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Biopharmaceutical Sector Update: Market Outlook for 2021

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Biopharmaceutical Sector Update: Market Outlook for 2021 Biopharmaceutical Sector Update Market Outlook for 2021 January 11, 2021 © 2021. All rights reserved. Securities offered in the United States are offered through Torreya Capital LLC, Member FINRA/SIPC. In Europe such services are offered through Torreya Partners (Europe) LLP, which is authorized and regulated by the UK Financial Conduct Authority. Table of Contents An Extraordinary Year: Top 10 Biopharma Events of 2020 4 Biopharma Sector Outlook for 2021 20 The Evolving World of Biotech Company Formation 26 Implications of the U.S. Election on the Biopharma Sector 31 Update on Covid-19, Capital Markets and M&A Activity 39 About Torreya 50 Key Topics in This Update In this report we discuss three topics that are front of mind in our industry: We have lived through an Given the exceptional performance of the biopharma extraordinary year for the #1 market in 2020, what does 2021 hold? biopharmaceutical industry. Given excellent protection data on two COVID-19 vaccines we now appear It appears likely that with widespread vaccination, #2 the COVID-19 pandemic will recede in 2021. What to be at the beginning of the end of does this imply for the biopharma sector? the COVID-19 pandemic. A “return to normalcy” appears possible in 2021 despite a very challenging situation What are the implications of the U.S. political #3 situation for the global biopharmaceutical sector? at present with the pandemic. 3 An Extraordinary Year: Top 10 Biopharma Events of 2020 4 Event #1 COVID-19 Vaccines Portend a New Normal The FDA has approved two COVID-19 vaccines as of Jan 2021 and more vaccine approvals are likely. High level of global coordination between regulators and industry a triumph for the industry. Jan '21 Feb '21 Mar '21 Apr '21 May• '21The numberJune '21 ofJul worldwide'21 Aug '21 casesSep of '21 COVIDOct- 19'21 infectionNov '21 exceedsDec '21 2 million according to the World Health Organization. • It is likely that the number of cases is substantially underreported given the lack of widespread testing. • New case growth went negative in the week ended April 17th, 2020. Sources: (1) Torreya estimates, (2) NY Times (https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html). Phase 3 Results FDA We expect that much of the world will be able to access COVID-19 vaccines by Q3 2021. Approval Early Availability Widespread availability 5 5 Vaccines are a Stunning Outcome for the Biopharma Sector and Involved Companies November 30, 2020 December 6, 2020 Dec 18, 2020 “The COVID-19 experience will “Continuing the spate of stunning news about “The world’s hopes have weighed heavily on the quest to develop coronavirus vaccines, with an especially intense almost certainly change the future COVID-19 vaccines, the biotech company Moderna focus on two front-runners: one from Moderna, the other of vaccine science, says Dan announced the final results of the 30,000-person from Pfizer and BioNTech. Both were a speedy but risky — Barouch, director of the Center for efficacy trial for its candidate in a press release today: even controversial — bet, based on a promising but still- Virology and Vaccine Research at Only 11 people who received two doses of the experimental medical technology. Why, some scientists Harvard Medical School in Boston, vaccine developed COVID-19 symptoms after being debated in the spring and summer, would the United States Massachusetts. “It shows how fast vaccine development can proceed infected with the pandemic coronavirus, versus 185 gamble on a type of vaccine that had never been deployed beyond clinical trials when the stakes were so high? when there is a true global symptomatic cases in a placebo group. That is an emergency and sufficient efficacy of 94.1%, the company says, far above what Vaccine development typically takes years, even decades. resources,” he says. New ways of many vaccine scientists were expecting just a few The progress of the last 11 months shifts the paradigm for making vaccines, such as by using weeks ago. More impressive still, Moderna’s what’s possible, creating a new model for vaccine messenger RNA (mRNA), have candidate had 100% efficacy against severe disease. development and a toolset for a world that will have to been validated by the COVID-19 response, he adds. ‘It has shown There were zero such COVID-19 cases among those fight more never-before-seen viruses in years to come. But the pandemic wasn’t a sudden eureka moment — it was a that the development process can vaccinated, but 30 in the placebo group, including catalyst that helped ignite lines of research that had been be accelerated substantially one death from the disease.” moving forward for years, far outside the spotlight of a without compromising on safety.’” global crisis.” 6 Event Unprecedented Access to Capital Built Balance Sheet #2 Strength in Biotech Global Equity Raised in the Biopharma Sector, 2015 – 2020 ($ Billions) 120 By our calculations, biopharma companies raised $120.3 billion in equity in 2020, shattering the all- 100 time previous record of $78.5 billion raised in 2018. Venture (private) equity raised was $36.9 billion – 80 up 31% from the previous high year of 2018. 60 Public follow-on equity raised $63.6 billion, up from $39.4 billion raised in 2018. 40 IPO equity raised was $19.8 billion up from the Equity Capital Raised ($Billions) Raised Capital Equity previous high of $8.5 billion in 2015. 20 An additional $5.8 billion was raised by healthcare SPACs in 2020. 0 2015 2016 2017 2018 2019 2020 Initial Public Offerings of Equity Follow-On Equity Venture Equity Sources: CapitalIQ, Torreya internal databases and Crunchbase. 7 7 Biotech Balance Sheet Status Total net cash on the balance sheets of the top 500 biotechs by value is at $77 billion, up from $48 billion, the year before. The number of biotechs with $100mm+ in net cash as of Q3 2020 was 214 versus 151 at year-end 2019. Spend is also up with 76 companies burning over $100mm a year versus 65 companies burning this much a year earlier. Not shown but also important, the number of companies with less than $30 million in net cash is down significantly from recent years. Aggregate Balance Sheet Position of Top 500 Aggregate Balance Sheet / Spend Behavior of Top 500 Global Biotechs Global Biotechs (By enterprise value, Jan 1, 2021) (by enterprise value, Jan 1, 2021) Net Cash Total Cash Over $100mm in net cash Over $300mm in net cash Burning Over $100mm/yr Burning Over $200mm/yr $100 $91.3 240 214 220 $77.1 $80 200 180 $60.4 160 151 $60 135 $49.9 $48.4 140 $42.5 120 $ Billions $ $40 100 71 76 80 65 60 42 $20 33 36 40 26 17 20 7 $0 0 Number of Companies in Top 500 Biotechs 500Top in Companies of Number 2018 2019 2020 2018 2019 2020 Source: CapitalIQ, Biotechs were defined as companies in the biopharma sector that do not yet have a commercial product. 8 Event #3 AstraZeneca and Gilead Grow by Acquisition We saw very little M&A activity in the first six months of 2020 and then activity picked up to essentially the same pace as was seen in 2019. Each year for the last five years has generally been dominated by one or two companies who are using M&A to reshape their strategy. In 2019, AbbVie and BMS were both busy with major acquisitions; 2018 saw Takeda buy Shire and Sanofi buy Bioverativ etc. The largest users of M&A and creative structuring in 2020 were AstraZeneca and Gilead. By year-end 2020 AZ had established itself as one of the world most important players in COVID-19 vaccines and the world leader in immunology. By year-end, Gilead has positioned itself as a major world player in oncology for the first time. Gilead carried out numerous deals including four major oncology transactions. The effect of the Alexion Acquisition of acquisition is significant. The Acquisition of Alexion consensus revenue estimate for Immunomedics $21 billion $39 billion Alexion in 2024 is $7.7bn. With brokers forecasting AZ at $44.8bn in revenue for 2024, the company’s new revenue forecast for 2024 is $52.5bn. Only four Acquisition of Option to other pharma companies are Myr GMBH for acquire Tizona expected to exceed this amount in HDV $300 million 2024. Without this deal, AZ would €1.15 billion have been ranked #10 by revenue in 2024. COVID-19 Major Branded vaccine Acquisition of Asset Collaboration agreement with Forty Seven for Divestitures with Arcus to Oxford immuno- develop IO drugs oncology Up to $2 billion $4.9 billion 9 9 Event Inflammasome Science and FcRn Biology Reshape #4 Immunology Traditionally, we have seen a very high level of focus in autoimmune disease therapeutics on targets like CD20, TNF-α, IL-4, IL-17 and IL-23. These therapies work through B-cell, T-cell and eosoniphil modulation. The science in autoimmune research has been moving at lightning speed and in 2020 we saw a major upswell in corporate development and capital markets activity in two key new areas: (1) inflammasome and (2) FcRn. Inflammasome FcRn Defined: regulates the innate immune response going from detection of Defined: Fc Neonatal receptor has an IgG binding site which facilitates the external threats to the mounting of a counterattack. Key upstream targets transcytosis of circulating antibodies. Blockage of the IgG binding site can treat include caspase-1, Gasdermin-D, MK2 and NLRP3. Key midstream targets any disease caused by autoantibodies. Because over 100 diseases are caused by include IL-1β, IL-18 and IL-1α.
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