The top 9 over­seas ac­counts in bio­phar­ma hold $133B in M&A fire­pow­er

Pic­tured (L-R): Stephen Ubl, CEO PhRMA; Ken Fra­zier, CEO Mer­ck; Robert Hug­in, Cel­gene chair­man; Robert Brad­way, CEO Am­gen on Jan­u­ary 31, 2017 at the White House af­ter meet­ing with Pres­i­dent Trump. An­drew Har­rer/Bloomberg via Get­ty

Dur­ing Am­gen’s Q1 dis­cus­sion with an­a­lysts on Wednes­day evening, CEO Bob Brad­way re­peat­ed one of the key themes in the land of Big Bio­phar­ma. Biotech val­u­a­tions are high, he not­ed, mak­ing it dif­fi­cult to ac­quire the kind of drug as­sets he’d like to lay his hands on.

But. Tax re­form could make M&A eas­i­er for Am­gen.

And why is that? Says Brad­way:

We’ve long ad­vo­cat­ed the need for cor­po­rate tax re­form. If in­no­v­a­tive U.S. com­pa­nies are to re­main com­pet­i­tive, we need a lev­el tax play­ing field. We don’t have one now, but we’re hope­ful this ad­min­is­tra­tion will de­liv­er that in 2017. Ob­vi­ous­ly, we think such change would im­prove our flex­i­bil­i­ty for cap­i­tal al­lo­ca­tion.

Am­gen has been shel­ter­ing a cache of about $35 bil­lion in ex-US ac­counts, ac­cord­ing to some num­bers that Ever­cor­eISI’s Umer Raf­fat put to­geth­er as he be­gan as­sess­ing the im­pact tax re­form could have on the top play­ers in over­seas hold­ings.

Raf­fat’s quick­ly as­sem­bled top 10 — based on fil­ings and con­ver­sa­tions with ex­ecs, re­arranged by or­der of ex-US hold­ings — add up to rough­ly $133 bil­lion. That’s enough to fu­el quite a few ac­qui­si­tions.

A year ago, by the way, a num­ber of sto­ries in the fi­nan­cial press cit­ed Pfiz­er for hold­ing $80 bil­lion in over­seas ac­counts. But this gives you an idea of some of the cash that would be avail­able to the big US play­ers if tax re­form al­lowed for quick repa­tri­a­tion.

Sweep­ing tax re­form, though, may be even hard­er to do than health­care re­form. But you’ll note that there are sev­er­al com­pa­nies on this list that have in­di­cat­ed that they are hunt­ing deals, par­tic­u­lar­ly Am­gen, Gilead, Pfiz­er and Bio­gen. At Cel­gene, the deal pace has been con­stant for years now.

So far, 2017 has been some­thing of a dis­ap­point­ment in the M&A world. Maybe some of these com­pa­nies are just hold­ing fire, though, to see how the land­scape changes in the next few weeks.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.