Analyst Conference Summary

biotechnology

conference date: May 6, 2021 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2021 (first quarter, Q1 2021)

Forward-looking statements

Overview: Profitable quarter on Covid vaccine sales revenue.

Basic data (GAAP):

Revenue was $1.94 billion, up sequentially from $571 million, and up from $8 million year-earlier.

Net income was $1.22 billion, up sequentially from negative $272 million, and up from negative $124 million year-earlier.

EPS (diluted) was $2,84, up sequentially from negative $0.69, and down from negative $0.35 year-earlier.

Guidance:

See estimates for mRNA-1231 and Slide 24 for 2021 updated financial framework. Cap Ex 2021 $450 to $550 million.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "In the first quarter, the Moderna team delivered on its supply commitments to many governments and helped protect more than 100 million people. This accomplishment translated into our first profitable quarter in the company's history, after 10 years of scientific innovation and several billion dollars invested to make our mRNA platform a reality."

Moderna is ramping up its R&D spend; it is now four times what it was year-earlier.

Moderna currently has 13 mRNA candidates now in clinical studies. The goal of the next phase of development is to submit multiple BLAs to the FDA. Other than the Covid vaccine, the most advanced candidate, for CMV, is preparing for a Phase 3 trial.

The FDA granted an emergency use authorization of COVID-19 vaccine candidate mRNA-1273 on December 18, 2020. Plans to file a BLA in May 2021. Moderna increased its 2021 supply forecast to between 800 million and 1 billion doses and began making investments to increase global supply of up to 3 billion doses in 2022. It signed APAs (advance purchase agreements) for scheduled delivery in 2021, for a total of $19.2 billion in anticipated product sales, including sales already recorded in the three months ended March 31, 2021.

A single booster dose of 50 µg of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and two variants of concern (B.1.351, P.1) in previously vaccinated clinical trial participants

The first cohort in the Phase 1 study of hMPV/PIV3 vaccine candidate (mRNA-1653) has been fully enrolled.

First 3 cohorts in age de-escalation study of RSV vaccine candidate (mRNA-1345) for the pediatric population fully enrolled. In Q1 2021 reported positive interim Phase 1 data. Also plans a study in elder patients.

In Q1 $1.73 billion of revenue was from product sales, $194 million from grants, and $10 million from collaborations.

In Q1 2021 dosed first mRNA-3927 propionic acidemia patient.

Cytomegalovirus (CMV) vaccine mRNA-1647 Phase 2 study announced positive interim data in Q1 2021. The Phase 3 chart should start in 2021. Estimates annual peak sales would be $2 to $5 billion if the vaccine is approved and adopted globally.

Moderna is planning to begin a Phase 1 study of mRNA-1189 for Epstein-Barr virus in 2021. There is no approved vaccine for EBV.

The OX40L (mRNA-2416) Phase 2 expansion cohort in ovarian cancer will focus only on the combination with durvalumab (Imfinzi). Interim Phase 1/2 data was positive, as reported at AACR.

Continued enrollment in Phase 1/2 MMA (mRNA-3704) study; actively recruiting patients at U.S. sites following a protocol amendment expanding the first cohort eligibility criteria to patients 8 years and older. The FDA previously granted Fast Track designation for mRNA-3704 for MMA (Methylmalonic Acidemia).

Numerous other vaccines are at various stages of development.

Cash ended the quarter at $8.2 billion, up sequentially from $5.25 billion. Cash balance includes advance deposits of $5.6 billion for vaccine. Operating cash flow $2.97 billion. Liabilities listed as $8.9 billion.

Operating expense (GAAP) of $671 millon consisted of $193 million for cost of sales, $401 million for R&D, and $77 million for SG&A. Operating income was $1.27 billion. $4 million interest income; $10 million other expense. Income tax $39 million.

NOL cary forwards balance was $2.3 billion at the end of 2020, now releasing valuation allowance, reducing the effective tax rate.

At the end of Q1 2021 Moderna had about 1,500 employees, up from 830 year-earlier.

Q&A selective summary:

WTO IP waiver effects? Believes changes nothing for us. We are not enforcing our patents during the pandemics. There is no available mRNA manufacturing capacity; the process of setting up manufacturing would be quite long and expensive.

2022 contract dynamics? Changing market. Efficacy, safety questions for competitors. Booster for variants question. Epidemologists believe this pandemic will last for a long time and require boosters and variants. We are in active discussions with many governments for supplies in 2022 and 2023.

PA data pipeline? Proprionic acedimia program will look for biomarkers, might be early data for that, but may not see anything at the lowest dose level. So may not see data until 2022.

We could see Phase 2 VEGF data in 2021. There are many other programs that could produce data in 2021.

For a refrigerator stable vaccine (1283), would you need to run an efficacy study? We are enrolling Phase 1. Too early to comment on regulatory path, but might not need a full primary series, it may function as a booster.

There was an extended discussion of strategies for boosting immunity, including against new virus variants.

Price points on future Covid vaccine contracts? Governments are not being as tough on price as they were in 2020. We are setting the price, capacity of high-quality vaccines is constrained, but we can supply every single dose that the market wants.

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