Moderna Third Quarter Investor Earning Call Summary as Company Gears Up for Regulatory Moves

Moderna Third Quarter Investor Earning Call Summary as Company Gears Up for Regulatory Moves

Moderna just today gave its Third Quarter 2020 Conference Call based on its earnings report, while disclosing its preparation for the global launch of its COVID-19 vaccine product and importantly highlighting the company just recently receiving $1.1 billion in government deposits. These buyers are now awaiting shipments of the potentially life saving drug from the biotech. On Oct. 22, the company reported that they just completed enrollment for the Phase 3 mRNA-1273 COVID-19 vaccine study.

Big Times Ahead if Approvals go Through

The company’s CEO Stephane Bancel reported in today’s press release that, “I believe that if we launch our COVID-19 vaccine, 2021 could be the most important inflection year in Moderna’s history. We will have resources to scale Moderna to maximize the impact we can have on patients in the next 10 years through numerous new medicines.”

COVAX Initiative Discussion

Apparently the Cambridge, MA-based biotech venture reported that it has initiated discussions with the COVAX initiative for a tiered pricing scheme, should the mRNA-1273 vaccine be approved or accepted via emergency use authorization (EUA). A World Health Organization (WHO) initiative, COVAX exists to help keep drug and vaccine prices lower in lower to middle-income countries.

A Frontrunner

CEO Bancel reported in their press release that, “We are actively preparing for the launch of mRNA-1273 and we have signed a number of agreements with governments around the world.”

Moderna is considered a frontrunner in this vaccine race targeting COVID-19 as it just wrapped up enrollment of its 30,000 clinical trial. By last week, over 25,650 participants received their second dose of mRNA-1273. The company reported that 37% of the participants originate from “diverse communities” while 42% could be deemed “high risk” candidates concerning exposure to COVID-19.

Deal with Takeda in Japan

Reuters recently reported that Takeda would import and distribute 50 million doses of the novel COVID-19 vaccine candidate. Taking on responsibility for regulatory approval in Japan, Takeda would plan on supplying the vaccine in the first half of 2021. Takeda has also inked a deal with American-based Novavax to license its novel COVID-19 vaccine in a deal aiming to produce up to 250 million doses for the Japanese market.

Competition

Moderna’s primary competition in the “West” includes Pfizer/BioNTech (BNT162b2) and AstraZeneca (AZD1222) followed by Johnson & Johnson (Ad26.COV2-S) and Novavax (although for this latter vaccine, reports of delays in manufacturing push its large Phase 3 trial start date back toward the end of November). Germany’s Curevac also is developing a promising candidate.

In the “East” comes Russia’s Sputnik V and vaccine prospects out of China, including CanSino Biologics Ad5-nCoV and Sinovac’s CoronaVac as well as Sinopharm’s inactivated vaccine investigational product. TrialSite has reported that the “East” has accelerated the release of these products before the completion of Phase 3 studies going against international research standards. Nonetheless, these companies are doing deals all over the world in a frantic push for market share.

TrialSite expects a Vaccine 2.0 wave in 2021 through 2022 as other vaccine candidates emerge targeting COVID-19 in the clinical trials pipeline.