Sun Pharmaceutical Industries Limited   and Concert Pharmaceuticals, Inc. today announced that they have entered into a definitive agreement pursuant to which Sun Pharma will acquire all of the outstanding shares of Concert by way of a tender offer for an initial cash payment of 8.00 dollars per common share, or $576 million in net worth. Concert shareholders will also receive a non-negotiable contingent value right (CVR) entitling them to receive cash up to an additional $3.50 per common share, payable if deuruxolitinib achieves certain net sales milestones during specified periods. , subject to the terms contained in a contingent value rights agreement specifying the terms of those rights. The transaction has been approved by the boards of directors of both companies.
The initial cash payment of $8.00 per common share represents a premium of approximately 33% to the 30-day volume-weighted average trading price as of January 18, 2023, the last trading day before the announcement of today.

Concert is a late-stage biotechnology company pioneering the use of deuterium in medicinal chemistry. Concert has an extensive patent portfolio, including its lead product candidate, deuruxolitinib – an oral inhibitor of Janus kinases JAK1 and JAK2 for the treatment of alopecia areata, an autoimmune dermatological disease – in late-stage development. Concert has completed evaluation of the efficacy and safety of deuruxolitinib in adult patients with moderate to severe alopecia areata in its Phase 3 clinical program, THRIVE-AA, and two long-term, open-label extension studies. term are underway in North America and Europe. Sun Pharma's immediate priority would be to follow Concert's plan to file a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) in the first half of 2023.

Alopecia areata is an autoimmune disease where the immune system attacks the hair follicles, resulting in partial or complete loss of hair and hair on the scalp and body. Alopecia areata can affect up to 2.5% of the US and global population during their lifetime [1],[2],[3] . The scalp is the most commonly affected area, but any site with hair can be affected, alone or with the scalp. The disease can manifest throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. The treatment options available for alopecia areata are currently limited.

“Sun Pharma is in the process of establishing a global franchise in dermatology and ophthalmology and aims to become a preferred commercial and development partner for these therapies worldwide. The acquisition of Concert adds a potentially best-in-class advanced treatment for alopecia areata, deuruxolitinib,” said Abhay Gandhi, CEO of Sun Pharma for North America. “There is a significant unmet need in the treatment of alopecia areata and we want to build on Concert's commitment to supporting the alopecia areata patient community. We are well positioned to successfully bring this product to market internationally. I look forward to welcoming the exceptionally talented team at Concert who have worked tirelessly to develop this product to bring it to market. »

"We are pleased to complete this exciting transaction with Sun Pharma, which brings substantial value to our shareholders and is the result of a rigorous evaluation process overseen by Concert's Board of Directors," said Roger Tung ., Ph.D., Chairman and CEO of Concert. “Our mission at Concert has always been to translate scientific innovations into clinical solutions to significantly improve the lives of patients. We are proud to see one of our team's accomplishments - the development of a valuable new drug candidate for a serious disease with limited treatment options - duly recognized and appreciated by Sun Pharma as a means of extending its ongoing international commitment in dermatology. I am confident that this transaction will maximize value for our shareholders and improve access to deuruxolitinib for patients with alopecia areata. »

Terms of the transaction and closing schedule

Under the terms of the merger agreement, Sun Pharma will promptly launch a tender offer to acquire all of Concert's outstanding common stock. Concert shareholders will be offered an initial cash payment of $8.00 per common share. Concert's board of directors unanimously recommends that Concert shareholders sell their shares under the tender offer.

Concert shareholders will also receive a non-negotiable contingent value right (CVR), which will entitle them to receive cash up to an additional $3.50 per common share, payable if deuruxolitinib achieves certain net sales milestones during specified periods, subject to the terms contained in a contingent value rights agreement specifying the terms of those rights. These milestones, subject to the terms specified in the Contingent Value Rights Agreement, include: (i) $1.00 per common share, payable the first time net sales of deuruxolitinib equal or exceed to 100 million dollars during$2.50 per common share, payable the first time net sales of deuruxolitinib equal or exceed $500 million in any four consecutive quarters from the time of first commercial sale of deuruxolitinib in the United States United States and December 31, 2029. There can be no assurance that any payment will be made under the CVRs.

The transaction is expected to close in the first quarter of 2023. The transaction is subject to the offer for sale of the majority of the outstanding common shares of Concert, as well as the receipt of applicable regulatory approvals and the satisfaction of other customary closing conditions. Following the successful closing of the tender offer, Sun Pharma will acquire all remaining shares of Concert not tendered into the tender offer and all preferred shares of such company through a second-stage merger at the same price of $8.00 per common share, plus a non-tradable CVR. The merger will be completed as soon as practicable after the closing of the tender offer.

For the nine-month period ended September 20, 2022, Concert reported revenue of $29,000 and a net loss of $90.6 million. R&D expenditures for this nine-month period amounted to $75.7 million. As of September 30, 2022, Concert had approximately $148.9 million in cash, cash equivalents and investments.

Sun Pharma had net liquidity of $1.6 billion as of September 30, 2022.

Advisors

Moelis & Company LLC is financial advisor to Sun Pharma, and Davis Polk & Wardwell LLP is legal advisor. MTS Health Partners, LP and Chestnut Partners, Inc. are financial advisors to Concert, and Goodwin Procter LLP is legal advisor. In addition, MTS Securities, LLC (an affiliate of MTS Health Partners, LP) has provided an opinion to the Concert board of directors regarding the fairness of the proposed offer consideration to holders of Concert common stock. as part of this transaction, subject to the reservations and restrictions set out therein.

À propos de Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050)

Sun Pharma is the fourth largest specialty generic pharmaceutical company in the world and the largest pharmaceutical company in India. Its vertically integrated model and skilled team enable it to deliver high-quality products trusted by customers and patients in more than 100 countries around the world, all at affordable prices. Its global presence is supported by manufacturing facilities spanning six continents and approved by multiple regulatory bodies, paired with a multicultural workforce comprising more than 50 nationalities. Sun Pharma cultivates excellence through innovation supported by strong research and development skills in multiple R&D centers, with investments of approximately 6% of annual R&D revenues. For more information, please visit the websitewww.sunpharma.com  and follow us on Twitter @SunPharma_Live

About Concert

Concert Pharmaceuticals is a late-stage biopharmaceutical company that has developed deuruxolitinib, a novel oral, deuterated inhibitor of the Janus kinases JAK1 and JAK2. The company has successfully completed two Phase 3 trials of deuruxolitinib in adults with alopecia areata, a serious autoimmune dermatological disease. Concert is also evaluating the use of deuruxolitinib in other indications and is evaluating a number of early-stage pipeline drug candidates. For more information, please visit www.concertpharma.com  or follow us on Twitter , Instagram  or LinkedIn .

Forward-looking statements

This press release contains forward-looking statements, expressed or implied, regarding Sun Pharmaceutical Industries Ltd. (“  Sun Pharma  ”), Concert Pharmaceuticals, Inc. (“  Concert ”) and the acquisition of Concert by Sun Pharma, including express or implied forward-looking statements regarding deuruxolitinib, its therapeutic benefits and regulatory development journey, and the future operations and performance of Sun Pharma and Concert. All statements other than statements of historical facts are statements that could be characterized as forward-looking, including all statements regarding the current intentions, beliefs or expectations of the companies and members of their management teams. Words such as "shall", "could", "should", "expect", "plan", "anticipate", "intend", "believe", "estimate", "predict", "project", "potential", "continue", "target", Variants thereof and similar expressions are used to identify such forward-looking statements, although not all forward-looking statements contain such identifying words. Examples of such forward-looking statements include, without limitation, express or implied statements:

• regarding the transaction and related matters, future performance and opportunities, post-closing transactions and outlook for the companies' businesses;
• regarding targets, plans, objectives or goals for future operations, including those relating to Sun Pharma's and Concert's products, their product research, product development, product launch and approvals as well as to cooperation in this area;
• containing projections or targets for revenue, costs, profit (or loss), earnings per share, capital expenditures, dividends, capital structure, net financial data and other financial measures;
• regarding future economic performance, future actions and the outcome of contingencies such as legal proceedings; and

regarding the assumptions underlying or relating to such statements.
These statements are based on current plans, estimates and beliefs. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. Sun Pharma and Concert each caution that a number of important factors, including those described herein, could cause actual results to differ materially from those indicated in the forward-looking statements.

Factors that could affect future results and cause these forward-looking statements to prove incorrect include, but are not limited to: uncertainties regarding the timing of the tender offer and merger; uncertainties as to the number of Concert shareholders who will sell their shares under the offer; the possibility of competing offers being made; the possibility that various conditions to closing of the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for completion of the transaction (or only grant approval subject to adverse conditions or restrictions); the possibility that the proposed transaction may not close within the timeframe anticipated by Sun Pharma and Concert, or at all; failure to realize the anticipated benefits of the proposed transaction within the expected timeframes, if at all; the effects of the transaction on relationships with employees, other business partners or governmental entities; possible adverse reactions or change in business relationships resulting from the announcement or completion of the proposed transaction; significant or unforeseen costs, charges or expenses occasioned by the proposed transaction; any adverse effects of such announcement or the completion of the proposed acquisition on the trading price of Sun Pharma stock or Concert common stock and/or Sun Pharma's or Concert's results of operations; difficulty in predicting the timing or outcome of regulatory approvals or actions; risks related to failure to complete the CVR milestones and the fact that CVR holders will not receive payments in their respect; other business effects, including the effects of industrial, economic or political factors beyond the companies' control; transaction costs; actual or contingent debts; the risk of litigation and/or regulatory actions in connection with the proposed acquisition; the negative impacts on the activity, the results of future operating or financial condition due to pandemics or epidemics, such as COVID-19, and their impact on business, operations, supply chain, patient recruitment and retention, clinical trials, the strategy, objectives and planned milestones of Sun Pharma and Concert; government or market-imposed price cuts on Sun Pharma or Concert products; the launch of competing products; reliance on information technology; Sun Pharma's or Concert's ability to successfully commercialize existing and new products; the ability of Sun Pharma, Concert and their associates to continue to conduct research and clinical programs; I' exposure to product liability and legal proceedings and investigations; and other risks and uncertainties described from time to time in the periodic reports filed by Concert with the U.S. Securities and Exchange Commission (the " SEC  ") as well as in Schedule 14D-9 form to be filed by Concert and in Schedule TO form and tender offer documents to be filed by Sun Pharma and Foliage Merger Sub, Inc, a subsidiary wholly owned by Sun Pharma ("  Buyer  ").

All forward-looking statements speak only as of the date of this press release and are based on the current beliefs and judgments of the management of Sun Pharma and Concert, and the reader is cautioned not to rely on forward-looking statements made by Sun Pharma or Concert. Factors not mentioned may constitute additional material obstacles to making the forward-looking statements. Unless required by law, Sun Pharma and Concert have no obligation to update or revise any forward-looking statements after the publication of this press release, and do not undertake to do so, whether either as a result of new information, future events or otherwise.

Additional information and where to find it

The tender offer described in this document has not yet started. This communication is for informational purposes only and does not constitute an offer to buy or a solicitation of an offer to sell securities of Concert, nor does it replace the documents relating to the tender offer. that Sun Pharma, Concert or the purchaser will file with the SEC. A solicitation and offer to purchase shares of Concert will only be made pursuant to an offer to purchase and related documents that Sun Pharma intends to file with the SEC. Upon commencement of the tender offer, Sun Pharma and the Buyer will file with the SEC a tender offer statement using Schedule TO form, and Concert will file a solicitation/recommendation statement on Form Schedule 14D-9 with the SEC regarding the tender offer. CONCERT SHAREHOLDERS AND OTHER INVESTORS ARE INSTRUCTED TO READ THE DOCUMENTS RELATING TO THE TENDER OFFER (INCLUDING AN OFFER TO PURCHASE, A SUPPORTING LETTER AND CERTAIN OTHER DOCUMENTS RELATING TO THE TENDER OFFER) AND THE SOLICITATION/RECOMMENDATION STATEMENT, AS THEY CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY BEFORE MAKING ANY DECISION REGARDING THE TENDER OFFER. The offer to purchase, the cover letter and certain other documents relating to the tender offer, as well as the statement of solicitation/recommendation, will be sent to all Concert shareholders free of charge. The Tender Offer Statement and the Solicitation/Recommendation Statement will be available for free on the SEC's website:www.sec.gov . Additional copies may be obtained free of charge by contacting Sun Pharma or Concert. Free copies of these and certain other offering documents are available by contacting Sun Pharma's Investor Relations Department at abhi.sharma@sunpharma.com , the Investor Relations Department of Concert at ir@concertpharma.com , or by directing requests for such materials to the Offer Information Agent, who will be named in the Tender Offer Statement. Copies of Concert's filings with the SEC will be available free of charge in the "Investors" section of Concert's website:www.concertpharma.com.

In addition to the solicitation/recommendation statement, Concert files annual, quarterly and current reports and other documents with the SEC. You may view and copy any reports or other documents filed by Concert at the SEC's public reference room at 100 F Street, NE, Washington, DC 20549. Please call the SEC at 1-800-SEC-0330 for more further information on the public reference room. Concert's filings with the SEC are also available to the public free of charge at commercial document search services and on the SEC's website at www.sec.gov .

Contacts :

Sun Pharma :

Investors

Dr Abhishek Sharma
+91 22 4324 2929
abhi.sharma@sunpharma.com

Media (International)

Gaurav Chugh
+91 22 4324 5373
gaurav.chugh@sunpharma.com

Media (US)

Janet Metz
Janet.Metz@sunpharma.com

Concert :

Investors

Justine Koenigsberg
(781) 674-5284
ir@concertpharma.com

 

Source:prnewswire.com

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