Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Decibel
Therapeutics, Inc. (NASDAQ: DBTX), a clinical-stage biotechnology
company dedicated to discovering and developing transformative
treatments to restore and improve hearing and balance, today
announced a definitive agreement for the acquisition of Decibel by
Regeneron at a price of $4.00 per share of Decibel common stock
payable in cash at closing, with an additional non-tradeable
contingent value right (CVR) to receive up to $3.50 per share in
cash upon achievement of certain clinical development and
regulatory milestones for Decibel’s lead investigational candidate,
DB-OTO, within specified time periods. The proposed acquisition
values Decibel at a total equity value of approximately $109
million based on the amount payable at closing, and a total equity
value of up to approximately $213 million if the CVR
milestones are achieved.
“We at Decibel are deeply committed to discovering and advancing
innovative new therapies with the potential to be transformative
for people with severe forms of hearing loss. We have built a
pipeline of gene therapy product candidates for the ear that we
believe have such potential. After full consideration, the Decibel
Board has determined that this transaction is the best way to
maximize shareholder value and ultimately benefit patients,” said
Laurence E. Reid, Ph.D., President and Chief Executive Officer of
Decibel. “We have collaborated with our colleagues at Regeneron for
the past six years and have huge respect for their research and
development capabilities. We have full confidence that with
Regeneron’s expertise and resources the Decibel pipeline can be
optimally developed, and our team is committed to enabling that
long-term success.”
Decibel and Regeneron established their initial collaboration in
2017, with an extension announced in 2021, and are developing three
gene therapy programs targeting different forms of congenital,
monogenic hearing loss. DB-OTO, which is currently in the global
Phase 1/2 CHORDTM clinical trial, is an investigational
cell-selective, adeno-associated virus (AAV) gene therapy designed
to provide durable, physiological hearing to individuals with
profound, congenital hearing loss caused by mutations of the
otoferlin gene. Preclinical programs include AAV.103 for people
with GJB2-related hearing loss and AAV.104 for people with
stereocilin (STRC)-related hearing loss.
“We are delighted to announce the planned acquisition of
Decibel, who have been long-standing collaborators, notable for
their deep scientific knowledge and commitment to people with
hearing loss,” said George D. Yancopoulos, M.D., Ph.D., Board
co-Chair, Chief Scientific Officer and President of Regeneron.
“DB-OTO, our shared lead investigational gene therapy, will soon
reach patients in its first clinical trial, offering new promise to
children with this rare form of congenital hearing loss, as well as
potential proof-of-concept for future gene therapies addressing
more common forms of genetic hearing loss. We believe that
Decibel’s assets and specialized team will further strengthen our
genetic medicines portfolio, enabling Regeneron to accelerate the
development of innovative genetic therapies and a rich pipeline of
hearing loss treatments.”
Congenital hearing loss is a significant unmet medical need with
no approved medical therapies that affects approximately 1.7 out of
every 1,000 children born in the United States. While hearing loss
caused by mutations of the otoferlin gene is rare, the majority of
permanent, congenital hearing loss cases diagnosed in developed
countries are sensorineural and result from a single gene defect,
making them appealing targets for gene therapy. Hearing aids and
cochlear implants may offer benefits, but they fall short of
replicating normal hearing function.
The merger agreement provides for Regeneron, through its wholly
owned subsidiary Symphony Acquisition Sub, Inc., to initiate a
tender offer to acquire all outstanding shares of Decibel at a
price of $4.00 per share of Decibel common stock payable in cash at
closing plus one CVR payable in cash subject to the terms and
conditions contained in a contingent value rights agreement (“CVR
Agreement”). CVR holders would become entitled to receive
contingent payments as follows: (i) $2.00 in cash, upon the fifth
participant being administered with DB-OTO in a clinical trial on
or prior to December 31, 2024 (the DB-OTO Milestone); and (ii)
$1.50 in cash, upon (a) the first participant being administered
with DB-OTO in a registration enabling trial (as defined in the CVR
Agreement) or (b) acceptance for review of a Biologics License
Application by the U.S. Food and Drug Administration, a Marketing
Authorization Application by the European Medicines Agency or the
U.K. Medicines and Healthcare Products Regulatory Agency, or an
equivalent application by the applicable national regulatory
authority in any of Germany, France, Italy or Spain for DB-OTO,
whichever occurs first, on or prior to December 31, 2028; provided
the DB-OTO Milestone is achieved on or prior to December 31, 2024.
There can be no assurance that any payments will be made with
respect to the CVR. The closing of the tender offer will be subject
to certain conditions, including the tender of at least a majority
of the outstanding shares of Decibel common stock and other
customary closing conditions. Upon the successful completion of the
tender offer, Regeneron will acquire all shares not acquired in the
tender through a second-step merger for the same consideration per
share paid in the tender offer. The transaction is expected to
close in the third quarter of 2023.
Regeneron’s legal advisor for the transaction is Wachtell,
Lipton, Rosen & Katz. Centerview Partners LLC and Leerink
Partners LLC are serving as Decibel’s financial advisors and Wilmer
Cutler Pickering Hale and Dorr LLP is serving as Decibel’s legal
advisor.
About Regeneron Regeneron (NASDAQ: REGN)
is a leading biotechnology company that invents life-transforming
medicines for people with serious diseases. Founded and led for 35
years by physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to nine
FDA-approved treatments and numerous product candidates in
development, almost all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, hematologic
conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our
proprietary VelociSuite® technologies, such
as VelocImmune®, which uses unique genetically humanized mice
to produce optimized fully human antibodies and bispecific
antibodies, and through ambitious research initiatives such as the
Regeneron Genetics Center, which is conducting one of the largest
genetics sequencing efforts in the world.
For additional information about the company, please
visit www.regeneron.com or follow Regeneron on
LinkedIn.
About Decibel TherapeuticsDecibel Therapeutics
is a clinical-stage biotechnology company dedicated to discovering
and developing transformative treatments to restore and improve
hearing and balance, one of the largest areas of unmet need in
medicine. Decibel has built a proprietary platform that integrates
single-cell genomics and bioinformatic analyses, precision gene
therapy technologies and expertise in inner ear biology. Decibel is
leveraging its platform to advance gene therapies designed to
selectively replace genes for the treatment of congenital,
monogenic hearing loss and to regenerate inner ear hair cells for
the treatment of acquired hearing and balance disorders. Decibel’s
pipeline, including its lead gene therapy product candidate,
DB-OTO, to treat congenital, monogenic hearing loss, is designed to
deliver on our vision of creating a world of connection for people
with hearing and balance disorders. For more information about
Decibel Therapeutics, please visit www.decibeltx.com or follow us
on Twitter.
Forward-looking Statements This press release
contains forward-looking statements that involve risks and
uncertainties relating to future events and the future performance
of Regeneron Pharmaceuticals, Inc. (“Regeneron”) and Decibel
Therapeutics, Inc. (“Decibel”), including regarding Regeneron’s
proposed acquisition of Decibel, the prospective benefits of the
proposed acquisition, the potential contingent consideration
amounts and terms and the anticipated occurrence, manner and timing
of the proposed tender offer and the closing of the proposed
acquisition. Actual events or results may differ materially from
these forward-looking statements. Words such as “anticipate,”
“expect,” “intend,” “plan,” “propose,” “provide,” “believe,”
“seek,” “estimate,” variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. Risks that may cause these forward-looking
statements to be inaccurate include, without limitation:
uncertainties as to the timing of the tender offer and merger;
uncertainties as to how many of Decibel’s stockholders will tender
their stock in the offer; the possibility that competing offers
will be made; the possibility that various closing conditions for
the transaction may not be satisfied or waived, including that a
governmental entity may prohibit, delay, or refuse to grant
approval for the consummation of the transaction (or only grant
approval subject to adverse conditions or limitations); the
difficulty of predicting the timing or outcome of regulatory
approvals or actions, if any; the possibility that the transaction
does not close; risks related to Regeneron’s ability to realize the
anticipated benefits of the proposed acquisition, including the
possibility that the expected benefits from the proposed
acquisition will not be realized or will not be realized within the
expected time period and that Regeneron and Decibel will not be
integrated successfully; the effects of the transaction on
relationships with employees, other business partners or
governmental entities; negative effects of this announcement or the
consummation of the proposed acquisition on the market price of
Regeneron’s or Decibel’s common stock and/or Regeneron’s or
Decibel’s operating results; significant transaction costs; unknown
liabilities; the risk of litigation and/or regulatory actions
related to the proposed acquisition; Regeneron’s and Decibel’s
ability to continue to conduct research and clinical programs;
Regeneron’s and Decibel’s ability to manage their respective supply
chains; Regeneron’s ability to manage net product sales of products
marketed or otherwise commercialized by Regeneron and/or its
collaborators or licensees (collectively, “Regeneron’s Products”);
the nature, timing, and possible success and therapeutic
applications of Regeneron’s Products, product candidates being
developed by Regeneron and/or its collaborators or licensees
(including without limitation Regeneron’s and Decibel’s
investigational gene therapy DB-OTO for the treatment of congenital
hearing loss and the other gene therapy programs being developed as
part of the companies’ collaboration (collectively,
“Regeneron’s Product Candidates”)), and development programs and
product candidates being developed by Decibel independently
(collectively, “Decibel’s Product Candidates”); the extent to which
the results from the research and development programs conducted by
Regeneron, Decibel, and/or their respective collaborators or
licensees may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic
applications, or regulatory approval; uncertainty of the
utilization, market acceptance, and commercial success of
Regeneron’s Products, Regeneron’s Product Candidates, and Decibel’s
Product Candidates and the impact of studies (whether conducted by
Regeneron, Decibel or others and whether mandated or voluntary) on
any of the foregoing or any potential regulatory approval of
Regeneron’s Products, Regeneron’s Product Candidates, and Decibel’s
Product Candidates; uncertainty regarding each of the contingent
value rights milestones referenced in this press release and the
possibility that any or all of such milestones will never be
achieved and that some or all milestone payments may not be made;
the likelihood, timing, and scope of possible regulatory approval
and commercial launch of Regeneron’s Product Candidates and
Decibel’s Product Candidates and new indications for Regeneron’s
Products; the ability of Regeneron’s and Decibel’s collaborators,
licensees, suppliers, or other third parties (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron’s Products,
Regeneron’s Product Candidates, and Decibel’s Product Candidates;
the ability of Regeneron and/or its collaborators to manufacture
and manage supply chains for multiple products and product
candidates; safety issues resulting from the administration of
Regeneron’s Products, Regeneron’s Product Candidates, and Decibel’s
Product Candidates in patients, including serious complications or
side effects in connection with the use of Regeneron’s Products,
Regeneron’s Product Candidates, and Decibel’s Product Candidates in
clinical trials; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron’s
ability to continue to develop or commercialize Regeneron’s
Products or Regeneron’s Product Candidates, or Decibel’s ability to
continue to develop Decibel’s Product Candidates; competing drugs
and product candidates that may be superior to, or more cost
effective than, Regeneron’s Products, Regeneron’s Product
Candidates, or Decibel’s Product Candidates; and the impact of
public health outbreaks, epidemics, or pandemics (such as the
COVID-19 pandemic) on Regeneron’s or Decibel’s respective
businesses.
A more complete description of these and other material risks
can be found in Regeneron’s and Decibel’s filings with the U.S.
Securities and Exchange Commission (the “SEC”), including their
Quarterly Reports on Form 10-Q for the quarterly period ended June
30, 2023 and March 31, 2023 for Regeneron and Decibel respectively,
and their Annual Reports on Forms 10-K for the fiscal year ended
December 31, 2022 as well as the Schedule TO and related tender
offer documents to be filed by Regeneron and its acquisition
subsidiary, Symphony Acquisition Sub, Inc., the Schedule 14D-9 to
be filed by Decibel, and, if applicable, the proxy statement
referenced below. Any forward-looking statements are made based on
the current beliefs and judgments of Regeneron’s and Decibel’s
management, and the reader is cautioned not to rely on any
forward-looking statements made by Regeneron or Decibel. Except as
required by law, Regeneron and Decibel do not undertake any
obligation to update (publicly or otherwise) any forward-looking
statement, including without limitation any financial projection or
guidance, whether as a result of new information, future events, or
otherwise.
Additional Information and Where to Find It The
tender offer referenced in this communication has not yet
commenced. This communication is for informational purposes only
and is neither an offer to purchase nor a solicitation of an offer
to sell any securities, nor is it a substitute for the tender offer
materials that Decibel, Regeneron or its acquisition subsidiary,
Symphony Acquisition Sub, Inc., will file with the SEC. The
solicitation and offer to buy Decibel stock will only be made
pursuant to an Offer to Purchase and related tender offer materials
that Regeneron intends to file with the SEC. At the time the tender
offer is commenced, Regeneron and its acquisition subsidiary will
file a Tender Offer Statement on Schedule TO and thereafter Decibel
will file a Solicitation/Recommendation Statement on Schedule 14D-9
with the SEC with respect to the tender offer. Under certain
circumstances described in the definitive transaction documents,
Regeneron may determine to instead terminate or withdraw the offer
and effect the transaction through a merger only, in which case the
relevant documents to be filed with the SEC will include a proxy
statement for the solicitation of votes of Decibel stockholders to
approve the merger. DECIBEL’S STOCKHOLDERS AND OTHER INVESTORS ARE
URGED TO READ CAREFULLY THE TENDER OFFER MATERIALS (INCLUDING AN
OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN
OTHER TENDER OFFER DOCUMENTS), THE SOLICITATION/RECOMMENDATION
STATEMENT ON SCHEDULE 14D-9, AND, IF APPLICABLE, THE PROXY
STATEMENT BECAUSE THEY WILL EACH CONTAIN IMPORTANT INFORMATION THAT
HOLDERS OF DECIBEL SECURITIES AND OTHER INVESTORS SHOULD CONSIDER
BEFORE MAKING ANY DECISION WITH RESPECT TO THE TENDER OFFER, OR, IF
APPLICABLE, VOTING ON THE TRANSACTION. The Offer to Purchase, the
related Letter of Transmittal, certain other tender offer
documents, as well as the Solicitation/Recommendation Statement on
Schedule 14D-9, and if applicable, the proxy statement will be made
available to all stockholders of Decibel at no expense to them and
will also be made available for free at the SEC’s website at
www.sec.gov. Additional copies may be obtained for free by
contacting either Regeneron or Decibel. Copies of the documents
filed with the SEC by Decibel will be available free of charge on
Decibel’s website at https://ir.decibeltx.com or by contacting
Decibel Investor Relations at (617) 370-8701. Copies of the
documents filed with the SEC by Regeneron will be available free of
charge on Regeneron’s website at https://investor.regeneron.com or
by contacting Regeneron’s Investor Relations Department at
invest@regeneron.com or (914) 847-7741.
In addition to the Offer to Purchase, the related Letter of
Transmittal and certain other tender offer documents, as well as
the Solicitation/Recommendation Statement on Schedule 14D-9, and if
applicable, the proxy statement, Regeneron and Decibel each file
annual, quarterly and current reports, proxy statements and other
information with the SEC, which are available to the public over
the Internet at the SEC’s website at http://www.sec.gov.
If the tender offer is terminated and the transaction is to be
effected by merger only, in which case, the approval of Decibel
stockholders must be obtained, Regeneron, Decibel and their
respective directors and executive officers may be deemed to be
participants in any such solicitation of proxies from Decibel’s
stockholders in connection with the proposed transaction.
Information regarding Regeneron’s directors and executive officers
is available in its proxy statement that was filed with the SEC;
information regarding Decibel’s directors and executive officers is
available in its proxy statement that was filed with the SEC. Other
information regarding potential participants in any such proxy
solicitation will be contained in any proxy statement filed in
connection with the transaction.
Regeneron Media
Contact Alexandra BowieTel: +1
914-847-3407Alexandra.Bowie@regeneron.com Regeneron
Investor Contact Vesna Tosic Tel: +1
914-847-5443 Vesna.Tosic@regeneron.com Decibel
Media ContactChris RaileyTel: +1
617-834-0936Chris@tenbridgecommunications.comDecibel
Investor ContactJulie SeidelTel: +1
212-362-1200Julie.Seidel@sternir.com |
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