Ref: Call Summarized by @PAC yahoo finance conversation —
Today's call again illustrated that the Novavax senior management team does not know how to:
- run a glitch-free conference call (lots of technical issues)
- effectively promote its products
- communicate with the investor community
- meet self-imposed deadlines
A great deal of the call seemed like they wanted to get it over with quickly. Low energy.
However, the only "real" negative was that things are being pushed 1 or 2 months down the road.
Here are the Pros and Cons I got from today's call:
PROS
- Far exceeded both EPS and Revenue expectations
- Nothing material has changed, except dates -- by a little, not much
- US Phase 3 results will be announced in Q2 (next few weeks)
- US FDA, UK MHRA, EU EMA filings in Q3 ("as early in the quarter as possible")
- Rolling reviews on-going /w CA, NZ, SK, WHO; all will happen in Q3
- 30-40M doses in stock (currently on shelves)
- All manufacturing sites in GMP manufacturing state
* "all problems at commercial scale have been resolved"
* producing about 35M doses / month currently (w/o SII)
- expecting full operating cadence (150M/mo) in Q4 (deferred from Q3)
- supply shortages to go away soon
- CMC has progressed with all regulatory agencies
- EU purchase agreement in progress
- "Best in class" efficacy, tolerance, manufacturing process, partners, multivalence, etc
- Development underway for both single and bivalent variant doses
- Clinical trials begin later this year for combo Flu/Covid dose
* animal studies already show same efficacy as individual shots
- NVAX is considered the "booster candidate" for all current vaccines
- Phase 3 trials of Malaria vaccine scheduled in 4 African countries this year
- Supply agreements already in progress for 2022 and beyond
- "Demand for our vaccines is here to stay"
- $2B in bank
- Compelling future
CONS
- US PREVENT-19 trial results deferred due to 60% dropouts (dropouts slowed by initiating crossover ...which deferred trial results)
- Other EUAs also deferred to Q3 ("as early in quarter as possible")
- 150M/mo goal moved from Q3 to Q4 due to shortage of raw materials
- No mention of when NanoFlu goes into arms
- No mention of why Texas production hasn't started
- Flu/Covid combo vaccine not broadly in arms until after 2022
OTHER
- The UK strain now represents of 60% of USA infections
SUMMARY
Stan: "Every quarter gets more data, pointing to a successful vaccine. We're getting close to the end ...which is really the beginning for us ... we've eliminated all of the serious hurdles"