From defence to offence in biotech

A number of challenges have combined to weigh on the sector: uncertainty around drug-pricing reform following the 2020 U.S. election. Regulatory surprises and COVID-19 delays. A frothy initial public offering (IPO) market. Clinical trial setbacks, and more recently, the prospect that rising interest rates could weigh on the valuations of long-duration assets. In short, over the past year, biotech has faced significant pressure, and consequently beaten a fast retreat.

We don’t believe the sector is defeated. On the contrary, we think many biotech stocks now trade well below the long-term value of their underlying businesses, potentially creating a unique opportunity to buy into the sector’s rapid innovation – at unusually low prices.

A punishing sell-off

To be fair, biotech was due for some rationalization. Over the past two years, the sector has experienced a surge in initial public offerings (IPOs) and blank-check mergers known as SPACs.³ Many drug makers came public at sizable premiums, including some that had yet to deliver positive clinical data. In fact, nearly a third of companies that completed IPOs in 2021 were in the preclinical stage of development, compared with 18% in 2018 (Exhibit 1).

Source: BioPharma Dive, as of 31 December 2021. IPO figures based on companies that raised a minimum of US $50 million.

But whereas the typical biotech drawdown has historically resulted in a 28% loss and persisted for less than 70 trading days, the current pullback is much deeper and has lasted much longer (240+ days).⁴ Many companies now trade below the value of the cash on their balance sheets, and biotech’s average forward price-to-earnings ratio (P/E) lags that of the S&P 500 and the sector’s long-term average (Exhibit 2).

Source: Bloomberg, data are quarterly from 30 September 1992 to 31 December 2021. The S&P Biotechnology (Biotech) Sector Index is a capitalization-weighted index consisting of GICS-classified biotechnology companies.

Source: U.S. Food and Drug Administration, as of 31 December 2021.

Is a bottom in sight?

Today, we see signs that some of the sector’s headwinds could start to abate. The Biden administration, for one, is working to nominate a permanent commissioner to the FDA, with a key deadline looming this year. A confirmed commissioner should bring more predictability to FDA decision-making, reducing downside surprises. Uncertainty around drug-pricing reform was prolonged when the Build Back Better bill failed to advance through Congress in late 2021. But we believe lawmakers will push for a resolution before midterm elections in November, with either no changes passed or with policy based on recent proposals, which we believe could have a modest impact on the sector.

A combination of low valuations and a cash-rich biopharma industry could also drive new mergers and acquisitions (M&A). Last year, biopharma M&A activity dropped to one of its lowest levels in a decade, totaling $108 billion, compared with $261 billion in 2019.⁷  Accordingly, some estimate that large-cap firms could have a combined $500 billion in cash to spend by the end of 2022.

So far, the industry has declined to pursue big deals (possibly due to worries about regulatory scrutiny). But large-cap companies have signaled their desire to bolster flagging pipelines through “bolt-on” acquisitions of smaller, innovation-driven firms. In mid-January, for example, UCB, a maker of epilepsy drugs, announced a bid for rare disease drug maker Zogenix for $1.9 billion, a roughly 70% premium. The deal will give UCB access to Zogenix’s Fintepla, which treats rare types of epilepsy, just as UCB’s own epilepsy drug, Vimpat, is set to lose U.S. market exclusivity. With so many factors lining up – large cash stockpiles, dramatically lower valuations, low interest rates and drug pricing clarity – we would expect to see a meaningful pickup in M&A activity in the coming year.

A sensible game plan

Not all of biotech’s problems are going away. This year, central bank tightening is likely to be a headwind for high-growth firms that don’t yet turn a profit, including areas of biotech. Against this backdrop, we believe revenue-generating companies or those in the later stages of pipeline development could be well positioned.

But we also are not discouraged. COVID-19 and the corresponding growth rally have overwhelmed returns for the last two years. Now, with the pandemic hopefully waning, we expect biotech to find a better balance. Clinical events over the next 18 months could help restore confidence, including gene therapy programs in muscular dystrophy, small molecule therapies for Huntington’s disease, and immuno-oncology programs in melanoma and lung cancer. The sector is also eyeing updates from a trio of medicines that aim to address Alzheimer’s disease, which could represent a multibillion-dollar market opportunity. Positive data could be positive for biotech – and put the sector back on the offensive.