Jenna Foger
Analyst · Citi. Please go ahead
Thank you so much, Joes, and good afternoon, everyone. As we begin to turn a new corner on this COVID-19 pandemic, which I'll speak to in a moment, life science industry fundamentals as Joes highlighted continue to be very strong, and provide the industry with the unique structural integrity to weather broader market volatility and cyclicality. The confidence of these drivers and key advances in our understanding of biology and next generation modalities will continue to fuel life science demands well into the future. So, as we spoke about last quarter, owing to the expediency at which the industry and our tenants move to protect the country in the world, we now have the tools and a roadmap at our disposal to end this pandemic, while also ushering in a historic new era for biotech and scientific innovation are none. So turning to our COVID-specific updates, by the numbers according to the World Health Organization, there has been a staggering 242 million confirmed cases of COVID-19 worldwide, about 20% of these reported in the U.S. alone, including over 4.9 million cumulative deaths. In the U.S., the incidence of new COVID-19 cases has welcomingly declined over 55% from its recent September peak of over 160,000 new cases to now 70,000 new cases, and we hope to see this trend and decline continue, of course. Three of the most widely distributed vaccines worldwide and authorized by the FDA has been developed by [indiscernible 0:09:36.3], Pfizer, Moderna and Johnson and Johnson. And roughly 67% of the vaccine eligible population in our country that's 12 and over have been fully vaccinated. So this is just over 57% of the total U.S. population. And we hope with boosters and expanding indications that this number of fully vaccinated individuals will continue to rise. As we saw last week, the FDA authorized the use of Moderna and Johnson and Johnson boosters, in addition to Pfizer's already authorized booster shots, as well as the mixing and matching of booster doses between Pfizer Moderna and J&J in eligible populations. In light of the evolving data on the duration of immunity and COVID-19 variants concerns, including the common Delta variant, and now the Delta plus variants hitting U.S. soil, it's highly likely that COVID-19 vaccines will be required long-term. With regard to vaccine efficacy, in a study evaluating the real-world effectiveness of the Pfizer and Moderna vaccines at preventing symptomatic illness, the Moderna vaccine had an efficacy rate of 96% and Pfizer at 89%. So as we've all heard, breakthrough infections have occurred in a high single digit percentage of vaccinated population. But, while current vaccines may not entirely prevent transmission or contraction of COVID-19, they do significantly prevent severe disease and deaths, with over 90% of all hospitalized COVID cases represented by unvaccinated individuals. With regard to vaccine safety, there have been very few vaccine related adverse events, less than seven per million reported overall, with nearly all cases resolving and without long-term side effects reported to-date. Given such a strong efficacy and safety profile, the FDA granted full approval for Pfizer's mRNA-based vaccine for people 16 and older, and Moderna’s mRNA-based vaccine is likely to achieve full approval for its vaccine for 18 and older in the fourth quarter. With regard to pregnancy in women of childbearing age, based on the safety data generated to-date and how we know vaccines work in the body, the CDC and top health officials have encouraged any Americans who was pregnant, planning to become pregnant or currently breastfeeding to get vaccinated against the Coronavirus as soon as possible. With regard to children, Pfizer reported that its COVID-19 vaccine for ages 5 to 11 was safe and nearly 91% effective. And on the basis of this data, the FDA is expected to authorize Pfizer's vaccine for this population in the fourth quarter. Moderna also just announced yesterday that its COVID vaccine is both safe and highly effective in children ages 6 to 11, which they will also submit to the FDA. For young children ages six months to four years, vaccine authorization will likely come in early 2022. So despite these advances in vaccines, given that COVID will likely remain on the planet for the foreseeable future, albeit as an endemic virus, with seasonal and sporadic geographic peaks therapies are going to continue to be important in mitigating the severity of COVID-19. And so most notably this past month, Alexandria tenant Merck in collaboration with Ridgeback Biotherapeutics submitted an EUA application to the FDA for oral antiviral molnupiravir. This drug demonstrated a 50% reduction in hospitalization or death in patients with mild or moderate COVID-19. If authorized, molnupiravir will be the first oral antiviral therapy for COVID-19 is a big deal. It's far easier and more cost effective to administer broadly compared to current antibody treatments in the mild and moderate COVID-19 population. So despite the COVID fatigue that we all absolutely feel on the multitude of challenges that this pandemic has placed on our countries or society and the world, of course, the scientific advances achieved at an unprecedented speed is the one saving grace of this tragic period in our history. The scientific attitude and adaptability of so many of our tenants to translate their broad platforms, and decades of work into safe and effective vaccines, therapies and testing in really a year's time is remarkable. And application of these tools will forever transform the way we develop vaccines against novel targets. It will also augment future surveillance testing and our nation's pandemic preparedness overall. So, to touch on another topic on the NIH and FDA leadership, the pandemic has also underscored how critical these agencies are, and that solid support for these key federal agencies is paramount for national security, for ensuring that the U.S. maintains its leadership in advancing scientific and biomedical innovation, and for maximizing our ability to address current and future health challenges. So interestingly, over the past several weeks the leadership positions at these two agencies have received increasing attention. On October 5, long tenured NIH Director Dr. Francis Collins announced that he would be stepping down as the Director of the agency by the end of the year. Dr. Collins is the longest serving presidentially appointed NIH Director, having served three U.S. Presidents over more than 12-years. During his tenure, the NIH has received increasing bipartisan support, and the agency's budget grew from $30 billion in 2009, when he started to nearly $50 billion in the upcoming fiscal year. The Biden administration is undergoing a formal process to name Collins replacement, which is expected later this year or more likely early next, and we're optimistic that his successor will continue to bolster biomedical and public health research in this country. As for the FDA, Acting Commissioner, Dr. Janet Woodcock has led the agency since the beginning of the Biden administration. Under her leadership in addition to the COVID-related emergencies authorizations that I just spoke about, the FDA’s CDER has approved 40 new molecular entities through the third quarter, putting the agency on pace in the 2020s near record high of 53 approvals. So because Dr. Janet Woodcock sort of fires on November 15, the administration now needs to select and appoint a new Commissioner in the coming weeks. So similarly, on October 14, the Biden administration announced that it’s likely to nominate Dr. Robert Califf as the next Commissioner of the FDA. Dr. Califf is a Cardiologist by training, and current Head of Clinical Policy and Strategy for Verily and Google Health. Dr. Califf also served as FDA Commissioner from 2016 to 2017, end of the Obama administration after being appointed Deputy Commissioner in 2015. Dr. Califf is also very well-known and dear to us at Alexandria as a regular participant in the Alexandria Summit for the past several years, and a partner in our OneFifteen Project to address the opioid epidemic, as Joes just spoke about. Dr. Califf's nomination would be viewed very favorably by the life science industry, key investors and stakeholders. Clearly, the strength of the FDA is instrumental for ensuring the continued pace and vitality of biomedical innovation in our country. And I just wanted to highlight, in addition to the COVID-19-related updates that we'll likely see in the fourth quarter, the FDA will also announce a handful of major approval decisions before the end of the year. Decisions that have positive will bring critical new drugs to patients as well as billions of dollars of additional revenue to the sector. For example, Eli Lilly is expected to submit an application for accelerated approval of an Alzheimer's therapy, known as donanemab. And given all the controversy surrounding FDA’s positive approval of Biogen's Aduhelm in the same application, the approval of Lilly's drug would likely inform future approvals in this area. There's also a major decision regarding a new class of drugs for severe atopic dermatitis from Pfizer and AbbVie, and several other awaited approvals for growing biotechs, including the approval of [indiscernible] for the treatment of bipolar disorder from longstanding Alexandria attendant and investment intracellular therapies. So just to wrap up, before I turn it to Steve, I wanted to share a quote from former FDA Commissioner Dr. Scott Gottlieb in his new book, uncontrolled spread by COVID-19 cross death and how we can defeat the next pandemic. In his book, Gottlieb writes, the brief history of COVID shows that innovation can't always be predicted, we don't know which platform will yield answers for future threats. As part of our national preparedness, it will be important to stockpile countermeasures to some of the known risks. But it's equally important to support the development of novel technology platforms that have broad applicability over a range of potential threats. The use of mRNA to customize synthetic vaccines show the value of having agile competencies at the ready. These are the technologies we will need to produce our nation's vulnerability. So does this opportune focus and unique ability and responsibility as a life science industry that continues to reaffirm why Alexandria has dedicated our business, our passion and our purpose to help drive this mission-critical industry forward. And with that, I'll turn it over to Steve. Thank you.