Gilead locks in Daniel O'­Day as CEO, tap­ping the Roche vet to re­ju­ve­nate growth

The sus­pense over who will suc­ceed John Mil­li­gan at Gilead has fi­nal­ly end­ed.

Daniel O’Day, cur­rent CEO of Roche’s Phar­ma di­vi­sion, has been tapped for the top job, Gilead an­nounced days be­fore Mil­li­gan is set to de­part from his cor­ner of­fice.

John Mil­li­gan

O’Day’s ap­point­ment ush­ers in a new era for the Fos­ter City, CA-based big biotech, which Mil­li­gan and his pre­de­ces­sor, John Mar­tin, ran for near­ly three decades, cre­at­ing an HIV pow­er­house and an in­dus­try-dom­i­nat­ing he­pati­tis C fran­chise. In re­cent years, how­ev­er, it’s seen its rev­enue shrink as com­pe­ti­tion heats up and the pain­less cure ef­fec­tive­ly down­sized the mar­ket.

Mar­tin has pre­vi­ous­ly an­nounced his de­par­ture as board chair­man, amid an ex­ec­u­tive ex­o­dus that al­so claimed R&D head Nor­bert Bischoberg­er, CMO An­drew Cheng and com­mer­cial chief James Mey­ers (who is re­tir­ing).

Be­fore O’Day as­sumes his role on March 1, 2019, Gregg Al­ton — a 20-year vet­er­an of the com­pa­ny who’s served as gen­er­al coun­sel and, most re­cent­ly, chief pa­tient of­fi­cer — will man the fort as in­ter­im CEO.

In­vestors wel­comed the news, send­ing Gilead shares $GILD up 2.5%.

O’Day, who Jef­feries’ Michael Yee de­scribes as “pret­ty straight down the road” in terms of risk tak­ing with­out a his­to­ry of big M&A deal­ing, grad­u­ates from Roche as a 30-year vet­er­an of the Swiss phar­ma gi­ant, hav­ing start­ed with com­mer­cial and sales roles in 1987. Since tak­ing con­trol of the phar­ma unit in 2012, he’s over­seen the launch of sev­er­al po­ten­tial block­buster drugs in­clud­ing Hem­li­bra and Tecen­triq.

Baird’s Bri­an Sko­r­ney, mean­while, of­fers a de­cid­ed­ly glow­ing re­view of the new CEO:

(I)n his role at Roche, we think he has done a phe­nom­e­nal job at nav­i­gat­ing the com­pa­ny in­to a next gen­er­a­tion of prod­ucts (Ocre­vus, Hem­li­bra, po­latuzum­ab are just a cou­ple of prod­ucts we see as new, im­pact­ful block­buster drugs). Most im­por­tant­ly, we be­lieve the long his­to­ry at Roche makes him a choice that isn’t like­ly to break an al­ready good com­pa­ny. While we ex­pect that re­plac­ing the head of one of the strongest man­age­ment teams ever seen in biotech to be a chal­leng­ing role, we think that O’Day is high­ly qual­i­fied and should ease in­vestor con­cerns lead­ing in­to Mil­li­gan’s re­tire­ment.

While in­vestors keen­ly await a strate­gic plan and vi­sion from O’Day, an­a­lysts at Jef­feries laid out a pos­si­ble sce­nario:

We be­lieve O’Day will look to de­vel­op a strat­e­gy over the course of 2019 and it will in­clude a view on de­ploy­ing GILD’s cur­rent cash of ~$32B to­wards more on­col­o­gy as­sets and oth­er key ar­eas, such as in­flam­ma­tion and liv­er dis­eases. Note’s GILD’s cur­rent debt-to-EBIT­DA ra­tio stands at rough­ly ~2.6x so the com­pa­ny could still lever up to do more deals. (…) we can as­sume his plan-of-ac­tion for 2019 is to en­sure that: (1) HCV sta­bi­lizes and be­comes more “pre­dictable”, (2) HIV grows as Bik­tarvy con­tin­ues to reach record rev­enues, and (3) Yescar­ta grows each quar­ter as the com­pa­ny con­tin­ues to ex­pand its pres­ence in hema­tol­ogy (e.g. al­lo­gene­ic CAR-T) and sol­id tu­mors (neo-anti­gens).

Faced with a wan­ing hep C fran­chise, Gilead has swal­lowed Kite Phar­ma in a bid to be­come a leader in CAR-T, snap­ping up new tech­nolo­gies along the way. It is now up to O’Day to gal­va­nize the sales of Kite’s CAR-T ther­a­py Yescar­ta, which de­spite im­pres­sive sur­vival rates gen­er­at­ed a pal­try $183 mil­lion for the first nine months of 2018.

Mean­while in Basel, Genen­tech CEO Bill An­der­son will fill O’Day’s shoes.


Im­age: Daniel O’Day. ROCHE

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,500+ biopharma pros reading Endpoints daily — and it's free.

Sushil Patel, Replimune

Ex­clu­sive: Genen­tech's for­mer Tecen­triq 'CEO' jumps ship to head up com­mer­cial at an on­colyt­ic virus play­er

Genentech has long been a headhunter’s paradise with biotechs shopping for top execs with premium résumés, so it’s not unusual to see some long-time employees jumping ship. Now, one of the commercial leads on the company’s oncology portfolio is leaving after a 20-year stint to try his hand at a tiny oncolytic virus biotech.

Sushil Patel, Genentech’s former global oncology franchise head for lung and skin cancer and rare/agnostic tumor types, will leave his post at the world’s first biotech to head commercial at a much smaller operation in Replimune, which is using oncolytic viruses to hunt solid tumors.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Kåre Schultz, Teva CEO (Christopher Goodney/Bloomberg via Getty Images)

Te­va CEO Kåre Schultz sees a 35% raise de­spite the com­pa­ny's con­tin­ued le­gal woes

Amid a year where revenues were mostly flat but lawsuits continued piling up, Teva CEO Kåre Schultz saw himself getting a raise.

In shareholder documents filed to the SEC on Wednesday, Teva revealed its executive compensation packages for 2020. Though his salary remained the same as each of the last two years, Schultz’s stock awards increased by about $4 million from 2019, accounting for almost all of the additional pay he received in his $15.7 million package.