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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
February 18, 2021
RIGEL PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
0-29889 |
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94-3248524 |
(Commission File
No.) |
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(IRS Employer
Identification No.) |
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1180 Veterans Boulevard |
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South San Francisco,
CA |
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94080 |
(Address of principal
executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (650)
624-1100
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is
intended to simultaneously satisfy the filing obligation of the
registrant under any of the following provisions (see General
Instruction A.2. below):
¨ Written communications pursuant to
Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to
Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to
Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ Pre-commencement communications pursuant to
Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Title of Each Class |
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Trading
Symbol(s) |
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Name of Each Exchange on
Which Registered |
Common Stock, par value $0.001 per share |
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RIGL |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ¨
Item 1.01. Entry into a Material Definitive Agreement.
On February 18, 2021, Rigel Pharmaceuticals, Inc. (“Rigel”)
entered into a license and collaboration agreement (the “License
Agreement”) with Eli Lilly and Company (“Lilly”) to co-develop and
commercialize R552, a receptor-interacting
serine/threonine-protein kinase 1 (RIPK1) inhibitor, for
the treatment of non-central nervous system (non-CNS) diseases. In
addition, the collaboration is aimed at developing additional RIPK1
inhibitors for the treatment of CNS diseases. Pursuant to the terms
of the License Agreement, Rigel granted to Lilly exclusive rights
to develop and commercialize R552 and related RIPK1 inhibitors in
all indications worldwide. The parties’ collaboration is governed
through a joint governance committee and appropriate
subcommittees.
Rigel and Lilly are jointly responsible for performing development
activities for R552 and other non-CNS disease development
candidates. Rigel is responsible for 20% of development costs for
R552 in the U.S., Europe, and Japan, up to a specified cap. Lilly
is responsible for funding the remainder of all development
activities for R552 and other non-CNS disease development
candidates. Rigel has the right to opt-out of co-funding the R552
development activities in the U.S., Europe and Japan at two
different specified times. If Rigel exercises the first opt-out
right, Rigel will continue to fund its share of the R552
development activities in the U.S., Europe, and Japan up to a
maximum funding commitment of $65,000,000. If Rigel does not
exercise either of the opt-out rights, Rigel will receive royalty
payments on net sales of non-CNS disease products at higher
percentage rates and have the right to co-commercialize R552 in the
U.S., with Lilly, on terms to be agreed by the parties.
Rigel is responsible for performing and funding initial discovery
and identification of CNS disease development candidates, and,
following candidate selection, Lilly will be responsible for
performing and funding all future development and commercialization
of the CNS disease development candidates.
Under the terms of the License Agreement, Rigel receives an upfront
cash payment of $125 million, with the potential for an additional
$330 million in milestone payments upon the achievement of
specified development and regulatory milestones by non-CNS disease
products and $255 million in milestone payments upon the
achievement of specified development and regulatory milestones by
CNS disease products. Rigel is also eligible to receive up to $100
million in sales milestone payments on a product-by-product basis
for non-CNS disease products and up to $150 million in sales
milestone payments on a product-by-product basis for CNS disease
products. In addition, depending on the extent of Rigel’s
co-funding of R552 development activities, Rigel would be entitled
to receive tiered royalty payments on net sales of non-CNS disease
products at percentages ranging from the mid-single digits to
high-teens, subject to certain standard reductions and offsets.
Rigel would be entitled to receive tiered royalty payments on net
sales of CNS disease products at percentages up to low-double
digits, subject to certain standard reductions and offsets.
Unless terminated earlier, the License Agreement has a term that
continues, on a product-by-product and country-by-country basis,
until the latest to occur of the expiration of specified licensed
patents covering such product in such country, the expiration of
market exclusivity for such product in such country, and 12 years
after first commercial sale of such product in such country,
subject to certain standard reductions and offsets. The
License Agreement may be terminated for cause by either party based
on uncured material breach of the other party, bankruptcy of the
other party, or if a party challenges or opposes any patent owned
by the other party and covered by the License Agreement. If the
License Agreement does not clear the Hart Scott Rodino Antitrust
Improvements Act of 1976, either party may terminate the License
Agreement. Lilly may terminate the License Agreement without cause
on specified notice periods, either in its entirety or with respect
to the non-CNS disease product program or the CNS disease product
program. Upon early termination by either party, all licenses
granted by Rigel to Lilly will automatically terminate.
The description of the License Agreement in this Current Report on
Form 8-K does not purport to be complete and is qualified in
its entirety by reference to the License Agreement, a copy of which
will be included as an exhibit to Rigel’ Quarterly Report on
Form 10-Q for the fiscal period ending March 31, 2021, to
be filed with the Securities and Exchange Commission.
Forward-Looking Statements
This Current Report on Form 8-K and information included
herein, contain forward-looking statements relating to, among other
things, Rigel's partnership with Lilly and the success thereof;
Lilly’s and Rigel’s abilities to successfully develop and
commercialize Rigel’s RIPK1 inhibitor program, including R552;
Rigel's ability and eligibility to receive development, regulatory
and commercial milestone payments under its agreement with Lilly;
and the potential indications that RIPK1 inhibitors may affect. Any
such statements that are not statements of historical fact may be
deemed to be forward-looking statements. Words such as "potential,"
"may," "expects" and similar expressions are intended to identify
these forward-looking statements. These forward-looking statements
are based on Rigel's current expectations and inherently involve
significant risks and uncertainties. Actual results and the timing
of events could differ materially from those anticipated in such
forward looking statements as a result of these risks and
uncertainties, which include, without limitation, risks that the
FDA, EMA or other regulatory authorities may make adverse decisions
regarding R552; risks regarding closing conditions under the
agreement with Lilly, including review under the Hart-Scott-Rodino
(HSR) Antitrust Improvements Act of 1976 in the U.S.; risks related
to Lilly’s decisions regarding development and commercialization of
R552; risks that R552 clinical trials may not be predictive of
real-world results or of results in subsequent clinical trials; the
availability of resources to develop Rigel's product candidates;
market competition; as well as other risks detailed from time to
time in Rigel's reports filed with the Securities and Exchange
Commission, including its Annual Report on Form 10-K for the
year ended December 31, 2019 and Quarterly Report on
Form 10-Q for the quarter ended September 30, 2020. Rigel
does not undertake any obligation to update any forward-looking
statements and expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned hereto duly authorized.
Dated:
February 18, 2021 |
RIGEL PHARMACEUTICALS, INC. |
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By: |
/s/ Dolly A. Vance |
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Dolly
A. Vance |
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Executive Vice President, General Counsel and Corporate
Secretary |