Full Press Release Details
The following is a transcript of a webcast presented by Illumina, Inc. (the "Company") at the JPMorgan Healthcare Conference (Virtual) on January 11, 2021.
C O R P O R A T E P A R T I C I P A N T S
Alexander Aravanis Illumina, Inc. - Senior VP CTO
Francis A. deSouza Illumina, Inc. - CEO, President Director
Sam A. Samad Illumina, Inc. - CFO Senior VP
C O N F E R E N C E C A L L P A R T I C I P A N T S
Tycho W. Peterson JPMorgan Chase Co, Research Division - Senior Analyst
P R E S E N T A T I O N
Tycho W. Peterson - JPMorgan Chase Co, Research Division - Senior Analyst
Okay. Good afternoon. I'm Tycho Peterson from the life science team. It's my pleasure to introduce our next company this afternoon, Illumina.
(Operator Instructions)
And with that, let me turn it over to Francis.
Francis A. deSouza - Illumina, Inc. - CEO, President Director
Thank you, Tycho and the JPMorgan team for hosting us. And thank you, everyone, for joining us today. Our presentation today includes non-GAAP
financial measures and forward-looking statements. Reconciliations to GAAP measures are included in our presentation. Please refer to our SEC
filings for a full presentation of risks.
Going to Slide 3. The current pandemic has highlighted the critical role that genomics and Illumina will play in global health. In December 2019,
Illumina worked with the Wuhan public health authorities to identify the cause of the COVID-19 outbreak. And in January 2020, the Shanghai Public
Health Clinical Center used our instruments to sequence and publish the first complete SARS-CoV-2 genome. This genomic sequence enabled
companies like Moderna and BioNtech with Pfizer to create groundbreaking vaccines. Using data from Illumina sequencers, Moderna shipped the
first doses of vaccine to clinical trial in 42 days without ever having the virus on site, an unprecedented achievement in scientific and medical
Our technology powers global COVID research and surveillance. Illumina technology helped identify the B117 strain through the COG-UK surveillance
program and were working with Helix and the U.S. CDC to track the emergence and prevalence of novel variants and strains. We are committed
to helping fight this pandemic, which will bring greater awareness and accelerate the use of sequencing in infectious disease and public health.
Moving to the next slide and turning to our fourth quarter and full year 2020 results. Illumina delivered a very strong finish to 2020 with Q4 top
line and bottom line results exceeding our expectations. Preliminary fourth quarter revenue of approximately $950 million grew roughly 20%
compared to the third quarter. Sequencing consumables revenue set a new record, growing approximately 20% sequentially and 5% compared
Q4 also saw record orders booked in the quarter, including record sequencing instrument orders. Preliminary non-GAAP EPS for the fourth quarter
of 2020 was approximately $1.20. Full year 2020 revenue of approximately $3.2 billion declined 9% year-over-year due to the pandemic, with the
biggest impact in the second quarter.
Our business has shown strong sequential growth since Q2. As we exited the year, average sequencing run rates in our clinical customers exceeded
pre-COVID levels, and our research customers have returned to pre-COVID levels. We'll provide additional details when we report our fourth quarter
and full year 2020 results in February.
Now on the next slide, I'll share progress on our instrument placements. We placed over 2,000 instruments in 2020. We now have a total of 17,000
systems at 7,300 customers in 131 countries, including 700 new customers in 2020. Notably, 2020 was the second consecutive year of record growth
for our mid-throughput platforms.
Now on the next slide, looking at our high-throughput platforms. NovaSeq became the first sequencer to generate over $1 billion in annual revenue,
and it generated an average pull-through exceeding $1 million per instrument. Customer reception to the version 1.5 consumables has been very
positive. Labs of any size can now access the $600 genome. And as we expected, this is unlocking demand elasticity from both new and existing
customers. As a result, Q4 was the second highest quarter of NovaSeq orders ever, 4 years after we launched the product in 2017. More than half
of our Q4 orders came from new to high-throughput customers.
We also saw record S4 revenues and customers in Q4. As an example with version 1.5 pricing and our TruSight software suite, Shriners Hospital for
Children converted from exome to whole-genome sequencing for genetic disease diagnosis and expanded their offerings to all their 22 hospitals
in the U.S., Canada and Mexico. Looking ahead, we also expect version 1.5 to further catalyze NovaSeq upgrades for the remaining 320 active HiSeq
customers that have yet to begin the transition.
The next slide, following last year's successful 1000 and 2000 launches, our mid-throughput NextSeq systems performed exceptionally well. NextSeq
beat its 2019 shipments record, setting a new record in 2020 driven by strong demand from clinical and research customers. For example, Adaptive
Biotechnologies uses NextSeq for MRD for hematological cancers, and Scripps uses it for single cell profiling of T cells.
We're launching a new NextSeq flow cell, the P1, in the second half of 2021. P1 adds a lower-throughput option to support applications such as
pathogen surveillance and targeted sequencing for tumor profiling. P1 offers an attractive upgrade option for MiSeq and NextSeq 550 customers.
Next slide. Our low-throughput systems continue to be a great entry point for many new to sequencing labs, including more than 500 new customers
in 2020. With a winning combination of affordability and ease of use, our low-throughput systems have an installed base of more than 10,000
instruments across approximately 6,100 customers in 122 countries.
Next slide. The major population initiatives are on track to grow in 2021, and we expect the number of whole genome equivalent sequenced in
2021 to increase by about 50% to approximately 450,000. This is driven primarily by All of Us and the NHS, which is rolling out the world's first
population scale clinical program, covering 21 rare diseases and 4 cancer groups. We were also selected as a clinical sequencing partner for Denmark,
and that will begin this year.
Managing the large volumes of data generated is a bottleneck for population genomics programs. And we are pleased to announce the availability
of Illumina Connected Analytics later this month to address this. This software solution enables population initiatives to analyze, interpret, aggregate,
explore and share multi-omic data at scale, combining the technology from our Edico, Enancio and BlueBee acquisitions into a single, fully integrated
solution. For example, the National Applied Research Labs in Taiwan uses ICA to accelerate their pipeline processing 50x and reduce data storage
Turning on the next page to clinical. Illumina is the world leader in clinical genomics with more than $1.5 billion in 2020 revenues from clinical
customers. We delivered the broadest clinical genomics menu, spanning reproductive health, oncology and genetic disease. Our commercial reach
extends to major health systems in 131 countries. And our regulatory and reimbursement teams deliver and support IVDs in more than 50 countries.
In total, more than 2,100 Illumina employees serve the clinical market. The growing adoption of sequencing and reimbursement are key themes
contributing to future growth.
And moving to the next slide. We are particularly excited about recent positive developments in noninvasive prenatal testing. With landmark
decisions from Aetna and UnitedHealthcare in 2020 and additional coverage expected, we anticipate an additional 1.1 million pregnancies to be
covered for NIPT in 2021, a 50% increase from 2019.
Our TruSight NIPT IVD module submission is in progress to deliver an FDA-approved, distributable end-to-end kit in the U.S. in 2022, further enabling
adoption. In Europe, more than 1.5 million samples in 35 countries have been processed using VeriSeq CE-IVD NIPT since its launch in 2017, with
sample volume growing 20% in 2020. Looking forward, Germany will start reimbursing NIPT in the second half of 2021, an opportunity of at least
200,000 pregnancies per year.
Moving to the next slide. Reimbursement for genetic disease testing increased tenfold in 2020. Less than 1% of the 300 million people living with
a genetic disease have been sequenced, and this represents a large growth opportunity for Illumina. We have over 400 customers in genetic disease
testing, like Invitae and the Mayo Clinic. And our industry-leading whole-genome sequencing workflow can go from sample to answer in less than
24 hours. We're also working on the first whole genome sequencing IVD for genetic disease.
As reimbursement grows and programs like the Medical Genome Initiative increase awareness among patients and clinicians, we expect whole
genome sequencing to become the standard of care in genetic disease testing.
Moving to the next slide. Comprehensive Genomic Profiling, CGP, is an NGS test that enables a single companion diagnostic for the 55 and growing
targeted oncology therapies. CGP simultaneously tests for targeted alterations in single genes and also cancer signatures like TMB and HRD, which
affect many genes and require large panels. By 2026, CGP is expected to be $1 billion-plus market.
Last year, more than 205 million lives were covered for CGP in the U.S., and Illumina customers' Foundation Medicine and Guardant received the
first single-site FDA approvals for liquid biopsy-based CGP companion diagnostics.
Moving to the next slide. Illumina's TruSight Oncology 500 is the leading distributed CGP test for tissue and liquid biopsy, with the largest number
of companion diagnostic and collaboration partners. We're announcing today partnerships with Merck, Gilead and Kura and an agreement with
Myriad for HRD testing using TSO 500. We also announced that we are expanding our collaboration with Bristol-Myers Squibb to develop a
companion diagnostic for microsatellite instability and the diagnostic based on our liquid version of TSO 500.
TSO 500 has over 250 customers worldwide, and revenue grew over 130% in 2020. We plan to launch TSO 500 as an IVD in Europe and the U.S. this
year, making this important test available more broadly.
Moving to the next slide and to our technology. We have now achieved the key technology breakthroughs to deliver the next order of magnitude
improvements in cost as well as significant steps forward in accuracy, speed and read length. These breakthroughs include 5x higher cluster density
than NovaSeq version 1.5 kits, yielding 5x the data from the same flow cell area. We've developed a flow cell manufacturing process using
300-millimeter wafers, doubling the wafer yield. Taken together, these innovations can reduce flow cell cost by 90%.
We've also made fundamental improvements to SBS, including new dies and blocking chemistries, enabling 3x higher accuracy, 2x faster cycle
times and 2x longer reads. We're excited to bring these breakthroughs to our customers in future products and confident in our path to get there.
Moving to the next slide. Illumina expanded the whole-genome sequencing market with the $1,000 genome in 2014. Today, NovaSeq's $600
human genome offers gold standard accuracy, 150x more scale and 10x lower cost for whole genomes -- whole human genomes than accurate
non-SBS platforms today. Making whole human genome sequencing routine for applications such as genetic disease testing and population
sequencing will require the next level of cost, scale and accuracy. Illumina's technology road map will allow us to continue raising the bar on