M&A slows to a trick­le in 2017, but Big Phar­ma could be on deck for mega deals

Free-flow­ing cash for star­tups, sky-high val­u­a­tions, and un­cer­tain­ty about tax re­form led to un­ex­pect­ed stag­na­tion in M&A this year. But big deals could be on the hori­zon as large phar­ma­ceu­ti­cal com­pa­nies get squeezed to de­liv­er top line growth.

Af­ter a lack­lus­ter 2016 (thanks to un­cer­tain­ty in an elec­tion year), many ex­perts in the in­dus­try pre­dict­ed — with Pres­i­dent Trump firm­ly seat­ed in the White House — that we would see an uptick in merg­ers and ac­qui­si­tions in 2017. They were wrong. Be­sides Gilead’s near­ly $12 bil­lion move on Kite, 2017 was rather qui­et on the M&A front, ac­cord­ing to a new re­port by Eval­u­atePhar­ma’s EP Van­tage.

Ex­perts are now won­der­ing if ac­quir­ers are on stand­by, wait­ing to see what will hap­pen with tax re­form be­fore mov­ing for­ward on big pur­chas­es. And it makes sense. It’s es­ti­mat­ed that big phar­ma and biotech has rough­ly $171 bil­lion held in oth­er ter­ri­to­ries to avoid the 35% cor­po­rate tax rate here in the US. If that mon­ey can come back over thanks to repa­tri­a­tion, then these com­pa­nies will have a lot more play mon­ey to take shop­ping.

Oth­er rea­sons for the slow­down in M&A this year could be climb­ing val­u­a­tions of small and mid-sized bio­phar­mas — es­pe­cial­ly in hot ar­eas of de­vel­op­ment. Some­times those big buy­outs came back to bite the buy­ers (look­ing at you, Medi­va­tion).

One of the per­haps most in­ter­est­ing rea­sons for the slow M&A could be the in­dus­try’s rel­a­tive­ly easy ac­cess to cap­i­tal. As you can see in the chart be­low, ven­ture cap­i­tal­ists have been giv­ing out big­ger chunks of cash to com­pa­nies — rem­i­nis­cent of the boom times of 2014. When com­pa­nies can raise their own mon­ey for more ex­pen­sive, lat­er-stage de­vel­op­ment, then they’re less like­ly to look for buy­ers. On top of big ven­ture deals, the IPO mar­ket has been hot this year, with even pre­clin­i­cal com­pa­nies go­ing pub­lic with rel­a­tive suc­cess.

But this deal hia­tus, both in 2016 and 2017, is like­ly putting pres­sure on big phar­mas, the Van­tage re­port says. Com­pa­nies re­ly­ing on old­er drug fran­chis­es are par­tic­u­lar­ly im­pli­cat­ed.

“Com­pa­nies that re­ly on lega­cy prod­ucts in ar­eas like di­a­betes or heart dis­eases are in huge trou­ble,” Lon­car In­vest­ments CEO Brad Lon­car told EP Van­tage. “In these ar­eas, pay­ers have the pow­er. This might mean we see M&A, and that would be the top in­gre­di­ent for hav­ing a good 2018.”

These large phar­ma­ceu­ti­cal com­pa­nies are the ones that saw some less-than-stel­lar fi­nan­cial per­for­mance ear­li­er this year. Missed ex­pec­ta­tions for the growth prospects of Cel­gene and Bio­gen, for ex­am­ple, caused a sig­nif­i­cant sell­off.

The EP Van­tage re­port spec­u­lates that poor fi­nan­cial per­for­mance of some big play­ers could mean bar­gain prices for some M&As down the road.

“So if val­u­a­tions of big cap biotechs re­main de­pressed, and progress on tax re­form emerges, then per­haps 2018 will see more, larg­er deals. Pfiz­er is still most fre­quent­ly named as an en­thu­si­as­tic big buy­er – fa­vorite tar­gets for the ru­mor mill cur­rent­ly in­clude Bris­tol-My­ers Squibb and Bio­gen. And ex­ec­u­tives from oth­er large play­ers – Mer­ck & Co and Gilead for ex­am­ple – have re­cent­ly made it clear that they are look­ing around.”

In short, this re­port in­di­cates that small and mid-stage com­pa­nies will con­tin­ue to see high val­u­a­tions, easy ac­cess to cash, and a friend­ly IPO mar­ket — as long as un­fore­see­able macro­eco­nom­ic fac­tors don’t tank the mar­ket. Large-cap com­pa­nies, how­ev­er, may see shrink­ing val­u­a­tions, af­ford­able price tags, and more sig­nif­i­cant con­sol­i­da­tion (should tax re­form go their way).

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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