Respiratory Syncytial Virus Vaccine(Moderna)

Reports fourth quarter revenue of $0.7 billion, GAAP net loss of $(0.8) billion and GAAP EPS of $(2.11) Reports full-year revenue of $1.9 billion, GAAP net loss of $(2.8) billion and GAAP diluted EPS of $(7.26) Reiterates plan to deliver up to 10% revenue growth and GAAP operating expense reductions in 2026 Announces influenza vaccine filing accepted for regulatory review in the EU, Canada and Australia; Company received Refusal-to-File letter from U.S. FDA and has requested Type A meeting to understand path forward Announces Norovirus Phase 3 trial fully enrolled with a data readout expected in 2026 Announces full enrollment of Phase 2 intismeran autogene trial in muscle invasive bladder cancer CAMBRIDGE, MA / ACCESS Newswire / February 13, 2026 / Moderna, Inc. (NASDAQ:MRNA) today reported financial results and provided business updates for the fourth quarter of 2025. "In 2025, we sharpened our commercial execution, launched our third product and brought online three international manufacturing sites, while advancing our mRNA pipeline. At the same time, we lowered our annual operating expenses by approximately $2.2 billion, significantly surpassing our cost-reduction targets," said Stéphane Bancel, Chief Executive Officer of Moderna. "We entered the new year with strong momentum despite the continued challenging environment in the U.S., poised to deliver up to 10 percent revenue growth through mNEXSPIKE expansion and our international strategic partnerships. We look forward to delivering multiple potential product approvals and late-stage clinical readouts, while driving continued innovation across our mRNA platform." Commercial Updates Moderna is entering the year with three approved products, Spikevax ® , mNEXSPIKE ® and mRESVIA ® , with seasonal vaccines expected to deliver up to 10% revenue growth in 2026. In line with its strategy to drive growth through geographic expansion and new product launches, the Company recently announced long-term agreements with Mexico and Taiwan for respiratory vaccines, received regulatory approvals in Canada and Australia for mNEXSPIKE, and the strain-updated Spikevax vaccine was authorized in the UK for use in the spring vaccination campaign. The Company also announced a strategic collaboration with Recordati to globally commercialize Moderna's propionic acidemia candidate. Fourth Quarter 2025 Financial Results Revenue : Total revenue for the fourth quarter of 2025 was $678 million, on the higher end of the Company's prior expectations, and was driven primarily by COVID vaccine sales. Product sales were $264 million in the U.S. and $381 million in international markets. Fourth quarter revenue decreased 30% compared to the same period in 2024, primarily reflecting lower COVID vaccine sales volume compared to the prior-year period. Cost of Sales: Cost of sales for the fourth quarter of 2025 was $452 million, including third-party royalties of $34 million and inventory write-downs of $144 million. Cost of sales decreased 39% compared to the same period in 2024, primarily reflecting lower contract manufacturing wind-down costs and inventory write-downs. Research and Development Expenses: Research and development expenses for the fourth quarter of 2025 were $775 million, a 31% decrease compared to the same period in 2024. The decrease was driven primarily by lower clinical development and manufacturing costs, reflecting the wind-down of large Phase 3 respiratory programs, continued portfolio prioritization and cost discipline across the organization. Selling, General and Administrative Expenses: Selling, general and administrative expenses for the fourth quarter of 2025 were $308 million, a 12% decrease compared to the same period in 2024. The decline was primarily driven by reductions in consulting and external services across multiple functions, reflecting continued discipline across the organization. Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets. Net Loss: Net loss was $(826) million for the fourth quarter of 2025, compared to net loss of $(1.1) billion for the fourth quarter of 2024. Loss Per Share: Loss per share was $(2.11) for the fourth quarter of 2025, compared to loss per share of $(2.91) for the fourth quarter of 2024. Full Year 2025 Financial Results Revenue : Total revenue for the full year 2025 was $1.9 billion, a 40% decrease compared to 2024, with the majority generated from COVID vaccine sales, along with $126 million of other revenue. U.S. revenue totaled $1.2 billion, while revenue from international markets was $745 million. The year-over-year decrease primarily reflected lower COVID vaccine sales volume across all regions. During 2025, the Company also began recognizing stand-ready manufacturing revenue related to its long-term strategic partnerships, which is reported in other revenue. Cost of Sales: Cost of sales for the full year 2025 was $868 million, including third-party royalties of $88 million and inventory write-downs of $291 million. Cost of sales decreased 41% compared to 2024, driven primarily by manufacturing productivity and operational efficiencies, lower inventory write-downs, lower contract manufacturing wind-down costs, and lower sales volume. Research and Development Expenses: Research and development expenses for the full year 2025 were $3.1 billion, a 31% decrease compared to 2024. The decrease was driven primarily by lower clinical development and manufacturing costs, reflecting the wind-down of large Phase 3 respiratory programs, continued portfolio prioritization and cost discipline across the organization. These decreases were partially offset by increased investment in the Company's norovirus vaccine and oncology programs. In addition, 2024 included costs related to the purchase of two priority review vouchers, which did not recur in 2025. Selling, General and Administrative Expenses: Selling, general and administrative expenses for the full year 2025 were $1.0 billion, a 13% decrease compared to 2024. The decrease was driven primarily by lower consulting and external services, along with reduced spending across multiple functions and operating areas, while the Company continued to invest in supporting its commercial operations and broader business activities. Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets. Net Loss: Net loss for the full year 2025 was $2.8 billion, compared to $3.6 billion for the full year 2024. Loss Per Share: Loss per share for the full year 2025 was $(7.26), compared to $(9.28) for the full year 2024. Cash Position: Cash, cash equivalents and investments as of December 31, 2025, were $8.1 billion, compared to compared to $9.5 billion as of December 31, 2024. The year-end balance included a $600 million initial draw on the Company's $1.5 billion credit facility, with the year-over-year decrease primarily driven by operating losses associated with continued investment in research and development and advancement of the Company's pipeline. 2026 Financial Framework Revenue: The Company is targeting up to 10% growth from 2025 revenue and expects 2026 revenue split to be approximately 50% U.S. and approximately 50% international. Cost of Sales: Cost of sales for 2026 is expected to be approximately $0.9 billion. Research and Development Expenses: Research and development expenses for 2026 are anticipated to be approximately $3.0 billion. Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2026 are projected to be approximately $1.0 billion. Income Taxes: The Company expects its full-year tax expense to be negligible. Capital Expenditures: Capital expenditures for 2026 are expected to be $0.2 to $0.3 billion. Cash and Investments: Year-end cash and investments for 2026 are projected to be $5.5 to $6.0 billion. Excludes any additional draw down from the Company's credit facility. Recent Progress and Upcoming Late-Stage Pipeline Milestones Infectious disease vaccines: Seasonal flu + COVID vaccine : Currently, the Company's mRNA-1083 regulatory filing is under review in Europe and Canada. Moderna is awaiting further guidance from U.S. FDA on refiling the submission for its flu/COVID combination vaccine. Seasonal flu vaccine : The Company's mRNA-1010 regulatory filings are under review in Europe, Canada and Australia and potential approvals are expected to begin in 2026. Moderna received a Refusal-to-File letter from the U.S. FDA and has requested a Type A meeting to understand the path forward. Norovirus vaccine : Moderna's ongoing Phase 3 safety and efficacy study of mRNA-1403 is fully enrolled in a second Northern Hemisphere season (2025-2026) with a data readout expected in 2026, subject to case accruals. Oncology therapeutics: Intismeran autogene : The Company is advancing mRNA-4157 in collaboration with Merck, with eight total Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. The Phase 3 adjuvant melanoma, the Phase 2 adjuvant renal cell carcinoma, and most recently, the Phase 2 adjuvant muscle invasive bladder cancer trials are fully enrolled. Moderna and Merck recently announced positive five-year Phase 2b adjuvant melanoma data, which showed intismeran autogene in combination with KEYTRUDA reduced the risk of recurrence or death by 49% compared to KEYTRUDA alone. Moderna expects Phase 3 adjuvant melanoma data potentially in 2026. mRNA-4359 : Moderna's Phase 1/2 study of mRNA-4359, an investigational wholly-owned cancer antigen therapy, is ongoing. The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and the Company expects a potential Phase 2 data readout in 2026. Rare disease therapeutics: Propionic acidemia (PA) therapeutic : The Company's PA candidate, mRNA-3927, is in a registrational study and target enrollment has been reached. Moderna expects a potential data readout in 2026. Methylmalonic acidemia (MMA) therapeutic : Moderna's mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, with a registrational study expected to begin in 2026. Moderna Corporate Updates Hosted Analyst Day event highlighting pipeline progress and business strategy updates on November 20, 2025. Published Moderna CEO Stéphane Bancel's annual letter to shareholders on January 5, 2026. Provided business and pipeline updates at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026. Appointed David Berman, M.D., Ph.D. to Chief Development Officer of Moderna, effective March 2, 2026. Scheduled the Moderna Annual Meeting of Shareholders to be held on Wednesday, May 6, 2026, at 8:00 a.m. ET. Company Accolades Moderna was recognized by TIME as one of America's Most Iconic Companies. Key 2026 Investor and Analyst Event Dates Analyst Day: November 12 Investor Call and Webcast Information Moderna will host a live conference call and webcast at 8:00 a.m. ET on February 13, 2026. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website. Telephone: Webcast: The archived webcast will be available on Moderna's website approximately two hours after the conference call and will be available for one year following the call. About Moderna Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn. MODERNA, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited, in millions, except per share data) Three Months Ended December 31, Years Ended December 31, 2025 2024 2025 2024 Revenue: Net product sales $ 645 $ 938 $ 1,818 $ 3,109 Other revenue 1 33 28 126 127 Total revenue 678 966 1,944 3,236 Operating expenses: Cost of sales 452 739 868 1,464 Research and development 775 1,122 3,132 4,543 Selling, general and administrative 308 351 1,018 1,174 Total operating expenses 1,535 2,212 5,018 7,181 Loss from operations (857 ) (1,246 ) (3,074 ) (3,945 ) Interest income 70 91 314 425 Other expense, net (12 ) (29 ) (8 ) (87 ) Loss before income taxes (799 ) (1,184 ) (2,768 ) (3,607 ) Provision for (benefit from) income taxes 27 (64 ) 54 (46 ) Net loss $ (826 ) $ (1,120 ) $ (2,822 ) $ (3,561 ) Net loss per share Basic and Diluted $ (2.11 ) $ (2.91 ) $ (7.26 ) $ (9.28 ) Weighted average common shares used in calculation of net loss per share Basic and Diluted 392 385 389 384 _______ 1 Includes grant, collaboration, licensing and royalty, and stand-ready manufacturing revenue. MODERNA, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited, in millions) December 31, December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 2,595 $ 1,927 Investments 3,204 5,098 Accounts receivable, net 184 358 Inventory 153 117 Prepaid expenses and other current assets 408 599 Total current assets 6,544 8,099 Investments, non-current 2,336 2,494 Property, plant and equipment, net 2,134 2,196 Right-of-use assets, operating leases 719 759 Other non-current assets 605 594 Total assets $ 12,338 $ 14,142 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 317 $ 405 Accrued liabilities 1,386 1,427 Deferred revenue 99 153 Other current liabilities 185 221 Total current liabilities 1,987 2,206 Deferred revenue, non-current 153 58 Operating lease liabilities, non-current 653 671 Financing lease liabilities, non-current 20 39 Long-term debt 590 - Other non-current liabilities 285 267 Total liabilities 3,688 3,241 Stockholders' equity: Additional paid-in capital 1,382 866 Accumulated other comprehensive income (loss) 45 (10 ) Retained earnings 7,223 10,045 Total stockholders' equity 8,650 10,901 Total liabilities and stockholders' equity $ 12,338 $ 14,142 MODERNA, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited, in millions) Years Ended December 31, 2025 2024 Operating activities Net loss $ (2,822 ) $ (3,561 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 483 429 Depreciation and amortization 215 189 Amortization/accretion of investments (67 ) (95 ) Loss on equity investments, net 8 52 Other non-cash items 77 60 Changes in assets and liabilities: Accounts receivable, net 156 534 Prepaid expenses and other assets 153 145 Inventory (34 ) 83 Right-of-use assets, operating leases 38 (53 ) Accounts payable (92 ) (69 ) Accrued liabilities (2 ) (385 ) Deferred revenue 41 (439 ) Operating lease liabilities (21 ) 28 Other liabilities (6 ) 78 Net cash used in operating activities (1,873 ) (3,004 ) Investing activities Purchases of marketable securities (5,768 ) (6,529 ) Proceeds from maturities of marketable securities 5,563 5,562 Proceeds from sales of marketable securities 2,353 3,967 Purchases of property, plant and equipment (192 ) (1,051 ) Purchase of intangible asset (10 ) - Net cash provided by investing activities 1,946 1,949 Financing activities Proceeds from credit facility 600 - Payments of credit facility issuance costs (22 ) - Proceeds from issuance of common stock through equity plans 35 66 Tax payments related to net share settlements on equity awards (2 ) - Changes in financing lease liabilities (18 ) (10 ) Net cash provided by financing activities 593 56 Effect of changes in exchange rates on cash and cash equivalents 2 - Net increase (decrease) in cash, cash equivalents and restricted cash 668 (999 ) Cash, cash equivalents and restricted cash, beginning of year 1,929 2,928 Cash, cash equivalents and restricted cash, end of period $ 2,597 $ 1,929 Spikevax ® , mRESVIA ® and mNEXSPIKE ® are registered trademarks of Moderna. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's 2026 financial framework, including its plan to deliver up to 10% revenue growth and GAAP operating expense reductions, and its projected year-end cash balance; Moderna's commercial growth drivers, including geographic expansion and new product launches; Moderna's continued cost discipline; anticipated mNEXSPIKE expansion; Moderna's international strategic partnerships; potential mRNA-4157 Phase 3 adjuvant melanoma data in 2026; the potential of Moderna's expanded oncology portfolio; pending and anticipated regulatory filings and potential approvals, including timing of approvals; Moderna's strategic collaboration with Recordati; Moderna's requested Type A meeting to understand the path forward for mRNA-1010; and anticipated progress and milestones for Moderna's pipeline programs, including potential near-term data readouts and other catalysts. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. ### Moderna Contacts Media: Chris Ridley Head of Global Media Relations +1 617-800-3651 Chris.Ridley@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire

iStock, nukrist After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape. BioNTech and Moderna were two of the big winners of the COVID-19 pandemic. Having gone into 2020 as leaders in the promising but unproven mRNA space, the biotechs quickly made vaccines that validated the modality, generated billions of dollars and further extended their leads over rivals such as CureVac. Both companies looked set for bright futures. A few years later, their fortunes have diverged, with BioNTech building an expansive pipeline beyond mRNA as Moderna has grappled with challenges. BioNTech commands a market cap north of $20 billion, making the company more than twice as valuable as Moderna. The valuations reflect Moderna’s decline over the past two years, with the company shedding value as BioNTech has held steady. Before the recent shift, Moderna and BioNTech followed seemingly similar trajectories. Equipped with mRNA platforms, the companies attracted mega-rounds and partnerships with top pharma companies before seeing their valuations skyrocket as they changed the course of the pandemic. Yet the similarities masked differences that sowed the seeds of the recent divergence in the biotechs’ fortunes. BioNTech Buys Bumper Pipeline While mRNA put BioNTech on the map, even early in the company’s history the modality was just one of a range of technologies at its disposal. This is a core difference between the companies. BioNTech applied an array of modalities to one therapeutic area, with some exceptions that took the company beyond its focus on cancer. Moderna applied one modality, mRNA, to a wide range of therapeutic areas. That difference has shaped the post-pandemic trajectories of BioNTech and Moderna. Flush with money from its Pfizer-partnered COVID-19 shot, BioNTech doubled down on its multi-modality cancer strategy. BioNTech supported its in-house mRNA pipeline with deals for assets including the anti-CTLA-4 antibody gotistobart , HER2-directed antibody-drug conjugate (ADC) BNT323 and PD-L1xVEGF-A bispecific BNT327 . The pipeline’s potential has analysts excited. “All eyes are now on whether BioNTech can move fast and execute on this impressive pipeline in a way that drives value, as they are playing in competitive spaces,” TD Cowen analysts said in a note to investors. “There is a lot here to drive interest, but we note that the company has historically had some slippage of timelines ... or outright attrition for pipeline assets.” Vaccines Pesky ‘Macro Factors’—aka RFK Jr.—Come for Vaccine Pharmas’ Wallets Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs. November 7, 2025 · 4 min read · Annalee Armstrong Read More BNT327, now known as pumitamig, is the main event. BioNTech secured rights to the asset before the surge in interest in PD-1/L1xVEGF bispecifics, allowing it to acquire the program for a relatively small sum. Bristol Myers Squibb paid BioNTech $3.5 billion to co-develop the asset, reflecting pumitamig’s potential to replace Keytruda as the backbone of immuno-oncology combinations. Pumitamig is one of several BioNTech assets that are in Phase III trials. BioNTech is on course to report Phase III results for gotistobart, pumitamig and BNT323, plus mRNA vaccine BNT113, next year. While pumitamig has the highest sales ceiling, TD Cowen analysts said gotistobart is “a nice commercial opportunity.” The analysts were writing after seeing non-pivotal Phase III data. Moderna’s mRNA Moves Miss the Mark The deal-driven creation of a pipeline stacked with promising late-phase cancer candidates has enabled BioNTech to move beyond the COVID-19 vaccine that transformed its fortunes. Phase III failures could cause the strategy to unravel but to date BioNTech has performed better than Moderna with investors in the post-pandemic era. As BioNTech diversified, Moderna bet big on its internal pipeline, seeking to replicate its COVID-19 success by developing mRNA vaccines against an array of respiratory diseases. The biotech’s R&D budget rose from $2 billion in 2021 to $4.8 billion in 2023 . With a broad late-phase push planned, Moderna told investors in its 2023 annual report that it aimed to launch up to 15 products in five years. Multiple factors derailed Moderna’s plans. The contraction of the COVID-19 market and loss of share to Pfizer and BioNTech caused the company’s product sales to fall from $18.4 billion in 2022 to $3.1 billion in 2024 . Moderna responded by cutting costs and dropping R&D programs in a push for profitability. At the same time, the biotech’s efforts to ease reliance on its COVID-19 vaccines suffered setbacks. The FDA approved Moderna’s RSV vaccine mRESVIA in 2024. The timing meant Moderna missed out on the bumper first year of the market. Moderna has struggled to win market share from GSK and Pfizer, with a Guggenheim Securities review of prescriptions for the week ended November 21 putting its stake at just 2%. Earnings BioNTech Commits to Infectious Diseases Amid Questions Over Vaccine Demand The company expects that the U.S. COVID-19 vaccination rate will be “maybe a couple of points lower” than the prior level of around 20% but that pricing and Comirnaty’s market share will hold steady. August 4, 2025 · 2 min read · Nick Paul Taylor Read More Moderna’s plans to launch a third product were delayed when the FDA requested efficacy data from a Phase III trial of its flu vaccine. The request prompted Moderna to withdraw a request for FDA approval of its flu/COVID combination vaccine. Moderna now sees the flu shot as a growth driver for 2027 onward and the combination vaccine as a product that will start to move the needle in 2028. A norovirus shot, which Moderna sees as a growth driver for 2028 onward, rounds out the biotech’s near-term seasonal vaccine strategy. The oncology candidates intismeran and mRNA-4359, plus the rare disease prospect mRNA-3927, give Moderna more shots on goal that could add to growth in the coming years. One concern is how the candidates, all of which are based on mRNA, will be received by regulators and patients. Piper Sandler analyst Ted Tenthoff said at an event with Moderna in December 2025 that “under the FDA and [Health Secretary] RFK Jr., it really feels like they’ve declared war on mRNA vaccines.” Moderna has now bowed to that pressure , with CEO Stéphane Bancel announcing at the World Economic Forum in Davos, Switzerland, last month that the famed biotech would scale down investment in late-stage vaccines as the U.S. market snaps shut. “You cannot make a return on investment if you don’t have access to the U.S. market,” Bancel said, according to a report from Bloomberg . Bancel’s remarks were vague, and the company has yet to clarify the future direction of the vaccine programs, and whether the shift will apply to just the infectious disease portfolio or all. Nevertheless, investors were happy with a change in direction. The company’s shares have risen 50% since the year began—but BioNTech’s are climbing too. Moderna will continue to face the challenge of executing its late-phase strategy while contending with an FDA that recently linked the deaths of children to COVID-19 vaccines and vowed to tighten regulations. Having moved beyond mRNA vaccines, BioNTech’s headaches are largely limited to the R&D uncertainties and operational challenges that are common to all drug development. .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to BioPharm Executive! 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