Intellia Therapeutics Annual Report 2020

Intellia Therapeutics Annual Report 2020 Form 10-K (NASDAQ:NTLA) Published: February 27th, 2020 PDF generated by stocklight.com UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 ☐ 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 001-37766 INTELLIA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-4785571 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 40 Erie Street, Suite 130 Cambridge, Massachusetts 02139 (Address of principal executive offices) (Zip Code) (857) 285-6200 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each Class Trade Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share NTLA The Nasdaq Global Market Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ 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 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 ☒ The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately $741,046,311 as of June 28, 2019 (based on a closing price of $16.37 per share as quoted by the Nasdaq Global Market as of such date). In determining the market value of non-affiliate common stock, shares of the registrant’s common stock beneficially owned by officers, directors and affiliates have been excluded. This determination of affiliate status is not necessarily a conclusive determination for other purposes. The registrant had 50,507,681 shares of Common Stock, $0.0001 par value per share, outstanding as of February 21, 2020. DOCUMENTS INCORPORATED BY REFERENCE Part III of this Annual Report on Form 10-K incorporates by reference certain information from the registrant’s definitive Proxy Statement for its 2020 annual meeting of shareholders, which the registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year end of December 31, 2019. Except with respect to information specifically incorporated by reference in this Form 10-K, the Proxy Statement is not deemed to be filed as part of this Form 10-K. Intellia Therapeutics, Inc. Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2019 Table of Contents Item No. PART I Page Item 1. Business 5 Item 1A. Risk Factors 41 Item 1B. Unresolved Staff Comments 93 Item 2. Properties 94 Item 3. Legal Proceedings 94 Item 4. Mine Safety Disclosures 94 PART II Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 95 Item 6. Selected Financial Data 96 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 97 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 111 Item 8. Financial Statements and Supplementary Data 111 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 111 Item 9A. Controls and Procedures 112 Item 9B. Other Information 114 PART III Item 10. Directors, Executive Officers and Corporate Governance 115 Item 11. Executive Compensation 115 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 115 Item 13. Certain Relationships and Related Transactions, and Director Independence 115 Item 14. Principal Accounting Fees and Services 115 PART IV Item 15. Exhibits, Financial Statement Schedules 116 Item 16. Form 10-K Summary 116 Signatures Forward-looking Information This Annual Report on Form 10-K contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward- looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding: • the initiation, timing, progress and results of our research and development programs and future preclinical and clinical studies, including the anticipated timing of our submission of investigational new drug applications and initiation of clinical studies for transthyretin amyloidosis, our lead in vivo indication, and for acute myeloid leukemia, our lead engineered cell therapy indication, and the nomination of candidates for other development programs; • the initiation, timing, progress and results of our research and development programs and future preclinical and clinical studies, including the anticipated timing of nominating a development candidate or an investigational new drug application for hereditary angioedema; • our ability to use a modular platform capability or other strategy to efficiently discover and develop product candidates, including by applying learnings from one program to other programs; • our ability to research, develop or maintain a pipeline of product candidates; • our ability to manufacture or obtain material for our preclinical and clinical studies, and our product candidates; • our ability to advance any product candidates into, and successfully complete, clinical studies, including clinical studies necessary for regulatory approval and commercialization, and to demonstrate to the regulators that the product candidates are safe and effective and that their benefits outweigh known and potential risks for the intended patient population; • our ability to advance our genome editing and therapeutic delivery capabilities; • the scope of protection we are able to develop, establish and maintain for intellectual property rights, including patents and license rights, covering our product candidates and technology; • our ability to operate, including commercializing products, without infringing or breaching the proprietary or contractual rights of others; • the issuance or enforcement of, and compliance with, regulatory requirements and guidance regarding preclinical and clinical studies relevant to genome editing and our product candidates; • the timing or likelihood of regulatory filings and approvals; • the commercialization of our product candidates, if approved; • the pricing and reimbursement of our product candidates, if approved; • the implementation of our business model, and strategic plans for our business, product candidates and technology; • estimates of our expenses, future revenues, capital requirements and our needs for additional financing; • the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; • our ability to maintain and establish collaborations with third parties under favorable terms; • our ability to acquire and maintain relevant intellectual property licenses and rights, and the scope and terms

Load more