The Tandem Q2 2019 conference call was held on August 1st, and a transcript is available at https://seekingalpha.com/article/4280541-tandem-diabetes-care-inc-tndm-ceo-john-sheridan-q2-2019-results-earnings-call-transcript
The big news is that the software upgrade to the Control-IQ closed loop algorithm will be free in the USA for all in-warranty t:slim X2 pumps. Actually, the broader statement is that all software upgrades will be free through the end of 2020 for in-warranty US customers who have the t:slim X2. One big reason they gave for this is that they didn’t want customers to defer a t:slim purchase to wait for Control-IQ version. (“Osborne Effect”) [snark]Nobody asked whether they were unable to convince any insurance companies to pay for a software upgrade.[/snark] They indicated that they wanted Control-IQ to be widely installed and used because they care about their pumpers, and anyway, the results will be so good that the word-of-mouth recommendations will help sell many additional pumps.
The Control-IQ study met all primary and secondary endpoints. And they suggest that it was good even for for people with A1C in the high 5’s. “The most important element of that study was the fact that, when you look at the stratification of time in range versus A1C. There was a very wide range of A1Cs from 5.5 to 10.5 and every group improved.” So time in range improved for all groups. The conference call did not state what happened to the A1C of people who started in the 5’s.
Control-IQ is expected to have a commercial launch in the 4th quarter of 2019 for age 14 and above, pending FDA approval. The study for patients age 6-13 is underway and half-enrolled. They are aiming to submit those results to the FDA early in 2020 to get approval before “kids summer camp season” in 2020.
They hope to launch the t:sport pump in late 2020, but didn’t say much about it.
They expect to launch Basal-IQ and the Device Updater software broadly outside the USA later this year, pending various regulatory approvals and insurance reimbursement arrangements.
The business is growing fast, and they expect 2019 as a whole to be cash-flow positive despite heavy spending to grow the manufacturing, sales, and support organizations. Pumpers and prescribers are happy. They hinted that they may be starting to make some progress with UnitedHealthcare: they definitely are not claiming any breakthroughs there, just that the Basal-IQ and Control-IQ results are helping those long-term discussions.