Friday After Hours - FTC approval of Sanofi Agreement

[mnholdem]

For those of you wondering why Sanofi still does not list Afrezza on its website, it's because they are forbidden from doing so until the Federal Trade Commission completes its review and issues approval per the Hart-Scott-Rodino Antitrust Act. Matt Pfeffer or Hakan Edstrom also eluded to this fact at the Morgan Stanley conference when he said they cannot even formally sit down with Sanofi for strategic meetings until the HSR is received.

The 2Q14 SEC filing noted that the Sanofi License Agreement would be filed with 3Q EOQ, which is in a few days (7 trading days). Hakan also confirmed at the Morgan Stanley Healthcare Conference that they had not received the HSR approval, which takes 15-30 days after submittal, meaning Sanofi/MannKind submitted the full Agreement at least 30 days before EOQ.

The FTC will announce its ruling and MannKind will issue a press alert by Tuesday, September 30 at the latest. However, the HSR approval could also be announced Friday after trading hours or Monday.

 MannKind's press release will likely say that details of the License Agreement will be disclosed at or near the next earnings conference, but could be a separate conference call as well.

Once this happens, folks WILL quickly see why Sanofi is the world's leading diabetes pharmaceutical company.

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I'll hedge this call by pointing out that I did not say which Friday (chuckle)... Too hard to predict, but it could be today or next Friday. It would appear MannKind submitted the Agreement in late August and the FTC has 15-31 days to make their ruling.

[Deleted]

Is there ANY chance the FTC will reject the agreement?  SAY IT ISN'T SO!!

[cybergym66]

Sept 19, 2014 9:16:24 GMT -5 avogadro said:

Is there ANY chance the FTC will reject the agreement?  SAY IT ISN'T SO!!

I'd say APPROVAL is about as close to 100% as you can get....FDA approval of Afrezza was MUCH more of a concern.

[obamayoumama]

This makes sense.  Matt told Roberta that the HSR would be done sometime after the 15th. of September to the end of September.  If they filed at the end of August, his timing statement would make sense.

[computerresearchtech]

How long after the FTC approval does the press release / details of License Agreement need to be announced?

[mrmookie123]

Excellent Post MNHOLDEM. I don't post much on here, but read almost all posts. Look forward to your knowledge.
Thank you for sharing. 

[mnholdem]

One error... FTC doesn't announce approval. If the investigator recommends no action, and the agency hasn't informed Mannkind otherwise, the Sanofi License Agreement is simply allowed to proceed after the waiting period expires. Hopefully, MannKind will release a simple press statement. As of two days ago, the waiting period had not yet expired according to Mr. Pfeffer.