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Friday, January 10, 2020

Codexis and Nestlé to advance GI candidate

Codexis (CDXS +1%) and collaboration partner NestlĂ© Health Science (OTCPK:NSRGY) have agreed to advance lead enzyme therapy candidate CDX-7108 for the potential treatment of an unspecified gastrointestinal (GI) disorder.
Concurrently, the companies have extended their agreement through 2021 to support the discovery of additional candidates.

Lots of cash and tasty targets signal deals to come—and it may be now or never

Brace yourselves, pharma watchers. With the annual J.P. Morgan Healthcare Conference around the corner, some major biopharma deal announcements could hit the headlines, just as Bristol-Myers Squibb unveiled its $74 billion Celgene buyout and Eli Lilly its $8 billion Loxo Oncology takeover last year.
Those announcements kicked off a year marked by record-breaking biopharma mergers and acquisitions, and signs point to a busy 2020, thanks to a growing deal appetite among major drugmakers, according to one group of analysts.
Plus, there’s increasing political scrutiny of the drug industry, the looming presidential election and intensifying antitrust scrutiny. That pressure is “likely contributing to a mentality of ‘get it done now or possibly not at all’ among large companies,” the analyst wrote in an investor’s note on Dec. 23.
Who could be snatched up by those hungry pharmas—conceivably as soon as the JPM conference kicks off Monday? SVB Leerink’s Geoffrey Porges counts 20 top targets, mostly in oncology and rare diseases, with estimated prices between $1 billion to $10 billion.

The targets

Big firms and perennial sources of buyout buzz like Alexion and Seattle Genetics also made the list, though. Porges noted rare disease-focused Alexion, maker of Soliris and Ultomiris, could be worth as much as $32.5 billion. Targeted oncology specialist Seattle Genetics, which recently won FDA approval for Astellas-partnered antibody-drug conjugate Padcev, could go for $29.7 billion.

Smaller shops include Biohaven, whose oral CGRP migraine drug rimegepant’s moving closer to the FDA finish line—and already triggering M&A chatter. There’s FibroGen, probably thanks to its potential blockbuster launch of anemia drug roxadustat. Recent gene therapy deals, marked by Roche’s acquisition of Spark Therapeutics and Astellas’ proposed Audentes Therapeutics buy, could spread to uniQure, as rumors have it that the biotech is looking for a sale.

The likely shoppers

Despite the spending spree last year, large biopharma companies still have enough dry powder to make $10 billion-and-up M&A moves. Industry-wide restructuring to focus more on specialty drugs means they have the incentive to do so, Porges said.
The 20 largest biopharma companies are worth about $2.84 trillion and ginned up revenue of $641 billion in 2018 with an expected growth rate of 5% to 6% for 2019. Their combined 2018 earnings of $255 billion means they could pay down their total debt of $474 billion with less than two years of EBITDA, Porges noted.
Those companies could “easily deploy sufficient capital to acquire 100% of the mid-cap biopharma companies over $10 billion in value, in one year,” he said.
As was the case in 2019, oncology and rare diseases will remain the two hot therapeutic areas for M&A deals moving forward, Porges figures. “[W]ith the scarcity of assets in these areas and the grassroots nature of innovation in rare diseases, M&A is the only way for large companies to build portfolios,” he said.
Which companies could be most active in dealmaking? Gilead Sciences and Sanofi, for two, and others like Amgen, Biogen, Novartis, Merck & Co., Eli Lilly and Pfizer might step up as well, Porges predicted. These firms share one commonality—they’re either already restructuring or in need of it.

Who needs it most?

For Porges’ top picks—Gilead and Sanofi—their new CEOs are actively pushing for changes.
Since officially joining Gilead from Roche in 2019, Daniel O’Day has quickly revamped the big biotech’s entire C-suite, the most recent change being the promotion of former chief BD officer, Andrew Dickinson, to the CFO role. That move “highlights the crucial importance that M&A and partnerships likely have in Gilead’s capital allocation strategy,” RBC Capital Markets analyst Brian Abrahams said in October.
As for Sanofi, CEO Paul Hudson has already laid out a restructuring plan. It includes retreating from the under-pressure cardiovascular and diabetes business, which already saw the French pharma shake up its collaboration with Regeneron on slow-progressing PCSK9 heart drug.
Consumer health is now a standalone unit within the group, a move that’s widely viewed as a prelude to a sale or spinoff. At the same time, Hudson recently said he plans to “manage the business to double down where we need to, but also be profitable.”

Other companies Porges listed as “moderate” in M&A activities early 2020 are in similar positions. Amgen just wrapped up a major overhaul that leaned heavily on internal efficiency rather than making deals. It just welcomed Peter Griffith as its new CFO and splashed out $13.4 billion for Celgene’s psoriasis drug Otezla.
Biogen has been under constant investor pressure to pursue deals given the uncertainty around its high-profile Alzheimer’s drug aducanumab. As Merck relies more heavily on Keytruda, shareholders have been questioning its life beyond that star PD-1. The New Jersey pharma has made two oncology-focused acquisitions in 2019, shelling out $1.1 billion upfront for Peloton Therapeutics and $2.7 billion for ArQule.
Eli Lilly is boosting its presence in oncology, too, while Novartis CEO Vas Narasimhan has put the Swiss pharma on a clear track focused on innovative medicines. Pfizer CEO Albert Bourla is also shifting the New York company’s portfolio to specialty drugs and new launches, having agreed to unload its established medicines business Upjohn to Mylan.
“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,” Porges said. Let the dealmaking begin.

AMAG’s CEO departure, drug dumps may not right the ship, analyst says

After forfeiting two board seats and undertaking a strategic review, AMAG Pharmaceuticals is saying goodbye to its CEO and two of its drugs. But with another med likely being pulled from the market, AMAG’s sudden decision to cut ties with its chief executive could be akin to shifting “deck chairs on the Titanic,” one analyst said.
AMAG CEO William Heiden has agreed to step down following a strategic review spurred by activist investor Caligan Partners that also recommended the sale or spinoff of two women’s health drugs, female libido treatment Vyleesi and painful sex med Intrarosa, the company said Thursday.
Heiden will stay on with AMAG through the successor search, which the company expects to wrap up by mid-2020, it said.
“It has been an honor and a privilege to lead the team at AMAG,” Heiden said in a release. “As we implement the strategic shift announced today, my fellow directors and I believe that this is the right time for the board to identify a new CEO for the next leg of AMAG’s journey.”

Heiden’s planned departure comes more than two months after an FDA advisory committee recommended AMAG pull premature birth med Makena from the market in a 9-7 vote after confirmatory testing showed little clinical benefit in patients.
Piper Jaffray analyst Christopher Raymond called the panel’s recommendation “surprisingly definitive” in a note to investors at the time and forecast that the FDA would likely pull Makena’s marketing approval and structure a phaseout through mid-2020.
With Makena likely being taken off the market, AMAG said it would focus on the success of its iron deficiency med Feraheme as it moves ahead and has already received tentative interest from buyers for both Vyleesi and Intrarosa. With Heiden departing, Chief Financial Officer Ted Myles will assume the additional role of chief operating officer, and general counsel Joseph Vittiglio will assume the additional role of chief business officer.
In a note to investors Thursday, Raymond said the “handwriting was on the wall’ in Heiden’s departure and the Vyleesi and Intrarosa divestures after both drugs showed little market impact in their short commercial lives. AMAG hasn’t yet disclosed revenue contributions from Vyleesi, which the FDA approved in June and AMAG launched in September. And Intrarosa, approved in 2017, hit just $21 million in sales in 2019 despite promise of a more than $500 million market for the drug.
Worse times could be coming, Raymond said, comparing AMAG’s plight to shifting “deck chairs on the Titanic”––particularly with Feraheme soon to face generic competition.
“While (Feraheme) has been a stalwart, recall that beginning (around) July 2021, Sandoz can launch its generic version of Feraheme,” Raymond wrote. “Combining this with a substantial debt burden from the acquisitions of these and other assets, we would avoid the stock.”

Just weeks before the FDA committee vote, AMAG opted to give two board seats to activist investor Caligan after the venture capital firm pushed for change at the top. The move temporarily expanded AMAG’s board to 11 seats before the company’s 2020 annual meeting, when nine permanent directors will be chosen.
Caligan acquired 10.3% of AMAG’s shares in early August, aiming to push the company to find an international marketing partner for Feraheme and investigate opportunities for its women’s health business. Caligan also floated the idea of splitting up the drugmaker.
In mid-September, in a proposal seeking to take four of AMAG’s board seats, Caligan lambasted AMAG’s share price—and what it called the failure of the drugmaker’s five-year strategic plan—despite the “immense value” of some of its pharmaceutical portfolio. The firm said AMAG’s board, recently elected in May, was approved because shareholders lacked options.

Quidel sees ~$152M in Q4 revenue

On a preliminary basis, Quidel (OTC:QDEL) expects $151M – 152M in Q4 revenue, about 9% above consensus (at midpoint).
Complete results for Q4 and 2019 will be released in next month.

Biofrontera reports preliminary Q4 and FY 2019 sales

Biofrontera AG (NASDAQ:BFRAreports preliminary Q4 and FY 2019 results.
FY 2019 turnover was between €31.1M and €31.4M.
U.S. product sales are expected to be around €23.3M.
In Germany, FY 2019 product sales will amount to approx. €4.6M, compared with €3.3M for FY 2018.
Q4 sales amounted to ~€12.2M, compared to €6.6M in the previous year.

Nektar up premarket on new Bristol-Myers collaboration

Nektar Therapeutics (NASDAQ:NKTR) is up 3% premarket on light volume in reaction to its revised collaboration agreement with Bristol-Myers Squibb (NYSE:BMY) aimed at advancing the combination of bempegaldesleukin and Opdivo (nivolumab) in a range of new registrational studies.
The new deal will expand the partnership beyond the three pivotal studies in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) to include two additional registrational trials in adjuvant melanoma and in muscle-invasive bladder cancer.
In addition, a Phase 1/2 study evaluating the combo + Pfizer’s (NYSE:PFE) Inlyta (axitinib) in first-line RCC will be conducted that will support a future pivotal trial.
Study costs will be shared per the terms in the original agreement.
BMY will independently conduct and fund a Phase 1/2 dose optimization and expansion trial assessing the combo in first-line non-small cell lung cancer.
Bempegaldesleukin is a CD122-preferential IL-2 pathway agonist designed to activate and proliferate certain cancer-killing immune cells.

Auris Medical nabs new patent in Europe

Auris Medical Holding (NASDAQ:EARS) is up 12% premarket on receiving a notice of “Intention to Grant” from European Patent Office (EPO) for its patent application entitled “Treatment of Tinnitus Through Modulation of Chloride Co-Transporter NKCC1 in the Auditory System” (Application 11 894 529.3).
The allowed claims cover compounds modulating the sodium potassium chloride co-transporter 1 for use in the oral treatment or prevention of tinnitus.