Issue 062.

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Digital health research from Brian Dolan.

Welcome to E&O.

Last week I wrote about two UnitedHealth acquisitions, Bristol Myers Squibb’s DTx timeline, and UHG’s multiple mulligans in digital diabetes. Here’s what’s happening this week:

• HHS re-re-confirmed yesterday that we are still in a public health emergency because of COVID–19, and this third declaration will also stay in effect for at least yet another 90 days.
• Bristol Myers Squibb emailed me last week after the newsletter went out. They asked me to remove the launch timeline for their multiple myeloma digital therapeutic. I found that timeline (Q3 2020 launch) on a (somewhat) blinded job posting for the project, while similar job postings explicitly from BMS didn’t provide as many details. BMS said their recruiting firm made a mistake and posted an inaccurate timeline, but wouldn’t share the actual timeline because it is “confidential”. I didn’t remove anything, but you can re-read the post and the note I added with remarks from BMS here. Q3 is pretty soon though, so I guess we’ll find out more about this then?
• Mymee published results from a feasibility study, and it’s worth a read to learn more about the company’s offering. It concludes: “preliminary results suggest that the use of a digital therapeutic platform facilitated the identification of dietary and other environmental symptom triggers in lupus.”
• The Digital Medicine Society reports that 38 sponsors of clinical trials have submitted 108 unique digital endpoints, according to its research. That includes Phase I/II studies, exploratory studies, plus one label claim. More here.
• Kaia Health published results from a cluster-randomized control trial focused on people with non-specific low back pain (NLBP) and included patients from 111 primary care practices across Bavaria. Pain reduction went down significantly in the intervention group by the end of the three months. More here.
• Indian biopharma company Biocon has inked a deal with Voluntis to pair the company’s digital therapeutic Insulia with the biopharma’s insulin medications for people with diabetes. While specific markets were not disclosed, the companies said they would launch in multiple markets around the world.
• And… Biofourmis and Roche’s Japan-based subsidiary Chugai plan to jointly develop a digital therapeutic for assessing pain from endometriosis.

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Livongo: One year in as a public company

It’s been almost exactly one year since Livongo went public on July 25, 2019. There are a few moves I expected the company to make post-IPO that never came to fruition as well as a couple I was surprised to see. Here are a few thoughts on Livongo at the one-year mark along with a couple of things to look for from Livongo next.

Not a single acquisition. I’ve been most surprised by how non-acquisitive Livongo, the public company, has turned out to be so far. Given that it acquired at least three companies prior to going public (Diabeto, Retrofit, myStrength), along with what seemed like Livongo’s longterm strategy of “platforming-out”, a cash-flush Livongo seemed all but assured to buy a few other digital health startups back in 2019.

Has Livongo tried to buy you? Many of my readers likely know this better than I do, but I have to imagine Livongo has taken a hard look at a number of digital health companies in the past year or two and decided for various reasons not to make a bid.

Cohero and Hinge. Back in May 2019 I wrote my first E&O research report, an attempt at writing Livongo’s S-1 before the company filed it. At the time I expected Livongo to acquire Cohero Health to add asthma/COPD capabilities. I also expected it to consider buying Hinge Health to move into MSK. (As I have noted before, Hinge likely took itself off the M&A store shelf when it raised its whopping $90 million round earlier this year.)

Congestive heart failure and chronic kidney disease are next. In recent months Livongo has pointed to congestive heart failure and chronic kidney disease as two areas it will likely move into next. I struggle to see an obvious digital health acquisition target for either of those medical conditions.

Modules. Livongo typically describes these future capabilities as “modules” it would like to add to its platform, just like it added a COVID–19-specific module focused on mental health. It built that one in-house. So, this next phase of platforming-out may be a strictly in-house initiative, too.

What about sleep? I’ve been beating this drum for months, but I still think sleep is an under-addressed area for companies like Livongo. Livongo’s myStrength mental health offering does include a program focused on insomnia, but sleep health — like mental health — could become both a new vertical for Livongo as well as a horizontal opportunity to improve outcomes across its other focus areas. Livongo acquiring Big Health would be an interesting move.

RPM and evolving beyond the competition. Livongo’s ability to reposition itself as perhaps the most relevant health company during the COVID–19 pandemic might be considered a master class in marketing someday. This newsletter has no designs on helping people make investment decisions, but without a doubt Livongo’s stock price has benefitted from its ability to convince the Street that its offerings are perfectly matched to meet new demands during the crisis.

Pandemic buffering. For a company that counts self-insured employers as a key customer group, there’s no denying that Livongo’s numbers have continued to impress despite record unemployment. But it also seems likely that the fallout from the pandemic just hasn’t hit Livongo yet because of its sales cycle and contract lengths. Watch this space in six months’ time.

CMS and telehealth. Livongo has begun to explore Medicare reimbursement for its telehealth services, but it’s not clear exactly how Livongo will fit in here. I suspect they may be waiting until it’s more clear what CMS plans to do with telehealth post-pandemic before Livongo announces anything more on this front.

No competitors? All of this talk, however, has helped Wall Street to think of Livongo as a telehealth company first. Recently, it even helped lead CNBC’s Jim Cramer to proclaim that Livongo had no competitors. Speaking of, where is that Omada Health IPO? And I think UnitedHealth launched its brand-new Level2 diabetes program just a day or two after he said that, which is coincidental timing.

Livongo is still diabetes-focused. Despite some of its posturing, Livongo hasn’t shared too much about its business beyond its diabetes management program. It still focuses on its diabetes program’s member base and hasn’t divulged much about its other programs’ participant counts. Its diabetes program has continued to post big numbers: At the end of Q1 2019, Livongo said it had 164,000 participants in its diabetes program. It now has 328,000. And, like others working in this space, Livongo is quick to point out how many tens of millions of people with diabetes — in the US alone — they have yet to reach.

What has surprised you about Livongo’s first year as a public company?

UnitedHealthcare’s SenSight and Simplifi — two digital health programs that never came to be?

Last week while I was digging into UnitedHealth Group’s past endeavors around diabetes, prediabetes, weight loss and mental health, I stumbled on a trademark and then a series of design specs that pointed to two digital health programs that UnitedHealth never pushed live. (Maybe they still will someday?)

The first was called SenSight. In a trademark filing from March 2017, UnitedHealth Group described this as a “kit consisting of wearable health monitoring trackers and health sensors to measure, track, and monitor biometric data, blood properties, heart rate, body movement, calories burned, and weight for medical purposes” and “to make positive lifestyle changes.” It also described the mark as related to “lifestyle wellness programs featuring one on one weekly health counseling” and “blood pressure”. Interestingly, the filing said the trademark was used for the first time in 2015, but I can’t find any mention of a commercial launch.

I think SenSight was what UnitedHealth planned to call a digital health program it piloted with Vida Health using iHealth devices and an Apple Watch. Some results from the pilot made their way into a press release back in 2016. UnitedHealth Group’s former Director of Digital Design, Ryan Shafer, also features mocked up photos of the kid for SenSight on his portfolio page. The Vida app, Apple Watch and iHealth weight scale and blood pressure cuff are all clearly visible.

Shafer left UnitedHealth in October 2019 right around the same time the health insurance company acquired a digital health company offering a somewhat similar kit of personal health devices, Vivify Health.

Shafer’s portfolio also included a mockup for a program from UnitedHealthcare called Simplifi. It looked to be an app-based stress management program also powered by Vida Health. Instead of iHealth, this program used an advanced physiological wearable from Empatica, which is perhaps best known for its work in epilepsy.

These projects probably never made it past the pilot stage — or even maybe the drawing board, but it’s fun to get a peek behind UHG’s digital health curtain.

Database: Prescription Digital Therapeutics Pipeline of Pipelines

As most of you know, biotech and pharma companies have an odd business quirk of transparently sharing their pipeline of products. This is pretty much unheard of among tech companies and, in general, you won’t find health tech companies sharing their product roadmap either. Prescription digital therapeutics companies, however, typically do post a pipeline on their websites.

This week I put together a beta version of a sortable, searchable database that tracks these Rx-only DTx pipelines. For starters, I’m tracking more than 75 Rx-only digital therapeutics across a variety of therapeutic areas.

The database is my attempt to keep E&O subscribers current with which prescription digital therapeutics are under development or in the market currently.

This beta version of the pipeline of pipelines is very much a work in progress. If your company’s pipeline is not featured here and you think it should (meaning your company is developing products that are Rx-only digital therapeutics for the US market), please hit reply to this newsletter or email me at b@exitsandoutcomes.com so that I can make an update.

I don’t want this to become overly complicated, but there is room for another column or two. What else should it track?

Quick links: E&O research reports and databases

The links below aim to make it easier for paying subscribers to find the long-form research reports and databases on the E&O site:

Database: Rx-only Digital Therapeutics Pipeline of Pipelines (Subscribers-only Link)
Database: Digital Health PPP Loans (Open access)
The Proteus Digital Health Report (Subscribers-only Link)
The Hinge Health Report (Subscribers-only Link)
The Digital Health Enrollment Report (Subscribers-only Link)
The Omada Health Report (Subscribers-only Link)
The Google Health Report (Subscribers-only Link)
The Pear Therapeutics Report (Subscribers-only Link)
The AliveCor Report (Subscribers-only Link)
Apple’s Healthcare Work Experience (Subscribers-only Link)
Approximating Livongo’s S-1 (Subscribers-only Link)

That’s a wrap on Issue 062 of E&O.