Sheldon Koenig, Esperion CEO

Es­pe­ri­on gets out the bud­get ax, chop­ping 170 staffers as its big drug launch sput­ters

Es­pe­ri­on’s ex­ec­u­tive team spent years in­sist­ing that they had found the sweet spot in the mar­ket for their cho­les­terol drug. But that strat­e­gy has soured bad­ly, and af­ter strug­gling to sell its heart dis­ease pill for more than a year, the biotech says it will cut about 40% of its staff over the next few weeks.

The lay­offs will take place across the board, from sales and mar­ket­ing to R&D, CEO Shel­don Koenig told End­points News on Mon­day. While the chief ex­ec­u­tive de­clined to elab­o­rate on how many em­ploy­ees will be af­fect­ed, an SEC fil­ing stat­ed that ap­prox­i­mate­ly 170 staffers are on the chop­ping block.

The re­duc­tions, which will be com­plete by the end of the month, are ex­pect­ed to save the com­pa­ny up to $80 mil­lion go­ing in­to 2022, Koenig said. Es­pe­ri­on’s stock $ES­PR dipped about 4.7% up­on the news, with shares pric­ing at $8.71 apiece. Shares have fall­en more than 74% over the last year.

Nexle­tol, Es­pe­ri­on’s “goldilocks” cho­les­terol ther­a­py al­so known as be­mpe­doic acid, was ap­proved back in ear­ly 2020 as an oral op­tion that’s bet­ter than decades-old statins, but not as ef­fec­tive — or as ex­pen­sive — as in­jectable PC­SK9 ther­a­pies. A week lat­er, the FDA ap­proved Nexl­izet, a com­bi­na­tion of be­mpe­doic acid and eze­tim­ibe (an­oth­er cho­les­terol-low­er­ing med­i­cine).

Es­pe­ri­on thought that with a smart pric­ing strat­e­gy — Nexle­tol costs just over $11 per day — it could beat out the pricey PC­SK9s Repatha and Pralu­ent.

But launch­ing a heart drug amid the pan­dem­ic proved to be a chal­lenge. Pa­tients were see­ing their doc­tors less of­ten, sales forces couldn’t trav­el, and even if they could, physi­cians’ of­fices weren’t nec­es­sar­i­ly open to reps. Es­pe­ri­on pock­et­ed just $12.1 mil­lion last year on a drug they al­ways be­lieved would be a block­buster.

In April, Es­pe­ri­on turned to Dai­ichi Sankyo, the Japan­ese phar­ma that was al­ready com­mer­cial­iz­ing Nexle­tol in Eu­rope and Japan. Es­pe­ri­on struck a deal with Dai­ichi to mar­ket the drug in oth­er re­gions in ex­change for $30 mil­lion cash, tiered roy­al­ties and $175 mil­lion in mile­stones.

“It def­i­nite­ly was prob­a­bly the hard­est time to ever launch prod­ucts, right in the mid­dle of Covid, which was March of 2020,” Koenig said.

Koenig took the helm in May, short­ly af­ter long­time for­mer CEO Tim Mayleben aban­doned his post. At the time, the com­pa­ny’s stock had been trad­ing for less than half of what it was when Nexle­tol was ap­proved in Feb­ru­ary.

The chief ex­ec­u­tive says the com­pa­ny has seen a bit of a boost in the last cou­ple quar­ters, with de­mand ris­ing 30% be­tween first and sec­ond quar­ter this year, and 10% be­tween sec­ond and third.

The com­pa­ny’s cur­rent­ly work­ing on a Phase III tri­al dubbed CLEAR Out­comes in car­dio­vas­cu­lar pa­tients who have statin in­tol­er­ance and el­e­vat­ed LDL-C, or “bad” cho­les­terol lev­els. Topline re­sults from that study are com­ing in ear­ly 2023, Koenig said.

“We still be­lieve that we can con­tin­ue to have con­sis­tent growth be­tween now and when the CLEAR Out­comes study re­ports out,” he added.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Richard Lerner (Scott Audette/AP Images)

Richard Lern­er, an­ti­body pi­o­neer and long­time pres­i­dent of Scripps Re­search, dies at 83

Richard Lerner, the esteemed biochemist who pioneered a new way to develop monoclonal antibodies and led Scripps Research Institute to prominence, has passed away.

A spokesperson for Scripps told the San Diego Union-Tribune that Lerner died of cancer in his La Jolla home. He was 83 years old.

Among other things, Lerner’s lab was known for devising a new technique for creating antibodies — deployed as cancer treatments as well as in immunology and disease research — one that the New York Times called a “major advance in biotechnology.” It led to companies making mAbs a thousand times faster, more accurately, at a lower cost. That foundational research cemented the discovery of Humira, which went on to become the world’s best-selling treatment.

Gary Glick, Odyssey Therapeutics founder

Al­ways busy, Gary Glick re­cruits Or­biMed in a mas­sive $218M Se­ries A for enig­mat­ic da­ta sci­ence biotech

Gary Glick is back at it again, founding yet another biotech company. And by the sheer size of its first raise, this may be the biggest one yet.

Glick has assembled what he calls an all-star roster and recruited one of the biggest healthcare investors in OrbiMed to put together a massive $218 million Series A for his newest venture, Odyssey Therapeutics. The launch, announced Tuesday morning and co-led by SR One Capital Management, comes not three months after Glick sold First Wave Bio to AzurRx for $229 million.

Klick Health agency employees appear in its annual holiday greeting video with this year's theme to #SpreadJoy (via Klick Health)

Klick Health hands out $100 bills in an­nu­al hol­i­day greet­ing that’s turned in­to de­fault re­cruit­ing tool

Editor’s Note: For more news, analysis and exclusive coverage from the marketing beat, subscribe to the Endpoints MarketingRx weekly report in your reader profile.

What would you do with $100 and the simple instruction to “spread joy?” That’s what pharma and healthcare agency Klick Health asked its employees as part of its annual holiday greeting for clients, friends and future recruits.

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