Valeant Pharmaceuticals Australasia Pty Ltd.

Shares in the biotech are currently down around 98.5% compared to highs in August 2020, when plans for the manufacturing of potential vaccines and Covid-19 therapeutics were in full swing. Image credit: GettyImages/SAUL LOEB. Emergent BioSolutions has initiated the next phase of its cost-saving plan as the struggling biopharma aims to turnaround financial performance. The company will lay off around 300 employees, along with the elimination of approximately 85 positions. Emergent also said it will shut down two of its US-based complexes – a drug substance manufacturing facility in Baltimore and a drug product facility in Maryland. Emergent will concentrate operations at its other sites in Winnipeg, Canada, and Lansing, Michigan. Shares in the biotech are currently down around 98.5% compared to highs in August 2020, when plans for the manufacturing of potential vaccines and Covid-19 therapeutics were in full swing. Most of the company’s sales come through its Narcan (naloxone) nasal spray and anthrax vaccines. The company also garnered success during the Covid-19 pandemic when it helped manufacture vaccines. However, a cross-contamination issue , noted in 2021, meant Emergent was instructed by the US Food and Drug Administration (FDA) to discard or destroy up to an estimated 400 million doses worth of the key component used in vaccines by Johnson & Johnson and AstraZeneca . The fallout from the controversy coupled with weakening sales meant Emergent needed to install a new operational plan to improve profitability. See Also: Magazine: Anticipation rises for RSV rollout as positive data emerges GRN-300 by Greenfire Bio for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval Last August, the company pushed its CDMO business to one side to focus on its core businesses of medical countermeasures and Narcan. Around 400 employees were also laid off during this time. While Emergent reported $300m in Q1 revenue this year, ready cash remained the key issue. Emergent had $78.5m in the coffers by the end of March. The sweeping changes laid out by CEO Joe Papa are expected to save the company $80m a year. Emergent will take an initial hit of between $18m and $21m to fully implement the restructuring plan. Papa said in a statement: “We have put in place a multi-year plan to position Emergent for sustainable and long-term success, and that starts by stabilising our operations, strengthening our balance sheet and managing our debt.” Papa added that “Decisions like these are never easy” and that Emergent is “committed to providing resources to those affected as they transition to new opportunities”. Emergent hired Joe Papa in February 2024 to turn around the fortunes of the company. Papa was previously CEO of Canadian drugmaker Bausch Health Companies (formerly Valeant Pharmaceuticals). With Papa at the helm, Valeant managed to pay off more than $6bn of debt. Despite financial issues, Emergent has had some regulatory success in the past year. The biotech won full FDA approval for its anthrax vaccine Cyfendus and entered a five-year contract with the US Department of Defense to supply the vaccine to the US military. The deal, signed in January this year, is worth up to $235.8m. In March 2023, Emergent won over-the-counter approval for its Narcan nasal spray, increasing accessibility to the opioid-overdose reversal medicine. In the same month, Emergent sold its travel vaccine portfolio to Bavarian Nordic in a deal that could rise in value to $384m.

Emergent BioSolutions will reduce its current workforce by about 300 employees “across all areas of the company” as part of an organizational restructuring. Just about two months into his CEO job at Emergent BioSolutions, Joseph Papa has laid out his turnaround plan for the CDMO-turned-biopharma company. And it involves a major organizational restructuring. Emergent will reduce its current workforce by about 300 employees “across all areas of the company” and will eliminate about 85 job openings, the company said Wednesday. Simultaneously, the company will close its Baltimore-Bayview drug substance manufacturing facility and its Rockville drug product facility, both of which are located in Maryland. The firm’s sites in Winnipeg, Cananda, and Lansing, Michigan, will conduct the bulk of operations going forward, while the company “actively explores strategic alternatives for its other sites throughout the year.” After the overhaul is fully implemented, Emergent expects to save about $80 million in annual costs. Emergent expects to take a financial hit of around $18 million to $21 million in the second half of 2024 in connection with the restructuring. “Today’s actions are about the future of Emergent,” Papa said in a statement. “We have put in place a multi-year plan to position Emergent for sustainable and long-term success, and that starts by stabilizing our operations, strengthening our balance sheet and managing our debt.” On a call with investors Wednesday afternoon, Papa admitted that the decision to lay off employees was “very difficult.” At the same time, the CEO stressed that the company’s internal review of its business emphasized the need to restructure the way Emergent operates. With regards to Emergent’s continued operations in Lansing and Winipeg, the company sought to prioritize sites that had “the most flexibility” to help the company streamline its facility footprint while still being able to meet demand for its products, Papa said. The reorganization comes as Emergent on Wednesday reported $300 million in first-quarter revenues, which were higher than its previous expectations of between $200 million and $250 million. However, the company’s cash position kept worsening. By the end of March, Emergent had $78.5 million in cash and cash equivalents, down from $112 million at the end of 2023 or $643 million a year prior to that. In another blow to Emergent’s business, the company said Wednesday in a securities filing that the Department of Health and Human Services (HHS) has cut back a 10-year contract signed in 2019 for the smallpox vaccine ACAM2000. For an option to purchase ACAM2000 from year 5 to 9 of the contract, the HHS is reducing the minimum number of doses set for purchase from 9 million to 3.5 million annually.  Papa, who previously served as CEO of Valeant and Bausch Health, was tapped in February to run the show at Emergent as the company works through its transformation from a CDMO to a drug developer. Papa took over for Haywood Miller, who transitioned from an advisory role to become interim CEO last June after Emergent’s previous helmsman Robert Kramer retired. Papa has a history of spearheading turnaround projects at struggling biopharmas, as was the case when he jumped from Perrigo to Valeant Pharmaceuticals in 2016. Under Papa’s leadership, Valeant managed to reduce its debt by more than $6 billion by 2018—the same year the company changed its name to Bausch Health. Emergent, for its part, garnered praise in the early days of the COVID-19 pandemic when the CDMO stepped up to help manufacture vaccines for AstraZeneca and Johnson & Johnson. Things quickly went south, however, after a cross-contamination snafu forced the company to discard hundreds of millions of COVID vaccine doses. In the aftermath of the cross-contamination controversy, Emergent in August unveiled a sweeping plan to de-emphasize its contract manufacturing and development business—alongside plans to scale back operations at its Bayview facility in Baltimore—in order to better focus on its core portfolio of medical countermeasures and the opioid overdose reversal spray Narcan. At the time, Emergent said it would continue to “maintain a level of operations” at its sites in Baltimore and Canton, Massachusetts, in order to respond to future production demand. As part of its business reform, Emergent at the time telegraphed the layoffs of around 400 employs across the entire company. Troubles aside, Emergent has managed to rack up a number of wins over the past year. Last March, the company made history by securing an over-the-counter nod for Narcan, in a move that many hailed as a breakthrough for harm reduction efforts in the U.S. A few months after, Emergent snagged a full approval for its anthrax vaccine Cyfendus in adults ages 18 to 65. And in January, the company picked up a 5-year, $238.5 million contract with the U.S. Department of Defense to supply its previous anthrax immunization, BioThrax, to various branches of the military. Meanwhile, Emergent recently received a clean bill of health at its Baltimore Bayview facility—now slated for closure—when the FDA granted the plant a “No Action Indicated” classification. The NAI tag means the FDA found the Bayview facility to be in an acceptable state of compliance with U.S. manufacturing standards. Editor's note: This story has been updated with additional details from a securities filing and Emergent's first-quarter earnings call. 

“At Santander Pharma Consulting, our mission is clear: to help our clients optimize their commercial success by leveraging our teams’ experience,” said Robert Yanez, the firm's co-founder and CEO. There’s a new life-sciences-focused consulting firm in town. Founded by a duo with about half a century’s worth of experience in biopharma and medtech between them, Santander Pharma Consulting—no relation to the major banking firm—stepped into the spotlight with a launch announcement Tuesday. The firm, based in Durham, North Carolina, will offer a range of support services to drug and devicemakers of all sizes, though its focus is on “small or emerging enterprises,” per Santander’s website. To those clients, it’ll offer guidance on commercial strategy development, team building, revenue generation, business planning and development, and financial management. Santander has pledged to provide “hands-on support” in each of those areas, with an aim of “delivering tailored solutions that drive growth, maximize efficiency, and ensure compliance,” according to Michelle Yanez, the firm’s co-founder and chief financial officer. “At Santander Pharma Consulting, our mission is clear: to help our clients optimize their commercial success by leveraging our teams’ experience,” Robert Yanez, another co-founder and the firm’s CEO, added in the announcement. Fierce Pharma Marketing has reached out to Santander for clarification on the relation, if any, between Michelle Yanez and Robert Yanez. Each of the founders arrives at the consultancy with more than two decades of experience in the life sciences industry. Michelle spent the bulk of her career—from 2002 to 2022—at specialty pharma BioDelivery Sciences International, including a stint as director of financial reporting through BDSI’s acquisition by Collegium Pharmaceutical in early 2022. She joined Mira Pharmaceuticals as financial controller and director in May of that year and was named its CFO a year later. Robert, meanwhile, got his start as a product manager at GSK, Valeant Pharmaceuticals—now Bausch Health—and Johnson & Johnson. From there, he spent about six years in increasingly senior marketing director roles at XenoPort, followed by stints as director of commercial operations at BDSI and as senior director first of marketing and global research sales, then of strategic partnerships within the Americas, for devicemaker Circassia, now known as NIOX Group. Since early 2021, he’s served as chief commercial officer of Bryn Pharma.