Outlook for the Biopharmaceutical Industry in 2021 Following Biden’s Victory

With Joe Biden’s victory in the U.S. presidential election -- and despite the fact that people across the globe have already received COVID-19 vaccines from Pfizer and Moderna -- the true impact on the biopharmaceutical industry will focus on a few highlights. They include collaboration with the U.S. Food & Drug Administration (FDA), providing affordable drugs to patients, innovation and venture capital investment. Obviously, the first priority will be to eliminate the current pandemic.

Biden has a history of working with the biopharmaceutical industry, which is expected to continue during his term in office. Between his Cancer Moonshot initiative, a bipartisan effort to increase cancer research; his 21st Century Cures negotiations in his role as vice president during the Obama Administration; working to reduce drug costs; and expanding the Affordable Care Act (ACA) to give more Americans access to health insurance; biopharma has been a top priority for him. He also hails from Delaware with its own longstanding tradition in life sciences research and development.

EisnerAmper spoke with a series of executives to get their perspectives on how the biopharmaceutical industry will be impacted with Biden taking office.

FDA Collaboration with Biopharmaceutical Companies

During the COVID-19 pandemic, the FDA was in the spotlight and collaborated with various companies to come up with COVID-19 vaccines, despite pushback that the vaccines rolled out too quickly.

“The COVID-19 pandemic changed everything, most notability the accessibility to the FDA who has been good at collaborating with pharmaceutical companies and academics and the hope is that continues going forward,” said J. Christopher Mizer, president and CEO of Vivaris Capital, a private equity group in San Diego that invests in middle-market health care and life sciences businesses. “The FDA’s Right to Try allowed for expedited development of unapproved drug treatments.”

The Biden Administration is expected to work to restore the public’s trust in the FDA and that its Emergency Use Authorization (EUA) to make medical devices and therapeutics available as quickly as possible to treat COVID-19 is used dependent on good science.

Affordable Drugs

Given Biden’s background with the Affordable Care Act, he is expected to press the biopharmaceutical industry to lower out-of-pocket costs for patients in health care.

“We must mention Trump’s plan to sabotage the ACA, something that was implemented when Biden served as vice president. And now with his takeover, we would expect higher coverage, more access to patients, and a thus easier-to-reach consumer base for pharma,” said Hector Jirau, managing partner of Jirau Capital Management, a Puerto Rico-based investment management firm focused on the biotechnology and pharmaceutical industries.

Debbie Hart, the president and CEO of BioNJ, a life sciences trade association in New Jersey, added: “We share the president-elect’s concerns that any patient is somehow unable to afford necessary and lifesaving medications. We look forward to working with our Congressional delegation and the new Biden Administration to enact common sense reforms that both protect patient access and biopharmaceutical innovation and address the pandemic and other health challenges head on.”

Beth Halpern, a partner at law firm Hogan Lovells who spoke at California Life Sciences Association’s (CLSA’s) Pantheon 2020 Virtual Conference in December, added that Biden is expected to expand access to affordable health care.

“There are two prongs to this,” she said. “The first one is building on and expanding the Affordable Care Act (Bidencare) including making Medicare available for younger people and making premiums more affordable. The second one is the affordable side including looking at drug pricing and addressing the Most Favored Nation (MFN) pricing model.”

Trump’s MFN was deemed detrimental for the biopharmaceutical industry since it lowered reimbursement to physicians, fostering challenges for people to pay for medicine.

Innovation

Amid pressing affordable health care concerns, Biden is expected to ensure the biopharmaceutical industry continues to innovate on many fronts. Throughout the COVID-19 pandemic, the FDA innovated in numerous ways: adopting remote policies such as telemedicine, fostering a new approach to clinical trials, leveraging technology to remotely inspect a factory rather than going on premise and more.

“Biden is known to support innovation and understands the complexity of the pharmaceutical industry and how biotechnology is a leading asset in our country, rather than an industry polluted with greed and not patient-centric,” Jirau said. “Lead by a science-driven agenda, 2021 will be the year of gene and cell therapies. Certainty brings risk-led opportunity, and I expect these two niches to dominate the industry.”

Biden is also expected to push for increased efforts to make coding and payments for new technologies accessible to patients, implement breakthrough devices being eligible for Medicare coverage, accelerating coverage of innovative technologies, and more.

Fritz Bittenbender, senior vice president of access and external affairs at Genentech, who also spoke at Pantheon 2020, said: “We have never seen a greater time for innovation between device, diagnostics and the pharmaceutical industry focus on how we can have the best outcomes against COVID-19, bringing hope to get America back up and running, bringing hope to allow families to gather again.”

Mizer added: “AI technology is starting to bear some fruit in terms of drug development and clinical trials and point of care, which will all accelerate in 2021.”

However, the industry needs to keep in mind that legislation needs to be created around innovation.

Mike Guerra, president and CEO of the California Life Sciences Association (CLSA), added: “American innovation leads the world. Investment into this innovation is critical; if drug prices are set arbitrarily low, based on what is paid by governments in foreign countries who spent nothing developing these products, then the ability to attract new investment within the United States virtually disappears. This is especially true for rare diseases or diseases with smaller patient populations.”

Venture Capital Interest

Due to continued innovation in the biopharmaceutical industry, venture capital interest has increased during the last year. According to data, in the first half of 2020, there has been $12.6 billion put to work by venture capital firms in the life sciences sector versus only $7.3 billion in the first half of 2019. In addition, including the larger life sciences plus the bio sector, the first half of 2020 saw $16.5 billion across 450 deals versus $13.4 billion across 600 deals in 2019 with a 50% increase in the plus $100 million rounds. With regards to sectors, oncology followed by cell and gene therapy received the most investor dollars.

“We see large scale Series A financings being done,” said John Pennett, the partner-in-charge of EisnerAmper’s Life Sciences Group, during BioNJ’s recent Virtual Finance Briefing. “Venture capital firms are drawn to great teams and high-potential novel technology, whether in later stage clinical trials or recently extracted from academia.

In 2021, the market is poised to be robust and the rise of special purpose acquisition companies (SPACs) in biotech are slated to continue.

Conclusion

The year 2021 will be a year where the biopharma industry plays a major role in bringing back some “normalcy” to everyone’s daily lives.

“It is a terrific opportunity to continue highlighting the innovation and cures we are delivering to patients around the world,” Hart said. “I believe the collaboration and resulting successes in vaccine and treatment development will only shine a bright and positive light on our sector in 2021.”

“For consensus, I would expect 2021 to be a very good year in pharma, but more specifically focusing on biotechnology, being it the leading innovation branch of the health care sector,” Jirau said. “No question that the industry should see a decent revenue growth, a boost in M&A activity and shifting towards higher-than-usual interest in the sector from both institutional investors and retail.”

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