Analyst Conference Summary

biotechnology

conference date: August 1, 2024 @ 5:00 AM Pacific Time
for quarter ending: June 30, 2024 (second quarter, Q2 2024)

Forward-looking statements

Overview: Plunging revenue, questions about RSV vaccine competition.

Basic data (GAAP):

Revenue was $241 million, up 44% sequentially from $167 million, and down 30% from $344 million year-earlier.

Net income was $ billion, down sequentially from negative $1.18 billion, and down from $ million year-earlier.

EPS (diluted) was $, down sequentially from negative $3.07, and down from $ year-earlier.

Guidance:

Reduced 2024 product sales guidance to $3.0 to $3.5 billion. 2024 cap ex $0.9 billion. Year-end cash $9 billion.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "During the second quarter, we marked the approval of our second mRNA product and significantly lowered our operating costs. We remain focused on execution for the 2024-25 COVID season and the launch of our RSV vaccine in the U.S. With continued positive Phase 3 data across our respiratory portfolio, we are using our mRNA platform to address significant unmet medical needs and advance public health. Our platform is poised to reach millions globally this year and we are excited by its continued positive impact on patients." Now has 5 vaccines with positive Phase 3 data.

The FDA approved Moderna's RSV vaccine, mResvia, in May 2024. The EMA recommended marketing authorization in the EU. Deliveries in US began in July. But it is a competitive market.

In Q2 Spikevax Covid vaccine sales were $184 million. Mainly from U.S. Moderna is also working with the FDA and international regulators to align the timing of flu and COVID-19 vaccine approvals, which is expected to result in higher uptake if Covid vaccines are available sooner and offered at the same time as the flu shot for the fall of 2024.

Moderna's flu vaccine had positive results in three Phase 3 trials. Discussing with regulators, intends to file for commercial approval in 2024. [But seems the timeline means will miss the 2024 flu season. - WM] Also the flu + Covid vaccine Phase 3 trial is fully enrolled, with data expected in 2024.

Six programs are now in Phase 3. By end of 2025 expects commercial sales of Covid, Flu, RSV, and Covid/Flu combo vaccines. CMV mRNA-1647 Phase 3 efficacy possible in 2024. Then a whole bunch of approvala in 2026, including in cancer and rare diseases.

Moderna's CMV (cytomegalovirus) vaccine (mRNA-1647) has fully enrolled its Phase 3 trial, with data expected before the end of 2024.

In A2 2024 Moderna received an award of $176 million through BARDA's Rapid Response Partnership Vehicle Consortium for an mRNA-based pandemic influenza vaccine.

Cash ended the quarter at $10.8 billion, down sequentially from $12.2 billion.

Operating expense (GAAP) of $1.60 billon consisted of $115 million for cost of sales, $1.22 billion for R&D, and $268 million for SG&A. Operating loss was $1.36 billion. $111 million interest income; $27 million other loss. Income tax $0 million.

Q&A Selective Summary:

Cash balance at year end guidance? Collecting defered revenue cash. Working capital. We are confident in the $9 billion.

Fall covid competition? On both covid and RSV there is supply chain and pricing pressure. We are entering an RSV market that is already dominated by two companies. We will provide updates as the season progresses.

Guidance, covid v. RSV? Three drivers are similar in size. Deferals are all related to Covid. EU is all Covid. Competitiveness is split between Covid and RSV.

RSV projections for fall? Not giving guidance, but this year has not turned out as expected. We hope to get access across retail chains, then have a better 2025.

We plan to return to growth in 2025, while keeping op ex minimal.

People are infected with RSV perhaps 20 times in their lives. We believe that there is a benefit to boosters as protection wanes. Especially for those at highest risk.

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