Beyond Borders 2022: Following robust growth and historic levels of investment, the biotech industry faces challenges to carefully navigate for a successful future, says EY report

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Jun 13, 2022, 08:00 ET

Dramatic revenue growth: The industry recorded significant top-line growth in 2021, with public company revenues surging 35% from $160.2 billion to hit $216.7 billion, largely driven by COVID-19 vaccines and antivirals.
A tectonic shift in the financing environment: In 2021 and 2020, new capital invested in IPOs and funding innovation reached an all-time high of $104.7 billion as biotech valuations also hit a record high in February 2021. However, thanks to novel vaccines and effective antivirals that moved the pandemic to the rear-view mirror in early 2022, reopening trade fueled a rotation by investors out of expensive growth sectors like biotech and into value names most leverage to the impending V-shaped economic recovery. This combined with a rapid acceleration in economic growth as well as a rapid rise in interest rates and inflation have sent biotech valuations plunging and access to new capital in the public markets became virtually non-existent.
Biotech remains the biopharma industry's engine of innovation and growth: The industry had over 50 new molecular entities (NMEs) approved by the U.S. Food and Drug Administration (FDA) in both 2020 and 2021, up from an annual total of 29 a decade ago. Biotechs currently account for a record 65% of the approximate 6,000 clinical asset candidates in active development, including more than 2,000 cell and gene therapies that are projected to play an increasingly important role in driving revenue growth in the next decade.
Fundamentals are still robust to fund the emerging revenue gap: Though industry valuations are currently experiencing a correction, which is most pronounced for the early-stage companies, its fundamentals remain strong, with biotech innovation projected to remain a major driver of pharma revenues in the coming years. Large pharma balance sheets have never been stronger with record firepower to fund M&A, collaborations and partnerships critical to achieving their growth targets, particularly as they head into a massive loss-of-exclusivity gap primarily due to biosimilar penetration.

NEW YORK, June 13, 2022 /PRNewswire/ -- Although the biotech industry performed strongly during the COVID-19 pandemic, it now faces challenges to valuations and access to capital, as detailed in the 32nd edition of the Beyond Borders report produced by Ernst & Young LLP (EY US). This report, which acts as a moment-in-time snapshot of the industry, shows that despite the recent market volatility and correction in biotech, the industry remains in a position of strength as evidenced by a promising outlook for revenues, the unprecedented investments already made in the innovation renaissance in R&D, and a massive tide of dollars waiting in the wings for future attractive investments.

Arda Ural, PhD, EY Americas Industry Markets Leader, Health Sciences and Wellness, says:

"Since the onset of the pandemic, biotech has experienced significant growth with the advent of the mRNA vaccines, antivirals, virtualization of clinical trials and more. In parallel, the large cap biopharma industry is facing a foundational growth gap due to upcoming patent expirations for its leading blockbusters biologics and pipelines, which are not sufficient to sustain their top-line growth aspirations. With the pandemic boom in the rear-view mirror, flush balance sheets and a huge correction in deal target development stage biotechs, now is an opportune time for big pharma to deploy its firepower to acquire biotech innovation."

Beyond Borders analyzes the state of the industry with reference to US and European public company revenues, FDA/European Medicines Agency product approvals, biotech capital activity and other factors. The report outlines the industry's performance via these key metrics, offering executives an overview of where the industry stands today, where it is heading next and what challenges need to be addressed to secure growth as the business environment evolves.

Ashwin Singhania, Principal, Ernst & Young LLP, in the EY-Parthenon Life Sciences Strategy practice says, "Biotech executives must have a clear vision of what they seek to accomplish to succeed post-pandemic. The unprecedented public health crisis coupled with the market downturn demonstrated biotech's resiliency, but now companies must address pain points to optimize their potential."

Other key findings include:

IPO bubble bursts: Biotech IPOs reached record levels in 2021 – 143 offerings totaling $19.3 billion – but the IPO and follow-on windows have shut, and biotech access to capital markets via IPOs or SPACs looks increasingly difficult.
VC money follows science: Venture financing reached a record $26.2 billion in 2021, and activity remains strong in 2022 as investors continue to bet on biotech's long-term viability.
Pausing M&A market: Dealmaking value decreased by 46% when compared to last year and remains slow thus far by mid-2022. With historic drops in target valuations, big pharma players may seize the opportunity for large-scale M&A later this year. In the interim, big pharma continues to favor strategic alliances, committing to a potential infusion of $314 billion in 2020 and 2021 alone. Even if the US were to experience a macro-economic slowdown, our research shows that biopharma M&A has been driven by industry's unique fundamental needs to drive growth.
Operational challenges: In the wake of COVID-19, biotechs face significant operational challenges, including addressing the shortfall of talent across the sector and anticipating policymaker-driven shifts in supply chain expectations, pricing and scaling commercial infrastructure.

The strength of biotech's R&D engine is cause for optimism, as is the normalization of health care delivery. After more than two years of pandemic disruption, this normalization has been demonstrated in a rebound in product demand. However, there are signs that the aftermath of the pandemic will also leave biotech with significant challenges.

A decisive shift in investor sentiment began in the first quarter of 2021 and has continued into 2022. Over the past decade, and particularly during the pandemic, biotech enjoyed soaring valuations. But since early 2021, these valuations have plunged, and the momentum of the decline accelerated in 2022. Smaller and earlier stage companies now face an existential path to the capital markets and access to capital in general. For some biotechs, reduced access to capital has forced a barrage of restructurings and may increase the desirability of exiting via acquisition and galvanize consolidation and M&A activity in the sector.

As valuations sink and financing becomes more challenging, a buyer's market may emerge, with big pharma CEOs reconsidering targets that proved too expensive to justify the acquisition price in the past. De-risked, late-stage biotech assets that fit naturally into a company's strategic pipeline will be an M&A priority, and strategic alliances may remain the preferred route to access higher-risk early-stage innovation over outright bolt-on acquisitions. While an M&A rebound seems probable, there is little evidence of it so far in 2022.

Further, the industry faces more uncertainty in the immediate future. The unforeseeable geopolitical environment along with the post-pandemic landscape create unknown market conditions and new challenges, including supply chain disruption; intensifying competition for talent; challenges to established commercial models; the ability to achieve scalability for the newly minted commercial companies; rising pressure to demonstrate commitment to addressing environmental, social and governance (ESG) issues, from patient access and drug affordability to clinical trial diversity. The skills to navigate these complex and unprecedented challenges will be essential in the biotech C-suite.

"While the biotech industry has experienced a substantial correction, the industry's fundamentals remain strong, and there is still a lot of firepower to invest in innovation and underpin growth strategies," said Ural. "While some biotechs may struggle with reduced access to the public markets, the sector as a whole will continue to flourish as long as companies work to innovate to help address unmet medical needs of the future."

To read Beyond Borders, visit http://www.ey.com/us/beyondborders.

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