Links for Dexcom Quarterly Earnings Calls. There are often great nuggets of information buried in these.
@Thomas, this is outstanding! Is it OK with you if we make it a wiki? This is a great reference!
Snippets from Dexcom 2017 Q3 Earnings Call:
Michael Weinstein - JPMorgan Securities LLC
Okay. And then, I want to make sure I understand, Kevin, your thoughts and plans for Verily. Well, let me step back. So I want to understand your thoughts and plans for G6 and no calibration. It sounded like you were saying by the end of the year, next year that you would need to get an initial approval for one calibration and make a supplement on that for no calibration. So, A, did I understand that correctly? And then, B, the timing of Verily Gen 1 is unclear at this point because it may be influenced by what happens with G6.
Kevin Ronald Sayer - DexCom, Inc.
That piece is correct, Mike. The way we look at this, and understand, we just completed the largest CGM study that the FDA has ever seen. We have match payers, almost 30,000 match payers in this study to YSI. There’s all sorts of data here. And people have seen what our no calibration G6 data looks like at numerous seminars over the past several months. As we looked at the results of that trial and we looked at that data, we felt the product is accurate enough to go no calibration now. And we’ve had open discussions with the FDA about how we would do that.
Now, the PMA is on file, and we have discussed three or four alternatives with the FDA with respect to how we do that. And one of them is the one you outlined to whereby we get the one calibration a day product approved and then file a supplement on top of that. We’re discussing a couple of other alternatives with them as well and I really don’t want to give the whole playbook here because it’s all very tentative.
Our first priority is to get a product to our patients with no calibration that serves the current patient base and can meet the cost profile that they’re looking for. That’s our G6 system as it is now with the reusable transmitter. Once we get through that filing, then the first Verily product becomes a priority. That product’s a disposable transmitter and will be thrown away. We have decisions to make, for example, about 14-day life versus 10 days and things of that nature that we’ll make as we go through these processes.
The second-generation Verily product will come after that. And we’re accelerating work on that product rapidly because that is our product with the most aggressive cost targets and really with the size and usability that we think our patients want ultimately. And that is a very, very – it’s going very well. It is a very aggressive timeframe and we need to work on that, too.
So we’ve got several things lined up in the pipeline, but they’re all dependent upon decisions we’ll make over the next six months. But I can tell you, by the time we’re out of the first quarter, we’ll know exactly what’s happening. We wouldn’t say we were comfortable with the no calibration G6 sensor if we weren’t. We’re very comfortable we have it.
I might even add the G6 system has a predictive low glucose alert that will predict when you’re going low in addition to the heart alert that has performed very well in our studies and been extremely accurate.
Sure. Is there a business category that the earnings call would make more sense in?
The Dexcom calls are really great because of all the Q&A. This 2017 Q3 was maybe 20 minutes prepared remarks and about 45 minutes of Q&A. The really give some good insight into what is going on and what they are working on.
BTW - I found the last snippet interesting that the G6 will have a predictive low alert. But the CEO also said something about a “heart alert” which I have NO idea what he refers to.
After listening to the audio clip a number of times, I think this was a transcription error and he actually said “hard alert” which makes sense in comparing a predicted low to an actual (ie - hard) low alert. So the G6 would have both - the predictive low alert and the “hard” low alert.
“Heart Alert” is probably a different device from a different company.
ha ha ha
That is hilarious!
I suppose we could put it in vendors, but I love the earnings calls because of all the stuff you find out about the equipment itself though – so I figure Tipwiki is the right category.
Done, and indexed on the wiki TOC!
On the no-calibration front, I hope they still allow it, even if they are reporting that it isn’t needed.
Calibration at least allows me to bring the G5 back into the right orbit every once-in-a-while.
I think we will have to wait to find out on that one.
However thinking about this from a general user perspective and trying to expand this out to as large of a population as possible, I think that issue with calibrations are likely one of the biggest problems achieving accurate results from the Dexcom.
Removing the ability to calibrate at all would impact a very small minority of the users while benefiting the great majority.
Just my thoughts on it.
Remember when we had to calibrate our glucometers? Each vial of strips came with a “code” that we had to put into the meter. The “code” was the calibration for that batch of strips. Then as the manufacturing tolerances became better the code was always 19 or 20, and later the code was always 20, and after that they advertised “no coding” meters which just means they put the 20 in at the factory.
The same progression is happening with CGM sensors. The study supporting the G6 has 30,000 pairs of data points comparing the G6 sensor with the YSI laboratory instrument, and Dexcom believes that the data already show that the G6 works as a no-calibration sensor. They had filed with the FDA for the G6 with smaller transmitter and easier inserter and 1 calibration per day because they thought that would be needed to get approval for insulin dosing without fingerstick confirmation in the first half of '18. The Libre approval for insulin dosing with no calibrations has changed the landscape. Now Dexcom is talking to the FDA to figure out what is possible and how to get there. At the December conference call we may hear the plan, but right now it looks like the most likely path is G6 with 1 daily calibration earlier in the year, and toward the end of 2018 approval for 0-calibration use. However, if talks with the FDA show a path to approval for a 0-calibration G6 well before year-end, Dex may go directly there.
Dexcom is eager to get to 0-calibration. We know they lost their position as CGM supplier to Bigfoot Medical’s hybrid closed loop pump because Bigfoot believes calibration errors are too great a safety hazard. And with a good enough sensor that’s absolutely true. Dexcom believes that 0-calibration is quite important for expanding their market to the many T1 and T2 who are not highly-motivated elite diabetics. And it will help when selling against the Libre.
Rather than allowing an optional calibration, I think it more likely they will say that if you don’t believe your CGM and your fingerstick shows the CGM is wrong, take another fingerstick to confirm it, and if the CGM really is wrong, the proper conclusion is that the sensor is broken, it should not be relied upon, and it needs to be replaced. xDrip+ could be the workaround for people who feel as you do.
Other tidbits from the conference call:
With respect to the collaboration with Google, look for a 0-calibration Verily CGM with disposable transmitter by the end of '18. This product will be marketed to people not on intensive insulin therapy, as something to be worn from time to time, perhaps for a month or two, while learning about the effect of diet and exercise on BG, and to help the physicians adjust medications and doses. They don’t know whether the Verily sensor will be approved for 10 days or 14 days, but the transmitter is built-in, disposable, and won’t have a long life. So don’t anticipate the ability to restart the Verily.
For the G6 Dexcom hasn’t decided on the sensor lifetime (the initial PMA said 10 days, but it may possibly be revised to 14 days or to 10 days but 0 calibrations.) They have not decided whether or not to use a suicide timer to kill the sensor and prevent restarts.
The Dexcom business approximately doubled in Europe and Canada over the last year. Dex competes well with the Libre despite a higher price because of the alerts, and the continuous flow of data which can be shared remotely. In particular, the Libre (as sold, without NotWaiting hardware) doesn’t wake anyone from an overnight hypo, or alert anyone while driving, and it doesn’t enable concerned parents to watch their childrens’ BG remotely. Supposedly the Libre is much less expensive, but given the fact that Dex users restart sensors and run them for close to 2 weeks on average, the sensor cost of the Dex is comparable with that of the Libre. (And this gives Dex a good reason to avoid putting a suicide timer on the sensor.)
So far Dexcom has shipped to 4000 systems paid by Medicare. There are another 20,000 people in the queue for Medicare approval, and Dexcom is working hard to handle them, hopefully by the end of 2017.
There was no mention of a touch-screen Dexcom receiver in this conference call. Maybe they’d rather have us just use our smartphones…
I would disagree with you on that. The thing is either accurate or not accurate. Removing calibrations means that people aren’t as aware of it being off. I don’t see how removing calibrations makes it more accurate.
I can try for a few days and never calibrate it and see what happens. But I suspect it would be totally useless.
I have tried it with both many calibrations and only the minimum calibrations every 12 hours. Didn’t make a difference for me.
Perhaps I am just more critical of it than others.
Just a few minutes ago, I knew I was rising and I tested at 136, and the Dex was saying 92 with a single up arrow. Perhaps some people are happy with that because it said they were moving up and that is helpful.
But I already knew that, and there is a huge difference between 92 and 136, so I am not excited about it and shouting “Yea! Dexcom knew I was rising!”. I am thinking - so what? The difference between 92 and 136 is not within 20%. Not even close.
If they remove the ability to calibrate, then I imagine I will be getting a lot of sensors replaced.
So what happened to the Dex over the next 15 minutes? Is this a only matter of our being able to start correcting 10 or 15 minutes earlier, or was the sensor “broken”? If the Dex mostly was just late, that would not affect the typical user, only folks like us. And the effect of a 15 minute delay on us isn’t all that big, in my view.
Anyway, Dex isn’t saying the G5 works without calibration, they are saying the G6 has that property, which to me means they’re not seeing the outliers that we sometimes get with the G5.
Under the assumption that the G6 accuracy doesn’t significantly improve on the G5.
Most of the time the Dex is far behind, like 30 minutes. To me that is very significant. If I hit a BG at 120 or whatever, it is much easier to bring back down into range. But the extra 30 minutes means that if I was waiting on the Dex, I’d be closer to 200 or whatever. That’s huge.
A lot of times I will take insulin based on my understanding of how laggy the Dex is. My wife will be curious - “Why are you taking so much insulin if you are only 110?” And I explain that the real number is not anywhere near the reported 110.
Anecdote: Last night my Dexcom was reading 6.1 (110) and I started to feel weird (high) so I did a finger stick and I was 10.8 (194). I starting to think that the Dex sensor had reached the end of it’s life (it was on day 14), but then all of a sudden there was an up arrow and within 10 minutes the Dex was reading 10 (180). Now I have no idea why I had gotten an up arrow… but at least I didn’t have to change my dex sensor.
For me, I rarely need to calibrate but I do a couple of BG checks a day anyways. When I am running a flat line (which is usually in the morning), the dex and my BG will read the same number or withing a few %.
I think early problems I had with sensors were due to poor calibration on my part.
On this point, the Dex CEO has already stated the G6 sensors can definitely be restarted.
Granted nothing is 100% sure until released, but on this, I do take the CEO’s word on it. This has been discussed by Dexcom on multiple occasions so it was more than just an offhand comment. Dexcom fully understands how their sensors are actually used in real life - they are not in the dark.
The touchscreen receiver was released in Q3. There was a brief mention somewhere but possibly not very explicit.
We did launch a new receiver this quarter. And while the actual cost profile on it to build it isn’t any higher, we believe the warranty return rates on it will be much less significant.
Real world has to factor in user error. This is just the reality and likely is the single biggest problem.
Point. The G6 uses a different sensor.
The G6 has a better MARD than the G5. I have already seen the numbers. If I find them again, I will post them.
I will be shocked if Bigfoot has an FDA approved pump, covered by insurance and shipped to patients before Dexcom gets their G6 approved and launched for zero calibrations. I think Bigfoot made a very bad business move by going away from Dexcom. Time will tell.
I am so much with you on this. Dexcom is a first class company, with great R&D, excellent understanding of its market, and outstanding customer service. I think that BigFoot will regret their move to the Libre in more than one way.
For those who are interested, here is a interesting discussion of BigFoot we had a little bit ago:
That may be in the PMA they filed for the G6, but they’re now looking into whether to modify
that. For example, it is possible that they would put in a suicide timer if this would be enable FDA approval for 0-calibrations in the first half of 2018.
In the conference call transcript I saw mention of a new receiver. I did not know that was the touchscreen one that they mentioned in earlier conference calls. Here’s the quote:
We did launch a new receiver this quarter. And while the actual cost profile on it to build it isn’t any higher, we believe the warranty return rates on it will be much less significant. And that will ultimately save us costs.
No, the issue is outliers, not the average performance. Eric was speaking of a Dex reading 92 mg/dL while his glucometer reads 136.
Me too, but my take on the public explanation is that Dexcom couldn’t guarantee it, whereas the Libre is already approved for 0 calibrations and non-adjunctive use. Perhaps we don’t know the real reason for the breakup.
Apparently it will ship in new CGM kits on 10/16/17 that are ordered direct from Dexcom, and later in the month from distributors. There’s no discounted upgrade program for folks with the old receiver.