August 4, 2009

From The News Wire: DexCom and Animas

3-Aug-2009 - Entry into a Material Definitive Agreement, Results of Operations and Financial Condit

ITEM 1.01. ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
On July 30, 2009, DexCom, Inc. ("DexCom"), entered into (i) a Letter of Amendment, amending the Amended and Restated Joint Development Agreement dated January 12, 2009, and (ii) Amendment No. 1 to the Commercialization Agreements, amending the OUS Commercialization Agreement dated January 12, 2009 (collectively, the "Amendments"), each with Animas Corporation ("Animas"). Pursuant to the Amendments, DexCom will collaborate with Animas to develop a modified version of DexCom's transmitter to support a single, global CGM-enabled insulin pump launch by Animas. DexCom is entitled to receive a one-time $1 million milestone payment upon the achievement of performance qualification of a manufacturing line for the modified transmitter and is also entitled to receive an additional one-time $4 million payment upon the first regulatory body approval outside the United States for the new system. The Letter of Amendment modifies the original $5.0 million milestone payment that DexCom was entitled to receive upon receipt of a CE Mark for the first commercializable OUS product. Pursuant to Amendment No. 1 to the Commercialization Agreements the initial term of the OUS Commercialization Agreement is three years from the first commercial product launch, but no later than three years after December 31, 2010.


YDMV Full Disclosure: I own shares of Dexcom. I am also trying to get the things for my kids passed insurance approval.

4 comments:

Sandra Miller said...

Bennet -

Any idea when Animas' CGM/pump combo will actually hit the streets?

Bennet said...

No clue

I keep looking for tea leaves in the FDA garbage to read.

Bernard said...

I'm not holding my breath, this has been on the cards since early last year. (And I also own shares of Dexcom).

Bennet said...

Up to this call Dex was saying '09-10. Animas wasn't say jack.

I listened to the call (haven't seen a transcript yet) and the changing of the terms of the Animas 5 million payment to Dexcom sounds like an admition it is gonna take longer to build one world sensor. So Dexcom get some of the money sooner than the previous agreement because the new plan pushes that payment threshold out.

Now it 1 million based on the sensor and 4 million based on governmant apporval Uutside the US (OUS). I got the impression that there are OUS requirements to be met with the sensor.

Gotta admit one sensor for the world sound like a better business plan for both Animas and Dexcom but sucks to be us waiting for it.

This doesn't seem to be an issue with the Pod sensor since it is US only.