CRISPR Therapeutics AG [CRSP] Filings

10-Q 1 crsp-20240930.htm 10-Q 10-Q

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, 2024


☐	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: 001-37923

CRISPR THERAPEUTICS AG

(Exact name of registrant as specified in its charter)


Switzerland	Not Applicable
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

Baarerstrasse 14 6300 Zug, Switzerland	Not Applicable
(Address of principal executive offices)	(Zip Code)

+41 (0)41 561 32 77

(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 Shares, nominal value CHF 0.03	CRSP	The Nasdaq Global Market

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 emerging growth company. See definition 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 registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 1, 2024, there were 85,353,479 shares of registrant’s common shares outstanding.

Throughout this Quarterly Report on Form 10-Q, the “Company,” “CRISPR,” “CRISPR Therapeutics,” “we,” “us,” and “our,” except where the context requires otherwise, refer to CRISPR Therapeutics AG and its consolidated subsidiaries; “our board of directors” refers to the board of directors of CRISPR Therapeutics AG; and we generally refer to CASGEVY (exagamglogene autotemcel [exa-cel]), formerly CTX001, as "CASGEVY".

“CRISPR Therapeutics®” standard character mark and design logo, “CRISPRX™,” “CRISPR TX™,” “CTX112™,” “CTX131™,” “CTX310™,” “CTX320™,” and “CTX211™” are trademarks and registered trademarks of CRISPR Therapeutics AG. The CASGEVY™ word mark and design are trademarks of Vertex Pharmaceuticals Incorporated. All other trademarks and registered trademarks contained in this Quarterly Report on Form 10-Q are the property of their respective owners. Solely for convenience, trademarks, service marks and trade names referred to in this Quarterly Report on Form 10-Q may appear without the ® or ™ symbols and any such omission is not intended to indicate waiver of any such rights.

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains “forward-looking statements” that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q are forward-looking statements. These statements are often identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “potential,” “will,” “would” or the negative or plural of these words or similar expressions or variations, although not all forward-looking statements contain these identifying words. Forward-looking statements in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

•

our strategic plans to develop and, if approved, subsequently commercialize any product candidates we may develop, including plans and expectations for the commercialization of, and anticipated benefits of, CASGEVY;

•

the safety, efficacy and clinical progress of various clinical programs, including those for CASGEVY, CTX112, CTX131, CTX211, CTX310 and CTX320;

•

the status of clinical trials, including development timelines and discussions with regulatory authorities related to product candidates under development by us and our collaborators;

•

the results of our preclinical studies and clinical trials, including our ongoing clinical trials and any planned clinical trials, and our research and development programs;

•

our ability to advance product candidates into, and successfully complete, clinical trials;

•

the size and growth potential of the markets for our product candidates and our ability to serve those markets, including our estimates regarding the addressable patient population and potential market opportunity for our current and future product candidates;

•

the rate and degree of market acceptance of our product candidates and the success of competing therapies that are or become available;

•

our internal manufacturing capabilities and operation of our cell therapy manufacturing facility;

•

our intellectual property coverage and positions, including those of our licensors and third parties as well as the status and potential outcome of proceedings involving any such intellectual property;

•

the expected benefits of our collaborations;

•

our strategy, goals, and anticipated financial performance;

•

our anticipated expenses, ability to obtain funding for our operations and the sufficiency of our cash resources; and

•

the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies.

Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and assumptions that could cause our actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors,” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q, if any, our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 21, 2024, and in other SEC filings. You should not rely upon forward-looking statements as predictions of future events. Such forward-looking statements speak only as of the date of this report. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make or enter into.

You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results, performance or achievements may be materially different from what we expect. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

Investors and others should note that we announce material information to our investors using our investor relations website (https://crisprtx.gcs-web.com/), SEC filings, press releases, public conference calls and webcasts. We use these channels as well as social media to communicate with the public about our Company, our business, our product candidates and other matters. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our Company to review the information we post on the social media channels listed on our investor relations website.

Index


	Page Number
PART I: FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements (unaudited)	2

Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023	2

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2024 and 2023	3

Condensed Consolidated Statements of Shareholders’ Equity for the three and nine months ended September 30, 2024 and 2023	4

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2024 and 2023	6

Notes to Condensed Consolidated Financial Statements	7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	18

Item 3. Quantitative and Qualitative Disclosures about Market Risk	27

Item 4. Controls and Procedures	28

PART II: OTHER INFORMATION

Item 1. Legal Proceedings	29

Item 1A. Risk Factors	29

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	29

Item 3. Defaults Upon Senior Securities	29

Item 4. Mine Safety Disclosures	29

Item 5. Other Information	29

Item 6. Exhibits	29

SIGNATURES	31

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements

CRISPR Therapeutics AG

Condensed Consolidated Balance Sheets

(unaudited, in thousands, except share and per share data)


	As of
	September 30,			December 31,
	2024			2023
Assets
Current assets:
Cash and cash equivalents	$	225,670		$	389,477
Marketable securities		1,709,975			1,304,215
Accounts receivable		—			200,000
Prepaid expenses and other current assets		8,246			14,386
Total current assets		1,943,891			1,908,078
Property and equipment, net		138,542			151,945
Marketable securities, non-current		—			1,973
Intangible assets, net		—			16
Restricted cash		11,520			11,591
Operating lease assets		146,286			153,993
Other non-current assets		15,891			1,975
Total assets	$	2,256,130		$	2,229,571
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable	$	15,578		$	38,147
Accrued expenses		47,204			45,335
Deferred revenue, current		4,483			4,105
Accrued tax liabilities		838			438
Operating lease liabilities		16,883			15,625
Other current liabilities		4,824			5,141
Total current liabilities		89,810			108,791
Deferred revenue, non-current		12,323			14,012
Operating lease liabilities, net of current portion		210,662			223,007
Other non-current liabilities		3,677			958
Total liabilities		316,472			346,768
Commitments and contingencies, see Note 7
Shareholders’ equity:
Common shares, CHF 0.03 nominal value, 132,477,166 and 126,536,183 shares authorized at September 30, 2024 and December 31, 2023, respectively, 85,506,092 and 80,214,694 shares issued at September 30, 2024 and December 31, 2023, respectively, 85,335,776 and 80,044,378 shares outstanding at September 30, 2024 and December 31, 2023, respectively		2,684			2,497
Treasury shares, at cost, 170,316 shares at September 30, 2024 and at December 31, 2023		(62	)		(62	)
Additional paid-in capital		3,255,112			2,878,155
Accumulated deficit		(1,328,641	)		(999,700	)
Accumulated other comprehensive income		10,565			1,913
Total shareholders' equity		1,939,658			1,882,803
Total liabilities and shareholders’ equity	$	2,256,130		$	2,229,571

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

CRISPR Therapeutics AG

Condensed Consolidated Statements of Operations and Comprehensive Loss

(unaudited, in thousands, except share and per share data)


	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2024			2023			2024			2023
Revenue:
Collaboration revenue	$	—		$	—		$	—		$	170,000
Grant revenue		602			—			1,623			—
Total revenue		602			—			1,623			170,000
Operating expenses:
Research and development		82,160			90,698			238,498			292,188
General and administrative		17,419			18,291			54,853			59,683
Collaboration expense, net		11,153			23,422			110,250			110,250
Total operating expenses		110,732			132,411			403,601			462,121
Loss from operations		(110,130	)		(132,411	)		(401,978	)		(292,121	)
Other income:
Other income, net		25,064			20,671			75,924			51,819
Total other income, net		25,064			20,671			75,924			51,819
Net loss before income taxes		(85,066	)		(111,740	)		(326,054	)		(240,302	)
Provision for income taxes		(876	)		(412	)		(2,887	)		(2,655	)
Net loss		(85,942	)		(112,152	)		(328,941	)		(242,957	)
Foreign currency translation adjustment		76			(49	)		66			12
Unrealized gain on marketable securities		13,368			2,160			8,586			8,838
Comprehensive loss	$	(72,498	)	$	(110,041	)	$	(320,289	)	$	(234,107	)

Net loss per common share — basic	$	(1.01	)	$	(1.41	)	$	(3.92	)	$	(3.07	)
Basic weighted-average common shares outstanding		85,234,926			79,414,098			83,988,063			79,063,415
Net loss per common share — diluted	$	(1.01	)	$	(1.41	)	$	(3.92	)	$	(3.07	)
Diluted weighted-average common shares outstanding		85,234,926			79,414,098			83,988,063			79,063,415

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

CRISPR Therapeutics AG

Condensed Consolidated Statements of Shareholders’ Equity

(unaudited, in thousands, except share and per share data)


	Common Shares				Treasury Shares
	Shares		CHF 0.03 Nominal Value		Shares		Amount, at cost			Additional Paid-in Capital		Accumulated Deficit			Accumulated Other Comprehensive Gain/(Loss)			Total Shareholders’ Equity
Balance at December 31, 2022		78,512,450	$	2,441		180,316	$	(63	)	$	2,734,838	$	(846,090	)	$	(15,647	)	$	1,875,479
Vesting of restricted shares		172,995		5		—		—			—		—			—			5
Exercise of vested options, net of issuance costs of $0.2 million		159,184		6		—		—			4,677		—			—			4,683
Purchase of common stock under ESPP		19,105		—		—		—			660		—			—			660
Stock-based compensation expense		—		—		—		—			20,875		—			—			20,875
Other comprehensive income		—		—		—		—			—		—			6,259			6,259
Net loss		—		—		—		—			—		(53,065	)		—			(53,065	)
Balance at March 31, 2023		78,863,734	$	2,452		180,316	$	(63	)	$	2,761,050	$	(899,155	)	$	(9,388	)	$	1,854,896
Vesting of restricted shares		97,631		4		—		—			—		—			—			4
Exercise of vested options, net of issuance costs of $0.3 million		411,001		18		—		—			16,605		—			—			16,623
Stock-based compensation expense		—		—		—		—			21,765		—			—			21,765
Other comprehensive income		—		—		—		—			—		—			480			480
Net loss		—		—		—		—			—		(77,740	)		—			(77,740	)
Balance at June 30, 2023		79,372,366	$	2,474		180,316	$	(63	)	$	2,799,420	$	(976,895	)	$	(8,908	)	$	1,816,028
Vesting of restricted shares		3,305		—		—		—			—		—			—			—
Exercise of vested options		16,900		2		—		—			645		—			—			647
Purchase of common stock under ESPP		34,177		—		—		—			1,192		—			—			1,192
Stock-based compensation expense		—		—		—		—			19,968		—			—			19,968
Other comprehensive income		—		—		—		—			—		—			2,111			2,111
Net loss		—		—		—		—			—		(112,152	)		—			(112,152	)
Balance at September 30, 2023		79,426,748	$	2,476		180,316	$	(63	)	$	2,821,225	$	(1,089,047	)	$	(6,797	)	$	1,727,794


	Common Shares				Treasury Shares
	Shares		CHF 0.03 Nominal Value		Shares		Amount, at cost			Additional Paid-in Capital		Accumulated Deficit			Accumulated Other Comprehensive Gain/(Loss)			Total Shareholders’ Equity
Balance at December 31, 2023		80,044,378	$	2,497		170,316	$	(62	)	$	2,878,155	$	(999,700	)	$	1,913		$	1,882,803
Issuance of common stock, net of issuance costs of $3.8 million		3,929,610		132		—		—			277,015		—			—			277,147
Vesting of restricted shares		214,913		7		—		—			—		—			—			7
Exercise of vested options, net of issuance costs of $0.6 million		632,683		22		—		—			23,844		—			—			23,866
Purchase of common stock under ESPP		16,026		—		—		—			764		—			—			764
Stock-based compensation expense		—		—		—		—			19,405		—			—			19,405
Other comprehensive loss		—		—		—		—			—		—			(3,465	)		(3,465	)
Net loss		—		—		—		—			—		(116,591	)		—			(116,591	)
Balance at March 31, 2024		84,837,610	$	2,658		170,316	$	(62	)	$	3,199,183	$	(1,116,291	)	$	(1,552	)	$	2,083,936
Vesting of restricted shares		163,013		6		—		—			—		—			—			6
Exercise of vested options, net of issuance costs of $0.2 million		44,878		1		—		—			1,069		—			—			1,070
Stock-based compensation expense		—		—		—		—			23,672		—			—			23,672
Other comprehensive loss		—		—		—		—			—		—			(1,327	)		(1,327	)
Net loss		—		—		—		—			—		(126,408	)		—			(126,408	)
Balance at June 30, 2024		85,045,501	$	2,665		170,316	$	(62	)	$	3,223,924	$	(1,242,699	)	$	(2,879	)	$	1,980,949
Issuance of common stock		97,040		4		—		—			5,939		—			—			5,943
Vesting of restricted shares		10,500		1		—		—			—		—			—			1
Exercise of vested options		161,516		14		—		—			2,732		—			—			2,746
Purchase of common stock under ESPP		21,219		—		—		—			974		—			—			974
Stock-based compensation expense		—		—		—		—			21,543		—			—			21,543
Other comprehensive gain		—		—		—		—			—		—			13,444			13,444
Net loss		—		—		—		—			—		(85,942	)		—			(85,942	)
Balance at September 30, 2024		85,335,776	$	2,684		170,316	$	(62	)	$	3,255,112	$	(1,328,641	)	$	10,565		$	1,939,658

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

CRISPR Therapeutics AG

Condensed Consolidated Statements of Cash Flows

(unaudited, in thousands)


	Nine Months Ended September 30,
	2024			2023
Operating activities:
Net loss	$	(328,941	)	$	(242,957	)
Reconciliation of net loss to net cash used in operating activities:
Depreciation and amortization		14,417			14,937
Equity-based compensation		64,620			62,608
Other non-cash items, net		(23,463	)		(11,779	)
Acquired in-process research and development		—			2,500
Changes in:
Accounts receivable		200,000			—
Prepaid expenses and other assets		5,109			16,769
Accounts payable and accrued expenses		(19,433	)		(11,056	)
Deferred revenue		(1,311	)		7,000
Operating lease assets and liabilities		(3,380	)		(1,729	)
Other liabilities, net		(361	)		(595	)
Net cash used in operating activities		(92,743	)		(164,302	)
Investing activities:
Purchase of property, plant and equipment		(1,647	)		(8,732	)
Purchase of in-process research and development		—			(2,500	)
Investment in equity securities		(20,385	)		—
Purchases of marketable securities		(1,199,072	)		(697,762	)
Maturities of marketable securities		834,795			1,165,094
Net cash (used in) provided by investing activities		(386,309	)		456,100
Financing activities:
Proceeds from issuance of common shares, net of issuance costs		285,736			—
Proceeds from exercise of options and ESPP contributions, net of issuance costs		29,372			23,725
Net cash provided by financing activities		315,108			23,725
Effect of exchange rate changes on cash		66			12
(Decrease) increase in cash		(163,878	)		315,535
Cash, cash equivalents and restricted cash, beginning of period		401,068			224,060
Cash, cash equivalents and restricted cash, end of period	$	237,190		$	539,595
Supplemental disclosure of non-cash investing and financing activities
Property and equipment purchases in accounts payable and accrued expenses	$	33		$	753
Equity issuance costs in accounts payable, accrued expenses, and other long-term liabilities	$	3,005		$	10


	As of September 30,
Reconciliation to amounts within the condensed consolidated balance sheets	2024		2023
Cash and cash equivalents	$	225,670	$	527,765
Restricted cash		11,520		11,830
Cash, cash equivalents and restricted cash at end of period	$	237,190	$	539,595

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

CRISPR Therapeutics AG

Notes to Condensed Consolidated Financial Statements

(unaudited)

1. Basis of Presentation and Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements are unaudited and have been prepared by the Company in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP.

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The Company views its operations and manages its business in one operating segment, which is the business of discovering, developing and commercializing therapies derived from or incorporating genome-editing technology. Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. These interim financial statements, in the opinion of management, reflect all normal recurring adjustments necessary for a fair presentation of the financial position and results of operations for the three and nine-month interim periods ended September 30, 2024 and 2023.

The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year. These interim financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2023, which are contained in the 2023 Annual Report on Form 10-K filed with the Securities and Exchange Commission, or the SEC, on February 21, 2024.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates, which include, but are not limited to, revenue recognition, equity-based compensation expense and reported amounts of expenses during the period. Significant estimates in these consolidated financial statements have been made in connection with revenue recognition and equity-based compensation expense. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Changes in estimates are reflected in reported results in the period in which they become known.

Significant Accounting Policies

The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and nine months ended September 30, 2024 are consistent with those discussed in Note 2 to the consolidated financial statements in the Company’s 2023 Annual Report on Form 10-K filed with the SEC on February 21, 2024.

New Accounting Pronouncements – Recently Adopted

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies that the Company adopts as of the specified effective date. The Company does not believe that the adoption of recently issued standards has or may have a material impact on its condensed consolidated financial statements and disclosures.

2. Marketable Securities

The following table summarizes cash equivalents and marketable securities held at September 30, 2024 and December 31, 2023 (in thousands), which are recorded at fair value. The table below excludes $103.8 million and $197.8 million of cash at September 30, 2024 and December 31, 2023, respectively.


	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
September 30, 2024
Cash equivalents:
Money market funds	$	89,098	$	—	$	—		$	89,098
Certificates and term deposits		25,098		—		—			25,098
Commercial paper		7,710		—		(1	)		7,709
Total cash equivalents		121,906		—		(1	)		121,905
Marketable securities:
U.S. Treasury securities		13,472		7		—			13,479
Corporate debt securities		1,151,792		9,185		(204	)		1,160,773
Certificates and term deposits		133,547		—		—			133,547
Government-sponsored enterprise securities		260,362		1,396		(24	)		261,734
Commercial paper		132,940		113		(2	)		133,051
Total marketable debt securities		1,692,113		10,701		(230	)		1,702,584
Corporate equity securities		7,500		—		(109	)		7,391
Total marketable securities		1,699,613		10,701		(339	)		1,709,975
Total cash equivalents and marketable securities	$	1,821,519	$	10,701	$	(340	)	$	1,831,880
December 31, 2023
Cash equivalents:
Money market funds	$	185,990	$	—	$	—		$	185,990
U.S. Treasury securities		5,731		—		—			5,731
Total cash equivalents		191,721		—		—			191,721
Marketable securities:

CRISPR Therapeutics AG [CRSP] Filings
10-Q	[2024-11]
10-Q	[2024-08]
10-Q	[2024-05-08]
10-K	[2024-02-21]
10-Q	[2023-11-06]
10-Q	[2023-08-07]
10-Q	[2023-05-08]
10-K	[2023-02-21]
10-Q	[2022-11-01]
10-Q	[2022-08-08]
10-Q	[2022-05-09]
10-K	[2022-02-15]
10-Q	[2021-11-03]
10-Q	[2021-07-29]
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