Libre2 Update – BIG NEWS

Ok let’s get right to the point as we only have short time between presentations and this is BIG news – as promised we asked Abbott about the status of the Libre2, specifically when would it get here and will it get an iCGM designation. Remember last week at CES Abbott representatives were telling attendees that Libre2 would not be here for another year, which if accurate would be a major blow to Abbott.

Well according to Abbott CEO Robert Ford they have submitted more data and information to the FDA and are confident they will gain iCGM.

The interesting part of that answer is what he didn’t say, specifically he did not counter what his reps were telling people at CES. We sort of anticipated this answer as during his prepared remarks Mr. Ford spent a great deal of time talking about Libre but made no mention of Libre2.

His answer also follows a dangerous pattern with Libre2 as when first submitted to the FDA Mr. Ford’s predecessor was very vocal about how Libre2 would not just gain FDA approval but also garner the iCGM designation. Yet with each conference call after that Abbott seemed to be backing away from this initial confidence, basically stating that Libre2 will get here someday.

To us this brought back memories of Navigator, Abbott’s first foray into CGM. For those new to Diabetic Investor our those with short memories indulge us for a moment while we take a trip down memory lane. After buying Therasense for $1.2 Billion in 2004 Abbott submitted Navigator to the FDA in October of that same year. As they are doing today with Libre2 initially the company was very confident the FDA would approve Navigator quickly and they would have a major first to market advantage. Yet it the product wasn’t approved until March of 2008 and was eventually pulled from the market in 2011. (Feel free to search the archives section of the web site for more details as we did write extensively on the Navigator.)

What should concern everyone is the similarities between Navigator and Libre2 most notably the comments made by the company. With Navigator it became almost a running joke with each conference call how much the company talked about Navigator and when it would get here. Just like Libre2 the initial comments were full of confidence but with each corresponding call this initial confidence faded away. It eventually got to the point where the company stopped talking about Navigator and people stopped asking about it.

There is no need to review the many missteps Abbott made with Navigator as they are well documented and available in the archives. However the BIG difference today is that unlike when Navigator was under consideration and Abbott had no presence or major competition in CGM, today they have a huge presence and major competition in CGM. Libre has been a huge success surpassing the billion dollar revenue mark and the 2 million patient mark. However Dexcom has G7 coming and as we have noted G7 has all the makings of being a Libre killer.

Abbott knows this and was banking on Libre2 to counter the coming G7. The company figured yes G7 would be a strong competitor but Libre2 would be here first and garner a strong presence before G7 was even available. Well Libre2 isn’t here and based on everything we’ve learned and heard it likely won’t be here anytime soon. On the flip side G7 will be here by the end of this year meaning that Libre2 and the G7 could be hitting the market at the same time.

Dexcom has already stated that G7 will have all the features and accuracy of the G6 but with a lower price point and lower COGS. Simply put they will take away any perceived price advantage from Abbott who is committed to a value strategy with Libre. Bottom line the Libre2 delay is costing Abbott dearly.

We’ll have more to say later today but we know this is big news and wanted to update everyone once we had it. Promise more later.