Brent Saun­ders has a mes­sage for Al­ler­gan in­vestors to­day: He feels your pain

The past three years have been a bumpy down­hill ride for share­hold­ers at Al­ler­gan $AGN. And dur­ing his Q1 call to­day he want­ed to un­der­score that he knows just how much that hurts. He and the board have been talk­ing with dozens of sig­nif­i­cant in­vestors, in­clud­ing Ap­paloosa’s ac­tivist chief David Tep­per — who tried and failed to force Saun­ders to bring in an in­de­pen­dent chair­man. And he tried to as­sure every­one on the call that he’s on the job.

David Tep­per

“Let me be clear. I share that frus­tra­tion, I un­der­stand that frus­tra­tion,” he said. “I am a very large share­hold­er rel­a­tive to my own per­son­al hold­ings in Al­ler­gan.” Same as the man­agers.

“The board is on it. The board is en­gaged. Stay tuned.”

Those re­marks dur­ing the Q&A echoed his pre­pared com­ments, which al­so dealt with a $2.5 bil­lion write­down pri­mar­i­ly due to the late-stage fail­ure of ra­pastinel. Said Saun­ders:

“The sense of ur­gency to cre­ate val­ue is high and the board is ac­tive­ly and con­tin­u­ous­ly re­view­ing al­ter­na­tive av­enues that could un­lock val­ue in the near term.”

In the mean­time, Saun­ders and the team tried to re­as­sure an­a­lysts that there were some sure things with­in reach, topped by 4 promised — the word “ex­pect­ed” was used — ap­provals for:

— Cariprazine for bipo­lar de­pres­sion.

— Ubro­gepant for acute mi­graine.

— Abic­i­par for neo­vas­cu­lar age-re­lat­ed mac­u­lar de­gen­er­a­tion.

— Bi­mato­prost for glau­co­ma.

You can wrap up the rest of the as­sur­ances in a se­ries of phras­es.

“Every­thing is on the ta­ble…Sense of ur­gency…Stay tuned.”

Af­ter a year of near si­lence on the deal front, we got an­oth­er burst of as­sur­ances from Saun­ders  — free of any specifics.

R&D is the lifeblood of Al­ler­gan. There’s a com­mit­ment to con­tin­u­ous in­no­va­tion to dri­ve growth. Ten Phase III stud­ies are un­der­way with a va­ri­ety of tri­als emerg­ing from their part­ner­ships. They are con­stant­ly look­ing for new sci­ence, new col­lab­o­ra­tions, re­cruit­ing the best sci­en­tists to up­grade the com­pa­ny’s skills.

And so on.

Marc Good­man at SVB Leerink summed it up like this:

A “glass is half emp­ty” view of these thoughts would be that man­age­ment keeps say­ing the same things over again re­gard­ing this top­ic. How many times have we heard the board has a sense of ur­gency? A “glass is half full” view would be that the CEO did say “stay tuned’ sev­er­al times dur­ing the call when asked about po­ten­tial change.

Vamil Di­van at Cred­it Su­isse doesn’t know how much wa­ter is in the glass, not­ing an­oth­er dip in the stock price that greet­ed the Al­ler­gan team’s re­marks.

Some of this was ob­vi­ous­ly due to the broad­er mar­ket weak­ness to­day but we think much of this was al­so due to in­vestors be­ing dis­ap­point­ed that there was not a more con­crete near-term plan laid out for al­ter­na­tive ways the com­pa­ny may look to gen­er­ate share­hold­er val­ue. It ap­pears the Board is con­sid­er­ing some op­tions fol­low­ing re­cent dis­cus­sions with var­i­ous share­hold­ers, but un­til we get more clar­i­ty on what steps the com­pa­ny may pur­sue, we be­lieve it will be dif­fi­cult for shares to gain any sig­nif­i­cant mo­men­tum.

How ex­act­ly did the mes­sage play with in­vestors? Al­ler­gan shares are down 5% Tues­day af­ter­noon.

Im­age Source: Brent Saun­ders. AP

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.