CRISPR Therapeutics AG [CRSP] Filings

10-Q 1 crsp-20230930.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, 2023


☐	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 2, 2023, there were 79,432,446 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.

“CRISPR Therapeutics®” standard character mark and design logo, “CRISPRXTM,” “CRISPR TXTM,” “CTX001TM,” “CTX110®,” “CTX112TM,” “CTX130TM,” “CTX131TM,” “CTX310TM,” “CTX320TM,” “VCTX210TM” and “VCTX211TM,” are trademarks and registered trademarks of CRISPR Therapeutics AG. 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:

•

the safety, efficacy and clinical progress of various clinical programs, including those for exagamglogene autotemcel, or exa-cel (formerly known as CTX001), CTX110, CTX112, CTX130, CTX131, VCTX210 and VCTX211;

•

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

•

the initiation, timing, progress and results of our preclinical studies and clinical trials, including ongoing clinical trials and any planned clinical trials, and our research and development programs, including delays or disruptions in clinical trials, non-clinical experiments and Investigational New Drug, or IND, application-enabling studies;

•

the actual or potential benefits of U.S. Food and Drug Administration, or FDA, designations, such as Orphan Drug, Fast Track and regenerative medicine advanced therapy, or RMAT, or such other equivalents, including PRIority MEdicines, or PRIME, designation;

•

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

•

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;

•

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, 2023, 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, 2023 and December 31, 2022	2

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2023 and 2022	3

Condensed Consolidated Statements of Shareholders’ Equity for the three and nine months ended September 30, 2023 and 2022	4

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2023 and 2022	6

Notes to Condensed Consolidated Financial Statements	7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	17

Item 3. Quantitative and Qualitative Disclosures about Market Risk	26

Item 4. Controls and Procedures	27

PART II: OTHER INFORMATION

Item 1. Legal Proceedings	28

Item 1A. Risk Factors	28

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	28

Item 3. Defaults Upon Senior Securities	28

Item 4. Mine Safety Disclosures	28

Item 5. Other Information	28

Item 6. Exhibits	29

SIGNATURES	30

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,
	2023			2022
Assets
Current assets:
Cash and cash equivalents	$	527,765		$	211,885
Marketable securities		1,212,061			1,603,433
Prepaid expenses and other current assets		20,760			37,708
Total current assets		1,760,586			1,853,026
Property and equipment, net		156,122			163,634
Marketable securities, non-current		—			53,130
Intangible assets, net		30			71
Restricted cash		11,830			11,635
Operating lease assets		156,215			156,921
Other non-current assets		2,047			4,640
Total assets	$	2,086,830		$	2,243,057
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable	$	26,152		$	27,428
Accrued expenses		66,405			77,682
Deferred revenue, current		3,500			—
Accrued tax liabilities		176			135
Operating lease liabilities		15,001			15,842
Other current liabilities		—			20
Total current liabilities		111,234			121,107
Deferred revenue, non-current		15,823			12,323
Operating lease liabilities, net of current portion		226,585			228,179
Other non-current liabilities		5,394			5,969
Total liabilities		359,036			367,578
Commitments and contingencies, see Note 7
Shareholders’ equity:
Common shares, CHF 0.03 nominal value, 79,607,064 and 78,692,766 shares issued at September 30, 2023 and December 31, 2022, respectively, 79,426,748 and 78,512,450 shares outstanding at September 30, 2023 and December 31, 2022, respectively		2,476			2,441
Treasury shares, at cost, 180,316 shares at September 30, 2023 and at December 31, 2022		(63	)		(63	)
Additional paid-in capital		2,821,225			2,734,838
Accumulated deficit		(1,089,047	)		(846,090	)
Accumulated other comprehensive loss		(6,797	)		(15,647	)
Total shareholders' equity		1,727,794			1,875,479
Total liabilities and shareholders’ equity	$	2,086,830		$	2,243,057

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,
	2023			2022			2023			2022
Revenue:
Collaboration revenue	$	—		$	94		$	170,000		$	430
Grant revenue		—			—			—			762
Total revenue		—			94			170,000			1,192
Operating expenses:
Research and development		90,698			116,622			292,188			358,090
General and administrative		18,291			27,001			59,683			81,295
Collaboration expense, net		23,422			38,859			110,250			103,427
Total operating expenses		132,411			182,482			462,121			542,812
Loss from operations		(132,411	)		(182,388	)		(292,121	)		(541,620	)
Other income:
Other income, net		20,671			7,264			51,819			11,171
Total other income, net		20,671			7,264			51,819			11,171
Net loss before income taxes		(111,740	)		(175,124	)		(240,302	)		(530,449	)
(Provision) benefit for income taxes		(412	)		575			(2,655	)		(9,151	)
Net loss		(112,152	)		(174,549	)		(242,957	)		(539,600	)
Foreign currency translation adjustment		(49	)		(100	)		12			(195	)
Unrealized gain (loss) on marketable securities		2,160			(1,820	)		8,838			(17,001	)
Comprehensive loss	$	(110,041	)	$	(176,469	)	$	(234,107	)	$	(556,796	)

Net loss per common share — basic	$	(1.41	)	$	(2.24	)	$	(3.07	)	$	(6.96	)
Basic weighted-average common shares outstanding		79,414,098			78,021,520			79,063,415			77,547,771
Net loss per common share — diluted	$	(1.41	)	$	(2.24	)	$	(3.07	)	$	(6.96	)
Diluted weighted-average common shares outstanding		79,414,098			78,021,520			79,063,415			77,547,771

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)

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


	Common Shares				Treasury Shares
	Shares		CHF 0.03 Nominal Value		Shares		Amount, at cost			Additional Paid-in Capital		Accumulated Deficit			Accumulated Other Comprehensive Loss			Total Shareholders’ Equity
Balance at December 31, 2021		76,990,066	$	2,391		180,316	$	(63	)	$	2,598,114	$	(195,915	)	$	(5,067	)	$	2,399,460
Vesting of restricted shares		123,564		4		—		—			—		—			—			4
Exercise of vested options, net of issuance costs of $0.2 million		261,280		12		—		—			9,998		—			—			10,010
Purchase of common stock under ESPP		11,495		—		—		—			740		—			—			740
Stock-based compensation expense		—		—		—		—			25,745		—			—			25,745
Other comprehensive loss		—		—		—		—			—		—			(11,826	)		(11,826	)
Net loss		—		—		—		—			—		(179,217	)		—			(179,217	)
Balance at March 31, 2022		77,386,405	$	2,407		180,316	$	(63	)	$	2,634,597	$	(375,132	)	$	(16,893	)	$	2,244,916
Vesting of restricted shares		14,705		—		—		—			—		—			—			—
Exercise of vested options, net of issuance costs of $0.2 million		391,053		13		—		—			10,333		—			—			10,346
Stock-based compensation expense		—		—		—		—			24,852		—			—			24,852
Other comprehensive loss		—		—		—		—			—		—			(3,449	)		(3,449	)
Net loss		—		—		—		—			—		(185,834	)		—			(185,834	)
Balance at June 30, 2022		77,792,163	$	2,420		180,316	$	(63	)	$	2,669,782	$	(560,966	)	$	(20,342	)	$	2,090,831
Issuance of common shares		12,365		—		—		—			970		—			—			970
Vesting of restricted shares		17,128		1		—		—			—		—			—			1
Exercise of vested options, net of issuance costs of $0.3 million		401,110		12		—		—			12,770		—			—			12,782
Purchase of common stock under ESPP		25,064		—		—		—			1,296		—			—			1,296
Stock-based compensation expense		—		—		—		—			24,543		—			—			24,543
Other comprehensive loss		—		—		—		—			—		—			(1,920	)		(1,920	)
Net loss		—		—		—		—			—		(174,549	)		—			(174,549	)
Balance at September 30, 2022		78,247,830	$	2,433		180,316	$	(63	)	$	2,709,361	$	(735,515	)	$	(22,262	)	$	1,953,954


	Common Shares				Treasury Shares
	Shares		CHF 0.03 Nominal Value		Shares		Amount, at cost			Additional Paid-in Capital		Accumulated Deficit			Accumulated Other Comprehensive 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

CRISPR Therapeutics AG

Condensed Consolidated Statements of Cash Flows

(unaudited, in thousands)


	Nine Months Ended September 30,
	2023			2022
Operating activities:
Net loss	$	(242,957	)	$	(539,600	)
Reconciliation of net loss to net cash used in operating activities:
Depreciation and amortization		14,937			18,326
Equity-based compensation

CRISPR Therapeutics AG [CRSP] Filings
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]
10-Q	[2021-04-27]
10-K	[2021-02-16]
10-Q	[2020-10-28]
10-Q	[2020-07-27]
10-Q	[2020-04-28]
10-K	[2020-02-12]
10-Q	[2019-10-28]
10-Q	[2019-07-29]
10-Q	[2019-04-29]
10-K	[2019-02-25]
10-Q	[2018-11-07]
10-Q	[2018-08-07]
10-Q	[2018-05-08]
10-K	[2018-03-08]
10-Q	[2017-11-08]
10-Q	[2017-08-10]
10-Q	[2017-05-11]
10-K	[2017-03-10]
10-Q	[2016-11-22]
S-1	[2016-09-09]