Kodiak(KOD) - 2024 Q4 - Annual Report

Part I Business Kodiak Sciences Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation therapeutics for retinal diseases using its proprietary Antibody Biopolymer Conjugate (ABC) Platform. The company's pipeline includes three clinical programs: tarcocimab tedromer (KSI-301), an anti-VEGF therapy; KSI-501, a bispecific antibody targeting IL-6 and VEGF; and KSI-101, an unconjugated bispecific protein. Kodiak is also advancing its ABCD Platform for small molecule drug conjugation and a digital health platform, VETi. The company has established commercial-scale manufacturing capabilities with Lonza and retains global rights to its product candidates Overview Kodiak Sciences, founded in 2009, is developing retinal medicines using its Antibody Biopolymer Conjugate (ABC) Platform. Its lead candidate, tarcocimab, has completed three successful Phase 3 studies and is in two ongoing Phase 3 trials (GLOW2 and DAYBREAK), with a single BLA filing planned for 2026 across wet AMD, RVO, and DR. The pipeline also includes KSI-501 (bispecific anti-IL-6/VEGF) in a Phase 3 study and KSI-101 (unconjugated bispecific) in a Phase 1b study. The company is expanding its technology with the ABCD Platform for small molecule drugs and has established manufacturing capabilities. As of December 31, 2024, Kodiak had $168.1 million in cash and cash equivalents and retains all global rights to its product candidates - Kodiak's lead product, tarcocimab, has completed three successful Phase 3 pivotal studies. Two additional Phase 3 studies, GLOW2 and DAYBREAK, are ongoing with topline data expected in 1Q 2026 and 2Q 2026, respectively. A single Biologics License Application (BLA) is planned for 2026 covering wet AMD, RVO, and DR[20] - The company is developing two other clinical programs: KSI-501, a bispecific antibody conjugate targeting IL-6 and VEGF, currently in the Phase 3 DAYBREAK study; and KSI-101, an unconjugated bispecific protein targeting IL-6 and VEGF, currently in the Phase 1b APEX study[21][22] - Kodiak is advancing its platform to include small molecule drugs through its Antibody Biopolymer Conjugate Drug (ABCD) Platform, with initial programs targeting glaucoma and geographic atrophy[23] Financial Position | Metric | Value | | :--- | :--- | | Cash and Cash Equivalents (as of Dec 31, 2024) | $168.1 million | Clinical Programs and Manufacturing Kodiak's clinical development is centered on three main candidates. Tarcocimab (KSI-301) has a mixed record, with three successful pivotal trials (GLOW1, BEACON, DAYLIGHT) but also three failed trials (GLEAM, GLIMMER, DAZZLE). Two ongoing Phase 3 trials, GLOW2 and DAYBREAK, are using an enhanced formulation to improve performance, with data expected in 2026. KSI-501, a bispecific conjugate, has advanced to the Phase 3 DAYBREAK study for wet AMD. KSI-101, a bispecific protein, is in a Phase 1b study (APEX) for inflammatory retinal conditions, with plans for pivotal studies in 2025. The company has also established commercial-scale manufacturing for tarcocimab at its dedicated 'Ursus' facility with Lonza and is progressing manufacturing for KSI-501 and KSI-101 Tarcocimab Ongoing Phase 3 Trials | Study | Indication | Status | Expected Topline Data | | :--- | :--- | :--- | :--- | | GLOW2 | Diabetic Retinopathy (DR) | Enrollment Complete | 1Q 2026 | | DAYBREAK | Wet AMD | Actively Enrolling | 2Q 2026 | - Tarcocimab has a mixed history in pivotal trials. It successfully met primary endpoints in GLOW1 (DR), BEACON (RVO), and DAYLIGHT (wet AMD). However, it failed to meet primary endpoints in GLEAM/GLIMMER (DME) and DAZZLE (wet AMD)[28][36][38][41][43][46] - KSI-501, a bispecific (anti-IL-6, VEGF-trap) conjugate, has advanced to the Phase 3 DAYBREAK study in wet AMD to evaluate its efficacy potential beyond anti-VEGF monotherapy[50][52] - KSI-101, a novel bispecific protein (anti-IL-6, VEGF), is being developed for retinal inflammation. Early data from the Phase 1b APEX study showed a strong treatment response, with plans to initiate pivotal studies in Q2 2025[22][53] - The company has established commercial-scale manufacturing through a partnership with Lonza. The custom-built 'Ursus' facility was commissioned in January 2023, and the first commercial-scale cGMP batch of tarcocimab was released in July 2023[49] Competition Kodiak faces significant competition from established anti-VEGF therapies like Avastin, Lucentis, and Eylea. Newer, formidable competitors include Roche's Vabysmo (faricimab), a bispecific antibody approved for wet AMD, DME, and RVO, which has gained significant market adoption, and Regeneron's Eylea HD (high dose aflibercept), approved for wet AMD, DME, and DR. The retinal disease market is becoming increasingly competitive with other companies developing novel treatments, gene therapies, and biosimilars - The standard of care includes well-established anti-VEGF therapies: Avastin, Lucentis, and Eylea[60] - Significant new competition comes from Roche's Vabysmo (faricimab), a bispecific antibody approved for wet AMD, DME, and RVO, which has seen strong market uptake[61] - Regeneron's Eylea HD (high dose aflibercept) was approved in August 2023 for wet AMD, DME, and DR, and is expected to be an important therapy due to Regeneron's established market presence[62] - The therapeutic landscape is expected to become more competitive with the development of other molecular targets, gene therapies, medical devices, and biosimilars[63] Government Regulation The company's operations are subject to extensive regulation by the FDA in the U.S. and comparable authorities abroad, covering research, development, manufacturing, and marketing. The approval process for a new biologic requires a Biologics License Application (BLA), supported by extensive preclinical and clinical data (Phase 1, 2, and 3 trials) demonstrating safety and efficacy. The FDA offers expedited programs like Fast Track and Priority Review. Post-approval, the company must adhere to ongoing requirements, including cGMP, adverse event reporting, and marketing restrictions. The business is also impacted by healthcare laws like the Anti-Kickback Statute, HIPAA, and pricing reforms such as the Inflation Reduction Act (IRA), which introduces Medicare drug price negotiations - Drug and biologic development in the U.S. is regulated by the FDA and requires a New Drug Application (NDA) or Biologics License Application (BLA) before marketing. The process involves extensive preclinical studies and three phases of clinical trials (Phase 1, 2, 3) to establish safety and efficacy[65][66][77] - The FDA has expedited programs such as Fast Track, Priority Review, and Accelerated Approval to facilitate the development and review of drugs for serious conditions with unmet medical needs[82][83][84] - Post-approval, the company is subject to continuous FDA regulation, including cGMP for manufacturing, adverse event reporting, and strict rules on promotion and advertising, which prohibit off-label marketing[91][94] - The business must comply with federal and state fraud and abuse laws, such as the Anti-Kickback Statute and the Physician Payments Sunshine Act, as well as data privacy laws like HIPAA and the EU GDPR[97][99][100] - Healthcare reform, particularly the Inflation Reduction Act (IRA) of 2022, will impact pricing and reimbursement. The IRA directs HHS to negotiate prices for certain high-expenditure Medicare drugs and imposes rebates for price increases that outpace inflation[111][223] Intellectual Property Kodiak protects its technology through patents, trade secrets, and trademarks. As of December 31, 2024, the company holds approximately 14 issued U.S. patents and has 18 pending U.S. applications, along with 49 issued and 63 pending patents internationally. The patent portfolio covers therapeutic conjugates, specific therapeutics like tarcocimab and KSI-501, and components of the ABC Platform. U.S. patents have expiration dates ranging from 2027 to 2040, with pending applications potentially extending to 2044. The company also has 33 pending and issued trademark registrations globally - As of December 31, 2024, Kodiak's patent portfolio includes approximately 14 issued U.S. patents, 18 pending U.S. applications, 49 issued foreign patents, and 63 pending foreign applications[129] Key U.S. Patent Expiration Dates | Patent Subject | Representative Patent/Application | Anticipated U.S. Expiration | | :--- | :--- | :--- | | Conjugates | US 8,846,021 | 2/28/2027 | | Copolymers (ABC Platform) | US 8,765,432 | 5/10/2030 | | Polymers | US 10,702,608 | 12/21/2034 | | Antibody Conjugate (tarcocimab) | US 11,066,465 | 12/29/2036 | | Fusion Proteins (KSI-501/101) | US Patent No. 12,071,476 | 3/1/2039 | - Issued U.S. patents are projected to expire between 2027 and 2040. Patents resulting from pending applications could expire between 2030 and 2044[134] - The company has 33 pending and issued trademark registrations, including for "Kodiak" and "Kodiak Sciences", to build brand recognition[135] Human Capital Management As of December 31, 2024, Kodiak employed 109 people worldwide, with 10 based outside the U.S. The workforce is heavily focused on research and development, with 74 employees in these roles, 29 of whom hold Ph.D. or M.D. degrees. The company emphasizes competitive compensation, including salary, bonuses, and equity, to attract and retain talent. None of the employees are covered by a collective bargaining agreement - As of December 31, 2024, the company had 109 employees worldwide[136] - 74 employees are engaged in research, development, and clinical activities, with 29 holding Ph.D. or M.D. degrees[136] Risk Factors The company faces substantial risks inherent in its clinical-stage status, including a history of significant net losses, no approved products, and reliance on the success of its lead candidates tarcocimab, KSI-501, and KSI-101. Key risks include the potential for clinical trial failures, regulatory hurdles, intense competition from established and new therapies, and manufacturing complexities. The company also highlights its dependence on third parties for manufacturing and clinical trials, challenges in protecting its intellectual property, and the need for additional financing to continue operations, which raises substantial doubt about its ability to continue as a going concern - The company is a clinical-stage entity with a limited operating history, no approved products, and has incurred significant net losses since inception, raising substantial doubt about its ability to continue as a going concern[17][334] - The company's prospects are heavily dependent on its lead candidates tarcocimab, KSI-501, and KSI-101. Previous clinical trial failures for tarcocimab (DAZZLE, GLEAM, GLIMMER) highlight the high risk of drug development[144][146] - Kodiak faces significant competition from established players like Roche (Vabysmo) and Regeneron (Eylea HD), which may impede market adoption of its products if approved[177][178][179] - The company relies on third parties, such as Lonza, for manufacturing, which introduces risks related to supply, quality, and cost. It also relies on third parties for conducting clinical trials[246][250] - Failure to obtain additional financing would jeopardize the completion of development and commercialization of its product candidates[339] Unresolved Staff Comments The company reports that it has no unresolved staff comments from the SEC - None[371] Cybersecurity Kodiak has implemented an information security program to manage cybersecurity risks, overseen by the Nominating and Corporate Governance Committee of the Board. The program, managed by a digital transformation team under the CFO and CEO, includes technical measures, employee training, vulnerability assessments, and a vendor management process. The company has not identified any cybersecurity threats or incidents that have materially affected or are likely to materially affect its business, operations, or financial condition - The Nominating and Corporate Governance Committee of the Board of Directors is responsible for overseeing cybersecurity risk management[379] - The company's cybersecurity risk management is implemented by a digital transformation team supervised by the CFO and CEO, utilizing measures like firewalls, multi-factor authentication, employee training, and vulnerability assessments[373][375][376][380] - The company has not identified any cybersecurity risks or incidents that have materially affected or are reasonably likely to materially affect its business, operations, or financial condition[378] Properties Kodiak's principal corporate offices are located in Palo Alto, California, where it leases approximately 155,000 square feet of office, R&D, and lab space across two buildings with lease terms extending to 2027 and 2033, respectively. In March 2025, the company subleased one of these buildings. Additionally, Kodiak leases about 1,000 square meters of office and lab space in Visp, Switzerland, under a 5-year initial term lease - The company leases approximately 155,000 square feet for its corporate offices in Palo Alto, California[382] - In March 2025, the company entered into a sublease agreement for its office space at 1200 Page Mill Road, effective until February 2027[383] - The company leases approximately 1,000 square meters of office and laboratory space in Visp, Switzerland[384] Legal Proceedings The company is not currently a party to any material legal proceedings. While it may be subject to various claims in the ordinary course of business, it does not expect any current litigation to have a material adverse effect on its business - As of the report date, the company is not a party to any material legal proceedings[385] Mine Safety Disclosures Not applicable. The company has no mine safety disclosures - None[386] Part II Market for Registrant's Common Equity, Related Stockholders Matters and Issuer Purchases of Equity Securities The company's common stock is traded on the Nasdaq Global Market under the symbol "KOD". As of February 28, 2025, there were approximately 21 holders of record. The company has never paid cash dividends and does not anticipate doing so in the foreseeable future. There were no recent sales of unregistered securities or issuer purchases of equity securities - Common stock trades on the Nasdaq Global Market under the symbol "KOD"[389] - As of February 28, 2025, there were approximately 21 holders of record of common stock[390] - The company has never declared or paid cash dividends and does not plan to in the foreseeable future[391] Reserved Not applicable Management's Discussion and Analysis of Financial Condition and Results of Operations Kodiak reported a net loss of $176.2 million for 2024, a decrease from the $260.5 million loss in 2023. The reduction was primarily due to an $80.2 million decrease in R&D expenses, driven by reduced manufacturing and clinical activities for tarcocimab. G&A expenses also decreased by $10.3 million. The company ended 2024 with $168.1 million in cash and cash equivalents. Management has stated there is substantial doubt about the company's ability to continue as a going concern and that it will need to raise additional capital to fund operations into 2026 and beyond Results of Operations For the year ended December 31, 2024, Kodiak's loss from operations decreased to $186.8 million from $277.3 million in 2023. This was driven by a 39% reduction in R&D expenses to $126.1 million, primarily from lower tarcocimab program costs, and a 14% decrease in G&A expenses to $60.8 million. Interest income fell to $11.1 million due to lower cash balances. The overall net loss for 2024 was $176.2 million, compared to a net loss of $260.5 million in 2023 Results of Operations (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $126,095 | $206,298 | $(80,203) | (39%) | | General and administrative | $60,754 | $71,023 | $(10,269) | (14%) | | Loss from operations | $(186,849) | $(277,321) | $90,472 | (33%) | | Interest income | $11,148 | $16,733 | $(5,585) | (33%) | | Net loss | $(176,207) | $(260,491) | $84,284 | (32%) | - R&D expenses decreased by $80.2 million (39%) in 2024, mainly due to a $51.0 million reduction in tarcocimab program expenses from reduced manufacturing and clinical activities for completed trials, and a $19.9 million decrease in payroll and personnel expenses[442][444] - General and administrative expenses decreased by $10.3 million (14%) in 2024, primarily due to lower stock-based compensation expense as previously issued higher-value awards became fully vested[446] Liquidity and Capital Resources As of December 31, 2024, Kodiak had $168.1 million in cash and cash equivalents. The company has a history of net losses and negative cash flows, with an accumulated deficit of $1.33 billion. Management has concluded there is substantial doubt about the company's ability to continue as a going concern, as current cash is not sufficient to fund operations for the next 12 months. The company plans to raise additional capital through equity or debt financing or collaborations to continue its R&D activities, but there is no assurance of success. Material cash requirements include operating lease obligations of $88.6 million and manufacturing commitments of $19.4 million, plus potential obligations of 105.3 million Swiss Francs for the Ursus facility - The company had $168.1 million in cash and cash equivalents as of December 31, 2024[450] - Due to recurring net losses and negative cash flows, management has expressed substantial doubt about the company's ability to continue as a going concern, as existing cash may not be sufficient to fund operations for the next 12 months[451][505] - The company plans to raise additional capital to maintain operations. Failure to do so may require pausing, scaling back, or discontinuing development programs[452] Material Cash Requirements | Commitment | Future Obligation | Due in Next 12 Months | | :--- | :--- | :--- | | Operating Leases | $88.6 million | $14.9 million | | Manufacturing Agreements | $19.4 million | $15.0 million | | Ursus Facility (Potential) | ~105.3 million CHF | N/A | Quantitative and Qualitative Disclosures About Market Risk The company is exposed to market risk from changes in interest rates on its cash and cash equivalents, which totaled $168.1 million as of December 31, 2024, and were primarily held in money market funds. Management believes this risk did not have a material impact on the financial statements. Other market risks, such as foreign currency exchange rate risk, are also not considered to have had a significant impact - The company's primary market risk is related to interest rate changes affecting its $168.1 million in cash and cash equivalents, which are mainly in money market funds[474] - Management does not believe that interest rate risk or foreign currency exchange rate risk had a material impact on the consolidated financial statements for the periods presented[474][475] Financial Statements and Supplementary Data The consolidated financial statements for Kodiak Sciences Inc. as of and for the year ended December 31, 2024, have been audited by PricewaterhouseCoopers LLP. The auditor's report includes an opinion that the financial statements are fairly presented but also highlights substantial doubt about the company's ability to continue as a going concern due to recurring net losses and negative cash flows. The financial statements show a net loss of $176.2 million for 2024 and total assets of $335.6 million as of year-end Report of Independent Registered Public Accounting Firm PricewaterhouseCoopers LLP issued an audit opinion stating that Kodiak's consolidated financial statements are fairly presented in conformity with U.S. GAAP. However, the report explicitly raises substantial doubt about the company's ability to continue as a going concern, citing its history of net losses and negative cash flows from operations. The audit identified 'Certain Research and Development Costs' as a critical audit matter due to the high degree of auditor effort required - The auditor's report expresses substantial doubt about the Company's ability to continue as a going concern due to its history of net losses and negative cash flows[482] - The audit identified 'Certain Research and Development Costs' as a critical audit matter, requiring a high degree of auditor effort to test and evaluate[488][489] Consolidated Financial Statements The consolidated financial statements detail Kodiak's financial position and performance. The Balance Sheet shows total assets of $335.6 million and total liabilities of $185.3 million as of Dec 31, 2024. The Statement of Operations reports a net loss of $176.2 million for 2024, an improvement from the $260.5 million loss in 2023. The Statement of Cash Flows indicates net cash used in operating activities was $117.3 million in 2024, leading to a year-end cash and cash equivalents balance of $168.1 million Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $168,074 | $285,507 | | Total current assets | $171,936 | $289,309 | | Total assets | $335,578 | $479,372 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $25,573 | $41,729 | | Total liabilities | $185,290 | $213,591 | | Total stockholders' equity | $150,288 | $265,781 | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | :--- | | Research and development | $126,095 | $206,298 | $267,591 | | General and administrative | $60,754 | $71,023 | $73,788 | | Loss from operations | $(186,849) | $(277,321) | $(341,379) | | Net loss | $(176,207) | $(260,491) | $(333,823) | | Net loss per share | $(3.35) | $(4.97) | $(6.39) | Consolidated Statement of Cash Flows Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(117,319) | $(154,183) | | Net cash provided by (used in) investing activities | $(755) | $249,226 | | Net cash provided by financing activities | $501 | $31 | | Net (decrease) increase in cash | $(117,573) | $95,074 | Notes to Consolidated Financial Statements The notes provide detailed explanations of the company's accounting policies and financial figures. Key disclosures include the 'Liquidity' section (Note 1), which reiterates the substantial doubt about the company's ability to continue as a going concern. 'Commitments and Contingencies' (Note 8) details significant lease and manufacturing obligations. 'Stock-Based Compensation' (Note 12) outlines the various equity plans, including the 2021 LTPIP, and reports a total stock-based compensation expense of $60.2 million for 2024. 'Liability related to Sale of Future Royalties' (Note 16) describes the $100 million liability from the 2019 funding agreement with BBA, for which royalty payments are not yet probable or estimable - Note 1 (Liquidity) states that existing cash may not be sufficient to meet operating requirements for the next 12 months, resulting in substantial doubt about the company's ability to continue as a going concern[505] - Note 8 (Commitments) discloses future undiscounted operating lease payments of $88.6 million and manufacturing agreement obligations of $19.4 million as of Dec 31, 2024[564][568] - Note 12 (Stock-Based Compensation) reports total stock-based compensation expense of $60.2 million in 2024, down from $88.6 million in 2023. As of Dec 31, 2024, there was $115.7 million of unrecognized compensation expense related to unvested awards[611] - Note 16 (Liability related to Sale of Future Royalties) confirms the $100 million liability from the funding agreement with BBA. As of Dec 31, 2024, royalty payments are not yet considered probable and estimable, so no interest expense has been accreted[622] Changes in and Disagreements With Accountants on Accounting and Financial Disclosures The company reports no changes in or disagreements with its accountants on accounting and financial disclosures - None[625] Controls and Procedures Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of December 31, 2024. Management also assessed the internal control over financial reporting based on the COSO framework and concluded it was effective. There were no material changes to internal controls during the fourth quarter of 2024. As a non-accelerated filer, an auditor attestation on internal controls is not required - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2024[627] - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2024[628] - No material changes were made to the internal control over financial reporting during the quarter ended December 31, 2024[629] Other Information The company reports no other information - None[631] Disclosure Regarding Foreign Jurisdictions that Prevent Inspections Not applicable Part III Directors, Executive Officers and Corporate Governance Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's definitive proxy statement for the 2025 Annual Meeting of Stockholders, which will be filed within 120 days of the fiscal year-end. The company has adopted a Code of Business Conduct and Ethics, which is available on its website - This section incorporates information by reference from the company's forthcoming Proxy Statement[635] Executive Compensation Information regarding executive and director compensation is incorporated by reference from the company's definitive proxy statement for the 2025 Annual Meeting of Stockholders - This section incorporates information by reference from the company's forthcoming Proxy Statement[638] Security Ownership of Certain Beneficial Owners and Management and Related Stockholders Matters Information regarding security ownership of certain beneficial owners, management, and related stockholder matters is incorporated by reference from the company's definitive proxy statement for the 2025 Annual Meeting of Stockholders - This section incorporates information by reference from the company's forthcoming Proxy Statement[639] Certain Relationships and Related Transactions, and Director Independence Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's definitive proxy statement for the 2025 Annual Meeting of Stockholders - This section incorporates information by reference from the company's forthcoming Proxy Statement[640] Principal Accountant Fees and Services Information regarding principal accountant fees and services is incorporated by reference from the company's definitive proxy statement for the 2025 Annual Meeting of Stockholders - This section incorporates information by reference from the company's forthcoming Proxy Statement[641] Part IV Exhibits and Financial Statement Schedules This section lists the documents filed as part of the Form 10-K. The consolidated financial statements are filed under Item 8, and all financial statement schedules are omitted as inapplicable. The exhibit index lists various corporate documents, agreements, and certifications, including the company's certificate of incorporation, bylaws, equity plans, material contracts such as the funding agreement with Baker Bros. and leases, and required certifications by the CEO and CFO - The consolidated financial statements are filed under Item 8 of this report[644] - All financial statement schedules have been omitted as they are not applicable or the required information is included in the financial statements[645] Form 10-K Summary No Form 10-K summary is provided - None[649]