You should read the following discussion and analysis of our financial condition
and results of operations together with our unaudited condensed financial
statements and related notes and the other financial information appearing
elsewhere in this report, as well as the other financial information we file
with the SEC from time to time. Some of the information contained in this
discussion and analysis or set forth elsewhere in this report, including
information with respect to our plans and strategy for our business and related
financing, includes forward-looking statements that involve risks and
uncertainties relating to our future plans, objectives, expectations, intentions
and financial performance and the assumptions that underlie these statements.
As a result of many factors, including those factors set forth in the "Risk
Factors" section of this report, our actual results could differ materially from
the results described in or implied by the forward-looking statements contained
in the following discussion and analysis.
Overview
We are advancing the field of immune-driven medicine by harnessing the inherent
biology of the adaptive immune system to transform the diagnosis and treatment
of disease. Our immune medicine platform applies our proprietary technologies to
read the diverse genetic code of a patient's immune system and understand
precisely how it detects and treats disease in that patient. We capture these
insights in our dynamic clinical immunomics database, which is underpinned by
computational biology and machine learning, and use them to develop and
commercialize clinical products and services that we are tailoring to each
individual patient. We have two commercial products and services and a robust
pipeline of clinical products and services that we are designing to diagnose,
monitor and enable the treatment of diseases such as cancer, autoimmune
conditions and infectious diseases.
Our immune medicine platform is the foundation for our expanding suite of
products and services. The cornerstone of our platform and core immunosequencing
product, immunoSEQ, serves as our underlying research and development engine and
generates revenue from academic and biopharmaceutical customers. Our first
clinical diagnostic product, clonoSEQ, is the first test authorized by the FDA
for the detection and monitoring of MRD in patients with MM and ALL and is being
validated for patients with other blood cancers. Leveraging our collaboration
with Microsoft Corporation ("Microsoft") to create the TCR-Antigen Map, we are
also developing a clinical diagnostic product, T-Detect (previously referred to
as immunoSEQ Dx), that may enable early detection of many diseases from a single
blood test. We are currently running our first clinical validation study in
acute Lyme disease following proof of concept in 2019. Our therapeutic product
candidates, being developed under the Genentech Agreement, leverage our platform
to identify specific immune cells to develop into cellular therapies in
oncology.
Since our inception, we have devoted a majority of our resources to research and
development activities to develop our immune medicine platform, which enables
the delivery of our products and services for life sciences research, clinical
diagnostics and drug discovery customers.
For our life science research customers, we provide two categories of products
and services using immunoSEQ, our core sequencing and immunomics tracking
technology. First, we provide immunosequencing services, the revenue from which
we record as sequencing revenue. Second, we provide certain research customers
professional support, for which we may receive payments upon those customers
achieving specified milestones. We record these support activities as
development revenue.
For our clinical diagnostics customers, we sell our clonoSEQ diagnostic tests,
which include our immunosequencing services and are thus recorded as sequencing
revenue. In the future, we intend to sell other diagnostics products and
services, which we also expect to record as sequencing revenue.
For our current drug discovery collaborator, Genentech, we screen, identify and
characterize TCRs in support of our collaboration. We record revenue from this
collaboration as development revenue.
Historically, we have sold immunoSEQ as a fee-for-service offering to academic
centers and biopharmaceutical customers and further deepened those relationships
over time by supporting their development initiatives. These research offerings
have comprised the majority of our revenue to date, although our business is
pursuing broader opportunities. As we continue to expand the use of our clonoSEQ
diagnostic tests, develop and commercialize T-Detect and develop and
commercialize therapeutic product candidates with our drug discovery
collaborator, we expect our mix of revenue to shift to clinical products and
services, which we believe will become our largest sources of revenue.
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We are actively pursuing opportunities to deepen our relationships with current
customers and initiate relationships with new customers. We have an experienced,
specialty salesforce that is targeting department heads, laboratory directors,
principal investigators, core facility directors, clinicians, payors and
research scientists and pathologists at leading academic institutions,
biopharmaceutical companies, research institutions and contract research
organizations. As MRD assessment becomes standard practice for patient
management across a range of blood cancers, we believe it will be essential for
clinicians and patients to have access to a highly accurate, sensitive and
standardized MRD assessment tool. We are focused on establishing and maintaining
collaborative relationships with payors, developing health economic evidence and
building billing and patient access infrastructure to expand reimbursement
coverage for our clinical diagnostics. We continue to seek expanded coverage of
our clonoSEQ diagnostic test and, in 2019, we successfully expanded coverage
through contractual agreements or positive medical policies with Medicare and
several of the largest national private health insurers in the United States.
We generated revenue of $26.3 million and $68.2 million for the three and nine
months ended September 30, 2020, respectively, and $26.1 million and $60.9
million for the three and nine months ended September 30, 2019, respectively.
Our net losses were $36.7 million and $101.7 million for the three and nine
months ended September 30, 2020, respectively, and $14.0 million and $48.0
million for the three and nine months ended September 30, 2019, respectively. We
have funded our operations to date principally from the sale of convertible
preferred stock and common stock and, to a lesser extent, sequencing and
development revenue. As of September 30, 2020 and December 31, 2019, we had
cash, cash equivalents and marketable securities of $851.5 million and
$682.3 million, respectively.
COVID-19 Developments
In March 2020, we extended our collaboration with Microsoft to decode the
adaptive immune response and pursue a diagnostic signal for COVID-19. In the
second quarter of 2020, we confirmed a clinical signal for the detection of the
virus that causes COVID-19, called SARS-CoV-2. We are actively exploring
T-Detect's ability to detect the TCR response to the virus and believe that
quantifying virus-specific T cells may enable new diagnostic applications and
inform our ability to assess immunity and response to vaccines or other drugs in
development. As part of this effort, we initiated the ImmuneCODE program to
collect, analyze and publicize data about the TCRs specific to SARS-CoV-2. We
continue to collect samples from our own prospective study, ImmuneRACE, and
participating institutions around the world that are interested in contributing.
We are making all of the sequencing data publicly available in our ImmuneCODE
database, which was launched in June 2020.
In August 2020, we launched immunoSEQ T-MAP COVID, a proprietary research
product and data analysis service to measure the T cell immune response to
vaccines being developed by third parties and track the persistence of that
response over time. In November 2020, we announced plans to launch T-Detect
COVID, a T cell-based clinical diagnostic product for COVID-19.
For a discussion of the risks presented by the COVID-19 pandemic, including
risks to our results of operations and inherent in development of new products
and services related to the pandemic, see the "Risk Factors" section of this
report.
Follow-On Offering
In July 2020, we completed an underwritten public offering of our common stock
in which we issued and sold 7,200,000 shares of common stock at a public
offering price of $40.00 per share. We received $271.8 million in net proceeds,
after deducting underwriting discounts and net offering expenses payable by us.
Components of Results of Operations
Revenue
We derive our revenue from two sources: (1) sequencing revenue and
(2) development revenue.
Sequencing revenue. Sequencing revenue reflects the amounts generated from
providing testing services through clonoSEQ to clinical and research customers
and from providing sequencing services through immunoSEQ to research customers.
For our clinical customers, we derive revenue from providing our clonoSEQ test
report to ordering physicians. We bill medical institutions and commercial and
government payors based on tests delivered to ordering physicians. Amounts paid
for clonoSEQ diagnostic tests by medical institutions and commercial and
government payors vary based on respective reimbursement rates and patient
responsibilities, which may differ from our targeted list price. To date, the
majority of our clonoSEQ diagnostic test revenue has been received from medical
institutions. We recognize clinical revenue by evaluating customer payment
history, contracted reimbursement rates, if applicable, and other adjustments to
estimate the amount of revenue that is collectible. Until 2019, we did not have
reimbursement available to us through any government payors for clonoSEQ.
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Adaptive Biotechnologies Corporation
For our clonoSEQ coverage under Medicare, we bill an episode of treatment when
we deliver the first eligible test results. This billing contemplates all
necessary tests required during a patient's treatment cycle, which is currently
estimated at approximately four tests per patient, including the initial
sequence identification test. Revenue recognition commences at the time the
initial billable test result is delivered and is based upon cumulative tests
delivered to date. Any unrecognized revenue from the initial billable test is
recorded as deferred revenue and recognized as we deliver the remaining tests in
a patient's treatment cycle.
For our research customers, which include biopharmaceutical customers and
academic institutions, delivery of the sequencing results may include some level
of professional support and analysis. Terms with biopharmaceutical customers
generally include non-refundable upfront payments, which we record as deferred
revenue. For all customers, we recognize revenue as we deliver sequencing
results. From time to time, we offer discounts in order to gain rights and
access to certain datasets. Revenue is recognized net of these discounts and
costs associated with these services are reflected in cost of revenue.
Development revenue. Development revenue primarily represents regulatory or
development support services, other than sequencing revenue, that we provide to
biopharmaceutical customers who seek access to our platform to support their
therapeutic development activities. Additionally, we generate development
revenue from the achievement of regulatory milestones. We enter into
collaboration and similar agreements with these customers. When these agreements
include sequencing activities, we separately classify those activities as
sequencing revenue. These agreements may also include substantial non-refundable
upfront payments, which we recognize as development revenue over time as we
perform the respective services.
We expect revenue to increase over the long term, particularly as the mix of
revenue migrates to clinical diagnostics and drug discovery. The pace by which
this mix migrates will be determined by the level of customer adoption and
frequency of use of our products and services. Our revenue may fluctuate from
period to period due to the uncertain nature of delivery of our products and
services, the achievement of milestones by us or our customers, timing of
expenses incurred, changes in estimates of total anticipated costs related to
our Genentech Agreement and other events not within our control, such as the
delivery of customer samples or customer decisions to no longer pursue their
development initiatives.
Due to the ongoing uncertainties related to the COVID-19 pandemic, we may
experience variability in revenue in the near term as restrictions in our
customers' abilities to procure samples for their research initiatives change,
as customer initiatives evolve and as clinical testing is impacted. For more
information, see the section of this report captioned "Risk Factors-The COVID-19
pandemic could adversely impact portions of our business that rely on research
and development activities or clinical trials and delay or disrupt our pipeline,
which may adversely impact revenue."
Cost of Revenue
Cost of revenue includes the cost of materials, personnel-related expenses
(comprised of salaries, benefits and share-based compensation), shipping and
handling, equipment and allocated facility costs associated with processing
samples and professional support for our sequencing revenue. Allocated facility
costs include depreciation of laboratory equipment, allocated facility occupancy
and information technology costs. Costs associated with processing samples are
recorded as expense, regardless of the timing of revenue recognition. As such,
cost of revenue and related volume does not always trend in the same direction
as revenue recognition and related volume. Additionally, costs to support our
Genentech Agreement are a component of our research and development activities.
We expect cost of revenue to increase in absolute dollars as we grow our
sequencing volume but the cost per sample to decrease over the long term due to
the efficiencies we may gain as sequencing volume increases from improved
utilization of our laboratory capacity, automation and other value engineering
initiatives. If our sample volume throughput is reduced as a result of the
COVID-19 pandemic or otherwise, cost of revenue as a percentage of total revenue
may be adversely impacted due to fixed overhead costs.
Research and Development Expenses
Research and development expenses consist of laboratory materials costs,
personnel-related expenses, equipment costs, allocated facility costs,
information technology expenses and contract service expenses. Research and
development activities support further development and refinement of existing
assays and products, discovery of new technologies and investments in our immune
medicine platform. We also include in research and development expenses the
costs associated with software development activities to support laboratory
scaling and workflow, as well as development of applications to support future
commercial opportunities. We are currently conducting research and development
activities for several products and services and we typically use our laboratory
materials, personnel, facilities, information technology and other development
resources across multiple development programs. Additionally, certain of these
research and development activities benefit more than one of our product
opportunities. We do not track research and development expenses by specific
product candidates.
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A component of our research and development activities is supporting clinical
and analytical validations to obtain regulatory approval for future clinical
products and services. Additionally, the costs to support our Genentech
Agreement are a component of our research and development activities. Some of
these activities have generated and may in the future generate development
revenue.
We expect our research and development expenses to continue to increase in
absolute dollars as we innovate and expand the application of our platform.
However, we expect research and development expenses to decrease as a percentage
of revenue in the long term, although the percentage may fluctuate from period
to period due to the timing and extent of our development and commercialization
efforts. While the pace and priorities of our research and development
initiatives may continue to be impacted by the COVID-19 pandemic, we expect to
continue to increase expenses in both the near and long-term to support our
ongoing initiatives, which include our initiatives with respect to COVID-19.
Sales and Marketing Expenses
Sales and marketing expenses consist primarily of personnel-related expenses for
commercial sales, account management, marketing, reimbursement, medical
education and business development personnel that support commercialization of
our platform products. In addition, these expenses include external costs such
as advertising expenses, customer education and promotional expenses, market
analysis expenses, conference fees, travel expenses and allocated facility
costs.
We expect our sales and marketing expenses to increase in absolute dollars as we
expand our commercial sales, marketing and business development teams and
increase marketing activities to drive awareness and adoption of our products
and services. However, we expect sales and marketing expenses to decrease as a
percentage of revenue in the long term, subject to fluctuations from period to
period due to the timing and magnitude of these expenses.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related
expenses, including share-based compensation, salaries and benefits for our
personnel in executive, legal, finance and accounting, human resources and other
administrative functions, including third-party billing services. In addition,
these expenses include insurance costs, external legal costs, accounting and tax
service expenses, consulting fees and allocated facility costs.
We expect our general and administrative expenses to continue to increase in
absolute dollars as we increase headcount. Though expected to increase in
absolute dollars, we expect these expenses to decrease as a percentage of
revenue in the long term as revenue increases.
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