Full Press Release Details
Sanofi to acquire Provention Bio, adding to portfolio TZIELD, the first disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D)
Paris and Red Bank, N.J. March 13, 2023 Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and
preventing immune-mediated diseases including type 1 diabetes (T1D), have entered into an agreement under which Sanofi has agreed to acquire Provention Bio, Inc., for $25.00 per share in cash, representing an equity value of approximately
The transaction adds an innovative, fully owned, first-in-class
therapy in type 1 diabetes to Sanofi s core asset portfolio in General Medicines and further drives its strategic shift toward products with a differentiated profile. TZIELD (teplizumab-mzwv) was approved
in the U.S. last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.
The acquisition is a strategic fit for Sanofi at the intersection of the company s growth in immune-mediated diseases and disease-modifying therapies in areas of
high unmet need, and its expertise in diabetes. Sanofi will continue to utilize its capabilities in diabetes to maximize TZIELD s potential as a transformative therapy globally and in the U.S., aiming to delay the onset of Stage 3 type 1
diabetes for some of the approximately 65,000 people diagnosed every year1. The purchase builds on an existing co-promotion agreement with Provention Bio
that is already delivering TZIELD to patients in need of this immune-mediated therapy.
Executive Vice President, General Medicines, Sanofi
The acquisition of Provention Bio builds on Sanofi s mission to deliver best- and first-in-class medicines and resonates with our purpose of chasing the miracles of science for the benefit of people. By coupling Provention Bio s transformative innovation with Sanofi s expertise,
we aim to bring life-changing benefits to people at risk of developing Stage 3 type 1 diabetes. Any additional indications, approvals and pipeline assets only serve to further our excitement. Given our existing partnership and complementary work in
the diabetes and immunology spaces, we foresee a seamless integration and execution.
TZIELD: First and only
treatment indicated to delay onset of Stage 3 T1D
TZIELD is a CD3-directed antibody indicated to delay the
onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D. Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening, and patients who progress to
Stage 3 T1D eventually require insulin injections for life.
TZIELD is also in late-stage clinical development for the treatment of pediatric and adolescent
patients that are newly diagnosed with clinical T1D (Stage 3). A Phase 3 trial, PROTECT, is currently underway and top line results are expected in the second half of 2023. Additional opportunities for TZIELD include
re-dosing and formulations as well as new therapeutic indications.
1 Based on Sanofi analysis derived from the 2020 CDC National Diabetes Statistics Report
Chief Executive Officer and Co-Founder, Provention Bio, Inc.
Sanofi and Provention Bio share a common vision of bringing new therapies to patients with autoimmune diseases. Under our co-promotion agreement, our companies have made significant progress educating healthcare providers and increasing patient access during the initial U.S. commercial launch of TZIELD. Sanofi s global expertise
and commitment to immunology makes them an ideal acquiror and positions our innovative therapy to reach more patients as quickly as possible.
Bio also brings certain pipeline assets in early development in immune-mediated diseases.
Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Provention Bio, Inc. for $25.00 per share in
cash, reflecting a total equity value of approximately $2.9 billion.
The consummation of the tender offer is subject to customary closing conditions,
including the tender of a number of shares of Provention Bio, Inc. common stock, that together with shares already owned by Sanofi or its affiliates, represents at least a majority of the outstanding shares of Provention Bio, Inc. common stock, the
expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions.
offer is successfully completed, then following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Provention Bio, Inc., and all of the outstanding Provention Bio, Inc. shares that are not
tendered in the tender offer will be converted into the right to receive the same $25.00 per share in cash offered to Provention Bio, Inc. shareholders in the tender offer. Sanofi plans to fund the transaction with available cash resources. Subject
to the satisfaction or waiver of customary closing conditions, Sanofi currently expects to complete the acquisition in the second quarter of 2023.
acting as exclusive financial advisor to Sanofi and Weil, Gotshal & Manges LLP is acting as its legal counsel. BofA Securities, Inc. and Centerview Partners LLC are acting as financial advisors to Provention Bio, Inc. and Ropes & Gray
LLP is acting as its legal counsel.
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while
putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
About Provention Bio, Inc.
Provention Bio, Inc. is a commercial-stage biopharmaceutical company focused on advancing the development and commercialization of investigational therapies that may
intercept and prevent debilitating and life-threatening immune-mediated diseases. The Company s pipeline includes clinical-stage product candidates that have demonstrated in pre-clinical or clinical
studies proof-of-mechanism and/or proof-of-concept in autoimmune diseases, including T1D,
celiac disease and lupus. Visit www.proventionbio.com for more information and follow on Twitter: @ProventionBio.
Provention Bio, Inc. is listed on Nasdaq:
Type 1 diabetes is a condition caused by autoimmune damage of the insulin-producing beta-cells of the pancreas. As a result of this autoimmune attack,
the body produces very little or no insulin which can lead to death if the insulin is not replaced.
Living with T1D is complex. In addition to
daily insulin injections or infusion via an insulin pump, people living with T1D also need to adopt a strict management plan which includes regular blood sugar monitoring, healthy diet and physical activity.
Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com
Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com
Sally Bain | + 1 617 834 6026 |
Eva Schaefer-Jansen | + 33 7 86 80 56 39 |
Del pine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 |
| + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Provention Bio, Inc. Investor Relations
Kristen Keller | investorrelations@proventionbio.com
Sanofi Forward-Looking Statements
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forward-looking statements. Forward-looking statements are statements that are not historical facts. These statements may include projections and estimates regarding the marketing and other potential of the product, or regarding potential future
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the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the
product, the fact that product may not be commercially successful and risks related to Sanofi s ability to complete the acquisition on the proposed terms or on the proposed timeline, including the receipt of required regulatory approvals, the
possibility that competing offers will be made, other risks associated with executing business combination transactions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult,
time-consuming or costly than expected or that the expected benefits of the acquisition will not be realized, as well as other risks related Sanofi s business, including the uncertainties inherent in research and development, including future
clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future
litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business
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AMF made by Sanofi, including those listed under Risk Factors and Cautionary Statement Regarding Forward-Looking Statements in Sanofi s annual report on Form 20-F for the year
ended December 31, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Provention Bio, Inc. Forward-Looking Statements
This press release includes
forward-looking statements that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of Provention Bio, Inc. ( Provention Bio, Inc. ) and members of its senior management team and can
typically be identified by words such as believe, expect, estimate, predict, target, potential, likely, continue, ongoing, could,
should, intend, may, might, plan, seek, anticipate, project and similar expressions, as well as variations or negatives of these words. Forward-looking
statements include, without limitation, statements regarding the proposed transaction, prospective performance, future plans, events, expectations, performance, objectives and opportunities and the outlook for Provention Bio, Inc. s business;
the commercial success of Provention Bio, Inc. s products and pipeline; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; and the accuracy of any
assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these
forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by
forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Provention Bio, Inc. s stockholders will tender their stock in the offer; 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; the
occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; the effects of the transaction (or the announcement thereof) on relationships with associates, customers, manufacturers,
suppliers, other business partners or governmental entities or patient groups; transaction costs; the risk that the merger will divert management s attention from Provention Bio, Inc. s ongoing business operations; changes in Provention
Bio, Inc. s businesses during the period between now and the closing; risks associated with litigation; failure to maintain FDA approval for TZIELD; uncertainties that the planned commercial launch in the U.S. for TZIELD is successful in part
or at all for various reasons including the actual market size and drug supply needed may not be consistent with Provention Bio, Inc. s expectations and its executed commercial readiness plans; uncertainties as to the degree to which TZIELD is