For No­vavax, part of the big ques­tion sur­round­ing the biotech was whether it could man­u­fac­ture a Covid-19 vac­cine — its first com­mer­cial prod­uct — prop­er­ly, in suf­fi­cient quan­ti­ty and de­liv­er it on time.

With months of de­lays due to fil­ings and man­u­fac­tur­ing con­cerns, the an­swer to that ques­tion might just be no. The newest de­vel­op­ment for the biotech marks the lat­est in missed dead­lines and bro­ken pledges for the com­pa­ny — and the CEO who has a mul­ti­tude on his record.

As we wrote pre­vi­ous­ly, No­vavax’s CEO Stan­ley Er­ck had told an­a­lysts that “we’re talk­ing weeks here, not months” on a EUA sub­mis­sion to the FDA on Au­gust 5. Three months lat­er, the com­pa­ny changed its tune and punt­ed the time­line to the end of 2021. And on New Year’s Eve? They said they ex­pect to sub­mit a re­quest for EUA in one month — which made that promise a re­al-life ex­am­ple of “third time’s the charm” as they ac­tu­al­ly met that dead­line last week.

And now, there are re­ports of mas­sive ship­ping de­lays.

No­vavax $NVAX is feel­ing the heat from in­vestors — with shares tum­bling down more than 10% this morn­ing af­ter clos­ing yes­ter­day at $94.80 a share and at one point, dip­ping be­low $80 a share.

Amy Speak

On­to the news: No­vavax has on­ly de­liv­ered a tiny per­cent­age of the 2 bil­lion Covid-19 shots it planned to send around the world this year, ac­cord­ing to Reuters — about 10 mil­lion shots in to­tal. The biotech has al­so de­layed first-quar­ter ship­ments in Eu­rope and low­er-in­come coun­tries such as the Philip­pines, which has not re­ceived any of the 30 mil­lion shots it had or­dered.

No­vavax se­nior spokesper­son Amy Speak told Reuters that some ship­ments have been held up by reg­u­la­to­ry process­es and are wait­ing in a dis­tri­b­u­tion ware­house to go to health­care providers.

Ship­ments to the EU, In­done­sia and the Philip­pines were held back by a se­ries of fac­tors, ac­cord­ing to of­fi­cials who spoke with Reuters — in­clud­ing late reg­u­la­to­ry ap­proval from the WHO, ex­port lim­i­ta­tions on No­vavax’s pro­duc­tion part­ner in In­dia, the Serum In­sti­tute, and de­layed ap­proval from Eu­ro­pean reg­u­la­tors for in­di­vid­ual vac­cine batch­es, who must ex­am­ine the shots be­fore they can be dis­trib­uted.

The com­pa­ny has al­so yet to de­liv­er vac­cine dos­es on its largest con­tract for Co­v­ax — with 1.1 bil­lion dos­es ex­pect­ed, which would make No­vavax its third-largest sup­pli­er, Reuters said — cit­ing busi­ness da­ta and an­a­lyt­ics firm Glob­al­Da­ta Plc.

While No­vavax did not pro­vide a time­line for Co­v­ax, the biotech said it ex­pects to de­liv­er around 80 mil­lion dos­es to Co­v­ax by the end of the quar­ter, which is less than 10% of what is list­ed on their con­tract.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.