UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE TO
TENDER OFFER STATEMENT
UNDER SECTION 14(D)(1) OR (13)(E)(1)
OF THE SECURITIES EXCHANGE
ACT OF 1934
REGULUS
THERAPEUTICS INC.
(Name of Subject Company (Issuer))
REDWOOD MERGER SUB INC.
(Offeror)
an indirect wholly owned subsidiary of
NOVARTIS AG
(Offeror)
(Name of Filing Persons (identifying status as offeror, issuer or other person))
Common Stock, par value $0.001 per share
(Title of Class of Securities)
75915K309
(CUSIP Number of Class of Securities)
Karen L. Hale
Chief Legal and Compliance Officer
Novartis
AG
Lichstrasse 35
CH-4056 Basel
Switzerland
Telephone: +41-61-324-1111
(Name, Address, and Telephone Number of Person Authorized to Receive Notices and Communications on Behalf of Filing Persons)
With a copies to:
Catherine J. Dargan, Esq.
Michael J. Riella, Esq.
Kerry S. Burke, Esq.
Covington & Burling LLP
One CityCenter
850 Tenth Street, NW
Washington, DC 20001-4956
+1 (202) 662-6000
| x |
Check the box if the filing
relates solely to preliminary communications made before the commencement of a tender offer. |
Check the appropriate boxes below to designate
any transactions to which the statement relates:
| x |
Third-party
tender offer subject to Rule 14d-1. |
| ¨ |
Issuer tender offer subject
to Rule 13e-4. |
| ¨ |
Going-private transaction
subject to Rule 13e-3. |
| ¨ |
Amendment to Schedule 13D
under Rule 13d-2. |
Check the following
box if the filing is a final amendment reporting the results of the tender offer: ☐
If applicable, check the appropriate box(es)
below to designate the appropriate rule provision(s) relied upon:
| ¨ |
Rule 13e-4(i) (Cross-Border
Issuer Tender Offer) |
| ¨ |
Rule 14d-1(d) (Cross-Border
Third-Party Tender Offer) |
The pre-commencement communication filed under cover of this tender
offer statement on Schedule TO is being filed by Novartis AG, a company organized under the laws of Switzerland (“Novartis”),
and Redwood Merger Sub Inc., a Delaware corporation (“Purchaser”), an indirect wholly owned subsidiary of Novartis, in connection
with a planned tender offer by Purchaser for all of the outstanding shares of common stock, par value $0.001 (the “Shares”),
of Regulus Therapeutics Inc., a Delaware corporation (“Regulus”). The planned tender offer will be made pursuant to an Agreement
and Plan of Merger, dated as of April 29, 2025, by and among Novartis, Purchaser and Regulus (the “Merger Agreement”).
Important Information about the Tender Offer
This document is neither an offer to purchase nor a solicitation of
an offer to sell any Shares or any other securities. The tender offer for the outstanding Shares described in this communication has not
commenced. At the time the tender offer is commenced, Novartis and Purchaser will file, or will cause to be filed, a tender offer statement
on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, with the U.S. Securities and Exchange Commission
(the “SEC”), and Regulus will file a solicitation/recommendation statement on Schedule 14D-9 with the SEC, in each case with
respect to the tender offer.
INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ BOTH
THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A LETTER OF TRANSMITTAL AND RELATED DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION
STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY
WILL CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING
THEIR SECURITIES.
An
offer to purchase the Shares will only be made pursuant to the offer to purchase, the letter of transmittal and related offer documents
filed as a part of the Schedule TO. Those materials and all other documents filed by, or caused to be filed by, Novartis, Purchaser and
Regulus with the SEC will be available at no charge on the SEC’s website at www.sec.gov or by directing such requests to the information
agent for the offer, which will be named in the tender offer statement. The offer to purchase and related materials also may be obtained
for free under the “Investors – Financial Data” section of Novartis’s website at https://www.novartis.com/investors/financial-data/sec-filings.
The solicitation/recommendation statement also may be obtained for free under the “Investors” section of Regulus’s website
at ir.regulusrx.com/overview. In addition, Regulus files annual, quarterly and current reports and other information, and Novartis
files annual reports and other information with the SEC, which are also available to the public at no charge at www.sec.gov.
Forward-Looking Statements
This
communication contains statements that are not statements of historical fact, or “forward-looking statements,” including
with respect to Novartis’s proposed acquisition of Regulus. Forward-looking statements can generally be identified by words such
as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,”
“expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,”
“pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals,
new indications or labeling for farabursen, regarding the proposed acquisition of Regulus and the expected timetable for completing the
proposed acquisition, the benefits sought to be achieved in the proposed acquisition, or regarding potential future revenues from farabursen.
You should not place undue reliance on these statements. Such forward-looking statements are based on Novartis’s current beliefs
and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more
of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from
those set forth in the forward-looking statements. There can be no guarantee that farabursen clinical trials will be successful, that
farabursen will be submitted for marketing approval or approved for sale or, if approved, receive approval for any additional indications
or labeling, in any market, or at any particular time, nor can there be any guarantee that, if approved, farabursen will be commercially
successful in the future. Neither can there be any guarantee that the conditions to the closing of the proposed acquisition will be satisfied
on the expected timetable or at all or that the expected benefits or synergies from this transaction will be achieved in the expected
timeframe, or at all. In particular, expectations regarding farabursen or the transaction described in this communication could be affected
by, among other things, the timing of the offer and the satisfaction of customary closing conditions, including the tender of a majority
of the outstanding Shares and the receipt of regulatory approvals on acceptable terms or at all; the risk that competing offers or acquisition
proposals will be made; uncertainty as to whether the milestone associated with the contingent value right (“CVR”) will be
achieved and that holders of CVRs will receive payments in respect thereof; the effects of disruption from the transactions contemplated
by the Merger Agreement and the impact of the announcement and pendency of the transactions on Novartis and/or Regulus’s businesses,
including their relationships with employees, business partners or governmental entities; the risk that the offer or the merger may be
more expensive to complete than anticipated; the risk that stockholder litigation in connection with the offer or the merger may result
in significant costs of defense, indemnification and liability; a diversion of management’s attention from ongoing business operations
and opportunities as a result of the offer, the merger or otherwise; general industry conditions and competition; general political,
economic and business conditions, including interest rate and currency exchange rate fluctuations; the uncertainties inherent in research
and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or
government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing
and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual
property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions;
safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions
of our information technology systems, and other risks and factors referred to in Novartis AG’s and Regulus’s filings and
reports with the SEC, including Novartis AG’s Annual Report on Form 20-F for the year ended December 31, 2024, Regulus’s
Annual Report on Form 10-K for the year ended December 31, 2024 and any subsequent filings made by either party with the SEC,
available on the SEC’s website at www.sec.gov. Novartis is providing the information in this communication as of
this date and Novartis does not undertake any obligation to update any forward-looking statements contained in this communication as
a result of new information, future events or otherwise, except to the extent required by law.
EXHIBIT INDEX
Exhibit 99.1
Subject: Regulus & Novartis
Dear Regulus Team,
On behalf of my Novartis colleagues, I
want to express our genuine excitement to partner with you to accelerate the development of potentially transformative new therapies for
patients living with renal diseases. From our earliest conversations with your leadership team to our deeper engagement, we’ve
been profoundly impressed by the people, expertise and capabilities you’ve cultivated. Most of all, we are inspired by your talent
and passion for innovation, which mirrors our own culture.
As an innovative medicines company, at
Novartis, we pursue a focused strategy of delivering high value medicines that alleviate society’s greatest burdens. We continue
to build on our strong heritage in treatments for renal disease, and it has been an inspirational time at Novartis with three FDA
approvals in renal in less than a year: Vanrafia® in IgA nephropathy (IgAN) earlier this month, and Fabhalta®
approvals for C3 glomerulopathy (C3G) and IgAN in March 2025 and August 2024, respectively. As
a potential first-in-class novel, next generation oligonucleotide, farabursen complements our
renal pipeline and leverages our expertise in renal disease.
Your dedication and hard work have been instrumental
in bringing farabursen to its current stage of development. At Novartis, we are focused on our people and are committed to cultivating
a culture that brings out the best in everyone so that we can continue to reimagine medicine to improve and extend people’s lives.
Working together to achieve potentially transformative scientific and medical advances makes both of our companies exceptional and rewarding
places to work. After the closing of the transaction, which we expect to occur in the second half of 2025, subject to the satisfaction
of customary closing conditions, we look forward to learning from you, supporting you, working together on our joint mission to improve
renal health, and contributing through our global reach to bring medical innovation to as many patients as possible.
I want to thank the Regulus leadership team and colleagues across the company who contributed to realizing this new relationship. In the
coming weeks, following the close of the transaction, you will learn more about how we will work together, but until then we will continue
operating as separate companies.
I look forward to connecting with you once the transaction closes to
reimagine medicine together and make a difference in the lives of patients worldwide. Thank you.
Best regards,
Ruchira Glaser, M.D., M.S.
Development Unit Head, Cardiovascular, Renal and Metabolic
Novartis
Important Information about the Tender Offer
This communication is neither an offer to purchase nor a solicitation
of an offer to sell any shares of common stock, par value $0.001 (the “Shares”), of Regulus Therapeutics Inc., a Delaware
corporation (“Regulus”) or any other securities. The tender offer for the outstanding Shares described in this communication
has not commenced. At the time the tender offer is commenced, Novartis AG, a company organized under the laws of Switzerland (“Novartis”),
and Redwood Merger Sub Inc., a Delaware corporation (“Purchaser”), will file, or will cause to be filed, a tender offer statement
on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, with the U.S. Securities and Exchange Commission
(the “SEC”), and Regulus will file a solicitation/recommendation statement on Schedule 14D-9 with the SEC, in each case with
respect to the tender offer.
INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ BOTH
THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A LETTER OF TRANSMITTAL AND RELATED DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION
STATEMENT ON SCHEDULE 14D-9 REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY
WILL CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND SECURITY HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING
THEIR SECURITIES.
An offer to purchase the Shares will only be made pursuant to the offer
to purchase, the letter of transmittal and related offer documents filed as a part of the Schedule TO. Those materials and all other documents
filed by, or caused to be filed by, Novartis, Purchaser and Regulus with the SEC will be available at no charge on the SEC’s website
at www.sec.gov or by directing such requests to the information agent for the offer, which will be named in the tender offer statement.
The offer to purchase and related materials also may be obtained for free under the “Investors – Financial Data” section
of Novartis’s website at https://www.novartis.com/investors/financial-data/sec-filings. The solicitation/recommendation statement
also may be obtained for free under the “Investors” section of Regulus’s website at ir.regulusrx.com/overview. In addition,
Regulus files annual, quarterly and current reports and other information, and Novartis files annual reports and other information with
the SEC, which are also available to the public at no charge at www.sec.gov.
Forward-Looking Statements
This communication contains statements that are not statements of historical
fact, or “forward-looking statements,” including with respect to Novartis’s proposed acquisition of Regulus. Forward-looking
statements can generally be identified by words such as “potential,” “can,” “will,” “plan,”
“may,” “could,” “would,” “expect,” “anticipate,” “look forward,”
“believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar
terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for farabursen, regarding
the proposed acquisition of Regulus and the expected timetable for completing the proposed acquisition, the benefits sought to be achieved
in the proposed acquisition, or regarding potential future revenues from farabursen. You should not place undue reliance on these statements.
Such forward-looking statements are based on Novartis’s current beliefs and expectations regarding future events and are subject
to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no
guarantee that farabursen clinical trials will be successful, that farabursen will be submitted for marketing approval or approved for
sale or, if approved, receive approval for any additional indications or labeling, in any market, or at any particular time, nor can there
be any guarantee that, if approved, farabursen will be commercially successful in the future. Neither can there be any guarantee that
the conditions to the closing of the proposed acquisition will be satisfied on the expected timetable or at all or that the expected benefits
or synergies from this transaction will be achieved in the expected timeframe, or at all. In particular, expectations regarding farabursen
or the transaction described in this communication could be affected by, among other things, the timing of the offer and the satisfaction
of customary closing conditions, including the tender of a majority of the outstanding Shares and the receipt of regulatory approvals
on acceptable terms or at all; the risk that competing offers or acquisition proposals will be made; uncertainty as to whether the milestone
associated with the contingent value right (“CVR”) will be achieved and that holders of CVRs will receive payments in respect
thereof; the effects of disruption from the transactions contemplated by the merger agreement, and the impact of the announcement and
pendency of the transactions on Novartis and/or Regulus’s businesses, including their relationships with employees, business partners
or governmental entities; the risk that the offer or the merger may be more expensive to complete than anticipated; the risk that stockholder
litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability; a diversion
of management’s attention from ongoing business operations and opportunities as a result of the offer, the merger or otherwise;
general industry conditions and competition; general political, economic and business conditions, including interest rate and currency
exchange rate fluctuations; the uncertainties inherent in research and development, including clinical trial results and additional analysis
of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment,
including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency;
our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and
patients; general political, economic and business conditions; safety, quality, data integrity or manufacturing issues; potential or actual
data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to
in Novartis AG’s and Regulus’s filings and reports with the SEC, including Novartis AG’s Annual Report on Form 20-F
for the year ended December 31, 2024, Regulus’s Annual Report on Form 10-K for the year ended December 31, 2024 and
any subsequent filings made by either party with the SEC, available on the SEC’s website at www.sec.gov. Novartis is providing the
information in this communication as of this date and Novartis does not undertake any obligation to update any forward-looking statements
contained in this communication as a result of new information, future events or otherwise, except to the extent required by law.
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