'The urgency is increasing': Moderna spotlights vaccine, orphan drug programs, as it plots growth beyond Covid
09 Sep 2022
VaccineOrphan DrugmRNA
At its R&D day two years ago, Moderna was still anxiously awaiting Phase III data on its Covid-19 vaccineCovid-19 vaccine. In a preview, CEO Stéphane Bancel talked about the next 12 months being “the biggest inflection point ever” if the shot got launched — as he laid out his new vision for a high-flying biotech vaulted three to four years ahead by the pandemic.
“We have 20 drugs in clinical development today,” Bancel told Endpoints News at the time. “Could we, in 18 months, 24 months from now have 40? 50? I think it’s possible.”
'The biggest inflection point ever': On R&D day, Moderna CEO Stéphane Bancel doubles down on vaccines and lays out a vision for a '40, 50'-drug biotech
It became reality Thursday on Moderna’s 2022 R&D day. The mRNA biotech now boasts more than 40 major programs outside Covid, including several late-stage vaccine programs and therapeutic proteins to treat orphan disease.
But as Cowen analyst Tyler Van Buren writes, “The urgency is increasing” for Moderna to deliver.
Moderna breaks down its programs into six big areas: respiratory infectious diseases; latent and public health infectious diseases; rare diseases; oncology; autoimmune and cardiovascular.
“These show the power of the platform and are important for unlocking value beyond vaccines,” wrote Michael Yee of Jefferies. “Early orphan data is promising (more data in ’23). Near-term cancer vaccine data is still set for Q4, with RSV vaccine interim YE22. There is much going on; as we move past COVID, the market should start looking at what’s on deck.”
Both the flu and RSV shots are expected to deliver data in the first half of next year. In particular for flu, Yee noted that Moderna confirmed the FDA will accept immunogenicity data for regulatory approval, which will open up the door to another mass market and pit Moderna against some established giants.
Weighing in on the RSV race, he added: “Competitors have shown 66% efficacy so far and MRNA believes it will be similar or better, due to cellular response (T-cell responses). This is the differentiation potential vs protein vaccines in RSV.”
Preview
Source: Endpts
Arpa Garay
For the top therapeutic programs, Van Buren highlighted how mRNA-3927 showed “early evidence of clinical benefit” in propionic acidemia, which is characterized by the buildup of acids, as assessed by a biomarker. Another program for GSD1a dubbed mRNA-3745 also seems to be “acting as intended.”
As the US market for Covid-19 vaccinesCovid-19 vaccines transitions from one funded by the federal government to a private one, Moderna is also getting ready to take on Pfizer’s commercial team. Chief commercial officer Arpa Garay estimates the annual market will eventually range from $5.2 billion to $12.9 billion.
Moderna reported $18.5 billion in 2021 revenue and its market cap currently sits at about $55 billion.
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