MENLO PARK Aug 8, 2020 (Thomson StreetEvents) -- Edited Transcript of Personalis Inc earnings conference call or presentation Thursday, August 6, 2020 at 9:00:00pm GMT

* Aaron L. Tachibana

Personalis, Inc. - CFO

Personalis, Inc. - Co-Founder, CEO, President & Director

Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst

* Subhalaxmi T. Nambi

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Caroline V. Corner

Good afternoon. My name is Jerome, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Personalis Q2 2020 Earnings Conference Call. (Operator Instructions)

Thank you. I would now like to turn the call over to Ms. Caroline Corner. Please go ahead.

Caroline V. Corner, Westwicke Partners, LLC - MD [2]

Thank you, operator. Welcome to Personalis' Second Quarter 2020 Earnings Call. Joining me on today's call are John West, President and Chief Executive Officer; and Aaron Tachibana, Chief Financial Officer.

This call will include forward-looking statements, including statements regarding the markets in which we operate, including potential market sizes; trends and expectations for products, services and technology; trends and demand for our products; Personalis' expected financial performance, expenses and position in the market; and the impact of the COVID-19 pandemic on our operations and our customers' operations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations. We encourage you to review our most recent filings with the SEC, particularly the risk factors described in our 10-K filing for fiscal year 2019 and in our 10-Q filing for our second quarter ended June 30, 2020.

The forward-looking statements we provide during this call, including expectations for future performance, are based on our reasonable beliefs and expectations as of today. Personalis undertakes no obligation to update these statements, except as required by applicable law.

Our press release with our second quarter 2020 results is available on our website, http://www.personalis.com under the Investors section and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website by 5:00 p.m. Pacific Time today.

Now I'd like to turn the call over to John for his comments on second quarter 2020 business highlights.

John Stephen West, Personalis, Inc. - Co-Founder, CEO, President & Director [3]

Thank you, Caroline. Personalis has been responding to COVID-19 in -- began responding to COVID-19 in Q1 before government's shelter orders. That early response helped us have a record quarter in Q1. Our continued response and execution has now led us to another record in Q2.

In April, we coordinated with the VA MVP program to take the largest shipment of samples from them that we have ever had just before their lab in Massachusetts was closed in response to the pandemic. The automation that we've put in place over the last 3 years then allowed us to efficiently maintain our whole genome sequencing work, even when we had a reduced workforce in our lab as a result of operational changes we implemented to comply with state and local orders related to COVID-19 and to protect the health and safety of our employees. As a result, in Q2, we were again able to sequence about 14,000 whole human genomes, up 70% from Q2 last year and matching the Personalis population sequencing revenue record we had set in Q1.

On the oncology side of our business, we also had to adapt rapidly. Some prospective clinical trials that our biotech customers are involved with were either slowed or stoped due to the pandemic. And also revenue from our leading biobank customer fell 98% from Q1. We were able to overcome these challenges by beginning to ramp revenue from our next platform. This allowed us to achieve a sequential revenue increase for biopharma and all other customers. Most of our biopharma business is for retrospective projects, which have been resilient during this pandemic. Over the last 4 quarters, biopharma customer orders have significantly exceeded revenue, driven by adoption of our NeXT platform and predominantly by large pharmaceutical customers. As we saw in Q2, these orders are now beginning to convert to revenue.

Another challenge we faced during the quarter was the timing of biopharma sample receipts. Many were delivered to us later in the quarter than expected so we were not able to process all of them for revenue. This does, however, put us in a good position heading into Q3.

Our laboratory operations team executed well during Q2 and carefully arranged the sample processing schedules to focus on VA MVP samples early within the quarter when labor capacity was lower due to shelter-in-place guidelines. That allowed us to utilize more capacity later in the quarter for biopharma sample processing. As a result, our revenue from pharmaceutical customers increased by more than 20% sequentially. This more than offset the dip in revenue from biobank and biotech customers and helped us achieve quarter-on-quarter growth in our oncology-focused business.

Driven by this growth of NeXT, our overall revenue increased for a 16th consecutive quarter to $19.5 million, up 23% from Q2 last year. All of this was accomplished, while more than 80% of our employees were working from home.

Shifting focus to our progress this quarter, there are several factors which give us confidence in the long-term growth of our business. In the month of June, we were able to bring our liquid biopsy development team members back into the lab. You may have seen our recent press release launching NeXT Liquid Biopsy, which is now available for customer orders. Both our tissue and liquid biopsy-based products have been designed specifically to meet the needs of our pharmaceutical customers and provide data on all 20,000 human genes. With the addition of our liquid biopsy product, we expect to enable comprehensive monitoring of patients across 20,000 genes at multiple time points.

Many new cancer drugs extend the lives of patients but do not eradicate the disease. So a growing segment of the cancer survivor population consists of patients who are still undergoing active disease management. Our first liquid biopsy product tracks the evolution of what can be hundreds or even thousands of cancer mutations in a single tumor. Importantly, we can also detect new mutations as they emerge under therapeutic pressure. Note that some cancer patients develop a second genetically independent cancer while being treated for the first. Our liquid biopsy product's ability to see new mutations may also provide early detection of some so-called second cancers.

I'm extremely proud of our team. We pulled together during this challenging time to get this exciting product into the marketplace. We expect to receive first orders in the coming months. And while we expect that liquid biopsy revenues will be modest initially, we think this new product puts us in an even stronger competitive position as we go forward.

Our liquid biopsy product is designed to be used together with our tissue biopsy product, not instead of it. We expect initial sales to be to customers using our tissue-based testing, who are also seeking liquid biopsy capabilities to monitor the same patients over time. We believe that our capabilities to offer both tissue and liquid biopsy-based products and to leverage the synergy between them, positions us favorably relative to companies who only offer one or the other.

In the future, we will be broadening our liquid biopsy product line to include personalized tests designed for a specific patient's tumors. The team is hard at work here and barring any COVID-19-related interruptions or other unexpected delays, we expect to launch this additional offering in 2021.

We have continued to gain traction with biopharma customers, realizing strong order levels once again in Q2. To frame the pace of customer orders in a different way, in the first half of 2020, we received about the same dollar value of biopharma orders as we received for the full year of 2019. As we've explained before, it takes time for orders to convert to revenue and the actual revenue recognized from an order may be less than expected due to failure of individual customer samples to meet our sample quality requirements and other factors. But this growth in orders gives us confidence in our future revenue stream.

We are winning business based on the value proposition of our NeXT platform. Our NeXT platform can identify biomarkers, including neoantigens across all types of cancer, providing comprehensive data across all 20,000 human genes, all from a small tissue sample.

Our customer base has also grown substantially over the last year. While we can't disclose all of our customer names, I can tell you that we have now received orders from a majority of the top 10 oncology-focused pharma companies. As of the end of Q2, we had 32 different customers who have placed orders for NeXT, up from 26 at the end of Q1. In addition, you may recall that new customers typically evaluate or run a small pilot before growing into larger contracts. Up until the last few quarters, a pilot order could be around $50,000. But with our recent progress, we are now receiving initial orders that can be several hundred thousands of dollars. And in a few cases, approaching $1 million. We believe that this growing adoption of NeXT further highlights the power of our platform and that the comprehensiveness of our platform is important to our customers.

In June, we announced a research collaboration with Sarepta Therapeutics, a leader in precision genetic medicine for rare disease. As part of the collaboration, Sarepta is working with us to characterize immune response precision genetic therapeutics, utilizing our advanced proprietary neoantigen analytics. We are excited that the value of our platform is now being recognized in areas beyond cancer.

We also announced in June that we are establishing a lab and commercial operations in the People's Republic of China. Several global pharmaceutical companies have asked us about China, underscoring our belief that it's a good time to expand there.

Additionally, we recently announced a partnership with Berry Genomics, a Chinese company focused on the development and commercialization of genetic test technologies in clinical applications with approximately 1,500 employees and 7 different clinical laboratories. We believe that our partnership with Berry Genomics will be complementary since our customer focus is pharma and theirs is clinics and hospitals.

We have continued to expand our commercial team in both the U.S. and Europe. In particular, we have added business development staff with extensive commercial experience in companion diagnostic development. And as a result, we are now engaging with an increasing number of biopharma companies for potential companion diagnostic development programs. We've also expanded our quality and regulatory team to support these efforts. And in June, we had our first FDA pre-submission meeting for a single-site PMA for NeXT, which went well.

I'd now like to update you on the population sequencing part of our business, which is sometimes referred to in the field as population genomics. As you may have seen in our June press release, our population sequencing business hit a big milestone with the 75,000th full human genome sample sequence, and we are well on track to reach 100,000 by the end of this calendar year. This could make Personalis the first for-profit company ever to sequence 100,000 whole human genomes in the United States, and we are really looking forward to achieving this milestone.

Our work with the VA MVP represents the largest population sequencing effort within the United States. The VA now targets enrollment of 2 million veterans and over 825,000 veterans have enrolled so far. Personalis has been contracted so far to sequence over 116,000 VA MVP samples, with approximately 41,000 remaining to be sequenced.

Having already received population sequencing orders totaling over $145 million from the VA MVP, we are now expanding our commercial team to address and extend our reach into what is projected to be a multibillion-dollar population health market. We expect our unparalleled experience with the VA MVP program to position us well for new opportunities in population sequencing. Given our clinical experience and work with pharma, we also see an opportunity to help transition population research to population health and to involve pharma in the future.

Our population sequencing and biopharma businesses share a unifying theme in the comprehensive and large-scale genomic characterization of human samples. Both our whole genome sequencing and our NeXT platform cover all 20,000 human genes. Because of their shared underlying technologies and operational implementation, we achieved considerable synergy between the 2 businesses.

I would now like to expand on the synergy between the population sequencing and oncology parts of our business, in particular, synergies that go beyond the operational and cost synergies already achieved. Our extensive experience with whole genome sequencing, combined with our deep expertise in cancer, has allowed us to launch whole genome sequencing from cancer samples. We believe that this will be increasingly important in the future, particularly in cancers such as breast and prostate, which have relatively low mutational burdens.

Using our cancer whole genome technology will identify up to 20x somatic variants to serve as the basis for personalized cancer assays. We believe this will let us achieve high sensitivity, even in cancers which have low mutation rates, which have been surgically resected or which had relatively low amounts of cell-free DNA into the blood. We believe this can be a leading technology in some very large market opportunities, and we'll have more to say about this as these product developments progress.

Before I wrap up, I'd like to give you an update on another pipeline product. As many of you know, we have been working for over 3 years on a combined laboratory and informatics project to advance our neoantigen characterization capabilities. We believe that neoantigens are the crucial centerpiece of a new generation of companion diagnostic biomarkers. We expect our biopharma customers will apply this capability to mainstream cancer drugs such as checkpoint inhibitors and also to experimental personalized cancer therapies, which explicitly target neoantigens.

Our new advanced capability may also be used for development of drugs that are designed for use outside of cancer, such as gene therapies. This Personalis R&D project has required multiple proprietary technologies, including genetic engineering of proprietary human cell lines, mass spectrometry to identify and quantify peptides binding to HLA and the training of novel machine learning algorithms. Our data shows that this project has achieved a leapfrog advance in this field. We expect to launch this capability as part of our NeXT platform in the fourth quarter of this year.

In summary, I'm very proud that our combined business has shown strong resilience throughout the pandemic. Customer adoption for NeXT has been excellent, and our pipeline of compelling new products is rich. We believe these factors, among others, put us in a strong position for long-term growth.

With that, I will now hand it over to Aaron for our financial results.

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Aaron L. Tachibana, Personalis, Inc. - CFO [4]

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Thank you, John, and good afternoon, everyone. Revenues for the second quarter of 2020 were $19.5 million, up 2% from $19.2 million for the prior quarter and up 23% from $15.8 million for the same period of the prior year. The $19.5 million was a new record high for quarterly revenues. The quarter-on-quarter revenue growth was driven by an increase in volume for genomic testing services provided to biopharma customers. Biopharma and all other customers accounted for revenues of $4.7 million for the second quarter, an increase of 8% from last quarter.

In the second quarter, revenues from our NeXT platform began to ramp and exceeded $2 million. Also to note, the revenue increase from NeXT more than offset the sequential decline of over $1 million from both our biobank customer that had sample collection and shipment delays due to the pandemic and also biotech customers that were impacted by the slowdown of clinical trials.

For the second quarter, the VA MVP revenue of $14.8 million was flat from last quarter and was 73% higher compared with $8.5 million for the same period of the prior year. The VA MVP unfulfilled orders at the end of the second quarter were $39.3 million and based upon current estimates, we expect the unfulfilled orders to convert to revenue over approximately the next 2 to 3 quarters. The balance of the unfulfilled orders will decline from the fourth quarter of the prior year through the second quarter of the current year since the annual new order is typically received late in the third quarter.

Gross margin was 24% for the second quarter compared with 21.1% for the prior quarter. The VA MVP gross margins continued to be solid and once again were higher than the corporate gross margin reported for the second quarter. The VA MVP being higher volume and a single-service offering has been automated and does not require a significant amount of labor and has a very efficient sample test process.

In the second quarter, the negative impact to gross margin from COVID-19 was approximately 80 basis points from higher labor costs related to overtime pay. Also, we had a 100 basis point impact from higher facility costs related to an increase in lease rates. As a reminder, we may see gross margin variability in the future as there are a few moving parts, such as sample receipt linearity from customers, the mix of customer projects and capacity utilization of labor and equipment.

During our last conference call, we mentioned our initiative to build out a lab operation in China this year, which will add start-up expenses beginning in 2020, and most of these expenses will be classified as SG&A this year. We expect revenue from China to begin ramping throughout 2021. And during this ramp-up period, we expect to have gross margin headwinds from the under-absorbed labor and overhead.

Operating expenses were $14.2 million in the second quarter compared with $10 million for the same period of the prior year. R&D expense was $6.5 million for the second quarter compared with $4.5 million for the same period last year, and SG&A expense was $7.7 million in the second quarter compared with $5.5 million for the same period last year.

Net loss for the second quarter was $9.3 million compared with a net loss of $5.9 million for the same period of the prior year. The net loss per share for the second quarter was $0.29, and the weighted average basic and diluted share count was 31.7 million compared with a net loss per share of $0.89 and a weighted average basic and diluted share count of 6.6 million for the same period of the prior year.

Now on to the balance sheet. We exited the second quarter with a strong balance sheet with cash and short-term investments of $105.2 million. Second quarter cash flow from operations was a usage of approximately $15 million, primarily due to the net loss and working capital needs. During the quarter, we maintained our buffer inventory level of approximately $1.5 million to help mitigate potential supply chain disruption.

Now for discussion about our guidance. During our May conference call, we did not provide any 2020 revenue guidance due to the uncertainty from the pandemic. And although we had a solid second quarter, too much uncertainty remains about whether or not work conditions for us, our customers and suppliers will remain the same as today or change in the near future. Potential changes could have an adverse effect on our financial results. And therefore, we are not providing revenue guidance for fiscal 2020 at this time. We plan to provide an update to this information during our next earnings call.

Now I will turn the call back over to the operator, Jerome, to begin the Q&A session. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from the line of Doug Schenkel from Cowen.

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Subhalaxmi T. Nambi, Cowen and Company, LLC, Research Division - Research Associate [2]

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This is Subbu on for Doug Schenkel. You posted a great update intra-quarter on the VA update. Given that you're on track to complete the project, how long -- so most of the database, given that you're on track to finish 100 case sequences, most often, we notice that database that has integrated electronic health record data has more value. Do you envision that to happen with the VA MVP project?

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John Stephen West, Personalis, Inc. - Co-Founder, CEO, President & Director [3]

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Yes. This is John West. I'm happy to answer that. Actually, a part of -- key part of the advantage that the Million Veterans Program has is that veterans have all been on the same electronic medical record system for years. And so they already have that in electronic format. And unlike other population sequencing efforts, they don't have to try to harmonize results from many different electronic medical record systems. All of the patients that are handled by the VA MVP are patients who would be -- have been on the same electronic medical record system during their time as patients with the VA. So it's actually really a major advantage that they have. I would also say that we're coming up on the 100,000 patients. That's nowhere near finishing the project. The project is the sequence -- to enroll 2 million patients. There are actually 825,000 samples that have already been collected. So actually, we're just beginning to scratch the surface of the project. We've been contracted to sequence 116,000, and we anticipate that there can be an additional order still this year that will extend the program even further.

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Subhalaxmi T. Nambi, Cowen and Company, LLC, Research Division - Research Associate [4]

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So you -- so if I heard it right, you're already doing that. You already have data with the -- the electronic health record data of all these individuals. Or do you plan to do that in the future?

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Aaron L. Tachibana, Personalis, Inc. - CFO [5]

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Let's see, our customer already has that information in the VA. They're the ones who have that health record data. They're the ones sharing it. It will be their database. They're the ones paying for it. But they do already have all of that health record data.

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Subhalaxmi T. Nambi, Cowen and Company, LLC, Research Division - Research Associate [6]

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Got it. And you recently partnered with Berry Genomics, and you also said that, that will serve as your local subsidiary opportunity. How do you plan to strategize that, given that NGS testing has just begun gaining traction there, and there are already a few high-profile local players? So what would be the key advantage? Would you call it your core technology? Or is there some other strategy that you're working on?

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John Stephen West, Personalis, Inc. - Co-Founder, CEO, President & Director [7]

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Yes. So thank you for the question. So the key reason that we are expanding to China is that there are international pharmaceutical companies that we already work with in the U.S. and Europe who are conducting international clinical trials. And so they have patients who are being enrolled into those clinical trials from China now in addition to other countries. And we've already been sequencing samples from patients that are from countries outside of China, but our pharmaceutical customers came to us and said, we're not allowed to export the samples of patients from China. We can't send them to you in California. They have to be sequenced inside China because of the regulations of China. And so they've asked us to set up this additional capability using our proprietary technology, our NeXT platform, to be able to run that inside China.

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Operator [8]

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Your next question comes from the line of Kevin DeGeeter from Oppenheimer.

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Kevin Michael DeGeeter, Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst [9]

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Congrats on a really nice quarter. Can you just talk a little bit about the recently launched liquid biopsy program? Specifically, in addition to breadth of coverage, how else do you envision differentiating the product in the market, at least initially? And then in terms of the, what I'll call, incremental or second-generation product that would provide additional functionality for really kind of personalized precision oncology programs, just kind of walk us through the development steps that may be necessary to have that functionality.

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John Stephen West, Personalis, Inc. - Co-Founder, CEO, President & Director [10]

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Edited Transcript of PSNL.OQ earnings conference call or presentation 6-Aug-20 9:00pm GMT - Yahoo Finance