Emergent BioSolutions, Inc.

Mpox last gained national attention during a 2022 outbreak. After years relying on the U.S. government to stockpile and distribute Jynneos, Bavarian Nordic is launching the mpox vaccine into the commercial market. Jynneos, the only FDA-approved mpox vaccine, is now commercially available in the U.S., Bavarian Nordic announced Tuesday. The commercial rollout means that interested individuals can access the shot at local pharmacies and physician offices, in addition to the limited number of clinics designated by health authorities. The launch builds on Jynneos’ availability through public health channels since an mpox—then known as monkeypox—outbreak in 2022. It also follows a unanimous decision in October from the U.S. CDC’s Advisory Committee on Immunization Practices to recommend Jynneos as a routine vaccination in adults at risk of mpox infection, backing the shot’s use beyond an outbreak. People at risk of mpox include men who have sex with men and others who engage in risky sex practices, according to the CDC. About 2 million individuals in the U.S. are eligible for Jynneos under the CDC’s new recommendation, Bavarian Nordic said, citing CDC estimates. About 60% of those people remain completely unvaccinated, and 15% have received only one of the two vaccine doses. A real-world case-match study conducted in 12 U.S. jurisdictions previously showed that Jynneos, when given in two doses, was estimated to be 85.9% effective against mpox. At one dose, the vaccine was found to be 75.2% effective. Back in 2022, when initial supplies were constrained, the FDA issued an emergency use authorization (EUA) allowing intradermal administration of Jynneos at a lower dose so that a single vial could be used on up to five people. The EUA prioritized sparing doses, while the regular FDA-approved dosing of Jynneos calls for an entire 0.5mL vial given subcutaneously, Peter Costa, the North America medical director at Bavarian Nordic, explained in an interview. Although mpox is no longer considered an emergency, infections still occur at an average monthly rate of about 200 cases in the U.S., with reports across most of the states so far this year. More than 32,000 mpox cases have been reported in the U.S. since the last outbreak in 2022. Jynneos was developed with support from the Biomedical Advanced Research and Development Authority as part of the U.S.’s preparedness efforts. The vaccine got its FDA approval for the prevention of smallpox and mpox in 2019 and has been supplied to the government for national stockpiling. Jynneos was Bavarian Nordic’s first revenue-generating product until the Danish company in 2020 decided to add more commercial products under a deal with GSK. Last year, Jynneos, which is also known as Imvamune or Imvanex outside the U.S., nearly tripled its prior-year sales to reach more than DKK 5 billion ($720 million). The revenues came from contracts with various governments, including the U.S. The mpox shot also received immunization recommendations from authorities outside the U.S., including Germany, which could potentially also enable a commercial launch in those countries, according to Bavarian Nordic. Despite setting a company revenue record in 2023, Bavarian Nordic realized that Jynneos’ sales wouldn’t be sustainable as the number of mpox cases declines in part thanks to the protection provided by the vaccine, CEO Paul Chaplin said on the company’s fourth-quarter earnings call in March. Still, Bavarian Nordic expects its total 2024 revenue to come in a range between DKK 5 billion to DKK 5.3 billion. This guidance includes contribution from travel vaccines, which contributed nearly DKK 1.9 billion in sales last year. The Danish company last year beefed up its offerings with the acquisition of Emergent BioSolutions’ travel health business, which includes the typhoid vaccine Vivotif and the cholera vaccine Vaxchora. For Jynneos, Chaplin touted additional customers in the public preparedness sector that the company signed on during the mpox outbreak, as well as “concrete discussions” with other governments for more contracts. The U.S. private market will give the Jynneos franchise another boost, he said. Jynneos is the first vaccine that Bavarian Nordic is taking through the entire U.S. commercial process, including signing reimbursement deals with payers, Lee Ann Kimak, the company’s U.S commercial lead, noted during the interview.  After the free government-run Jynneos program winds down, Bavarian Nordic will work to make sure that uninsured people also have access to Jynneos, including by working with the CDC’s Vaccines for Adults program, which offers recommended vaccinations to people at no cost, Kimak said. Jynneos isn't expected to be a seasonal vaccine like flu shots, but Kimak said the company expects some spikes in demand prior to pride events. Bavarian Nordic has partnered with organizations such as the National Coalition of STD Directors and the National Coalition of LGBTQ Health to raise awareness and promote access to Jynneos. Editor's Note: The story was updated with additional information from an interview with Bavarian Nordic's Peter Costa and Lee Ann Kimak.

Appoints Abigail “Abbey” Jenkins, a veteran biotech executive with over 20 years of experience in commercial leadership, to Board of DirectorsWARREN, N.J., April 01, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the appointment of Abigail Jenkins to the Company’s Board of Directors, effective April 1, 2024. Ms. Jenkins has two decades of leadership in large and small biotech and pharmaceutical companies, with a focus on commercial launch and corporate strategy roles. “I am very pleased to welcome Abbey to the Aquestive Board of Directors. Her two decades of experience in the commercialization of pharmaceutical products, as well as her general management and leadership experience in the biopharmaceutical industry, will make her a vital asset to the Company, especially as we continue to develop our first and only orally administered epinephrine product candidate, Anaphylm™,” said Dan Barber, President and Chief Executive Officer of Aquestive. “The appointment of Abbey is one of our first steps in re-establishing our commercial capabilities.” Aquestive’s Board of Directors will now be comprised of eight directors, seven of whom are independent directors. “We are delighted to welcome Abbey to the Board of Directors,” said Santo J. Costa, Chairman of the Board of Aquestive. “Abbey is a highly skilled and experienced leader who will significantly contribute to the Board of Directors carrying out its mandate. Her experience with innovative drug delivery systems and the launches of novel therapeutics will be extremely valuable to the Company as it moves forward.” Ms. Jenkins said, “I am pleased to be joining the Aquestive Board of Directors during these exciting times. I see great promise in Aquestive’s innovative delivery technologies, including Anaphylm which has the potential to transform the treatment of anaphylaxis.” About Abigail JenkinsAbigail “Abbey” L. Jenkins, M.S., is President and Chief Executive Officer of Gamida Cell Ltd. (NASDAQ: GMDA), a pioneer in cell therapies, and a member of the company’s Board of Directors. Ms. Jenkins brings more than 20 years of leadership experience in the biopharmaceutical industry delivering life-enhancing therapies from research to commercialization for patients in need. Prior to joining Gamida Cell, Ms. Jenkins served as the chief commercial and business officer at Lyndra Therapeutics, Inc., a clinical-stage biopharmaceutical company, where she established and led global commercial, business development, corporate strategy and portfolio management across multiple therapeutic areas. Prior to Lyndra Therapeutics, Ms. Jenkins served as senior vice president and business unit head of vaccines at Emergent BioSolutions, Inc. (NYSE: EBS) where she oversaw the company’s largest therapeutic division from discovery through commercialization. Ms. Jenkins also served as chief commercial officer and U.S. business head at Aquinox Pharmaceuticals, Inc. Additionally, Ms. Jenkins has held senior commercial and business development positions at Relypsa, Inc., Actavis (now Teva Pharmaceuticals Ltd.), Pfizer and Medimmune, LLC (now AstraZeneca). Ms. Jenkins holds a Master of Science in biotechnology and biotech business enterprise from The Johns Hopkins University, a Bachelor of Arts in psychology and biology from Indiana University, and a certificate of achievement in General Management as a Kellogg Executive Scholar. Ms. Jenkins was recognized in 2022 as one of the PharmaVoice 100, one of the industry’s 100 Most Inspiring Leaders, Disrupter Category, for change agents who define excellence in leadership in biopharma. About AquestiveAquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. The Company is developing pharmaceutical products to deliver complex molecules, through administrations that are alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis. For more information, visit Aquestive.com and follow us on LinkedIn. Forward-Looking Statement Certain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of Anaphylm™ (epinephrine) Sublingual Film for the treatment of severe allergic reactions, including anaphylaxis, through clinical development and regulatory approval by the U.S. Food and Drug Administration, the potential benefits Anaphylm could bring to patients, and other statements that are not historical facts. These forward-looking statements are based on our current expectations and beliefs and are subject to a number of important, factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including, but not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials for Anaphylm and other risks and uncertainties affecting the Company described in the section entitled “Risk Factors” and in other sections included in Aquestive’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in any subsequent reports filed with the SEC. These documents contain and identify important factors that could cause the actual results for Aquestive to differ materially from those contained in Aquestive’s forward-looking statements. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. Aquestive specifically disclaims any obligation to update any forward-looking statement, except as required by law. PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. Investor Inquiries:ICR Westwicke Stephanie Carrington stephanie.carrington@westwicke.com646-277-1282

As the first-ever U.S. Food and Drug Administration (FDA) approved over-the-counter (OTC) naloxone in 2023, Emergent is working to expand access with NARCAN® Nasal Spray and build on its longstanding efforts with public interest entities across the country Hundreds of thousands of NARCAN® Nasal Spray cartons are available in over 32,000 retail locations in the U.S., and Emergent is working to increase reach into workplaces, businesses and other locationsApproximately 22 million doses of NARCAN® Nasal Spray were distributed in the U.S. and Canada in 2023, and Emergent is committed to meeting any increase in demand driven by the evolving and worsening epidemicThe recently announced ‘White House Challenge to Save Lives from Overdose’ is a nationwide call-to-action that includes increasing access to life-saving opioid overdose reversal medications, a program with direct alignment to Emergent’s strategy and efforts since the launch of NARCAN® Nasal Spray in 2016Naloxone, the active ingredient in NARCAN® Nasal Spray, is a life-saving medication that can reverse an overdose from opioids, including heroin, fentanyl, and prescription opioid medications, when given in time GAITHERSBURG, Md., March 28, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) remains committed to fighting the ongoing opioid crisis by broadening access to, and awareness of, NARCAN® Nasal Spray to help save lives in opioid overdose emergencies. In 2022, the U.S. Centers for Disease Control and Prevention (CDC) reported over 107,000 overdose deaths – a number that has risen almost every year and which has continued to break annual records.1 This includes a rise in synthetic opioid overdoses mainly driven by fentanyl.1 There is an inherent risk of potential overdose, wherever opioids are present, which has tragically become the leading cause of accidental death in the U.S.2 These statistics only further underscore the need for multi-sectoral action to address and prevent opioid overdose deaths. One year after Emergent obtained the historic OTC U.S. FDA approval in March 2023 and seven months since retail launch in August 2023, the availability of NARCAN® Nasal Spray in pharmacies, grocery stores and online retailers has helped more people gain access to this life-saving product. Emergent and other stakeholders in the fight must continue raising awareness about the availability of products like NARCAN® Nasal Spray, reducing stigma and further improving access for all Americans. Since the OTC launch, NARCAN® Nasal Spray can be purchased at more than 32,000 mass drug, grocery, online retailers and e-commerce sites. Emergent is working with retail partners to make it easy to find and access, however each retailer ultimately determines in-store product placement. In 2023, Emergent distributed approximately 22 million doses (~11 million two-dose cartons) in the U.S. and Canada through public interest organizations like state and harm reduction groups and retail locations. Emergent also announced a shelf-life extension from 36 to 48 months for NARCAN® Nasal Spray in the U.S., further demonstrating its commitment to ensuring more medicine is available for the public to access. “We’re living in a time when one person dies approximately every six minutes from an accidental opioid overdose – prevention and response efforts require an all-hands on deck approach toward lessening this devastating public health crisis,” said Joseph Papa, president and CEO of Emergent. “In my first month leading Emergent, and alongside our dedicated colleagues, we continue to advance our mission to protect the public from threats such as the opioid epidemic and am proud of our efforts to help save lives.” Emergent is now engaging with partners who are aligned with its mission to expand access, awareness and availability, such as the National Safety Council (NSC*), working together to educate and reach businesses and employers. Specifically, Emergent sees brick and mortar stores, airlines, restaurants, hotels and schools as critical locations where NARCAN® Nasal Spray should be made available in case of an emergency, alongside AED kits. “We know that NARCAN® Nasal Spray alone can’t solve the opioid crisis – and that opioid overdose reversal medication can only be useful if present and administered when a person is experiencing an overdose. When bystanders are unable to provide life-saving measures such as naloxone in nearly half of fatal overdoses, our role to help expand the reach of this medication has never been more important,” said Paul Williams, senior vice president, products business, Emergent. “That’s why we remain committed to increasing awareness of NARCAN® Nasal Spray availability. We also applaud the Biden Administration for their recently announced plan to address the opioid crisis, and Emergent remains prepared to support efforts to our fullest capacity and help save more lives.” Emergent is also maintaining affordability of NARCAN® Nasal Spray and is ready to meet public need as necessary and arm individuals with an essential tool to combat against opioid overdose. As announced at the OTC retail launch last year, the Manufacturer’s Suggested Retail Price of NARCAN® Nasal Spray is $44.99 per two-dose carton, which is equivalent to roughly $22.50 per dose. While Emergent works with partners to help maintain access and affordability, the price of the product is set by individual retailers. Emergent set the public interest price at $41.00 per two-dose carton, building on its long-standing engagement with public interest groups to ensure naloxone is readily available to at-risk communities. In addition, Emergent continues to prioritize efforts to reduce the barriers to access, including addressing stigma, encouraging businesses and school districts to carry naloxone, supporting policy to ensure Health Spending Account (HSA) and Flexible Saving Account (FSA) eligibility for naloxone and working with state Medicaid agencies to provide coverage. NARCAN® Nasal Spray is an appropriate choice for a known or suspected opioid overdose as immediate administration, however it is not a substitute for emergency assistance. To learn more about this life-saving medicine and access resources, education and advocacy tools, visit NARCAN.com. *As a contracted commercial partner of Emergent, NSC will receive a fee for service. About NARCAN® Nasal Spray NARCAN® Naloxone HCl Nasal Spray 4 mg is the first FDA-approved, over-the-counter (OTC) 4 mg naloxone product for the emergency treatment of opioid overdose. NARCAN® Nasal Spray is not a substitute for emergency medical care. Repeat dosing may be necessary. Use as directed. About Emergent BioSolutions At Emergent, our mission is to protect and enhance life. For 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “intend,” “may,” “plan,” “position,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statements will be accurate. Readers should realize that if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake any obligation to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by any forward-looking statements. Readers should consider this cautionary statement, as well as the risk factors and other disclosures included in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements. Investor Contact:Richard S. LindahlExecutive Vice President, CFOlindahlr@ebsi.com Media Contact:Assal HellmerVice President, Communicationsmediarelations@ebsi.com 1 Centers for Disease Control and Prevention. (March 21, 2024). Drug Overdose Deaths in the United States, 2002–2022. https://www.cdc.gov/nchs/products/databriefs/db491.htm 2 Centers for Disease Control and Prevention. (February 14, 2022). Understanding Drug Overdoses and Deaths. https://www.cdc.gov/drugoverdose/epidemic/index.html