When BIO 2019 closed its doors in Philadelphia last June, none of the delegates of the industry’s largest event would have predicted that the next meeting, scheduled for San Diego, would be canceled and the event would be transformed into a virtual version. In just a few months, the COVID-19 pandemic has decimated our normal way of life and, until effective therapeutics and vaccines become available, how we conduct the business of biotechnology will remain radically different. This will be one of the many themes explored during BIO Digital Week that kicked off today.

While face-to-face meetings and social events are off the agenda this time around, the BIO Digital virtual event is still helping companies interact via its one-on-one partnering platform. BIO said that the more than 6,500 registrants will have the opportunity to “meet” hundreds of companies focused in 31 therapeutic areas and hear them make their pitches online and describe their pipelines, growth objectives and capital and partnering needs. In fact, according to BIO, more than 5,500 partnering meetings have already been booked on the platform. Also, starting today, there will be plenty of live and “on demand” sessions to be accessed during the week.

New leadership, new era

The biotechnology sector is certainly adapting to the changes that the pandemic has forced upon it. The Biotechnology Innovation Organization (BIO) is also seeing changes. It is reacting to this new environment under new leadership. Michelle McMurry-Heath has become the organization’s next president and CEO, succeeding Jim Greenwood, who has led the organization since 2005. McMurry-Heath has served in numerous senior leadership roles at Johnson & Johnson (J&J) since 2014. Most recently, as vice president of external innovation and global leader for regulatory science, she led a team of 900 new leadership employees charting the evidence generation and regulatory strategy across J&J’s medical device companies, specializing in using cutting-edge tools and innovative methods to bring new breakthroughs to patients. Prior to her work at J&J, she served on the Obama administration’s Science Transition Team before being appointed to a scientific leadership role at the FDA Center for Devices and Radiological Health from 2010 to 2014.

She participated in BIO Digital’s opening session, “Biotech’s Finest Hour,” along with BIO Chairman Jeremy Levin and outgoing CEO Jim Greenwood, in which they explored how the biotech sector is working to combat COVID-19.

In these challenging times, she said she views BIO as having a significant social role to play going forward. “As BIO president and CEO, I will work every day to fulfill our social compact with patients. We will listen to them. We will honor their struggle. And we will make their concerns ours. And together, we will turn an age of fear into one of hope.

“I have no doubt that the innovators in our midst at BIO Digital will tip the scales in every major challenge we face. We will lay the foundation for economic development in communities hard hit by COVID, we will slow global warming, we will strengthen the food supply, and we will succeed in ending this pandemic. I know this because we are a can-do industry of bright minds and committed hearts. And the world has never needed us more,” she added.

Fighting COVID-19

The event will bring delegates up to speed on how the biopharma industry has ramped up development of therapeutics and vaccines and altered business plans to fight the SARS-CoV-2 virus in a way that no one could ever have imagined a couple of months ago. Heading into the meeting, companies have a significant 318 therapeutics and 115 vaccines in development to treat COVID-19 infections, according to BioWorld. Tracked diagnostics featured in BioWorld MedTech have reached approximately 275, including antibody, antigen and molecular-based tests, of which 117 have emergency use authorization from the FDA.

Expectations that the sector will eventually provide a therapeutic solution, or solutions, to the COVID-19 pandemic has certainly been the catalyst for growth of biotech equities on the capital markets during the past two months. That return has contributed to an excellent performance since the close of BIO 2019.

Writing in their monthly Biotechnology Thermometer report, Cowen & Co. analysts note that “specialists are proud of their industry, which will almost certainly produce new treatments and vaccines to counter the pandemic. But the experience of biotech investors with the ups and downs of drug development instills concern that the market's expectations for the speed of development and profitability of programs may be aggressive.”

Overall, the BioWorld Biopharmaceutical index recorded a 36% jump in valuation during the period since BIO 2019, compared to a 4.6% drop in the Dow Jones Industrial Average. (See BioWorld Biopharmaceutical Index BIO 2019- BIO 2020, below.)

Accolades for drug developers

While there has been a significant resurgence of investor interest in small and midcap (smid) drug developers since March 2020, because of their focus on COVID-19, Cowen analysts caution in their report that investors “worry that the market's steep rally in the face of a deep recession may be overdone, that smid valuations may be getting stretched, and that clinical disappointments or a market retrenchment could spell trouble for biotech stocks.”

There is no doubt that drug developers have had a turbulent ride in past 12-month period, culminating in a 33% jump in valuation since March. That has contributed to the BioWorld Drug Developers Index showing a BIO to BIO increase of about 11%. (See BioWorld Drug Developers Index BIO 2019- BIO 2020, below.)

Cash flows

Despite the uncertainties of the capital markets during the past 12 months, public and private biopharma companies have had no difficulty raising capital – almost $80 billion, in fact, generated from 1,249 transactions, according to data from BioWorld. The amount is 36% higher than the comparable BIO 2018 to BIO 2019 period. (See Biopharma capital raised: BIO to BIO, below.)

Of that amount, approximately 57% was raised by companies completing public offerings, including follow-on financings and IPOs. It is notable that the uncertainties experienced in the general markets did not serve to dampen the enthusiasm for IPOs, with a steady flow of biopharma company IPOs completed throughout the period. A total of 58 companies closed their offerings, generating almost $10 billion in the process, compared to the more than $11 billion generated in the BIO 2018-BIO 2019 period.

Private companies also continue to generate record amounts of capital, with 459 companies raising a massive $17.2 billion since BIO 2019. This year alone, global private companies have attracted more than $8 billion, an amount that keeps them on pace to surpass the record $17 billion in private financings established in 2018.

By the numbers

Last year, according to BioWorld data, about $58 billion was raised by global companies from public and private sources. Already this year, the sector has raised $45.2 billion, which is double the amount raised within the same timeframe of 2019, partly due to two large financings completed last month by Sanofi SA, which is working on candidates to treat or prevent COVID-19. (See 22 years of biopharma financings, below.)

Business development for the sector has been equally robust. The value of partnering transactions so far this year has totaled about $62 billion, an amount that will probably reach over $100 billion by year end, well short of the record value of $160 billion in 2019. (See 22 years of biopharma deals, below.)

Transactional values of mergers and acquisitions appear to be on pace with last year’s total of $224 billion, with BioWorld recording a total of $116 billion up until the end of May this year. (See 22 years of biopharma M&As, below.)

Innovation

These investments and business transactions are translating to the sector’s increasing innovation as measured by the number of new medicines that are being successfully brought to market. Since BIO 2019, 59 new molecular entities have been approved by the FDA topping the 55 in the BIO 2018 to BIO 2019 period.

(See New molecular entities approved by FDA: BIO to BIO, below.)

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