The past couple of years have been challenging for many biotech/startup companies, particularly for raising funds. Key obstacles include high interest rates; uncertainty in the capital markets after the 2020 and 2021 funding boom; and investors’ lower risk tolerance. At the same time, large biopharma companies were less willing to pursue early-stage opportunities, and favored de-risked, late-stage assets or companies – even if that meant paying top dollar.
Thanks to the Fed’s interest rate cut in September, and another anticipated cut in Q4, analysts anticipate that biopharma’s access to capital will improve. Of course, nothing is certain in the current geopolitical and economic landscape, but we do see encouraging signs for biotech investment. As one recent example, Bain Capital Life Sciences and ARCH Venture Partners each closed separate $3B funds.
As companies prepare for more affordable access to capital, and anticipate the clinical development, commercialization and BD&L initiatives it will fund, management teams should prepare now to optimize their pipeline’s potential and align on some of the critical success factors that will guide investment decisions in this new market environment.
In preparation for advancing trials and deals that had been put on hold, it will be important to consider four key questions:
What are the trade-offs to consider in advancing an asset through clinical development and partnering after proof of concept, versus partnering the asset when only pre-clinical or early signal data is available? Biotech executives need to weigh several factors:
To make this decision, it’s important to weigh strategic considerations such as:
Two examples illustrate the risk-premium balance that companies have weighed:
Whether multiple suitors are lining up for a highly sought-after program – or it’s a much narrower selection of potential partners – the buy-side and sell-side each have their own complementary considerations.
Acquiror (Big Pharma; VC/PE) | Out-Licensor / Biotech |
What are the most promising targets/pathways to pursue, based on their scientific attractiveness, commercial opportunity, and strategic fit? | Which biopharma partners might be the best fit? Who has a portfolio gap that our asset/technology could fill? |
Which assets are actionable, and can demonstrate a strong value proposition, differentiated clinical profile, scientific reason to believe, and commercial potential? What trade-offs are we willing to make, assuming that a ‘perfect’ asset isn’t available? | Who has a technology platform or asset that could be synergistically combined with our internal asset/platform (thereby improving clinical outcomes, and commercial potential)? |
Which biotechs have a proven management team that has prior experience in advancing assets through clinical development? | What is the asset/technology’s unique value proposition and deal terms that would attract a prospective partner?
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While each company’s deliberations and strategic considerations often aren’t publicly disclosed, we can look at any number of deals and hypothesize how the deal came out – and what each partner saw in the other.
Earlier this year, Biogen acquired HI-Bio to add a nephrology franchise to their drug development efforts in a deal valued up to $1.75B.
Biogen’s Head of Development commented: “We believe Felzartamab has demonstrated impact on key biomarkers and clinical endpoints in three renal diseases with serious unmet needs, and is a strategic addition to the Biogen portfolio as we continue to augment our pipeline and build on our expertise in immunology.”
In this case, an asset with compelling science and an acceptable risk profile fit a portfolio gap that Biogen sought to fill.
No matter how strong the fundraising environment becomes, budgets will be finite, and companies will need to prioritize which trials to initiate and deals to pursue.
As companies consider the optimal portfolio composition that will deliver on strategic and financial goals within a specified budget, there are key questions to address at both the asset and portfolio level:
Asset | Portfolio level |
Which development opportunities should we prioritize? What should be the lead, and how should we sequence follow-on opportunities? | What are the trade-offs among probability of success, total market opportunity, level of investment required and ability to leverage existing capabilities? |
What would be the downstream impact on an approved indication in a later line of therapy, if we pursue early-stage settings? | What is a short- long-term strategy for sustaining and growing leadership in a specific disease or therapy area, including clinical development and mechanisms of action? |
How should IRA considerations factor into our decision about opportunity sequencing? | |
Which opportunities will best meet our strategic goals: speed to market? Ability to address unmet need? Commercial potential? Developmental risk? |
As companies think about which internal development or BD&L opportunities to prioritize, portfolio strategy and BD teams will need to consider: should we focus on core areas or expertise (e.g., modalities, TA’s, platforms) or expand into adjacencies?
A few questions can help guide this decision:
Putnam supports a wide array of clinical development and BD&L strategy decisions among biotech, large pharma and investment firms. As our clients prepare to invest in the internal programs or external assets/platforms that will deliver on their strategic and financial goals, we help them make well-informed decisions that have a significant impact on their corporate strategy and portfolio value. Given how quickly due diligence happens, it is critical for biopharma companies to be prepared and have clarity on the questions we’ve discussed.
Learn more about our Portfolio, Licensing & Development capabilities.
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