News from the Tandem Q4 2018 conference call

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Tandem held their 4th quarter 2018 conference call on February 26, 2019. A transcript is available at https://seekingalpha.com/article/4244554-tandem-diabetes-care-inc-tndm-ceo-kim-blickenstaff-q4-2018-results-earnings-call-transcript

Here’s the news as I see it.

They are working on FDA approval for the Control-IQ hybrid closed-loop algorithm that will adjust basal and give correction boluses. The study for patients 14 and over is underway, should complete by April and be presented at the ADA conference in June. The study for pediatric patients 6 and over is also underway and should be completed soon after the adult study. Depending on timing, both may be combined for a single FDA submission, or they may be split. They “continue to plan for Control-IQ launch sometime between summer and the end of third quarter.”

They want to get paid for Control-IQ but haven’t decided on a pricing strategy yet. They’re working to convince the insurance companies to pay for an upgrade to Control-IQ based on the cost savings that have resulted from reduced hypos with Basal-IQ.

They know from a study in France that Control-IQ enables parents of pediatric T1 pumpers to get much more sleep and have much less worry. This is great for the parents, and will be great for Tandem’s business.

They and their clinical investigators were truly surprised to learn that the reduction in lows from Basal-IQ also leads to a significant reduction in rebound highs. “And I think physicians are sort of stunned to see that that’s the case.” (I’m shaking my head sadly…)

They are working on what comes after Control-IQ and won’t give any detail for competitive reasons, but they’re considering no carb counting (just small, medium, or large meal indication, for example) and “personalized settings.” To me the latter comment suggests that the initial Control-IQ will have a fixed BG target.

They hope that Basal-IQ and Control-IQ will help them talk their way back into UnitedHealthcare coverage, but recently it went the wrong way when Medtronic became the sole covered pediatric pump supplier for United Health.

They continue to work on the t:sport, which is about half the size of t:slim and is controlled from a
phone app. They are designing and testing this year, and want to get approval from the FDA as an Alternate Controller Enabled (ACE) pump by the second half of next year and the CE Mark in Europe also during 2020.

They anticipate approval of a phone app (iPhone and Android) in the first half of this year to display pump and CGM data received from the t:slim X2. Eventually they want the app to be able to fully control the pump, i.e. change settings and dose insulin, as will be required for the t:sport.

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@bkh, great summary, thank you! I absolutely LOVE your coverage of earnings calls, it is super useful to all of us.

I had a huge laugh here!

That would be extremely disappointing.

Maybe we should consider some kind of an email-writing campaign to let Tandem know how much we want individual BG targets.

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Too late for the first version of Control-IQ. The clinical tests are well underway, I don’t think it’s practical to ask them to change the algorithm now. Their goal is to get to market quickly because they think their system will be significantly better than the 670G.

I do believe they already know that people want to set their own BG targets, the issue is that it will take an unknown length of time to sufficiently prove to the FDA that this is safe and effective. I imagine it will become much easier after the first release of Control-IQ has amassed a track record in real world use.

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Only if they are interested in adding that function. I think I could make the case that it would translate to additional sales, but unless their marketing and product team has their eye on this feature, they probably wouldn’t spend the money to make this happen. The easiest thing is to get approval and then only add on discrete functionality that can be tested separately and added on with minimal fuss. i.e. put it in their existing patients, collect what would have been done if it had been turned on, then turn it on for a short period of time to collect the data after they are sure it is safe.

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For some reason I’d had in my head that these would be free upgrades. Hopefully it’s still substantially cheaper than a new pump. The way this is all shaping up, and the delay in the G6 coming to Canada (could be early 2020 before it’s really available) really makes me think I’m just going to continue using my Animas pump for the next few years and then re-evaluate all the various pumps available in 2020 or 2021 (by which point I’ll have used my Animas pump for ten years, heh). Also, one concern I have with the Tandem pumps is how long the battery might last beyond warranty, and also whether the screens will have a n issue with becoming dim, seeing as how the dimming-screen and battery-compartment-cracking issue is a major weakness on Animas pumps that are out of warranty. If I switch, I want a pump that could potentially last another ten years… So by 2021, people should have a better idea whether that battery will last for years or will die fairly quickly and whether the screen remains “bright” (I didn’t find the t:slim screen all that bright when I saw it, though) after the warranty period is up.

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2.5 years in and no dimming problem and no battery problem. 10 years is a long time, I wouldn’t expect any battery to last that long. With that said, once it is out of warranty cracking the case and replacing the battery probably isn’t that hard. (fingers crossed)

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Well, I guess by “last” I mean is just usable…if it was ten years old, then I’d be willing to carry it around attached to a USB power bank all the time if it wouldn’t hold a charge. But that would mean it would still have to have at least some functionality to the battery. :slight_smile:

And, yes, it will be interesting to see when people start attempting to replace the t:slim batteries!

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Asking any battery to still pass electricity (i.e. function) is a tall order if it won’t hold a charge. That is because when they do finally degrade, it often is via a mechanism that prevents electrons from continuing to move in the system. With that said, I am sure that Tandem used the best available battery technology for their system. On the hopeful side, I do have a 7 year old ipad whose battery still works so there is hope.

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Yes, I have an original iPad from 2010 and the battery still works quite well!

Though the battery in my iPhone 3GS from 2009 swelled up quite alarmingly in 2015, so I guess there’s no guarantee to these things.

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I am amazed you have been able to make it last so long! None of the batteries of our iPhones have been truly usable more than about 2.5 years (they weren’t lasting a long enough part of the day afterwards).

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We get 5 years out of our iphone batteries. In the last year or so, you just need to turn off all that cellphone data so it only uses the data when it is connected to Wifi and you get decent performance for quite a while.

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You could consider this written in stone for Control-IQ.

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There is definitely a cost to the Control-IQ as there is a license fee that is required to be paid to TypeZero which has been acquired by Dexcom.

Whether the cost is passed on to the consumer is not yet publicly stated.

My best guess of the incremental cost is $200.

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I have a feeling a LOT of people will be expecting this. I won’t be surprised if there is an upgrade charge, but the question will be, how do they get insurances to pay for it? Some people won’t want to pay OOP for it, but would be willing to let their insurance cover it. If it sounds like it’s worth the cost, I’ll use my HSA to pay for it. But then again, you probably need a physician’s order to move forward, like people had to do with Basal-IQ. Fun!

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Not just your head, but I think this is just because they pitched the become a Tandem X2 user now and we will give you the Basal IQ upgrade when it becomes available for free. So I would think that because of this marketing many people will think the upgrade will be free.

If they can get insurance to pay for it once a doctor prescribes it great, but this isn’t always an easy task because while they say look it prevents lows, that doesn’t automatically mean it will reduce costs, and without a cost study to back it up, insurance companies won’t be pulling out their pocketbooks unless the cost is very modest.

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Unless I am wrong, I think the cost to insurance for the X2 is already substantially lower than the cost to insurance for the 670g.

@Nickyghaleb - Do you have information about what the charge to insurance is for the 670g?

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Not yet…

But I’ll be right back.

:running_woman:t2:

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$8703… Does that sound right, @Thomas?

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@Nickyghaleb
Yeah. But does that also include cgm equipment?

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Be right back…