Analyst Conference Summary

biotechnology

conference date: May 4, 2023 @ 5:00 AM Pacific Time
for quarter ending: March 31, 2023 (first quarter, Q1 2023)

Forward-looking statements

Overview: Rapidly declining revenue as Covid bolus tapers off, but lots of cash.

Basic data (GAAP):

Revenue was $1.86 billion, down 63% sequentially from $5.08 billion, and down 71% from $6.07 billion year-earlier.

Net income was $79 million, down 95% sequentially from $1.47 billion, and down 98% from $3.66 billion year-earlier.

EPS (diluted) was $0.19, down 95% sequentially from $3.61, and down 98% from $8.58 year-earlier.

Guidance:

Moderna has COVID-19 vaccine sales of approximately $5 billion currently contracted for 2023 delivery. It is in negotiations for additional COVID-19 vaccine orders in key markets, including the US, Japan, and the EU. Expects total product sales in the first half of 2023 of approximately $2.0 billion (second quarter 2023 sales are expected to be between $0.2-$0.3 billion).

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "We had a strong first quarter, with $1.9 billion in revenue, clearly indicating that we are on our way to deliver on the $5 billion of signed Advance Purchase Agreements for 2023. In addition, we are encouraged by the progress of new COVID-19 vaccine contracts in the U.S. for this fall with pharmacy chains, hospital networks and multiple U.S. government agencies. Similar discussions are ongoing with Japan, the EU, and other key markets such as Australia, which recently ordered additional COVID-19 vaccines. At AACR, we presented detailed results for the treatment of melanoma with our individualized neoantigen therapy in combination with Keytruda, showing a 44% reduction of recurrence or risk of death in melanoma compared to Keytruda alone. These data could represent a profound change in the treatment of melanoma, and we are quickly beginning Phase 3 trials in melanoma as well as lung cancer. We also are pleased with our progress in rare disease, where we have now advanced to the dose-expansion phase of our investigational mRNA therapy for propionic acidemia, and have upcoming interim data being shared at ASGCT this month. At the same time, we are fully preparing for potential commercial launches of two products in 2024, our RSV and flu vaccines." Now has 4 medicines in Phase 3.

Moderna plans to file for regulatory approval for mRNA-1345, Moderna's investigational RSV vaccine for older adults, in the first half of 2023. In Q4 2022 the Phase 3 trial met its primary endpoint. A pediatric trial is fully enrolled.

In Q1 2023 Flu (mRNA-1010) interim analysis from Phase 3 P301 immunogenicity and safety trial demonstrated mRNA-1010 achieved superiority on seroconversion rates for A/H3N2 and A/H1N1, superiority on geometric mean titer ratios for A/H3N2, and non-inferiority on geometric mean titer ratios for A/H1N1. Non-inferiority was not met for seroconversion rates, and geometric mean titer ratios for the influenza B/Victoria- and B/Yamagata-lineage strains. mRNA-1010 was found to be generally well-tolerated. The Phase 3 P302 trial is ongoing, which focusses on influenza A.

In Q3 2022 the Moderna Omicron Covid variant vaccine received FDA approval in the U.S. and regulatory approval in many other nations. For 2023 Moderna has $5 billion in sales contracted for deliery and expects additional sales. In Q4 2022 the Spikevax Bivalent BA.4/BA.5 was authorized for everyone over 5 months old.

Moderna currently has 48 mRNA candidates now in development. 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. There are 3 other indications in Phase 3.

All product revenue is from COVID-19 vaccine mRNA-1273 (Spikevax) and its omnicron booster variants. In Q4 $4.86 billion of revenue was from product sales and $225 million from was from other.

Vertex initiated a Phase 1 trial for VX-522 for the cystic fibrosis therapy in Q1 2023.

The personalized cancer vaccine (PCV) Phase 2 study evaluating mRNA-4157/V940 in combination with Keytruda as adjuvant treatment for patients with high-risk melanoma is fully enrolled. The primary efficacy analysis showed a 44% reduction in recurrence of death. On October 12, 2022, Merck exercised its option to jointly develop and commercialize mRNA-4157/V940 pursuant to the terms of its existing Collaboration and License Agreement. Moderna received $250 million from Merck in Q4 2022 for the option exercise.

Cash ended the quarter at $16.4 billion, down sequentially from $18.2 billion. $ billion is deposits for future vaccine sales. Operating cash flow $ billion. $ million capital expense. $ billion was used to repurchase million shares of stock in the quarter.

Operating expense (GAAP) of $ billon consisted of $ billion for cost of sales, $ million for R&D, and $ million for SG&A. Operating income was $ billion. $ million interest income; $ million other expense. Income tax $ million.

Q&A Selective Summary:

not available at this time

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