Perrigo to Acquire Leading Consumer Self-Care Company, HRA Pharma

On September 8, 2021 Perrigo Company plc (NYSE, TASE: PRGO) ("Perrigo" or the "Company") reported that it has signed a binding offer to acquire Héra SAS ("HRA" or "HRA Pharma"), a leading global consumer self-care company, from funds affiliated with private equity firm Astorg and Goldman Sachs Asset Management (Press release, Perrigo Company, SEP 8, 2021, View Source,-HRA-Pharma [SID1234587403]). The transaction is valued at €1.8 billion, or approximately $2.1 billion in cash. HRA is one of the fastest growing over-the-counter ("OTC") companies globally, with three category-leading self-care brands in blister care (Compeed), women’s health (ellaOne) and scar care (Mederma). This scale acquisition would complete Perrigo’s transformation to a global leader in consumer self-care, bolster its presence in high-potential European markets and meaningfully improve its already strong operational and financial profile.

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"Over the last two and one-half years, we have been on a journey to transform Perrigo into a focused and high-performing consumer self-care company, all while delivering a successful track record of well executed acquisitions and divestitures. The acquisition of HRA would be the crowning achievement in that transformation. With the addition of HRA and its talented leadership team, Perrigo would be a consumer self-care global leader that is poised to deliver top tier net sales growth and double-digit EPS growth in the near-term while concurrently expanding margins," said Murray S. Kessler, CEO and President, Perrigo. "Importantly, HRA’s focused portfolio of fast-growing self-care brands, which are market share leaders in growing categories, would be accretive to Perrigo’s 3% revenue growth goal. And, HRA’s expertise in migrating products from prescription to OTC would represent even further upside. The complementary geographic footprint of HRA to that of Perrigo would allow for significant and actionable synergies. And it is the totality of these factors that makes the combination of Perrigo and HRA strategically and financially compelling. It’s literally a one-of-a-kind opportunity to simultaneously enhance our financial profile, while driving even greater value for consumers, shareholders and the communities in which we work and live."

"I’m incredibly proud of the hard work of the HRA team, who have helped establish the company as a world-class organization – one positioned to embark on the next chapter of its journey as part of the Perrigo family," said David Wright, CEO, HRA. "Perrigo is the ideal partner to continue growing these brands across the globe and into attractive adjacent categories, as we build on Perrigo’s platform and sizable product portfolio. We are excited about the opportunity to join the Perrigo team and with a shared vision and principles, deliver on the tremendous value opportunity of the combined business. As one of the world’s leading self-care companies, Perrigo is uniquely positioned to advance these brands for years to come."

Strategic Highlights

The addition of HRA would strengthen Perrigo’s OTC self-care offerings and expand its portfolio with highly recognizable consumer brands in their respective categories, including:

Compeed – a well-known and trusted global OTC brand with leading market share that offers a wide variety of high-quality innovative solutions for preventing and treating blisters, bunions, calluses, corns and cracked heels, as well as its recent successful entry into cold sores as part of its strategy to expand into adjacencies including wound care;
ellaOne – a women’s health OTC emergency contraception brand with leading market share, that is available without a prescription in 59 countries;
Mederma – the leading U.S. OTC scar care brand with high-quality solutions for reducing the appearance of scars, stretch marks and cold sores.
Separately, approximately 15% of HRA’s net sales are derived from a rare disease portfolio of three leading prescription products.

HRA would also bring expertise and a successful track record in leading the switch of prescription-to-OTC women’s health products, evidenced by ellaOne emergency contraception achieving OTC status in 59 countries. Of note, the HRA team recently received approval and launched Hana, a once-daily OTC oral contraceptive in the U.K. This represents the first OTC approval of a daily oral contraceptive in the U.K.

This transaction would bolster Perrigo’s footprint in its European markets while adding scale to its operations in key underpenetrated European markets, providing significant opportunities for additional growth.

Financial Highlights

The transaction would enable Perrigo to deliver substantial value by improving its financial profile, including growth, margins, earnings and cash flow. It would also advance Perrigo’s long-term goal to align its growth profile at the high-end of the world’s top-tier consumer packaged goods companies.

HRA’s net sales growth is expected to be in the mid-teen percentage range, with an adjusted operating margin near 30%range.

Perrigo would plan to save more than €30 million annually by 2023 from unlocking meaningful operational synergies from this transaction. Perrigo would use its existing global infrastructure to achieve selling efficiencies, streamline logistical efforts and reduce overlapping fixed costs. These synergies, along with HRA’s strong market position and attractive financial profile, are anticipated to add approximately €400 million in net sales and $1.00 in adjusted EPS in FY 2023.

After thorough consideration of capital allocation alternatives, Perrigo believes this acquisition to be the most compelling use of its capital based on the return on investment, internal rate of return and net sales growth, margin and earnings accretion compared to other alternatives.

Transaction Terms

Perrigo has signed a binding offer to acquire HRA in a cash transaction valued at €1.8 billion, or approximately $2.1 billion, on a cash-free, debt-free basis. The agreement between Perrigo and the selling shareholders would be finalized following the information and consultation process with HRA’s Works Council in France then enabling the applicable selling shareholders to execute a put option granted by Perrigo. The proposed final transaction would close by the end of the first half of 2022, subject to the satisfaction of customary closing conditions, including regulatory approvals.

Perrigo would pay the purchase price using cash on hand at closing. In addition, Perrigo has full capacity available under its current credit facility and depending on market conditions, may also consider new debt financing. The closing of the acquisition would not be subject to a financing condition.

Perrigo Conference Call and Webcast

Perrigo will host a conference call and webcast today, September 8, 2021, at 8:30 A.M. EDT to discuss this transaction. The live conference call can be accessed via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 4920640. A taped replay of the call will be available beginning at approximately 12:00 P.M. (EDT) September 8, 2021, until midnight September 15, 2021. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code10160053.

Advisors

Centerview Partners is serving as financial advisor to Perrigo. Wachtell, Lipton, Rosen & Katz and Darrois Villey Maillot Brochier are serving as its legal counsel.

Sawaya Partners, Goldman Sachs Investment Banking Division and Rothschild & Co. are serving as financial advisors to the selling shareholders. Latham & Watkins, LLP is serving as the selling shareholders’ legal counsel and Dechert LLP is serving as counsel to HRA management.

Nuvalent Announces Business and Program Highlights and Reports Second Quarter 2021 Financial Results

On September 8, 2021 Nuvalent, Inc., (Nasdaq: NUVL), a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported recent pipeline and business highlights and second quarter 2021 financial results (Press release, Nuvalent, SEP 8, 2021, View Source [SID1234587401]).

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"At Nuvalent, we are leveraging our team’s deep expertise in chemistry and structure-based drug design to advance a novel pipeline of product candidates for patients with cancer. Our therapies are specifically designed to solve for challenges limiting the activity and durability of currently available therapies, such as kinase resistance, adverse events due to off-target activity, and metastases to the brain," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "In the first half of 2021, our team has made meaningful progress to deliver on our clear vision for advancing the field of precision oncology. We have received clearance from the FDA to proceed with the Phase 1/2 study for our ROS1-selective inhibitor NVL-520, advanced our parallel lead product candidate, the ALK-selective inhibitor NVL-655, into IND-enabling studies, and progressed multiple additional discovery-stage research programs. With the recent talented additions to our team and capital raised in our upsized IPO, we stand well positioned to fuel our upcoming transition to a clinical organization and efforts to renew hope for patients in need."

Second Quarter Highlights

IND Application for NVL-520 Cleared by FDA, Enabling Clinical Trial Initiation: The U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for NVL-520, its brain-penetrant ROS1-selective inhibitor. The company is preparing to initiate the Phase 1 portion of a global, Phase 1/2 clinical trial for NVL-520 in patients with ROS1-positive NSCLC and other advanced solid tumors in the second half of 2021.

$190.6 Million Upsized Initial Public Offering (IPO) Successfully Completed: In July 2021, Nuvalent sold 11,212,500 shares of common stock at a price to the public of $17.00 per share. The gross proceeds from the offering were approximately $190.6 million, before deducting underwriting discounts and commissions and other offering expenses.

Company Leadership Strengthened through Appointments to Management and Board: Nuvalent recently appointed Deborah Miller, Ph.D., J.D., as Chief Legal Officer, and Sapna Srivastava, Ph.D., Chief Financial Officer of eGenesis, to its Board of Directors.
Dr. Miller most recently served as Senior Vice President, Deputy General Counsel and Chief IP Counsel for Sumitomo Dainippon Pharma America (SDPA). Prior to that, Dr. Miller served as Deputy General Counsel and Chief IP Counsel at Sunovion Pharmaceuticals Inc., a subsidiary of SDPA. She previously held various roles at Infinity Pharmaceuticals, Inc. including Vice President, Deputy General Counsel and Chief Patent Counsel, where she built and managed the intellectual property group and supported various in-licensing, out-licensing and financing ventures. Earlier in her career, Dr. Miller was IP corporate counsel at Sepracor Inc. (currently, Sunovion Pharmaceuticals Inc.), and an associate at the law firm Nutter McClennen & Fish LLP. Dr. Miller earned her J.D. from Suffolk University Law School, Ph.D. in biological chemistry and molecular pharmacology from Harvard University, M.S. in medical sciences from Harvard Medical School and B.S. in chemistry from Swarthmore College.

Dr. Srivastava brings over 20 years of experience as a senior executive in the biopharmaceutical industry. She has served as the Chief Financial Officer at eGenesis Bio since April 2021. Prior to eGenesis, she held similar roles as the Chief Financial and Strategy Officer at Abide Therapeutics (acquired by Lundbeck) and at Intellia Therapeutics. Before Intellia, Dr. Srivastava was a senior biotechnology analyst at Goldman Sachs, Morgan Stanley and ThinkEquity Partners, and began her career as a research associate at J.P. Morgan. Dr. Srivastava received her Ph.D. in neuroscience from the New York University School of Medicine and her B.S. in biology from St. Xavier’s College at the University of Bombay.

Second Quarter 2021 Financial Results

As of June 30, 2021, Nuvalent had cash of $138.9 million, which does not include net proceeds from its IPO, which was completed on August 2, 2021.
Research & Development expenses for the second quarter of 2021 were $7.8 million.
General & Administrative expenses for the second quarter of 2021 were $2.0 million.
Net Loss for the second quarter was $9.8 million, or $3.17 per share.

Sandoz strengthens pipeline by entering into agreement for biosimilar bevacizumab, a key oncology medicine

On September 8, 2021 Sandoz, a Novartis division, reported that it has entered into a commercialization agreement with Bio-Thera Solutions, Ltd. for biosimilar bevacizumab (BAT1706) (Press release, Novartis, SEP 8, 2021, View Source [SID1234587400]). Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that targets vascular endothelial growth factor (VEGF), a key mediator of angiogenesis in cancer, and is used in combination with other treatments1,2.

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Bio-Thera Solutions, Ltd. will maintain responsibility for development and manufacturing, Sandoz will have the right to commercialize the medicine upon approval in the US, Europe**, Canada and selected other countries. According to the terms of the agreement, Bio-Thera Solutions, Ltd. will receive an upfront and milestone payments and is entitled to receive profit share payments in the partnered territory.

This agreement builds on Sandoz’s leading off-patent oncology portfolio, which comprises four marketed oncology biosimilars and over 50 generic medicines worldwide3,4. We see external collaborations as complementary to our internal programs, with an appropriate strategic balance enabling us to drive patient access by delivering portfolio breadth, balancing risks and costs and positioning us to play a leading role in the future biosimilar market.

Bio-Thera Solutions, Ltd. is a biopharmaceutical company located in Guangzhou, China, and dedicated to research and development into novel therapeutics, as well as biosimilars to treat a range of cancer and autoimmune diseases.

Labcorp to Speak at Morgan Stanley 19th Annual Global Healthcare Conference

On September 8, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that members of its executive management team will participate in a virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on Monday, Sept. 13 at 3:30 p.m. ET (Press release, LabCorp, SEP 8, 2021, View Source [SID1234587398]).

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A live webcast of the presentation will be available via the Investor Relations section of the company’s website at www.Labcorp.com and archived for replay.

Regeneron Announces Investor Conference Presentations

On September 8, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows (Press release, Regeneron, SEP 8, 2021, View Source [SID1234587396]):

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Morgan Stanley 19th Annual Global Healthcare Conference at 8:45 a.m. ET on Monday, September 13, 2021

Cantor Fitzgerald Virtual Global Healthcare Conference at 9:20 a.m. ET on Monday, September 27, 2021
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.