10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________ to _________

Commission File Number: 001-38682

 

KODIAK SCIENCES INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

27-0476525

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

1200 Page Mill Road

Palo Alto, CA

94304

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (650) 281-0850

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock, par value $0.0001

KOD

The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

As of May 1, 2023, the registrant had 52,356,241 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or Exchange Act. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time those statements are made and/or management’s good faith beliefs as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements.

Forward-looking statements include all statements that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan”, “hope” or the negative of these terms, or similar expressions and comparable terminology intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties, including those set forth under the section of this Quarterly Report on Form 10-Q titled “Part II, Item 1A — Risk Factors” and elsewhere in this Quarterly Report. Forward-looking statements include, but are not limited to, statements about:

the success, cost and timing of our development activities, preclinical studies, clinical trials and regulatory filings;
the translation of our preclinical results and data and early clinical trial results in particular relating to safety, efficacy and durability into future clinical trials in humans;
the continued durability, efficacy and safety of our product candidates;
the portfolio of clinical trials planned for submission in our Biologics License Application, or BLA, of tarcocimab tedromer (formerly KSI-301, also known as tarcocimab);
the scope, progress, results and costs of developing tarcocimab, KSI-501 or any other product candidates we may develop, and conducting preclinical studies and clinical trials, including for tarcocimab and KSI-501;
our ability to present clinical data across our pivotal trials during 2023;
our and Lonza’s ability to successfully execute on our manufacturing development plan;
the number, size and design of clinical trials that regulatory authorities may require to obtain marketing approval, including the order and number of clinical studies required to support a BLA in diabetic macular edema, or DME, retinal vein occlusion, or RVO, diabetic retinopathy, or DR and wet age-related macular degeneration, or wet AMD;
our expectations regarding chemistry manufacturing and controls, or CMC, requirements of the United States Food and Drug Administration, or FDA, and other regulatory bodies to support our BLA submission and potential commercial launch;
the timing or likelihood of regulatory filings and approvals, including the potential to achieve FDA approval of tarcocimab in DME, RVO, DR, wet AMD and/or of KSI-501;
our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of any approved product candidate;
our ability to obtain funding for our operations, including funding necessary to develop, manufacture and commercialize our product candidates;
the rate and degree of market acceptance of our product candidates;
the success of competing products or platform technologies that are or may become available;
our plans and ability to establish sales, marketing and distribution infrastructure to commercialize any product candidates for which we obtain approval;
our expectation as to the concentration of retinal specialists in the United States and its impact on our sales and marketing plans;
our expectations regarding our ability to enter into manufacturing-related commitments, and the timing thereof;
future agreements with third parties in connection with the commercialization of our product candidates;
the size and growth potential of the markets for our product candidates, if approved for commercial use, and our ability to serve those markets;

i


 

existing regulations and regulatory developments in the United States and foreign countries;
the expected potential benefits of strategic collaboration agreements and our ability to attract collaborators with development, regulatory and commercialization expertise;
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
potential claims relating to our intellectual property and third-party intellectual property;
our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
the pricing and reimbursement of our product candidates, if approved;
our estimates regarding the impact of the unfavorable U.S. and global economic conditions on our business and operations, the business and operations of our collaborators, and on the global economy;
our aspirational goals and objectives related to our human capital resources and workforce objectives;
our ability to attract and retain key managerial, scientific and medical personnel;
the accuracy of our estimates regarding the sufficiency of our cash resources, expenses, future revenue, capital requirements and needs for additional financing; and
our financial performance.

All forward-looking statements are based on information available to us on the date of this Quarterly Report on Form 10-Q and we will not update any of the forward-looking statements after the date of this Quarterly Report on Form 10-Q, except as required by law. Our actual results could differ materially from those discussed in this Quarterly Report on Form 10-Q. The forward-looking statements contained in this Quarterly Report on Form 10-Q, and other written and oral forward-looking statements made by us from time to time, are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, and you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Factors that might cause such a difference include, but are not limited to, those discussed in the following discussion and within the section of this Quarterly Report on Form 10-Q titled “Part II, Item 1A — Risk Factors”.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and although we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted a thorough inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

All brand names or trademarks appearing in this Quarterly Report are the property of their respective holders. Unless the context requires otherwise, references in this Quarterly Report to “Kodiak” the “Company,” “we,” “us,” and “our” refer to Kodiak Sciences Inc. and its subsidiaries.

ii


 

SELECTED RISKS AFFECTING OUR BUSINESS

Investing in our common stock involves numerous risks, including the risks described in “Part II—Other Information, Item 1A. Risk Factors” of this Quarterly Report on Form 10-Q, any one of which could materially adversely affect our business, financial condition, results of operations, and prospects. These risks include, among others, the following:

We are in the clinical stage of drug development and have a very limited operating history and no products approved for commercial sale, which may make it difficult to evaluate our current business and predict our future success and viability.
We have incurred significant net losses in each period since our inception and anticipate that we will continue to incur significant and increasing net losses for the foreseeable future.
Drug development is a highly uncertain undertaking and involves a substantial degree of risk. We have never generated any revenue from product sales, and we may never generate revenue or be profitable.
Our prospects are heavily dependent on our tarcocimab product candidate, which is currently in clinical development for multiple indications.
A failure of tarcocimab in clinical development may require us to discontinue development of other product candidates based on our ABC Platform.
Research and development of biopharmaceutical products is inherently risky. We cannot give any assurance that any of our product candidates will receive regulatory, including marketing, approval, which is necessary before they can be commercialized.
We may encounter substantial delays in our clinical trials, or we may not be able to conduct or complete our clinical trials on the timelines we expect, if at all.
We may encounter difficulties enrolling patients in our clinical trials, and our clinical development activities could thereby be delayed or otherwise adversely affected.
Our clinical trials may fail to demonstrate substantial evidence of the durability, efficacy and safety of our product candidates, which would prevent, delay or limit the scope of regulatory approval and commercialization.
The topline results from our Phase 2b/3 pivotal study of tarcocimab in wet AMD and from our Phase 3 pivotal study BEACON in RVO may lead to further study design modifications in our other ongoing pivotal studies and may impact the timeline of completion and likelihood of success of these pivotal studies.
We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may retain their market share with existing drugs or achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours, which may negatively impact our ability to successfully market or commercialize any product candidates we may develop and ultimately harm our financial condition.
The manufacture of our product candidates is highly complex and requires substantial lead time to produce.
We have no experience manufacturing any of our product candidates at a commercial scale. If we or any of our third-party manufacturers encounter difficulties in production or fail to meet rigorously enforced regulatory standards, our ability to provide supply of our product candidates for clinical trials or our ability to provide the information needed in the regulatory dossiers for our planned BLA filing, or our ability to supply our products for patients, if approved, could be delayed or stopped, or we may be unable to establish a commercially viable cost structure.
The regulatory approval processes of the FDA, EMA and comparable foreign regulatory authorities are lengthy, time consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to generate product revenue and our business will be substantially harmed.
We are conducting clinical trials for our product candidates outside the United States, and the FDA, EMA and applicable foreign regulatory authorities may not accept data from such trials.
Our business is subject to complex and evolving U.S. and foreign laws and regulations relating to privacy and data protection. These laws and regulations are subject to change and uncertain interpretation, and could result in claims, changes to our business practices, or monetary penalties, and otherwise may harm our business.
If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

iii


 

We expect to rely on third parties to conduct many aspects of our clinical trials and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.
If we are unable to obtain and maintain patent protection for any product candidates we develop or for our ABC Platform, our competitors could develop and commercialize products or technology similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop, and our technology may be adversely affected.
If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical technology and product candidates would be adversely affected.
Third-party claims of intellectual property infringement, misappropriation or other violation against us or our collaborators may prevent or delay the development and commercialization of our ABC Platform, product candidates and other technologies.
We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming and unsuccessful.
We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
Unfavorable U.S. and global economic conditions could adversely affect our business, financial condition or results of operations.
Our business could be materially and adversely affected in the future by the effects of disease outbreaks, epidemics and pandemics, such as the COVID-19 pandemic, as well as the business or operations of our manufacturers, CROs or other third parties with whom we conduct business.

 

iv


 

Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

 

Condensed Consolidated Statements of Stockholders’ Equity

3

Condensed Consolidated Statements of Cash Flows

4

Notes to Unaudited Condensed Consolidated Financial Statements

5

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

11

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

18

Item 4.

Controls and Procedures

18

PART II.

OTHER INFORMATION

19

Item 1.

Legal Proceedings

19

Item 1A.

Risk Factors

19

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

63

Item 3.

Defaults Upon Senior Securities

63

Item 4.

Mine Safety Disclosures

63

Item 5.

Other Information

63

Item 6.

Exhibits

64

 

Signatures

65

 

v


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited).

Kodiak Sciences Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

March 31,
2023

 

 

December 31,
2022

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

316,615

 

 

$

190,433

 

Marketable securities

 

 

104,576

 

 

 

288,500

 

Prepaid expenses and other current assets

 

 

9,927

 

 

 

7,072

 

Total current assets

 

 

431,118

 

 

 

486,005

 

Restricted cash

 

 

6,324

 

 

 

6,324

 

Property and equipment, net

 

 

134,545

 

 

 

56,384

 

Operating lease right-of-use asset

 

 

59,150

 

 

 

59,369

 

Other assets

 

 

9,197

 

 

 

58,546

 

Total assets

 

$

640,334

 

 

$

666,628

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

6,262

 

 

$

9,130

 

Accrued and other current liabilities

 

 

54,732

 

 

 

33,440

 

Operating lease liability

 

 

7,944

 

 

 

9,926

 

Total current liabilities

 

 

68,938

 

 

 

52,496

 

Operating lease liability, net of current portion

 

 

78,809

 

 

 

77,807

 

Liability related to sale of future royalties

 

 

100,000

 

 

 

99,996

 

Other liabilities

 

 

 

 

 

162

 

Total liabilities

 

 

247,747

 

 

 

230,461

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value, 10,000,000 shares authorized;
   
0 shares issued and outstanding at March 31, 2023 and
   December 31, 2022, respectively

 

 

 

 

 

 

Common stock, $0.0001 par value, 490,000,000 shares authorized
   at March 31, 2023 and December 31, 2022;
52,344,741 and
   
52,333,850 shares issued and outstanding at March 31, 2023 and
   December 31, 2022, respectively

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

1,355,498

 

 

 

1,329,509

 

Accumulated other comprehensive income (loss)

 

 

(96

)

 

 

(1,307

)

Accumulated deficit

 

 

(962,820

)

 

 

(892,040

)

Total stockholders’ equity

 

 

392,587

 

 

 

436,167

 

Total liabilities and stockholders’ equity

 

$

640,334

 

 

$

666,628

 

 

 

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,

 

 

 

2023

 

 

2022

 

Operating expenses

 

 

 

 

 

 

Research and development

 

$

56,520

 

 

$

76,177

 

General and administrative

 

 

18,095

 

 

 

19,590

 

Total operating expenses

 

 

74,615

 

 

 

95,767

 

Loss from operations

 

 

(74,615

)

 

 

(95,767

)

Interest income

 

 

3,617

 

 

 

76

 

Interest expense

 

 

(4

)

 

 

(5

)

Other income (expense), net

 

 

222

 

 

 

(13

)

Net loss

 

$

(70,780

)

 

$

(95,709

)

Net loss per common share, basic and diluted

 

$

(1.35

)

 

$

(1.83

)

Weighted-average shares of common stock outstanding used
   in computing net loss per common share, basic and diluted

 

 

52,337,603

 

 

 

52,172,918

 

Other comprehensive income (loss)

 

 

 

 

 

 

Change in unrealized gains (losses) related to available-for-sale
   debt securities, net of tax

 

 

1,211

 

 

 

 

Total other comprehensive income (loss)

 

 

1,211

 

 

 

 

Comprehensive loss

 

$

(69,569

)

 

$

(95,709

)

 

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, 2022

 

 

52,333,850

 

 

$

5

 

 

$

1,329,509

 

 

$

(1,307

)

 

$

(892,040

)

 

$

436,167

 

Issuance of common stock upon
   exercise of stock options

 

 

1,098

 

 

 

 

 

 

9

 

 

 

 

 

 

 

 

 

9

 

Issuance of common stock upon
   vesting of restricted stock units

 

 

9,793

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation
   expense

 

 

 

 

 

 

 

 

25,980

 

 

 

 

 

 

 

 

 

25,980

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

1,211

 

 

 

 

 

 

1,211

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(70,780

)

 

 

(70,780

)

Balances at March 31, 2023

 

 

52,344,741

 

 

$

5

 

 

$

1,355,498

 

 

$

(96

)

 

$

(962,820

)

 

$

392,587

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balances at December 31, 2021

 

 

51,826,257

 

 

$

5

 

 

$

1,221,532

 

 

$

 

 

$

(558,217

)

 

$

663,320

 

Issuance of common stock upon
   exercise of stock options

 

 

110,043

 

 

 

 

 

 

1,678

 

 

 

 

 

 

 

 

 

1,678

 

Issuance of common stock upon
   vesting of restricted stock units

 

 

3,581

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation
   expense

 

 

 

 

 

 

 

 

28,095

 

 

 

 

 

 

 

 

 

28,095

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(95,709

)

 

 

(95,709

)

Balances at March 31, 2022

 

 

51,939,881

 

 

$

5

 

 

$

1,251,305

 

 

$

 

 

$

(653,926

)

 

$

597,384

 

 

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,

 

 

2023

 

 

2022

 

Cash flows from operating activities

 

 

 

 

 

Net loss

$

(70,780

)

 

$

(95,709

)

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

 

 

 

 

 

Depreciation

 

3,810

 

 

 

298

 

Stock-based compensation

 

25,980

 

 

 

28,095

 

Net amortization (accretion) of premium (discount) on marketable securities

 

(518

)

 

 

 

Amortization of operating lease right-of-use asset

 

1,846

 

 

 

1,904

 

Amortization of issuance costs

 

4

 

 

 

13

 

Changes in assets and liabilities:

 

 

 

 

 

Prepaid expenses and other current assets

 

2,326

 

 

 

(7,159

)

Other assets

 

(12

)

 

 

7,869

 

Accounts payable

 

(1,900

)

 

 

6,505

 

Accrued and other current liabilities

 

(5,370

)

 

 

13,696

 

Operating lease liability

 

(2,607

)

 

 

1,328

 

Net cash provided by (used in) operating activities

 

(47,221

)

 

 

(43,160

)

Cash flows from investing activities

 

 

 

 

 

Purchase of property and equipment

 

(12,170

)

 

 

(17,460

)

Deposits on property and equipment

 

(77

)

 

 

(829

)

Purchase of marketable securities

 

(49,347

)

 

 

 

Maturities of marketable securities

 

235,000

 

 

 

 

Net cash provided by (used in) investing activities

 

173,406

 

 

 

(18,289

)

Cash flows from financing activities

 

 

 

 

 

Proceeds from issuance of common stock upon options exercise

 

9

 

 

 

1,678

 

Principal payments of tenant improvement allowance payable

 

(12

)

 

 

(12

)

Net cash provided by (used in) financing activities

 

(3

)

 

 

1,666

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

126,182

 

 

 

(59,783

)

Cash, cash equivalents and restricted cash, at beginning of period

 

196,757

 

 

 

737,834

 

Cash, cash equivalents and restricted cash, at end of period

$

322,939

 

 

$

678,051

 

Reconciliation of cash, cash equivalents and restricted cash to consolidated balance sheets

 

 

 

 

 

Cash and cash equivalents

$

316,615

 

 

$

671,727

 

Restricted cash

 

6,324

 

 

 

6,324

 

Total cash, cash equivalents and restricted cash in consolidated balance sheets

$

322,939

 

 

$

678,051

 

 

 

 

 

 

 

Supplemental disclosures of non-cash investing and financing information:

 

 

 

 

 

Operating lease right-of-use asset obtained in exchange for operating lease liability

$

1,473

 

 

$

74

 

Purchase of property and equipment under accounts payable and accruals

$

28,795

 

 

$

11,488

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4


 

Kodiak Sciences Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

1. The Company

Kodiak Sciences Inc. (the “Company”) is a clinical stage biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases. 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, 2023, the Company had cash, cash equivalents and marketable securities of $421.2 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 Quarterly Report on 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 state 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, 2022 and notes thereto, the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 28, 2023. 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, 2023, 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 in the consolidated financial statements have been reclassified to conform to the current period presentation.

Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. 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 consolidated financial statements and expenses during the reporting period. Such estimates include, but are not limited to, accrued research and development and stock-based compensation. Actual results could differ from those estimates.

Risks and Uncertainties

Global economic and business activities continue to face widespread macroeconomic uncertainties, including health epidemics, labor shortages, bank failures, inflation and monetary supply shifts, recession risks and potential disruptions from the Russia-Ukraine conflict. The Company continues to actively monitor the impact of these macroeconomic factors on its financial condition, liquidity, operations, and workforce. The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected timeframe, will depend on future developments, which are uncertain and cannot be predicted; however, any continued or renewed disruption resulting from these factors could negatively impact the Company’s business.

5


Kodiak Sciences Inc.

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

 

The Company’s future results of operations involve a number of risks and uncertainties common to clinical stage companies in the biotechnology industry. The Company’s product candidates are in development and the Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s potential drug candidates, uncertainty of market acceptance of any of the Company’s product candidates that receive regulatory approval, competition from new technological innovations, substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals, contract manufacturer and research organizations, and other suppliers.

Products developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance that any of the Company’s product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approvals, it could have a materially adverse impact on the Company. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales.

The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to complete clinical trials, launch and commercialize any product candidates for which it receives regulatory approval. There can be no assurance that such financing will be available or will be on terms acceptable by the Company.

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, 2023, 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, 2022, except as noted below within the “Recent Accounting Pronouncements” section.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB"), under its Accounting Standards Codification ("ASC") or other standard setting bodies, and adopted by the Company as of the specified effective date. There have been no new accounting pronouncements issued nor adopted during the three months ended March 31, 2023 that are of significance to the Company.

3. Accrued and Other Current Liabilities

Accrued and other current liabilities consist of the following (in thousands):

 

 

 

March 31,
2023

 

 

December 31,
2022

 

Accrued property and equipment

 

$

28,645

 

 

$

1,893

 

Accrued clinical trial and related costs

 

 

17,379

 

 

 

18,334

 

Accrued manufacturing and research & development costs

 

 

4,117

 

 

 

5,978

 

Accrued salaries and benefits

 

 

3,251

 

 

 

6,033

 

Accrued legal fees and professional fees

 

 

190

 

 

 

283

 

Accrued other liabilities

 

 

1,150

 

 

 

919

 

Total accrued and other current liabilities

 

$

54,732

 

 

$

33,440

 

 

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, 2023

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

299,788

 

 

$

 

 

$

 

 

$

299,788

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

 

 

 

 

104,576

 

 

 

 

 

 

104,576

 

Total

 

$

299,788

 

 

$

104,576

 

 

$

 

 

$

404,364

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair Value Measurements at December 31, 2022

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

173,617

 

 

$

 

 

$

 

 

$

173,617

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

 

 

 

 

288,500

 

 

 

 

 

 

288,500

 

Total

 

$

173,617

 

 

$

288,500

 

 

$

 

 

$

462,117

 

 

As of March 31, 2023, the fair value of the liability related to sale of future royalties is based on the Company's current estimates of future royalties expected to be paid to Baker Bros. Advisors, LP (“BBA”), which are considered Level 3 inputs.

5. Marketable Securities

Marketable securities are classified as available-for-sale. The Company obtains fair value measurement data from third party pricing services and understands the valuation methods and data sources to validate this information.

The following table presents the Company's marketable securities by major security type (in thousands):

 

As of March 31, 2023

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

U.S. treasury securities

 

$

104,672

 

 

$

 

 

$

(96

)

 

$

104,576

 

Total

 

$

104,672

 

 

$

 

 

$

(96

)

 

$

104,576

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of December 31, 2022

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

U.S. treasury securities

 

$

289,807

 

 

$

 

 

$

(1,307

)

 

$

288,500

 

Total

 

$

289,807

 

 

$

 

 

$

(1,307

)

 

$

288,500

 

 

The marketable securities held as of March 31, 2023 had effective maturities of less than one year. There were no reclassifications out of accumulated other comprehensive income (loss), impairment charges or recoveries and no allowance for credit losses recorded during the three months ended March 31, 2023.

6. Derivatives

The Company recognized the fair value of foreign currency forward contracts of $0.2 million as of March 31, 2023 in the condensed consolidated balance sheet. For the three months ended March 31, 2023, the change in fair value of $0.2 million was recognized in other income (expense), net.

 

 

7


Kodiak Sciences Inc.

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

 

7. Commitments and Contingencies

Ursus Facility

In August 2020, the Company and its wholly-owned subsidiary Kodiak Sciences GmbH entered into a manufacturing agreement with Lonza Ltd (“Lonza”) for the clinical and commercial supply of the Company’s antibody biopolymer conjugate drug substance which included a custom-built manufacturing facility. 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 and Lonza each have the ability to terminate this agreement upon the occurrence of certain conditions.

In April 2021, the agreement was amended to provide for greater manufacturing flexibility, to define a comprehensive mandate as an antibody biopolymer conjugates manufacturing facility to be used for the Company’s antibody biopolymer conjugates pipeline, at clinical as well as commercial scales, across a broad capacity range under the tight quality controls required for ophthalmology and retinal medicines, and to allow for future process and equipment changes as needed.

The Company expanded and finalized the design and scope of the antibody biopolymer conjugates manufacturing facility with a revised estimated capital contribution of approximately 75.0 million Swiss Francs. Over the period from 2022 through 2030, manufacturing payments totaling approximately 150.0 million Swiss Francs may be incurred for the potential clinical and commercial supply of tarcocimab and other antibody biopolymer conjugates medicines based on the amended agreement.

The Company concluded that this agreement contained an embedded lease as the custom-built manufacturing suite would be dedicated for the Company’s use. On January 31, 2023, the custom-built manufacturing suite was commissioned as a cGMP facility. The consideration was allocated to lease and non-lease components as this agreement contained a significant service component (manufacturing services). The Company recognized an operating lease right-of-use asset and corresponding liability based on the present value of remaining lease payments discounted at the Company’s estimated incremental borrowing rate of 6.3% over the remaining lease term of 7.2 years. The Company determined that the renewal options were not reasonably certain at lease inception. The Company recognized $0.1 million as part of operating lease costs during the three months ended March 31, 2023.

Fixed assets of approximately 75.0 million Swiss Francs, equivalent to $81.7 million, in leasehold improvements and machinery and equipment, were placed in service and capitalized as of January 31, 2023. As of March 31, 2023, $26.8 million of these fixed assets were unpaid and recorded to accrued property and equipment under accrued and other current liabilities on the condensed consolidated balance sheet.

Manufacturing Agreements

The Company has entered into service and equipment purchase agreements in the normal course of business with various providers, pursuant to which such providers agreed to perform activities in connection with the manufacturing process of certain materials. These agreements, and any related amendments, state that planned activities and purchases 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.

Legal Proceedings

From time to time, the Company may become involved in legal proceedings arising from the ordinary course of its business. Management is currently not aware of any matters that could have a material adverse effect on the Company’s financial position, results of operations or cash flows. The Company records a legal liability when it believes that it is both probable that a liability may be imputed, and the amount of the liability can be reasonably estimated. Significant judgment by the Company is required to determine both probability and the estimated amount.

8


Kodiak Sciences Inc.

Notes to Unaudited Condensed Consolidated Financial Statements (Continued)

 

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. Stock-Based Compensation

In January 2023 and 2022, the number of shares of common stock available for issuance under the 2018 Equity Incentive Plan (the "2018 Plan") was increased by approximately 2.1 million and 2.1 million shares, respectively, as a result of the automatic increase provision in the 2018 Plan.

Stock Options

Stock option activity, including stock options and performance-based stock options under the 2021 Long-Term Performance Incentive Plan (“2021 LTPIP”), 2018 Plan and 2015 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, 2022

 

 

16,542,107