Wojcicki: I’m transforming 23andMe to be ‘viable’ and thriving–but had ‘no idea why her board resigned’

Transform it till it survives. That seems to be the meme of 23andMe’s CEO/founder Anne Wojcicki in a “CBS Mornings” ‘exclusive’ with co-host Gayle King. Dropping on 27 November (Wednesday morning before Thanksgiving), the 10-minute segment was primarily a pre-recorded eight-minute interview done in a ‘living room’ setting earlier with an introduction and closing commentary with two others. For a non-business interviewer, King directed it better than expected, though the context was soft, with an intro and early questioning that focused on the company’s problems and a Fortune article (more below), then moving towards the end to Wojcicki’s family and personal challenges this year. 

Wojcicki believes that the company is ‘viable’ and ‘transforming’ under her. King redirected Wojcicki from her initial corporate boilerplate-speak twice within the first few minutes back to the troubles of the company, including “How does a company survive when it’s lost 98% of its value though?” The answer was rather pat: “We absolutely are in a situation where we’re figuring out cash burn and we’re looking at all the ways that we’re gonna drive revenue growth.” which is about as much as a CEO and controlling shareholder would want to say about a public company potentially facing shareholder lawsuits.

King touched on the instances of last year’s massive data breach [TTA 19 Jan, 2 Feb], the layoff in November of 40% of its remaining workforce [TTA 14 Nov], and the entire resignation of the board [TTA 17 Sept]. This last elicited the surprising revelation that Wojcicki had “no idea why her board resigned” nor “great insights into what the strategic differences were” or that “there was not an overt disagreement.” King did not drill down into that brace of amazing statements about a hand-picked board of a public company during a financial crisis, trying to decide on a course of action whether to sell or go private. She also did not address the role that the data breach and 23andMe’s widely derided treatment of their customers had in precipitating the company’s decline.

Regarding content in the generally negative Fortune article from October, Wojcicki rebutted the former employees’ view that all decisions ran through her and that she was “outwardly charming, but stubborn and controlling behind the scenes.” saying that ‘”I love getting feedback” and that she encouraged everyone to voice their opinions and share suggestions, which is not quite the same as a collaborative management style or delegation. To her, her vision was centered on using genetic data for consumer empowerment, research, and discovery. Unfortunately, the company moved away from the consumer part which remained largely one-off testing, despite the late adoption of a subscription model and refocusing on consumer products such as GLP-1 drugs. The corporate focus became drug discovery and development (closed) and the GSK data (ended).

To Wojcicki, the closures and layoffs are justified in what she envisions as the ultimate transformation of the company, her new mantra. King closed by asking her about her one and five-year predictions for the company. At one year, Wojcicki without blinking and with a small smile said that 23andMe would be “thriving”. Five years? With a large, confident, and convincing smile, with clasped hands, Wojcicki said it would be “transforming healthcare”. This Editor has heard that song before.

News roundup: Oak Street’s Pykosz departs CVS, Musk’s Neuralink gains Canadian clinical trial, VA healthcare improvement bill omits EHR oversight measures, 23andMe’s Mirador precision medicine partnership

Another CVS departure. As Glenview Capital taps its feet waiting for CVS financials to improve, Mike Pykosz, appointed less than a year ago to head up their Health Care Delivery unit, is departing. His replacement is Dr. Sreekanth Chaguturu. Unsurprisingly, Dr. Chaguturu will be working two jobs–president of Health Care Delivery as well as EVP and chief medical officer of CVS Health, saving an executive salary. This may be the capper of a two-month 52-card pickup that started with rumors of a breakup that would split off Aetna, replacement of CEO Karen Lynch, a new head of Aetna, and four new board seats given to Glenview. [TTA 19 Nov]

No date was given for Mr. Pykosz’s departure, but the wording in the release made it appear that it was effective immediately. His LinkedIn post from last Tuesday indicated that he was moving on by end of November, this week. According to new CEO David Joyner, Pykosz had informed management earlier in the year that he was planning to depart and had worked to ensure a smooth transition. Mike Pykosz had previously been CEO and co-founder of Oak Street Health, acquired by CVS for $10 billion in May 2023. In the following months, OSH integrated with elements of Signify Health, in-store Minute Clinics, and grew from 170 units to 250 locations. Whether any of them are profitable is not disclosed and likely not probable, though CVS made much of OSH’s and Signify’s 36% increase in quarterly revenue versus prior year. There is also no disclosure of Mr. Pykosz’s future plans though his LinkedIn post mentions that he was “excited to be able to dedicate time to investing in, advising, and supporting innovative healthcare companies, helping them meet their strategic goals and build better healthcare solutions as well as spend more time with family and friends.” including coaching grade 3 basketball. Bet on hearing from Mr. Pykosz after what is likely a prolonged non-compete agreement and a good rest. Healthcare Dive

Elon Musk’s brain-computer implant, Neuralink, to enter a clinical trial with Health Canada. This is the first outside-US trial for Neuralink. It comprises the N1 brain implant and R1 robot, which is used to place the 64-thread implant into the brain. The study will be performed by the University Health Network (UHN) hospital at its Toronto Western Hospital. The “Canadian Precise Robotically Implanted Brain-Computer Interface” (CAN-PRIME) subjects will be Canadian-resident patients with tetraparesis or tetraplegia resulting from cervical spinal cord injury or the neurological disease ALS who also have a life expectancy of at least 12 months. Earlier this year, an American implant patient moved a mouse by thought [TTA 21 Feb] and is now playing video games and online chess. Neuralink received approval last month for Blindsight, an implant for sight restoration. Mobihealthnews

VA service improvement bill manages to omit Oracle EHR oversight measures. The bipartisan omnibus bill titled ‘The Senator Elizabeth Dole 21st Century Veterans Healthcare and Benefits Improvement Act” (H.R. 8371) passed the House last week. It introduced many benefits to VA healthcare workers and to veterans, but managed to pass the House without the ‘guardrails’ that the House Veterans Affairs committee deemed necessary to continue the Oracle EHR rollout, replacing the obsolete VistA system. The committee spokesman, Mark Takano, D-Calif., attributed the omission of requirements included under the EHR Program RESET Act to “a lack of political viability in both the House and Senate”. The chair of the Technology subcommittee, Matt Rosendale (R-Montana), went considerably further and voted against the entire bill. Both blamed Oracle: Takano attributed it to “the army of lobbyists that Oracle unleashed to kill it” and Rosendale stated that “Oracle Cerner bought and bullied their way into getting this bill passed without their company being scrutinized.” The bill now goes to the Senate in the minimal time before the ending of the 118th Congress next month.   

The requirements in the omitted RESET Act included most of what has been discussed in both Senate and House to remedy Oracle Cerner Millenium’s stopped-dead implementation in the VA.

  • Increased Congressional oversight of EHR deployments, ensuring that each implementation of the new EHR “met or exceeded”  pre-deployment efficiencies before moving to the next one
  • Requiring VA to provide lawmakers with quarterly reports with additional data “on user adoption and employee satisfaction” with the Oracle Cerner system
  • Requiring VA to supply data on “employee retention and turnover at medical facilities where such electronic health record system is in use.”

Nextgov.com

Rep. Rosendale issued a press release blasting H.R. 8371. “…this bill ignored years of bipartisan work focused on requiring Oracle Cerner to fix its EHR System, that has resulted in veteran deaths, before it could be expanded to new VA Medical Centers and the company can continue to collect on its multibillion-dollar contract.” Omnibus bills like this are always shotgunned together as well. “The House Veterans’ Affairs Committee ignored regular order with this legislation which, by uniparty design, prohibited scrutiny and debate on the final product. That decision spearheaded a bad process for passing this bill which resulted in an unacceptable final product for our veterans. When a uniparty agreement comes together overnight, like it did with the Dole Act, it means a small group of individuals negotiated it and the American people – and in this case our nation’s heroes – get the short straw.”  

(Editor’s note: Senator Elizabeth Dole, who is still with us at 88, was a single-term Senator from North Carolina 2002-2006, but Cabinet member in two prior administrations as well as the widow of Senator Bob Dole from Kansas.)

Signs of life at 23andMe? The troubled genetic data company, which earlier this month shuttered what remained of its drug therapeutics unit and laid off 40% of its remaining employees, announced this week a research partnership with Mirador Therapeutics, a precision medicine company focused on immunology and inflammation. Mirador is using a targeted set of aggregated, de-identified genetic and phenotypic data from the 23andMe research database to combine with its Mirador 360 development “engine”. Most of the release is boilerplate with the requisite quote from the Mirador CEO, mixed with copy hyping previous 23andMe collaborations and their patient privacy policy which carefully omits the fact that you, personally, can withdraw from the research program, but your genetic data and limited identifiers cannot [TTA 8 Nov]. No financials or agreement duration are disclosed. 23andMe release, Endpoints News (paywalled)

Bad News roundup: DOJ drops the hammer on UHG-Amedisys, 23andMe lays off 40% and closes therapeutics, Lyra Health lays off 2% in restructuring, Forward primary care + kiosks shuts down abruptly

Shoe drop! The long-anticipated Department of Justice (DOJ) lawsuit against UnitedHealth Group and Optum to prevent the acquisition of  home health and hospice operator Amedisys was filed yesterday (12 November) in the District of Maryland. UHG’s offer to acquire Amedisys was made in June 2023 for $3.3 billion in an all-cash deal, but approval was held up in DOJ review ever since. Even with location divestitures proposed in July to VitalCaring Group to reduce anti-trust concerns with Optum’s home health operations (acquired with LHC Group), UHG remained a DOJ target. The civil lawsuit was filed by DOJ together with the Attorneys General of Maryland, Illinois, New Jersey, and New York. No timeline is provided in the release.

The rationale cited is of course anti-trust and elimination of competition between Amedisys and UHG’s Optum. “We are challenging this merger because home health and hospice patients and their families experiencing some of the most difficult moments of their lives deserve affordable, high quality care options,” said Attorney General Merrick B. Garland. The fact that the US Attorney General was quoted first in their release indicates the importance of the case to the DOJ. It’s also a race to the finish as come 20 January 2025, there will be a new president appointing a new AG immediately.

The DOJ states that both companies are “fierce competitors” and that the divestiture is insufficient. “The proposed divestiture does not alleviate harm in over 100 home health, hospice, and labor markets, which generate at least a billion dollars in revenue annually, serve at least 200,000 patients, and employ at least 4,000 nurses.”  Their case is well-built in this Editor’s view. From the release:

 UnitedHealth’s market share after the transaction would make the merger presumptively illegal in:

    • Hundreds of local home health care markets, with an annual volume of commerce exceeding $1.6 billion annually, in 23 states and the District of Columbia;
    • Dozens of local hospice markets, with an annual volume of commerce exceeding $300 million annually, in 8 states; and
    • Hundreds of local markets for home health and hospice nurse labor, employing at least 8,000 nurses, in 24 states.

The lawsuit also seeks civil penalties against Amedisys for falsely certifying compliance with its obligations under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) by failing to produce millions of documents or disclosing the deletion of other documents. For each day that Amedisys was in violation of the HSR, DOJ is seeking a fine of up to $51,744 daily. Amedisys was originally set to be acquired by OptionCare, which does not directly compete in home health, but UHG won a bidding war.

As this Editor said at the time of the Change Healthcare acquisition win against DOJ in Federal court (and we know how that turned out long term), “DOJ has a long memory, a Paul Bunyan-sized ax to grind, and doesn’t like losing.” FierceHealthcare

23andMe continues their long jump down to…who knows where? CEO Anne Wojcicki is minusing out 200+ employees or 40% of its remaining workforce, and fully shuttering its therapeutics development unit. The latter is running two clinical trials which will be wound down ‘as quickly as practical.’ These cuts will save $35 million annually but incur $12 million in one-time severance and termination-related costs. The much-touted therapeutics discovery unit was shut in late summer [TTA 14 August].

What’s left? Not much–the Lemonaid remote prescribing unit, with an entree into GLP-1 prescribing, some published studies, a new AI chatbot called “DaNA”, and a longevity service dubbed Total Health. During their Q2 FY2025 earnings call and release, revenue sank to $44 million versus prior year’s $50 million (-12%)–slightly from Q1’s $40 million–operating expenses reduced 17% to $84 million versus prior year’s $101 million, but the company remained firmly in the red with a GAAP loss of $59 million, 21% less than last year’s $75 million and reduced versus Q1’s $69 million loss. The board, as previously noted, now consists of three financial non-healthcare people, replacing the seven who resigned. Meanwhile, customers wonder about the security and use of their genetic and personal information [TTA 8 Nov]. Release, AP, Healthcare Dive

Another telemental health unicorn, Lyra Health, laid off 2% of staff in a restructuring. 77 people on non-clinical operational teams were released. Some may receive severance for 12 weeks with health benefits, according to one of the anonymous released. Noted in the FierceHealthcare article are reported changes at Lyra, including larger provider caseloads demanded and deletion of seven core values that put clients and clinicians first. Lyra’s last raise was a $235 million Series F in January 2022 for a total of over $910 million (Crunchbase). That high valuation of $5.6 billion has been tough to maintain in the current funding environment–and to not take a down round that affects valuation. 

Health kiosk/primary care practice Forward goes backward, shuts immediately. Nearly on the first anniversary of a $100 million Series E raise from Khosla Ventures and four other investors to deploy self-serve kiosks (left) in major cities [TTA 17 Nov 23], tech-driven primary care practice Forward announced its sudden closure today, effective immediately. What remains on their website is a goodbye-and-good-luck note to patients canceling appointments and zeroing out its app. Patients can email clinicians for care support until 19 December. There is no information available on accessing records nor transferring to new providers, leaving patients in the lurch. 200 employees will lose their jobs immediately as well.

Forward had primary care practices in 14 markets such as New York, San Francisco, and others. Last year it claimed 100+ primary clinicians at 19 locations, with patients paying $150/monthly (no insurance accepted) for un­lim­it­ed vis­its to For­ward’s pri­ma­ry clin­ics. (Refunds, anyone?) The CarePods self-serve kiosks were designed to be self-contained units placed in malls, offices, and gyms. Inside, subscribing patients could access AI-powered health apps for disease detection, biometric body scans, blood testing in disease areas, including diabetes, hypertension, weight management, and mental health (depression and anxiety). They were scheduled last year to be deployed in the San Francisco Bay Area, New York, Chicago, and Philadelphia. Nice idea, but like the earlier HealthSpot Station of 2012-2016, they are equally defunct.

In its eight-year life, Forward had raised $325 million (Crunchbase), which also reported last year’s Series E as only $75 million. At the time of their Series D, Forward was valued at over $1 billion and had a roster of flashy investors such as music’s The Weeknd, Salesforce’s founder Marc Benioff, actor Matthew McConaughey, Eric Schmidt, and Softbank. What’s stunning? Reports indicated that it only gen­er­at­ed un­der $100 mil­lion in to­tal rev­enue since its founding. There has to be more to this, like lawsuits….    FierceHealthcare, Endpoints News

Weekend reading: 23andMe’s up in the air future, including genetic data; Walgreens debates What To Stop and Start; what if healthcare pursued a zero-failure rate?

While 23andMe figures out a future….what happens to the genetic data?  Troubled 23andMe today announced that it will be reporting its FY2025 Q2 numbers next Tuesday 12 November. An interesting part of their release is that shareholders can submit and upvote questions to management via the Say Technologies portal–and they’re blistering. They ask about the plan for recovery (132 votes, 60K shares represented), whether the company will be sold off piecemeal (128 votes, 73.5K shares) and a sale of the company (78 votes, 47.8K shares. Also questioned (38 votes, 3.4K shares): the addition of three new board members, none of whom have biopharmaceutical experience as all former CFOs outside of healthcare. These replace the seven that ankled on 17 September [TTA 17 Sept]. 

To Wojcicki, of course, with her reported 49.99% of voting control, shareholders’ questions aren’t really going to matter. Whether they will be addressed on Tuesday is anyone’s guess.

Many 23andMe customers have questioned how to remove their personal genetic data from their database, which if en masse will reduce the value of the company. This TechCrunch article explains how that data is not covered by HIPAA privacy regulations, but 23andMe’s own retention rules.

If 23andMe sells, the data goes with it. If there is no sale, apparently recent Wojcicki statements indicate that the model going forward for the company is the sale of that data to pharma developers and researchers, ditching its independent drug discovery, and moving into telehealth prescribing of GLP-1 drugs through its Lemonaid subsidiary. 

For those concerned about their privacy, or wary of a change of ownership, accounts can be easily deleted–but not the genetic information. TechCrunch gives how to delete your account–but apparently that won’t delete your genetic information, date of birth, and gender. 23andMe will also retain limited personal information attached to your account for an undefined time. Individuals can also reverse their consent for sharing that information with researchers, but cannot remove it. 12 million people have reportedly given consent–deliberately or not. A real lesson on oversharing for millions–if they care. 

What can Walgreens reasonably stop or reverse in its multiple series of Bad Decisions? A short interview at HLTH with US Healthcare head Mary Langowski indicates that there’s not much that hasn’t been already announced. We know that VillageMD is shuttering locations and is up for sale. 1,200 retail locations will be closed over the next three years. But what else to stop? “A lot of what I’ve fo­cused on in the first six months, is re­al­ly, it’s okay to stop stuff. What are we gonna stop?” While it’s totally fine to fail ‘at some things’, these weren’t small fails. Wentworth is concentrating on the new chief commercial officer selling Wal­greens’ ser­vices to pay­ers, providers, and life sci­ence com­pa­nies, such as clinical trials capabilities, CareCentrix, and Shields Health. There’s also some push towards “build­ing a stand­alone phar­ma­cy busi­ness rather than a ver­ti­cal­ly in­te­grat­ed busi­ness”. Endpoints News

Thinking about if healthcare adopted a ‘zero-failure’ rate. Michael Alkire’s (CEO, Premier Inc., a health system operational improvement provider) daughter was on Alaska Airlines’ Flight 1282 on 5 January 2024. That was the Boeing 737-9 MAX flight that had a blowout of a mid-cabin exit door plug placed there instead of an emergency exit door. The blowout was due to four improperly installed (loose) bolts. It occurred at 16,000 feet and the lower altitude, combined with no one seated in that row, contributed to a 100% survivability rate and a successful landing, though passengers were injured. Anyone with an interest in aircraft knows that one little thing, like a worn jackscrew on a rudder or an untightened bolt, can lead to a non-survivable crash.

Mr. Alkire’s point is that we should be striving, as the airlines and aircraft manufacturers have done (which failed in this case) for zero failure in healthcare.  He cites the well-known statistic that 98,000 people die each year from medical errors. We don’t have a culture of continuous performance improvement. For one, clinical innovations can take nearly two decades to become standard practice. Yet it works. Simple things, such as clinical surveillance in nursing homes, can reduce adverse drug events by 92%.  Much more to ponder in this Influencer contribution to MedCityNews. (And Boeing has a long way to go to restore trust–buying back Spirit AeroSystems, the former Boeing Wichita, is a necessary start they are finally making.)

Two follow ups: Steward Health CEO resigns–and sues the Senate HELP committee, Wojcicki will take 23andMe private

Ralph de la Torre MD hasn’t sailed the $40 million boat south yet–but he doesn’t have to go into his office anymore, only the lawyers’. Yesterday (30 September), Dr. de la Torre stepped down from his CEO and board positions of the bankrupt Steward Health. He had submitted his resignation on 19 September, the day that the Senate Health, Education, Labor and Pensions (HELP) Committee voted to hold him in criminal and civil contempt due to his failure to appear before the committee on 12 September. The full Senate voted to refer the contempt charges to the Department of Justice (DOJ) on 25 September. [TTA 26 Sept]

de la Torre filed his own lawsuit on 30 September in the District of Columbia US District Court against each member of the HELP Committee, charging them with violating his Constitutional rights, specifically the Fifth Amendment on self-incrimination, in seeking to subpoena him for a hearing which “was simply a device…to attack Dr. de la Torre and publicly humiliate and condemn him” as part of a “coordinated campaign to villainize and scapegoat him.” The lawsuit seeks to have the subpoena and the contempt referral invalidated and declared unenforceable as a result, seeking declaratory and injunctive relief. He had previously asserted his Fifth Amendment rights before the Committee in view of the company’s Chapter 11 proceedings. Given the threatening and extreme language of several of the committee Members and the actions that de la Torre’s filing singles out, the DC District Court hopefully will give this a fair hearing.

It is unknown if anyone will replace de la Torre as CEO even on an interim basis, as the company is selling its assets via the US Bankruptcy Court for the Southern District of Texas.

“While Dr. de la Torre has amicably separated from Steward on mutually agreeable terms, he will continue to be a tireless advocate for the improvement of reimbursement rates for the underprivileged patient population,” a Steward spokesperson said to Becker’s in a 28 September statement. “Dr. de la Torre urges continued focus on this mission and believes Steward’s financial challenges put a much-needed spotlight on Massachusetts’ ongoing failure to fix its healthcare structure and the inequities in its state system.” (Our Readers will not be blamed for being slightly amazed at this last statement, as most of Steward’s troubled hospitals, including two hospitals that no one would buy, were in that state–and Steward’s interests ranged all the way to London and Malta.) FierceHealthcare, Healthcare Dive 

She’ll do it herself, because nearly 50% of voting shares says she can–No Third-Parties Need Apply. Per an SEC regulatory filing yesterday (30 September), beleaguered 23andMe CEO Anne Wojcicki declared that she is no longer seeking proposals from third parties and is moving forward to acquire the company. “It has become even clearer to me that the best path forward for the (company) is for me to take the company private.” Since the board of directors is vacant–except for her–and she holds effective voting control, it is hard to contradict her. While the company is public via a SPAC that cracked hard, with shares hovering around $0.37, her $0.40 bid per share was rejected by the board in no uncertain terms. However, Wojcicki is the only one who counts here, as she has sole voting power over 9.7 million shares and shared voting power over 101.1 million shares of the company equaling 24.8% of the company’s shares. Replacements have not been made for the seven departed independent directors–and this Editor doesn’t expect any until (and if) Wojcicki buys the company [TTA 17 Sept].

In the SEC filing, Wojcicki said “Importantly, I remain committed to our customers’ privacy and pledge to maintain the (company’s) current privacy policy in effect for the foreseeable future, including following completion of the acquisition I am currently pursuing.” This Editor ironically notes that had that position on site and database security prevailed a year or so ago, none of this would have happened.

Wojcicki may be buying a near-empty shell of a company that preferred to blame users versus clean up its security act, but it will be All Hers. There you go. Reuters, The Business Journals, Yahoo News

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

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.)

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

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.  

Breaking: Teladoc’s Q2 sinks on $790M BetterHelp impairment; Wojcicki files to take 23andMe private

Teladoc posts Q2 loss of $838 million, takes $790 million impairment on BetterHelp’s sinking performance. New CEO Chuck Divita had nothing but bad news to deliver to Mr. Market (right below). It was so bad that they withdrew their FY2024 outlook for both consolidated operations and BetterHelp stated in April and all three-year outlooks. TTA Q1 Teladoc results and outlook  

  • Q2 revenue declined 2% versus prior year to $642.4 million. Integrated Care (main business) segment revenue increased 5% to $377.4 million while BetterHelp declined 9% to $265 million. Readers will recall that previous CEO Jason Gorevic assured investors that BetterHelp would carry Teladoc to profitability. Au contraire, along with his job.
  • The bright spot was that adjusted EBITDA increased to $89.5 million, up 24% versus prior year, but adjustments reflect all sorts of financial legerdemain, including impairments.
  • First half results were essentially flat versus prior year, with revenue up 1% to $1,288 million with Integrated Care up 7% to $754.5 million–but BetterHelp again sinking results with a decrease of 7% to $534.0 million.

BetterHelp’s rolling failure is almost inexplicable, with telemental health being the ‘IT’ clinical category in digital health funding. Spring Health just scored a $100 million Series E [TTA 31 July]. Younger companies such as Talkiatry and Brightside Health seem to have no problem raising funds or gaining partners/customers. One would think that with established customers in the enterprise space, Teladoc would have no problem adding on telemental services. This Editor has previously analyzed the problems that have led to the decline of both Teladoc and Amwell, but Teladoc stands apart in one factor. It is still recovering in its huge failure in buying and failing to integrate Livongo. But in the telemental health space, the profitable companies are largely in the enterprise and payer space. Even DTC, they have slicker solutions and extensive networks. It’s a cost-sensitive market, both to benefit admins and to prospective members. 

Here’s the pivot. On the earnings call, CEO Divita and CFO (former acting CEO) Mala Murthy announced a pivot for BetterHelp to international, non-English-speaking markets, where customer acquisition costs are lower. (This Editor would add that competition is also less.) They also blamed advertising cost inflation and jacked-up acquisition costs during a US election year–something that is completely predictable and should be baked in the 2024 marketing expenses. Unbelievably, if advertising costs remain high, Murthy stated that they expect a low double-digit revenue decline, whatever that means.

The shocker here is that it finally dawned on them that the big problem with BetterHelp is that it does not accept insurance and has a high DTC cost. Their leavers in research cite both as reasons why. Hellooooo? What took so long?  So their fix is to negotiate insurance coverage–but that won’t take effect till 2025. 

From FierceHealthcare in an on-point close of their article: “Divita was adamant that Teladoc runs BetterHelp well and that it’s an important part of the company.”  Morningstar (Teladoc release)  How much more can Mr. Market stomach? This story is developing.

As we predicted, CEO/founder Anne Wojcicki has made an offer to take 23andMe private. She has filed with the Securities and Exchange Commission (SEC) amendments to their Schedule 13D form that confirm that on 29 July, she sent a non-binding proposal to the Special Committee that has been looking at alternatives since late March [TTA 20 April]. The Exploding Plastic Inevitable offer of $0.40 per share is to shareholders of Class A and B common stock. It became public yesterday (31 July). The current price is around $0.40, so there is no premium. 23andMe is also on a six-month delisting deadline with Nasdaq from November, which they have since passed but may have been extended due to the Special Committee formation.

Wojcicki holds supervoting privileges that have always given her effective control of the company. According to analyst TD Cowen, she currently holds 22.5% of the company’s outstanding Class A common stock and 59.2% of outstanding Class B common stock. In going private, she would be right in line to be paid out by outside funders (Other People’s Money). Other alternatives to her buyout, such as Chapter 11 or 7 bankruptcies, are even more bleak and would leave shareholders with effectively 0.

As TTA noted in our April coverage, the company is yet another cracked SPAC (2021) hitting a $4.8 billion valuation, acquiring companies, and falling precipitously. It never found a recurring revenue model, being largely ‘one and done’ on ancestry and genetic reports. Recently, it lost a lucrative contract with GSK for research data. It stumbled badly after a major data breach in Fall 2023 that exposed 6.9 million records. Then, they blamed members for their poor cyberhygiene and lack of security. This once bright light has burnt out; is it even relevant anymore other than giving the CEO a job? Yahoo Finance, CNBC, MedCityNews  Developing. Our recent 23andMe coverage: 29 May (FY24 earnings and the committee’s poor choices), 2 Feb (data breach timeline, financials)

First half digital health investment — a true rebound or a ‘dead cat bounce’? A Gimlety look at Rock Health’s H1 report.

Gimlet EyeFirst, your Editor assures our Readers that no felines were harmed or poorly thought of. It’s just words expressing concepts!

In ever-dapper Mr. Market’s picturesque and blunt language of finance, a ‘dead cat bounce’ is a temporary improvement, a short-term recovery that does not reverse the reality of the long-term downward trend, which resumes shortly thereafter the pick-me-up. It’s applied to assets, stock prices, market sectors, and even political polling. 

So…let’s debate the point. Is digital health investment in the US recovering, or taking a few lungfuls of air at the surface before sinking again?

Rock Health’s first half (H1) report. It is, like most of theirs, heavy on the optimistic ‘glass half full’ view. Its headline ‘Resilience Leads to Brilliance’ is certainly a catchy rhyme or meme, but in this Editor’s Gimlety View, an overstatement. It does look like the logjam in funding and M&A has broken, but where’s the brilliance?

Let’s take a cold look at the Rock Health findings for the first half (H1) of 2024. Rock Health only looks at US digital health fundings above $2 million and includes some companies those of us in the professional field do not consider ‘digital health’. FTR:

  • US digital health startups raised $5.7B across 266 deals. Average deal size: $21.4 million.
  • The action was in Series A and B raises, which were roughly comparable to prior years. Series C and D were anemic, with Series C especially lagging even anemic 2023.
  • 40% of H1 2024’s fundraises (107 deals) were unlabeled; by quarter, Q1 47% and Q2 33%. This is only slightly down from the 44% for full year (FY) 2023.
  • The top ‘value propositions’ for fundraising companies were disease treatment (including food as medicine), non-clinical workflow, R&D, clinical workflow, on demand healthcare and precision medicine. The first two are no change from FY 2023. The biggest shifts up from FY2023? Clinical workflow, on-demand healthcare, and precision medicine. These categories are not defined by Rock Health.
  • The top ‘clinical indications’ are mental health, cardiovascular, oncology, weight management, reproductive/maternal health, and neurology. Again, the first three are basically little changed from FY 2023. The big upward shift was funding for reproductive health.
  • “AI momentum underpinned deals in categories next on the list, including nonclinical workflow ($896M), R&D for pharma and medical devices ($737M), and clinical workflow ($639M).”
  • Until Q2 2024, there had not been any into the public markets for 21 months. Starting in May and June, there were three: fetal monitoring Nuvo (public exit via SPAC (!!) in May) and two in June: revenue cycle management company Waystar and precision diagnostics Tempus AI.
  • There were only 66 acquisition deals made in H1, about half between digital health companies. Private equity acquired 10 companies and 12 in “other”. 

In nearly every metric above, H1’s trends are comparable to 2023 extrapolated to a full year, as well as in line in numbers to pre-inflationary 2019–the investments in absolute terms are worth less. 

But overall, it is as if the boom of 2020-2022 never happened except in the wreckage of overfunded/foolish funded companies. And 2023 was marked by four tech bank lender bankruptcies and many high profile bankruptcies such as Babylon Health, Quil Health, and Pear Therapeutics. 2024 should look better than 2023, by that logic.

But let’s factor in the following for 2024 H2:

  • The raises are there and they’re fairly steady–but with only a few exceptions, usually AI related, they are far less than in the past, again using 2019-2020 as a baseline.
  • At the same time, layoffs are also prevalent and substantial at all levels, indicative of retrenching. And there is little real hiring versus resume collection.
  • This is an election year like no other in the US, UK, and France, as well as political and terror turmoil worldwide. 
  • Two active wars in Ukraine and Israel, possibly a third on the horizon with major impact (Taiwan)
  • Drying up of now unwanted Chinese capital that fed into Sand Road VCs
  • The very underdiscussed FTC/DOJ pre-merger notification and Merger Guidelines–and a hostile FTC

Socially and physically, there’s little respite, from the fool’s spectacle of the opening Olympic ceremony to increased volcanic activity worldwide seen from Yellowstone to Italy. Natural disasters add to nervousness. 

As usual, there are two metrics missing from Rock Health’s analysis: companies in deep trouble or bankrupt. Capital destruction matters. Granted, Rock’s report is about digital health investment, but considering what and why it fails is part of the investment picture. What comes after all those rounds and exits? 

  • Bankruptcies: Cue Health, Cano Health, Invitae, SmileDirectClub (late Dec 2023)
  • On the way: 23andme, NeueHealth (probably 2025), Amwell (which avoided delisting by a reverse stock split)

There is also the shutdown of Walmart Health’s telehealth / remote health unit, formerly MeMD, acquired by Fabric. There is also the Veradigm mystery–delisted and as of May, up for sale, despite having positive revenue. Added context: the failure of melding retail health with clinic operations–Walgreens’ VillageMD, CVS scaling back Oak Street, Amazon folding Clinic into One Medical.

AI is also proving to be ‘not all that’. Health systems are using them to automate procedures and some interfaces with patients. But the investment/payout equation is still tilted heavily to the former.

Conclusion: this Editor is leaning towards ‘dead cat bounce’ through this year unless something drastically changes, as in improves.

Agree? Disagree? Comment below!

Referenced: Rock Health FY 2023 report, Rock Health Q1 2024 ‘flat spin’ report, Mobihealthnews

News roundup: Waystar $1B IPO is on (updated); CVS looking for Oak Street PE partner; 23andMe net loss doubles to $667M, may go private; Otsuka dives into digital therapeutics; HoneyNaps’ $12M no snooze

Waystar finally getting around to starring in its IPO. Again. The on-again/off-again public offering for this healthcare payments software platform developer is back on, according to their Form S-1 filed yesterday (28 May) with the Securities and Exchange Commission (SEC). Their first filing draft was in October 2023 on Nasdaq which would have valued the company at $8 billion. The IPO was again revived in December and postponed. This filing for WAY floats 45 million shares valued between $20 and $23 which would raise $1 billion with a far more reasonable valuation of $3.7 to $3.83 billion (latter updated per Waystar). Lead book-running managers are JP Morgan, Goldman Sachs & Co. LLC, and Barclays.

Cornerstone investors, who purchase stock before the formal listing, have expressed interest in buying up to $225 million in shares; these investors include funds managed by Neuberger Berman and a wholly-owned subsidiary of sovereign wealth fund Qatar Investment Authority. 

Underwriters have a 30-day option to purchase up to 6.75 million shares at the IPO price less the underwriter discount. Their current investors are EQT AB, Bain Capital, Francisco Partners, and the Canada Pension Plan Investment Board. The net proceeds from the offering will repay outstanding indebtedness. No timing is stated for when the IPO will happen. Usually, there are roadshows for institutional investors that showcase the prospectus (in the S-1) and positive points such as their $5 billion in annual transactions. After the listing, the current investors will still have substantial shares: EQT, CPPIB, and Bain will own about 29.2%, 22.3%, and 16.8% stakes respectively. 

Release, Morningstar, FierceHealthcare, Reuters

CVS Health is reaching out for a private equity partner to expand Oak Street Health’s clinics. Bloomberg News reported this unusual move by CVS with a handful of private equity firms to explore what was termed by ‘insiders’ as a joint venture. It’s all very preliminary and a JV may not be the final form. OSH is far smaller than rivals One Medical (Amazon) and VillageMD (Walgreens) but CVS apparently does not want to go it alone to fully take on the development cost. On February investor calls, CVS projected building out to 300 clinics by 2026. Reuters

Even in early 2023 with rivals Amazon (One Medical), Walgreens (VillageMD), and Walmart Health on primary care clinic buying and building binges, CVS’ buy for $10.6 billion for the ‘runt of the litter’ was widely derided as a waste of money [TTA 16 Feb, 2 Mar 2023]. OSH had only 169 offices in 21 states. It was also a money loser, $510 million in the red in 2022 and $200 million projected in 2023, with no breakeven predicted until 2025. A large part was due to OSH’s patient population, heavily skewed towards Medicare Advantage and underserved, high-risk patients. Those factors have gotten worse, not better. CMS has now tightened payments on MA with new rates and on reimbursement for diagnoses, making the growth of this population even riskier. Further dimming prospects for a willing partner: Walmart Health is shutting at end of June and VillageMD has shed or is shedding 140 locations to perhaps 620.  

23andMe’s losses double while revenue shrinks by 31%. Things continue to dim at the beleaguered genetics testing company. Their Q4 ending 31 March 2024 (FY24) closed with a net loss of $209 million on $64 million in revenue, compared to a net loss of $64 million on $94 million in revenue in the prior year Q4. In adjusted EBITDA, Q4 lost $33 million, compared to a loss of $39 million in prior year Q4. Net loss in full year FY24 was $667 million on revenue of $220 million, versus prior year’s loss of $312 million on revenue of $299 million. Adjusted EBITDA was $176 million versus prior year’s $161 million. As previously reported [TTA 20 Apr], CEO and co-founder Anne Wojcicki may offer to buy out the 80% of shares she does not already own. In developments, 23andMe has introduced an ancestry feature called Historical Matches, three new genetic reports for 23andMe+ members covering breast, colorectal, and prostate cancer based on polygenic risk scores, and some clinical trials moving forward. 23andMe also lost revenue in mid-year from GSK’s expiring agreement, had an impairment relating to Lemonaid Health, and of course (but not mentioned here) their massive 6.9 million record data breach. Shares closed today at $0.61, slightly up from April’s lows. Release

Otsuka America bucks the down trend, moves into digital therapeutics with Otsuka Precision Health. The Japanese pharmaceutical company’s US division is moving forward with a new digital health unit, Precision Health (OPH), headed by 14 year veteran Sanket Shah. Their first rollout later this summer will be based on the newly FDA-cleared Rejoyn, the first prescription digital therapeutic authorized for the adjunctive treatment of major depressive disorder (MDD) symptoms. Rejoyn was developed in conjunction with Click Therapeutics. Mr. Shah and Otsuka are taking the longer view in terms of development, that future developments will be about both partnerships and solo effort, and that the road is long–and littered with the burnt-out shells of failed companies like Pear Therapeutics, Babylon Health, and way back to Happtique. Otsuka has had its own digital health learning experience. They partnered in 2017 with Proteus Digital Health’s smart pill tech for its Abilify MyCite anti-depressant. After abruptly ending the partnership, Otsuka bought the smart pill technology out of bankruptcy [TTA 19 Aug 2020]. Release, Healthcare Dive 

One funding of note this week is HoneyNaps‘ $11.6 million Series B. Hi Investment Partners, QUAD Investment Management, and Industrial Bank of Korea led the South Korean sleep diagnostics company’s funding. HoneyNaps has an FDA-cleared (2023) bio-signal monitoring and AI-assisted sleep diagnosis software, SOMNUM, that will be introduced to the US market. In the release, the company CFO announced plans to “further advance the AI to expand its application to other critical areas such as cardiovascular disease, dementia, and Parkinson’s disease”. Mobihealthnews

Weekend reading: 23andMe’s exploding plastic inevitable fate–and what might have been

23andMe may go private, break up, or go bankrupt. Not many other options. A major end-of-week news item in healthcare was that 23andMe, the beleaguered genetic testing company, may be taken private by its CEO and founder Anne Wojcicki per an SEC 8-K filing on 18 April and a press release issued the same day. Currently, she is a major shareholder controlling more than 20% of the total outstanding shares with ‘supervoting’ rights that entitle her to approximately 49% voting power. She filed a Schedule 13D the prior day indicating her intent to buy all outstanding shares. No offer value nor timing was specified. Bloomberg, LinkedIn

23andMe shares closed Friday at $0.48 on the Nasdaq Global Select Market. On Wednesday, they closed at an all-time low of $0.36. It has not had a close above $1.00 since 29 September 2023. In November, Nasdaq notified them that the company had 180 days to bring the share price above $1.00 or face delisting–and there is little time remaining on the clock. CNBC

In February, after a disastrous fiscal Q3 with net loss tripling and revenue down 32%, Wojcicki floated the idea of separating the consumer genomics/virtual care and the commercial genomic database/drug discovery businesses but has turned now to taking the company private and fully under her control. Its market cap is now about $200 million with $200 million cash on hand, creating a zero-sum situation. The release states that on 28 March, the board of directors formed a special committee to evaluate alternatives to maximizing shareholder value. But when ‘shareholder value’ has to be approved by one shareholder with 49% of the votes, the BOD’s options may be constrained.  

What a difference in three years. In February 2021 after much anticipation, 23andMe went public in a SPAC founded by Richard Branson and soared to a $3.5 billion valuation. It achieved a $4.8 billion market capitalization after buying in October 2021 Lemonaid, a quick-diagnosis/quick-prescription telehealth company for minor but troublesome conditions that was touted, but never became, a nexus of, to quote the announcement, “healthcare that is based on the combination of your genes, your environment, and your lifestyle.”  At the time, its future seemed unlimited between consumer genetic testing (genotyping, not diagnostic) for health and ancestry, building up Lemonaid into a full-featured virtual diagnostics and health service, while taking the deidentified data and marketing it for commercial research to Big Pharma, initially via a five-year exclusive deal with GSK.

That commercial use proved to be a sticky wicket with consumers concerned about how their data was being protected, with opting out made (deliberately?) opaque and difficult. Other than Lemonaid, 23andMe failed to successfully diversify beyond the core ‘one and done’ genotype testing until very late last year. Last February, after their disastrous 6.9 million record data breach turned the spotlights on, the Wall Street Journal revealed that a pricey subscription program for lifestyle counseling that included clinical exome sequencing plus Lemonaid called Total Health failed to gain traction after its late 2023 debut and their in-house drug discovery moved only two out of 50 into early-stage human trials. The GSK deal expired and was not renewed. 23andMe was also torching through cash. [TTA 2 Feb]. The thick and sticky icing on the cake was 23andMe’s antagonistic response to the breached customers, blaming them for recycling passwords and using multiple features they offered [TTA 19 Jan]. This was rightfully blasted in the industry and the subject of multiple consumer class-action lawsuits.

In this Editor’s opinion, 23andMe’s ship must pass between the Scylla and Charybdis of financial choices. Splitting up a near-worthless company into three money-losing parts, like Gaul, is rearranging deck chairs on the sinking ship (to really scramble our metaphors). In either a Chapter 7 (closure) or Chapter 11 (reorganization) option, Wojcicki would lose control and her spot as CEO, wiping out the shareholders, but she might retain some value in Chapter 11 in the IP, depending on how it is structured. Then finally, there is Wojcicki’s buying out the other shareholders. That is dependent on her having or being able to access the cash from investors. None of this solves the failure of the business model, which was for most customers ‘one and done’ testing, not subscribing to additional services, and unsubscribing from any further data use. They saw nothing attractive or useful in the other services. Then as a member to be hacked and blamed for it? That is a run, do not walk, to the exit.

Chapter 7s are usually forced situations where there is little value left in the company other than intellectual property (as in Pear) and equipment (if applicable), zero confidence in management and product delivery (Olive AI), withdrawal of key client business, collapsing in a heap of litigation (Theranos), and any of the above coupled with overwhelming debt that lenders will no longer carry (Babylon Health).

A Must Read for your weekend is Arundhati Parmar’s gem of an essay on 23andMe in MedCityNews–the company’s current dilemma contrasted with what if co-founder Linda Avey had not been ousted in 2009. She expertly sets off interviews with Avey and Wojcicki into an illuminating virtual debate that should be part of an MBA candidate’s case study. Parmar sets them off with analyst views, the experience of a referred 23andMe customer who illuminates the life-changing nature of genetic testing as well as 23andMe’s service drawbacks, and a sparkling view from an empty 23andMe cocktail reception at this past January’s JPM.

23andMe data breach may have targeted those of Jewish and Chinese heritage; company valuation crashes (updated)

23andMe’s hole gets deeper. And deeper. As more dots are connected on their data breach–and financial situation.

Part 1: The data breach that exposed 6.9 million records at genetic testing and data company 23andMe isn’t only being fought in the courts as to who to blame (customers recycling already corrupted passwords versus a site vulnerability to brute-force hacking). It appears the hackers had specifically targeted people with Chinese or Ashkenazi Jewish heritage. Worse, 23andMe is not addressing that. The evidence was there as early as October.

  • 1 October: an unknown person posts on the 23andMe subReddit that they had customer records, posting a sample of the stolen data. Supposedly this is how 23andMe found out that their user data had been hacked and stolen. (Editor’s note–this zero-trust breach beggars credibility in a tech-oriented company.)
  • 6 October: 23andMe’s blog post announcement of the initial 14,000 records hacked in their customer base, which later grew to 6.9 million records revealed through the links to MyHeritage, in adding functionality to Family Tree, or sharing their information by opting into 23andMe’s DNA Relatives feature. 
  • 6 October: Wired’s reveal that earlier in that week, a hacker posted on BreachForums a data sample of what they claimed were 1 million records exclusively on those of Ashkenazi Jewish heritage, plus hundreds of thousands of records on those of Chinese heritage. By Wednesday, the hacker was selling what was claimed as 23andMe profiles with information on display name, sex, birth year, and details on genetic ancestry results, but not raw genetic data. Pricing was between $1 and $10 per account depending on number purchased.
  • By December, 23andMe was squarely blaming users for reusing passwords (credential stuffing), even if they created a unique password, and denigrating their right to demand legal accountability from 23andMe on their lax security procedures. [TTA 6 Dec 23, 19 Jan]

None of the contacts that 23andMe has made with users since October, including the letter sent to breached users (via TechCrunch) refers to any specific ethnic group targeting. 

World events made this targeting and timing very important. The brutal attack by Hamas in the south of Israel was the very next day after the breach was disclosed, 7 October. It killed 1,200 civilians, with over 200 hostages. Israel declared war on Hamas in Gaza which still goes on, as do the demonstrations against Israel and overt anti-semitism. Given the targeting evident in this breach of individuals with information for sale, by 11 January Representative Josh Gottheimer (CD-5, NJ) sent a letter to the director of the FBI to investigate the hacking, specifically because the information could be purchased via sites used by hackers to merch this type of information–and used to target Jews globally.

Third-party data included in the hack? There is also the possibility that DNA information from third parties such as Sequencing entered 23andMe’s database. In Illinois and other states, this type of sharing is illegal without specific consent. This information could also have been stolen without the knowledge of the individual. This has sparked additional class action lawsuits. The Times of Israel

Part 2: 23andMe is in poor shape financially. Like all too many companies that went public in 2021, 23andMe is a cracked SPAC that debuted in February 2021 above $16, with a company valuation of $6 billion, and now is trading on Nasdaq at $0.73 which gives the company a negligible value. Revenue is upside down and the company is torching through the $1.4 billion it raised both in the market and through private investment. The WSJ’s estimate in a far-reaching article is that it is 80% gone. Founder Anne Wojcicki’s stock has supervoting privileges which means she effectively controls the company, not the shareholders.

Both Ancestry (remember them?) and 23andMe had ups and downs from 2015 but the hype, especially after the Theranos implosion that year, was stunning. Genetics became The Next Big Thing That Would Save Health Tech. The large flaw–the market for genetic testing for ancestry and/or health is a ‘one and done’, which TTA predicted back in 2020 and earlier. Wojcicki guessed early on that a revenue model lay in selling de-identified genetic information to pharma. But their five-year exclusive deal with GSK ended last year and led to an 11% layoff [TTA 10 Aug 23]. Subscriptions for lifestyle counseling starting at $200 and exceeding $1,100 never took off. Growing their $4oo million Lemonaid buy from fall 2021 into a more robust and integrated telehealth platform never happened. Her long-term bet was moving into drug discovery using all that DNA data, but only two drugs of 50 have reached early-stage human trials.

Whether 23andMe will climb out of this crater, both financial and data security, as they did several times in early days, is to be seen. But Wojcicki’s personal brand apparently remains in great shape, unlike their data security. Also Futurism

*Updated 2 Feb for additional references, content, and copy editing

Got a data breach? Blame the victims like 23andMe did!

23andMe wished its breached customers Happy New Year by putting the blame…on them!

The hacking that started with 14,000 records and grew to exposing the records and personally identifiable information (PII) of 6.9 million users, about half their customer database, has spawned over 30 class action lawsuits in the US, plus lawsuits in Ontario and British Columbia, Canada. 23andMe, in their responses to law firms and on their blog, told lawyers and users–not unexpectedly–that the data breaches were due to 23andMe users recycling log in credentials, such as passwords, that were used on other–breached–websites, and failed to update them on 23andMe after these incidents.

However, as this Editor noted when this first broke in December, this credential stuffing doesn’t account for the targeting nor the hacking of users who claimed they had unique credentials, including the US National Security Agency (NSA) cybersecurity director Rob Joyce who creates a unique email for each of his accounts (!). It also doesn’t account for how 14,000 brute-force hacked records grew exponentially to 6.9 million records. One reason may be data sharing with a partner, MyHeritage, in adding functionality to Family Tree, or sharing their information by opting into 23andMe’s DNA Relatives feature. 

It also does not account for how 23andMe squarely blamed users–that they were negligent in whatever passwords they used, that two-factor authentication was available since 2019 (but optional), that the information taken didn’t include highly sensitive information such as Social Security number, driver’s license number, or financial information. Therefore any lawsuits were futile, per a letter from 23andMe’s Greenberg Traurig to one of the class action firms, Tycko & Zavareei LLP. Afterwards, 23andMe reset all passwords and instituted mandatory multi-factor authentication, closing the barn door after the horse, cow, and goat got out and made it to the next county.

Playing into this is the weakness of US law around what constitutes ‘reasonable security procedures’ for securing personal information–and that is from the wording of the California Privacy Rights Act (CPRA), which may be the US’ toughest privacy law. On one hand, users have responsibility for a decent, unique password every time–but on the other hand, 23andMe bears responsibility for securing its shared data and not letting a breach get wildly out of hand like this one did. And what if next time it’s the actual DNA information?

The insult to injury: In December, 23andMe changed their terms of service to essentially indemnify themselves. Users had to agree, in the terms of service, exactly 30 days to opt out of the right to participate in a class action lawsuit and instead submit to private arbitration in the event of a dispute.

Not owning up to some fault is not the way to build customer confidence. Especially with a company in a faltering sector now trading around $0.70 per share. TechCrunch, ArsTechnica

23andMe hacking may have affected 6.9 million+ users–not 14,000–in massive PII breach

What was 14,000 may affect up to 6.9 million users. Genetic testing and information company 23andMe is now admitting that the October data breach that affected 0.1% of their 14 million customer base, or 14,000 users per their SEC filing last Friday, may have exposed the records and personally identifiable information (PII) of 6.9 million users, about half their customer database. In later replies to industry publications TechCrunch and WIRED, a 23andMe spokesperson admitted that hackers accessed the PII of about 5.5 million people who opted-in to 23andMe’s DNA Relatives feature. Add into that an additional 1.4 million “had their Family Tree profile information accessed”. an enhancement to DNA Relatives. The DNA Relatives breach stole individual and family names, birth year, relationship labels, the percentage of DNA shared with relatives, ancestry reports, and self-reported location. Family Tree information exposed display names, relationship labels, birth year, self-reported location, and whether the user decided to share their information.

(Editor’s note: The size of the breach is enough to revive this vintage picture of WWF/WWE wrestler Hulk Hogan in his ‘Hulkamania Running Wild’ persona.)

23andMe has attributed the massive breach to credential stuffing–the reuse of leaked login credentials from other websites and services. But many users have gone public with the information that their logins were unique to 23andMe. 23andMe’s credibility on this issue took a beating from none other than the US National Security Agency (NSA) cybersecurity director Rob Joyce. He wrote on his personal X account that “They disclose the credential stuffing attacks, but they don’t say how the accounts were targeted for stuffing. This was unique and not an account that could be scraped from the web or other sites.” In fact, Mr. Joyce creates a unique email for each account. The cause for the wider breach may lie in data sharing with a partner, MyHeritage, in adding functionality to Family Tree. It seems clear that credential stuffing wasn’t the only technique used to break into the 23andMe user data.

23andMe, as well as Ancestry.com and MyHeritage, now require or strongly recommend two-factor authentication for access to personal accounts. About time. They have also changed terms of service to “encourage a prompt resolution of any disputes”.

What is distressing is that the hacks on the retail side of 23andMe are only the tip of the iceberg–that the really valuable part of their genetic data goes to pharmaceutical companies. Cyberthieves know that motherlode is incredibly valuable to bad actors like the Chinese and the Chinese Communist Party, both key markets for stolen health data. (Developing)

Mid-week short takes: Amwell lowers 2023 outlook, DocGo goes up, Imprivata + PFH win Ireland HSE contract, Oracle Health’s Nashville move, layoffs at 23andMe, Doximity

Amwell missed Wall Street earnings analyst estimates and lowered its 2023 outlook. Q2 revenue of $62.4 million was a 3% drop versus prior year. Net loss was $93.5 million, added to a nearly $400 million net loss in Q1. Both quarters included goodwill impairment charges totaling nearly $400 million to reflect losses in stock value and market capitalization. Amwell is projecting downgraded revenue between $257 and $263 million compared with earlier guidance of $275 million to $285 million. Their adjusted EBITDA range for the year was also downgraded to lose $160-165 million from $150-160 million. Much of this is due to payer and provider migrations to their new platform, Converge, which will consolidate its offerings plus third-party tools, in a process that is losing providers and reducing visits. Release, Healthcare Dive

DocGo, a telehealth and medical transportation provider, upped its outlooks. First, they reported a tidy bump in Q2 revenue of $125.5 million, up from $109.5 million in prior year. Once known for mass Covid testing which has largely disappeared, which was $28 million in Q2 2022, non-testing revenue grew 53% versus prior year. Revenue is split between transportation ($45 million) and mobile health ($80 million). Adjusted EBITDA was $9.1 million for Q2, rising from $5.6 million in Q1. With $325 million in contracts not fully rolled out and wins with the NYC Department of Housing, their full-year 2023 revenue guidance is now projected to increase from $500-$510 million to $540-$550 million and monitoring over 50,000 patients. Release, Mobihealthnews

Ireland’s Health Service Executive (HSE) awarded a national framework contract to Imprivata and regional partner PFH Technology Group. Imprivata OneSign is a single sign-on (SSO) enterprise access solution for clinicians logging into various systems which eliminates repeated username/password entries. Logins will be via entering their password once per shift and reauthenticating with a tap of their ID badge, potentially saving 50 minutes per shift. Initial rollout will be to the following: Tallaght University, Beaumont, Rotunda, Galway University, Cork University Maternity, National Forensic Mental Health Service, and National Rehabilitation Hospitals. Imprivata release

Oracle Health on the move. Apparently Oracle Health, largely the former Cerner, will be moving to Nashville, Tennessee. This is a commitment that Oracle made in 2021 before purchasing Cerner. Oracle is building a $1.35 billion facility at a riverfront site, planning to locate 8,500 jobs in Nashville by 2031. Nashville has become a southeastern hub of healthcare companies and development. Oracle Health chair David Feinberg, MD and Seema Verma, a SVP there, were at a healthcare meet and greet there last week.  This adds to the de-Kansas City-ing of Oracle and perhaps more attrition among long-time employees. Becker’s

Two healthcare companies reported layoffs and revenue rethinks this week:

  • Genetic tester and data merchandiser 23andMe announced layoffs of 11%. This affects 71 employees primarily in their therapeutics segment, a cut of 47% in that segment and 11% of the company’s workforce. The staff downsizing reflected the end of a five-year partnership in therapeutics development with GSK and adds to April cuts of 75 jobs. The new cuts will be in Q2 of their 2024 fiscal year ending 31 March 2024 which will be by September this year. Revenues also fell in the quarter ending 30 June (their Q1) 6% to $60.9 million from $64.5 million in prior year, with a net loss of $104.6 million. Interestingly, 70% of their revenue is from direct-to-consumer services in genetic testing, subscriptions, and telehealth.  StreetInsider, GenomeWeb
  • Doximity also is laying off 10% of staff, or about 100 people. A digital platform for medical professionals with online networking tools, scheduling, CMEs, secure messaging and telehealth for consults, it is facing slowing growth and renewals among paying customers that include hospitals, health systems, pharmaceutical companies, and medical recruiting firms that purchase subscriptions for services on Doximity. The company adjusted its FY2024 (March end) financials downward to $452 to $468 million and $468 million from $500-$506 million, with adjusted EBITDA for the year to $193-$209 million from $216-$222 million. Release, FierceHealthcare

 

Mid-week roundup: Promising Langone AI/LLM predicts hospital readmits; Huma gains FDA 510(k) Class II clearance; telepsychiatry’s challenges; layoffs/asset buys/losses from 23andMe, Cityblock, Thirty Madison, Butterfly

New York University’s Langone Health’s large language model (LLM) accurately predicting hospital readmissions, more. NYU’s academic medical center NYU Langone Health has developed an LLM using medical language, NYUTron, from unstructured clinical notes in patient records, then fine-tuned it across a wide range of clinical and operational predictive tasks. The dataset was immense:  ‘NYU Notes’ covers 7.25 million clinical notes (for example, radiographic reads, history, and physicals) from 387,144 patients across four hospitals, and more. According to their study published in Nature on 7 June, it was tested for predictive ability in five areas: 30-day all-cause readmissions, in-hospital mortality, comorbidity index, length of stay, and insurance denial. The NYUTron system in testing has achieved results improved over conventional structured models’ baselines. From the Nature study:

  • For 30-day readmission prediction, it had a median area under the curve (AUC) of 79.9% ± 0.168% with a 5.36% improvement
  • On in-hospital mortality prediction, NYUTron had a median AUC of 94.9% ± 0.168% with a 7.43% improvement.
  • On comorbidity index imputation, NYUTron had an OVR median AUC of 89.4% ± 0.275%
  • On binned LOS prediction, NYUTron had a median AUC of 78.7% ± 0.179% with a 12.3% improvement 
  • On insurance denial prediction, NYUTron had a median AUC of 87.2% ± 0.246% with a 14.7% improvement.

In a test of the system during January-April 2022, the system analyzed 29,286 discharged encounters, with 3,271 patients (11.17%) returning within 30 days. NYUTron predicted 2,692 of the 3,271 readmissions (82.30% recall) with 20.58% precision. Also HealthcareITNews

London-based Huma (the former Medopad) gained US FDA 510(k) Class II clearance for their Software as a Medical Device (SaMD) platform. This is defined as disease and age-agnostic digital health pathways through which data are collected from patients for self-management or to be assessed remotely by healthcare professionals. Huma also recently obtained EU MDR Class IIb approval and with Health Canada through the FDA’s joint eStar program. Huma’s tech also includes remote patient monitoring (RPM) systems and companion apps to enable disease management, with third-party device integration. For providers, the platform hosts AI algorithms that use automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making, and prognostication for identification of at-risk patients and early intervention. In 2020, Huma acquired BioBeats and TLT; more recently, last year iPLATO patient engagement and in January clinical trials data specialist Alcedis.   Huma release, Mobihealthnews

The growth of behavioral health has come to a screeching halt with the demonstrated abuse of online prescribing, then the US Drug Enforcement Administration (DEA)’s uncertainty around controlled substance prescribing. This interview with the CEO of Array Behavioral Care, one of the Ur-companies in telepsychiatry (1999, originally InSight Telepsychiatry and Regroup Telehealth), points out how the DEA’s post-Public Health Emergency (PHE) policies around Schedule II and higher teleprescribing disrupted their operations. The flexibilities established during the PHE have been waivered to 11 November, though a final rule must replace the temporary extension rule and comply with the Federal Ryan-Haight Act [TTA 11 May]. Other issues addressed are dealing with medical affairs (clinical licensure, primary source credentialing, facility privileging, and payer enrollment), and the potential for AI to create new tools to aid clinicians in evaluating mental health, such as natural language processing (NLP) in transcribing video sessions and suggesting clinical notes, as well as scanning patient intake stories and analyzing that information for the likelihood of certain diagnoses. HealthcareITNews

The slow drip-drip-drip of layoffs, folded companies’ asset sales, and company losses that started in 2022 continue, though at a diminished pace compared to consumer companies:

  • Genomics and DNA testing company 23andMe announced layoffs of 9% of staff or 75 people. This will take place by the end of their FY 2024, which ends next 31 March. In a 9 June filing, the company claimed that it would reduce annualized payroll and benefit expenses by $12.8 million, which leads one to wonder about the compensation level of those 75 and from what area they are in. South San Francisco-based 23andMe continues to be money-losing, increasing annual net losses from $217 million to $317 million in the 12 months ending in March, according to its May earnings report despite a 10% revenue gain. 23andMe is yet another ‘cracked SPAC’, having gone that route in 2021 with a Virgin-backed SPAC. Once trading at highs of $12-13 on the NYSE, it closed today at $1.96. However, they don’t have debt, are hanging on to a valuation of $924 million, and their cash position is apparently strong enough to hold it for two years.  Becker’s, SF Chronicle, Yahoo Finance, SimplyWallStreet
  • Another well-financed company, Cityblock Health, is laying off 12%, or 155 staff. Spun off from Sidewalk Labs (Alphabet Health-Google) at the end of 2017, their CEO announced the layoffs in a blog post late last week and effective immediately for those affected. Cityblock serves Medicaid and low-income ‘duals’ with both Medicare and Medicare in value-based care models with a heavy reliance on technology. Their CEO who joined the company in March phrased it as a restructuring, using technology to automate processes, and reducing staff layer. In contrast to others, Cityblock has had no trouble raising funding in the past; in December 2020 they raised $160 million in a December 2020 Series C, plus another $192 million in a Series C extension in March 2021, then a reported $400 million Series D in September 2021 with total raises over $890 million. But their cash burn with high-cost operations in six states (HQ New York, Massachusetts, Indiana, North Carolina, Ohio, and Washington DC) is also likely high. FierceHealthcare
  • Thirty Madison buys assets from bankrupt The Pill Club. The assets? Over 100,000 patient files for $32.3 million. The Pill Club entered Chapter 11 in April after being charged by California authorities of defrauding the state Medicaid program. It paid $18.3 million to settle the charges. But that wasn’t all. According to Mobihealthnews, “the settlement came just days after a state court unsealed a whistleblower complaint against the company in which former nurse practitioners alleged it had defrauded private insurers in at least 38 states. According to a statement from their attorneys regarding the settlement, the whistleblowers would receive approximately $5 million.” The patients covered by The Pill Club’s prescriptions will be converted over to another Thirty Madison brand, Nurx, and offered other services such as behavioral health and dermatology services. The Pill Club raised a lot of money from 2016–$51 million in Series B funding in 2019 and another $41.9 million in 2021. Thirty Madison is a private multi-line of consumer-marketed brands such as Keeps (hair), Picnic (allergies), Cove (migraine), and Facet (psoriasis, eczema) and is at a Series C with a total raise of $209 million. Axios, 
  • Butterfly Network, which some years back developed a hand-held ultrasound device (Butterfly iQ) and entered a crowded field with GE HealthCare’s VScan, Mobisante (apparently defunct), and Philips Lumify, reported Q1 revenue of $15.5 million, flat year-over-year compared to Q1 2022 and which missed analyst estimates (again). Somewhat better news was narrowing last year’s loss to a Q1 loss of $33.5 million which was less than Q1 2022’s loss of $44.5 million. It’s another early SPAC that hasn’t had a great time of it. Since its debut on the NYSE in December 2021, the stock has had the typical drop in altitude from $19.79 to $2.42. It has since expanded to enterprise imaging with Blueprint. Mobihealthnews, Yahoo Finance, Zachs