Analyst Conference Summary

biotechnology

conference date: February 26, 2020 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2019 (fourth quarter, Q4 2019)

Forward-looking statements

Overview: Has raised a lot of cash to pay for R&D programs.

Basic data (GAAP):

Revenue was $14.1 million, down sequentially from down from $17.0 million, and down from $35.4 million year-earlier. All revenue is from collaboration and grants.

Net income was negative $124.2 million, down sequentially from negative $123.2 million, and up from negative $144.1 million year-earlier.

EPS (diluted) was negative $0.37, flat sequentially from negative $0.37, and up from negative $1.14 year-earlier.

Guidance:

Moderna expects net cash used in operating activities and for purchases of property and equipment in 2020 to be between $490 and $510 million.

Conference Highlights:

Stephane Bancel, Moderna's CEO, said "The Moderna team continues to execute our strategy, including our CMV Phase 2 study enrolling ahead of plan, shipping the coronavirus Phase 1 clinical materials to NIH/NIAID in just 42 days, and announcing five new development candidates in the last two months. We have up to $2 billion of capital to invest in the company, a great team, a powerful mRNA platform and a state-of-the-art manufacturing site. I am more energized than ever about our future."

Moderna currently has 24 mRNA candidates, with 12 now in clinical studies. The goal of the next phase of development is to submit multiple BLAs to the FDA.

Raised $550 million cash after the quarter ended, in Feb. 2020.

Moderna's Phase 1 study evaluating the safety and tolerability of escalating doses of mRNA-1944 for Chikungunya Virus continued dosing.

Cytomegalovirus (CMV) vaccine mRNA-1647 Phase 2 study enrollment is near completion, with interim data expected in Q3 2000. The Phase 1 study reported positive interim results in Q3 1019. 25,000 newborns infected in US each year, has proven difficult to vaccinate against. 6 RNA sequences are included in 1647. Estimates annual peak sales would be $2 to $5 billion if the vaccine is approved and adopted globally.

The first clinical-grade batch of novel coronavirus vaccine (mRNA-1273) shipped to the NIH for use in Phase 1 study in the U.S.; delivered from Company’s cGMP facility in 42 days from sequence selection.

Three new vaccines were announced in February 2020: mRNA-1345 for pediatric RSV; mRNA-1189 for EBV; and mRNA-1273 for SARS-CoV-2.

The OX40L (mRNA-2416) Phase 2 expansion cohort in ovarian cancer will focus only on the combination with durvalumab (Imfinzi).

In 2019 the first participant was dosed in Phase 1b age de-escalation study of hMPV+PIV3 vaccine (mRNA-1653). This is a Phase 1b study of pediatric subjects protect against human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3).

Moderna's follow-on Zika vaccine candidate, mRNA-1893, continues to progress toward an IND filing. The FDA granted Fast Track designation for this Zika vaccine. The Biomedical Advanced Research and Development Authority remains committed to its grant of up to approximately $125 million for development.

The randomized Phase 2 study to assess whether post-operative adjuvant therapy with mRNA-4157, in combination with Merck's Keytruda, improves recurrence-free survival in adjuvant cutaneous melanoma compared to Keytruda alone continues. The Phase 2 patients are at 34 neoantigens, more than the Phase 1 trial used.

The Phase 1/2 MMA (mRNA-3704) study is actively recruiting patients following a protocol amendment expanding the eligibility criteria to patients 8 years and older

The Phase 1 KRAS cancer vaccine (mRNA-5671 or Merck V941) study continues. About 20% of human cancers are driven by mutated KRAS. 5671 codes for the most common mutations.

The Phase 1 study of mRNA encoding IL12 (MEDI1191) injected intratumorally continues. Collaborator is AstraZeneca

The FDA granted Fast Track designation to mRNA-3927 for PA ; study start-up is ongoing for the open-label, multi-center Phase 1/2 study of multiple ascending doses of mRNA-3927 in pediatric patients with PA in the U.S.

Inherited metabolic disease GSD1a results in a buildup of glycogen in tissues and an inability to regulate glucose, leading to life-threatening hypoglycemia and long-term liver and kidney damage. mRNA-3745 is an IV-administered mRNA encoding G6Pase enzyme, designed to restore deficient or defective intracellular enzyme activity.

Three clinical trial sites are open and actively recruiting patients for the Phase 1/2 open-label, dose escalation study evaluating mRNA-3704 for the treatment of MMA, or Methylmalonic acidemia.

AZD8601, which now is in an ongoing Phase 2a study led by AstraZeneca.

First patient enrolled 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).

Cash ended the quarter at $1.26 billion, down sequentially from $1.34 billion. In Q1 2020 $550 million more was raised with a share offering.

Operating expense (GAAP) of $145 millon consisted of $119 million for R&D and $26 million for SG&A. Operating income was negative $131 million. $8 million interest income; $2 million other expense. Income tax benefit $0.2 million.

Q&A summary:

Corona virus? Our part was to manufacture and ship. NIH will run the trial and provide updates. We will update you on scale up when the path is clearer.

MMA enrollment? Just one patient is enrolled. The age barrier is difficult. Once we have 3 patients, we can go to lower ages, where the unmet need is.

Process for licensing for corona virus? We don't know yet, is rapidly evolving.

CMV timing for administration? Start with women of childbearing age, then adolescents.

Monetary model for corona virus? Just doing this for public health.

PCV and KRAS, any new data, why not core franchise? Phase 1, so we will disclose when we get a full data set. In oncology you need to show a clinical benefit before we would call it core.

Timeline for Phase 3 CMV? Enrollment within 18 months, duration 2 years, then analysis.

MRNA technology is cell-free, so that makes it easier and reduces capital expense for manufacturing. The process is the same for every vaccine and therapy. That is why we were able to produce a corona virus vaccine so quickly. And why we can have such a broad pipeline for relatively little expense.

Yes, we now want to be cautious on the exploratory front. We want to see more results first.

RSV? Partnered with Merck, for elderly patients.

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