Working Paper

Vasileva, Detelina, Larry Norton, Marc Hurlbert, and Andrew W. Lo, 2019, Working Paper.

ABSTRACT Using survey data gathered from grantees of the non-profit Breast Cancer Research Foundation (BCRF), we investigated the commercial and non-commercial impact of their research funding. We found significant impact in both domains. Commercially, 19.5% of BCRF grantees filed patents, 35.9% had a project that has reached clinical development, and 12 companies have or will be spun off from existing projects, thus creating 127 new jobs. Non-commercially, 441 graduate students have been trained by 116 grantees, 767 post-doctoral fellows have been trained by 137 grantees, 66% of grantees have used funding for faculty salaries, 93% have achieved collaboration with other researchers, and 42.7% have enacted process improvements in research methodology. Econometric analysis identifies BCRF funding and associated process improvements as key factors in driving the likelihood to file patents. However, we also found that the involvement of more than one institution in a collaborative project had a negative impact on subsequent development. This may point to frictions introduced by multi-university interactions.

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Hull, John C., Andrew W. Lo, and Roger M. Stein, 2019, Working Paper.

ABSTRACT We define long shots as investment projects with four features: (1) low probabilities of success; (2) long gestation lags before any cash flows are realized; (3) large required up-front investments; and (4) very large payoffs (relative to initial investment) in the unlikely event of success. Funding long shots is becoming increasingly difficult—even for high-risk investment vehicles like hedge funds and venture funds—despite the fact that some of society’s biggest challenges such as cancer, Alzheimer’s disease, global warming, and fossil fuel depletion depend critically on the ability to undertake such investments. We investigate the possibility of improving financing for long shots by pooling them into a single portfolio that can be financed via securitized debt, and examine the conditions under which such funding mechanisms are likely to be effective.

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Kim, Esther and Andrew W. Lo, 2019, Working Paper.

ABSTRACT Advances in biomedical research have created significant opportunities to bring to market a new generation of therapeutics. However, early-stage assets often face a dearth of funding, as they have a high risk of failure and significant development costs. Historically, this has been particularly true for assets intended to treat rare diseases, where market sizes are often too small to attract much attention and funding. Venture philanthropy (VP)—which, for the purpose of this paper, is defined as a model in which nonprofit, mission-driven organizations fund initiatives to advance their objectives and potentially achieve returns that can be reinvested toward their mission—offers an alternative to traditional funding sources like venture capital or the public markets. Here we highlight the Cystic Fibrosis (CF) Foundation, widely considered to be the leading VP organization in biotech, which facilitated the development of Kalydeco, the first disease-modifying therapy approved to treat cystic fibrosis. We evaluate the CF Foundation’s example, including its agreement structures and strategy, explore the challenges that other nonprofits may have in adopting this strategy, and draw lessons from the CF Foundation for other applications of VP financing.

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Thakor, Richard T. and Andrew W. Lo, 2018, Working Paper.

ABSTRACT We develop a theory of optimal financing for R&D-intensive firms that uses their unique features—large capital outlays, long gestation periods, high upside, and low probabilities of R&D success—that explains three prominent stylized facts about these firms: their relatively low use of debt, large cash balances, and underinvestment in R&D. The model relies on the interaction of the unique features of R&D-intensive firms with three key frictions: adverse selection about R&D viability, asymmetric information about the upside potential of R&D, and moral hazard from risk shifting. We establish the optimal pecking order of securities with direct market financing. Using a tradeoff between tax benefits and the costs of risk shifting for debt, we establish conditions under which the firm uses an all-equity capital structure and firms raise enough financing to carry excess cash. A firm may use a limited amount of debt if it has pledgeable assets in place. However, market financing still leaves potentially valuable R&D investments unfunded. We then use a mechanism design approach to explore the potential of intermediated financing, with a binding precommitment by firm insiders to make costly ex post payouts. A mechanism consisting of put options can be used in combination with equity to eliminate underinvestment in R&D relative to the direct market financing outcome. This optimal intermediary-assisted mechanism consists of bilateral “insurance” contracts, with investors offering firms insurance against R&D failure and firms offering investors insurance against very high R&D payoffs not being realized.

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Jorring, Adam, Andrew W. Lo, Tomas J. Philipson, Manita Singh, and Richard T. Thakor, 2017, Working Paper.

ABSTRACT The high cost of capital for firms conducting medical research and development (R&D) has been partly attributed to the government risk facing investors in medical innovation. This risk slows down medical innovation because investors must be compensated for it. We propose new and simple financial instruments, Food and Drug Administration (FDA) hedges, to allow medical R&D investors to better share the pipeline risk associated with FDA approval with broader capital markets. Using historical FDA approval data, we discuss the pricing of FDA hedges and mechanisms under which they can be traded and estimate issuer returns from offering them. Using various unique data sources, we find that FDA approval risk has a low correlation across drug classes as well as with other assets and the overall market. We argue that this zero-beta property of scientific FDA risk could be a main source of gains from trade between issuers of FDA hedges looking for diversified investments and developers looking to offload the FDA approval risk. We offer proof of concept of the feasibility of trading this type of pipeline risk by examining related securities issued around mergers and acquisitions activity in the drug industry. Overall, our argument is that, by allowing better risk sharing between those investing in medical innovation and capital markets more generally, FDA hedges could ultimately spur medical innovation and improve the health of patients.

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Stein, Roger, 2016, Working Paper.

ABSTRACT Longevity risk is the risk that the promised recipient of lifetime cashflows ends up living much longer than originally anticipated, thus causing a shortfall in funding. A related risk, reimbursement risk is the risk that providers of health insurance face when new and expensive drugs are introduced and the insurer must cover their costs. Longevity and reimbursement risks are particularly acute in domains in which scientific breakthroughs can increase the speed of new drug development. An emerging asset class, research-backed obligations or RBOs (cf., Fernandez et al., 2012), provides a natural mechanism for hedging these risks: RBO equity tranches gain value as new life-extending therapies are developed and do so in proportion to the number of successful therapies introduced. We use the stylized case of annuity underwriting to show how RBO equity could be used to hedge some forms longevity risk on a retirement portfolio. Using the same framework, we then show how RBO securities may be used to hedge a much broader class of reimbursement risks faced by health insurance firms. We demonstrate how to compute hedge ratios to neutralize specific exposures. Although our analytic results are stylized, our simulation results suggest substantial potential for this asset class to reduce financial uncertainty for those institutions exposed to either longevity or reimbursement risks. For example, our simulation results indicate that the correlation between the return on RBO equity and the reimbursement shortfall for a health insurer is about 0.66 under reasonable assumptions. Even under extremely
conservative assumptions, this correlation is still 0.34, suggesting that RBO equity offers substantial hedging benefits, producing more favorable outcomes in about 87% of scenarios.

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