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Friday, January 10, 2020

TELA Bio up premarket on revenue outlook

TELA Bio (NASDAQ:TELA) is up 5% premarket on announcing preliminary Q4 and FY 2019 revenue.
Q4 and FY 2019 revenue is expected in the range of $4.7M to $4.9M and $15.3M to $15.5M, respectively.
These strong results were driven by expansion of the commercial organization and introduction of larger sizes of OviTex during 2019.
The company will report its final Q4 and FY 2019 financial results during a conference call in March 2019.

Sorrento up premarket on non-binding takeover bid

Sorrento Therapeutics (NASDAQ:SRNE) jumps 58% premarket on robust volume in reaction to a non-binding proposal from an unnamed private equity fund to acquire all of its outstanding shares at $7 per share. The board is reviewing the proposal.
Yesterday’s close was $3.41.

Top Biopharma M&As in 2019

The year was marked by mergers and acquisitions (M&A) both big and small. Although not comprehensive, here’s a look at some of the top deals for 2019.
Bristol-Myers Squibb Buys Celgene
The year started off in January when Bristol-Myers Squibb announced plans to acquire Celgene for about $75 billion. Quickly afterwards, the deal hit a snag as one of its biggest shareholders, Wellington Management Company LLP, objected to the deal. Wellington owns about 8% of Bristol-Myers. Another BMS shareholder, Starboard Value, also opposed the deal. Starboard has about a 1% ownership share. Dodge & Co, who has about a 2% stake, also opposed the deal.
For several months Bristol-Myers and Celgene launched a campaign to convince shareholders of the value of the merger. In mid-April, shareholders voted to approve the acquisition.
AbbVie to Acquire Allergan
In June, AbbVie announced plans to acquire Allergan for $63 billion. AbbVie noted that a deal of this size was planned to deliver immediate scale to its growth platform and meet its strategic goal of decreasing reliance on Humira. The company noted at the time, “Smaller bolt-on acquisitions provide opportunities for future growth, but also require significant R&D investment amid scientific and clinical uncertainty. This transaction offers immediate compelling financial and strategic value to our shareholders with a much lower risk profile.”
The merged companies will have strong franchises across immunology, hematologic oncology, medical aesthetics, neuroscience, women’s health, eye care and virology.
Roche Acquires Spark Therapeutics
In February, Roche announced plans to acquire all outstanding shares of Spark Therapeutics stock at $114.50 per share, or about $4.8 billion. In 2017, the FDA approved Spark’s gene therapy, Luxturna (voretigene neparvovec), a gene therapy for a rare, genetic type of blindness. After 10 months, the deal was finally completed on December 17. Roche saw Spark’s gene therapies for hemophilia as complementary to its own hemophilia treatment, Hemlibra. In a clinical trial, Spark’s hemophilia gene therapy, SPK-8011, demonstrated a 97% response rate in reducing bleeding events after a one-time treatment. In November, Roche also acquired Promedior for up to $1.4 billion.
Novartis Acquires The Medicines Company
In late November, Novartis bought The Medicines Company for $9.7 billion. Under the terms of the deal, Novartis is paying $85 per share in cash, which is about a 41% premium of The Medicines Company’s 30-day volume weighted average of $60.33 on November 22 and about 24% of its closing share price of $68.55 on the same day. The boards of both companies have unanimously approved the acquisition.
“We are excited about entering into an agreement to acquire The Medicines Company as inclisiran is a potentially transformational medicine that reimagines the treatment of atherosclerotic heart disease and familial hypercholesterolemia,” said Vas Narasimhan, chief executive officer of Novartis.
Alkermes Acquires Rodin Therapeutics
Alkermes, based in Dublin, acquired Boston-based Rodin Therapeutics for $100 million up front and up to $850 million in milestone payments.
Rodin focuses on developing small molecule therapeutics for synaptopathies, which are diseases of the central nervous system related to a dysfunction of synapses. Rodin has been working to develop first-in-class, orally-available, brain-permeable drugs for this class of diseases by engineering molecules that target specific histone deacetylase (HDAC) complexes. Inhibition of the HDAC-co-repressor of repressor element-1 silencing transcription factor (CoREST) complex is thought to reactivate neuron gene expression, improve existing synapses and promote the growth and creation of new synapses.
Under the terms of the deal, Alkermes is paying $100 million in cash up front. Rodin will be eligible for future payments of up to $850 million based on clinical and regulatory milestones and sales thresholds.
Alkermes focuses on drugs for CNS diseases. Its commercial products include Aristada (aripiprazole lauroxil) for schizophrenia and Vivitrol (naltrexone) for alcohol dependence and opioid dependence. It also has licensed a number of products using its proprietary technologies to third parties in Europe.
Sumitomo Dainippon Pharma Acquires 5 Vant Companies
Roivant Sciences, Vivek Ramswamy’s umbrella companies, sold ownership of five Vant companies to Japan’s Sumitomo Dainippon Pharma for $3 billion. Sumitomo Dainippon also was buying an equity stake of more than 10% of Roivant shares.
Sumitomo will create an as-yet unnamed company to shift the five companies into. They will be run by Myrtle Potter, a former Genentech executive who has been the operating chair of Roivant since July 2018.
There is a $3 billion upfront fee. In addition, Sumitomo will offer a $350 million loan facility to Myovant to fund the launch of relugolix, its Phase III candidate for uterine fibroids if it is approved. The Japanese firm will also loan Urovant $200 million for its vibegron for overactive bladder.
If Sumitomo options the other six companies, it will have acquired a pipeline of more than 25 clinical programs with multiple possible launches from 2020 to 2022. In addition to buying the five initial companies, the deal gives Sumitomo access to Roivant’s proprietary technology platforms, DrugOme and Digital Innovation. It will also enter separate strategic client relationships with Datavant and Alyvant.
The five Vant companies are Myovant Sciences, Urovant Sciences, Enzyvant Therapeutics, Altavant Sciences, and Spirovant Sciences. Spirovant is a new Vant that focuses on developing gene therapies for cystic fibrosis.
Eli Lilly Buys Loxo Oncology
Eli Lilly and Company announced it was buying Loxo Oncology for $235 per share in cash, which comes to about $8 billion. Under the terms of the deal, Lilly acquired all outstanding Loxo shares for $235 in cash. This amounts to a premium of about 68 percent on top of Loxo’s stock price as of January 4.
Loxo’s Vitrakvi (larotrectinib) was recently approved by the U.S. Food and Drug Administration (FDA). It is an oral TRK inhibitor developed and commercialized in collaboration with Bayer. Its pipeline includes LOXO-292, an oral RET inhibitor being evaluated across multiple cancer types. It was recently granted Breakthrough Therapy status by the FDA.
In addition, Loxo has LOXO-305, an oral BTK inhibitor currently in Phase I/II. It is being evaluated in various B-cell leukemias and lymphomas. It also has LOXO-195, a follow-on TRK inhibitor also being studied by Loxo and Bayer.
“Using tailored medicines to target key tumor dependencies offers an increasingly robust approach to cancer treatment,” stated Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories. “Loxo Oncology’s portfolio of RET, BTK and TRK inhibitors targeted specifically to patients with mutations or fusions in these genes, in combination with advanced diagnostics that allow us to know exactly which patients may benefit, creates new opportunities to improve the lives of people with advanced cancer.”
Sanofi Buys Synthorx
On December 9, based Sanofi announced it was acquiring San Diego-based Synthorx for $68 per share in cash, a value of $2.5 billion. Synthorx focuses on immuno-oncology. Its lead product candidate is THOR-707, a form of interleukin-2 (IL-2) that is being developed in multiple solid tumors types as a monotherapy and in combination with checkpoint inhibitors. The companies believe it has the potential to be a best-in-class IL-2 therapeutic for solid tumors.
In addition, Sanofi will gain access to Synthorx’s Expanded Genetic Alphabet platform. This is noted as being synergistic with Sanofi’s existing platforms, including its Nanobody technology, which allows it to develop a broad range of novel biologics, including drug conjugates, protein fusions, and multi-specific biologics.
UCB Buys Ra Pharma
In October, Brussels, Belgium-based UCB announced plans to acquire Cambridge, Massachusetts-based Ra Pharmaceuticals for $2.1 billion.
Under the terms of the deal, Ra Pharma shareholders will receive $48 in cash per each Ra Pharma share. The boards of both companies have unanimously approved the merger, though Ra Pharma shareholders still need to approve it.
Ra Pharma was founded in 2008 and uses synthetic peptides to develop drugs for diseases caused by excessive or uncontrolled activation of a major component of the innate immune system called the complement system.
Mylan Merged with Pfizer’s Upjohn
In July, Pfizer announced that its off-patent drug company, Upjohn, would merge with generic drugmaker Mylan to form a new pharmaceutical company. The new company will have well-known brands, including Epi-Pen, Viagra, Lipitor, Celebrex and others.
Johnson & Johnson Acquired Auris Health
In February, Johnson & Johnson announced that its Ethicon was acquiring Auris Health for about $3.4 billion in cash. Auris is a privately held maker of robotic technologist with an initial focus on lung cancer. Auris’s Monarch Platform robotic technology will fit well into J&J’s Lung Cancer Initiative. In December, J&J also announced it was acquiring the remaining stake in Verb Surgical after a successful strategic collaboration with Verily, an Alphabet/Google company. Verb is also a robotics and data management company.
Alexion Pharmaceuticals Bought Achillion Pharmaceuticals
In December, Alexion Pharmaceuticals completed its acquisition of Achillion Pharmaceuticals, which was announced on October 16, 2019. Alexion acquired Achillion for an initial consideration of about $930 million, or $6.30 per share in cash. The deal is expected to close in the first half of 2020.
Astellas Acquired Audentes Therapeutics
Tokyo-based Astellas Pharma announced plans to acquire San Francisco-based Audentes Therapeutics for $60 per share in cash, a total equity value of about $3 billion.
Under the terms of the deal, which both companies’ boards have unanimously approved, Astellas will buy Audentes through Asilomar Acquisition Corp., a wholly-owned subsidiary of Astellas US Holding. The offer represents a 110% premium of Audentes’ closing share price of $27.61 as of December 2.
The merger is an effort on the part of Astellas to strengthen its genetic medicine and gene therapy business. Hidemaru Yamaguchi, an analyst with Citi, wrote in a note for clients that it was a positive move for Astellas because Audentes had “cutting-edge gene therapy modalities. We thought it was only a matter of time before Astellas entered the gene therapy market.”
Merck to Acquire ArQule
Merck announced intentions to buy ArQule on December 9, for $20 per share in cash for a total equity value of $2.7 billion. ArQule’s lead product candidate, ARQ 531, is an oral Bruton tyrosine kinase (BTK) inhibitor currently in Phase II trial for B-cell cancers.
Charles River Laboratories Buys HemaCare for $380 Million
Contract research organization (CRO) Charles River Laboratories announced a partnership with Bit Bio earlier in December, then on December 16, announced it was buying HemaCare for $380 million in cash. HemaCare provides human-derived cellular products for the cell therapy space.

JP Morgan Preview: Small, Medium and Large, with a Lot of M&A Speculation

It can be a bit difficult to predict exactly what the big stories out of the JP Morgan Healthcare Conference are going to be. In 2019, it was the year’s biggest dealBristol-Myers Squibb’s acquisition of Celgene Corporation for $74 billion only days before the conference that became the talk of the meeting.
There’s no telling if some surprise deal will take the air out of the room, but here’s a look at some of the top presentations expected at the 38th annual JP Morgan Healthcare Conference taking place January 13-16 in San Francisco. With 12,000 attendees and 1,250 exhibitors from 155 countries, it’s safe to say there will be plenty of news, way too much to sum up in a single article, but here are some of the highlights.
Keynote speakers include Jamie Dimon, chief executive officer of JPMorgan Chase & Co., Ann C. Gallo, senior managing director and global industry analyst for Wellington Management, Sandra E. Peterson, partner with Clayton, Dubilier & Rice, Emma Walmsley, chief executive officer of GlaxoSmithKline, and Seema Verma, administrator of the U.S. Centers for Medicare and Medicaid Services (CMS).
The conference has suggested that one of the key themes of the meeting will be what the biopharmaceutical industry can look for in a U.S. presidential election year. So, drug pricing will undoubtedly be a hot topic, as will U.S. efforts to allow consumers to acquire drug from Canada, as well as efforts that have been made for the FDA to allow certain imports of drugs approved outside the U.S. but not by the FDA.
Literally hundreds of biopharma companies will be making presentations. Here are just a few:
Exelixis president and chief executive officer, Michael M. Morrissey, will provide a corporate overview on Tuesday, January 14 at 4:30 PM PST.
Intercept Pharmaceuticals president and chief executive officer Mark Pruzanski will make a presentation on Wednesday, January 15 at 10:00 AM PST followed by a breakout Q&A.
Theravance Biopharma‘s executives will make a presentation on Wednesday, January 15 at 8:30 AM PST.
Sara Boyce, president and chief executive officer of Avidity Biosciences, will present an overview of the company’s approach to rare muscle disorders. The company recently closed on a successful $100 million Series C round. The presentation is Wednesday, January 15 at 10:30 AM PST.
Kodiak Sciences management will present a company overview on Tuesday, January 14 at 7:30 AM PST.
Stephane Bancel, chief executive officer of Moderna, will present an update on the company and its pipeline of mRNA programs on Monday, January 13, at 4:30 PST.
Those, of course, are just a small sampling of the numerous company presentations.
Expect there to be a lot of discussion about Biogen and its aducanumab, which is headed to the FDA for potential approval for Alzheimer’s disease. The company is presenting on Monday, January 13 at 3:30 PM PT. Investors are likely to have some hard questions about what the company plans to do if the FDA approves the drug, but likely even tougher questions on what it plans to do if the FDA rejects the drug.
Aducanumab is an antibody against beta-amyloid, the protein associated with the disease, but there is also another protein, tau, which is indicated in Alzheimer’s as well. On December 13, 2019, Biogen announced that its gosuranemab, which focused on tau, had failed a Phase II clinical trial in progressive supranuclear palsy (PSP). In addition to Alzheimer’s, tau is implicated in a number of other diseases, including chronic traumatic encephalopathy (CTE), frontotemporal dementia, and parkinsonism.
Right around the same time Biogen killed its gosuranemab program and announced the rebirth of aducanumab, it licensed an antisense therapy against microtubule-associated protein tau (MAPT) from Ionis Pharmaceuticals.
It won’t be surprising if investors quiz Biogen management on plans to acquire more pipeline drugs or even a major merger to bolster its pipeline.
The JP Morgan conference is also a big arena for speculation about mergers and acquisitions (M&A). Geoffrey Porges, an analyst with SVB Leerink, came up with a top 20 target list, most of which were biopharma companies specializing in oncology and rare diseases. They include Alexion and Seattle GeneticsBiohaven, and FibroGen.
And the buyers? Most likely investors will be keeping an eye on Gilead Sciences and Sanofi, as well as Amgen, Biogen, as mentioned earlier, NovartisMerck & Co., Eli Lilly and Pfizer—the usual suspects, in other words.
Gilead and Sanofi’s chief executives appear to be actively pushing for changes that may require picking up something big, as opposed to a $10 billion or less bolt-on acquisition. Porges argues that all of the big firms mentioned above have one thing in common—they are in the process of restructuring or need it.
Sanofi’s chief executive officer Paul Hudson described a restructuring plan in December, which included backing away from the cardiovascular and diabetes markets.
Many investors and analysts feel Merck has undue reliance on its blockbuster checkpoint inhibitor Keytruda, even though it’s projected to be the bestselling drug in the near future. Still, shareholders would like to see what the company has in mind to expand beyond Keytruda, and M&A could fit the ticket.
Another company that is the center of intense acquisition speculation is Amarin, which markets a fish-oil derivative, Vascepa, to lower triglycerides and lipids. The company’s been the speculation of acquisition rumors for a while, but the recent acquisition of The Medicines Company by Novartis reignited the rumors. Potential buyers include Pfizer and Amgen, who have a vested interest in the cardiovascular disease space, although Gilead would be a possibility as well.
Porges noted, “These newly restructured diversified specialty biopharma companies require a constant stream of new products, technologies and development programs to maintain investor confidence in the durability of the growth outlook in their core franchises.”
One area that appears to be a big target of M&A is gene therapy companies. In late-December, Roche inked a deal with Sarepta Therapeutics for Sarepta’s SRP-9001, an investigational gene therapy for Duchenne muscular dystrophy (DMD), outside the U.S.
What would be surprising is if there WASN’T a surprise announcement at the conference. Stay tuned!

Elanco guides up to $3.1B in 2020 revenue

Elanco Animal Health (NYSE:ELANannounces 2020 guidance:
Revenue: $3.05B – 3.11B; EPS: $0.04 – 0.16; non-GAAP EPS: $1.09 – 1.16.
2019 results should be consistent with November guidance.
China regulators have signed off on the Bayer AG animal health merger.
Management will host a conference call today at 8:00 am ET to discuss its 2020 outlook.

Aquestive sees Q4 revenue above consensus; shares ahead

Aquestive Therapeutics (NASDAQ:AQST) is up 13% premarket on light volume on the heels of its announcement of preliminary Q4 and 2019 revenues of ~$16M and ~$52M, respectively, both above consensus.
Cash and equivalents at year-end: ~$49M.
Final Q4 and 2019 results will be released on March 12.
2020 guidance: Revenues: $35M – 45M (below consensus of ~$57M). Non-GAAP gross margin: 70 – 75%. Non-GAAP EBITDA loss: ($70M – 65M). Cash consumption: ($70M – 65M).

Aclaris up on positive ATI-450 data

Aclaris Therapeutics (NASDAQ:ACRS) is up 19.9% after hours following positive results from its Phase 1 trial of ATI-450, an investigational oral MK2 inhibitor.
The trial covered single ascending dose and multiple ascending dose approaches. The treatment was well tolerated at all doses and resulted in marked inhibition of TNFa, IL1ß, IL8, and IL6, the company says.
“We believe these data support the progression of ATI-450 into Phase 2 clinical development,” says Chief Medical Officer Dr. David Gordon.
The company plans to initiate a Phase 2 trial in subjects with rheumatoid arthritis in the first half of the year.