Kodiak Sciences Inc. 10-Q

Item 1. Financial Statements (Unaudited). Kodiak Sciences Inc. Condensed Consolidated Balance Sheets (in thousands, except share and per share amounts) (Unaudited) March 31, 2021 December 31, 2020 Assets Current assets: Cash and cash equivalents $ 920,461 $ 944,396 Marketable securities 8,524 24,578 Prepaid expenses and other current assets 2,912 3,031 Total current assets 931,897 972,005 Restricted cash 6,324 6,324 Property and equipment, net 7,307 5,136 Operating lease right-of-use asset 72,054 73,672 Other assets 15,152 10,210 Total assets $ 1,032,734 $ 1,067,347 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 9,176 $ 8,646 Accrued and other current liabilities 24,075 20,402 Operating lease liability 1,807 2,374 Total current liabilities 35,058 31,422 Operating lease liability, net of current portion 75,851 75,028 Liability related to sale of future royalties 99,903 99,890 Other liabilities 245 256 Total liabilities 211,057 206,596 Commitments and contingencies (Note 6) Stockholders’ equity: Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized; 0 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively — — Common stock, $ 0.0001 par value, 490,000,000 shares authorized at March 31, 2021 and December 31, 2020; 51,225,861 and 51,112,302 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively 5 5 Additional paid-in capital 1,163,328 1,151,920 Accumulated other comprehensive income 18 53 Accumulated deficit ( 341,674 ) ( 291,227 ) Total stockholders’ equity 821,677 860,751 Total liabilities and stockholders’ equity $ 1,032,734 $ 1,067,347 The accompanying notes are an integral part of these condensed consolidated financial statements. 1 Kodiak Sciences Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (Unaudited) Three Months Ended March 31, 2021 2020 Operating expenses Research and development $ 40,337 $ 20,170 General and administrative 10,221 5,553 Total operating expenses 50,558 25,723 Loss from operations ( 50,558 ) ( 25,723 ) Interest income 149 1,208 Interest expense ( 6 ) ( 7 ) Other income (expense), net ( 32 ) 130 Net loss $ ( 50,447 ) $ ( 24,392 ) Net loss per common share, basic and diluted $ ( 0.98 ) $ ( 0.54 ) Weighted-average common shares outstanding used in computing net loss per common share, basic and diluted 51,573,909 44,824,587 Other comprehensive income (loss) Change in unrealized gains related to available-for-sale debt securities, net of tax ( 35 ) 479 Total other comprehensive income (loss) ( 35 ) 479 Comprehensive loss $ ( 50,482 ) $ ( 23,913 ) The accompanying notes are an integral part of these condensed consolidated financial statements. 2 Kodiak Sciences Inc. Condensed Consolidated Statements of Stockholders’ Equity (in thousands, except share and per share amounts) (Unaudited) Common Stock Additional Paid-In Accumulated Other Comprehensive Accumulated Total Stockholders’ Shares Amount Capital Income (Loss) Deficit Equity Balances at December 31, 2020 51,112,302 $ 5 $ 1,151,920 $ 53 $ ( 291,227 ) $ 860,751 Issuance of common stock upon exercise of stock options 113,559 — 1,483 — — 1,483 Stock-based compensation expense — — 9,925 — — 9,925 Other comprehensive income — — — ( 35 ) — ( 35 ) Net loss — — — — ( 50,447 ) ( 50,447 ) Balances at March 31, 2021 51,225,861 $ 5 $ 1,163,328 $ 18 $ ( 341,674 ) $ 821,677 Common Stock Additional Paid-In Accumulated Other Comprehensive Accumulated Total Stockholders’ Shares Amount Capital Income (Loss) Deficit Equity Balances at December 31, 2019 44,413,404 $ 5 $ 503,475 $ 10 $ ( 158,131 ) $ 345,359 Issuance of common stock upon exercise of stock options 39,297 — 159 — — 159 Stock-based compensation expense — — 6,082 — — 6,082 Other comprehensive income — — — 479 — 479 Net loss — — — — ( 24,392 ) ( 24,392 ) Balances at March 31, 2020 44,452,701 $ 5 $ 509,716 $ 489 $ ( 182,523 ) $ 327,687 The accompanying notes are an integral part of these condensed consolidated financial statements. 3 Kodiak Sciences Inc. Condensed Consolidated Statements of Cash Flows (in thousands) (Unaudited) Three Months Ended March 31, 2021 2020 Cash flows from operating activities Net loss $ ( 50,447 ) $ ( 24,392 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 229 120 Stock-based compensation 9,925 6,082 Amortization (accretion) of premium (discount) on marketable securities 19 ( 125 ) Amortization of operating lease right-of-use asset 1,958 98 Amortization of issuance costs 13 9 Changes in assets and liabilities: Prepaid expenses and other current assets 119 ( 133 ) Other assets 603 ( 1,602 ) Accounts payable ( 165 ) 1,887 Accrued and other current liabilities 3,205 228 Operating lease liability ( 84 ) ( 104 ) Net cash used in operating activities ( 34,625 ) ( 17,932 ) Cash flows from investing activities Purchase of property and equipment ( 1,237 ) ( 180 ) Deposits on property and equipment ( 5,545 ) — Purchase of marketable securities — ( 86,317 ) Maturities of marketable securities 16,000 19,300 Net cash provided by (used in) investing activities 9,218 ( 67,197 ) Cash flows from financing activities Proceeds from issuance of common stock upon options exercise 1,483 159 Proceeds from sale of future royalties, net of issuance costs — 99,643 Principal payments of capital lease — ( 5 ) Principal payments of tenant improvement allowance payable ( 11 ) ( 9 ) Net cash provided by financing activities 1,472 99,788 Net increase (decrease) in cash, cash equivalents and restricted cash ( 23,935 ) 14,659 Cash, cash equivalents and restricted cash, at beginning of period 950,720 211,937 Cash, cash equivalents and restricted cash, at end of period $ 926,785 $ 226,596 Reconciliation of cash, cash equivalents and restricted cash to consolidated balance sheets Cash and cash equivalents $ 920,461 $ 226,456 Restricted cash 6,324 140 Cash, cash equivalents and restricted cash in consolidated balance sheets $ 926,785 $ 226,596 Supplemental disclosures of non-cash investing and financing information: Operating lease right-of-use asset obtained in exchange for operating lease liability $ 335 $ — Purchase of property and equipment under accounts payable and accruals $ 1,966 $ — The accompanying notes are an integral part of these condensed consolidated financial statements. 4 Kodiak Sciences Inc. Notes to Unaudited Condensed Consolidated Financial Statements (in thousands, except share and per share data) 1. The Company Kodiak Sciences Inc. (the “Company”) is a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases in the United States and additional international markets. The Company devotes substantially all of its resources to the research and development of its product platforms and product candidates including activities to conduct clinical studies of its product candidates, manufacture product candidates and provide general and administrative support for these operations. Liquidity As of March 31, 2021, the Company had cash, cash equivalents and marketable securities of $ 929.0 million. Although the Company has incurred significant operating losses since inception and expects to continue to incur operating losses and negative operating cash flows for the foreseeable future, the Company believes that the cash, cash equivalents and marketable securities will be sufficient to meet the anticipated operating and capital expenditure requirements for the 12 months following the date of this Form 10-Q. 2. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) applicable to interim periods. The condensed consolidated financial statements , in the opinion of management, include all normal and recurring adjustments necessary to present fairly the Company's financial position and results of operations for the reported periods. These condensed consolidated financial statements have been prepared on a basis substantially consistent with, and should be read in conjunction with the audited financial statements for the year ended December 31, 2020 and notes thereto, the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 1, 2021. Certain information and note disclosures normally included in the audited financial statements prepared in accordance with GAAP have been condensed or omitted from this report. The results of operations for any interim period are not necessarily indicative of the results for the year ending December 31, 2021, or for any future period. The accompanying condensed consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. Reclassification Certain prior period amounts have been reclassified to conform to the current period presentation. Such reclassifications had no impact on subtotals in the prior year condensed consolidated financial statements. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the date of the condensed consolidated financial statements and expenses during the reporting period. The impact of the ongoing COVID-19 pandemic continues to evolve. As a result, certain estimates and assumptions required increased judgment and carried a higher degree of variability and volatility, including but not limited to, the fair value of marketable securities, performance-based equity awards, and research and development accruals for the three months ended March 31, 2021. As events continue to unfold and additional information becomes available, these estimates may change materially in future periods. Actual results could differ from those estimates. 5 Kodiak Sciences Inc. Notes to Unaudited Condensed Consolidated Financial Statements (Continued) Risks and Uncertainties In March 2020, the World Health Organization declared a pandemic due to the global COVID-19 outbreak. The significant uncertainties caused by the ongoing COVID-19 pandemic may negatively impact the Company’s operations, liquidity, and capital resources and will depend on certain evolving developments, including the duration and spread of the outbreak, regulatory and private sector responses and the impact on employees and vendors including supply chain and clinical partners, all of which are uncertain and cannot be predicted. During this pandemic, the Company continues to work closely with clinical sites towards maximal patient safety and the lowest number of missed visits and study discontinuations. The Company has taken and continues to take proactive measures to maintain the integrity of its ongoing clinical studies. Despite these efforts, the ongoing COVID-19 pandemic could significantly impact clinical trial enrollment and completion of its clinical studies. During this pandemic, the Company continues to work closely with our manufacturing suppliers, partners and facilities to maintain the supply of our product candidates needed for the expansion of our clinical trials and to retain the number, scale and design of manufacturing runs that regulatory authorities may require to obtain marketing approval, including those required to support a BLA submission. Despite these efforts, the ongoing COVID-19 pandemic could significantly impact the timing or likelihood of clinical resupply and of regulatory filings and approvals. The Company will continue to monitor the COVID-19 situation and its impact on the ability to continue the development of, and seek regulatory approvals for, the Company’s product candidates, and begin to commercialize any approved products. Summary of Significant Accounting Policies The significant accounting policies used in preparation of these condensed consolidated financial statements for the three months ended March 31, 2021 are consistent with those discussed in Note 2 to the consolidated financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, except as noted within the “Recent Accounting Pronouncements – Recently Adopted Accounting Pronouncements” section. Recent a ccounting p ronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) , under its ASC or other standard setting bodies, and adopted by the Company as of the specified effective date, unless otherwise discussed below. Recently Adopted Accounting Pronouncements In October 2020, the FASB issued ASU 2020-10, Codification Improvements , which updates various codification topics and disclosure requirements to improve alignment with the SEC's regulations. The Company adopted this new guidance as of January 1, 2021, which did not have a material impact on its consolidated financial statements and related disclosures. New Accounting Pronouncements Not Yet Adopted The Company continues to monitor new accounting pronouncements issued by the FASB. All other newly issued accounting pronouncements issued through the date of this report have been deemed either immaterial or not applicable. 3. Accrued and Other Current Liabilities Accrued and other current liabilities consist of the following (in thousands): March 31, 2021 December 31, 2020 Accrued clinical trial and related costs $ 15,206 $ 11,119 Accrued research and development 4,679 3,082 Accrued salaries and benefits 2,574 5,094 Accrued legal fees 288 252 Accrued professional fees 226 253 Accrued other liabilities 1,102 602 Total accrued and other current liabilities $ 24,075 $ 20,402 6 Kodiak Sciences Inc. Notes to Unaudited Condensed Consolidated Financial Statements (Continued) 4. Fair Value Measurements The following tables present the Company’s fair value hierarchy for assets measured at fair value on a recurring basis (in thousands): Fair Value Measurements at March 31, 2021 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 892,285 $ — $ — $ 892,285 Marketable securities: Corporate notes — 8,524 — 8,524 Total $ 892,285 $ 8,524 $ — $ 900,809 Fair Value Measurements at December 31, 2020 Level 1 Level 2 Level 3 Total Cash equivalents: Money market funds $ 917,485 $ — $ — $ 917,485 Marketable securities: U.S. treasury securities — 10,006 — 10,006 Corporate notes — 14,572 — 14,572 Total $ 917,485 $ 24,578 $ — $ 942,063 As of March 31, 2021 and December 31, 2020, the fair value of the liability related to sale of future royalties is based on our current estimates of future royalties expected to be paid to Baker Bros. Advisors, LP (“BBA”) , which are considered Level 3 inputs. 5. Marketable Securities The marketable securities are classified as available-for-sale and consist of U.S. treasury securities, commercial paper and corporate notes. The fair value measurement data for marketable securities is obtained from independent pricing services. The Company validates the prices provided by the third-party pricing services by understanding the valuation methods and data sources used and analyzing the pricing data in certain instances. The following table summarizes the marketable securities (in thousands): As of March 31, 2021 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Corporate notes $ 8,506 $ 18 $ — $ 8,524 Total marketable securities, current $ 8,506 $ 18 $ — $ 8,524 As of December 31, 2020 Amortized Cost Unrealized Gains Unrealized Losses Fair Value U.S. treasury securities $ 10,003 $ 3 $ — $ 10,006 Corporate notes 14,522 50 — 14,572 Total marketable securities, current $ 24,525 $ 53 $ — $ 24,578 All marketable securities held at March 31, 2021 and December 31, 2020 had effective maturities of less than one year . There were no realized gains or losses recognized on the sale or maturity of available-for-sale debt securities during the three months ended March 31, 2021 and as a result, the Company did not reclassify any amounts out of accumulated comprehensive loss. As of March 31, 2021 and December 31, 2020, the Company had no allowance for credit losses for available-for-sale debt securities. There were no impairment charges or recoveries recorded during each of the three months ended March 31, 2021 and March 31, 2020. 7 Kodiak Sciences Inc. Notes to Unaudited Condensed Consolidated Financial Statements (Continued) 6. Commitments and Contingencies Embedded Lease In August 2020, the Company and its subsidiary Kodiak Sciences GmbH entered into a manufacturing agreement with Lonza Ltd (“Lonza”) for the clinical and commercial supply of drug substance for KSI-301, the Company’s proprietary therapeutic candidate for the treatment and prevention of retinal vascular diseases. A custom-built manufacturing suite is planned to be completed and dedicated to the manufacture of the Company’s drug substance with an estimated capital contribution of 40 million Swiss Francs from the Company. The Company will be required to pay annual suite fees of 12 million Swiss Francs for 2021 and 16 million Swiss Francs for each year thereafter, which covers the manufacturing fees for a specified number of batches, and the Company may pay for additional batches to be manufactured. The manufacturing agreement has an initial term of eight years , and the Company has the right to extend the term up to a total of 16 years. The Company concluded that this agreement contains an embedded lease as the custom-built manufacturing suite will be dedicated for the Company’s use. As of March 31, 2021, the Company did not have control of this manufacturing space and therefore, did no t record a right-of-use asset and corresponding lease liability. Manufacturing Agreement The Company has entered into service agreements with Lonza and its affiliates, pursuant to which Lonza agreed to perform activities in connection with the manufacturing process of certain compounds. Such agreements, and related amendments, state that planned activities that are included in the signed work orders are, in some cases, binding and, hence, obligate the Company to pay the full price of the work order upon satisfactory delivery of products and services or obligate the Company to the binding amount regardless of whether such planned activities are in fact performed. Per the terms of the agreements, the Company has the option to cancel signed orders at any time upon written notice, which may or may not be subject to payment of a cancellation fee. The level of cancellation fees may be dependent on the timing of the written notice in relation to the commencement date of the work, with the maximum cancellation amount dependent on the agreement or the work order. Other Funding Commitments In the normal course of business, the Company enters into agreements with third-parties for services to be provided to the Company. Generally, these agreements provide for termination upon notice, with specified amounts due upon termination based on the timing of termination and the terms of the agreement. The actual amounts and timing of payments under these agreements are uncertain and contingent upon the initiation and completion of services to be provided to the Company. The Company has also entered into various cancellable license agreements for certain technology. The Company may be obligated to make payments on future sales of specified products associated with such license agreements. Such payments are dependent on future product sales and are not estimable. Indemnification To the extent permitted under Delaware law, the Company has agreed to indemnify its directors and officers for certain events or occurrences while the director or officer is, or was serving, at the Company’s request in such capacity. The indemnification period covers all pertinent events and occurrences during the director’s or officer’s service. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is not specified in the agreements; however, the Company has director and officer insurance coverage that reduces its exposure and enables the Company to recover a portion of any future amounts paid. The Company believes the estimated fair value of these indemnification agreements in excess of applicable insurance coverage is minimal. 8 Kodiak Sciences Inc. Notes to Unaudited Condensed Consolidated Financial Statements (Continued) 7. Stock-Based Compensation In January 2021 and 2020, the number of shares of common stock available for issuance under the 2018 Equity Incentive Plan was increased by approximately 2.0 million and 1.8 million shares, respectively, as a result of the automatic increase provision in the 2018 Plan. Stock Options Stock option activity under the 2018 Plan and 2015 Equity Incentive Plan is summarized as follows: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (in years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2020 6,897,276 $ 24.52 8.07 $ 841,704 Granted 222,231 $ 130.50 Exercised ( 113,559 ) $ 13.05 Forfeited or canceled ( 6,333 ) $ 50.81 Outstanding at March 31, 2021 6,999,615 $ 28.01 7.79 $ 601,096 Restricted Shares Restricted share activity, including restricted stock awards, restricted stock units, and performance-based restricted stock units, under the 2018 Plan and 2015 Plan is summarized as follows: Number of Restricted Shares Weighted Average Grant Date Fair Value Unvested at December 31, 2020 359,945 $ 59.54 Granted 10,950 $ 117.09 Canceled ( 1,000 ) $ 46.33 Unvested at March 31, 2021 369,895 $ 61.28 Performance-Based Stock Options and Restricted Stock Units The Company granted 190,831 performance-based stock options d uring the three months ended March 31, 2021. The Company did no t grant any performance-based equity awards during the three months ended March 31, 2020. The performance-based equity awards granted will vest one-quarter upon the achievement of specific clinical development milestones. The remaining shares will then vest ratably over three years thereafter. Performance-based stock options and performance-based restricted stock units are recorded as expense beginning when vesting events are determined to be probable. None of these performance-based equity awards are vested as of March 31, 2021. The Company believes that the achievement of the requisite performance condition continues to be probable. Stock-based compensation expense recognized was $ 2.5 million during the three months ended March 31, 2021 and $ 1.8 million during the three months ended March 31, 2020. 9 Kodiak Sciences Inc. Notes to Unaudited Condensed Consolidated Financial Statements (Continued) 2018 Employee Share Purchase Plan In August 2018, the Company adopted the 2018 Employee Share Purchase Plan (“ESPP”), which became effective on the business day prior to the effectiveness of the registration statement relating to the IPO. A total of 460,000 shares of common stock were initially reserved for issuance under the ESPP. The initial offering period of the ESPP was authorized by the Company’s board of directors and commenced on January 4, 2021. Each offering period is approximately twelve months long, with two purchase periods. ESPP participants will purchase shares of common stock at a price per share equal to 85 % of the lesser of (1) the fair market value per share of the common stock on the enrollment date or (2) the fair market value of the common stock on the exercise date. During the three months ended March 31, 2021, no shares were issued under the ESPP and the stock-based compensation expense related to the ESPP was less than $ 0.1 million. Stock-Based Compensation Expense Stock-based compensation for options and restricted shares is classified in the condensed consolidated statements of operations and comprehensive loss as follows (in thousands): Three Months Ended March 31, 2021 2020 Research and development $ 5,399 $ 3,448 General and administrative 4,526 2,634 Total stock-based compensation $ 9,925 $ 6,082 As of March 31, 2021, total unrecognized compensation cost related to the unvested share-based awards was $ 100.0 million, which is expected to be recognized over a weighted-average period of 2.6 years. 8. Net Loss per Common Share The following common share equivalents were excluded from the computation of diluted net loss per common share for the periods presented because their inclusion would have been antidilutive: As of March 31, 2021 2020 Outstanding stock options 6,999,615 6,725,173 Unvested restricted shares 369,895 154,900 Total 7,369,510 6,880,073 9. Subsequent Event In April 2021, the Company and its subsidiary Kodiak Sciences GmbH amended the Bioconjugation Clinical and Commercial Development and Manufacturing Addendum with Lonza. The amendment provides for an expanded design and scope of the custom-built manufacturing facility resulting in a higher annual manufacturing capacity and includes a revised maximum capital contribution of 74.5 million Swiss Francs. Construction of the manufacturing facilities is targeted for completion in early 2022, with a manufacturing suite fee of 14.5 million Swiss Francs in 2022 and 20.0 million Swiss Francs for each year thereafter through 2029. The Company is currently evaluating the impact the amendment will have on its consolidated financial statements and related disclosures. 10