that. I'll just ask Sabeen to answer the second part of your question about ZW191.
In terms of ZW191 being differentiated from other ADCs, we can clearly see that ZW191 activity is much higher than current standard of care in this therapeutic area in platinum-resistant ovarian cancer. We also see that for approved folate receptor alpha ADCs like mirvetuximab soravtansine, we're clearly showing much stronger response rate as well as a very well-differentiated and improved safety profile. Comparing to other emerging ADCs that are in development, even there, numerically, we're showing the strongest response rate. We haven't really seen many others show longer duration like we have from their phase I trials. We are dosing our ADC at higher dose levels, like we talked about earlier in my presentation, compared to many of the other ADCs in this space.
We believe that these higher dose levels, in terms of the safety profile, we still have a very manageable safety profile, but at higher level of dose that we're delivering to our patients that would ultimately translate into better efficacy at these higher dose levels in larger populations. That we think would be what's gonna be able to differentiate us from our competitors. From a safety profile perspective, we don't have some of the liabilities that some of our competitors have. Our cytopenia rate is pretty low. We do not use prophylactic growth factors. Our agent is, our drug is pretty well tolerable.
Thank you.
Thank you for the questions.
Thank you very much. One moment, please. Our next question is from Reni Benjamin with Citizens. Your line is open.
Hey, good afternoon, guys. Thanks for taking the questions, and congratulations on all the progress. Great AACR for you guys. Maybe just starting off, the first one was for Sabeen. The ESMO Gynae conference that's coming up, can you give us a sense as to, you know, what we should be expecting? Is it just further follow-up from the existing patients, or might we see some updated or initial data from the cohorts that have been fully enrolled? Just related to that, in the data you presented at AACR, I probably missed this, but can you just talk us through the rates of discontinuation and dose reduction that occurred? I'm just trying to, you know, look at these data through a lens of maybe Project Optimus. The second question would be for Paul.
You know, can you walk us through the decision-making process when you determine whether to make a biparatopic antibody versus not? You know, especially the pan-RAS payloads, you have, you know, one that does and two that don't. I'm kind of curious as to how you guys make that decision. Thanks.
Okay. No, thanks, Reni. We'll stop you there too. Maybe, Sabeen, do you wanna answer Reni's questions first, then we'll go to Paul?
Yes. I think one of your questions was with regards to folate receptor alpha ADC presentation at ESMO Gynae. We will be presenting data with regards to folate receptor alpha expression level from our phase I dose escalation study. Our data from dose optimization is gonna be presented sometime later when the data is mature. We just finished enrollment of that cohort. With regards to the data that we did present at AACR for our dose reductions and discontinuations, I mean, I can say that those reductions are fairly very common with ADCs. Our dose reduction rate was very much expected given the long-term follow-up that we've had. Most of these reductions occurred much later in time while patients were on treatment.
These represent. I would say that despite these, we still see a pretty strong efficacy profile, which plays into the fact that many of these patients did get pretty high dose intensity in terms of treatment as we went through their discontinuation levels. In terms of discontinuations, I mean, again, this has happened much longer follow-up, 'cause our median follow-up was over seven months, and many of our patients were in follow-up for much longer than that.
Thanks, Sabeen. Paul, do you want to take the second part of the question?
Sure. It is an easier answer for me to answer, or easier question. What we do when we decide what the antibody vehicle is for the payload is, we basically screen empirically for what gives us the best delivery and activity with the payload, the best internalization, the best tumor penetration. If you look at our papers, we show that. What we test there is if we have an antibody that we can find, a monoclonal antibody that can achieve the optimal level, we go with the antibody. We will test also biparatopic.
For instance, for ZW191, when we tested ZW191, we actually found an antibody that's way better than any other FRα antibody that we had at that time, and since then has also, you know, looks better when we look at other competitor antibodies. Making a biparatopic there didn't give us anything. In the case of something like PTK7, there, what we found was that you can get good internalization with, you know, bispecific looking for antibodies. Based on the structure and the design or the structure of PTK7, it is amenable to biparatopic intervention, you know, binding. It has enough kind of binding sites to give you a meaningful biparatopic.
When we looked at those, we found that those could give us activity way, you know, beyond what you could achieve with just a monoclonal antibody. That's what drove it there. We're always striving to get the best delivery vehicle, the one that gives us the best penetration. Then another important point that, you know, we also bear in mind is actually the pharmacokinetics of those types of molecules. We must make sure we maintain that, and that's something that we also factor into our design of our biparatopics. Hopefully that gives you an answer for your question.
Yeah, it totally does. Just, you know, very quickly as a follow-up, you know, you saw a lot of other companies or the competition increasing, especially in PTK7 and the like. When you guys are doing your preclinical evaluations, are you also comparing it to other products that are in development, if you can, you know, get the structure?
Yes.
You know, how do you do your best comparisons?
Yeah, we do that actually, and it's actually in that PTK7 poster. You know, there was an original antibody, cofetuzumab, that was generated that has been in the clinic before. We compared against that. Subsequently, we know the other PTK7 antibodies. We can make those antibodies and then compare them, you know, for their properties. If you look back at that poster, you'll see the biparatopic also competes those as well.
Excellent. Thanks for taking the questions.
Thanks, Reni.
Thank you. Our next question is from Stephen Willey with Stifel. Your line is open.
Yeah, good afternoon. Thanks for taking the question. Just curious how you're thinking about the scope of incremental development that you're willing to independently pursue with ZW191 here. Do you wanna generate more data in other tumor types besides ovarian? Do you wanna initiate combo trials? I'm just trying to think about the differentiation you've been able to establish to date, and then just how you're thinking about the ROI that's associated with additional work on this asset. Thanks.
Yeah. Thanks, Stephen. I think it's no different than all the programs we have. I think we try to be very thoughtful about staging investments along the way just to make sure we can understand, you know, strategic and competitive positioning of that asset, how that might change, and how an individual dataset might convince us to make additional investment for moving forward. You know, it's very clear with ZW191, we, you know, we're quite encouraged by our dose escalation data initially. We funded, you know, some additional investment in backfill patients to get to the dataset we present at AACR. We think it's very compelling dataset.
We moved very quickly to invest in, you know, a dose optimization cohorts of, you know, 30 each as opposed to, you know, 20 each of those might have done because we think that'll give us a, you know, additional data point that's interesting and, you know, we'll let that data mature and go from there. At the same time, we've been very clear that, you know, it's a very competitive positioning right now in gynecological tumors, both ovarian in different settings and even endometrial. With so many competitors ahead of us, it's hard to see how, without a partner, we could move quickly to take advantage of the properties that we see in ZW191. At some point, that is going to have to be something that we, that we secure to continue to move forward.
I think we'll, you know, continue to present the dose escalation data next month. We'll let the dose optimization cohort mature, and then we'll have to make a decision then about the extent of how that encourages to make additional investments versus, you know, focusing on a partnering transaction that might allow a partner to take on the further investment to push that forward. We'll do that, and we do that the same way with every program that we have.
All right. Thanks for taking the question.
Yeah. No, thanks, Stephen. Appreciate it.
Thank you. Our next question is from Yaron Werber with TD Cowen. Your line is open.
Great. Thanks so much. I guess my first question is, as you kind of think about developing the next, you know, target, how do you determine between an oncology target or an inflammation target, just given the flexibility of the platform? Secondly, the RAS inhibitor itself, can you maybe give us a little bit more information about, was that developed sort of the chemistry completely in-house? Is that something that was using, you know, a kind of a scaffold that's known that you then kind of varied? Where did that agent come from? Thank you.
Yeah, thanks, Yaron. I'll maybe I'll take your first question. I'll leave the second one for Paul. I, you know, I think historically in Zymeworks, all of our initial work starting from zanidatamab were in solid tumor indications. I think when we decided to also add ADCs to our multispecific antibodies, we focused on solid tumor. I think, you know, since then, we've been a little more open to looking at targets that might have some interest in heme-onc, as well as in autoimmune inflammatory, and that's why we started working more closely in that area. I think we do like the breadth, the additional breadth of opportunity that's provided by having something that goes beyond solid tumors to look for opportunities.
I think for the most part, we're kind of indifferent as to the therapeutic area, as opposed to looking for something that's a real need that we think our technology approach can provide a potential for a superior patient benefit. We'll just allow the opportunities that we might have in front of us in our platform be applied, taken into those therapeutic areas. We don't really predetermine targets in specific areas or quotas or allocations of where we wanna spend our time. We're just open to looking at a broader context than maybe we did earlier in Zymeworks' history. We'll just go where the opportunities where we find them. I'll let Paul answer the second question about the medicinal chemistry for the RAS payload.
Yeah. Yeah. Thanks, Ken. Yeah. What we did there was to get the proof of concept, we actually did use the RevMed pan-RAS inhibitor. That gave us indication that we could, you know, an ADC could work for this type of payload. What we then did after that was we then generated a whole panel in-house of novel payloads, really more focusing though on those payloads for their chemistry properties and their structural properties that, again, were compatible with the ADC. These are novel structures that we had generated by tweaking certain chains and, you know, working off of a structure, but making new modifications there that were compatible with ADC and all the properties I just talked about. These would be considered novel payloads.
Thank you for your question. Our next question is from Brian Cheng with JPMorgan. Your line is open.
Hey, guys. Thanks for taking our question this afternoon. I'm just curious if you could give us directionally how we should think about your development path or your development strategy for your pan-RAS ADC approaches here. You know, you have different targets attached to a pan-RAS. How should we think about the positioning here? You know, whether it makes the most sense to go after PDAC first or lung or colorectal, you know, do you have a sense of which is the best target, which one has the best probability of success based on where you are today? Thank you.
No, thanks for the question, Brian. I'll let Paul answer that question, other than the observation that, you know, I just thought AACR, we don't like to do things one at a time. I think as you saw with our TOPO1i payload ADCs, we just believe trying to apply the technology to multiple opportunities at the same time, and that's why you saw three disclosed at AACR. I think it gives us some optionality of the ordering and how to pursue prioritization, make sure we pay attention to competitive advantage of what we might be doing versus what others might be. I'll just let Paul maybe describe a little bit more about our approach and why those three and why those indications were selected and what they bring, and each of those targets brings something different.
Thank you, Ken. Yeah, that's right. The thinking there, Brian, is we wanted to have ADCs that are really, you know, designed with the tumor in mind. This is a big, you know, one of our sort of differentiating factors here is that we can target to the tumor. By having antibodies that can give us coverage across the different tumor types that are mutated by RAS, it just gives us the whole sort of universe of RAS and have RAS tumors that we can go after. Each one of them will have strength for particular tumor types, as you allude to. That puts us now in a position where we can think through, you know, development strategies and not be restricted by just having one ADC against a particular target.
Regarding where we think we will go, I think that, you know, I'm not in a position to discuss that in detail. That is definitely something that the molecules provide a lot of optionality, and again, it could provide optionality through certain partnerships or programs that we take through ourselves. That's about as best I can answer that. What I can say is that, you know, the design of those, again, the features of those molecules, we thought very much about the antibody and the target because the coverage it can give you within the RAS space. Some of our publications presented showed that.
For instance, the reason we picked PTK7 for lung cancer is that the penetrance of PTK7 expression in lung cancer supports, but also in the RAS mutated lung cancer, we see very high penetrance of that tumor marker. We think we're well-positioned.
Okay. That's very helpful, Paul. Thank you.
Thank you, Brian.
This does conclude our question and answer session. I would now like to turn it back to Ken for closing remarks.
Thank you very much. Thank you everyone for joining us. I know it's been a very busy earnings season this week in particular, so really appreciate you taking the time to listen to our progress. We very much look forward to reporting progress over the weeks and months ahead. Thank you very much.
Thank you for your participation in today's conference. This does conclude our program. You may now disconnect.
Investor releaseQuarter not tagged2026-05-05Vertex Pharmaceuticals (VRTX) Q1 Earnings and Revenues Beat Estimates
Zacks
Vertex Pharmaceuticals (VRTX) Q1 Earnings and Revenues Beat Estimates
Vertex Pharmaceuticals (VRTX) came out with quarterly earnings of $4.47 per share, beating the Zacks Consensus Estimate of $4.23 per share. This compares to earnings of $4.06 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +5.76%. A quarter ago, it was expected that this drugmaker would post earnings of $5.07 per share when it actually produced earnings of $5.03, delivering a surprise of -0.79%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Vertex, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $2.99 billion for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 0.19%. This compares to year-ago revenues of $2.77 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Vertex shares have lost about 6.5% since the beginning of the year versus the S&P 500's gain of 5.6%. While Vertex has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Vertex was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy…Read full documentShow less
Vertex Pharmaceuticals (VRTX) came out with quarterly earnings of $4.47 per share, beating the Zacks Consensus Estimate of $4.23 per share. This compares to earnings of $4.06 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +5.76%. A quarter ago, it was expected that this drugmaker would post earnings of $5.07 per share when it actually produced earnings of $5.03, delivering a surprise of -0.79%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Vertex, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $2.99 billion for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 0.19%. This compares to year-ago revenues of $2.77 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Vertex shares have lost about 6.5% since the beginning of the year versus the S&P 500's gain of 5.6%. While Vertex has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Vertex was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $4.74 on $3.18 billion in revenues for the coming quarter and $18.96 on $13.01 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Zymeworks Inc. (ZYME), another stock in the same industry, has yet to report results for the quarter ended March 2026. The results are expected to be released on May 7. This company is expected to post quarterly loss of $0.10 per share in its upcoming report, which represents a year-over-year change of +66.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Zymeworks Inc.'s revenues are expected to be $44.85 million, up 65.4% from the year-ago quarter. 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 Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report Zymeworks Inc. (ZYME) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

