業績公告
即時報告
8-K
2026-07-31
Moderna第二季虧損收窄至8.2億美元 重申全年收入增長目標
AI 繁中摘要
Moderna(納斯達克:MRNA)於7月31日公佈2026年第二季度業績(8-K文件),並更新業務進展。期內收入為1.45億美元(約0.1十億),較去年同期的1.42億美元輕微增長;淨虧損為8.2億美元(GAAP),每股虧損1.97美元,對比去年同期虧損8.25億美元及每股虧損2.13美元,虧損幅度收窄約5%。
📊 財務重點:
- 美國市場收入8,700萬美元,國際市場收入5,800萬美元。
- 銷售成本9,300萬美元,按年下降22%,主要受惠於生產效率提升。
- 研發開支6.51億美元,按年減少7%;銷售及行政開支2.16億美元,按年減少6%。
- 截至2026年6月30日,現金、現金等價物及投資總額為69億美元,低於3月底的75億美元;7月已支付9.5億美元訴訟和解款項。
🚀 業績指引及展望:
- 重申2026年收入目標為較2025年增長最多10%,預期美國及國際市場各佔約一半。
- 下調全年銷售成本預測至約17億美元(前值約18億美元);研發開支預測降至約29億美元(前值約30億美元)。
- 預期2026年底現金及投資改善至47億至52億美元,較先前預測增加約2億美元。
- 管理層指下半年將迎來多個重要催化劑。
💊 管線進展:
- 季節性流感疫苗mFLUSIVA獲美國FDA諮詢委員會一致推薦,PDUFA目標日期為8月5日,有望成為公司第五款獲批產品。
- 諾羅病毒疫苗mRNA-1403的第三期中期分析未達早期成功統計標準,試驗將繼續,並計劃增聘額外隊列。
- 黑色素瘤候選藥物intismeran(mRNA-4157)與默沙東合作,第三期輔助治療數據有望於2026年公佈;早前公佈的五年第二期數據顯示,與KEYTRUDA聯合用藥可將復發或死亡風險降低49%。
- 其他監管進展包括:mRESVIA獲澳洲及墨西哥批准、mNEXSPIKE獲日本及台灣批准;mCOMBRIAX獲歐盟授權。
🏢 企業動態:
- 委任Ester Banque為新任首席商務官,6月15日生效。
- 委任前Biogen財務總監Michael McDonnell為董事會成員,7月8日生效。
- Moderna獲《時代》雜誌評為全球最具影響力企業第一位。
整體而言,Moderna第二季度收入持平,但虧損收窄,成本控制見效;管理層維持收入增長目標,並上調年底現金預測,反映財務狀況略有改善。惟諾羅病毒疫苗中期數據未達標,為管線前景增添不確定性;投資者需留意8月5日mFLUSIVA的FDA審批結果,以及下半年其他關鍵臨床數據公佈。📉📈
展開英文正文
EX-99.1 2 exhibit9912026q2pressrelea.htm EX-99.1 Document Exhibit 99.1 Moderna Reports Second Quarter 2026 Financial Results and Provides Business Updates Reports second quarter revenue of $0.1 billion, GAAP net loss of $(0.8) billion and GAAP EPS of $(1.97) Reiterates plan to deliver up to 10% revenue growth in 2026 Improves 2026 GAAP operating expense outlook by approximately $0.2 billion from previous estimate and improves expected 2026 year-end cash balance to $4.7 - 5.2 billion Anticipates potential approval of Moderna's fifth product with the August 5th PDUFA date for mFLUSIVA, the Company's seasonal influenza vaccine candidate Announces that mRNA-1403, Moderna’s norovirus vaccine candidate, did not meet statistical criteria for early success at the Phase 3 interim analysis and the Company is preparing to enroll an additional cohort CAMBRIDGE, MA / ACCESSWIRE / July 31, 2026 / Moderna, Inc. (NASDAQ:MRNA) today reported financial results and provided business updates for the second quarter of 2026. "The second quarter marked another period of strong execution for Moderna as we advanced our pipeline and strengthened our financial profile with an improved 2026 operating expense outlook," said Stéphane Bancel, Chief Executive Officer of Moderna. "In the second half of 2026, we are preparing for the potential approval of mFLUSIVA in the U.S., which would be our fifth approved product, and continue to anticipate important pivotal readouts for our intismeran in melanoma and propionic acidemia programs." Commercial Updates During the second quarter, Moderna continued to advance its multi-year revenue growth strategy by executing on strategic partnerships and key approvals. In Brazil, a collaboration was signed with a local manufacturer in support of a supply agreement for COVID vaccines. In the EU, the Company signed a joint procurement contract with the European Commission on behalf of six countries for up to 24 million doses of mRESVIA®. Moderna also received regulatory approvals in Australia and Mexico for mRESVIA and in Japan and Taiwan for mNEXSPIKE®, and its investigational seasonal influenza vaccine, mFLUSIVA®, received a unanimous recommendation from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) ahead of an August 5 Prescription Drug User Fee Act (PDUFA) goal date in the U.S. Second Quarter 2026 Financial Results Revenue: Total revenue for the second quarter of 2026 was $145 million, compared to $142 million in the same period in 2025. Lower COVID vaccine sales in the U.S. and South America were offset by deliveries in the United Kingdom under a long-term strategic government partnership and higher 1 stand-ready manufacturing and collaboration revenue. Revenue was $87 million in the U.S. and $58 million in international markets. Cost of Sales: Cost of sales for the second quarter of 2026 was $93 million, including $41 million of inventory write-downs, $23 million of unutilized manufacturing capacity costs, and $11 million of third-party royalties. Cost of sales decreased by 22% compared to the same period in 2025, primarily reflecting lower unutilized manufacturing capacity costs resulting from continued manufacturing productivity improvements and operational efficiencies. Research and Development Expenses: Research and development expenses for the second quarter of 2026 were $651 million, a 7% decrease compared to the same period in 2025. The decrease was primarily driven by lower clinical development costs following the wind-down of several late-stage programs. Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of 2026 were $216 million, a 6% decrease compared to the same period in 2025. The decrease reflected 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 $(0.8) billion for the second quarter of 2026, an improvement of $43 million, or 5%, compared to the second quarter of 2025. Loss Per Share: Loss per share was $(1.97) for the second quarter of 2026, compared to loss per share of $(2.13) for the second quarter of 2025. Cash Position: Cash, cash equivalents and investments as of June 30, 2026, were $6.9 billion, compared to $7.5 billion as of March 31, 2026. The decrease primarily reflected cash used to fund operations, continued investment in research and development and advancement of the Company’s pipeline. The Company subsequently paid $950 million in July 2026 related to the litigation settlement announced in the first quarter of 2026. 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. Moderna expects approximately 55% of its second half 2026 revenue to be recognized in the third quarter. Cost of Sales: Cost of sales for 2026 is expected to be approximately $1.7 billion, lowered from approximately $1.8 billion, and including the $0.9 billion non-recurring litigation settlement charge. Research and Development Expenses: Research and development expenses for 2026 are now anticipated to be approximately $2.9 billion, lowered from approximately $3.0 billion. Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2026 are projected to be approximately $1.0 billion. 2 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 now projected to be $4.7 to $5.2 billion, an improvement of approximately $0.2 billion. This excludes any further drawdowns from the Company's remaining $0.9 billion available under its credit facility. Recent Progress and Upcoming Late-Stage Pipeline Milestones Infectious disease vaccines: •Seasonal flu + COVID vaccine: Moderna has received European Commission marketing authorization for mCOMBRIAX in the EU and its mRNA-1083 regulatory filings are under review in Japan, Canada and Australia. The Company is awaiting further guidance from the U.S. FDA on refiling the submission for its flu plus 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. The U.S. FDA has assigned a PDUFA date for mRNA-1010 of August 5, 2026. •Norovirus vaccine: Moderna's Phase 3 safety and efficacy study of mRNA-1403 did not meet statistical criteria for early success at the Phase 3 interim analysis. The trial is ongoing and remains blinded as the Company works toward enrolling an additional cohort. Oncology therapeutics: •Intismeran autogene: The Company is advancing mRNA-4157 in collaboration with Merck, with nine 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. This includes the Phase 3 study of intismeran as monotherapy and in combination with KEYTRUDA QLEX for the treatment of high-risk Stage 1 NSCLC announced last quarter. Fully enrolled studies include a Phase 3 adjuvant melanoma, a Phase 2 adjuvant renal cell carcinoma, and a Phase 2 adjuvant muscle invasive bladder cancer. Moderna expects Phase 3 adjuvant melanoma data potentially in 2026. The Company recently presented positive five-year Phase 2b adjuvant melanoma data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, which showed a sustained benefit with intismeran in combination with KEYTRUDA, reducing the risk of recurrence or death by 49% compared to KEYTRUDA alone. •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. Rare disease therapeutics: 3 •Propionic acidemia (PA) therapeutic: The Company's PA candidate, mRNA-3927, is in a registrational study and target enrollment has been reached. Moderna expects potential data in 2026. •Methylmalonic acidemia (MMA) therapeutic: The Company deferred its decision on a pivotal trial for mRNA-3705 until PA registrational data readout. Moderna Corporate Updates •Appointed Ester Banque to Chief Commercial Officer of Moderna, effective June 15, 2026. •Appointed Michael McDonnell, former Chief Financial Officer of Biogen, to Moderna's Board of Directors, effective July 8, 2026. Company Accolades •Moderna was ranked no. 1 by TIME on its list of the World's Most Impactful 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 July 31, 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: https://register-conf.media-server.com/register/BI9a3abdd346bd413a90a4701513c4ca38 •Webcast: https://investors.modernatx.com 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. 4 MODERNA, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited, in millions, except per share data) Three Months Ended June 30,Six Months Ended June 30, 2026202520262025 Revenue: Net product sales$94 $114 $446 $200 Other revenue1 51 28 88 50 Total revenue145 142 534 250 Operating expenses: Cost of sales93 119 1,048 209 Research and development651 700 1,300 1,556 Selling, general and administrative216 230 389 442 Total operating expenses960 1,049 2,737 2,207 Loss from operations(815)(907)(2,203)(1,957) Interest income67 81 139 171 Other (expense) income, net(19)8 (37)4 Loss before income taxes(767)(818)(2,101)(1,782) Provision for income taxes15 7 24 14 Net loss$(782)$(825)$(2,125)$(1,796) Net loss per share Basic and Diluted$(1.97)$(2.13)$(5.36)$(4.64) Weighted average common shares used in calculation of net loss per share Basic and Diluted398 388 396 387 _______ 1Includes grant, collaboration, licensing and royalty, and stand-ready manufacturing revenue. 5 MODERNA, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited, in millions) June 30,December 31, 20262025 Assets Current assets: Cash and cash equivalents$1,723 $2,595 Investments3,415 3,204 Accounts receivable, net17 184 Inventory280 153 Prepaid expenses and other current assets380 408 Total current assets5,815 6,544 Investments, non-current1,772 2,336 Property, plant and equipment, net2,059 2,134 Right-of-use assets, operating leases697 719 Other non-current assets618 605 Total assets$10,961 $12,338 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$167 $317 Accrued liabilities1,909 1,386 Deferred revenue295 99 Other current liabilities163 185 Total current liabilities2,534 1,987 Deferred revenue, non-current147 153 Operating lease liabilities, non-current638 653 Financing lease liabilities, non-current6 20 Long-term debt591 590 Other non-current liabilities284 285 Total liabilities4,200 3,688 Stockholders’ equity: Additional paid-in capital1,644 1,382 Accumulated other comprehensive income19 45 Retained earnings5,098 7,223 Total stockholders’ equity6,761 8,650 Total liabilities and stockholders’ equity$10,961 $12,338 6 MODERNA, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited, in millions) Six Months Ended June 30, 20262025 Operating activities Net loss $(2,125)$(1,796) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation224 245 Depreciation and amortization122 96 Amortization/accretion of investments(21)(37) Loss on equity investments, net2 8 Other non-cash items10 36 Changes in assets and liabilities: Accounts receivable, net167 310 Prepaid expenses and other assets70 (150) Inventory(126)(122) Right-of-use assets, operating leases21 19 Accounts payable(128)(203) Accrued liabilities475 (395) Deferred revenue195 68 Operating lease liabilities(15)(10) Other liabilities(27)(25) Net cash used in operating activities (1,156)(1,956) Investing activities Purchases of marketable securities(1,904)(3,059) Proceeds from maturities of marketable securities1,442 3,424 Proceeds from sales of marketable securities814 1,059 Purchases of property, plant and equipment(99)(120) Purchase of intangible asset— (10) Net cash (used in) provided by investing activities 253 1,294 Financing activities Proceeds from issuance of common stock through equity plans42 17 Tax payments related to net share settlements on equity awards(4)(1) Changes in financing lease liabilities(7)(3) Net cash provided by financing activities 31 13 Effect of changes in exchange rates on cash and cash equivalents(1)1 Net decrease in cash, cash equivalents and restricted cash(873)(648) Cash, cash equivalents and restricted cash, beginning of year2,597 1,929 Cash, cash equivalents and restricted cash, end of period$1,724 $1,281 7 Spikevax®, mRESVIA®, mNEXSPIKE®, mCOMBRIAX® and mFLUSIVA® 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 multi-year revenue growth strategy, including geographic expansion and new product approvals; Moderna's continued cost discipline; Moderna’s international strategic partnerships; expectations regarding mRNA-4157 Phase 3 adjuvant melanoma data in 2026; the potential of intismeran as monotherapy and in combination with KEYTRUDA QLEX; the potential of Moderna’s oncology portfolio; pending and anticipated regulatory filings and potential approvals, including timing of approvals; Moderna's PDUFA date in the U.S. for mRNA-1010 and the potential product approval of mFLUSIVA; enrollment of an additional cohort for mRNA-1403; and anticipated progress and milestones for Moderna's pipeline programs, including potential near-term data 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, 2025, 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 www.sec.gov. 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 RidleyVice President, Head of Global Communications 8 +1 [email protected] Investors:Lavina TalukdarSenior Vice President & Head of Investor Relations+1 [email protected] SOURCE: Moderna, Inc. 9