Biotech's Future in a Post-Pandemic World

Immediate Impact of COVID-19 on Biotech

COVID-19's immediate impact on biotech includes a significant decline in vaccine sales, with JNJ reporting a 13.7% drop in Europe and 7.7% internationally. Despite this, companies like Moderna and Pfizer continue investing in next-generation vaccines and public health efforts to address the ongoing burden of COVID-19.

"In the fiscal first quarter of 2024, the impact of the Covid-19 Vaccine sales decline on the European region operational sales was a negative 13.7%." --- (JNJ, sec filing, 2024/Q1)

"Recent Program Developments COVID-19 • We continue to address the needs of the endemic COVID-19 market by focusing on public health efforts to increase vaccination coverage rates to reduce the substantial burden of COVID-19, as well as by advancing next-generation vaccines." --- (MRNA, sec filing, 2024/Q1)

"As part of our strategy for COVID-19, we are continuing to make significant investments in breakthrough science and global manufacturing." --- (PFE, sec filing, 2024/Q1)

"In the fiscal first quarter of 2024, the impact of the Covid-19 Vaccine sales decline on the international operational sales was a negative 7.7%" --- (JNJ, sec filing, 2024/Q1)

"COVID-19 continues to cause a more significant burden than #influenza in the U.S. https://t.co/QHFerK1rpv" --- (MRNA, twitter, 2024/07/11)

Changes in Biotech Funding and Investment

Biotech companies are adapting their funding and investment strategies post-pandemic. Vertex anticipates income fluctuations due to stock price volatility. Amgen focuses on funding mid- to late-stage drug development and purchasing royalty rights. Gilead's significant acquisition was funded by liquidating marketable debt securities. Biogen and Regeneron are reallocating R&D investments to high-conviction assets and new acquisitions, respectively.

"To the extent that we continue to hold strategic equity investments in publicly traded companies, we expect that due to the volatility of the stock price of biotechnology companies, our other income (expense), net will fluctuate in future periods based on increases or decreases in the fair value of our strategic equity investments." --- (VRTX, sec filing, 2024/Q1)

"Its business model focuses on funding programs in mid- to late-stage drug development in return for economic rights, purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing its technology to help partners discover and develop medicines." --- (AMGN, press release, 2024/05/07)

"The change was primarily due to the $3.9 billion net cash payment for the CymaBay acquisition, partially offset by proceeds from liquidation of marketable debt securities to fund the acquisition." --- (GILD, sec filing, 2024/Q1)

"And while our overall expense in research and development has decreased, this focus has actually enabled us to increase the investment in those assets where we have the most conviction." --- (BIIB, earning call, 2024/Q1)

"The change in R&D guidance is solely due to the inclusion of operating expenses associated with the acquisition of 2seventy bio's development programs, which closed on April 1." --- (REGN, earning call, 2024/Q1)

Regulatory Shifts in the Biotech Industry

Biotech companies are navigating significant regulatory shifts by achieving key clinical and regulatory milestones. Johnson & Johnson, Moderna, and Oncolytics Biotech highlight their progress in regulatory engagements and funding arrangements to meet evolving standards, ensuring sustainable growth and innovation in the post-pandemic landscape.

"We have strong momentum with key end-market products and continue to advance our pipeline with significant clinical and regulatory milestones being attained. Our MedTech business delivered growth that fell below our expectations of growing in the upper range of our markets, which as you recall correlates to a weighted-average market growth rate of 5% to 7% from 2022 through 2027." --- (JNJ, earning call, 2024/Q2)

"In March, we entered into a development and commercialization funding arrangement, which commits Blackstone to providing us with up to $750 million of funding for our flu program so that we can strengthen the product label and fulfill our remaining regulatory applications. Subject to the" --- (MRNA, earning call, 2024/Q1)

"Following a Fast Track Designation by the FDA in late 2022 for Oncolytics Biotech Inc.'s (NASDAQ:ONCY) (TSX:ONC) drug candidate, pelareorep, for pancreatic cancer treatment, the company is now gaining traction towards another pivotal FDA engagement, this time focusing on breast cancer." --- (ONCY, press release, 2024/04/30)

"As we continue to bring new innovations to market and execute against clinical and regulatory milestones, Innovative Medicine is well-positioned to achieve sustainable growth in both the near and long-term.Turning to MedTech, we continue to advance our pipeline, launch new commercial products and integrate strategic acquisitions that broaden and further differentiate our portfolio." --- (JNJ, earning call, 2024/Q2)

"As we move forward, we remain focused on advancing our differentiated portfolio and achieving key clinical and regulatory milestones across Innovative Medicine and MedTech." --- (JNJ, earning call, 2024/Q2)

Advancements in Biotech Technologies

Illumina's DRAGEN v4.3 and the acquisition of Fluent BioSciences enhance genomic mapping and multiomics capabilities. Editas Medicine advances in vivo gene editing and next-generation delivery technologies. These developments signify significant strides in biotech technologies, driving deeper genomic insights and transformative medical applications.

""DRAGEN v4.3 includes our next-generation and most accurate multigenome mapping technology, built-in mosaic calling, advancements in machine learning, and the ability to genotype difficult genes to unlock deeper insights into the human genome with greater power, accuracy, and efficiency." DRAGEN's innovation in multigenome mapping complements the efforts led by the Human Pangenome Reference Consortium (HPRC)." --- (ILMN, press release, 2024/06/11)

"We have ample resources to continue the advancement of our reni-cel program, support the progression of our in vivo capabilities to develop our pipeline, and leverage our strong IP position for additional business development and licensing opportunities. With that, I'll hand the call back to Gilmore." --- (EDIT, earning call, 2024/Q1)

""The addition of Fluent BioSciences to Illumina will provide significant and new capabilities to our customers in a key growth area and advances our multiomics growth strategy," said Steven Barnard, chief technology officer of Illumina." --- (ILMN, press release, 2024/07/09)

"Additionally, we're evaluating next generation delivery technology. Second, our in vivo capabilities with the potential to be used in developing transformative in vivo gene editing medicines are demonstrated by the preclinical data we are presenting at the American Society of Gene and Cell Therapy or ASGCT Annual Meeting in three presentations taking place on Thursday and Friday of this week." --- (EDIT, earning call, 2024/Q1)

""Mostafa has valuable experience in translating innovative concepts in genomics and sequencing that ultimately lead to advancements in patient care through his work at Illumina, Grail, and his continuing ventures."" --- (ILMN, press release, 2024/04/11)

Biotech's Role in Future Pandemic Preparedness

Biotech companies are actively enhancing pandemic preparedness through innovative technologies. Pfizer collaborates with governments to advance biopharmaceutical technologies, Moderna focuses on mRNA-based vaccines, and Novavax explores mucosal vaccination and nanoparticle formats for pandemic strains. These efforts underscore the biotech sector's pivotal role in future pandemic readiness.

"I look forward to continuing to work with the Japanese government to improve pandemic preparedness, to advance critical biopharmaceutical technologies, and to shape pro-innovation proposals that enhance the country’s biopharmaceutical sector. (Photo credit: Ian Wagreich at the U.S. Chamber of Commerce, @USChamber)" --- (PFE, Twitter post, 2024/04/10)

""We are pleased to continue our collaboration with BARDA to expedite our development efforts for mRNA-based pandemic influenza vaccines and support the global public health community in preparedness against potential outbreaks."In 2023, Moderna initiated a Phase 1/2 study to generate safety and immunogenicity data of investigational pandemic influenza vaccine (mRNA-1018) in healthy adults 18 years of age and older." --- (MRNA, press release, 2024/07/02)

"We continue to believe this asset may also be attractive from a pandemic preparedness perspective and that similar performance in terms of comparative immunogenicity may be expected for A/H5N1 pandemic strains." --- (NVAX, sec filing, 2024/Q1)

"If they did, if they made that leap and became respiratory influenza viruses in humans, you would expect unfortunately a pandemic, not dissimilar to what we just felt with COVID because none of us would have been exposed to those H5 strains and therefore we would need to be vaccinated or become infected." --- (MRNA, conference, 2024/06/10)

"Finally, I want to introduce you to two innovative expansions of our technology, mucosal vaccination and the development of a novel nanoparticle format, which we are exploring is an avian H5N1 pandemic vaccine." --- (NVAX, earning call, 2024/Q1)

Market Outlook for Biotech Post-Pandemic

The biotech market is poised for significant growth post-pandemic, driven by advancements in cancer treatments and diagnostics. The global pancreatic cancer market is projected to grow at a 13.5% CAGR, reaching $7.5 billion by 2033. Rising cancer incidences among Generation X and innovative therapies and diagnostics underscore the sector's robust future.

"A report from Future Market Insights projects that the global pancreatic cancer market is projected to accelerate at a CAGR of 13.5% to top US$ 7,541.09 Million by 2033." --- (AMGN, press release, 2024/06/20)

"USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 12, 2024 /PRNewswire/ -- After looking at public health records for 3.8 million patients with invasive spreading cancer, researchers recently discovered that Generation X may be experiencing larger per-capita increases in the incidence of leading cancers, including the very deadly pancreatic cancer, compared to previous generations." --- (REGN, press release, 2024/06/12)

"Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) Doses First Patient in Study of Pelareorep/FOLFIRINOX Combination Therapy in Pancreatic Cancer - Demonstrating pelareorep's synergy with modified FOLFIRINOX +/- atezolizumab in pancreatic cancer could expand the number of patients it may benefit. Funding for the study comes from the US$5 million Therapeutic Accelerator Award from PanCAN – Oncolytics Biotech® Inc., ($ONCY $ONC), a leading clinical-stage company specializing in immunotherapy for oncology, presented two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting." --- (AMGN, press release, 2024/06/20)

"USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 12, 2024 /CNW/ -- After looking at public health records for 3.8 million patients with invasive spreading cancer, researchers recently discovered that Generation X may be experiencing larger per-capita increases in the incidence of leading cancers, including the very deadly pancreatic cancer, compared to previous generations." --- (REGN, press release, 2024/06/12)

"USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 15, 2024 /PRNewswire/ -- USA News Group – Hope is rising in the fight against one of the deadliest cancers in the world, as a new study recently claimed that a blood test can accurately detect early-stage pancreatic cancer with 97% accuracy." --- (Oncolytics Biotech Inc., press release, 2024/05/15)

Workforce Changes in the Biotech Industry

Biogen is integrating Hi Bio employees post-acquisition, introducing a new employee stock purchase plan, and undergoing strategic leadership changes to stabilize and thrive, reflecting significant workforce transformations in the biotech industry.

"We are very much looking forward to welcoming a number of the many of the Hi Bio employees to the Biogen family likely next quarter when that transaction closes." --- (BIIB, conference, 2024/06/05)

"The Biogen Inc. 2024 employee stock purchase plan if approved would replace the Biogen Inc. 2015 employee stock purchase plan and would permit qualifying employees to purchase stock of the company during certain offering periods." --- (BIIB, event transcript, 2024/06/20)

"I just want to let everybody know that actual results might be different. But I'll just start just really quickly with Biogen has been on a journey for the last few years, and it's all really been about returning to growth and really almost taking a view of survive, stabilize and then thrive, all right, went through the Aduhelm issue, came out of that, but had a company that was really declining, took a really hard look at the company, new CEO came in." --- (BIIB, conference, 2024/06/12)

Collaborations and Partnerships in Biotech

Biotech companies are leveraging partnerships to drive innovation and commercialization. Moderna's collaborations have accelerated mRNA and lipid nanoparticle development, while Johnson & Johnson's Janssen Biotech has teamed up with Legend Biotech to develop CARVYKTI®. Pfizer's alliance with Bristol-Myers Squibb exemplifies transparency and shared goals in biotech advancements.

"This capital will greatly fuel our origination activities and accelerate value creation from our transformational companies. Partnering to Scale Innovation and ImpactFlagship's unique approach to pioneering science and to breakthrough biotech platforms has led to several novel partnerships within the pharmaceutical industry and beyond." --- (MRNA, press release, 2024/07/10)

"In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI®." --- (JNJ, press release, 2024/04/05)

"BMS, our alliance partner, is leading that process. You've heard them describe and we also described that there will be transparency around the outcome of that for impact in '26 in the September time frame. And so at that point, we'll be in a position to share more." --- (PFE, earning call, 2024/Q1)

"You couldn't imagine a better partner. Their deep understanding about that disease and our hopefully deep understanding about messenger RNA and lipid nanoparticles was born as a partnership in 2016, and it took us a solid 5, 6 years to get into the clinic." --- (MRNA, conference, 2024/06/10)

"In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI®." --- (JNJ, press release, 2024/07/02)

Public Perception of Biotech Post-Pandemic

Public perception of biotech post-pandemic has been influenced by the pandemic experience and the politicization of vaccination, which was not related to the science or data of mRNA technology but rather the duration of its development.

"of this, which is perception or experience that having gone through the pandemic and maybe to some extent that politicization vaccination that happened there that was not related to the science of mRNA and not even related to the amount of data we have, but really related to the number of years." --- (MRNA, conference, 2024/06/10)

"And in general, that is incredibly reassuring data. And so there's an aspect of this, which is perception or experience that having gone through the pandemic and maybe to some extent that politicization vaccination that happened there that was not related to the science of" --- (MRNA, conference, 2024/06/10)