SEC Filing | 2seventy bio

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tsvt-20220930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q


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

For the quarterly period ended September 30, 2022


☐			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 001-40791

2seventy bio, Inc.

(Exact name of registrant as specified in its charter)


Delaware						86-3658454
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

2seventy bio, Inc.

60 Binney Street

Suite 200

Cambridge, MA 2142

(339) 499-9300

Registrant's telephone number, including area code

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 per share	TSVT	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 and posted on its corporate web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes ☒ No ☐

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


			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 Act). Yes ☐ No ☒

The registrant had outstanding 37,916,693 shares of common stock as of November 1, 2022.

TABLE OF CONTENTS


		Page
Part I- Financial Information
Item 1.	Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021	1
	Condensed Consolidated and Combined Statements of Operations and Comprehensive Loss for the Three and Nine Months E nded September 30, 2022 and September 30, 2021	2
	Condensed Consolidated and Combined Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2022 and September 30, 2021	3
	Condensed Consolidated and Combined Statements of Cash Flows for the Nine Months Ended September 30, 2022 and Septem b er 30, 2021	5
	Notes to Condensed Consolidated and Combined Financial Statements	6
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	26
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	41
Item 4.	Controls and Procedures	42
	Part II. Other Information
Item 1	Legal Proceedings	43
Item 1A.	Risk Factors	43
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	45
Item 3.	Defaults Upon Senior Securities	45
Item 4.	Mine Safety Disclosures	45
Item 5.	Other Information	45
Item 6.	Exhibit Index	46
	Signatures	47

CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q and other materials we have filed or will file with the SEC include, or will include, forward-looking statements. All statements in this Quarterly Report on Form 10-Q, in other materials we have filed or will file with the SEC and in related comments by our management, other than statements of historical facts, including statements about future events, future financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations, are forward-looking statements that involve certain risks and uncertainties. Use of the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “seeks,” “intends,” “evaluates,” “pursues,” “anticipates,” “continues,” “designs,” “impacts,” “affects,” “forecasts,” “target,” “outlook,” “initiative,” “objective,” “designed,” “priorities,” “goal” or the negative of those words or other similar expressions may identify forward-looking statements that represent our current judgment about possible future events, but the absence of these words does not necessarily mean that a statement is not forward-looking.

Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, our actual results may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions and the following:

•our business and operations following the separation from bluebird bio and any benefits or costs of the separation, including the tax treatment;

•our post-separation relationships with bluebird bio, third parties, collaborators and our employees;

•our ability to operate as a stand-alone company and execute our strategic priorities;

•our ability to finance our operations and business initiatives and obtain funding for such activities;

•the timing, investment and associated activities involved in developing, obtaining regulatory approval for, launching, and commercializing our product candidates;

•our plans with respect to the development, manufacture or sale of our product candidates and the associated timing thereof, including the design and results of pre-clinical and clinical studies;

•the safety profile and related adverse events of our product candidates;

•the efficacy and perceived therapeutic benefits of our product candidates and the potential indications and market opportunities therefor;

•U.S. and foreign regulatory requirements for our product candidates, including any post-approval development and regulatory requirements, and the ability of our product candidates to meet such requirements;

•our ability to attract and retain key employees needed to execute our business plans and strategies and our expectations regarding our ability to manage the impact of any loss of key employees;

•our ability to obtain and maintain intellectual property protection for our product candidates and the strength thereof;

•our future financial performance, revenues, expense levels, payments, cash flows, profitability, tax obligations, capital raising and liquidity sources, real estate needs and concentration of voting control, as well as the timing and drivers thereof, and internal control over financial reporting;

•our ability to compete with other companies that are or may be developing or selling products that are competitive with our product candidates;

•the status of government regulation in the life sciences industry, particularly with respect to healthcare reform;

•the potential benefits of strategic collaboration agreements;

•potential indemnification liabilities 2seventy bio may owe to bluebird bio after the separation;

•the tax treatment of the distribution and the limitations imposed on 2seventy bio under the tax matters agreement that 2seventy bio entered into with bluebird bio in connection with the separation and distribution;

•the impact of rising inflation rates on our business, financial condition and results of operation;

•the fluctuation of the market price of our shares; and

•trends and challenges in our potential markets.

See “Risk Factors” for a further description of these and other factors. Although we have attempted to identify important risk factors, there may be other risk factors not presently known to us or that we presently believe are not material that could cause actual results and developments to differ materially from those made in or suggested by the forward-looking statements contained in this Quarterly Report on Form 10-Q. If any of these risks materialize, or if any of the above assumptions underlying forward-looking statements prove incorrect, actual results and developments may differ materially from those made in or suggested by the forward-looking statements contained in this Quarterly Report on Form 10-Q. For the reasons described above, we caution you against relying on any forward-looking statements, which should also be read in conjunction with the other cautionary statements that are included elsewhere in this Quarterly Report on Form 10-Q. Any forward-looking statement made by us in this Quarterly Report on Form 10-Q speaks only as of the date thereof. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update or to revise any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by law.

PART I. FINANCIAL INFORMATION

Item 1. Financial Information

2seventy bio, Inc.

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands, except par value amounts)


	As of September 30, 2022		As of December 31, 2021
Assets
Current assets:
Cash and cash equivalents	$	127,021	$	130,414
Marketable securities	196,089		134,643
Prepaid expenses	14,270		9,512
Receivables and other current assets	12,037		16,995
Total current assets	349,417		291,564
Property, plant and equipment, net	46,650		34,913
Marketable securities	1,407		97,124
Intangible assets, net	7,479		9,892
Goodwill	12,056		12,056
Operating lease right-of-use assets	253,458		275,534
Restricted cash and other non-current assets	38,277		38,592
Total assets	$	708,744	$	759,675
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	7,983	$	6,024
Accrued expenses and other current liabilities	52,156		55,410
Operating lease liability, current portion	10,798		9,769
Deferred revenue, current portion	—		5,000
Collaboration research advancement, current portion	8,960		22,185
Total current liabilities	79,897		98,388
Deferred revenue, net of current portion	40,762		25,762
Collaboration research advancement, net of current portion	—		1,135
Operating lease liability, net of current portion	262,490		272,446
Other non-current liabilities	2,415		2,122
Total liabilities	385,564		399,853
Commitments and contingencies (Note 8)
Stockholders’ equity:
Preferred stock, $0.0001 par value; 10,000 shares authorized, 0 shares issued and outstanding at September 30, 2022 and December 31, 2021	—		—
Common stock, $0.0001 par value; 200,000 shares authorized, 37,912 and 23,585 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively	4		2
Additional paid-in capital	597,566		400,026
Accumulated other comprehensive loss	(3,886)		(712)
Accumulated deficit	(270,504)		(39,494)
Total stockholders’ equity	323,180		359,822
Total liabilities and stockholders’ equity	$	708,744	$	759,675

See accompanying notes to unaudited condensed consolidated and combined financial statements.

2seventy bio, Inc.

Condensed Consolidated and Combined Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands, except per share data)


	For the three months ended September 30,				For the nine months ended September 30,
	2022		2021		2022		2021
Revenue:
Service revenue	$	4,642	$	6,312	$	14,363	$	17,544
Collaborative arrangement revenue	7,903		12,337		18,425		15,527
Royalty and other revenue	863		608		2,531		5,417
Total revenues	13,408		19,257		35,319		38,488
Operating expenses:
Research and development	61,739		61,131		199,423		202,394
Selling, general and administrative	19,610		22,996		60,749		69,025
Share of collaboration loss	—		—		9,642		10,071
Cost of royalty and other revenue	377		320		1,252		2,111
Change in fair value of contingent consideration	50		48		181		464
Total operating expenses	81,776		84,495		271,247		284,065
Loss from operations	(68,368)		(65,238)		(235,928)		(245,577)
Interest income, net	1,113		—		1,441		—
Other (loss) income, net	(624)		5,237		3,494		14,340
Loss before income taxes	(67,879)		(60,001)		(230,993)		(231,237)
Income tax (expense) benefit	—		—		(17)		—
Net loss	$	(67,879)	$	(60,001)	$	(231,010)	$	(231,237)
Net loss per share - basic and diluted	$	(1.76)	$	(2.57)	$	(6.67)	$	(9.90)
Weighted-average number of common shares used in computing net loss per share - basic and diluted	38,573		23,369		34,612		23,369
Other comprehensive loss:
Other comprehensive loss, net of tax benefit (expense) of $0.0 million and $0.0 million for the three and nine months ended September 30, 2022 and 2021, respectively.	$	(504)	$	—	$	(3,174)	$	—
Total other comprehensive loss	$	(504)	$	—	$	(3,174)	$	—
Comprehensive loss	$	(68,383)	$	(60,001)	$	(234,184)	$	(231,237)

See accompanying notes to unaudited condensed consolidated and combined financial statements.

2seventy bio, Inc.

Condensed Consolidated and Combined Statements of Stockholders’ Equity

(unaudited)

(in thousands)


	Common stock			Net parent investment		Additional paid-in capital		Accumulated other comprehensive loss		Accumulated deficit		Total stockholders’ equity
	Shares	Amount
Balances at December 31, 2021	23,585	$	2	$	—	$	400,026	$	(712)	$	(39,494)	$	359,822
Vesting of restricted stock units	97	—		—		—		—		—		—
Exercise of stock options	—	—		—		1		—		—		1
Issuance of common stock in private placement, net of issuance costs	13,934	2		—		165,655		—		—		165,657
Stock-based compensation	—	—		—		9,739		—		—		9,739
Other comprehensive loss	—	—		—		—		(2,092)		—		(2,092)
Net loss	—	—		—		—		—		(85,711)		(85,711)
Balances at March 31, 2022	37,616	$	4	$	—	$	575,421	$	(2,804)	$	(125,205)	$	447,416
Vesting of restricted stock units	18	$	—	$	—	$	—	$	—	$	—	$	—
Exercise of stock options	—	—		—		1		—		—		1
Additional issuance costs related to issuance of common stock in private placement	—	—		—		(124)		—		—		(124)
Stock-based compensation	—	—		—		9,689		—		—		9,689
Other comprehensive loss	—	—		—		—		(578)		—		(578)
Net loss	—	—		—		—		—		(77,420)		(77,420)
Balances at June 30, 2022	37,634	$	4	$	—	$	584,987	$	(3,382)	$	(202,625)	$	378,984
Vesting of restricted stock units	245	$	—	$	—	$	—	$	—	$	—	$	—
Exercise of stock options	—	—		—		—		—		—		—
Stock-based compensation	—	—		—		12,207		—		—		12,207
Purchase of common stock under ESPP	33	—		—		372		—		—		372
Other comprehensive loss	—	—		—		—		(504)		—		(504)
Net loss	—	—		—		—		—		(67,879)		(67,879)
Balances at September 30, 2022	37,912	$	4	$	—	$	597,566	$	(3,886)	$	(270,504)	$	323,180

See accompanying notes to unaudited condensed consolidated and combined financial statements.

2seventy bio, Inc.

Condensed Consolidated and Combined Statements of Stockholders’ Equity - (continued)

(unaudited)

(in thousands)


	Common stock			Net parent investment		Additional paid-in capital		Accumulated other comprehensive loss			Accumulated deficit		Total stockholders’ equity
	Shares	Amount
Balances at December 31, 2020	—	$	—	$	74,629	$	—	$	—		$	—	$	74,629
Stock-based compensation - bluebird bio allocation	—	—		17,109		—		—			—		17,109
Transfers from bluebird bio, net	—	—		71,101		—		—			—		71,101
Net loss	—	—		(87,196)		—		—			—		(87,196)
Balances at March 31, 2021	—	$	—	$	75,643	$	—	$	—		$	—	$	75,643
Stock-based compensation - bluebird bio allocation	—	—		11,967		—		—			—		11,967
Transfers from bluebird bio, net	—	—		45,119		—		—			—		45,119
Net loss	—	—		(84,040)		—		—			—		(84,040)
Balances at June 30, 2021	—	$	—	$	48,689	$	—	$	—		$	—	$	48,689
Stock-based compensation - bluebird bio allocation	—	—		11,230		—		—			—		11,230
Transfers to bluebird bio, net	—	—		(58,325)		—		—			—		(58,325)
Net loss	—	—		(60,001)		—		—			—		(60,001)
Balances at September 30, 2021	—	$	—	$	(58,407)	$	—	$	—	—	$	—	$	(58,407)

See accompanying notes to unaudited condensed consolidated and combined financial statements.

2seventy bio, Inc.

Condensed Consolidated and Combined Statements of Cash Flows

(unaudited)

(in thousands)


	For the nine months ended September 30,
	2022		2021
Cash flows from operating activities:
Net loss	$	(231,010)	$	(231,237)
Adjustments to reconcile net loss to net cash used in operating activities:
Change in fair value of contingent consideration	181		464
Depreciation and amortization	9,208		12,815
Stock-based compensation expense	31,635		40,306
Other non-cash items	1,074		247
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(354)		3,036
Operating lease right-of-use assets	22,076		11,146
Accounts payable	422		607
Accrued expenses and other liabilities	(1,598)		32,066
Operating lease liabilities	(8,927)		(13,305)
Deferred revenue	10,000		(820)
Collaboration research advancement	(14,361)		(4,920)
Net cash used in operating activities	(181,654)		(149,595)
Cash flows from investing activities:
Purchases of property, plant and equipment	(19,676)		(10,600)
Purchases of marketable securities	(115,692)		—
Proceeds from maturities of marketable securities	147,597		—
Purchase of intangible assets	—		(8,000)
Net cash provided by (used in) investing activities	12,229		(18,600)
Cash flows from financing activities:
Transfers from bluebird bio	—		168,195
Proceeds from issuance of common stock in private placement, net of issuance costs	165,531		—
Proceeds from exercise of stock options and ESPP contributions	466		—
Net cash provided by financing activities	165,997		168,195
Decrease in cash, cash equivalents and restricted cash	(3,428)		—
Cash, cash equivalents and restricted cash at beginning of period	163,266		—
Cash, cash equivalents and restricted cash at end of period	$	159,838	$	—
Reconciliation of cash, cash equivalents, and restricted cash
Cash and cash equivalents	$	127,021	$	—
Restricted cash included in restricted cash and other non-current assets	32,817		—
Total cash, cash equivalents, and restricted cash	$	159,838	$	—
Supplemental cash flow disclosures:
Purchases of property, plant and equipment included in accounts payable and accrued expenses	$	2,828	$	321
Non-cash return of bRT related assets to bluebird bio	$	—	$	110,300

See accompanying notes to unaudited condensed consolidated and combined financial statements.

2seventy bio, Inc.

Notes to Condensed Consolidated and Combined Financial Statements

(unaudited)

1. Description of the business

2seventy bio, Inc. (the “Company” or “2seventy bio”) was incorporated in Delaware on April 26, 2021 and is a cell and gene therapy company focused on the research, development, and commercialization of transformative treatments for cancer. The Company’s approach combines its expertise in T cell engineering technology and lentiviral vector gene delivery approaches, experience in research, development, and manufacturing of cell therapies and a suite of technologies that can be selectively deployed to develop highly innovative, targeted cellular therapies for patients with cancer. The Company is advancing multiple preclinical and clinical programs in oncology and, together with Bristol-Myers Squibb (“BMS”), delivering the first U.S. Food and Drug Administration (“FDA”)-approved CAR T therapy in multiple myeloma, ABECMA (idecabtagene vicleucel, or ide-cel), to patients in the United States. Please refer to Note 9, Collaborative arrangements and strategic partnerships for further discussion of the collaboration with BMS.

2seventy bio Securities Corporation is a wholly-owned subsidiary of the Company which was incorporated in Massachusetts on December 13, 2021 and was granted securities corporation status in Massachusetts for the 2021 tax year. 2seventy bio Securities Corporation has no employees.

The separation from bluebird bio, Inc.

In January 2021, bluebird bio, Inc. (“bluebird bio”) announced its plans to separate its oncology portfolio and programs from its severe genetic disease portfolio and programs, and spin off its oncology portfolio and programs into a separate, publicly traded company. In furtherance of this plan, on September 30, 2021, bluebird bio’s board of directors approved the distribution of all of the issued and outstanding shares of 2seventy bio common stock on the basis of one share of 2seventy bio common stock for every three shares of bluebird bio common stock issued and outstanding on October 19, 2021, the record date for the distribution. As a result of the distribution, which occurred on November 4, 2021, 2seventy bio became an independent, publicly traded company.

On November 3, 2021, the Company also entered into a separation agreement with bluebird bio, which is referred to in this quarterly report as the “Separation Agreement”, as well as various other agreements with bluebird bio, including a tax matters agreement, an employee matters agreement, an intellectual property license agreement, a transition services agreement under which 2seventy bio temporarily receives certain services from bluebird bio, and a second transition services agreement under which 2seventy bio temporarily provides certain services to bluebird bio. These agreements also govern certain of 2seventy bio’s relationships with bluebird bio after the separation. For additional information regarding the Separation Agreement and the other related agreements, refer to Note 13, Related-party transactions and the section captioned “Part III. Item 13. Certain Relationships and Related Transactions, and Director Independence,” included in our Annual Report on Form 10-K, which was filed with the SEC on March 22, 2022.

Going concern

In accordance with Accounting Standards Codification 205-40, Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that the condensed consolidated and combined financial statements are issued. The Company has incurred losses and has experienced negative operating cash flows for all historical periods presented. During the nine months ended September 30, 2022, the Company incurred a net loss of $231.0 million and used $181.7 million of cash in operations. The Company expects to continue to generate operating losses and negative operating cash flows for the next few years. The Company's continued operations are dependent on its ability to raise additional funding.

As of September 30, 2022, the Company had cash, cash equivalents, and marketable securities of $324.5 million. The Company expects that its cash, cash equivalents, and marketable securities will be sufficient to fund current planned operations for at least the next twelve months from the date of issuance of these financial statements. The Company intends to pursue additional cash resources through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances or licensing arrangements with third parties. There can be no assurance that such financing will be available in sufficient amounts or on acceptable terms, if at all, and some could be dilutive to existing stockholders. If the Company is unable to obtain additional funding on a timely basis, it may be forced to significantly curtail, delay, or discontinue one or more of its planned research or development programs or be unable to expand its operations.

2. Summary of significant accounting policies and basis of presentation

Significant accounting policies

The significant accounting policies used in preparation of these condensed consolidated and combined financial statements are consistent with those discussed in Note 2 to the consolidated and combined financial statements for the year ended December 31, 2021 included in the Company’s 2021 Annual Report on Form 10-K.

Basis of presentation

The Company did not operate as a separate, stand-alone entity prior to its separation from bluebird bio. Accordingly, the Company’s consolidated and combined statements of operations and comprehensive loss, stockholders’ equity and cash flows for the three and nine months ended September 30, 2021, have been prepared on a carve out basis, derived from bluebird bio’s consolidated financial statements and accounting records.

The accompanying condensed consolidated and combined financial statements reflect the historical results of the operations, financial position and cash flows of the Company and have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as included in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASUs”) of the Financial Accounting Standards Board (“FASB”).

The historical results of operations and cash flows of 2seventy bio presented in these condensed consolidated and combined financial statements for periods prior to the separation may not be indicative of what they would have been had 2seventy bio operated as an independent, stand-alone entity for those periods. The historical results of operations, financial position and cash flows of 2seventy bio presented in these condensed consolidated and combined financial statements for periods subsequent to the separation are not necessarily indicative of 2seventy bio's future results of operations, financial position and cash flows.

In the opinion of management, the unaudited interim condensed consolidated and combined financial statements reflect all normal recurring adjustments considered necessary for a fair presentation of the Company’s financial position and the results of its operations for the interim periods presented.

Use of estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate

future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements.

Estimates and judgments are used in the following areas, among others: allocations of revenue, expenses, assets and liabilities from bluebird bio's historical consolidated financial statements to the Company for periods prior to the separation, future undiscounted cash flows and subsequent fair value estimates used to assess potential and measure any impairment of long-lived assets, including goodwill and intangible assets, the measurement of right-of-use assets and lease liabilities, contingent consideration, stock-based compensation expense, accrued expenses, income taxes, and the assessment of the Company's ability to fund its operations for at least the next twelve months from the date of issuance of these financial statements. In addition, estimates and judgments are used in the Company’s accounting for its revenue-generating arrangements, in particular as it relates to determining the stand-alone selling price of performance obligations, evaluating whether an option to acquire additional goods and services represents a material right, estimating the total transaction price, including estimating variable consideration and the probability of achieving future potential development and regulatory milestones, assessing the period of performance over which revenue may be recognized, and accounting for modifications to revenue-generating arrangements.

3. Marketable securities

The following table summarizes the marketable securities held at September 30, 2022 and December 31, 2021 (in thousands):


	Amortized cost/ cost		Unrealized gains		Unrealized losses		Fair Value
September 30, 2022
U.S. government agency securities and treasuries	$	124,212	$	—	$	(2,700)	$	121,512
Corporate bonds	6,397		—		(75)		6,322
Commercial paper	69,786		—		(124)		69,662
Total	$	200,395	$	—	$	(2,899)	$	197,496
December 31, 2021
U.S. government agency securities and treasuries	$	128,899	$	—	$	(507)	$	128,392
Corporate bonds	49,368		—		(58)		49,310
Commercial paper	54,065		—		—		54,065
Total	$	232,332	$	—	$	(565)	$	231,767

No available-for-sale debt securities held as of September 30, 2022 or December 31, 2021 had remaining maturities greater than five years.

Accrued interest receivable on the Company's available-for-sale debt securities totaled $0.2 million and $0.4 million as of September 30, 2022 and December 31, 2021, respectively. No accrued interest receivable was written off during the three and nine months ended September 30, 2022 or 2021.

The Company determined that there was no material change in the credit risk of the above investments during the nine months ended September 30, 2022. As such, an allowance for credit losses was not recognized. As of September 30, 2022, the Company does not intend to sell such securities and it is not more likely than not that the Company will be required to sell the securities before recovery of their amortized cost bases.

4. Fair value measurements

The following table sets forth the Company’s assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2022 and December 31, 2021 (in thousands):


	Total		Quoted prices in active markets (Level 1)		Significant other observable inputs (Level 2)		Significant unobservable inputs (Level 3)
September 30, 2022
Assets:
Cash and cash equivalents	$	127,021	$	99,349	$	27,672	$	—
Marketable securities:
U.S. government agency securities and treasuries	121,512		—		121,512		—
Corporate bonds	6,322		—		6,322		—
Commercial paper	69,662		—		69,662		—
Total assets	$	324,517	$	99,349	$	225,168	$	—
Liabilities:
Contingent consideration	$	2,129	$	—	$	—	$	2,129
Total liabilities	$	2,129	$	—	$	—	$	2,129
December 31, 2021
Assets:
Cash and cash equivalents	$	130,414	$	130,414	$	—	$	—
Marketable securities:
U.S. government agency securities and treasuries	128,392		—		128,392		—
Corporate bonds	49,310		—		49,310		—
Commercial paper	54,065		—		54,065		—
Total assets	$	362,181	$	130,414	$	231,767	$	—
Liabilities:
Contingent consideration	$	1,948	$	—	$	—	$	1,948
Total liabilities	$	1,948	$	—	$	—	$	1,948

Contingent consideration

In connection with bluebird bio's prior acquisition of Precision Genome Engineering, Inc. (“Pregenen”), the Company may be required to pay future consideration that is contingent upon the achievement of certain commercial milestone events. Contingent consideration is measured at fair value and is based on significant unobservable inputs, which represents a Level 3 measurement within the fair value hierarchy. The valuation of contingent consideration uses assumptions the Company believes would be made by a market participant. The Company assesses these estimates on an on-going basis as additional data impacting the assumptions is obtained. Future changes in the fair value of contingent consideration related to updated assumptions and estimates are recognized within the condensed consolidated and combined statements of operations and comprehensive loss. In the absence of new information related to the probability of milestone achievement, changes in fair value will reflect changing discount rates and the passage of time. Contingent consideration is included in other non-current liabilities on the condensed consolidated balance sheets.

The table below provides a roll-forward of fair value of the Company’s contingent consideration obligations that include Level 3 inputs (in thousands):


	For the nine months ended September 30, 2022
Beginning balance	$	1,948
Additions	—
Changes in fair value	181
Payments	—
Ending balance	$	2,129

Please refer to Note 8, Commitments and contingencies, for further information.

5. Property, plant and equipment, net

Property, plant and equipment, net, consists of the following (in thousands):


	As of September 30, 2022		As of December 31, 2021
Laboratory equipment	$	35,238	$	31,710
Leasehold improvements	26,709		28,479
Construction-in-progress	18,688		3,462
Office equipment	6,080		6,080
Computer equipment and software	5,625		5,260
Total property, plant and equipment	92,340		74,991
Less accumulated depreciation and amortization	(45,690)		(40,078)
Property, plant and equipment, net	$	46,650	$	34,913

Cambridge, Massachusetts drug product manufacturing facility

In February 2022, the Company began construction of a drug product manufacturing facility within its Cambridge, Massachusetts headquarters. The facility will enable rapid translational research in clinical trials and the manufacture of drug product for use in Phase 1 clinical development activities. Construction-in-progress as of September 30, 2022 includes $16.8 million related to the ongoing build-out of the facility.

6. Accrued expenses and other current liabilities

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


	As of September 30, 2022		As of December 31, 2021
Manufacturing costs	$	15,516	$	5,459
Collaboration research costs	9,889		2,576
Employee compensation	9,657		24,655
Royalties	7,828		6,768
Clinical and contract research organization costs	2,285		3,229
Property, plant and equipment	683		2,241
Separation related costs	405		762
Professional fees	349		1,688
Other	5,544		8,032
Accrued expenses and other current liabilities	$	52,156	$	55,410

7. Leases

The Company leases certain office and laboratory space, primarily located in Cambridge, Massachusetts and Seattle, Washington, that was assigned to it in connection with the separation. There have been no material changes to the lease obligations from those disclosed in Note 7, Leases, to the consolidated and combined financial statements included in the Company's 2021 Annual Report on Form 10-K.

8. Commitments and contingencies

Contingent consideration related to business combinations

On June 30, 2014, bluebird bio acquired Pregenen. All assets, liabilities and future obligations related to the Pregenen acquisition, including the resulting goodwill and contingent consideration, were assumed by the Company in connection with the separation. As of September 30, 2022, the Company may be required to make up to $99.9 million in contingent cash payments to the former equity holders of Pregenen upon the achievement of certain commercial milestones related to the Pregenen technology. In accordance with accounting guidance for business combinations, contingent consideration liabilities are required to be recognized on the condensed consolidated balance sheets at fair value. Estimating the fair value of contingent consideration requires the use of significant assumptions primarily relating to probabilities of successful achievement of certain clinical and commercial milestones, the expected timing in which these milestones will be achieved and discount rates. The use of different assumptions could result in materially different estimates of fair value. Please refer to Note 4, Fair value measurements, for further information.

Other funding commitments

Certain agreements that were assigned by bluebird bio to the Company in connection with the separation relate principally to licensed technology and may require future payments relating to milestones that may be met in subsequent periods or royalties on future sales of specified products. Additionally, to the extent an agreement relating to licensed technology was not assigned to the Company, bluebird bio entered into a sublicense with the Company, which may require the Company to make future milestone and/or royalty payments. Please refer to Note 9, Collaborative arrangements and strategic partnerships, for further information on the BMS, Regeneron

Pharmaceuticals, Inc. (“Regeneron”), and Novo Nordisk A/S (“Novo”) agreements and to Note 10, Royalty and other revenue, for further information on license agreements.

Based on the Company's development plans as of September 30, 2022, the Company may be obligated to make future development, regulatory and commercial milestone payments and royalty payments on future sales of specified products. Payments under these agreements generally become due and payable upon achievement of such milestones or sales. When the achievement of these milestones or sales has not occurred, such contingencies are not recorded in the Company’s financial statements. As further discussed in Note 9, Collaborative arrangements and strategic partnerships, BMS assumed responsibility for amounts due to licensors as a result of any future ex-U.S. sales of ABECMA.

In July 2021, bluebird bio and National Resilience, Inc. (“Resilience”) announced a strategic manufacturing collaboration aimed to accelerate the early research, development, and delivery of cell therapies. Agreements related to the collaboration were executed in September 2021. As part of the agreement, Resilience acquired bluebird bio's North Carolina manufacturing facility and retained all staff employed at the site. Concurrent with the sale of the manufacturing facility in Durham, North Carolina, bluebird bio entered into certain ancillary agreements, including two manufacturing agreements and a license agreement (the “Resilience License Agreement”), among others (together referred to as the “Ancillary Agreements”). One manufacturing agreement will support the future manufacturing of lentiviral vector for the commercial product marketed in collaboration with BMS, ABECMA (the “Commercial Supply Agreement”), while the other will support ongoing manufacturing for lentiviral vector for development candidates (the “Development Manufacturing Supply Agreement”). Certain rights and obligations under these agreements were assigned by bluebird bio to 2seventy bio on November 4, 2021 upon the separation of 2seventy bio from bluebird bio. The assignments under the asset purchase agreement and the development manufacturing supply agreement commit the Company to reimburse Resilience for an amount equal to 50% of the net operating losses of and relating to the manufacturing facility’s business incurred during the twelve-month period ending on the first anniversary of the closing of the transaction, as calculated in accordance with the asset purchase agreement, subject to a cap of $15.0 million. In exchange, under the terms of the development manufacturing supply agreement, the Company was entitled to receive up to eight batches of lentiviral vector during the twelve-month period ending on the first anniversary of the closing of the transaction. The Company therefore committed to a minimum purchase of at least the Company's 50% share of the net operating losses during the twelve-month period ending on the first anniversary of the closing of the transaction, which occurred in September 2022. As of September 30, 2022, the Company has accrued $14.8 million representing our estimated share of the net operating losses of Resilience. The disposition of the net assets of the manufacturing facility previously assigned to 2seventy bio has been reflected as a transfer to bluebird bio via net parent investment as a result of bluebird bio’s sale of such facility. 2seventy bio is not a party to the sale of the manufacturing facility and, therefore, did not recognize any gain or loss arising from the transaction.

Additionally, 2seventy bio is party to various contracts with contract research organizations and contract manufacturers that generally provide for termination on notice, with the exact amounts in the event of termination to be based on the timing of the termination and the terms of the agreement. There have been no material changes in future minimum purchase commitments from those disclosed in Note 8, Commitments and Contingencies, to the consolidated and combined financial statements included in the Company's 2021 Annual Report on Form 10-K.

Litigation

From time to time, the Company expects to be party to various claims and complaints arising in the ordinary course of business. However, the Company is not currently a party to any litigation or legal proceedings that, in the opinion of its management, are probable of having a material adverse effect on its business. The Company enters into standard indemnification agreements in the ordinary course of business. Pursuant to these agreements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified party for losses suffered or incurred by the indemnified party, generally the Company’s business partners. In addition, pursuant to the Separation Agreement, the Company indemnifies, holds harmless, and agrees to reimburse bluebird bio for its indemnification obligations with respect to the Company’s business partners, relating to the Company’s business or arising out of the Company’s activities, in the past or to be conducted in the future. The term of these indemnification agreements is

generally perpetual any time after execution of the agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. Management does not believe that any ultimate liability resulting from any of these claims will have a material adverse effect on its results of operations, financial position, or liquidity. However, management cannot give any assurance regarding the ultimate outcome of any claims, and their resolution could be material to operating results for any particular period.

The Company indemnifies each of its directors and officers for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity, as permitted under Delaware law and in accordance with its certificate of incorporation and by-laws and indemnification agreements entered into with each of its directors and officers. The term of the indemnification period will last as long as a director or officer may be subject to any proceeding arising out of acts or omissions of such director or officer in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company holds director and officer liability insurance.

9. Collaborative arrangements and strategic partnerships

To date, the Company’s service and collaborative arrangement revenue has been primarily generated from collaboration arrangements with BMS, Regeneron, and Novo, each as further described below. These agreements were assumed by the Company in connection with the separation.

Bristol-Myers Squibb

BMS Collaboration Agreement

In March 2013, bluebird bio entered into a collaboration agreement with BMS. The details of the collaboration agreements and the payments the Company has received, and is entitled to receive, are further described in Note 10, Collaborative arrangements and strategic partnerships, to the consolidated and combined financial statements included in the Company's 2021 Annual Report on Form 10-K. During 2022, there have been no changes to the terms of the collaboration agreement with BMS.

ABECMA

Under the collaboration agreement with BMS, the Company shares equally in the profit and loss related to the development and commercialization of ide-cel in the United States (marketed as ABECMA). The Company has no remaining financial rights with respect to the development or commercialization of ide-cel outside of the United States. The Company accounts for its collaborative arrangement efforts with BMS in the United States within the scope of ASC 808 given that both parties are active participants in the activities and both parties are exposed to significant risks and rewards dependent on the commercial success of the activities. The calculation of collaborative activity to be recognized for joint ABECMA efforts in the United States is performed on a quarterly basis and is independent of previous quarterly activity. This may result in fluctuations between revenue and expense recognition period over period, depending on the varying extent of effort performed by each party during the period. The Company recognizes revenue related to the combined unit of accounting for the ex-U.S. license and lentiviral vector manufacturing services under Topic 606.

Ide-cel U.S. Share of Collaboration Profit or Loss

The U.S. commercial and development activities under the Amended Ide-Cel CCPS are within the scope of ASC 808. On a quarterly basis, the Company determines its share of collaboration profit or loss for commercial activities (i.e., commercial sales of ABECMA by BMS). The Company’s share of any collaboration profit for commercial activities is recognized as collaborative arrangement revenue and its share of any collaboration loss for commercial activity is recognized as an operating expense and classified as share of collaboration loss on the Company's condensed consolidated and combined statement of operations and comprehensive loss.

The Company recognized the following on the 2022 and 2021 condensed consolidated and combined statements of operations and comprehensive loss, respectively, related to its share of collaboration profit or loss associated with ide-cel commercial activities following approval (in thousands). The amounts reported for these periods represent the Company’s share of BMS’ ABECMA product revenue, cost of goods sold, and selling costs, along with reimbursement by BMS of commercial costs incurred by the Company, and exclude expenses related to ongoing development, which are separately reflected in the condensed consolidated and combined statements of operations and comprehensive loss as described below.


	Three months ended						Nine months ended
	March 31, 2022		June 30, 2022		September 30, 2022		September 30, 2022
Collaborative arrangement revenue from ide-cel commercial activities (1)	$	—	$	—	$	4,064	$	4,064
Share of collaboration loss from ide-cel commercial activities (1)	$	(5,352)	$	(4,290)	$	—	$	(9,642)

_________________

(1)As noted above, the calculation is performed on a quarterly basis. The calculation is independent of previous activity, which may result in fluctuations between revenue and expense recognition period over period.


	Three months ended						Nine months ended
	March 31, 2021		June 30, 2021		September 30, 2021		September 30, 2021
Collaborative arrangement revenue from ide-cel commercial activities (1)	$	—	$	—	$	10,607	$	10,607
Share of collaboration loss from ide-cel commercial activities (1)	$	—	$	(10,071)	$	—	$	(10,071)

_________________

The Company is also responsible for equally sharing in the ongoing ide-cel research and development activities being conducted by BMS in the United States as BMS continues conducting ongoing clinical studies to support the use of ABECMA in earlier lines of therapy. The net amount owed to BMS for research and development activities determined on a quarterly basis is classified as research and development expense on the condensed consolidated and combined statement of operations and comprehensive loss. If BMS is obligated to reimburse the Company because the Company’s research and development costs exceeds BMS’ research and development costs in a particular quarterly period, the net amount is recorded as collaborative arrangement revenue.

The following table summarizes the amounts associated with the research activities under the collaboration included in research and development expense or recognized as collaborative arrangement revenue for the three and nine months ended September 30, 2022 and 2021 (in thousands):


	For the three months ended September 30,				For the nine months ended September 30,
	2022		2021		2022		2021
Net expense (included as a component of research and development expense)	$	(9,252)	$	(5,660)	$	(21,608)	$	(31,678)

Ide-cel ex-U.S. Service Revenue

The Company accounts for any ex-U.S. activities under the Amended Ide-cel CCPS pursuant to ASC 606. The following table summarizes the revenue recognized related to ide-cel ex-U.S. activities for the three and nine months ended September 30, 2022 and 2021 (in thousands):


	For the three months ended September 30,				For the nine months ended September 30,
	2022		2021		2022		2021
ASC 606 ide-cel license and manufacturing revenue - ex-U.S. (included as a component of service revenue)	$	3,122	$	5,314	$	9,437	$	14,698

bb21217

In addition to the activities related to ide-cel, BMS previously exercised its option to obtain an exclusive worldwide license to develop and commercialize bb21217, the second product candidate under the collaboration arrangement with BMS which is further described in Note 10, Collaborative arrangements and strategic partnerships, to the consolidated and combined financial statements included in the Company's 2021 Annual Report on Form 10-K.

Under the collaboration arrangement with BMS, the Company had an option to co-develop and co-promote bb21217 within the United States. However, following completion of the CRB-402 clinical trial, in January 2022 the Company, along with BMS, evaluated its plans with respect to bb21217. Based in part on the strength of ABECMA clinical data and commercial sales to date, the Company and BMS elected to discontinue development of bb21217 and, as such, the Company did not exercise its option to co-develop and co-promote bb21217 within the United States. The Company is still eligible to receive U.S. milestones and royalties for U.S. sales of bb21217, if further developed by BMS. Additionally, pursuant to the terms of the collaboration agreement, because it did not exercise its option to co-develop and co-promote bb21217, the Company received an additional fee in the amount of $10.0 million from BMS during the second quarter of 2022. Pursuant to the variable consideration allocation exception, the $10.0 million of consideration received was allocated to the combined performance obligation for the bb21217 license and vector manufacturing services through development, described further below. As the Company has not yet commenced manufacturing, the entire $10.0 million payment received is included within deferred revenue, net of current portion on the September 30, 2022 condensed consolidated balance sheet.

The transaction price associated with the collaboration arrangement consists of $31.0 million of upfront payments and option payments received from BMS, the $10.0 million bb21217 opt-out payment discussed above, and $1.8 million in variable consideration which represents reimbursement to be received from BMS for manufacturing vector and associated payloads through development which has not yet been received. The Company identified two performance obligations with respect to the arrangement with BMS. The initial performance obligation was for research and development services that were substantially completed in September 2019, associated with the initial phase 1 clinical trial of bb21217. The Company allocated $5.4 million of consideration to the research and development services performance obligation and fully recognized the consideration through September 2019. The other performance obligation relates to a combined performance obligation for the bb21217 license and vector manufacturing services through development, and the remaining $37.4 million in consideration was allocated to this combined performance obligation. The Company will satisfy this combined performance obligation as the bb21217 manufacturing services are performed. All of the remaining development, regulatory, and commercial milestones related to U.S. development, regulatory and commercialization activities are fully constrained and are therefore excluded from the transaction price.

As of September 30, 2022, the Company has not commenced manufacturing and the full amount of the allocated transaction price remains unsatisfied. The Company had $35.8 million and $25.8 million of deferred revenue as of September 30, 2022 and December 31, 2021, respectively, associated with the combined performance obligation consisting of the bb21217 license and manufacturing services. The Company expects to recognize the

remaining $35.8 million as these services are performed or upon BMS’s formal notification to the Company that these services will no longer be required.

Contract assets and liabilities – ide-cel and bb21217

The Company receives payments from its collaborative partners based on billing schedules established in each contract. Up-front payments and fees are recorded as deferred revenue upon receipt or when due until such time as the Company satisfies its performance obligations under these arrangements. A contract asset is a conditional right to consideration in exchange for goods or services that the Company has transferred to a customer. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional.

The following table presents changes in the balances of the Company’s BMS receivables and contract liabilities during the nine months ended September 30, 2022 (in thousands):


	Balance at December 31, 2021		Additions		Deductions		Balance at September 30, 2022
Receivables	$	652	$	10,000	$	(10,652)	$	—
Contract liabilities:
Deferred revenue	$	25,762	$	10,000	$	—	$	35,762

The decrease in the receivables balance for the nine months ended September 30, 2022 is driven by amounts paid to the Company from BMS in the period under the settlement terms of the collaboration agreement. The increase in the deferred revenue balance for the nine months ended September 30, 2022 is driven by the $10.0 million payment made to the Company by BMS upon the Company opting out of co-development and co-promotion of bb21217 in the United States.

Regeneron

Regeneron Collaboration Agreement

In August 2018, bluebird bio entered into a Collaboration Agreement (the “Regeneron Collaboration Agreement”) with Regeneron pursuant to which the parties will apply their respective technology platforms to the discovery, development, and commercialization of novel immune cell therapies for cancer. In August 2018, following the completion of required regulatory reviews, the Regeneron Collaboration Agreement became effective. As noted above, the agreement was assumed by the Company in connection with the separation. Under the terms of the agreement, the parties will leverage Regeneron’s proprietary platform technologies for the discovery and characterization of fully human antibodies, as well as T cell receptors directed against tumor-specific proteins and peptides and the Company will contribute its field-leading expertise in gene therapy.

In accordance with the Regeneron Collaboration Agreement, the parties jointly selected six initial targets and intend to equally share the costs of research up to the point of submitting an IND application for a potential gene therapy product directed to a particular target. Additional targets may be selected to add to or replace any of the initial targets during the five-year research collaboration term as agreed to by the parties.

Regeneron will accrue a certain number of option rights exercisable against targets as the parties reach certain milestones under the terms of the agreement. Upon the acceptance of an IND for the first product candidate directed to a target, Regeneron will have the right to exercise an option for co-development/co-commercialization of product candidates directed to such target on a worldwide or applicable opt-in territory basis, with certain exceptions. Where Regeneron chooses to opt-in, the parties will share equally in the costs of development and commercialization and will share equally in any profits or losses therefrom in applicable opt-in territories. Outside of the applicable opt-in territories, the target becomes a licensed target and Regeneron would be eligible to receive, with respect to any resulting product, milestone payments of up to $130.0 million per product and royalties on net sales outside of the applicable opt-in territories at a rate ranging from the mid-single digits to low-double digits. A target would also

become a licensed target in the event Regeneron does not have an option to such target, or Regeneron does not exercise its option with respect to such target.

Either party may terminate a given research program directed to a particular target for convenience, and the other party may elect to continue such research program at its expense, receiving applicable cross-licenses. The terminating party will receive licensed product royalties and milestone payments on the potential applicable gene therapy products. Where the Company terminates a given research program for convenience, and Regeneron elects to continue such research program, the parties will enter into a transitional services agreement. Under certain conditions, following its opt-in, Regeneron may terminate a given collaboration program and the Company may elect to continue the development and commercialization of the applicable potential gene therapy products as licensed products.

Regeneron Share Purchase Agreement

A Share Purchase Agreement (“SPA”) was entered into by bluebird bio and Regeneron in August 2018. In August 2018, on the closing date of the transaction, bluebird bio issued Regeneron 0.4 million shares of bluebird bio’s common stock, subject to certain restrictions, for $238.10 per share, or $100.0 million in the aggregate. The purchase price represents $63.0 million worth of common stock plus a $37.0 million premium, which represents a collaboration research advancement, or credit to be applied to Regeneron’s initial 50 percent funding obligation for collaboration research, after which the collaborators will continue to fund ongoing research equally. The collaboration research advancement only applies to pre-IND research activities and is not refundable or creditable against post-IND research activities for any programs where Regeneron exercises its opt-in rights.

Accounting analysis – Regeneron

At the commencement of the arrangement, two units of accounting were identified, which are the issuance of 0.4 million shares of bluebird bio’s common stock and joint research activities during the five-year research collaboration term. The Company determined the total transaction price to be $100.0 million, which comprises $54.5 million attributed to the bluebird bio equity sold to Regeneron and $45.5 million attributed to the joint research activities. In determining the fair value of the bluebird bio common stock at closing, the Company considered the closing price of the bluebird bio common stock on the closing date of the transaction and included a lack of marketability discount because Regeneron received shares subject to certain restrictions.

The Company analyzed the joint research activities to assess whether they fall within the scope of ASC 808, and will reassess this throughout the life of the arrangement based on changes in the roles and responsibilities of the parties. Based on the terms of the arrangement as outlined above, for the collaboration research performed prior to submission of an IND application for a potential gene therapy product, both parties are deemed to be active participants in the collaboration. Both parties are performing research and development activities and will share equally in these costs through IND submission. Additionally, Regeneron and the Company are exposed to significant risks and rewards dependent on the commercial success of any product candidates that may result from the collaboration. As such, the collaboration arrangement is deemed to be within the scope of ASC 808.

The $45.5 million attributed to the joint research activities includes the $37.0 million creditable against amounts owed to the Company by Regeneron. The collaboration research advancement will be reduced over time for amounts due to the Company by Regeneron as a result of the parties agreeing to share in the costs of collaboration research equally. The remainder of the amount attributed to the joint research activities will be recognized over the five-year research collaboration term.

Consistent with its collaboration accounting policy, the Company will recognize collaboration revenue or research and development expense related to the joint research activities in future periods depending on the amounts incurred by each party in a given reporting period. That is, if the Company’s research costs incurred exceed those research costs incurred by Regeneron in a given quarter, the Company will record collaboration revenue and reduce the original $37.0 million advance by the amount due from Regeneron until such advancement is fully utilized, after which the Company would record an amount due from Regeneron. If Regeneron’s research costs incurred exceed

those research costs incurred by the Company in a given quarter, the Company will record research and development expense and record a liability for the amount due to Regeneron. As of September 30, 2022 and December 31, 2021, the Company has $9.0 million and $23.3 million, respectively, of the amount attributed to the joint research activities remaining to be recognized, which is classified as collaboration research advancement, current portion and collaboration research advancement, net of current portion on the condensed consolidated balance sheets.

The Company recognized $3.8 million and $14.4 million of collaborative arrangement revenue from the Regeneron Collaboration Agreement during the three and nine months ended September 30, 2022, respectively. The Company recognized $1.7 million and $4.9 million of collaborative arrangement revenue from the Regeneron Collaboration Agreement during the three and nine months ended September 30, 2021, respectively.

Novo Nordisk

Novo Collaboration and License Agreement

On December 23, 2021, the Company entered into a Collaboration and License Agreement (the “Novo Collaboration Agreement”) with Novo for the discovery, development, and commercialization of a potential new gene therapy in hemophilia A. The Company and Novo have agreed to develop an initial research program with the goal of researching and developing a lead candidate directed to hemophilia A. The Company will provide Novo with research licenses to support the companies’ activities during the initial research program and an option to enable Novo to obtain an exclusive license to commercialize the product derived from or containing compounds developed during the initial research program.

Under the terms of the Novo Collaboration Agreement, Novo agreed to pay the Company:

•a non-refundable, non-creditable upfront payment of $5.0 million;

•$15.0 million upon achievement of certain scientific milestones during the initial research program, or $9.0 million should Novo decide to continue the initial research program without achieving the scientific milestones;

•