23andMe Holding Co. (NASDAQ:ME) Q3 2024 Earnings Call Transcript

23andMe Holding Co. (NASDAQ:ME) Q3 2024 Earnings Call Transcript February 7, 2024

23andMe Holding Co. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Hello, and welcome to 23andMe’s Fiscal Year 2024 Third Quarter Financial Results Conference Call. As a reminder, this call is being recorded. At this time, all participants are in a listen-only mode. After the prepared remarks, there will be a question-and-answer session. I would like to turn the call over to Ian Cooney, Senior Director of Investor Relations at 23andMe to lead off the call. Thank you. Please go ahead.

Ian Cooney: Thank you, Valerie. Before we begin, I encourage everyone to go to investors.23andme.com to find the press release we issued earlier today reporting our financial results for the third quarter. A replay of today’s webcast will also be available on our website. Please note that certain statements made during this call regarding matters that are not historical facts, including, but not limited to, management’s outlook or predictions for future periods are forward-looking statements. These statements are based solely on information that is now available to us. We encourage you to review the section entitled Forward-Looking Statements in our press release, which applies to this call. Also, please refer to our SEC filings, which can be found on our website and the SEC’s website for a discussion of numerous factors that may impact our future performance.

We also discuss certain non-GAAP measures, important information on our use of these measures and reconciliation to U.S. GAAP may be found in our earnings release. Joining us on our call today are Anne Wojcicki, our Chief Executive Officer and Co-Founder; and Joe Selsavage, our Interim Chief Financial and Accounting Officer; Jennifer Low, our Head of Therapeutics Development; and Bill Richards, Head of Therapeutics Discovery; will join us for Q&A. I’d now like to turn the call over to Anne.

Anne Wojcicki: Thank you, Ian. The third quarter was busy and productive at 23andMe. We made meaningful strategic progress across our three businesses. We introduced our first integrated care offering with Total Health, signed a non-exclusive research agreement with GSK and filed our second IND in Therapeutics. I am extremely proud of the effort put forth by our team as we work towards creating a new future of healthcare powered by genetics. Starting with our Consumer business. The third quarter saw the company execute on our strategic shift towards actively engaging with our customers on managing their health based on their unique genetics and lifestyle. In November, we introduced a new membership called Total Health, a personalized preventative care service.

It includes clinical grade exome sequencing, biannual blood testing and access to clinicians from our Lemonaid acquisition with unique training in genetics. Members of Total Health received all the reports and features offered in our existing 23andMe+ membership along with personalized guidance for ongoing disease prevention and early detection. This is an exciting step in our vision to bring accessible genetics-driven preventative care to millions of our U.S. customers. In addition to the introduction of Total Health, added more value to the 23andMe+ membership with the introduction of 23andMe Health Action Plan and 23andMe HealthTracks. These personalized action plans are part of our broader effort to help our customers take action based on their genetic insights and other data.

Over time, we will continue to add more dynamic recommendation content and intuitive ways to track phenotypic inputs with the ultimate goal of helping customers improve their health span. 23andMe HealthTracks is a digital health tool that helps customers gain a more holistic picture of the risk for developing a particular condition by integrating lifestyle and genetic factors into a single model for the first time with the goal of motivating behavior change. Health Action Plan helps customers take the next step to improve their health by drawing on genetics, health history and blood and biomarker data to provide tailored bite-sized health recommendations. We will continue to innovate in this area to create a dynamic, meaningful experience to help our customers optimize their health.

We also continue to refine and improve our genetic reports and insights. Our updated BRCA test allows us to report 44 additional variants in the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian, prostate and pancreatic cancer. Many of these additional variants occur more often in populations that have traditionally been underserved by genetic testing, including the African-American and Hispanic-Latino communities. As part of our August FDA clearance, we were granted the first-ever FDA predetermined change control plan, allowing us to continue to update our BRCA report with additional validated variants without additional pre-market review. As we continue to invest in our personal genomics service business, we also focus on creating value for our customers through the uptake of membership services.

We see repeated engagement by our customers, and they have shown interest in learning more about their genetics and how to apply those learnings for their lives. We are focused on moving to a membership model so that we can meet customer demand for more services as well as develop a recurring revenue stream that will allow us to continue to innovate and grow the business in a way that is most helpful to our customers and shareholders. We continue to prioritize price and efficient marketing spend as we look to move our PGS segment toward cash flow breakeven. We recognize this effort is likely to cause some uneven results in our business in the short-term, and we saw some of that effect in Q3. PGS kit volumes were impacted in the quarter as we entered the holiday promotional period with firmer pricing discipline after raising prices for the first time since 2015.

This, plus an environment of macroeconomic and consumer uncertainty led to lower PGS kit sales volume. We remain confident in our ability to transform our PGS segment into a sustainably growing and profitable business and we are incredibly excited to help build toward a future of personalized preventative health. Transitioning over to therapeutics. We continue to advance our pipeline of clinical and preclinical programs. In November, we presented positive safety and preliminary efficacy data from a Phase I/IIa clinical trial of our wholly owned immuno-oncology program, 23ME-00610 at the Society for Immunotherapy of Cancer Annual Meeting. The study demonstrated that 23ME-00610 is well tolerated and shows promising preliminary efficacy in a number of patients with advanced solid malignancies.

In December, we announced the further expansion of the ongoing Phase I/IIa study to include an additional 30 patients with advanced neuroendocrine and ovarian cancers, above the original enrollment goals. We are encouraged by the progress of 610 and anticipate reporting further data later this year. The company recently announced the U.S. Food and Drug Administration has cleared the IND application for 23ME-01473, a natural killer cell activator intended to treat cancer. 23andMe plans to evaluate 1473 in participants with advanced solid tumors in a Phase I clinical study beginning in the first half of 2024. 1473 targets ULBP6 to restore anti-tumor immunity through NK and T cells. ULBPs are stress-induced ligands found on the surface of cancer cells that bind to the receptor NKG2D on NK and T cells.

Cancers escape immune cell recognition by shedding ULBP ligands from their cell- surface, which acts as immunosuppressive molecular decoys. Blocking the binding of soluble ULBP6 to NKG2D may restore immune cell recognition and killing of cancers. Further, 1473 is Fc-effector enhanced which provides an additional mechanism for NK cells to induce cell death of ULBP6-expressing cancer cells. 1473 also has the potential to address a major unmet need in cancer treatment. Patients who may have or may develop tumor resistance to checkpoint inhibitors. By combining NK and T cell activation, 1473 may initiate a broader and deeper response of the immune system to treat cancer cells and delay tumor resistance seen in treatment with traditional checkpoint inhibitors.

This program validates the power of the 23andMe database for identifying novel therapeutic targets and highlights the team’s ability to develop molecules and advance them into the clinic. I also want to highlight that we launched our new therapeutics website at the end of December. We think the new site does a great job explaining how our team turns genetic insights into potential new therapies with a higher probability of success in the clinic and provides a great initial diligence resource for potential partners, collaborators and investors. I encourage everyone to visit the new site at therapeutics.23andme.com. Moving to the research business. In Q3, extended our collaboration with GSK into the sixth year. The new one-year non-exclusive data license pays 23andMe $20 million upfront in exchange for GSK using the 23andMe database to conduct drug target discovery and other research.

Importantly, this new collaboration is a sign of the significant value in the 23andMe database and the potential for continuous new insights and discoveries as we grow in size. The new collaboration is important for 23andMe as it generates $20 million and enables us to continue to collaborate with GSK, but in a non-exclusive way. We are actively pursuing new partnerships with other therapeutic companies. The excitement around AI and data opens up a tremendous opportunity for 23andMe as companies are establishing their data strategies. Genetics is fundamental to the world of AI-driven drug discovery. We look forward to updating you as discussions progress. As I look to 2024, I’m excited about the opportunities for 23andMe. There is a growing recognition about the potential for data and AI and drug discovery, and we have an incredible asset that can accelerate and improve drug discovery for the industry.

For customers, we are getting closer to our ultimate vision of having a complete solution for people who want to actively engage in their wellness and prevent disease. We look forward to an exciting year. With that, I’ll turn the call over to Joe to review our financial results for the quarter.

Joseph Selsavage: Thank you, Anne, and hello, everyone. I’d like to reiterate Anne’s excitement about the future of Precision Healthcare 23andMe, and I’m proud of our ability to execute while maintaining cost discipline amid our shift towards a more sustainable operating profile. Revenue for the quarter was $45 million, representing a 33% decrease on another strong prior year comparable. Similar to last quarter, the year-over-year decrease in revenue was primarily due to the conclusion of our exclusive discovery term under the GSK collaboration in July as well as lower consumer services revenue in our PGS Kit and telehealth businesses. The decrease in consumer revenue was driven primarily by lower sales volume as we entered the holiday promotional period with higher pricing than prior years.

These efforts were intended to increase product margin to improved average selling prices and advertising efficiency, which remain a core focus of the company, but resulted in lower-than-expected unit sales for the quarter as we believe the combination of higher prices and extended macro headwinds placed the temporary damper on demand for our products. These decreases were partially offset by non-recurring payments from other research partners in the current quarter and continued growth in our subscription services. Looking at the composition of our revenue, consumer services revenue represented approximately 96% of total revenue for the quarter. And research services revenue, which was primarily derived from other research partners accounted for approximately 4% of total revenue for the same period.

As a reminder, the new GSK data license announced in Q3 is expected to have minimal impact on this year’s results with the majority landing in fiscal year 2025, given the terms of the agreement. Our gross profit for the third quarter was $20 million, representing a 35% decrease over the same period in the prior year. The decrease in Q3 gross profit was driven primarily by the decrease in research services revenue, while subscription revenue and improved telehealth margins following the August 2023 disposition of Lemonaid Health Limited in the UK helped to offset through continued margin accretion within their respective categories. Turning to our expenses. Total operating expenses for the quarter were $301 million compared to $128 million for the same period in the prior year.

The increase in operating expenses was primarily due to a $199 million non-cash goodwill impairment charge taking over the quarter, which was partially offset by lower personnel-related expenses following workforce reductions in prior quarters and the disposition of the UK entity. A non-cash impairment charge for intangible assets in the prior period and lower therapeutics-related R&D spend due to significant IND-enabling activities also in the prior year. Looking at the bottom line, net loss for the quarter was $278 million compared to $92 million in the prior quarter. The increase in the third quarter net loss was driven mainly by the lower revenues and goodwill impairment charge mentioned previously. Next, our adjusted EBITDA. For details on how we define adjusted EBITDA as well as the corresponding reconciliations to GAAP, please see our earnings press release.

Total adjusted EBITDA deficit for the third quarter was $48 million compared to a $43 million deficit for the same period in the prior year. The increase in the adjusted EBITDA deficit was primarily due to lower revenue, partially offset by lower personnel costs and lower R&D spend described previously. We ended the quarter with $242 million in cash and cash equivalents compared to $387 million as of March 31, 2023. We intend to be judicious with our cash usage and believe the current level of cash supports 23andMe’s plans for targeted investment and high ROI growth initiatives. Now turning to our guidance. As a reminder, the company’s full-year fiscal 2024 guidance is based on the conservative approach, recognizing challenges in recent performance, continuing uncertainties in consumer sentiment, the macroeconomic environment and geopolitical conditions.

The company is adjusting its full-year guidance for fiscal year 2024, which ends on March 31, 2024. For revenue, we are updating our fiscal year 2024 guidance to be in the range of $215 million to $220 million, with net loss adjusted to be in the range of $520 million net loss to $525 million net loss. Full-year adjusted EBITDA deficit is adjusted to be in the range of $180 million deficit to $185 million deficit for fiscal year 2024. Our focus within the existing lines of the PGS and telehealth consumer businesses remain unchanged. We continue to prioritize margin expansion and progress towards cash flow profitability. These efforts include remaining disciplined with our pricing strategy to realize higher average selling prices, ongoing value additions to our current services like the Health Action Plan and HealthTracks features within 23andMe+, expanding the recently introduced Total Health membership to a broader audience and streamlining the expense profiles of our Consumer and Therapeutics segment.

Within the therapeutics and research businesses, we are investing only in projects we believe are most strategically and financially valuable and continue to explore potential partnerships and collaborations. Wrapping up, we are pleased with the company’s strategic progress and improved operating discipline. Given the current operating environment, we are being prudent in our planning and project prioritization, while remaining incredibly optimistic about the future of the company and our ability to help people access, understand and benefit from the human genome. With that, let’s open it up to questions.

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Q&A Session

Operator: Thank you. [Operator Instructions] And the first question that we have today will be coming from Steve Mah of TD Cowen. Your line is open.

Steven Mah: Oh, great. Can you guys hear me? Hello?

Anne Wojcicki: Yes.

Steven Mah: Oh, hi. Yes. Okay, great. Yes, sorry. Apologies for the background noise. Could you comment on the recent – Anne – this question is for Anne. A no kind of came across the wire. Could you comment on your recent interview you gave on the consideration of splitting the consumer and therapeutics business? How would that look? Would it be a spin out of the therapeutics business into a private company with external financing or some other structure? How should we think about that?

Anne Wojcicki: Yes. So you’ve said this before, that we are definitely pursuing and exploring all different options for being able to fund progress going forward on the therapeutic side. So as you know, discovering and developing drugs is expensive. So if you look at where we are with a Phase II program with P006 and just initiating P014 into the clinic as well as a very robust pipeline behind it, that’s going to require capital. So we have not made any definitive decisions about what we are going to do, but there is definitely opportunities and things that we are exploring with potentially having therapeutics be independent versus consumer. These are all just ideas that we are exploring right now. There’s nothing definitive. But it is opportunities that we’re considering about what’s going to be the best way to make consumers successful in the therapeutics group.

Steven Mah: Okay. Thanks. Yes, appreciate the color. And with regards to 1473, are you still on track to initiate Phase I clinical trials in the first half of this year?

Anne Wojcicki: Yes, I have Jennifer Low here as well, if you want further questions. But yes, we are on track for that.

Steven Mah: Okay. Got it. Okay. I’ll get back in the queue. Thanks.

Anne Wojcicki: Okay. Great. Thanks.

Operator: Thank you. One moment for our next question. And our next question comes from David Lebowitz of Citi. Your line is open.

Unidentified Analyst: Hi guys. John on for David. Thanks for taking our questions. Got a few on our end. So building off of that report in Bloomberg about the potential split between the Consumer business and the Therapeutics business. Just want to dive into that a little bit more if you guys don’t mind. When thinking about potential implications as it relates to the different segments in your business, you have the consumer business, tech business and a biotech business, basically all in one. I guess, can you just again talk to the implications as it relates to maybe expanding your investor base and better teasing out the individual value of the components within your business?

Anne Wojcicki: Sorry, do you want to repeat the – like the core part of the question?

Unidentified Analyst: Sure. Just as it relates to a potential spin out, can you talk about the potential implications as it relates to expanding your investor base and potentially better teasing out the value of the individual components of your business?

Anne Wojcicki: Yes. I mean, look, I think that you – again, you deal with – you interact with different investors all the time, and you recognize that people have very specific mandates. So there are some investors who are only looking at biotech and some investors that are only looking at consumer and others that are focused on AI. And you are absolutely right that we are an unusual company in that we have all of that. We have a very robust consumer business. We have a very robust research database business, and we have a very robust therapeutics business. So that has definitely been brought to our attention that there’s a number of different businesses within this and what’s the best way to make sure that we’re maximizing value.

Unidentified Analyst: Got it. Okay. That makes sense. And then one on the product launch. With respect to Total Health, can you just walk us through some of your key learnings from the soft launch over the holidays and how you plan to use that experience to inform your rollout going forward?

Anne Wojcicki: Yes. Total Health – I think Total Health has an incredible potential. And where we look at that we be taking off is in the world of self-pay preventive care. I guess the market that I think does not – people want it and it doesn’t really exist right now. So Total Health right now goes in the lineup, if you look on the website. It goes in the lineup with other tests. You have ancestry, you have health and ancestry, you have health and ancestry plus and you have Total Health. What we’re really offering here is care, it’s an opportunity to engage with a clinical product that – or clinicians, healthcare providers that are looking all across your genome and really thinking thoughtfully about how can you leverage your genetic information, your blood information, your wearables, your lifestyle, your family history, your medical records, to think about a true preventive care plan.

So it’s a real – we’ve soft launched it really with knowing that there’s going to be an early market of people who just want an exome, but the product is a very different type of experience. And I think that’s more and more what you can imagine us doing with Total Health is being able to help people not just get access to this information, but to leverage it and integrate it into their life.

Unidentified Analyst: Okay. That’s helpful. Thank you. And then one more, one last one just on your new drug candidate, 1473 targeting ULBP6. Can you just talk a little bit more about the target? Like how it was determined, if there are any other therapies going after ULBP6? And if there’s any clinical data that you’re aware of that has helped to validate or de-risk the target?

Anne Wojcicki: Yes. Let me point you over to Jennifer Low.

Jennifer Low: Hi. The ULBP6 target was one of those that has been identified through our genetic database. It’s the premise of how we’ve been discovering potential targets at 23andMe therapeutics, and this was right along that lane. And we’re really interested in this because it highlights a different way of approaching immune cells to attack cancer. And there are a lot of different other modalities out there right now that are activating NK cells are trying to co-opt NK cells. We believe that our new drugs that we’re bringing into the clinic addressable lot of shortcomings of other programs. And so we – this is a dual mechanism antibody that has monoclonal antibodies like half-life. It should be tolerated. It should really provide a novel way of activating NK cells and address an unmet need.

Unidentified Analyst: Got it. And then just to the last part. I’m sorry if I missed that. Did you say if there’s any clinical data that you’re aware of that has helped to validate or de-risk it?

Jennifer Low: There are other programs that are also looking at the NK pathway, but we have a lot of reasons to believe that this is a better way of addressing the issues that have plagued certain other programs.

Unidentified Analyst: Okay. Got it.

Jennifer Low: We are very aware of the competition. But we really think that this is a novel and better way of addressing NK cell activation.

Unidentified Analyst: Okay. Great. Thanks for the questions.

Operator: Thank you. One moment for our next question. And we have a follow-up from Steven Mah of TD Cowen. Your line is open.

Steven Mah: Yes. Hi. Great. Thanks for taking the additional question. Apologies again for the noise up back here. Maybe just digging in a little bit more on the Total Health launch. Maybe give us some color on how that’s going, how you guys are measuring internally the success of that launch. And then yes, if there’s any learnings that could be instructive to the launch into the existing customers, which I believe is slated for the spring.