We presented compelling early-stage lung cancer MRD data with our partners at TRACERx. We entered collaborations with multiple leading cancer centers to develop robust clinical evidence. We entered partnerships with companies including Myriad, Tempus, and Moderna, and we extended our agreement with Natera. With momentum across our business, we’re excited for what lies ahead. Taking a step back, we’re focused on achieving scale and our $100 million in 2025 plan where we intend to cross $100 million in annual revenue in 2025 and then we put in place a growth strategy with three engines to propel us there. First, and most importantly, we are executing on our Win-in-MRD strategy. The MRD market using liquid biopsy to find evidence of molecular residual disease or cancer recurrence, is estimated to mature into a $20 billion opportunity and we are establishing Personalis as the leading company in the space.

The clinical evidence is coming together to demonstrate that an ultra-sensitive test provides tremendous value to patients, doctors, and partners, and that puts Personalis in a position to grow rapidly. Second, we’re leveraging our core ImmunoID NeXT platform to support biopharma customers in their drug discovery efforts and personalized cancer vaccine companies in their efforts to establish a new generation of therapies. Our proprietary solutions create a unique molecular fingerprint of a patient’s cancer, allowing for new insights and pushing the entire field forward. Third, we are deepening and expanding our relationships with our enterprise customers such as Natera and the VA MVP with our Personalis and side approach that allows customers to leverage our technology and ability to produce cost-effective assays.

I’m now walking through a more tactical view of our 2024 strategy as we push into delivering on our $100 million in 2025 plan, before I’ll turn it over to Aaron, who will detail our 2023 financial highlights and our guidance for this year like 2024. Starting with NeXT Personal, our first growth engine. I’ll quickly remind you that our Win-in-MRD strategy has four pillars: first, focus and launch our test in cancer types who are an ultra-sensitive liquid biopsy test can unlock significant value for patients, payers and partners; second, to drive reimbursement by developing robust clinical evidence and partnering with the top global collaborators; third, to leverage our deep farmer relationships to accelerate adoption and power revenue growth by using NeXT Personal and clinical trials; and fourth, to commercialize NeXT Personal with a partner-centric model.

Now, delving into the first pillar, we’ve previously explained how we’re developing evidence to support NeXT Personal’s clinical usage in early-stage lung cancer, breast cancer and IO-therapy monitoring. Our focus on these cancers is intentional as we believe we can win with our ultra-sensitive approach. In each indication we believe that detecting a recurrence as early as possible can dramatically impact a patient’s health and that a highly sensitive test can be used to deescalate patients from ineffective therapies, potentially saving payers money, inspiring patients, therapies, and procedures they may not need. You might recall that we launched our NeXT Personal Dx LDT for MRD in October 2023, and we are currently selectively launching that under an early access program, or EAP.

We are the first ultra-sensitive test-to-market and the adoption of our test has been rapid, and indeed it’s exceeding our initial targets. We now have characterized and are monitoring more than 250 patients referred to us by only 10 doctors involved in the program. Now, we’ve capped the number of MDs in our early access program and we have a wait list of more than 150 doctors that have indicated they want to be included. Moving to our second pillar, I believe many of you saw the compelling early-stage lung cancer clinical MRD data presented by Professor Charles Swanton and Dr. James Black with TRACERx in October. The TRACERx study is greatly advancing the understanding of lung cancer and cancer biology. And NeXT Personal is enabling an ultra-sensitive specific detection of ctDNA before and after surgery through treatment and during surveillance for recurrent cancer, which we believe will ultimately allow clinicians to make more informed decisions about patient care.

To put it in the simplest terms, the data show that our ultra-sensitive approach can detect cancer up to 11 months before imaging. We are completing the testing of the full cohort for the TRACERx study and expect our collaborators to submit in 2024 for publication. We expect that work once published to form the foundation of a Medicare submission for lung cancer. In breast cancer, we completed processing samples from our collaboration with the Royal Marsden, one of the leading global institutions of breast cancer. Our work here is focusing on patients with early stage disease for several subtypes, including ER-positive, HER2-positive, triple-negative breast cancer. The Royal Marsden collaboration provides access to a well annotated set of samples with no clinical outcomes.

We plan to use our work here to provide a clinical data set to support Medicare coverage of breast cancer. This data set is expected to be showcased in mid-2024. We’re also working with the Dana-Farber Cancer Institute in breast cancer, which provides us with a robust set of HER2-positive prospectively gathered samples, and with the Curie Institute, which provides access to a study in triple-negative breast cancer. These collaborations are extremely important, because we have multiple cohorts that we can leverage to drive commercial success and underpin our reimbursement submission. Additionally, for breast cancer, our own perspective clinical trial called B-STRONGER is underway. We’ve made progress establishing committed sites, and we’ve begun enrolling patients.

Breast cancer is an important priority for us, and we continue to deepen our collaborations and expand our clinical evidence. Turning to IO-therapy monitoring, our key study is a pan-cancer data set with the Vall d’Hebron Institute of Oncology or VHIO design, to demonstrate and leverage the efficacy of NeXT Personal. VHIO gives us access to a large well-annotated bank of prospectively gathered samples that are the cornerstone of our efforts to achieve reimbursement coverage for pan-cancer IO-therapy monitoring. We’ve begun testing VHIO patient samples and expect clinical data to be presented in the middle of 2024. This exciting collaboration joins existing work we’ve announced on melanoma and IO-therapy with the University Medical Center Hamburg-Eppendorf, also known as UKE, and our Duke and UC San Diego relationships.

These data sets will form the core of our Medicare submission for coverage for IO-therapy monitor. Reimbursement coverage is accomplished with great products that demonstrate clinical utility and are relentless focused on execution to build and publish the data. Our team of Personalis’ focused on delivering data to collaborators that spotlight the compelling performance of our approach and then submitting for reimbursement coverage for all three cancer types this year. The third pillar of our NeXT Personal strategy is to leverage our biopharma relationships to drive the use of NeXT Personal clinical trials. We are engaged with most of the world’s top biopharma customers and have received positive feedback on our platform. Customers want an ultra-sensitive approach to ensure that only the most appropriate patients enter into a clinical trial.

The promise of an ultra-sensitive assay is that we believe patients testing negative are much less likely to recur. This would mean for our biopharma customers that these patients are less likely to benefit from a therapeutic intervention. The data that the TRACERx team analyzed on lung cancer indicated that patients testing ctDNA negative on our assay largely didn’t recur and were still alive 5 years later. This holds out the promise that NeXT Personal could be an excellent approach to optimize biopharma trials. Indeed, here in the first quarter, we’ve already booked record new orders for NeXT Personal and we believe it will be a driver of revenue moving forward an important way for us to deepen the clinical utility of NeXT Personal. Now, I’ll move on to the fourth and final pillar, commercializing NeXT Personal using a partner-centric model.

On our last call, we mentioned that we are seeking partnerships that help us amplify our message to the marketplace, allowing us to market and sell our test in a capital-efficient manner. In December, we announced our key partnership with Tempus to commercialize NeXT Personal Dx in clinics with oncologists. We are thrilled that Tempus selected us as their MRD tumor-informed choice to offer to their customers. Under the agreement, we will leverage Tempus’ sales channel, which consists of more than 200 sales professionals calling on oncologists to co-commercialize NeXT Personal Dx an accelerate growth. Personalis’ will process samples in our lab. We will obtain reimbursement and invoice health insurance payers and patients under the arrangement, while paying Tempus’ fair market value for the commercial services they provide to us.

Overall, the deal is worth approximately $30 million for Personalis should all the milestone payments be triggered and if Tempus fully exercises their warrants. Most importantly, though, it allows us to ramp up our commercial efforts quickly with minimal cash investments. We will work through 2024 to expand our early access program to include Tempus, and we’ll learn how to work together as partners, integrating our business systems and refining our message to oncologists. This is an exciting relationship that paves the way to achieving commercial traction in a capital efficient manner. Now, while we’ve made strides with our first growth engine, our Win-in-MRD strategy to establish NeXT Personal was a leading MRD test, we’ve also made progress with our second growth engine, leveraging our ImmunoID NeXT platform to deepen relationships with biopharma customers who use the offering to pioneer new therapies and enterprise customers as they develop or ramp up volume for tissue-informed products.

We’ve previously told you about our partnership with Moderna and Personal cancer therapies, where Moderna is utilizing our platform in their mRNA cancer program. We have several other partners that work in the space as well. Moderna and its partner, Merck, enrolling patients in clinical trials, and we expect our collaboration with Moderna to be a driver of revenue for us in 2024 and 2025. In November, we disclosed that Myriad is expanding its pharma service offerings by introducing our ImmunoID NeXT platform to its pharmaceutical partners who use the Myriad’s cancer testing. This is another exciting opportunity to continue to grow our biopharma customer base. Myriad is a pioneer in the industry and we’re excited to be collaborating with them.

Last month, we disclosed that we also partnered with ClearNote Health. ClearNote has an epigenomic platform that we believe is gaining traction with biopharma customers by allowing those partners to detect cancer earlier, monitor disease progression, and understand mechanisms of resistance with the aim of identifying promising drug targets and biomarkers. In this relationship, Personalis’ biopharma sales team will bring ClearNote’s products to our customers, which provide another growth vehicle. Relationships like the Myriad and ClearNote deals are examples of how we expect our partner-centric approach to drive our revenue going forward. We are laser focused on adding value to biopharma customers with a comprehensive suite of products and services and accelerating our growth rate.

You will know when Aaron walks through guidance for the year ahead that we expect our biopharma segment to grow in 2024 by more than 20%. This is a reflection of the progress we are making serving the segment. The third engine of our growth strategy is growing our Personalis and side approach as we service enterprise customers. In these relationships, partners adopt our platforms and technologies to power their solutions and provide new insight to their customers. We have two large relationships where this is the case. First with Natera, we’ve partnered with Natera for a few years and they’ve leveraged our sequencing platform to analyze the exome as a part of their signatory product. At the end of the year, we extended our agreement with Natera through the end of 2024.

We work this year with Natera to evolve our platform, so we can reduce our price to them while growing our margins. To those ends, we expect our revenue to decline this year from Natera, but expect our margins to improve and are optimistic we put in place the foundation to continue the relationship over time. Our second key enterprise relationship is with the VA. The VA utilizes our whole genome sequencing capabilities to power the Million Veterans Program, a national research program looking at how genes, lifestyle, military experience, and exposure affects health and wellness in veterans. We have helped power this program with the VA for years and we’re excited to continue the work in 2024. Both of these relationships are examples of how our platforms drive value for partners.

We’re focused on expanding our efforts with additional partners this year. We’ve made significant progress across multiple fronts and we appreciate our collaborators, partners, and investors being part of the journey to establish an ultra-sensitive test at the forefront of the MRD market. I want to especially thank my colleagues and our team at Personalis for their extraordinary efforts in 2023 to navigate through a challenging climate as we reduced headcount, grew our revenue, launched new products, achieved coverage, and showcased truly transformative clinical data. 2024 is an exciting year and we look forward to updating you on our progress towards our $100 million in 2025 initiative and our Win-in-MRD strategy. With that, I will now turn it over to Aaron to review our financial results.

Aaron Tachibana: Thank you, Chris. Our fourth quarter and full year 2023 financial results and milestone achievements demonstrate our ability to execute crisply. And importantly, we continue to meet our financial commitments. I will be providing details about the fourth quarter and full year 2023 financial results and guidance for the first quarter and full year of 2024. Total company revenue for the fourth quarter of 2023 was $19.7 million, and increased 18% compared to $16.7 million for the same period of prior year. The increase in revenue was due to higher volume for biopharma customers and the VA MVP. For the full year of 2023, total company revenue was $73.5 million, and increased 13% compared to $65 million for the full year of 2022.

The full year revenue increase was due to higher volume for biopharma customers, Natera, and the VA MVP. Gross margin was 26.5% for the fourth quarter, compared to 13.8% for the same period of the prior year. The year-over-year increase of 12.7 percentage points was primarily due to operating leverage from the 18% higher revenue volume, and also an increase in work performed for product development and clinical evidence generation that is classified as R&D expense. For the full year of 2023, gross margin was 24.8%, compared with 20.5% for the full year of 2022. The 4.3 percentage points of margin expansion was primarily due to favorable operating leverage from the 13% increase in revenue volume. Operating expenses were $29.2 million in the fourth quarter, and included a one-time expense of $4 million for employee severance costs from the reduction in workforce, compared with $34.4 million for the same period of the prior year.

Excluding the employee severance costs, operating expenses were $25.1 million and decreased $9.3 million from the same period last year. R&D expense was $13.6 million in the fourth quarter, compared with $16.6 million for the same period last year, and SG&A expense was $11.5 million, compared with $17.8 million for the same period last year. For the full year of 2023, operating expenses were $128.1 million and included severance and lease impairment costs of $13.6 million, compared with $128.9 million for the full year of 2022. In 2023, we made significant progress in reducing our expense base by approximately $35 million annually. Net loss for the fourth quarter was $26.6 million compared with $31.1 million for the same period of the prior year.

The fourth quarter net loss included $4 million for employee severance cost and also an additional $4 million of non-cash expense related to the fair value accounting of the outstanding warrants issued to Tempus. This non-standard expense was a result of the increase in fair value of the warrants at December 31, 2023, compared with the fair value, the fair market value when the warrants were issued. The net loss per share for the fourth quarter was $0.54 and the weighted average basic and diluted share count was 49.6 million compared with $0.67, and the weighted average basic and diluted share count of 46.3 million for the same period of the prior year. For the full year of 2023, net loss was $108.3 million compared with $113.3 million for the full year of 2022.

The full year net loss included $8.1 million of employee severance costs, $5.6 million of a lease impairment write-down for the Menlo Park facility previously vacated, and a $4 million expense related to the fair value accounting of the outstanding warrants issued to Tempus. The net loss per share for the full year of 2023 was $2.25 and the weighted average basic and diluted share count was 48.2 million compared with $2.48 and a weighted average basic and diluted share count of 45.7 million for the full year of 2022. Now on to the balance sheet. We finished the fourth quarter with a strong balance sheet with cash and short-term investments of $114.2 million. During the quarter, we used $6.5 million and for the full year of 2023, we used $53.5 million of cash primarily to fund operations.

In the fourth quarter, we received $6 million from Tempus related to the first 2 milestone payments and we estimate the remaining $6 million of payments to be received equally in 2024 and 2025. We have approximately 2 years of cash on the balance sheet, which is expected to last through the first quarter of 2026. Now, I’d like to turn to guidance. For the first quarter of 2024, we expect total company revenue in the range of $18 million to $19 million, revenue from pharma tests, enterprise sales, and other customers in the range of $16 million to $17 million, and revenue from population sequencing of approximately $2 million. And for the full year of 2024, we expect total company revenue in the range of $73 million to $75 million, with oncology revenue from pharma tests, enterprise sales, and other customers in the range of $65 million to $67 million, and population sequencing revenue to be approximately $8 million.

Our full year revenue guidance of $73 million to $75 million includes an estimated revenue decline of approximately 25% from Natera, which reduces our total revenue by 10% to 12%. In late 2023, we amended our volume supply agreement with them. This amendment extends the minimum quarterly volumes out through the end of 2024 compared with Q1 in the prior agreement. In addition, we have modified selling prices to Natera in this amendment along with the ability to convert to a cost-optimized product, so that the amended terms are beneficial for both companies. We expect revenue growth from biopharma customers to offset the decline from Natera. In addition, we expect net loss of approximately $80 million, which is $28 million lower than the loss of $108 million in 2023.

And this estimate does not include any income or expense related to the outstanding warrants issued to Tempus. Cash usage is expected to be approximately $62 million, and includes employee severance payments of approximately $3 million from the Q4 2023 reduction in headcount. We look forward to updating you on our progress during the next conference call in a few months. And with that, I will turn the call back over to the operator to begin the Q&A session. Operator?

Operator: Thank you. [Operator Instructions] Thank you. First question comes from Tejas Savant. Your line is open.

Madison Pasterchick: Hi, this is Madison Pasterchick on for Tejas. Thanks for taking the question. I think I just had two for you. One, starting out within biopharma, I was just wondering, could you comment on like some other peers are seeing, if you’re seeing any headwinds from the tightening of customers budgeting or if you’re seeing just stabilization on that front? And as we look at 2024, do you have any headwinds based into the guide, or do you expect to see just a recovery in the biopharma spend?

See also 15 African Countries With English As Official Language and 17 Countries That Give Citizenship by Marriage in the World.

To continue reading the Q&A session, please click here.