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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Winselow Tucker, Eli Lilly's new Loxo unit chief commercial officer

Eli Lil­ly plucks a new com­mer­cial chief from Bris­tol My­ers in man­age­ment shuf­fle as HR chief re­tires

Eli Lilly has found a new chief commercial officer from among the ranks at Bristol Myers Squibb, as it says farewell to its longtime head of human resources Stephen Fry.

Fry announced on Thursday his plans to retire after more than 35 years with Lilly. He’ll vacate his seat as SVP of human resources and diversity at the end of the year, and current Loxo CCO Eric Dozier is slated to take his place. As a result, BMS’ Winselow Tucker is joining the team as Loxo CCO at the end of the month.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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