Ionis Pharmaceuticals: Material Agreement – Form 8-K

SAFETY AND EXCHANGES COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT 1934

Report Date (Date of First Reported Event): November 10, 2022

IONIS PHARMACEUTICALS, INC.

(Exact name of the holder as specified in the charter)

Delaware

000-19125

33-0336973

(State or other jurisdiction of incorporation)

(Commission file number)

(IRS employer identification number)

2855 Courtyard of the Gazelles

Carlsbad, CA92010

(Address of main executive offices and postal code)

Holder’s telephone number, including area code: (760) 931-9200

Check the appropriate box below if the filing of Form 8-K is intended to concurrently satisfy the filer’s filing obligation under any of the following provisions:

Written communications pursuant to Rule 425 of the Securities Act (17 CFR 230.425)

Solicit material in accordance with Rule 14a-12 of the Exchange Act (17 CFR 240.14a-12)

Pre-opening communications pursuant to Rule 14d-2(b) of the Exchange Act (17 CFR 240.14d-2(b))

Pre-opening communications pursuant to Rule 13e-4(c) of the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trade symbol

Name of each exchange listed on

Common shares, par value $0.001

“IONS”

The Nasdaq Stock Market, LLC

Indicate with a check mark whether the registrant is an emerging growth company within the meaning of Rule 405 of the Securities Act of 1933 (Section 230.405 of this Chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (Section 240.12b- 2 of this chapter).

Growing emerging company

If the company is an emerging growth company, indicate with a check mark whether the registrant has elected not to use the extended transition period to comply with new or revised financial accounting standards under the section 13(a) of the Exchange Act.

Item 1.01

Conclusion of a significant definitive agreement.

On November 10, 2022, Ionis Pharmaceuticals, Inc. (the “Company“) has entered into a collaboration and license agreement (the “OK“) with Metagenomi, Inc. (“metagenome“) to research, develop and commercialize experimental drugs for up to eight potential genetic targets using gene editing technologies.

Under the terms of the agreement, the Company and Metagenomi will collaborate to discover investigational drugs for up to four initial genetic targets selected by the Company and, upon reaching certain development milestones, four additional genetic targets selected by the Company. The Company will have the exclusive, worldwide right to develop and commercialize the products discovered as part of the parties’ drug discovery collaboration (“Some products“), subject to a limited option exercisable by Metagenomi to co-develop and co-market Products intended for a limited number of genetic targets (“co-co products“). For each option exercised by Metagenomi, Metagenomi will pay the Company a license fee and the parties will negotiate a co-development and co-marketing agreement.

In addition, each party has agreed not to, independently or with a third party, develop or commercialize any product targeting the genetic targets selected by the Company and using certain gene editing modalities for periods of time specified under of the Agreement.

In payment for granting the Company rights under the Agreement, the Company paid an initial fee of $80 million. The Company will also pay Metagenomi certain fees for the selection of genetic targets, and subject to the achievement of certain development, regulatory and commercial events, milestone payments and royalties. In addition, the Company will reimburse Metagenomi for some of its costs related to conducting its research and drug discovery activities under the collaboration.

The Agreement continues (a) with respect to Products on a Product-by-Product and country-by-country basis until the expiration of the last royalty period to expire with respect to a Product in the applicable country, and (b) with respect to Co-Co Products until the parties cease all operation of such Co-Co Products.

The above summary of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed as an attachment to the Company’s Annual Report on Form 10- K for the year ending December 31, 2022.

Item 2.02

Results of Operations and Financial Condition.

As part of the Company’s entry into the Agreement, the Company has increased its full-year 2022 guidance for operating expenses and net loss, on a non-GAAP basis, to to integrate the initial payment into Metagenomi, all as indicated in the table below.

Orientations for the year 2022

amended

Tips

Previous Dated

Q3 2022

Revenue

>$575 million

>$575 million

Operating expenses on a non-GAAP basis

$900-925 million

$825–850 million

Net loss on a non-GAAP basis

Cash, cash equivalents and short-term investments

~2.0 billion

~$2.0 billion

The information in item 2.02 of this current report on Form 8-K is not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Law“) or otherwise subject to the obligations of this Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of the general language of incorporation into such a repository.

Item 9.01.

Financial statements and supporting documents.

(d) Exhibits.

Part No.

The description

104

Cover page interactive data file (embedded in the Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, duly authorized thereto.

Ionis Pharmaceuticals, Inc.

Dated: November 14, 2022

By:

/s/ Patrick R. O’Neil

Patrick R. O’Neil

Executive Vice President, General Counsel and General Counsel

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