Where oh where is Libre2

As expected, Abbott posted strong fourth quarter and full year results for Libre. Let’s take a quick look at the numbers in the fourth quarter global sales reached $691 million, full year global just over $2.5 Billion. No matter how you slice these numbers they are impressive, but the scary part is they are just the tip of the iceberg. As we keep noting CGM adoption will only increase in the future as it becomes the standard for glucose measurement regardless of the patient’s therapy regimen. Simply put CGM isn’t just for intensive insulin users anymore.

Now onto the most pressing question where oh where is Libre2 and when oh when will it get here. Robert Ford incoming CEO basically parroted the comments he made when asked about Libre2 at JPM. What he didn’t provide was any specific update on when Libre2 will receive FDA approval. What’s becoming very obvious here is the company has no clue when Libre2 will get here.

Perhaps more disturbing is the way the company keeps backtracking from the initial confidence that Libre2 would receive FDA approval with the iCGM designation. While Mr. Ford again expressed confidence that Libre2 would gain iCGM, his overall comments indicated that analysts should not lose sight of the fact that Libre is doing just fine and will continue to do just fine.

Once you get past this corporate speak what this means is the company isn’t factoring Libre2 into their sales calculations. They obviously will be delighted if Libre2 ever gets here but it’s just as obvious and becoming more obvious they have no idea when this might happen.

While we don’t see the absence of Libre2 adversely impacting results in the near term, it could become a big problem should the G7 from Dexcom hit the market before Libre2. Dexcom has already noted G7 will be launched late in the year putting even more pressure on Abbott to get Libre2 here. The problem is all the pressure in the world won’t change one very large and very pesky fact, they don’t control the approval process.

Excuse the expression but the FDA is taking their sweet time approving Libre2 and from what we can tell is in no hurry either. So in a blast from the past we once again are waiting on the FDA to approve an Abbott CGM. Once again, the company is backtracking from their initial confidence. Once again, they seem to have misread what the FDA wanted.

The big difference between now and then is Libre is doing just fine. However competition is intensifying. The reality is Libre2 isn’t vital to the present, but it is critical for the future especially with G7 on its way. So here we go again.