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spk01: Good morning, and welcome to 23andMe's Fiscal Year 2022 First 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 now like to turn the call over to Wade Walt, Vice President of Investor Relations, to lead off the call. Thank you. Please go ahead.
spk06: Thank you. 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 quarter. In addition to the GAAP financial reporting, our press release also contains a reconciliation of the GAAP to non-GAAP financial measures we will discuss today. I would also remind everyone that we will be making forward-looking statements on our call today that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please consult the risk factors discussed in our SEC filings for additional detail. Joining us on our call today are Ann Wojcicki, our chief executive officer and co-founder, Steve Schuch, our chief financial officer, and Kenneth Hillen, our head of therapeutics. With that, I'll turn the call over to Ann.
spk04: Thank you, Wade, and welcome, everyone, to our first earnings call. I'm thrilled that 23andMe is now a publicly traded company. And again, I want to thank our customers, investors, board members, and employees for getting us to this point in the company's growth. I want to start by saying that our vision of a consumer-centered, personalized healthcare world remains at the forefront of all the work we are doing at 23andMe. I am more optimistic every day because even though the challenge we face is huge, we know the opportunity to make a meaningful, positive change is also huge. And we believe we have the tools and the plan to tackle it. The size and scale of our unique database enables us to use genetics to transform how we diagnose, treat, and prevent human disease. Capitalizing on the momentum we built as a private company, we recorded a solid start to fiscal year 2022 with Q1 revenues of $59 million, up $11 million, or 23% versus the prior year's Q1. Steve will cover the numbers in more detail. We also recorded several important milestones on the consumer side. We grew our genetic database to 11.6 million genotype customers, further increasing the value of our premier recontactable database. We also launched three new health reports in the first quarter of our 23andMe Plus members. 23andMe Plus is our premium content subscription service, launched late last year that provides subscribers with unique and new reports and features through the course of their subscription, giving them even deeper insights into their health. First, we launched a new medication insights report. Many people don't know that most of us have at least one genetic variant that may alter how our bodies process certain commonly prescribed medications. That's because genetic testing for these variants, also known as pharmacogenetic testing, is rare. We can offer these reports to our 23andMe Plus members because we are the first and only direct-to-consumer company with FDA-authorized pharmacogenetic reports. This new report provides insights on how a person's genetics may impact their body's ability to process two drugs, citalopram, an antidepressant, and clopidogrel, a blood thinner commonly known as Plavix. About 22 million people in the U.S. are prescribed the talopram, and about 20 million people have prescriptions for clopidogrel. So these medication insight reports can have a real impact on many customers. Next, we launched a new wellness report on cat allergies and on dog allergies. It is estimated that 10% to 20% of people are allergic to dogs or cats worldwide. We used statistical modeling that utilizes thousands of genetic variants as well as a customer's ethnicity and sex to estimate the likelihood of developing a dog or cat allergy. Finally, in June, we launched an eczema report. While the report does not diagnose eczema, it does estimate a person's likelihood of having this condition. This report is powered by a proprietary polygenic risk score, or PRS, which we are uniquely able to calculate by using more than 2,100 genetic variants, and a customer's ethnicity and sex. Our premier genetic database, combined with greater than 4 billion phenotypic data points, we have amassed, gives us the statistical power to generate these PRS reports. In addition to our new reports, we also published key genetic research over the past quarter. This includes our own research on a genetic link tied to loss of smell that is found in some individuals diagnosed with COVID-19. as well as research we've published in collaboration with academic institutions. Just this quarter, our published research spans the genetics of allergies, cataracts, depression, and even how we use genetics to study rare diseases. If you're interested in learning about the new reports and the research we publish, I encourage you to follow our blog at blog.23andme.com. We also continue to make progress with our pipeline of therapeutic programs, Our collaboration with GSK continues to be very productive. We have over 40 programs in various stages of research and development. Our most advanced program is currently in a clinical trial, and another is expected to start in the clinic by the end of March next year. Kenneth will go into more detail on these later in the call. Finally, we are pleased to welcome three new board members this past quarter, including Evan Lovell, Chief Investment Officer of the Virgin Group, Dr. Valerie Montgomery-Wright, the President of Dean of Morehouse School of Medicine, and Peter Taylor, President of the ECMC Foundation. All three are impactful leaders who will bring diverse perspectives. They will be great partners as we scale the company to transform the continuum of healthcare. I want to close by sharing how excited I am as we enter our next phase of growth as a public company. This quarter has gotten us off to a great start. And with that, I will turn the call over to Steve to review our financial results for the quarter.
spk07: Thanks, Anne. As Anne mentioned, we began this fiscal year with a solid first quarter, with revenues coming in at $59 million, which is a 23% increase over last year's first quarter. This increase was primarily driven by growth in the consumer and research services segment reflecting the relatively higher pace of delivery of our kit-based personal genome service, or PGS, to our customers versus the prior period. It is important to note that last year's quarter numbers were negatively impacted by the onset of the global pandemic in March of 2020. The increased delivery of PGS was partially offset by lower year-over-year research services revenue within the segment as prior year non-GSK contract revenues diminished and our efforts turned to providing services to the exclusive GSK collaboration activities. While this is a solid start to fiscal 22, we will remind you that our revenue comes significantly from our PGS business. which fluctuates during the year due to many seasonal, promotional, competitive, and economic factors which shape our full year results and all of which may be different in individual quarters and year to year. We also ended the quarter with a strong balance sheet following our merger with Vici Acquisition Corp. As of June 30th, we had $770 million in cash. During the quarter, we also continued to steadily build our unprecedented re-contactable consumer database, reaching 11.6 million genotype customers as of June 30th. As we have noted in prior communications, the continued increase in data leads to new insights on the role of genetics in human health and wellness, and benefits our consumer, research, and therapeutics activities. The increase in the number of genotype customers will closely track the revenues for our consumer services component of the overall consumer and research services segment. This is because we recognize revenue only once the customer sends us their saliva sample, we test the sample, and we provide the customer with their results. Moving down the income statement, gross profit for the quarter was $31 million, an $8 million increase, or a 36% increase over the prior year. This increase was driven by the above-mentioned revenue increase and aided by the addition of higher margin subscription service revenue and to a lesser extent by decreased PGS unit costs of sales. As we have noted, the subscription product is still in its launch phase and we are continuing to refine options with pricing, promotions, and bundling in order to optimize the value of this product. Operating expenses were $72 million, a $13 million or 22% increase over the prior period as we continue to invest in our therapeutics portfolio, including the most advanced CD96 program being developed in collaboration with GSK and in our own wholly owned P006 program. In addition, we had higher sales and marketing expenses as we resumed investing in advertising and marketing programs designed to grow our consumer business after a more cautious spending approach in the prior year. G&A expense was lower for the period by $2 million versus the prior year. Moving on to the bottom line, net loss for the period was $42 million, which was a 6 million or 17% greater loss versus the prior period. In addition to these GAAP results, we will also report adjusted EBITDA, which is net income or loss, adding back the non-cash categories of depreciation and amortization, interest and other income and expense, non-cash stock-based compensation charges, and changes in fair value of warrant liabilities. In the first quarter of fiscal year 22, we saw a full company adjusted EBITDA loss of $27 million versus a loss of $20 million in the prior year. Within that, the adjusted EBITDA for our consumer and research services segment was a loss of $1 million compared to a loss of $4 million in the prior year. We continue to focus on the aim of economically efficient growth of that business over time. Given the previously referenced sources of variability in our PGS business, we will not provide guidance on some of our non-GAAP business metrics, but we'll provide amounts on a historical basis when we report the applicable period. Turning to Outlook, this is our first quarterly reporting cycle as a public company. We are providing our initial full year fiscal 22 guidance. We believe our first quarter results put us on track to achieve full year fiscal 22 revenue guidance in the range of $250 million to $260 million and a net loss in the range of $210 to $225 million. Finally, we expect full year adjusted EBITDA loss in the range of $143 to $158 million. You will find detail on this in the back of our press release. With that, Let me turn the call over to Kenneth Hillen to provide an update on our therapeutics progress.
spk00: Thank you, Steve. With over 80% of our 11.6 million genotype customers opting in to participate in research, we believe that the 23andMe database is the world's largest crowdsourced platform for genetic research, and it has the unique potential to offer new insights about diseases and how they can be treated. We are passionate about how our customer-driven research platform may yield insights that could transform therapeutic target discovery, drug development, and ultimately to benefit patients. Understanding how changes in a gene affect our risk of disease is a powerful way to identify drug targets. And it has been shown that targets backed by human genetic evidence have a significantly higher chance of becoming medicines. Our first example of a product candidate based on target discovery from our database is our immune oncology investigational antibody targeting CD96, which we are developing in partnership with GSK. On their recent earnings call, GSK highlighted that we should see data from combinations of anti-CD96 with tostarlimab, their PD1 inhibitor, in 2022. Our second immune oncology antibody product candidate, P006, is wholly owned by 23andMe. We expect it to enter clinical development for the treatment of patients with locally advanced or metastatic solid malignancies before the end of March 2022. In addition to these two more advanced programs, we have a robust pipeline of earlier stage programs, including programs in immuno-oncology, cardiometabolic diseases, immunology, neurology, and other disease areas. We continue to identify new drug targets from our database, and the number that have been both genetically and biologically validated has increased from five in March of 2019 to 18 by the end of 2020. As our database of genotype customers and phenotypic data grows, we continue to invest in efforts to take advantage of our unique and growing understanding of human genetics and biology. And now I'll turn the call back over to Anne. Thanks Kenneth.
spk04: In sum, we believe our large database of genetic phenotypic data has the potential to fuel massive market opportunities and further advance drug development. We feel we are well positioned to take advantage of these opportunities and we are excited for what is ahead. Now with that, let's open it up for questions. Thank you.
spk01: Thank you. To ask a question, you will need to press star then one on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Daniel Grosslight with Citi. Your line is now open.
spk05: Hi, thanks for taking the question, and congrats on a solid first quarter as a public company. Can you provide an update on how Mother's Day and Father's Day and Prime Day shaped up this year versus your expectations? And correct me if I'm wrong, but just due to the cadence of kit returns, we should see most of that revenue hit next quarter or fiscal second quarter.
spk04: Thanks for the question. Do you take that?
spk07: Yeah, I can take that. So, look, you're right on the last part for sure. The lag in recognizing revenue will reflect some of that activity in the coming quarters. I would say, you know, if you look at what we have given in the way of revenue guidance, you know, that's really our – you know, it kind of reflects our expectation, including what we've seen in the leading indicator of kit transactions as time goes along. The fact is that compositionally, there's sort of equal weight in the way that our business, that consumer business works between promotional periods and the daily run rates, which by number of days in a year are far bigger than the promotional days. So I would say that, as you can see, we gave guidance that's consistent with what we've been talking about in the proxy going back to really last January for this year. And, you know, when things are kind of staying consistent in terms of those expectations, and I think that's the most we can say about, you know, things as they're going and as we expect them to go.
spk05: Got it. Okay. And then I guess in that respect, adjusted EBITDA guidance was about 16.5 million less at the midpoint than proxy estimates. This quarter seems like consumer gross margins in EBITDA were pretty strong. Curious where you're seeing the greatest pickup in spend versus your original expectations in the proxy for the rest of this year.
spk07: Yeah, so in terms of you're talking about operating expense?
spk05: Yeah, yeah. So adjusted EBITDA is about $16.5 million less at the midpoint of guidance versus the proxy. So, yeah, the delta there.
spk07: Yeah, for sure. So a couple things to talk about. In terms of spending, it's about spending. So as you can see in the quarter spend, for instance, higher OPEX was part of the story of the quarter. It's one of the more dominant factors. And within that, two things are going on. More spending on therapeutics. One of the things that we are adding to our disclosures and our 10Q is now filed is we're splitting out and helping people understand what we're spending within R&D on the consumer business versus the therapeutics business. And, you know, the composition of spending in that category of R&D has moved from, you know, for the quarter has moved from being 37% of that total last year to 47% of that total this year. And so, you know, when you do the math of an increase in the R&D line and an increase in the composition of therapeutics, you can see that we're really putting our back into investing in the programs that Kenneth has just talked about and can talk more about. So that's important. That's a big driver in here. And the mirror image of that is that we're trying not to spend more than is warranted on the consumer business, which As you can see from the EBITDA number for the consumer business, we're doing a pretty good job of keeping expenses in line with revenues. And so that is a dominant factor as we go. And then the other thing that's going on in EBITDA is a little bit in the kind of overall company EBITDA, which is really kind of more hitting the G&A line, is some additional costs we didn't anticipate of going public and being a public company. And so that's what's at work there. It's nothing too complicated.
spk05: Got it. Okay. And maybe that's a good segue to Kenneth on the therapeutic side. I guess first on the CD96 program, how do you think Delta is going to impact enrollment in trials there, if at all?
spk00: Yeah, no, it's a great question. I think one of the advantages we've had with having the partnership with GSK is, as you know, they have a global footprint. And so I think we've really been able to take advantage of that when we've been planning out the CD96 study. So we haven't seen significant impact from Delta with enrollment with the CD96 study. We continue to make good progress. And then as GSK, as I said on the call, as GSK said in their earnings, I would anticipate seeing data from the combination of CD96 with the Storlomab in 2022.
spk05: Okay, that's helpful. And then on the pipeline of products, maybe just spend a little bit more time going into detail there. Where are you kind of seeing the most uptick in spend? And remind us, are those programs being done in conjunction with GSKA with the 50-50 cost and rev splits?
spk00: Yeah, so obviously the clinical stage programs are the most expensive. And so that would be the CD96 program. And then T006, as it's moving through its IND enabling studies and towards the clinic by the end of March of next year, obviously that ramps up in expenses. And then for the earlier stage pipeline, you know, those programs, obviously it depends on where they are. If they're very early, they're less expensive. And as you de-risk them, you make a greater investment as you have conviction around moving things forwards. CD96 is 50-50 cost split with GSK. P006 is, of course, wholly owned by 23andMe. So we bear all of the expenses there. But I would say that we don't have the same expense basis with GSK. So actually, we can be more efficient when we have our own programs just because we're a smaller, more nimble company than GSK. Then, you know, we haven't really spoken much about our earlier stage programs. We have, you know, we've talked about the fact that we have over 40 programs that have been generated from the database through the collaboration. And, you know, we continue to, you know, move those forwards in collaboration with GSK. And in general, they're 50-50. But in some cases, they're unilateral programs for GSK. And in some cases, they're unilateral programs for 23andMe. But we haven't broken those out.
spk05: Got it. Very helpful. All right. I'll hop back in the queue. Thanks, everyone.
spk01: Thank you. As a reminder, to ask a question, you would need to press star then one of your telephones. Our next question comes from the line of Tiago Fauth with Credit Suisse. Your line is now open.
spk02: Thanks for the good questions and congratulations on all the progress. Just have a follow-up on 006 actually. You guys have had more limited disclosures around that program, but with the upcoming trial start, phase one trial start, when could we get a little more detail on what's so unique about this IO target so we can have a better sense of the potential application of that molecule? And I guess a related but bigger picture question, how should I think about the productivity of the therapeutics engine, right? So you've outlined some some validation of targets that has grown substantially with the last few years. How much of that is correlated to the growth of the database or just collecting additional phenotypical data points from that recontactable database? And how much of the consumer growth could kind of help to accelerate the validation of additional targets? Thanks.
spk00: Yeah, of course. So your first part of your question was related to P006 and certainly, you know, communication and data flow is very much front of mind as we advance that program forward into the clinic. So I think in sort of contemporaneous with us moving that program into the clinic, you should anticipate hearing an update on that program and more specifically around, you know, we haven't disclosed the target yet for that program for competitive reasons, but obviously as we advance to the clinic and we're working with investigators and enrolling patients and posting on clinicaltrials.gov, you should anticipate in the timeframe between now and March of 2022 getting additional information on that program. We're excited. We'll be excited to be able to share that in due course. On the earlier stage pipeline, you know, I would just take a step back and You know, I think if you think we signed the collaboration deal with GSK in the summer of 2018, and from the database, we've had over 40 programs. And for those of you who cover pharmaceutical companies, you know, I was at Genetic for, as you know, many years. To have over 40 programs is sort of remarkable productivity. Of course, ultimately, it depends, you know, how many products become medicines and get approved by the FDA. So we're still in the early days of this. In terms of where things come from, is it just from data growth? Growth is important because that gives us greater statistical power to discover targets. But I think we've been very focused on the strategic growth that are certain areas where we've prioritized. And we not only just have the, you know, we don't just have the consumer kits being sold, but we'll also recruit in customers with diseases that we're particularly interested in. So we'll often partner with others to do that. We also always are becoming more sophisticated in our analytical methods to interrogate the data. So that allows us to discover new targets. So it's a combination of different things that allows us to maintain the productivity from the database.
spk02: Got it. No, I appreciate the context there. Thanks again for taking the questions. Of course.
spk01: Thank you. There are no further questions. I will now turn the call back to Ann Wojcicki for closing remarks.
spk03: Well, thank you very much, everyone. We appreciate the questions, and we look forward to staying engaged. And with that, that's the end. Thank you.
spk01: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
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