CRSP CRISPR Therapeutics AG

 

 

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 June 30, 2024

or

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

 

For the transition period from to .

Commission File Number: 001-37923

 

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 August 1, 2024, there were 85,168,158 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™,” “CTX330™,” 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:

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 June 30, 2024 and December 31, 2023	2
Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2024 and 2023	3
Condensed Consolidated Statements of Shareholders’ Equity for the three and six months ended June 30, 2024 and 2023	4
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023	5
Notes to Condensed Consolidated Financial Statements	6
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
		June 30,				December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents		$	484,472			$	389,477
Marketable securities			1,517,147				1,304,215
Accounts receivable			—				200,000
Prepaid expenses and other current assets			8,788				14,386
Total current assets			2,010,407				1,908,078
Property and equipment, net			143,031				151,945
Marketable securities, non-current			11,216				1,973
Intangible assets, net			—				16
Restricted cash			11,520				11,591
Operating lease assets			148,538				153,993
Other non-current assets			15,141				1,975
Total assets		$	2,339,853			$	2,229,571
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable		$	9,452			$	38,147
Accrued expenses			91,883				45,335
Deferred revenue, current			4,759				4,105
Accrued tax liabilities			454				438
Operating lease liabilities			16,451				15,625
Other current liabilities			4,824				5,141
Total current liabilities			127,823				108,791
Deferred revenue, non-current			12,583				14,012
Operating lease liabilities, net of current portion			214,852				223,007
Other non-current liabilities			3,646				958
Total liabilities			358,904				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 June 30, 2024 and December 31, 2023, respectively, 85,215,817 and 80,214,694 shares issued at June 30, 2024 and December 31, 2023, respectively, 85,045,501 and 80,044,378 shares outstanding at June 30, 2024 and December 31, 2023, respectively			2,665				2,497
Treasury shares, at cost, 170,316 shares at June 30, 2024 and at December 31, 2023			(62	)			(62	)
Additional paid-in capital			3,223,924				2,878,155
Accumulated deficit			(1,242,699	)			(999,700	)
Accumulated other comprehensive (loss) income			(2,879	)			1,913
Total shareholders' equity			1,980,949				1,882,803
Total liabilities and shareholders’ equity		$	2,339,853			$	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								Six Months Ended
		June 30,								June 30,
		2024				2023				2024				2023
Revenue:
Collaboration revenue		$	—			$	70,000			$	—			$	170,000
Grant revenue			517				—				1,021				—
Total revenue			517				70,000				1,021				170,000
Operating expenses:
Research and development			80,165				101,555				156,338				201,490
General and administrative			19,481				19,032				37,434				41,392
Collaboration expense, net			52,131				44,636				99,097				86,828
Total operating expenses			151,777				165,223				292,869				329,710
Loss from operations			(151,260	)			(95,223	)			(291,848	)			(159,710	)
Other income:
Other income, net			26,139				18,406				50,860				31,148
Total other income, net			26,139				18,406				50,860				31,148
Net loss before income taxes			(125,121	)			(76,817	)			(240,988	)			(128,562	)
Provision for income taxes			(1,287	)			(923	)			(2,011	)			(2,243	)
Net loss			(126,408	)			(77,740	)			(242,999	)			(130,805	)
Foreign currency translation adjustment			2				28				(9	)			60
Unrealized (loss) gain on marketable securities			(1,329	)			452				(4,783	)			6,679
Comprehensive loss		$	(127,735	)		$	(77,260	)		$	(247,791	)		$	(124,066	)
Net loss per common share — basic		$	(1.49	)		$	(0.98	)		$	(2.92	)		$	(1.66	)
Basic weighted-average common shares outstanding			84,920,929				79,091,061				83,357,780				78,885,168
Net loss per common share — diluted		$	(1.49	)		$	(0.98	)		$	(2.92	)		$	(1.66	)
Diluted weighted-average common shares outstanding			84,920,929				79,091,061				83,357,780				78,885,168

 

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
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

 

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)

 

		Six Months Ended June 30,
		2024				2023
Operating activities:
Net loss		$	(242,999	)		$	(130,805	)
Reconciliation of net loss to net cash used in operating activities:
Depreciation and amortization			9,678				10,012
Equity-based compensation			43,077				42,640
Other non-cash items, net			(16,566	)			(5,620	)
Acquired in-process research and development			—				1,500
Changes in:
Accounts receivable			200,000				(70,000	)
Prepaid expenses and other assets			5,297				15,952
Accounts payable and accrued expenses			18,724				13,637
Deferred revenue			(775	)			—
Operating lease assets and liabilities			(1,874	)			(1,277	)
Other liabilities, net			(392	)			(485	)
Net cash provided by (used in) operating activities			14,170				(124,446	)
Investing activities:
Purchase of property, plant and equipment			(1,428	)			(6,614	)
Purchase of in-process research and development			—				(1,500	)
Investment in equity securities			(12,885	)			—
Purchases of marketable securities			(797,509	)			(452,363	)
Maturities of marketable securities			587,117				795,229
Net cash (used in) provided by investing activities			(224,705	)			334,752
Financing activities:
Proceeds from issuance of common shares, net of issuance costs			279,733				—
Proceeds from exercise of options and ESPP contributions, net of issuance costs			25,735				22,169
Net cash provided by financing activities			305,468				22,169
Effect of exchange rate changes on cash			(9	)			60
Increase in cash			94,924				232,535
Cash, cash equivalents and restricted cash, beginning of period			401,068				224,060
Cash, cash equivalents and restricted cash, end of period		$	495,992			$	456,595
Supplemental disclosure of non-cash investing and financing activities
Property and equipment purchases in accounts payable and accrued expenses		$	20			$	1,029
Equity issuance costs in accounts payable, accrued expenses, and other long-term liabilities		$	3,029			$	293

 

		As of June 30,
Reconciliation to amounts within the condensed consolidated balance sheets		2024				2023
Cash and cash equivalents		$	484,472			$	444,796
Restricted cash			11,520				11,799
Cash, cash equivalents and restricted cash at end of period		$	495,992			$	456,595

 

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

---

CRISPR Therapeutics AG

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

 

---