Now CVS Health may be reviewing ‘options’–including a possible breakup–report

October 1, 2024 | by

Perhaps CVS needs to take a medication for Corporate Indigestion. It turns out that CVS did not entirely avoid the agita that is sickening Walgreens. Instead, it has other reasons. Reuters reported that according to their sources (unnamed), their management, board, and financial advisers are exploring ‘options’ that may lead to a partial breakup of the company. Prominently mentioned: a spinoff of their insurance businesses from their retail business. CVS acquired Aetna for this back in 2018 for a pricey $69 billion. Being debated: where the Caremark pharmacy benefit manager (PBM) unit will reside, under retail or insurance. PBM feeds into both retail and the insurance plans.

Glenview Capital Management is reported to be one of the financial institutions in talks with management on an improvement plan. Glenview owns 1% of CVS stock according to the Wall Street Journal, but that 1% accounts for over $700 million of its $2.5 billion war chest. That gives them cause for concern–and leverage.

CVS has confirmed none of this, going to the Boilerplate Folder to pull copy about “driving performance and delivering high quality healthcare products and services enabled by our unmatched scale and integrated model.”

Industry observers aren’t expressing anything more than mild surprise about this, based on a concatenation of recent events and backwash from their 2022-2023 spending binge.

  • CVS cut its 2024 outlook again in August for the third quarter running…and has lost 25% in share value YTD.
  • The kneejerk of a $1 billion cost-cutting plan is being implemented; this week, about 2,900 corporate jobs will be cut. This is after a 5,000-employee layoff that was announced in October 2023, taking place into 2024.
  • Aetna’s Brian Kane was booted in August after less than one year on the job due to his numbers going the wrong way–and his job filled in and not replaced [TTA 8 August]. Who’s next?
  • The outlook for Medicare Advantage is glum into 2025 and later, with utilization costs soaring, new lower Federal reimbursement rates for diagnoses, and Federal clawbacks on overpayments from 2018 on. 2025 plan exits have multiplied with CVS’ affecting about 10% of their membership.
  • PBMs are under attack. The latest is a 20 September FTC administrative complaint (= suit) against the Big Three (CVS Caremark, Express Scripts/Cigna and Optum/UHG plus their respective group purchasing organizations for inflating insulin drug pricing. Insulin is the prime example of inflated drug costs in the FTC view. The latest action doubles down on FTC’s mid-year report. MedCityNews  Readers should note that drug costs have been consistently under attack in Washington not only with this administration, but the prior one, which makes the current election a continuation of the same negative atmosphere.
  • In May, CVS openly sought private equity partners to expand their Oak Street Health locations to a promised 300 by 2026. No partner nor expansion has been announced to date. OSH was bought for a stunning $10.6 billion only 17 months ago.at the very tail end of the ‘buy anything/FOMO’ boom.  This Editor noted that this summer, there were direct response TV commercials to rustle up members airing on various cable channels that target the mature demographic. OSH was regarded as the runt of the litter of primary care practice groups since the larger ones had already been bought by Walgreens and Amazon. Its drawbacks in addition to small size: its model was overly wedded to Medicare value-based (ACO REACH) and Medicare Advantage models, and it had never turned a profit nor was about to. Even at the time, CVS was heavily criticized as making “a deal that made no sense” and “CVS better have a plan they implement in 18 months or they’ll get slaughtered” by an industry figure. [TTA 2 Mar 2023,16 Mar 2023]  We’re at 18 months. Is OSH quietly on the block?
  • Signify Health was another expensive 2022 buy that sounded good on calls to support the “integration” objective ($8 billion, cash). It put CVS into burgeoning home health and practices–but cost not only the inflated purchase price but also part of the cost of unwinding Remedy Health’s failed Episodes of Care model. CVS also put $100 million into Carbon Health which had to unwind several lines of business including public health before their Series D [TTA 11 Jan 2023], and earlier this year had both their CEO and their president depart. Biotech Networks

Is it time to call healthcare the Sick Man of the American Economy? Or just these big pillars? Crain’s Chicago Business. FierceHealthcare, Healthcare Dive

What’s next for: Steward CEO now in criminal contempt of Congress; Walgreens’ Pessina’s fortune vanishes by 97%; Masimo’s Kiani now a man without a company

September 26, 2024 | by

Senate unanimously votes to hold Steward Health CEO in contempt. The resolution passed on Wednesday 25 September refers the contempt charges against Dr. Ralph de la Torre, the CEO of Steward Health, to the Department of Justice (DOJ). The Senate Committee on Health, Education, Labor and Pensions (HELP) voted on 19 September to recommend two contempt charges–criminal and civil–to the full Senate. It is the first time since 1971 that a criminal contempt charge has been passed. The DOJ’s actions can include prosecution by the District of Columbia’s US Attorney which can mean arrest and possible incarceration, with a fine that doesn’t exceed $100,000, or civil contempt which usually involves a fine and another subpoena to appear. FierceHealthcare, Becker’s

The threatening language of the HELP committee members such as Bernie Sanders and Ed Markey surely did not encourage de la Torre or his legal counsel to appear on 12 September, with the anger across the board among all members regardless of party. All that it promised to be was, in street language, the worst kind of beatdown. Formally, the appearance was rejected because of Steward’s bankruptcy in adjudication in the US Bankruptcy Court for the Southern District of Texas supervising the sale of Steward assets. There is also a court order that prevents de la Torre from commenting during the sale process. To the press, his legal counsel depicted the HELP committee hearing as “a pseudo-criminal proceeding in which they use the time, not to gather facts, but to convict Dr. de la Torre in the eyes of public opinion.” TTA 14 Sept

Steward Health’s spectacular collapse opens even more Pandora’s Boxes for de la Torre. He possibly faces additional lawsuits attempting to ‘pierce the corporate veil’ to claw back his bank and personal, sizeable maritime and aviation assets–or hold him criminally liable, far more complicated, long-term, and damaging. A cynical view would be that de la Torre would be well advised to get on his $40 million yacht or one of his private aircraft–and depart for a destination that is reluctant to extradite to the US. 

Walgreens Boots Alliance’s troubles drastically shrink executive chairman Stefano Pessina’s personal fortune. Chairman Pessina, who holds 17% of WBA stock and is the single largest shareholder, has seen his holdings shrink in value by 97%, from $12 billion in 2015 to a current $1.3 billion, according to Bloomberg data. The 83-year-old WBA head has seen hard times before. He pulled a rabbit out of the proverbial hat in 2007 by going private with Boots and then merging it with Walgreens in 2015, but time and Mr. Market are not on his side with taking on the debt load necessary.

Is WBA or Walgreens attractive to an acquirer? With stock trading at a record low of around $8 and a market capitalization of about $7.5 billion, it may be a bargain if an investor ignores or doesn’t blanch at the debt load. But those who understand the business cannot buy due to US antitrust regulations, which rules out any retail competitor or PBM. Or the company could be parted out to healthcare providers or a health insurer, but that ignores their miseries, such as reduced Medicare Advantage reimbursements. Their mistakes such as VillageMD and unprofitable locations are in the middle of being worked out and the company is shrinking. Meanwhile, their 15 October full-year earnings report will be dripping with red ink, as their Q1-3 lost $314 million versus prior year earnings of $1.2 billion. Crain’s Chicago Business

Vanishing for Joe Kiani is his day job at Masimo after a dramatic proxy fight. The founder of the audio and health monitor company was voted out of his board seat by shareholders. He followed by resigning as CEO after founding the company 35 years ago. Michelle Brennan, a board member (from Politan) has been appointed as interim CEO. Previously, she was a senior executive at Johnson & Johnson’s companies, including international experience in business development, for over 30 years. She also is on the board of Cardinal Health. Korn Ferry is coordinating the search for a permanent CEO.

The proxy battle wasn’t even close, according a CNBC report reported by Strata-gee. Quoting an inside source, the Politan slate of two directors, Darlene Solomon and William Jellison, received twice as many votes as Joe Kiani and Christopher Chavez on the Masimo slate. 

The company is continuing ‘strategic alternatives’ (read: sale) of its consumer health and audio businesses, the latter mostly acquired in the utterly snakebit 2022 acquisition of Sound United’s consumer audio brands. Masimo is using Centerview Partners and Morgan Stanley as financial advisors and Sullivan & Cromwell as a legal advisor. Presumably, the Kiani-arranged sales to or joint ventures of these units with unnamed investors is off. Masimo will be retaining their professional healthcare and pulse oximetry products. For Q3 2024, Masimo reiterated its financials from early August, with earlier guidance here.

Whether others will depart with Kiani is too soon to tell. During the proxy fight in July, Masimo’s chief operating officer, Bilal Muhsin, promised to resign if Kiani was forced out, specifically citing that he would refuse to work with Quentin Koffey, a Masimo director and chief investment officer of Politan Capital. Other managers signed similar letters around the same time.  However, in the Masimo release on the Kiani resignation, financials, and management changes, CFO Micah Young and Muhsin stated that would provide more details on an earnings call in October.

The Strate-gee view was that shareholders got tired of hearing promises about Sound United and that Kiani was high-handed with them–treating it as his personal company and not theirs. Healthcare Dive

News roundup: Owlet expands to EU, mPulse buys Zipari, New Mountain PE merges 3 payment integrity firms in $3B smush, Candid Health’s $29M raise, Oura buys Veri, Bloomer Tech’s cardio bra

September 18, 2024 | by

It’s a dogpile of catchup news.

Owlet announced that it’s expanding its European distribution of the Dream Sock. The new countries are Greece, Poland, the Czech Republic, Romania, Slovakia, Hungary and Bulgaria. It is currently, according to its website, available in France, Belgium, the Netherlands, and Luxembourg. It received its CE Mark certification in May. The Dream Sock is a non-prescription device that reports, for babies 1-13 months and 6 to 30 pounds, pulse rate, oxygen, wakings, and sleep trends in real-time via the Owlet Dream App. The app also allows alerts outside of range to be set. Owlet’s financials have improved substantially, though still in the loss column, as detailed in the Mobihealthnews article.

mPulse acquired Zipari for an undisclosed price. Both companies are in the healthcare ‘consumer experience (CX)’ segment which broadly includes using consumer information to ‘personalize health journeys’ that enhance the consumer experience for its health plans. Zipari is apparently more the back end of CX software solutions for insurers, third party administrators, and healthcare payers. There was no disclosure of sale price nor of transition of Zipari staff or the brand name. mPulse now covers 400+ leading healthcare organizations, including 29 of the 30 largest health plans in the country. mPulse is private and controlled by PSG. Release

Private equity company New Mountain Capital, in a $3 billion move, merges three payment integrity companies. New Mountain merged The Rawlings Group, Apixio’s Payment Integrity business, and Varis into a single $3 billion, 2,000 employee company around payment accuracy using various technologies. Rawlings is the largest with over 1,400 employees. It identifies third parties responsible for paying medical claims and is over 40 years old. Apixio provides administration, clinical, and financial program services for payers, previously part of Centene. The remainder of the company–its connected care platform and value-based care services–will be acquired by Datavant. Varis provides overpayment identification solutions including diagnosis-related groups (DRG) and ambulatory payment classification (APC) prospective payments. ‘Smushing’ makes sense if there is one controlling investor and the services dovetail with each other; from the description, the main company will be Rawlings. One hopes that they work out the ‘big bang’ details. FierceHealthcare

In a rare fairly large Series B funding, Candid Health scored $29 million. Candid is a revenue cycle automation and integration platform that simplifies billing for providers through API integrations with current system. The raise was led by 8VC with participation from existing investors First Round Capital, BoxGroup, and Y Combinator. Their total funding since 2019 is $47 million. Release

The Oura ring from Finland is not only still around, but is acquiring a metabolic health company, Veri. One of those ‘neat ideas’ which this Editor thought was gone is still around, having sold 2.5 million rings both direct and through Best Buy currently for $69.99 annually plus local tax, and now tracks over 20 biometrics around sleep, activity, heart health, and stress. Oura has had $148 million of funding since 2013, with its last big $100 million Series C back in the Palmy Days of 2021, with a small venture round in 2022. Veri is also Finnish, already partners with Oura, and has an app that via CGM (Abbott FreeStyle Libre) guides users to the right foods and habits for their bodies. Oura will be launching in conjunction with Veri a new feature, Meals, to help members to see how meal timing affects health metrics like sleep, stress, and recovery. Many of Veri’s team will be joining Oura, including their three founders. Release, Mobihealthnews 

An ECG that looks and wears like a bra. That is the device designed by Bloomer Tech, a MIT spinout. This wearable violates the “smaller and less obtrusive is better” dictum to collect more and more accurate data. The bra design places sensors all around a woman’s torso, the best position for heart data, in an accustomed way to collect data on heart function, lungs, hormones, and metabolism. It connects to an app that collects information and sends it to the wearer’s health provider. Bloomer Tech’s market will be women at risk or with heart disease, with the bra as a prescription item. Its first clinical trial was launched in March, funded by a $1.9 million grant from the National Institutes of Health. It comes in 12 sizes from 32B to 44C, Axios Boston

The two women founders, Chong Rodriguez and Aceil Halaby met in the MIT’s masters degree program, founding it in 2018. They named it after Amelia Bloomer, a 19th Century American suffragette, social reformer, publisher/writer, and advocate for less restrictive forms of dress than the whalebone corsets and tight dresses customary of the period. MedCityNews

23andMe settles 6.9M data breach lawsuit for $30M. Breaking–all seven independent directors quit

September 17, 2024 | by

23andMe settles, not fights. And their independent directors just quit. The troubled (understatement) company is paying $30 million to settle a massive class action lawsuit around the 6.9 million data breach that started a year ago. This infamous data breach that TTA timelined here was discovered last October, with 23andMe claiming it only affected 14,000 records. Reality dawned as it rapidly grew to millions through the 23andMe databases of over 14 million. By December, 23andMe then resorted to blaming users reusing previously breached passwords (credential stuffing) which was easily disproved. It was one of the worst corporate faux pas since Bud Light.

The hackers had also specifically targeted people with Chinese or Ashkenazi Jewish heritage which wasn’t disclosed until February, though part of the October 2023 hack. It added to the suspicion that those of Jewish heritage were specifically targeted.

Users as a group will receive $30 million along with three years of credit monitoring called Privacy & Medical Shield + Genetic Monitoring. The settlement reached 13 September requires approval by the Federal District Court in the Northern District of California, San Francisco division.

Notably, 23andMe spokesperson Katie Watson confirmed to The Verge that $25 million will be covered by cyber insurance, so most of the cash is there. The settlement document also refers to the extremely uncertain financial condition of the company and asks that the judge halt any further arbitrations by tens of thousands of other class members. 23andMe’s parlous financial status is publicly well known, but no other buyer since the board’s turndown in August of Anne Wojcicki’s offer of $0.40 per share has stepped up to make an acceptable offer. (Perhaps the board was premature–it closed today at $0.34.) Reuters 

Breaking: Wojcicki won’t have to worry about her independent directors anymore. They’ve resigned, effective today, leaving a board of one. The seven directors sent a letter today (Tuesday 17 September) to CEO Wojicki citing that the Special Committee of the board, after months of work, never received from Wojcicki a “fully financed, fully diligenced, actionable proposal that is in the best interests of the non-affiliated shareholders”. It was quite an ask, given that Wojcicki controls the company through a supervoting arrangement. She reportedly holds 22.5% of the company’s outstanding Class A common stock and 59.2% of outstanding Class B common stock (according to analyst TD Cowen)–other reports state that she has in total 49.99% of the voting power. In their letter, they made it clear that the differences were irreconcilable: “Because of that difference and because of your concentrated voting power, we believe that it is in the best interests of the Company’s shareholders that we resign from the Board rather than have a protracted and distracting difference of view with you as to the direction of the Company.” Your move, Anne. Release

(An examination of the board posted online reveals that only one of the resigning members, Richard H. Scheller, ever worked at 23andMe. According to his online bio, he joined 23andMe in 2015 as Chief Scientific Officer and Head of Therapeutics. According to his Caltech board of trustees bio, he retired from 23andMe in 2019.)

Rounding up follow ups: Walgreens shareholder suit on pharmacy performance, Steward CEO no-shows Senate committee, Masimo-Politan proxy fight has court win for Politan–vote on for 19 September

September 14, 2024 | by

Another shovelful topping Walgreens’ Mound of Misery. Filed in the US District Court for the Northern District of Illinois, this shareholder lawsuit points to the poor performance of Walgreens’ pharmacy division. The fault is assigned to Walgreens management, specifically CEO Tim Wentworth and CFO Manmohan Mahajan plus 10 other executives including chairman Stefano Pessina, in overstating the division’s performance between 12 October 2023 to 26 June 2024 . It charges that they “falsely and materially claimed confidence in the brand inflation, volume growth, cost execution, discipline, and overall contributions of [Walgreens’] pharmacy division”, leading to an overvaluation of Walgreens’ share price. In addition, Walgreens “veiled the reality: that (Walgreens’) pharmacy division was not actually equipped to adapt to ongoing hurdles within the industry”.

The shareholder is Mark Tobias, a shareholder since late 2022. Key to the suit is the 12 October 2023 earnings conference call that contained positive comments about the pharmacy operation made by Wentworth, new at that time to Walgreens, and Mahajan. Their tune changed by the 27 June 2024 conference call where they admitted that the pharmacy model was “not sustainable”. Walgreens’ share price on 12 October 2023 was $24.19.  As of 4pm New York time today, 13 September, Walgreens closed at $9.21.

From the Crains Chicago Business article, the lawsuit demands restitution and reforms:

  • Walgreens should be awarded damages and restitution from the individual defendants
  • The company and defendants take steps to reform and improve corporate governance and internal procedures
  • Those reforms may include
    • Strengthening the board’s supervision of operations
    • Permitting Walgreens shareholders to nominate at least five candidates for election to the board
    • Ensure the establishment of effective oversight of compliance with applicable laws, rules and regulations

The Crains article also includes a Scribd copy of the filing.  Also Healthcare Dive

Another very large Mound of Misery buried Steward Health…but CEO Ralph de la Torre doesn’t plan to comply with a Senate committee subpoena. His testimony before the Senate’s Health, Education, Labor and Pensions committee was scheduled for 12 September but last week on 4 September, his attorneys informed the committee that Dr. de la Torre would not appear. They cited the ongoing US Bankruptcy Court for the Southern District of Texas sale of Steward assets (Healthcare Dive update) and a court order that silences him from comment during the sale process. The committee, chaired by Senator Bernie Sanders, is also accused by the CEO’s attorneys of using the bankruptcy and de la Torre’s marine possessions (a $40 million yacht and $15 million fishing boat) and private jets as “a pseudo-criminal proceeding in which they use the time, not to gather facts, but to convict Dr. de la Torre in the eyes of public opinion.”

The committee plans to decide on 19 September among two options: whether Dr. de la Torre will be brought up on criminal contempt charges that would be referred to the District of Columbia US Attorney, or civil contempt which usually involves a fine and another subpoena to appear. Several Senators on the committee–Sanders, Elizabeth Warren, and Edward Markey–have called de la Torre’s no-show “outrageous”. Sanders has issued threats of de la Torre being held accountable for his greed, but exactly how much of this is for the press and what the committee will do is unclear.  More of concern to the CEO would be whether further lawsuits would attempt to ‘pierce the corporate veil’ and claw back his bank and personal assets–or hold him criminally liable. Healthcare Dive, AP

The ugly Masimo-Politan Capital proxy fight continues–with a win for Politan. The attempt by Masimo, a consumer audio company that branched out into professional healthcare and pulse oximetry products–and last year won a big patent infringement decision against Apple on pulse oximetry—to further postpone a shareholder vote on giving control to activist shareholder Politan Capital ended in a loss yesterday. The US District Court, Central District of California denied Masimo’s request for a preliminary injunction to block Politan’s nominees for the Masimo board. Unless Masimo’s motion asking the same court to find Politan in contempt due to breaking the court’s sealing order on the decision, and the court grants a further delay, the shareholder vote will be held next Thursday 19 September. The likely outcome, according to Strata-gee which is covering this from the consumer audio perspective, is that shareholders will turn the board over to Politan by electing their representatives to the two open seats, booting CEO Joe Kiani–and total corporate chaos will ensue. Strata-gee has all the gory details. Background in TTA 8 August and prior.

US telehealth controlled substances prescribing waiver may expire at year’s end; DEA may further restrict

September 13, 2024 | by

Current waivers end 31 December without DEA, Congressional action. The Drug Enforcement Administration (DEA) apparently through inaction, will allow the current virtual prescribing flexibilities impacting Schedule II and higher drugs to expire at the end of year. These waivers which removed the in-person examination requirement under the Ryan-Haight Act were instituted during the Covid pandemic and extended twice [TTA 11 Oct 23, 11 May 23] with a final expiration of 31 December 2024.

Reportedly, the DEA is not only wishing to reinstate the status quo ante, but also reportedly wants to institute additional restrictions. However, any draft rule that would reimpose or changes restrictions has not been put out for the public comment period, review, and final rule implementation which typically takes anywhere from 60 to 120 days, well past year’s end. Last year, when a draft rule was released for comment, nearly 40,000 comments were received.

At the time of the 2023 extension that kicked this particular can down the road into the end of a presidential election year, DEA had stated that they would use 2024 to finalize telemedicine prescribing rules, but no action has been taken. Since then, the Department of Justice has filed multiple charges of Medicare and Medicaid fraud and illegal distribution of controlled substances against seven Done Global employees [TTA 3 July and prior], with investigations pending on practices by provider Cerebral and pharmacy Truepill. 

Under the aegis of the American Telemedicine Association (ATA), a coalition of 330+ organizations have again written as of Tuesday 10 September to the current administration and both houses of Congress to 1) extend the waivers for two years, as part of the end of the Federal fiscal year (starting 1 Oct) package, and 2) use the time for DEA to “to fulfill its congressional mandate to establish a special registration pathway that balances access to medically necessary care with appropriate enforcement.” The rationale centers on the lack of time, but strongly around the availability of psychiatrists throughout most of the US–there are none in half of US counties especially in rural areas. (The average MD psychiatrist is well over 50, nearing retirement, and not well reimbursed for his or her time–which is why med school grads in heavy debt don’t gravitate to the specialty.) What is not stated is that many if not most telepsychiatry providers do not have models that will support in-person evaluations as required without waivers.

There are no public actions or responses either by Congress or by the DEA as of today (13 September).

ATA press release, Biden Administration letter, House letter, Senate Leadership letter, Healthcare Dive

ATA Action, ATA’s trade organization and advocacy arm, has also formed a political action committee (PAC), ATA Action PAC. Its stated purpose is to support incumbent Federal candidates including Congressmembers who support their goals in virtual care policy. Candidates on the Federal or state levels will not receive support.  Release

Evolent Health talking major acquisition by payer Elevance, private equity

August 27, 2024 | by

Management services organization Evolent Health moving down the road in selling itself. Another deal perking below the Labor Day wire to brew into September or October coffee is a full or partial buyout of Evolent Health.  Potential buyers or partners include Elevance Health (the former Anthem), to position against Optum/UHG, and several private equity companies: TPG, KKR, and Clayton, Dubilier & Rice (CD&R). Evolent provides organizational and administrative services for primary plus specialty care physicians and payers for patients with complex conditions, within and outside of value-based care models such as ACOs, utilizing connected care and workflow automation technologies. In June, it agreed to acquire many of the AI utilization management assets of Machinify, not yet closed. 

Evolent’s (EVH, NYSE) current market capitalization is about $3.65 billion; stock price closing yesterday was $31.62 (Yahoo Finance). Industry analyst Jailendra Singh of Truist projected earlier this month, before this news dropped, that the stock was underpriced at the time in the ~$20 range and justified a target price at $33, citing their ability to manage utilization trends and rate adjustments for FY 2024. Seeking Alpha went so far as to state that at an acquisition price of $35, it would still generate a profitable internal rate of return (IRR).

A buyout won’t be cheap. With an estimated $114-116 billion shares outstanding, an outright purchase price at $35/share could approach or top $4 billion. Which means that the buyout lift could be shared. Projections with the information available range from PEs negotiating a leveraged buyout (LBO), a tuck-in by Elevance, or possibly a PE/Elevance partnership. Elevance already works with CD&R in the Mosaic Health care delivery platform partnership.  The shape of the buyout will develop over the next few weeks. FierceHealthcare

Another activist shareholder forcing a sale? Medical Buyer added to the above reports that long-time shareholder Engaged Capital pushed for this, to the degree that the board of directors needed to settle with them by forming a strategy committee focused on “value creation initiatives”.  As far back as 2021, Evolent was courting suitors or partners–at that time, Walgreens Boots Alliance, which may have been a far better but more complex buy than VillageMD. Hat tip to HIStalk 8/26

Evolent’s potential sale complicates the outlook for other MSOs such as Aledade, Optum, Privia Health, Health Catalyst, Accolade, Alignment Health, and Collaborative Health Systems (now part of Centene–disclaimer, CHS was this Editor’s former employer). In addition, a payer buying a large MSO with provider contractual relationships may pique the interest of FTC and DOJ, which already have Optum on their radar.

Sidebar: Revealed yesterday was Evolent’s CEO Blackley Seth cleaning up his stock option portfolio. According to Investing.com, he “sold shares totaling approximately $5.6 million at an average price of $30.00, with transactions ranging from $30.00 to $30.02. Additionally, the CEO acquired shares worth roughly $1.6 million through option exercises with prices between $6.87 and $10.27.” The sales were prearranged on 29 February under SEC Rule 10b5-1 to avoid insider trading charges. Both the sale and buy were over 100,000 shares.

Truepill to be acquired by LetsGetChecked for $525 million

August 22, 2024 | by

When is $525 million not $525 million?  Ireland’s LetsGetChecked and California-based Truepill have two things in common: backed by Optum and burning through cash. The deal went under the Labor Day wire:

  • How the buy is structured: $25 million in cash, another $200 million in possible earnouts tied to revenue milestones, and $150 million via a convertible note offering to finance the deal….which doesn’t add up to $525 million.
  • While LetsGetChecked is technically is doing the buying, it is creating a merger NewCo to unify both businesses. Truepill will be the surviving trade name as it has the slightly healthier business.
  • This creates a digital pharmacy to market and fulfill LetsGetChecked’s at-home testing kits.
  • Most of Truepill’s senior management, including their CEO, Paul Greenall, will remain. Greenall also received a $7.25 million forgivable loan. (The reason why is unstated, but these loans usually cover stock option purchases.)

No closing date nor required regulatory reviews are disclosed.

According to Axios, both businesses are in the red. “Truepill lost $15 million on $64 million in revenue for the first four months of this year (increased revenue run rate), while LCG lost $32 million on $39 million in revenue over the first five months of 2024 (declining revenue run rate)”. Truepill was valued in 2021 at $1.6 billion and had acquired $370 million in VC funding. 

As projected at the beginning of the year, health tech M&A are either tuck-ins or throwing in together to survive. Truepill had been shopped since March but received only one other offer. During the Cerebral and more recently developing Done Schedule II drug prescribing scandal in mid-2022, Truepill, as a mail-order pharmacy for both, found itself in the middle of it and under DEA scrutiny with a ‘show cause’ action. LetsGetChecked was also deeply underwater and not looking like it was surfacing. With the NewCo, it seems like an Optum Ventures-engineered ‘shotgun wedding’.  TTA 19 June,  19 Dec 2022

Signs of life: another view on healthcare investments and exits as of mid-year

August 22, 2024 | by

Silicon Valley Bank and their reports live! Now under the aegis of First Citizens Bank, SVB’s 14th Healthcare Investments & Exits Mid-Year Report for 2024 covers four healthcare areas: biopharma, health tech, DX (diagnosis)/tools, and device. Concentrating on health tech, highlighting their findings which are very different than the other three sectors and mostly in line with H1 findings from Rock Health that this Editor analyzed as possibly a ‘dead cat bounce’:

  • Series A raises are easier than in other sectors, and growing. It is the second-strongest start for Series A health tech investment since 2021. While average valuation sizes are remaining static around $10 million, and deals to date are just under $8 billion.
  • For later-stage companies, their high valuations during the palmy days of 2020-early 2022 created a ‘valuation trap’. The report uses ‘nadir’ to describe it–“now investors (who) are now opening up their coffers for new investments.” (The picture might be less optimistic if one pulled out Transcarent, which is controlled by two investors, General Catalyst and 7wireVentures.) Flat and down rounds are the norm.
  • They term the above ‘price discovery’, defined as the opportunities to extend due diligence, “build conviction” and build the “right syndicate” of investors.(Above all page 14)
  • Investment is accelerating at a rate above the other sectors (page 18). 
  • Exits have cratered at $0.2 billion with only four M&A deals reported. “Companies are preparing themselves to be good public market performers by tuning their cash efficiency and ensuring good unit economics”. Their view is that this may accelerate in H2 2024. (page 21).

SVB is offering the report online as a free preview download. Contact them for the full report.

Are patients and physicians ready for generative AI? How will it be most acceptable?

August 22, 2024 | by

As the flood of news will ebb over the next two to three weeks or so (and your Editor takes annual leave), some reading for your pondering.

Gimlet EyeBain and Company, the well-known (and well-feared when they come to your company) management consultants (and investors), recently published results from March’s “US Frontline of Consumer Healthcare Survey“ taken from 500 (undefined) respondents. Unfortunately, with the article, there is no opportunity to download the full survey or review the methodology. From their featured toplines, though, we can savvy that there are still many patient and clinical doubts around generative AI. 

Bain’s article generally spins positives from the results. For instance, their lead is that patients are ‘more comfortable with generative artificial intelligence (AI) analyzing their radiology scan and making a diagnosis than answering the phone at their doctor’s office.’  Their second lead is that clinicians generally have ‘a positive view, recognizing generative AI’s potential to alleviate administrative burdens and reduce clinician workload”.

Your Editor takes a more Gimlety view. First, let’s review consumer comfort with generative AI in five functions:

  • No ‘comfortable’ response is above 37%. Adding in ‘neutral’ at 18%, the only area breaking 50% is “taking notes during appointments to send follow-ups” at 55%. Consumers are not comfortable with generative AI “providing medical advice, treatment plans, and prescriptions” at 21% (11% and 10% respectively).
  • ‘Not comfortable’ is lowest for notes for follow up at 45%. The highest is for medical advice at a eye-blinking 79%. In between, the range is 52% to 68%–indicating strong consumer resistance across the board.
  • As to analyzing radiology scans, there is a lot more comfort with that report going to the doctor for review than AI making a diagnosis. For reports to the doctor, the ‘comfortable’ response is 31% but falls to 21% for diagnosis. ‘Not comfortable’ notches from 52% to 62%
  • For answering calls for providers or insurers, there is definite unacceptance at 68% with only 33% ‘neutral’ or ‘comfortable’.

Provider perspectives are split between physicians and (undefined) administrators. (No neutral in these responses)

  • They both believe that administrative burden and workload will be reduced, with admins far more hopeful than physicians at 43% and 35% by area respectively.
  • What neither group likes is the potential to undermine the patient-provider experience: 19% negative for the physicians and the admins not far behind at -17%.

The takeaway: Generative AI is following the telehealth curve in initial low acceptance. The responses and proportions resemble the early days of telehealth and to a lesser degree, remote patient monitoring. Information didn’t fit into workflows, wasn’t seen as critical, and increased administrative burdens. With acceptance languishing for over a decade, it took a black swan event called the Covid Pandemic to overcome–and in the end it reshaped telehealth, as Teladoc and Amwell have learned.

But in present time, if your Editor as a consultant were presenting this to an AI developer, a physician group, or investors, she would advise preparing for a long, hard road. A road which needs validation, real revenue models, demonstrated accuracy, acceptances, and proven value in solving crucial problems and cost reductions. Natural-language processing (NLP) is being touted as a tool for most of this–but it is only part of the picture. 

Views at variance: Healthcare IT News (NLP interest), MedCityNews (LLMs losing to humans on medical knowledge), MedCity News (on proving value)

“I will survive” updates: NeueHealth survives Q2 with small net loss, Steward sells off Stewardship Health practices to private equity firm for $245M

August 16, 2024 | by

Mid-August’s pre-Labor Day news deluge was so chock-full of developments that your Editor missed these two survival specials:

NeueHealth, a New Reality casualty that’s decided to create its Own New Reality (or the equivalent of the Twinkie Defense), reduced its Q2 net loss, eked out positive EBITDA.  NeueHealth, which has made an art form of Dodging Disaster, notched Q2 revenue of $226 million with a net loss of $53 million and a slight positive adjusted EBITDA of $3.96 million. Diluted loss per share was reported as $8.65, more than $5.00 worse than Q1. Revenue and losses were reduced as expected from Q2 2023 as their business model drastically changed with the sale or closure of its health plans by close of last year. Their covered lives are slightly down (value-based consumers meaning patients) or way up (enablement services lives, a fancy term for non-clinical support services such as health education and care coordination).

Their forecasts for 2024 are oh-so-rosy, with total revenue of $950 million, segmented for NeueCare (primary care in Florida and Texas plus affiliates) at $320 million plus NeueSolutions (management services including ACO management) at $640 million, with adjusted EBITDA in the $15-20 million range.

CEO Mike Mikan touted the $150 million debt financing round from Hercules Capital, which in this Editor’s view had more hedges than France’s Bocage [TTA 26 June]. Stock, which had a brief bump to over $6.60 in July, languishes in the $5.00 range. There is no update on the 16 June NYSE non-compliance notice for a market cap below $50 million that had a 45-day deadline for a plan to remediate within 18 months. Market cap is presently at $41 million. There is also no update on their ticking time bombs: the CMS Repayment Agreements due on or before 14 March 2025 nor $89 million owed to Texas from last year to cover risk liabilities for its shuttered ACA plans [TTA 14 Feb]. It’s those Gordian Knots again! Yahoo Finance, NeueHealth release, Fierce Healthcare

A bright spot in the messy bankruptcy unwinding of Steward Health Care is the pending sale of Stewardship Health, its practice arm, to be reviewed today. The teed-up proposed buyer offering $245 million is a new company, Brady Health Buyer, set up by private equity company Kinderhook Industries, LLC, on behalf of its existing investment, Nashville-based Rural Healthcare Group.

  • Kinderhook is a $8.5 billion PE with investments across healthcare services, environmental/business services, and automotive/light manufacturing sectors.
  • RHG has 14 clinics in rural North Carolina and Tennessee.
  • Stewardship operates practices in nine states, has 5,000 doctors, and serves 400,000 patients.
  • They will have to move facilities from Steward hospital properties. There are no location or state overlaps with RHG.

Their prior sale arrangement to Optum preceded the bankruptcy and was withdrawn after a DOJ challenge. The only other offer from 57 potential bidders approached, other than Kinderhook/Brady/RHG, were their FILO lenders.

Judge Christopher Lopez, the bankruptcy court judge in Texas, is expected to rule on the sale today (Friday), along with a separate sale of up to six Massachusetts hospitals. Regulatory approvals are required. WBUR, Healthcare Dive

Short takes: Stryker to buy Care.ai, Masimo W1 medical watch clears FDA for oxygen, heart monitoring, Create Health Ventures forms $21M fund

August 16, 2024 | by

Medical/surgical device giant Stryker snapping up Care.ai. Price and financing are not disclosed. Orlando-based Care.ai specializes in sensor-based smart room technologies for hospitals and post-acute care facilities along with virtual care data analysis and workflows. Timing of the closing is based upon the usual regulatory approvals and Care.ai will operate separately until then. After that, it’s projected that it will be integrated into Stryker’s 2022 acquisition Vocera Communications’ platform and devices.  Care.ai may be just the first deal for Stryker’s second half, as their CEO Kevin Lobo promised on the Q2 investor call a “very active deal pipeline” of tuck-in acquisitions. According to HIStalk, Care.ai co-founder and CEO Chakri Toleti sold his previous venture, HealthGrid, to Allscripts (now Veradigm) in 2018 for $60 million. MedTech Dive, Stryker release

Despite the proxy fight, business as usual goes on with Masimo. Their W1 medical watch for remote patient monitoring, integrated into the Masimo SafetyNet telemonitoring platform, received FDA 510(k) clearance. The watch MW-1 module monitors high-resolution SpO2, pulse rate, perfusion index (Pi), and heart rate from an ECG from a single wearable device. Readouts are both on desktop for the clinician and on an app for patients and caregivers. All can receive customized notifications and manage care remotely. The Masimo W1 medical watch and the integrated Masimo MW-1 module are indicated for adults in hospitals, clinics, long-term care facilities, and homes. No cost is provided and it is not available on the website, but the W1 Sport consumer version is $549.  SleepReview, Masimo product page.

Another sign of digital health investment revival–a new venture capital fund not started by Glen Tullman. Create Health Ventures is kicking off its inaugural fund with $21 million. Its focus will be on early-stage startups founded by experienced healthcare veterans on two tracks, according to their announcement release: 

  1. For payers, improve access to care for everyone, enhance the patient experience, and facilitate better health outcomes
  2. For pharmaceutical companies, technologies they can use to recruit and retain patients for clinical trials, as later-stage trial needs swell in the industry

The two founders and managing partners, who started the firm in Austin and Chicago in 2021, are Emma Cartmell and Amit Aysola. They have advised or invested in over 80 companies. Venture Capital Journal, Mobihealthnews

Veradigm update report: initial bids collected to take company private

August 15, 2024 | by

Veradigm (formerly Allscripts), which announced in May that it was seeking ‘strategic alternatives’, reportedly has some initial bids for parts or all of the sprawling data and tech platform company. Bids are coming in at above $9.50/share according to Axios, but only three players have been mentioned by the usual ‘inside sources’.

  • Thoma Bravo, which took NextGen Healthcare EHR private for $1.8 billion last November [TTA 19 Sept 2023]. NextGen has worked with Veradigm in a strategic data exchange partnership dating back to 2019.
  • Roche, current owner of Flatiron Health, which also has a specialized EHR for managing cancer data. However, Roche recently put Flatiron up for sale, which could make serious interest in Veradigm doubtful. 
  • Vista Equity Partners, which owns EHR Greenway Health,

Because some parts are more interesting to bidders than others, two or more could partner to buy Veradigm’s assets in healthcare data systems and services. Veradigm’s market capitalization remains about $1 billion.

Veradigm was delisted from Nasdaq on 29 February because of software problems making their 2022 and 2023 reporting inaccurate and being unable to file required current financial reports. It trades OTC under MDRX closing today at $9.55. Yet they reported profitable results in 2023 with net income from continuing operations between $49 million and $58 million and shortly after acquired two companies this year, ScienceIOfor $140 million in cash [TTA 15 Mar] and Koha Health [TTA 3 Jan]. For 2024, Veradigm forecasts revenue between $620 million and $635 million, with adjusted EBITDA between $104 million and $113 million. One wonders why there aren’t more bids, even joint bids, financing, and other structured offers for what appears to be a fairly healthy going business. Ionanalytics.com

News roundup: SleepioRx clears FDA 510(k), Caregility adds AI fall detection, Otsuka releases Rejoyn depression app, MD Ally’s $14M Series A, Alcove launches CallConnect247 (UK), Health Catalyst buys Lumeon for $40M

August 15, 2024 | by

Big Health’s SleepioRx digital insomnia therapeutic gains 510(k) FDA clearance. The 90-day treatment is based on a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I). The treatment adjunct is tailored to symptoms and provides daily sleep tracking, enables goal setting, and content for help falling asleep. Sleepio was originally developed in the UK (we covered in 2013!) but moved to San Francisco in 2015.  Their original Sleepio is marketed to employers and health plans to support treatment for sleep disorders and insomnia, along with other products for digital support for anxiety and depression. Their last funding was a Series C of $75 million raised in the palmy days of January 2022 and a year later acquired Limbix, provider of SparkRx, a depression management app targeted to adolescents. Release, Mobihealthnews

In my home state of NJ, Caregility announced an AI-powered fall detection upgrade to their acute care clinical observation platform. iObserver is used by hospital care teams for observation of patients at risk for falls or self-harm. Interestingly, the fall detection system is run on computer vision, which means it runs entirely on telehealth edge devices in the patient room with the AI capable of identifying and deriving information from objects and people in images and videos. Edge device use means that processing is done within the devices themselves, which eliminates bandwidth issues and upstreaming to the cloud, a failure point for privacy and as we now see, hacking risk. According to the release, the computer vision capability is available for use on every one of the more than 15,000 Caregility edge devices currently installed in hospitals around the globe. 

Otsuka Precision Health (OPH) launches Rejoyn digital therapeutic for depression.  As previewed earlier this summer [TTA 29 May], OPH launched Rejoyn, the first and sole prescription digital therapeutic cleared by the FDA for the adjunctive treatment of major depressive disorder (MDD) symptoms. Rejoyn was developed in conjunction with Click Therapeutics. It is for use by those aged 22+ on antidepressive medication. After being prescribed from the patient’s provider or Wheel Health, the Rejoyn app can be downloaded from major app stores after keying in an access code that is furnished to the provider by BlinkRx. It is currently being priced on a cash-pay basis at $50 for the six-week course, which will increase later to $200 for insurer coverage, though it is not yet covered. In a six-week trial, the use of Rejoyn reduced depression symptoms and improvement across multiple scales typically used by patients and clinicians to track depression improvement. The Otsuka release and commitment are significant as it’s also the first true involvement of a major pharmaceutical company in telemental health with a highly targeted clinical app that isn’t tied to one of their medications. It’s a long road with a lot of bumps, as Otsuka experienced with Proteus Digital Health’s smart pill tech for its Abilify MyCite, as well as failed companies like Pear and Babylon Health.  Release, Healthcare Dive

In funding news, emergency services telehealth company MD Ally now has $14 million in a Series A to add to its previous $11 million.  The raise was led by Frist Cressey Ventures, founded by Senator Bill Frist and Bryan Cressey, and anchored by General Catalyst, with participation from Techstars, Seae Ventures, Red & Blue Ventures, and Alumni Ventures. MD Ally’s value proposition centers on the non-emergency 911 call. Dispatchers and first responders, after determining the non-emergency status, can divert the call to other telehealth and community-based resources to assist the person plus a ‘care assistant’ for treatment plans and long term outcome management. MD Ally is currently in test in Phoenix and locations in Florida, Arizona, and California serving about 5 million patients. Release, Mobihealthnews

In UK related news:

Alcove expands TEC services with CallConnect247. It is a state-of-the-art 24/7 Alarm Receiving Centre (ARC) designed for communities and local authorities who are modernizing their call services for alarm management to incorporate virtual care and video welfare calls. It includes AI-powered and automated services to reduce false alarms and minimize the ‘white noise’ calls that often inundate traditional ARCs. It’s expected to grow coverage up to 8,000 users by October. Alcove release, Thiis.co.uk

Health Catalyst buys US/UK care management company Lumeon Ltd for $40 million. The $40 million purchase price was funded with a mix of $2.5 million in stock and $37.5 million in cash plus a potential recurring revenue-based earn-out of up to $25 million that, if achieved, would be paid solely in cash. (page 42 of SEC Form 10-Q). No information was provided concerning staff transitioning at Lumeon’s current HQs in Boston and London, where it adds a UK/EU footprint to Health Catalyst’s current data analytics and software businesses. Lumeon’s Care Orchestration automates care coordination processes for providers in outpatient, acute care, and post-acute settings.

Health Catalyst’s earnings were also reported in the 10-Q. Revenue for Q2 was up slightly from last year to $75.9 million, but burdened with a net loss of $13.5 million which was more than 50% reduced from Q2 2023’s $32.6 million. Q2 adjusted EBITDA improved to $7.5 million versus $3.5 million in prior year. Release, Mobihealthnews

Food–allergy and metabolism–takes center stage with Series A fundings for Amulet and Levels

August 14, 2024 | by

Food, as nutrition and more nebulously, ‘food as medicine’, has become a popular part of the disease treatment value proposition in funding. Two examples gained Series A funding in just the past few days.

Amulet announced a $5.8 million Series A round led by HealthX Ventures, with participation from Incite Ventures, AllerFund, Mendota Venture Capital, Great Oaks Venture Capital, plus Julie Bornstein (Pinterest/Daydream) and serial founder and investor Diede van Lamoen. Total funding including grants from Imperial College London and Dartmouth and seed rounds is now $10.7 million. The fresh funding will enable the company to scale its team, expand its detection portfolio, and execute a full product launch.

Amulet’s two products are a pocket-sized consumer wearable, Allergy Amulet (left), that can test food for allergens right at the table in about one minute. A professional testing system, Amulet Scientific, is for use by the food industry–restaurants, suppliers, manufacturers, and related–to test for food toxins and environmental contaminants. The proprietary molecular detection technology recognizes and binds target molecules, then measures binding via electrical current, and reads both on the wearable device and on its app. Amulet’s devices and software are pre-launch, although it has secured two patents and received grant funding from the National Institutes of Health (NIH) and the US Department of Agriculture. For those with multiple food sensitivities ranging from mild (magnesium stearate, casein, lactose) to significant (gluten, peanut, sulfites, shellfish), having a tester beats asking the waiter and crossing your fingers.   Release

Levels takes the metabolic road to nutrition centering primarily on continuous glucose monitoring (CGM). The Series A extension of $10 million was unusually raised two ways: $7 million from venture capital companies Long Journey, a16z, and others, while $3 million was raised from 2,000 crowdfunders. The original Series A raised $5 million from crowdfunding (1,400 individuals). Funding to date is $57 million.  Levels seeks to improve metabolic health from feedback tracking metrics such as real-time blood sugar, blood testing, nutritional intake, and sleep and exercise data. Their featured CGM is Dexcom’s G7. Synched with the CGM, the Levels app monitors blood sugar and lifestyle factors to calculate scores and provide personalized choices plus feedback. Membership to date is over 60,000. Fitt Insider (release) 

23andMe drops drug discovery group, expands Lemonaid into GLP-1 weight loss medications, loses $69M in Q1–and board rejects CEO’s buyout offer

August 14, 2024 | by

Troubled 23andMe disbands drug discovery group, moves into weight loss meds, loses $69 million in FY25 Q1–and soundly rejects CEO buyout offer. The next shoes have dropped in the 23andMe drama.

The latest from both the Q1 earning announcement and their SEC filing, both 8 August:

  • 23andMe has abandoned its drug discovery dreams and closed the unit, terminating 30 employees in the Therapeutics Discovery unit including Bill Richards, the head of Therapeutics Discovery (package details in the 8-K), effective 9 August.  SEC Form 8-K 
  • 23andMe will retain their Therapeutics Development unit for the two drugs currently in early-stage clinical trials. They are also collaborating with Nightingale Health to pilot a metabolomics blood biomarker panel with a cohort of 23andMe+ members.
  • The Lemonaid telehealth unit is moving into prescribing GLP-1 semaglutide weight loss drugs through a membership program and receive either brand-name or compounded medications. (Editor’s note: why anyone would be a member of 23andMe after their epic user and member data breach last year–that they blamed on users’ passwords–is beyond me.)
  • This is coupled with what the company terms in its Q1 press release “a large-scale genetic research study to help identify the genetic mechanisms that may drive the efficacy and potential side effects of GLP-1 medications”

Their Q1 FY 2025 was singularly depressing, with revenue sinking 34% to $40 million, well below the $52 million projected by Street analysts. The drop was attributed to the loss of the GSK genetics collaboration in mid-2023.  The only bright spot was that losses also shrank 34% to $69 million from $105 million in the prior year. 

Stock delisting pending. ME closed on Tuesday at $0.35. The company received an extension from Nasdaq to 4 November and is seeking shareholder approval for a reverse stock split to raise the price above $1.00 as required. Endpoints, MedWatch, FierceHealthcare

CEO’s buyout rejected. On 2 August, the $0.40 per common share non-binding offer from CEO and controlling shareholder Anne Wojcicki offered on 29 July [TTA 1 Aug] was soundly, roundly rejected by the impressively named Special Committee of the Board of Directors of 23andMe. From the letter:

“We are disappointed with the proposal for multiple reasons, including because it provides no premium to the closing price per share on Wednesday, July 31st, it lacks committed financing, and it is conditional in nature. Accordingly, we view your proposal as insufficient and not in the best interest of the non-affiliated shareholders. Therefore, we are not prepared to move forward under the terms provided. Importantly, we request that you immediately withdraw your stated intent to oppose any alternative transaction so that we can fully assess whether there is interest from third parties in a transaction that would maximize value for all shareholders.” (Editor’s emphasis)

It closes with a demand:

“In the absence of a revised offer at a more appropriate price per share that meets the other requirements set forth above, we will pursue other alternatives in striving to maximize value for all shareholders. In that regard, given both the lack of certainty regarding a path forward with you and your potential investors and the current liquidity position of the Company, in parallel with your work to submit a revised bid, we intend to immediately begin the process of engaging a consultant to advise the Special Committee on a revised business plan that would provide the Company with a path to a more sustainable financial profile and achieving profitability. In your capacity as CEO, we expect your full support in these efforts.“

Given that she reportedly holds 22.5% of the company’s outstanding Class A common stock and 59.2% of outstanding Class B common stock (according to analyst TD Cowen)–other reports state that she has in total 49.99% of the voting power–that is quite a defiant statement. Based on her supervoting privileges–a trick picked up from her Silicon Valley tech friends back when–Wojcicki could kill any buy not in her interest. Or any interest, period. Developing.