Microchips Biotech, Inc.

Some analysts are checking their crystal balls to get an idea if 2020 will be a busy year for investors. The early thinking on biotech is yes. Some analysts are checking their crystal balls to get an idea if 2020 will be a busy year for investors. The early thinking on biotech is yes. The Boston Globe notes that since summer, there have been more than $7 billion in deals for biotech and technology. The biggest deal in the industry this year, of course, was Bristol-Myers Squibb’s acquisition of Celgene for $74 billion. Another big deal was just announced this week, Novartis’ acquisition of The Medicines Company for $9.7 billion. Other deals in the biopharma, medical device and diagnostic space include Eli Lilly’s takeover of Loxo Oncology for $8 billion, Johnson & Johnson’s (Ethicon) buyout of Auris Health for $5.8 billion, and Roche’s merger with Spark Therapeutics for $4.3 billion. A bigger mover than M&A in 2019 was research-and-development deals and commercial partnerships. BioPharma Dealmakers notes, “Since June last year, 1,000 biopharma research and development and commercial partnerships have been signed, with a total potential value of ~$100 billion, including $11 billion upfront in cash.” hbspt.cta.load(4413123, '92ebc33d-a4a8-4c10-b41e-a52c39dc69ea', {}); Most of these deals were in oncology, the top therapeutic area for partnerships—in that period there were three times as many oncology deals than the second-place spot, neurology. Of the top 10 deals, seven were in oncology, including a $1.3 billion upfront with $5.5 billion potential deal between AstraZeneca and Daiichi Sankyo in March 2019. The Boston Globe also notes that some of these partnership deals are relatively small when it comes to upfront payments, but very high in potential milestone payments. For example, Daré Bioscience acquired Microchips Biotech recently for $2.3 million in stock upfront. However, the deal could hit $101 million in milestone payments. But what about 2020? Ben Howe, chief executive officer of the Boston investment bank AGC Partners, told The Boston Globe , that with current unemployment low and stock market indices high, “it feels like it is a safe environment” for sellers to get a fair market value for their companies, “for a couple quarters, if not years.” But he added that there is an undercurrent of fear, that “an eventual downturn or the elections next year will cause a negative business climate, and when you talk to people, they say they want to get ahead of that.” One biopharma company that is the center of acquisition speculation is Amarin. The company, which markets a fish-oil derivative, Vascepa, to lower triglycerides and lipids, has been rumored to be a hot target for a while, but the Novartis acquisition of The Medicines Company has reignited the rumors. Some analysts think an Amarin deal could go higher than $20 billion. Companies that would be potential buyers include Pfizer and Amgen, who have a vested interest in the cardiovascular disease space, although everyone always brings up Gilead Sciences as a potential buyer—for almost anything . Sanofi and Regeneron, who have been battling Amgen in the PCSK9 cholesterol-lowering space for about five years with Amgen’s Repatha and Sanofi/Regeneron’s Praluent, could potentially be interested in Amarin as well. Particularly with the likelihood of Novartis and The Medicines Company getting approval for their own PCSK9 inhibitor that would only be dosed twice a year. Amarin has an FDA target action date of December 28 for a label expansion for Vascepa. Big companies expected to lean on big deals include Biogen, although much of that will likely depend on the FDA decision over its Alzheimer’s drug aducanumab, Eli Lilly, Pfizer, Amgen, Merck & Co., and Gilead Sciences. Gilead, as of June 30, has $11.24 billion in cash and cash equivalents to play with. All are facing patent cliffs on some of their biggest drugs and may want to acquire companies and/or assets to bolster their pipelines and fend off generic and biosimilar competition.

SAN DIEGO, Nov. 11, 2019 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARÉ), a leader in women’s health innovation, today announced it entered into an agreement to acquire privately-held Microchips Biotech, Inc.  Daré entered into the agreement to secure Microchips’ innovative, drug delivery technology.  The technology, which has been validated in a first-in-human clinical study in osteoporosis patients, is designed to store and precisely deliver hundreds of therapeutic doses over months or years in a single implant.  The implant is intended to be operated by the patient to deliver medication on demand or on a pre-determined schedule that can be activated or deactivated wirelessly, as required. The microchip-based implant, originally developed at the Massachusetts Institute of Technology by renowned researchers Robert Langer, Ph.D. and Michael J. Cima, Ph.D., is protected by 98 patents granted and 19 patent applications pending.  Microchips, with the support of the Gates Foundation in the form of approximately $17.9 million in grant funding to date, has been developing an implantable long-acting, reversible contraceptive application of the technology, which, if successful, will provide women with unparalleled control over the management of their fertility, which can be individually timed to meet her family planning goals and objectives.  The device is intended to deliver all the benefits of a traditional long-acting, reversible contraceptive product, utilizing the active pharmaceutical ingredient levonorgestrel, to provide precise dosing and extended implant duration with the added flexibility of wirelessly controlling the duration of ovulatory suppression based on individual user needs. “Integrating the two companies creates a unique opportunity to continue the product and clinical development of this important new drug delivery technology platform with the support of the Bill & Melinda Gates Foundation,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “The addition of this user-controlled, long-acting reversible contraceptive opportunity to Daré’s pipeline, which already includes the novel monthly, hormone-free contraceptive Ovaprene, will uniquely position Daré with two of the potentially most disruptive innovations in the contraceptive category. We look forward to announcing topline data from our Ovaprene postcoital test clinical trial, a pre-pivotal study to support product registration.” Microchips’ cash balance at closing is anticipated to be approximately $6.9 million, and approximately $5.7 million after payment of one-time transaction related expenses.  Microchips is eligible to receive up to $2.5 million in additional funding from the Gates Foundation in 2020 to cover the costs of ongoing development activities of its contraceptive program.  In the aggregate, at the closing, Daré will issue three million shares of its common stock in consideration of the cash and cash equivalents of Microchips, less liabilities, at the time of closing to the Microchips stockholders, which include Polaris Venture Partners, MS Pace, Intersouth Partners, and Teva Pharmaceuticals. Daré may pay up to $46.5 million in contingent consideration for product development, regulatory and funding milestones and up to $55.0 million in contingent consideration for commercial development milestone payments, the amount of which will depend on the extent to which various milestones are achieved, as well as tiered royalty payments.  Daré expects that less than $1.3 million of the contingent consideration may become payable through 2021. “We are tremendously excited to bring this new, potentially game-changing platform to Daré’s compelling pipeline of women’s health innovations,” said Cheryl R. Blanchard, Ph.D, President and CEO of Microchips Biotech.  Dr. Blanchard will be joining Daré’s board of directors post-closing. “I am excited to contribute to Daré’s mission to advance innovative products for women’s health,” continued Dr. Blanchard.  “New and innovative contraceptive options that better meet the needs of women around the world are crucial.  The Microchips technology holds immense promise to provide women with a sophisticated and flexible contraceptive product that adapts to their individual family planning needs. It also has the potential to provide critical drug delivery solutions that address significant unmet needs in treating a number of chronic diseases.” The closing of the merger with Microchips is subject to a number of conditions, including approval of the merger by Microchips’ stockholders.  Additional information regarding the terms of the transaction will be provided in Daré’s Current Report on Form 8-K expected to be filed with the Securities and Exchange Commission on November 12, 2019.