Pin­ing for a megadeal, an an­a­lyst kicks the tires for an­oth­er Gilead M&A test dri­ve

John Mil­li­gan

Gilead CEO John Mil­li­gan drew plen­ty of nods re­cent­ly when he said you have to ig­nore what’s go­ing on in Wash­ing­ton DC and just run your busi­ness. But he was ig­nor­ing top an­a­lysts long be­fore he got a chance to tune out the Trump ad­min­is­tra­tion.

Some promi­nent stock watch­ers have been in­sist­ing for some time now that Mil­li­gan and Gilead $GILD have to use a moun­tain of cash on hand to grab a big pipeline/port­fo­lio that can reen­er­gize the falling num­bers in their rev­enue fore­casts. With the hep C peak be­hind it, the stock needs new moun­tains to climb to in­spire in­vestors. But the CEO sits on Gilead’s cash and qui­et­ly bides his time – just like al­most every oth­er big play­er that’s sup­posed to be in the buy­ers’ cir­cle this year.

Ge­of­frey Porges, Leerink

Not too both­ered by that, Leerink’s Ge­of­frey Porges has not on­ly spelled out the rea­sons why he’d cheer a Ver­tex $VRTX buy­out, twice, he’s now ex­pand­ing Mil­li­gan’s menu with an­oth­er biotech that is on every­one’s M&A watch list: In­cyte $IN­CY.

Porges still likes Ver­tex best. It has a proven pres­ence in the cys­tic fi­bro­sis mar­ket with a good pipeline. The num­bers can work. An In­cyte deal would de­pend on see­ing its IDO1 star epaca­do­stat come through with an ap­proval and a mar­ket hit to war­rant the cash need­ed to buy a com­pa­ny with a mar­ket cap of $27 bil­lion. But Porges be­lieves that if they get in there and re­al­ly carve up the ex­pense side of the busi­ness at the Delaware biotech — read: big lay­offs — an ac­qui­si­tion can play out quite nice­ly. There’s up­side in the hot im­muno-on­col­o­gy field and In­cyte has a flag­ship drug as well. Notes Porges:

In­cyte’s flag­ship prod­uct, Jakafi (rux­oli­tinib), is ap­proved in mul­ti­ple hema­to­log­i­cal in­di­ca­tions and ge­o­gra­phies and fits the pro­file of Gilead’s port­fo­lio and or­ga­ni­za­tion, par­tic­u­lar­ly since the demise of their own JAK in­hibitor, mo­melo­tinib. In­cyte has a promis­ing im­munother­a­py drug in late-stage de­vel­op­ment with epaca­do­stat, as well as a port­fo­lio of emerg­ing on­col­o­gy prod­ucts of un­cer­tain val­ue. Our pre­lim­i­nary analy­sis and il­lus­tra­tive merg­er mod­el in­di­cates that Gilead could af­ford to pay ~30-40% pre­mi­um ($173-187/share) for In­cyte and still gen­er­ate a ro­bust ~19% ac­cre­tion by year 5. Sim­i­lar­ly, our analy­sis in­di­cates that the trans­ac­tion could gen­er­ate a sig­nif­i­cant 11% in­ter­nal rate of re­turn (IRR) for Gilead share­hold­ers over the next ten years. This rate of re­turn is slight­ly high­er to the ex­pect­ed re­turn from our ear­li­er analy­sis of an ac­qui­si­tion of Ver­tex, and would amount to a suc­cess­ful de­ploy­ment of cap­i­tal, at least up to a price of $220/share.

The year got start­ed with a tremen­dous burst of en­thu­si­asm for the buy­outs to come this year. But M&A has large­ly been a bust, with big dis­trac­tions on tax re­form as well as an un­re­solved case of stick­er shock for every­thing on the mar­ket with a nice set of as­sets to in­spect. In the mean­time, a lit­tle on­line win­dow shop­ping will have to sub­sti­tute for the re­al thing.

 

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Vikram Sheel Kumar, Clear Creek Bio CEO

In search for next-gen Covid treat­ment, Pfiz­er taps tiny biotech for re­search deal

Pfizer has inked a deal to develop a new Covid therapy with Clear Creek Bio — a 10-person biotech out of RA Capital with an office in Cambridge, MA, but one that operates fully remotely.

Paxlovid has become a big moneymaker for Pfizer this year, projecting $22 billion in sales on the year. But the Big Pharma has begun its search for a next-generation Covid antiviral and potential combination therapies as supply of Paxlovid greatly eclipses actual use of the antiviral.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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