Illumina, Inc.

Thank you all for standing by and welcome to the Illumina Q2 2021 earnings conference call. Please note that all participants will be in listen-only mode until the question and answer session of today's conference. To ask a question over the phone by that time, you may press the star key followed by the number one. Please also note that today's call is being recorded. I'll now turn the call over to your host, Brian Blanchett. Sir, you may now begin.

Good afternoon, everyone, and welcome to our earnings call for the second quarter of 2021. During the call today, we will review the financial results released after the close of the market and offer commentary on our commercial activity, after which we will host a question and answer session. If you have not had the chance to review our earnings release, it can be found in the investor relations section of our website at Illumina.com. Participating for Illumina today will be Francis D'Souza, President and Chief Executive Officer, and Sam Samad, Chief Financial Officer. Francis will provide an update on the State of Illumina's business, and Sam will review our financial results. This call is being recorded, and the audio portion will be archived in the investor section of our website. It is our intent that all forward-looking statements regarding our financial results and commercial activity made during today's call will be protected under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risk and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward-looking statements are based upon current available information, and Illumina assumes no obligation to update these statements. To better understand the risk and uncertainties that could cause actual results to differ, we refer you to the documents that Illumina files with the Securities Exchange Commission, including Illumina's most recent forms 10Q and 10K. With that, I now turn the call over to Frances.

Thank you and good afternoon, everyone. Illumina delivered Q2 revenues of $1.126 billion, representing 78% year-over-year growth, significantly exceeding expectations across all geographic regions and market segments. Our clinical markets, including oncology, reproductive health, and genetic disease testing are expanding as reimbursement coverage increases, patient awareness grows, and more sequencing applications enter the clinic. Ramping population sequencing programs are contributing to the robust growth in our research business. Additionally, genomic surveillance has emerged as a critical tool in the global fight against the pandemic. with over 70 countries now using Illumina platforms for COVID-19 surveillance. Looking forward, there's momentum for this global surveillance infrastructure to be the backbone of a durable global genomic epidemiology capability to combat future outbreaks, including zoonotic transmissions, antimicrobial resistance, and bioterrorism. Q2 is the second consecutive quarter of record instrument sales, with revenue up 113% year-over-year, and we ended the quarter with the highest instrument backlog since launching NovaSeq. Now, looking at our performance by platform, our high throughput portfolio continued its spectacular run, with NovaSeq achieving its highest order volume since launch in Q1 2017. Demand for high throughput sequencing capacity continues to expand, with over half of the orders in Q2 coming from customers who are new to high throughput. Additionally, our customers are continuing to use these systems at a high rate to meet demand in oncology testing, genetic disease testing, and population sequencing programs. Our mid-throughput platforms continue to drive growth, with record placements in Q2. The strength of the NexSeq 2000, with almost three times the output of NexSeq 550, is enabling exciting new applications for customers like Cold Spring Harbor Labs in single-cell analysis. Clinical customers drove new NexSeq 550 placements. NexSeq DX again set a record for shipments, as we see a trend toward decentralization of clinical sequencing outside the U.S. Benchtop platforms also had an excellent quarter. with instrument revenue up over 50% year-over-year. We shipped more MiSeq instruments this quarter than any prior quarter in the last five years. This record demand has been driven by our core business as well as emerging areas like pre-implantation genetic screening and COVID surveillance. Turning to our clinical and research and applied segments, sequencing consumables revenue of $4 million was up 82% year-over-year. driven by demand in both our clinical and research segments. Starting with our clinical business, our focus on market access and collaborations are expanding reimbursement, powering new and existing testing providers, and benefiting patients around the world. There are now over 1 billion covered lives globally across NIPT, WGS for rugged, and CGP in oncology. demonstrating the expertise and impact of Illumina's market access team to drive coverage and also the opportunity in our clinical segment. Oncology testing, our largest market segment, recorded its third consecutive quarter of outstanding year-over-year growth. Our customers announced additional offerings for therapy selection and MRD tests. In therapy selection, expanding reimbursement for comprehensive genomic profiling is fueling the shift from small to large panels. With 74% of lives now covered for CGP in the U.S. and additional indications approved, new customers are entering the oncology testing field, and existing customers like Karis are expanding their footprint. TruSight Oncology 500, Illumina's RUO comprehensive genomic profiling assay, achieved its 100,000-sample milestone in Q2 and added over 40 additional customers so far this year across 23 countries. In addition, over the last year, MRD testing has emerged as a key driver of future growth in the oncology segment, with positive reimbursement decisions, more customers, and multiple approaches entering the market. It's also exciting to see pharma invest in MRD-based clinical trials to bring proven drugs to early stage disease and improve patient outcomes. Reproductive health consumable shipments continue to benefit from the revised ACOG guidelines. In January, we expected that NIPT would be covered for approximately 3 million pregnancies in the U.S. by the end of 2021. We have already surpassed that milestone, and we expect coverage to continue to expand. We're also making progress outside the U.S. to ensure all expecting families have access to NIPT. In Germany, for example, national coverage will be implemented in 2022. Additionally, we're seeing continued growth from our CEIDD March VeriSeq NIPT solution in Europe and Asia. In Q2, Next Generation Genomic in Thailand adopted our VeriSeq NIPT solution version 2. broadening access to expanded NIPT for expectant parents in Southeast Asia. Genetic disease testing delivered another outstanding quarter, driven by reimbursement coverage increasing across Europe and lower sequencing prices, enabling an accelerated shift from exomes to genomes. In the quarter, we also saw promising research and guidelines recognizing the diagnostic yield and cost effectiveness of whole genome sequencing for genetic disease. In June, Rady's Children's Hospital in the state of California published the results of Project Baby Bear, a groundbreaking program that showcases the significant benefits of rapid whole genome sequencing in decreasing both time to diagnosis and healthcare spending for critically ill infants. More than 30% of these patients had a change of care due to the diagnosis enabled by WGS. This rapid whole genome sequencing protocol is now available through Rady's growing network of over 60 hospital partners, as well as other hospital networks across the country. Turning to our research and applied segments, we saw strong year-over-year and sequential growth. Momentum from population genomics programs continued to grow in Q2. In the U.S., All of Us is now operating at full scale, running thousands of genomes a week. We also saw multiple initiatives ramped internationally, providing an ongoing pipeline of new PopGen opportunities. We expect revenue from over 30 different PopGen initiatives in the second half of the year. Multiomic, spatial, and single-cell approaches are gaining traction in many of our research segments, driving high-intensity sequencing. The success of Illumina's partnerships with companies such as O-Link, NanoString, and 10X will enable novel discoveries and expanded applications to enter the clinic. The emergence of the Delta variant has renewed focus on and heightened awareness for genomic surveillance in the fight against COVID-19 and future pathogens. The launch of the RUO 96 sample COVID-Seq assay and the expanded EUA for COVID-Seq and NexSeq 2000 this quarter demonstrate our continued commitment to provide the workflows, instruments, and bioinformatics to meet this challenge. We are now working with governments and testing labs on COVID surveillance initiatives in over 70 countries. These efforts have driven increased COVID consumable revenue in Q2 relative to Q1, And at this time, we expect the consumable revenue in the second half to remain relatively steady to the first half. Through our philanthropic efforts, we are working to ensure that countries with high needs for COVID surveillance but limited resources also have access to our sequencers and consumables. Earlier this week, we announced the donation of $1 million in sequencing capabilities, including two Nexseq 2000s, to the Molecular Diagnostic Reference Laboratory at Kasturba Hospital, This will enable COVID surveillance in Mumbai, an epicenter of India's devastating second wave. Before I hand the call over to Sam, I'll provide a brief update on Grail. In Q2, Grail launched the first-of-its-kind multi-cancer screening test, Gallery. We made this test available to our employees and are encouraged by the positive feedback we've received. It's exciting to see the promise of genomics come to fruition in oncology screenings. and we're committed to supporting all companies innovating in this space. As we shared in late July, we remain committed to closing this pro-competitive deal and believe with this acquisition, Illumina will be uniquely positioned to help save tens of thousands of lives.