News roundup: Apple Watch flagships cease sale due to Masimo ITC ruling (updated); Noom, WW enter GLP-1 telehealth business; Oracle sees health side up despite Cerner drag; Cigna has multiple bidders for MA business

Apple Watch Series 9 and Ultra 2 going off sale in the US this week, upholding the ITC patent ruling favoring medical device developer Masimo. On 26 October, the International Trade Commission (ITC) ruled that Apple in the Series 6 and later violated Masimo’s patents on pulse oximetry (SpO2) sensors and software. [TTA 27 Oct] While this is awaiting presidential approval in the 60-day review period which ends on Christmas Day, Apple proactively restricted US sales of its flagship Series 9 and Ultra 2 watches which contain the blood oxygen sensors. (The SE model does not and continues to be available for direct sale.) According to 9to5Mac, online sales end on 3 pm Eastern Time on Thursday 21 December, while in-Apple Store sales stop after Christmas Eve. Of course, this won’t stop resales of existing stock through outlets like Amazon, Best Buy, and eBay. Under the ITC order, Apple cannot import either model after 25 December as the ITC issued a Limited Exclusion Order (LEO) plus a Cease and Desist Order (CDO). 

The ITC is rarely vetoed by the White House in patent actions. After that point, Apple is free to appeal in Federal District Court, which is highly likely and where the deepest pockets usually win. Also HIStalk 20 Dec and Strata-gee 21 Dec

There are other wrinkles with Masimo, though. Strata-gee.com earlier this month (13 Dec) timelines Masimo’s patent difficulties with the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruling against the very same patents, decisions upheld by the Federal Circuit Court. The PTAB also ruled against Masimo in the requested review of two Apple patents. Apple’s retaliation is to threaten lawsuits on Masimo’s new smartwatches. The icing on this messy cake is the November Delaware Chancery Court decision against Masimo, awarding $17.8 million in legal fees to activist investors/shareholders Politan Capital Management and Politan Capital NY LLC in a board fight that culminated in two seats to Politan directors.  One can sense that Apple is biding its time, though they could end all of this by negotiating a royalty to Masimo. Updated: see report on the stay effective 27 December here.

Noom and WW enter the weight loss drug-by-telehealth race. Ozempic and Wegovy, GLP-1 agonists, are increasingly popular in off-label use for obesity to produce weight loss, prescribed and managed by telehealth teams.

  • Noom, previously stressing behavioral change via app coaching direct-to-consumer, in October announced at HLTH Noom Med, a drug-focused program prescribing medications such as Saxenda (liraglutide), Wegovy (semaglutide), and the new Zepbound (tirzepatide), a dual GLP-1/G1P, all of which are injectable medications along with other GLP-1 medications such as Ozempic.
  • WW or WeightWatchers last week announced the WeightWatchers Clinic program. Via their recently acquired telehealth weight loss platform Sequence, it will offer weight loss meds and team management.  

They join Teladoc in developing weight loss programs, though Teladoc supports a physician-based care product for employers [TTA 21 April]. Both Noom and WW emphasize that member patients must qualify for the programs based on weight, BMI, and medical condition. Participants are educated through materials, coaching on behavioral management, managing appetite, and nutrition, especially in maintaining adequate protein as these medications not only induce weight loss, but also muscle loss (sarcopenia). One hopes that their teams are also knowledgeable on how these medications that slow down digestion to induce a feeling of fullness don’t mix well with surgical sedation, and that they issue cautions to patients before elective surgery. MedCityNews, FierceHealthcare, Forbes   

Noom has also replaced most of its top management since its new CEO joined in July. There’s a new CFO, chief technology officer (CTO), general counsel, two senior VPs (corporate development and partnerships, healthcare sales and services) a senior director of brand and communications, chief growth officer, chief product officer, and head of people. FierceHealthcare

Oracle Q2 results miss forecasts in rebuilding Cerner. Oracle Health, including the former Cerner, and slowing cloud growth were the culprits in their fiscal Q2 2024. Total revenue was $12.9 billion, up 5% in US dollars (4% in constant currency). Analysts expected $13.05 billion. Excluding Cerner, growth would have been 6% though Oracle did not separately break out revenue for the Cerner EHR business. Investors have noted two consecutive quarters of off-track growth and a weaker forecast for the remainder of the year. According to CEO Safra Catz and chairman Larry Ellison on the earning call, many upgrades and “modernizations” are being made to Cerner Millenium that will wrap up this FY. Half of Millenium customers will be moving over to Oracle Cloud Infrastructure (OCI) by February. They are also “rewriting” Cerner’s health and data intelligence platform, Cerner HealtheIntent, to get into population-scaled health management. ‘Transforming healthcare’ is an expensive proposition indeed. No word on the VA.  FierceHealthcare, Oracle release

And a quick follow up on Cigna’s sale of their Medicare Advantage business. Two payers so far–Health Care Service Corp. (HCSC) and Elevance–are reported to be bidding for Cigna’s MA business. The value of the business is estimated to be about $3 billion and with just under 600,000 members as of September. Both HCSC and Elevance are much larger players in MA. HCSC has over 1 million MA members in Blue Cross Blue Shield affiliates in Illinois, Texas, New Mexico, Oklahoma, and Montana. Elevance, the former Anthem, has over 2 million MA members. Bidding is expected to close this week. While MA is losing money for Cigna, they could refuse to sell if bids are unsatisfactory. FierceHealthcare, Becker’s

News roundup: CVS sells bswift; Babylon puts Meritage IPA up for sale, financially realigning to prevent delisting; Redesign Health sheds 20%, Noom 10%

Companies shedding ancillary businesses, and more than a few of their people that make them go. 

CVS Health is selling bswift to Francisco Partners. Bswift, a benefits technology and HR services company, was acquired by Aetna in 2014 for $400 million. It became part of CVS Health in 2018 after CVS acquired Aetna. Based on the website, it was operated independently. Francisco Partners, an investment group specializing in tech, recently acquired IBM Watson (now Merative) [TTA 7 July] and added it to 400-odd portfolio companies. Acquisition cost and management transitions were not disclosed, but expected to close by Q4 this year. The company will continue to partner with CVS Health and Aetna. Francisco Partners/bswift release, Mobihealthnews, FierceHealthcare, HealthcareFinanceNews

Babylon Health exiting the provider business, transitioning to US financial reporting requirements, and reversing stock to boost price. Babylon has put on the block Meritage Medical Network, an independent physician association (IPA) based in Northern and Central California with 1,800 providers in six counties serving 90,000 patients. The sale was announced 12 October and is expected to complete in early 2023. Babylon’s rationale is “to focus on its core business model through further investment in its digital-first contracts”. It was a short-lived foray, as Meritage was bought only last year along with First Choice Medical Group [TTA 7 Oct 21], which is not mentioned, and completed prior to their SPAC.

Babylon is also financially realigning.

  • On 12 October they also announced conversion to US financial reporting and GAAP accounting from reporting as a foreign private issuer. This will be effective in January 2023.
  • In September, shareholders approved a reverse share split to take place in Q4 to consolidate shares within the approved range of 15:1 to 25:1. All shares will be converted to Class A ordinary shares from a previous A/B structure.

These address a major problem that threatened Babylon’s listing on the New York Stock Exchange (NYSE). In September, Babylon received notice that it violated NYSE rules in not maintaining an average closing share price of at least $1 over 30 consecutive days. Today’s close (12 October) was $0.42. A reverse split will boost the stock price and prevent Babylon from being delisted. Babylon release, Mobihealthnews

After a brief break, healthcare layoffs continue even at richly valued companies with recent raises.

  • Redesign Health is releasing 20% of its workforce, or 67 people from its NYC-based workforce. This is one month after a $65 million Series C raise in late September from General Catalyst, CVS Health Ventures, and other investors, and a valuation in the $1.7 billion range. According to a company spokesperson, these had nothing to do with the Series C or financially driven, but according to the CEO, part of a “ongoing evolution, and given the need to prioritize in a challenging market”. Departments affected in the ‘restructuring’ are engineering, product, marketing, and recruiting. Redesign is unusual in that it creates startups from its own research, assembles management teams, brands, and funds them. To date, it has created about 40, including a few that have had layoffs of their own (Calibrate). Redesign had planned to create more than 25 new companies by the end of 2022, which apparently will not happen. Fast Company, Mobihealthnews
  • The heavily advertised weight loss app Noom reportedly will be laying off 10% of their staff, or 500 people primarily in coaching. Noom currently has a valuation around $3.7 billion and a cumulative funding of $650 million. Apparently there is also a change in direction from the original (and successful) concept of nutrition, behavioral, and exercise coaching via live chat to scheduled video consults as part of a mind and body platform with a higher degree of personalization, including mental health. The company CFO is also departing for TripAdvisor, according to the Wall Street Journal. TechCrunch

Week-end roundup of not-good news: Teladoc’s Q2 $3B net loss, shares down 24%; Humana, Centene, Molina reorg and downscale; layoffs at Included Health, Capsule, Noom, Kry/Livi, Babylon Health, more (updated)

Teladoc continues to be buffeted by wake turbulence from the Livongo acquisition. The company took a $3 billion goodwill impairment charge in Q2, adding to the $6.3 billion impairment charge in Q1. The total impairment of $9.3 billion was the bulk of the first half loss of nearly $10 billion. While their revenue of $592.4 million exceeded analyst projections of $588 million, adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of $46.7 million were barely up from projections and were down from $66.8 million year prior. Losses per share mounted to $19.22, versus $0.86 in Q2 2021.

Another weak spot is their online therapy service, BetterHelp, which in the US is pursuing a substantial TV campaign. CEO Jason Gorevic in the earnings release pointed out competitors buying the business at low margins and consumer spending pullbacks. Teladoc’s forward projections are bolstered by Primary360 and Chronic Care Complete. Projected revenue for Q3 is $600 million to $620 million. Shares on Thursday took a 24% hit, adding to the over 50% YTD drop misery. At best, Teladoc will muddle through the remainder of the year, if they are lucky. MarketWatch, Mobihealthnews, FierceHealthcare

Health plans are also presenting a mixed picture. 

  • Humana announced a healthy earnings picture for the quarter and YTD. It earned $696 million in profit for Q2, up nearly 20% year over year. For first half, Humana earned $1.6 billion, an increase of 14.8% from 2021’s $1.4 billion. Cited were growth in their primary care clinics, Medicaid membership, and investment in Medicare Advantage. Earnings surpassed Wall Street projections and Humana increased its guidance to $24.75 in earnings per share. At the same time, they announced a reorganization of its operating units that separates their insurance services (retail health plans and related) and CenterWell for healthcare services including home health. Some key executives will be departing, including the current head of retail health plans who will stay until early 2023, ending a 30 year Humana career. FierceHealthcare, Healthcare Dive
  • Under new leadership, Centene posted a Q2 loss of $172 million which in reality was a significant improvement over Q2 2021’s $535 million and looked on favorably by analysts.
    • Their ‘value creation plan’ has sold off its two specialty pharmacy operations to multiple investors, using third-party vendors in future, and agreed this week to sell its international holdings in Spain and Central Europe — Ribera Salud, Torrejón Salud, and Pro Diagnostics Group — to Vivalto Santé, France’s third-largest private hospital company.
    • Medicaid, their largest business line, has been growing by 7%.
    • Centene is continuing to divest much of its considerable owned and leased real estate holdings, which marks a radical change from the former and now late CEO’s* ‘edifice complex’ to house his ‘cubie culture’. As a result, it is taking a $1.45 billion impairment charge.  Healthcare Dive. [* Michael Neidorff passed away on 7 April, after 25 years as CEO, a record which undoubtedly will never be matched at a health plan.)
    • A cloud in this picture: Centene’s important Medicare Advantage CMS Star quality ratings for 2023 will be “disappointing” which was attributed to the WellCare acquisition (accounting for most of the MA plans), two different operating models between the companies, and the sudden transition to a remote workforce. For plans, WellCare operated on a centralized model, Centene on a decentralized one, and the new management now seems to prefer the former. (Disclosure: your Editor worked over two years for WellCare in marketing, but not in MA.) Healthcare Dive
  • One of the few ‘pure’ health plans without a services division, Molina Healthcare, is also going the real estate divestment route and going full virtual for its workforce. Their real estate holdings will be scaled down by about two-thirds for both owned and leased buildings. Molina does business in 19 states and owns or leases space across the US. Net income for the second quarter increased 34% to $248 million on higher revenue of $8 billion. Healthcare Dive

Many of last year’s fast-growing health tech companies are scaling back in the past two months as fast as they grew in last year’s hothouse–and sharing the trajectory of other tech companies as well as telehealth as VCs, PEs, and shareholders are saying ‘where’s the money?’. 

  • Included Health, the virtual health company created from the merger of Grand Rounds and Doctor on Demand plus the later acquisition of care concierge Included Health, rebranding under that name, has cut staff by 6%. The two main companies continued to operate separately as their markets and accounts were very different: Grand Rounds for second opinion services for employees, and Doctor on Demand for about 3 million telehealth consults in first half 2020. As Readers know, the entire telehealth area is now settling down to a steady but not inflated level–and competition is incredibly fierce. FierceHealthcare
  • Unicorns backed by big sports figures aren’t immune either. Whoop, a Boston-based wearable fitness tech startup with a valuation of $3.6 billion, is laying off 15% of its staff. (Link above)
  • Digital pharmacy/telemedicine Capsule is releasing 13% of its over 900 member staff, putting a distinct damper on the already depressed NYC Silicon Alley.  FierceHealthcare also notes layoffs at weight loss program Calibrate (24%), the $7 billion valued Ro for telehealth for everything from hair loss to fertility (18%), Cedar in healthcare payments (24%), and constantly advertising Noom weight loss (495 people). Updated: Calibrate’s 150-person layoff was reported as particularly brutally handled with employees. Many were newly hired the previous week, given 30 minutes notice of a two-minute webinar notice, then their laptops were wiped. Given that the company makes much of its empathy in weight loss, facilitating prescription of GLP-1 along with virtual coaching, for a hefty price of course. HISTalk 8/3/22
  • Buried in their list are layoffs at Stockholm-based Kry, better known as Livi in the UK, US, and France, with 100 employees (10%).
  • Layoffs.fyi, a tracker, also lists Babylon Health as this month planning redundancies of 100 people of its current 2,500 in their bid to save $100 million in Q3. Bloomberg

Weekend news and deals roundup: Allscripts closes sale of hospital EHRs, closing out CEO; DEA scrutiny of Cerebral’s ADHD telehealth prescribing; more telehealth fraud; Noom lays off; fundings; and why healthcare AI is only ML

That was fast. Allscripts closed its $700 million March sale of its hospital and large physician practice EHRs to Constellation Software Inc. through N. Harris Group. The Allscripts EHRs in the transaction are Sunrise, Paragon, Allscripts TouchWorks, Allscripts Opal, and dbMotion. They reported their Q1 results today. According to HISTalk earlier this week, CEO Paul Black will be stepping down, with President Rick Poulton stepping in immediately. Update–this was confirmed on their investor call Thursday and the transition is effective immediately. No reasons given, but there were no effusive farewells.  Healthcare Dive

A damper on telemental health? Online mental health provider Cerebral, which provides talk therapy, audio/video telehealth, and prescriptions for anxiety, depression, insomnia, ADHD, and other conditions, is finding itself under scrutiny. This week, its main mail fulfillment pharmacy partner, Truepill, stopped filling prescriptions for Adderall, Ritalin, Vyvanse, and other controlled Schedule 2 pharmaceuticals. Cerebral is redirecting current patients with these prescriptions to local pharmacies and as of 9 May, will not prescribe them to new ADHD patients.

Based on reports, the Drug Enforcement Agency (DEA) is looking at Cerebral in particular as part of a wider scrutiny of telehealth providers and pharmacies filling telehealth-generated prescriptions due to allegations of overprescribing. It also didn’t help that a former VP of product and engineering plus whistleblower claims in a wrongful dismissal lawsuit that Cerebral execs wanted to prescribe ADHD drugs to 100% of diagnosed patients as a retention strategy. Bloomberg Law. Unfortunately, Insider is paywalled but you may be able to see a report in the Wall Street Journal. Becker’s Hospital Review, FierceHealthcare

Also troubling telehealth is recurrent fraud, waste, and abuse cases involving Medicare and Medicaid. Back in 2020 the National Healthcare Fraud Takedown took down over 80 defendants in telemedicine fraud [TTA 2 Oct 20, 30 Jan 21]. The Eastern District of NY based in Brooklyn has indicted another physician, an orthopedic surgeon, in a $10 million fraud involving durable medical equipment (DME). In exchange for kickbacks from several telemedicine companies, he allegedly prescribed without examination and with only a cursory telephone conversation DME such as orthotic braces. DOJ release

Some fundings and a sale of note–and a big layoff at a well-known digital health leader:

  • Blue Spark Technologies, an RPM company with a patented Class II real-time, disposable, continuous monitoring body temperature patch good for 72 hours, TempTraq, raised a $40 million intellectual property-based debt solution (??) to fund growth led by GT Investment Partners (“Ghost Tree Partners”) with support from Aon plc (NYSE: AONRelease
  • Specialty EHR Netsmart acquired TheraOffice, a practice management platform for physical therapy and rehabilitation practices which will be added to its existing CareFabric platform. Neither terms nor management transitions were disclosed in the release.
  • ‘White label’ telehealth/virtual health provider Bluestream Health is implementing its systems in Mankato Clinic, with 13 facilities across southern Minnesota. It’s a rarity–physician-owned and led–and in business since 1916. This also fits into a new telehealth trend–providers working with ‘white label’ telehealth companies and not with the Big 5. Release
  • Ubiquitously advertised (in US) weight-loss app Noom is laying off a substantial number of employees–180 coaches plus 315 more employees. Reportedly they are pivoting away from on-demand text chat to scheduled sessions that don’t require so many people. While profitable in 2020 ($400 million) and with Series F funding of over $500 million in 2021, it’s come under criticism that while its pitch heavily features easy behavioral change achieved through cognitive behavioral therapy (CBT), their real core of weight loss is severe calorie restriction. Engadget
  • Element5, an administrative software provider for post-acute facilities, raised a $30 million Series B from Insight Partners. They claim that their software is AI and RPA (robotic process automation) based. ReleaseMobihealthnews

And speaking of the AI pitch in healthcare, a VC named Aike Ho explains why she doesn’t invest in healthcare AI companies because there’s no such thing in healthcare–it’s just machine learning. On that, Ms. Ho and your Editor agree. She also makes the point that the market they address is ancillary and not core services, plus they have difficulty clinching the sale because they don’t relate well to achieving or can’t prove at this stage improved clinical outcomes. Ms. Ho’s looooong series of Tweets is succinctly summarized over at HISTalk (scroll down halfway).

News and deals roundup: CoverMyMeds ‘big bang’, Noom’s $540M Series F, insurtech Bright Health’s IPO, Grand Rounds-Included Health, GoodRx, Cedar-OODA, Huma, Bluestream Health’s outreach

McKesson shmushes four units into CoverMyMeds. McKesson’s Big Bang combines four McKesson business units–RelayHealth (pharmacy networking), McKesson Prescription Automation (software), CoverMyMeds (medication access for patients), and RxCrossroads by McKesson (therapeutic and drug commercialization). They are being reassembled into one massive unit under the CoverMyMeds name. The unit will have about 5,000 people and will be headed by Nathan Mott. More here in a blog post/announcement posting that’s short on information and long on cheerleading.

And the funding rounds keep marching down the alphabet. Noom, the weight loss app, gained a generous Series F of $540 million led by Silver Lake with participation from Oak HC/FT, Temasek (Singapore), Novo Holdings, Sequoia Capital, RRE and Samsung Ventures. Valuation is now at $4 billion. Adam Karol, a managing director at Silver Lake, and former TaskRabbit chief executive Stacy Brown-Philpot will join Noom’s board. The fresh funding will be used to expand into areas such as stress and anxiety, diabetes, hypertension, and sleep.

Noom had a banner year in 2020, with $400 million in revenues as people tried to shed Pandemic Pounds (aided by a near-ubiquitous ad push). The app has had 45 million downloads to date in 100 countries, largely in the US, UK, Canada, Australia, Ireland, and New Zealand. According to a (paywalled) Bloomberg News report, feelers are out for an IPO which may be valued at $10 billion. TechCrunch, Reuters, FierceHealthcare

Bright Health Group filed its S-1 registration statement with the Securities and Exchange Commission (SEC). Their rumored $1 billion IPO will be on the NYSE and trade under the symbol BHG. Timing, share value, and number of shares are to be determined. It’s speculated that the valuation at that point is expected to be between $10 and $20 billion. Bright Health is an insurtech operating exchange and Medicare Advantage (MA) health plans under Bright HealthCare  in 14 states and 50 markets, covering over 620,000 lives. They also have a separate care delivery channel called NeueHealth, 61 advanced risk-bearing primary care clinics delivering in-person and virtual care to 75,000 unique patients. Last month, they purchased Zipnosis, adding their white-labeled telemedicine for large health systems business. Bright Health Group release, Mobihealthnews

Short takes:

Doctor on Demand and Grand Rounds, which finalized their merger earlier this month, have agreed to acquire Included Health. Terms and timing were not disclosed. Included Health specializes in care concierge and healthcare navigation services for the LGBTQ+ community. FierceHealthcare, Release

GoodRx acquired rival RxSaver for $50 million in cash in late April to bulk up against Amazon. FierceHealthcare

Medical billing and pre-visit tech company Cedar is acquiring payer workflow tech company OODA Health for $425 million deal in a mix of cash and equity. It’s expected to close at end of May. OODA’s co-founder, chairman, and co-CEO is Giovanni Colella, MD, also co-founded Castlight Health and founded RelayHealth (see above), so another successful exit for him. FierceHealthcare, HISTalk

London-based Huma, raised $130 million in a Series C. Leaps by Bayer and Hitachi Ventures led the round. The former, mysterious Medopad now seems to have settled on a platform that supports ‘hospital at home’ plus pharma and research companies in large, decentralized clinical trials. There’s an add-on of $70 million to the Series C that can be exercised at a later date. Release, HISTalk

White-label telehealth provider Bluestream Health is partnering with The Azadi Project to provide virtual care services to refugee women and girls fleeing from countries like AfghanistanIranIraq, and Syria for safety in Greece. “Bluestream Health has teamed with The Azadi Project to provide a virtual care platform that stretches around the world. The women fleeing war-torn and conflict-affected countries have suffered unspeakable abuse, and while seeking safety in Greece, they are further exposed to terrible living conditions and hostility.”  said Matthew Davidge, co-founder and CEO of Bluestream Health.  Release

NYDHA names eight companies for funding, shared equity

The New York Digital Health Accelerator named its second class of eight companies last week. Each, sponsored by the Partnership Fund for New York City and the New York eHealth Collaborative (NYeC), receive approximately $100,000 in funding through a syndicate of investors in exchange for 1-2 percent in equity and access to SHIN-NY’s (Statewide Health Information Network of New York, colloquially called ‘shiny’) healthcare data. The winning companies are  AllazoHealth, Clinigence, Covertix, iQuartic, Noom, Quality Review and Sense Health.In the four month program, the companies are provided with mentoring and networking opportunities with insurance companies, medical centers and hospital groups. However, a number of these companies are past the pure startup stage with real clients and business. Modern Healthcare, iHealthBeat