CEO Ron Cohen (Acorda)

Acor­da of­floads man­u­fac­tur­ing op­er­a­tions to Catal­ent for $70M amid lat­est re­struc­tur­ing to keep the ship afloat

Just over a year af­ter the Supreme Court quashed any hopes Acor­da had of pro­tect­ing its once-lu­cra­tive mul­ti­ple scle­ro­sis drug Ampyra from cheap­er knock­offs, the New York biotech con­tin­ues to bleed cash. Now, as part of its third re­struc­tur­ing since 2017, the drug­mak­er is of­fload­ing one of its key as­sets.

As part of a sweep­ing over­haul Acor­da will sell its man­u­fac­tur­ing op­er­a­tions for In­bri­ja — an in­haled pow­der for­mu­la­tion of lev­odopa — to Catal­ent for $70 mil­lion in up­front cash that will save Acor­da an ad­di­tion­al $10 mil­lion.

Catal­ent will ab­sorb all Acor­da em­ploy­ees who work at the Chelsea, MA fa­cil­i­ty, but that’s not the case for much of the com­pa­ny’s re­main­ing work­force. CEO Ron Co­hen an­nounced that be­tween the Ard­s­ley, NY head­quar­ters and its Waltham, MA fa­cil­i­ty, Acor­da would lay off rough­ly 16% of its work­force.

Co­hen por­trayed the re­struc­tur­ing, which is es­ti­mat­ed to re­duce op­er­at­ing ex­pens­es by $40 mil­lion, as “dif­fi­cult” but need­ed, and a way to bol­ster Acor­da’s bal­ance sheet and en­sure that the sup­ply of In­bri­ja was not in­ter­rupt­ed.

“The re­struc­tur­ing is nec­es­sary for Acor­da to have an in­fra­struc­ture and ex­pens­es that are right-sized for our prod­ucts and rev­enue,” Co­hen said. “This is a dif­fi­cult step for us all, not least for those who will no longer be em­ployed at the com­pa­ny.”

The sale of the man­u­fac­tur­ing op­er­a­tions is ex­pect­ed to close in the first quar­ter, the com­pa­ny said in a press re­lease.

Acor­da on Wednes­day al­so an­nounced it had en­tered in­to a $15.25 mil­lion at-the-mar­ket of­fer­ing, which comes less than two weeks af­ter a re­verse 1-for-6 stock split. That split re­duced the com­pa­ny’s to­tal stock shares from 371 mil­lion to 61.6 mil­lion af­ter the stock price had fall­en be­low the re­quired $1 per share price to con­tin­ue trad­ing on the Nas­daq.

The com­pa­ny last re­struc­tured in Oc­to­ber, when Co­hen slashed a quar­ter of Acor­da staff while cut­ting back R&D and SG&A ex­pens­es af­ter Ampyra rev­enue plum­met­ed and In­bri­ja rev­enue wasn’t near­ly enough to make up the dif­fer­ence. Ampyra rev­enue con­tin­ued to drop in Q4, falling from $37 mil­lion in Q3 to $25 mil­lion (the drug brought in $138 mil­lion in net rev­enue in 2018 Q3).

In 2017, Acor­da laid off 20% of its staff (which at the time amount­ed to over 100 staffers) in an ef­fort to pre­empt loom­ing loss­es over the Ampyra patent de­ba­cle. That move saved the com­pa­ny $21 mil­lion, but those moves didn’t ul­ti­mate­ly staunch the bleed­ing.

Acor­da didn’t an­nounce specifics Wednes­day on any plans to re­struc­ture its debt — which End­points News re­port­ed in Oc­to­ber sat around $345 mil­lion — oth­er than to say the man­u­fac­tur­ing op­er­a­tions sale would pro­vide more flex­i­bil­i­ty to “re­duce” debt.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

Man­u­fac­tur­ing roundup: GSK opens a new fa­cil­i­ty at Barnard Cas­tle lo­ca­tion; Tenaya Ther­a­peu­tics com­pletes build­out of Bay Area ge­net­ic med­i­cine man­u­fac­tur­ing site

GSK is continuing to build out its Barnard Castle site in the UK.

According to the company, it has opened a new aseptic smart manufacturing facility at the site, which is located in County Durham in the northeast of England.

The new facility, known as Q Block, is a fully automated and digital facility that leverages digital technology to make manufacturing operations as efficient as possible.

The 11,500-square-meter facility started construction in 2018 and according to the UK news site Business Live, the costs for the new building were £90 million, or around $110 million.

FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

A drug manufacturing facility in Mexico is drawing the ire of the FDA after it ignored the US regulator’s inspection requests and phone calls.

According to the warning letter issued on June 13, Glicerinas Industriales refused a pre-announced inspection during a phone call with FDA prior to the inspection at the company’s facility in Zapopan, Mexico, a city next to Guadalajara, which was planned for May 16 to May 20.

invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.