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Item 2. Management’s Discussion and Analysis

2022-05-09 compared with 2021-11-08 · 284 added, 300 removed, 144 unchanged (80% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes and other financial information included in this Quarterly Report on Form 10-Q and our audited financial statements and notes thereto as of and for the years ended December 31, 2020 and 2019 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, including Critical Accounting Policies and Significant Judgments and Estimates, included in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission, or the SEC, on March 11, 2021.

You should read the following discussion and analysis of financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes and other financial information included in this Quarterly Report on Form 10-Q and our audited financial statements and notes thereto as of and for the years ended December 31, 2021 and 2020 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, including the section entitled “Critical Accounting Estimates,” included in our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2022.

Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “we,” “us” and “our” refer to Castle Biosciences, Inc.

Forward-Looking Statements

The information in this discussion contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those sections.

The information in this discussion contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are subject to the “safe harbor” created by those sections.

These forward-looking statements include, but are not limited to, statements concerning the impacts of COVID-19 on our business, our strategy, future operations, future financial position, future revenues, projected costs, prospects and plans and objectives of management.

The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

The words “anticipate,” “believe,” “estimate,” “expect,” “potential,” “may,” “plan,” “will,” “would” or the negative or plural of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements.

Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make.

Actual results or events could differ materially from the plans, intentions or expectations disclosed in the forward-looking statements that we make.

These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, the risks set forth in Part II, Item 1A., “Risk Factors” in this Quarterly Report on Form 10-Q and in our other filings with the SEC.

The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

We are a commercial-stage dermatological cancer company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions.

We believe that the traditional approach to developing a treatment plan for certain cancers using clinical and pathology factors alone is inadequate and can be improved by incorporating personalized genomic information.

Our non-invasive products utilize proprietary algorithms to provide an assessment of a patient’s specific risk of metastasis or recurrence of their cancer, allowing physicians to identify patients who are likely to benefit from an escalation of care as well as those who may avoid unnecessary medical and surgical interventions.

Since our inception in 2008, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, discovering product candidates, conducting clinical study activities to generate evidence demonstrating the clinical validity, clinical utility, economic benefits, and patient outcomes of our products, and commercialization activities for those products.

We currently market five proprietary multianalyte assay with algorithmic analysis gene expression profile, or GEP, products and generate substantially all of our revenue from DecisionDx-Melanoma and DecisionDx-UM.

Our lead product, DecisionDx®-Melanoma, is a proprietary GEP test that predicts the risk of metastasis or recurrence (risk-stratifies) for patients diagnosed with invasive cutaneous melanoma, a deadly skin cancer.

This test has two current clinically actionable uses.

The first use immediately following diagnosis predicts a patient’s likelihood of having a sentinel lymph node negative biopsy result so that physicians and patients can discuss the risk and benefit of undergoing sentinel lymph node biopsy, or SLNB, surgery.

The second use is to inform the appropriate treatment plan, regardless of the decision to undergo or avoid the SLNB surgery.

In a typical year, we estimate more than 130,000 patients are diagnosed with invasive cutaneous melanoma in the United States.

Castle Biosciences is improving health through innovative tests that guide patient care.

For the diseases that our portfolio of tests cover, we believe the traditional approach to developing a treatment plan for cancers and other diseases using clinical and pathology factors alone is inadequate and can be improved by incorporating the personalized information our diagnostic and prognostic tests provide.

We currently market five proprietary multi-analyte assays with algorithmic analysis (“MAAAs”) designed to answer clinical questions in dermatologic cancers, uveal melanoma (“UM”) (a rare cancer of the eye) and Barrett’s esophagus (“BE”).

We also have a pharmacogenomic test to guide optimal drug treatment for patients suffering from depression, anxiety and other mental health conditions following our acquisition of AltheaDx, Inc.

(“AltheaDx”) in April 2022, as discussed below.

Our revenue is primarily generated by our DecisionDx®-Melanoma risk stratification test for cutaneous melanoma, a deadly skin cancer, and our DecisionDx®-UM risk stratification test for UM.

The foundation of our business is our dermatologic cancer franchise, and our lead product is DecisionDx-Melanoma, a proprietary risk stratification gene expression profile (“GEP”) test that predicts the risk of metastasis or recurrence for patients diagnosed with invasive cutaneous melanoma.

In the management of melanoma, as with nearly all diseases, treatment plans are directed by patient risk-stratification.

This test has two distinct, complementary clinically actionable uses.

The first revolves around predicting the likelihood of having a sentinel lymph node (“SLN”) negative biopsy result so that physicians and patients can discuss the risk and benefit of undergoing the SLN biopsy (“SLNB”) surgical procedure.

The second use is to inform the appropriate treatment plan during the initial five years post-diagnosis, regardless of the decision to undergo or avoid invasive SLNB surgery.

In a typical year, we estimate approximately 130,000 patients are diagnosed with invasive cutaneous melanoma in the United States.

We launched DecisionDx-Melanoma in May 2013.

We also market DecisionDx®-UM, which is a proprietary GEP test that predicts the risk of metastasis (risk-stratifies) for patients with uveal melanoma, a rare eye cancer.

Based on the substantial clinical evidence that we have developed, we have received Medicare coverage for DecisionDx-Melanoma, which represents approximately 50% of the addressable patient population for this test.

On August 31, 2020, we commercially launched our cutaneous squamous cell carcinoma (“SCC”) proprietary GEP test, DecisionDx®‑SCC, for use in patients with one or more risk factors (also referred to as “high-risk” SCC).

On November 2, 2020, we commercially launched our proprietary GEP test for difficult-to-diagnose melanocytic lesions, DecisionDx® DiffDx™-Melanoma, for use in patients with a melanocytic lesion and uncertainty related to the malignancy of the lesion.

We believe that these two additional skin cancer tests address areas of high clinical need in dermatological cancer and, together, represent an estimated addressable population of approximately 500,000 patients in the United States.

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We further expanded our commercially available dermatologic portfolio in May 2021 when we acquired Myriad myPath, LLC (the “Myriad myPath Laboratory”) from Myriad Genetics, Inc.

for a cash purchase price of $32.5 million.

myPath Melanoma is a clinically validated GEP test that addresses the same unmet clinical need as our DecisionDx DiffDx-Melanoma test.

Today, we offer both our myPath Melanoma test and our DecisionDx DiffDx-Melanoma test under an offering that we refer to as our comprehensive diagnostic offering (“CDO”) of molecular testing solutions.

By offering both of these tests in a single offering, we believe we have demonstrated the ability to improve the test result performance for patients with difficult-to-diagnose melanocytic lesions.

In 2021, we announced the launch of our innovative pipeline initiative to develop a genomic test aimed at predicting response to systemic therapy in patients with moderate to severe psoriasis, atopic dermatitis and related inflammatory skin conditions.

In the United States alone, there are approximately 18 million patients diagnosed with psoriasis and atopic dermatitis.

Approximately 450,000 of these patients annually are eligible for systemic therapies.

If successful, this inflammatory skin disease pipeline test has the potential to add approximately $1.9 billion to our current estimated U.S.

total addressable market (“TAM”).

In 2021, we initiated a 4,800 patient, prospective, multi-center clinical study to develop and validate this pipeline test and have 52 committed sites and approximately 146 patients enrolled.

Based upon our current development and validation timelines, we expect to have initial validation and development data in 2023 and to commercialize this pipeline test by the end of 2025.

In addition to our dermatologic franchise, we also market a test for patients diagnosed with UM.

DecisionDx®-UM is a proprietary, risk stratification GEP test that predicts the risk of metastasis for patients with UM.

We believe DecisionDx-UM is the standard of care in the management of newly diagnosed UM in the majority of ocular oncology practices in the United States.

We launched DecisionDx-UM in January 2010.

Based on the substantial clinical evidence that we have developed, we have received Medicare coverage for DecisionDx-Melanoma and DecisionDx-UM, which represents approximately 50% of the addressable patient population for both of these tests.

In August 2020, we commercially launched our cutaneous squamous cell carcinoma, or SCC, proprietary GEP test, DecisionDx® ‑ SCC, and on November 2, 2020, we commercially launched our proprietary GEP test for suspicious pigmented lesions, DecisionDx® DiffDx™-Melanoma.

These two indications are areas of high clinical need in dermatological cancer and, together, represent an addressable population of approximately 500,000 patients in the United States.

In May 2021, we completed the acquisition of all the equity of Myriad myPath, LLC, or the Myriad myPath Laboratory, from Myriad Genetics for a cash purchase price of $32.5 million.

myPath Melanoma is a clinically validated GEP test designed to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone.

Our myPath Melanoma offering complements our DecisionDx DiffDx-Melanoma offering and enables us to provide a comprehensive diagnostic offering (or CDO) molecular testing solution for difficult-to-diagnose melanocytic lesions.

In May 2021, we announced the launch of our innovative pipeline initiative to develop a genomic test aimed at predicting systemic therapy response in patients with moderate to severe psoriasis, atopic dermatitis and related conditions.

alone, there are approximately 18 million patients diagnosed with psoriasis and atopic dermatitis, and approximately 450,000 of these patients annually are eligible for these systemic therapies, which has the potential to add approximately $1.9 billion to our current estimated U.S.

total addressable market.

We recently initiated a 4,800 patient, prospective, multi-center clinical study to develop and validate this pipeline test, and plan to enroll more than 50 centers with the leading experts in the field.

Based upon our current development and validation timelines, we expect to launch this pipeline test by the end of 2025.

In October 2021, we signed a definitive agreement to acquire Cernostics, Inc., or Cernostics.

Cernostics specializes in spatial biology and artificial intelligence-driven image analysis of tissue biopsies.

Its TissueCypher® Barrett’s Esophagus Assay is a precision medicine test designed to predict future development of high-grade dysplasia and/or esophageal cancer in patients with Barrett’s esophagus.

Under the terms of the definitive agreement, Cernostics will become our wholly owned subsidiary.

Upon finalization of the transaction, the management team and other staff based in Pittsburgh are expected to stay with us.

Cernostics’ laboratory and operations will remain in Pittsburgh.

We believe the combined strengths of Castle and Cernostics will position us for continued growth and success in the diagnostics space, complementing our first-to-market dermatologic franchise.

At closing, we will pay upfront consideration of approximately $30 million, which may consist entirely of cash or a combination of $20 million in cash and $10 million in shares of our common stock, at our sole discretion.

Under the definitive agreement, we have also agreed to pay up to an additional $50 million in cash or our common stock, at our sole discretion, based on the achievement of certain commercial milestones relating to the year ending December 31, 2022.

The closing is subject to delivery of certain financial statements to us by Cernostics, the continued of employment of certain Cernostics personnel and satisfaction of other customary conditions.

We have processed over 90,000 clinical samples since our inception.

For the nine months ended September 30, 2021 our revenue was $69.0 million compared to $45.4 million for the nine months ended September 30, 2020.

Based on the substantial clinical evidence that we have developed, we have received Medicare coverage for DecisionDx-UM, which represents approximately 50% of the addressable patient population for this test.

In December 2021, we extended our commercial portfolio of proprietary tests into the gastroenterology market through our acquisition of Cernostics, Inc.

(“Cernostics”) and the TissueCypher® platform.

The TissueCypher platform focuses on unlocking, in the case of the initial test for use in patients with BE, the importance of the location of the expression of proteins or lack thereof within the morphology of the disease (also known as spatialomics).

This “spatialomic” information is then interpreted using artificial intelligence approaches to predict the likelihood of progression to high-grade dysplasia and/or esophageal cancer in patients with non-dysplastic, indefinite or low-grade dysplasia BE.

We believe the addition of expertise in the spatialomics area positions us for continued growth and success in the diagnostics space, complementing our first-to-market dermatologic franchise and our proprietary test for UM.

On April 26, 2022, we completed our acquisition of AltheaDx, a commercial-stage molecular diagnostics company specializing in the field of pharmacogenomics (“PGx”) testing services that are focused on mental health, and the provider of IDgenetix, a PGx test for mental health conditions.

At closing, $65.0 million in initial consideration was payable by us to AltheaDx security holders, which consisted of $32.5 million in cash, subject to adjustments for cash, debt, transaction expenses and working capital, and $32.5 million in shares of our common stock.

Further, up to an additional $75.0 million in cash and common stock may become payable in connection with the achievement of certain milestones based on 2022, 2023 and 2024 performance and expanded Medicare coverage for the IDgenetix test.

This acquisition enables us to offer a testing solution that we believe has the potential to accelerate our impact on patient care in an area of high unmet clinical need, significantly expand our in-market estimated U.S.

TAM by approximately $5.0 billion and offer incremental value to patients and clinicians over the standard of care trial-and-error approach.

A randomized controlled trial showed that patients diagnosed with depression, who were assessed with the IDgenetix test, showed a 2.5 times improvement in remission rates compared to those who did not have their genes tested.

The number of test reports we generate is a key indicator that we use to assess our business.

A test report is generated when we receive a sample in our laboratory, the relevant information relating to that test is entered into our Laboratory Information Management System, the genomic profile of the sample is performed and a report providing the results of that profile is sent to the physician who ordered the test.

The numbers of DecisionDx-Melanoma, DecisionDx-SCC, DecisionDx DiffDx-Melanoma and myPath Melanoma (collectively, our comprehensive diagnostic offering for difficult-to-diagnose melanocytic lesions, or CDO), and DecisionDx-UM test reports delivered by us during the nine months ended September 30, 2021 and 2020 are presented in the table below:

A test report is generated when we receive a sample in our laboratory, and then the relevant test information is entered into our Laboratory Information Management System, the expression of the biomarkers is measured, then a proprietary algorithmic analysis of the combined biomarkers is performed to generate a report providing the results of that analysis, which is sent to the clinician who ordered the test.

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The number of GEP test reports delivered by us during the three months ended March 31, 2022 and 2021 and for the year ended December 31, 2021 are presented in the table below:

Proprietary Dermatologic GEP Tests

DecisionDx-SCC (1)

Dermatologic Total DecisionDx-UM Grand Total

Q1 2021 4,060 527 218 4,805 337 5,142

Melanoma DecisionDx-SCC CDO (1)

Dermatologic Total DecisionDx-UM TissueCypher Barrett’s Esophagus (2)

Q1 2022 6,023 1,142 950 8,115 456 56 8,627

Q1 2021 4,060 527 218 4,805 337 — 5,142

For the nine months ended September 30, 2021

14,693 2,245 1,758 18,696 1,180 19,876

Q2 2021 5,128 784 627 6,539 468 — 7,007

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Q4 2021 5,635 1,265 904 7,804 438 27 8,269

For the nine months ended September 30, 2020 11,986 57 — 12,043 985 13,028

(1) We commercially launched the DecisionDx-SCC test on August 31, 2020.

(2) Includes DecisionDx DiffDx-Melanoma, which we commercially launched on November 2, 2020, and myPath Melanoma, which we began offering following the completion of the acquisition of Myriad myPath Laboratory on May 28, 2021.

For a discussion of how we recognize revenue derived from our GEP tests, refer to “Net Revenues” under “Components of Results of Operations” below.

The principal focus of our current commercial efforts is to distribute our molecular diagnostic testing products through our direct sales force in the U.S.

We began 2020 with 32 outside sales territories.

In the third quarter of 2020, we expanded our commercial team to create a dedicated sales force of ten territories to support the launch of our DecisionDx Diff-Dx Melanoma test to dermatopathologists.

During the first half of 2021, we folded this dedicated team into our existing sales team as well as completed a further expansion, bringing our dermatologic sales force to the mid-60s.

In connection with our pending acquisition of Cernostics, we expect to hire a dedicated commercial team of initially 13 to 15 outside sales territories, along with commensurate internal sales associates and medical science liaisons, to support the TissueCypher Barrett’s Esophagus Assay.This dedicated team will focus on gastroenterology specialists that diagnose and manage patients with Barrett’s Esophagus.

For year ended December 31, 2021 20,328 3,510 2,662 26,500 1,618 27 28,145

(1) Includes DecisionDx DiffDx-Melanoma, which we commercially launched on November 2, 2020, and myPath Melanoma, which we began offering following our acquisition of the Myriad myPath Laboratory on May 28, 2021.

We offer both myPath Melanoma and DecisionDx DiffDx-Melanoma under our CDO.

(2) We began offering the TissueCypher Barrett’s Esophagus test on December 3, 2021, following the completion of our acquisition of Cernostics.

For the three months ended March 31, 2022, our dermatologic test report volume increased by 68.9% compared to the prior period in 2021, largely driven by continued growth from our DecisionDx-Melanoma test.

For a discussion of how we recognize revenue derived from our tests, refer to “Net Revenues” under “Components of Results of Operations” below.

The principal focus of our current commercial efforts is to educate clinicians and pathologists on the value of our molecular diagnostic testing products through our direct sales force in the United States.

During the first half of 2021, we expanded our dermatologic commercial team, bringing our dermatologic sales force to the mid-60s.

In connection with our acquisition of Cernostics in December 2021, we hired an initial commercial team of approximately 14 outside sales territories, along with commensurate internal sales associates and medical science liaisons, to support our launch of the TissueCypher Barrett’s Esophagus test.

This dedicated team focuses on gastroenterology specialists that diagnose and manage patients with BE.

Similar to our dermatology commercial team, we will continue to assess market response and determine what an appropriate commercial expansion will look like.

Based on our initial market research, as well as initial provider response, we expect to add approximately 10-15 additional outside sales territories sometime in the third quarter, ending the year with approximately 25-30 outside sales territories.

AltheaDx, which we acquired in late April 2022, had a commercial team covering approximately 20 outside sales territories, all of whom have continued with Castle following the transaction.

We continue to see new clinicians order our dermatologic tests for the first time.

For the nine months ended September 30, 2021, we saw approximately 1,408 new ordering clinicians for our dermatologic tests compared to 1,047 during the same period of 2020.

For the three months ended March 31, 2022, we saw approximately 592 new ordering clinicians for our dermatologic tests compared to 410 during the same period of 2021.

Total ordering clinicians for our dermatologic tests were approximately 3,629 and 2,456 for the three months ended March 31, 2022 and 2021, respectively.

For additional information on the metrics we disclose, refer to “Information About Certain Metrics” below.

In developing our DecisionDx-SCC and DecisionDx DiffDx-Melanoma tests, we believed that in addition to addressing significant unmet clinical needs, we would see leverage as many of the current DecisionDx-Melanoma clinicians would likely be the same clinicians who would find value in these other skin cancer tests.

For example, we found that for the nine months ended September 30, 2021, approximately 76% of all DecisionDx-SCC ordering clinicians were clinicians that had also ordered our DecisionDx-Melanoma test during that same period.

In developing our DecisionDx-SCC and DecisionDx DiffDx-Melanoma tests, we believed that in addition to addressing significant unmet clinical needs, we would see strategic opportunities for leverage, as many of the clinicians currently ordering DecisionDx-Melanoma would likely be the same clinicians who would find value in these other dermatologic GEP tests.

For example, we found that for the three months ended March 31, 2022, approximately 56% of all clinicians ordering DecisionDx-SCC had also ordered our DecisionDx-Melanoma test during that same period.

We bill third-party payors and patients for the tests we perform.

The majority of our revenue collections is paid by third-party insurers, including Medicare.

We have received Local Coverage Determinations, or LCDs, which provide coverage for our DecisionDx-Melanoma, myPath Melanoma and DecisionDx-UM tests that meet certain criteria for Medicare and Medicare Advantage beneficiaries, representing approximately 60 million covered lives.

As it relates to DecisionDx-UM, we have contracts or have received positive medical policy decisions from additional payors representing approximately 83 million covered lives.

A ‘‘covered life’’ means a subscriber, or a dependent of a subscriber, who is insured under an insurance policy for such an insurance carrier.

Palmetto GBA MolDx, or Palmetto, the Medicare Administrative Contractor, or MAC, responsible for administering MolDX, the program that assesses molecular diagnostic technologies, issued a final expanded LCD for DecisionDx-Melanoma, effective November 22, 2020.

We have received local coverage determinations (“LCDs”), which provide coverage for our DecisionDx-Melanoma, myPath Melanoma, DecisionDx-UM and IDgenetix tests that meet certain criteria for Medicare and Medicare Advantage beneficiaries, representing approximately 60 million covered lives.

In 2022, DecisionDx-UM received coverage from United Healthcare that represents approximately 43 million covered lives.

A ‘‘covered life’’ means a subscriber, or a dependent of a subscriber, who is insured under an insurance carrier’s policy.

The TissueCypher Barret’s Esophagus test is paid by Medicare at the rate published on Medicare’s Clinical Laboratory Fee Schedule (“CLFS”) for the test.

Effective March

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24, 2022, we received ADLT status for our TissueCypher test, as discussed further below.

ADLT status exempts TissueCypher from what is called the “14-day rule,” which simplifies the billing process for Medicare patients.

Palmetto GBA MolDX (“Palmetto”), the Medicare Administrative Contractor (“MAC”) responsible for administering MolDX, the program that assesses molecular diagnostic technologies, issued a final expanded LCD for DecisionDx-Melanoma, effective November 22, 2020.

With this expanded LCD and the accompanying billing and coding articles, we estimate that a significant majority of the DecisionDx-Melanoma tests performed for Medicare patients will meet the coverage criteria.

Noridian Healthcare Solutions, LLC, or Noridian, the MAC responsible for administering claims for laboratory services performed in Arizona, has adopted the same coverage policy as Palmetto and also issued an expanded final LCD for DecisionDx-Melanoma, effective December 6, 2020.

On May 17, 2019, the Centers for Medicare & Medicaid Services, or CMS, determined that DecisionDx-UM meets the criteria for existing advanced diagnostic laboratory test, or ADLT, status, also referred to as “existing ADLT” status.

Accordingly, in 2021 the DecisionDx-UM Medicare rate will be set annually based upon the median private payor rate for the first half of the second preceding calendar year.

Note that our rate for 2020 was set by Noridian, our local MAC, but our rate for 2021 for DecisionDx-UM is $7,776 based on the median private payor rate.

Noridian Healthcare Solutions, LLC (“Noridian”), the MAC responsible for administering claims for laboratory services performed in Arizona, has adopted the same coverage policy as Palmetto and also issued an expanded final LCD for DecisionDx-Melanoma, effective December 6, 2020.

Separately, Palmetto issued a final LCD for DecisionDx-UM, which became effective in July 2017, and Noridian issued a similar LCD that became effective in September 2017.

The Noridian LCD provides for coverage to determine metastatic risk in connection with the management of a patient’s newly diagnosed UM and to guide surveillance and referral to medical oncology for those patients.

On May 17, 2019, Centers for Medicare & Medicaid Services (“CMS”) determined that DecisionDx-UM meets the criteria for “existing advanced diagnostic laboratory test” status, also referred to as “existing ADLT” status.

For 2020, our rate was set by Noridian, our local MAC, but effective in 2021 our rate is set annually based upon the median private payor rate for the first half of the second preceding calendar year.

Our rate for 2021 was $7,776 and will remain at $7,776 for 2022, in each case based on the calculation of the median private payor rate.

Also, on May 17, 2019, CMS determined that DecisionDx-Melanoma meets the criteria for “new ADLT” status.

Accordingly, from July 1, 2019, through March 31, 2020, the Medicare reimbursement rate was equal to the initial list price of $7,193.

From April 1, 2020 through December 31, 2021, CMS notified us that the rate will also be $7,193, which was calculated based upon the median private payor rate for DecisionDx-Melanoma from July 1, 2019 to November 30, 2019.

B eginning in 2022, the rate for both DecisionDx-Melanoma and UM will be set annually based upon the median private payor rate for the first half of the second preceding calendar year.

From April 1, 2020, through December 31, 2021, the rate was also $7,193, which was calculated based upon the median private payor rate for DecisionDx-Melanoma from July 1, 2019 to November 30, 2019.

CMS has informed us that the rate for 2022 will continue to be $7,193, based on the median private payor rate.

myPath Melanoma is currently covered under a MolDX LCD policy through Noridian, which oversees laboratories in both Utah and Arizona.

Noridian issued an LCD that became effective in June 2019.

On September 6, 2019, myPath Melanoma was approved as a new ADLT.

The rate for 2022 will be $1,950.

Beginning in 2023, the rates for DecisionDx-Melanoma, DecisionDx-UM, and myPath Melanoma tests will be set annually based upon the median private payor rate for the first half of the second preceding calendar year.

For example, the rate for 2023 will be set using median private payor rate data from January 1, 2021 to June 30, 2021.

TissueCypher is performed in our Pittsburgh, Pennsylvania laboratory and falls under the Medicare jurisdiction that is managed by Novitas Solutions (“Novitas”).

Novitas previously reviewed TissueCypher and we are receiving payments for claims according to the CLFS.

For 2022, CMS published in its CLFS a payment amount of $2,513 for the test.

On March 24, 2022, CMS determined that TissueCypher meets the criteria for “new ADLT” status.

From April 1, 2022 through December 31, 2022, CMS has set the initial period rate equal to the original list price of $2,350, subject to the possible recoupment provision described below.

Effective January 1, 2023, the rate will be based on the median private payer rates received between April 1, 2022 and August 31, 2022.

Note that for TissueCypher tests reported for April 1, 2022 through December 31, 2022, CMS has the right to recoup the difference between the actual list and 130% of the weighted median if the original list price was greater than 130% of the weighted median of private payor rates.

IDgenetix is currently covered under a MolDX LCD policy and an accompanying billing and coding article through Noridian, which oversees laboratories in California.

The Medicare coverage includes depression and was recently expanded for the following seven additional mental health conditions beyond major depressive disorder:

schizophrenia, bipolar disorder, anxiety disorders, panic disorder, obsessive-compulsive personality disorder, post-traumatic stress disorder and attention deficit hyperactivity disorder.

The IDgenetix multi-gene panel is currently reimbursed by Medicare at approximately $1,500.

In the second quarter of 2020, we submitted our technical assessment dossier for DecisionDx-SCC to Palmetto and Noridian.

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The dossier was accepted as complete in the first quarter of 2021.

As of today, the Palmetto MolDx program has not posted a second open comment period for 2021.

Accordingly, given the proximity to year end, we believe that the next open comment period for MolDx LCDs will be in the first quarter of 2022.

However, there is no assurance

that the timing of any draft LCD or final LCD will match our expectations or our historical experience with LCDs for our other tests.

In the second quarter of 2021, Noridian and certain other MACs posted a draft revised LCD for DecisionDx-Melanoma.

The draft LCD includes commentary about certain recent publications regarding the clinical utility of GEP tests and was posted to give providers an opportunity to comment.

Each of the draft LCDs include an assessment stating that the MAC does not believe that the new data are sufficient to change the coverage criteria.

We have submitted comments on the draft LCD.

The comment period on the last of these draft LCDs closed on August 8, 2021.

We are unable to predict any future developments related to this matter.

Since becoming a public company, we have financed our operations with the revenue generated from the sale of our products, proceeds from our July 2019 initial public offering, or IPO, follow-on public offerings of common stock in June 2020 and December 2020 and bank debt, which has since been repaid in full.

We believe that our existing cash and cash equivalents and anticipated cash generated from sales of our products will be sufficient to fund our operations for the foreseeable future.

However, we have based these estimates on assumptions, including those related to the impact of COVID-19 on our financial condition, that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

Our net (loss) income may fluctuate significantly from period to period, depending on the timing of our planned development activities, the growth of our sales and marketing activities and the timing of revenue recognition under Accounting Standards Codification Topic 606, Revenue from Contracts with Customers , or ASC 606.

We are unable to predict when draft LCDs for DecisionDx-SCC and DecisionDx DiffDx-Melanoma will be posted and there is no assurance that any draft or final LCD will match our expectations, be posted in a timeframe consistent with our historical experience or will be posted at all.

In the second quarter of 2021, Palmetto and the other MACs that participate in the MolDX program each released a revised draft LCD for DecisionDx-Melanoma.

The draft LCD includes commentary about two publications regarding the clinical utility of GEP tests and includes an assessment stating that the new data is not sufficient to change the coverage criteria.

There was an open public comment period, and we submitted comments in support of Medicare coverage.

The comment period ended on

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August 8, 2021.

Potential outcomes following the public comment period include the posting of a final LCD consistent with the draft LCD, issuing a final LCD with coverage changes or not issuing a final LCD at all.

We are unable to predict the ultimate outcome of this matter.

Since becoming a public company, we have financed our operations with the revenue generated from the sale of our products, proceeds from our initial public offering of our common stock (our “IPO”) that closed in July 2019, follow-on public offerings of common stock in June 2020 and December 2020 and bank debt, which has since been repaid in full.

We believe that our existing cash and cash equivalents and anticipated cash generated from sales of our products will be sufficient to fund our operations for the next 12 months and into the foreseeable future.

However, we have based these estimates on assumptions which may prove to be wrong and could result in us depleting our capital resources sooner than expected.

We expect our expenses will increase substantially over time as we:

• execute clinical studies to generate evidence supporting our current and future product candidates;

• execute our commercialization strategy for our current and future products;

• continue our ongoing and planned development of new products;

• execute our commercialization strategy for our current and future commercial products;

• continue our ongoing and planned development of new products in our pipeline;

• seek to discover and develop additional product candidates;

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Impact of COVID-19 Pandemic

We are continuing to closely monitor the impact of the COVID-19 pandemic on our business and are taking proactive efforts designed to protect the health and safety of our workforce, continue our business operations and advance our corporate objectives.

We are continuing to closely monitor the impact of the ongoing COVID-19 pandemic on our business and taking proactive efforts designed to protect the health and safety of our workforce, continue our business operations and advance our corporate objectives.

We are providing the following update with respect to the impact of COVID-19 on our business:

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We have continued to maintain our previously implemented adjustments to our operations designed to keep employees safe and comply with federal, state and local guidelines, including those regarding social distancing.

• Following the onset of the COVID-19 pandemic, we began experiencing declines in orders and test report volume.

For the year ended December 31, 2020, our growth in DecisionDx-Melanoma test report volume was 4.5%, compared to year-over-year growth of 29.1% for the year ended December 31, 2019.

In the first quarter of 2021, test reports delivered for DecisionDx-Melanoma decreased by 11.2% compared to the first quarter of 2020.

We believe the decreases in our test report volume in the first quarter of 2021 were linked to delays in the diagnoses as well as the cumulative impact on promotional responsiveness as a result of reduced sales calls per day and in-person sales call during the COVID-19 pandemic.

• We saw positive trends in orders and test report volume in the second and third quarters of 2021.

In the second and third quarters of 2021, test reports delivered for DecisionDx-Melanoma increased by 70.5% and 25.0%, respectively, compared to the same quarters in 2020.

On a sequential basis, second quarter 2021 test report volume for DecisionDx-Melanoma increased by 26.3% compared to the first quarter of 2021 and third quarter 2021 test report volume for DecisionDx-Melanoma increased by 7.4% compared to the second quarter of 2021.

• Following the onset of the COVID-19 pandemic, we experienced declines in orders and test report volume in certain periods.

For example, in the second quarter of 2020, test reports delivered for our lead product, DecisionDx-Melanoma, decreased 18.5% compared to the second quarter of 2019.

We believe these decreases in our test report volume were linked to delays and/or cancellations in patient visits, resulting in fewer diagnostic biopsies and thus a reduction in the number of diagnoses of cutaneous melanoma in response, as well as the cumulative impact on promotional responsiveness as a result of reduced sales calls per day and in-person sales calls during the ongoing COVID-19 pandemic.

• Our commercial team uses a combination of in-person, virtual and non-personal promotional and educational efforts.

Since the beginning of 2021, we have seen improvement in both the number of promotional calls per day as well as a continued shift from virtual to in-person sales calls.

During the three-months ended September 30, 2021, in-person sales calls accounting for approximately 90% of all calls during such period.

Since the beginning of 2021, we have seen improvements in the number of promotional calls per day, as well as a continued shift from virtual to in-person sales calls.

During the three months ended March 31, 2022 and 2021, in-person sales calls accounted for over 95% and 75% of all calls during such periods, respectively.

However, we have not yet achieved pre-COVID-19 levels of calls per day per sales representative.

• Our future results will be dependent upon the extent and duration of the COVID-19 crisis, including the emergence and spread of variants of the virus, such as the Delta variant, and government restrictions, which are beyond our control.

• Our future results will be dependent upon the extent and duration of the COVID-19 crisis, including the emergence and spread of variants of the virus, and government restrictions, which are beyond our control.

Although state and local government restrictions put in place to slow the spread of the virus have been eased in certain locations, restrictions may be reinstated from time to time in various regions depending on the circumstances, potentially impacting the flow of future patient visits as well as access to our sales targets.

Even with the easing of state and local restrictions and the availability of vaccinations, patient visits and diagnosis of cutaneous melanoma may be impacted by continued apprehension regarding possible exposure to the virus.

For example, our analysis of third-party data indicates that cutaneous melanoma diagnoses during the three months ended September 30, 2021 remain approximately 16% below historical 2019 levels.

• We continue to believe our cash and cash equivalents and anticipated cash to be generated from sales of our products, will be sufficient to fund our operations for the foreseeable future.

As conditions are continuously evolving, we are unable to predict how our future test report volume will be impacted or the extent to which our results of operations, financial condition or cash flows will be impacted by the COVID-19 pandemic, or other future public health crises.

Even with the easing of state and local restrictions and the availability of vaccinations, patient visits and diagnoses of the diseases covered by our diagnostic and prognostic test may be impacted by continued apprehension regarding possible exposure to the virus as well as a general shift from in-person clinical visits to telehealth approaches, which may result in missed or delayed diagnoses of skin cancer and other diseases.

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As conditions are continuously evolving, we are unable to predict how our future test report volume will be impacted, or the extent to which our results of operations, financial condition or cash flows will be impacted, by the ongoing COVID-19 pandemic or other future public health crises.

Accordingly, the test report data presented above is not necessarily indicative of our results of operations that can be expected for future periods.

For more information on the potential impact of the COVID-19 pandemic on our business, see the risk factors included under “Risks Related to Our Business” and the other risk factors included in Part II, Item 1A., “Risk Factors,” of this Quarterly Report on Form 10-Q.

For more information on the potential impact of the ongoing COVID-19 pandemic on our business, see the risk factors included under “Risks Related to Our Business” and the other risk factors included in Part II, Item 1A., “Risk Factors” in this Quarterly Report on Form 10-Q.

Factors affecting our performance

We believe there are several important factors that have impacted and that we expect will impact our operating performance and results of operations, including:

We believe there are several important factors that have impacted, and that we expect will continue to impact, our operating performance and results of operations, including:

• Report volume.

We believe that the number of reports we deliver to physicians is an important indicator of growth of adoption among the healthcare provider community.

We believe that the number of reports we deliver to physicians is an important indicator of the growth of adoption among the healthcare provider community.

Our revenue and costs are affected by the volume of testing and mix of customers.

Our performance depends on our ability to retain and broaden adoption with existing prescribing physicians, as well as attract new physicians.

In the near term, our report volume may be negatively impacted by ongoing developments with the COVID-19 pandemic, as discussed above.

In the near term, our report volume may be negatively impacted by ongoing developments of the ongoing COVID-19 pandemic, as discussed above.

• Reimbursement.

We believe that expanding reimbursement is an important indicator of the value of our products.

Payors require extensive evidence of clinical utility, clinical validity, patient outcomes and health economic benefits in order to provide reimbursement for diagnostic products.

Payors require extensive evidence of clinical utility, clinical validity, patient outcomes and health economic benefits in order to provide reimbursement for diagnostic and prognostic products.

Our revenue depends on our ability to demonstrate the value of our products to these payors.

• Gross margin.

We believe that our gross margin is an important indicator of the operating performance of our business.

Higher gross margins reflect the average selling price of our tests, as well as the operating efficiency of our laboratory operations.

• New product development.

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The following provides additional information about certain metrics we have disclosed in this Management’s Discussion and Analysis of Financial Condition and Results of Operation.

Test reports delivered for DecisionDx-Melanoma, DecisionDx-SCC, DecisionDx DiffDx-Melanoma, myPath Melanoma and DecisionDx-UM represents the number of completed test reports delivered by us during the reporting period indicated.

Test reports delivered for DecisionDx-Melanoma, DecisionDx-SCC, myPath Melanoma/DecisionDx DiffDx-Melanoma, DecisionDx-UM and the TissueCypher Barrett’s Esophagus test represents the number of completed test reports delivered by us during the reporting period indicated.

The period in which a test report is delivered does not necessarily correspond with the period the related revenue, if any, is recognized, due to the timing and amount of adjustments for variable consideration under ASC 606.

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We also sometimes present, on a limited basis, data on the number of orders received.

We believe order data can provide additional insight on current demand trends, particularly during the COVID-19 pandemic

and with respect to new product launches, when considered in conjunction with test report volume.

We believe order data can provide additional insight on current demand trends, particularly during the ongoing COVID-19 pandemic and with respect to new product launches, when considered in conjunction with test report volume.

However, orders received in a particular period do not necessarily correspond with actual delivered test reports or reported revenues for the same period or subsequent periods.

New ordering clinicians for our dermatologic tests represents the number of clinicians who ordered a dermatologic test from us for the first time during the reporting period specified.

A dermatologic test is DecisionDx-Melanoma, DecisionDx-SCC or our CDO.

We believe this metric is useful in evaluating the effectiveness of our sales and marketing efforts in establishing new relationships with clinicians and increasing the adoption of our dermatologic tests.

Our dermatologic tests consist of DecisionDx-Melanoma, DecisionDx-SCC and our CDO.

We also believe this metric provides useful information to investors in assessing our ability to expand the use of our dermatologic tests.

Since this metric is based upon the reporting period in which an order is placed, it does not necessarily correspond to the reporting period in which a test report was delivered or in which any revenue was recognized.

Since this metric is based upon the reporting period in which an order is placed, it does not necessarily correspond to the reporting period in which either a test report was delivered or revenue was recognized.

Components of the Results of Operations

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We bill third-party payors and patients for the tests we perform.

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Under ASC 606, we recognize revenue at the amount we expect to be entitled, subject to a constraint for variable consideration, in the period in which our tests are delivered to the treating physicians.

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Variable consideration is evaluated each reporting period and adjustments are recorded as increases or decreases in revenues.

Variable consideration for Medicare claims that are not covered by an LCD, including those claims subject to approval by an Administrative Law Judge, or ALJ, at an appeal hearing, is deemed to be fully constrained due to factors outside our influence (i.e., judgment or actions of third parties) and the uncertainty of the amount to be received is not expected to be resolved for a long period of time.

Variable consideration for Medicare claims that are not covered by an LCD or otherwise, including those claims undergoing appeal, is deemed to be fully constrained due to factors outside our influence (i.e., judgment or actions of third parties) and the uncertainty of the amount to be received is not expected to be resolved for a long period of time.

For these fully constrained claims, we generally recognize revenue in the period the uncertainty is favorably resolved, if at all.

Due to potential future changes in Medicare coverage policies and appe al cycles, insurance coverage policies, contractual rates and other trends in the reimbursement of our tests, our revenues may fluctuate significantly from period to period.

Due to potential future changes in Medicare coverage policies and appeal cycles, insurance coverage policies, contractual rates and other trends in the reimbursement of our tests, our revenues may fluctuate significantly from period to period.

Additionally, our ability to recognize revenue for our recently launched tests, DecisionDx-SCC and DecisionDx DiffDx-Melanoma, is dependent on the development of reimbursement experience and coverage decisions for these tests.

Due to limited reimbursement experience, we are currently recognizing revenues for these two tests on the basis of actual cash collections.

Our ability to increase our revenues will depend on our ability to further penetrate our target market, and, in particular, generate sales through our direct sales force, develop and commercialize additional tests, obtain reimbursement from additional third-party payors and increase our reimbursement rate for tests performed.

Cost of Sales (exclusive of amortization of acquired intangible asset)

The components of our cost of sales are material and service costs associated with testing samples, personnel costs (including salaries, bonuses, benefits and stock-based compensation expense), electronic medical records, order and delivery systems, shipping charges to transport samples, third-party test fees, and allocated overhead including rent, information technology costs, equipment and facilities depreciation and utilities.

Costs associated with performing tests are recorded when the test is processed regardless of whether and when revenues are recognized with respect to that test.

Our ability to increase our revenues will depend on our ability to further penetrate our target markets, and, in particular, generate sales through our direct sales force, develop and commercialize additional tests, obtain reimbursement from additional third-party payors and increase our reimbursement rate for tests performed.

Cost of Sales (exclusive of amortization of acquired intangible assets)

The components of our cost of sales are material and service costs associated with testing samples, personnel costs (including salaries, bonuses, benefits and stock-based compensation expense), electronic medical record set up costs, order and delivery systems, shipping charges to transport samples, third-party test fees, and allocated overhead including rent, information technology costs, equipment and facilities depreciation and utilities.

Costs associated with testing samples are recorded when the test is processed regardless of whether and when revenues are recognized with respect to that test.

As a result, our cost of sales as a percentage of revenues may vary significantly from period to period because we do not recognize all revenues in the period in which the associated costs are incurred.

We expect cost of sales in absolute dollars to increase as the number of tests we perform increases.

Additionally, we expect cost of sales to increase with the expansion of laboratory capacity and staffing in advance of anticipated growth of our recently launched tests.

Additionally, we expect cost of sales to increase with the expansion of laboratory capacity and staffing in advance of the anticipated growth of our recently launched tests.

Gross margin and gross margin percentage are key indicators we use to assess our business.

See the table in “Results of Operations—Comparison of the three months ended March 31, 2022 and 2021” for details.

Research and Development

Research and development expenses include costs incurred to develop our genomic tests, collect clinical samples and conduct clinical studies to develop and support our products.

Research and development expenses include costs incurred to develop our diagnostic and prognostic tests, collect clinical samples and conduct clinical studies to develop and support our products.

These costs consist of personnel costs (including salaries, bonuses, benefits and stock-based compensation expense), prototype materials, laboratory supplies, consulting costs, regulatory costs, electronic medical records set up costs, costs associated with setting up and conducting clinical studies and allocated overhead, including rent, information technology, equipment depreciation and utilities.

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We expect our research and development expenses to increase in absolute dollars as we continue to invest in research and development activities related to developing enhanced and new products.

We expect to use a portion of the proceeds from the June 2020 and December 2020 follow-on public offerings to further support and accelerate our research and development activities, including three important studies that are underway to support our DecisionDx-Melanoma test.

We expect to use a portion of our cash and cash equivalents to further support and accelerate our research and development activities, including three important studies that are underway to support our DecisionDx-Melanoma test.

The first is the PERSONALize study, in which we are evaluating DecisionDx-Melanoma for interactions with adjuvant therapies.

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The third is the DECIDE study, which is designed to determine the association of GEP test results with SLNB surgical decisions in patients eligible for SLNB as well as to track outcomes for patients who did and did not undergo SLNB.

Also, as noted above, we recently initiated a 4,800 patient, prospective, multi-center clinical study to develop, validate and bring to market a pipeline test aimed at predicting systemic therapy response for patients with moderate to severe psoriasis, atopic dermatitis and related conditions.

Also, as noted above, in 2021, we initiated our 4,800 patient, prospective, multi-center clinical study to develop, validate and bring to market a pipeline test aimed at predicting response to systemic therapy in patients with moderate to severe psoriasis, atopic dermatitis and related inflammatory skin conditions.

We have also initiated two additional disease studies for pipeline tests for new indications.

Selling, General and Administrative

Selling, general and administrative, or SG&A, expenses include executive, selling and marketing, legal, finance and accounting, human resources, billing and client services.

These expenses consist of personnel costs (including salaries, bonuses, benefits and stock-based compensation expense), direct marketing expenses, audit and legal expenses, consulting costs, training and medical education activities, payor outreach programs and allocated overhead, including rent, information technology, equipment depreciation, and utilities.

We expect continued increases in SG&A expenses related to compliance with the rules and regulations of the SEC and The Nasdaq Stock Market LLC, or Nasdaq, investor relations activities, and additional insurance expenses.

Selling, general and administrative (“SG&A”) expenses include executive, selling and marketing, legal, finance and accounting, human resources, billing and client services.

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equipment depreciation, and utilities.

We expect continued increases in SG&A expenses related to compliance with the rules and regulations of the SEC and The Nasdaq Stock market LLC (“Nasdaq”) (in particular as we have become a large accelerated filer), investor relations activities and additional insurance expenses.

Other administrative and professional services expenses within SG&A are expected to increase with the scale of our business, but selling and marketing-related expenses are expected to increase significantly, consistent with our growth strategy.

Amortization of Acquired Intangible Asset

Amortization of acquired intangible asset is related to the developed technology we acquired in May 2021, which is attributable to the myPath Melanoma test for difficult-to-diagnose melanocytic lesions.

Other Operating Loss

Other operating loss reflects the reversal of previously recognized other operating income associated with an automatic payment for relief funds received from the U.S.

Department of Health and Human Services, or HHS, pursuant to the Coronavirus Aid, Relief and Economic Security Act enacted on March 27, 2020, or the CARES Act, as discussed further below.

Amortization of Acquired Intangible Assets

Amortization of acquired intangible assets are primarily associated with developed technology.

Change in Fair Value of Contingent Consideration

Change in fair value of contingent consideration is associated with our acquisition of Cernostics and the related additional consideration of up to $50.0 million that may become payable based on the achievement of certain commercial milestones relating to the year ending December 31, 2022 (the “Earnout Payments”).

Interest Income

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Interest Expense

Interest expense, if any, is attributable to borrowings under our term debt and also includes the amortization of debt discount and issuance costs.

Interest expense is primarily attributable to a finance lease.

Income Tax Expense

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Certain prior year amounts in the tables below have been reclassified to conform to the current year presentation.

Specifically, we no longer present gross margin and therefore the cost of sales line is now presented within the operating expenses section.

This reclassification had no impact on operating (loss) income, loss before income taxes or net loss.

Comparison of the three months ended September 30, 2021 and 2020

Specifically, we no longer present gross margin on the face of our financial statements and therefore the cost of sales line is now presented within the operating expenses section.

This reclassification had no impact on operating loss, loss before income taxes or net loss.

The calculation of our gross margin is instead presented in a separate table in following section.

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Comparison of the three months ended March 31, 2022 and 2021

The following table summarizes our results of operations for the periods indicated (in thousands, except percentages):

Three Months Ended

September 30, Change

March 31, Change

Net revenues $ 26,852 $ 22,813 $ 4,039 17.7 %

Operating expenses and other operating loss:

Cost of sales (exclusive of amortization of acquired intangible asset) 4,500 2,475 2,025 81.8 %

Operating expenses

Cost of sales (exclusive of amortization of acquired intangible assets) 5,944 3,028 2,916 96.3 %

Research and development 10,761 5,908 4,853 82.1 %

Selling, general and administrative 30,453 18,161 12,292 67.7 %

Amortization of acquired intangible asset 694 — 694 NA

Other operating loss — 1,882 (1,882) (100.0) %

Amortization of acquired intangible assets 1,648 — 1,648 NA

Change in fair value of contingent consideration 2,562 — 2,562 NA

Total operating expenses 51,368 27,097 24,271 89.6 %

Operating loss (11,814) (3,901) (7,913) NM

Interest income 23 18 5 27.8 %

Interest expense — (706) 706 100.0 %

Loss before income taxes (11,791) (4,589) (7,202) NM

Operating loss (24,516) (4,284) (20,232) (472.3) %

Interest income 30 4 26 NM

Interest expense (3) — (3) NA

Loss before income taxes (24,489) (4,280) (20,209) (472.2) %

Income tax expense 134 — 134 NA

Net loss $ (11,791) $ (4,589) $ (7,202) NM

Net loss $ (24,623) $ (4,280) $ (20,343) (475.3) %

NA = Not applicable

NM = Not meaningful

The following table indicates the amount of stock-based compensation expense reflected in the line items above (in thousands):

The following table provides a disaggregation of net revenues by type (in thousands):

Three Months Ended

September 30,

2022 2021 Change

Cost of sales (exclusive of amortization of acquired intangible asset) $ 555 $ 268 $ 287

Research and development 1,135 370 765

Selling, general and administrative 3,520 1,480 2,040

Total stock-based compensation expense $ 5,210 $ 2,118 $ 3,092

For the three months ended September 30, 2021 net revenues increased by $8.3 million, or 54.3%, to $23.5 million compared to the three months ended September 30, 2020 and was primarily attributable to higher DecisionDx-Melanoma and DecisionDx-UM test revenues.

Overall, the increased revenues reflect both higher report volumes for both DecisionDx-Melanoma and DecisionDx-UM and higher per-unit revenues, partially offset by the effects of revenue adjustments related to tests delivered in prior periods.

We believe the higher test report volume during the three months ended September 30, 2021 reflects the relaxing of COVID-19 restrictions and the related positive impacts on the flow of patient visits as well as the effects of our sales force expansion.

The higher per-unit revenues include the effect of the expanded LCD for DecisionDx-Melanoma that became effective in the fourth quarter of 2020 and the higher Medicare rate for DecisionDx-UM that became effective January 1, 2021, as discussed above.

For the three months ended September 30, 2021, we experienced a 24.5% increase in total DecisionDx-Melanoma and DecisionDx-UM test reports delivered, compared to the three months ended September 30, 2020.

For the three months ended September 30, 2021 and 2020, we recorded net (negative) positive revenue adjustments of $(0.1) million and $1.5 million, respectively, related to tests delivered in previous periods, associated with changes in estimated variable consideration.

Cost of Sales (exclusive of amortization of acquired intangible asset)

Cost of sales (exclusive of amortization of acquired intangible asset) for the three months ended September 30, 2021 increased by $2.0 million, or 81.8%, compared to the three months ended September 30, 2020, primarily due to increased costs for supplies and services, attributable to the higher activity levels, as well as higher personnel costs due to additional headcount in our laboratory testing operations.

Due to the nature of our business, a significant portion of our cost of sales expenses represent fixed costs associated with our testing operations.

Accordingly, our cost of sales expense will not necessarily increase or decrease commensurately with the change in net revenues from period to period.

Research and Development

Research and development expenses increased by $4.4 million, or 145.3%, for the three months ended September 30, 2021, compared to the three months ended September 30, 2020.

Approximately 55% of the increase was associated with increased personnel costs, which were primarily attributable to additional headcount, with the remainder primarily attributable to increases in other expenses associated with increased clinical study activity.

Stock-based compensation expense included in research and development expense was $1.1 million for the three months ended September 30, 2021 compared to $0.4 million for the same period in 2020, reflecting both higher post-IPO stock option valuations as well as additional awards outstanding due to growth in headcount.

Selling, General and Administrative

SG&A expense increased by $10.9 million, or 93.1%, for the three months ended September 30, 2021 compared to the three months ended September 30, 2020.

Approximately 67% of the increase is attributable to higher personnel costs, particularly due to increased headcount.

We expanded our sales organization headcount in the third quarter of 2020 in preparation for the commercial launch of our DecisionDx DiffDx-Melanoma test and further expanded our sales team during the first and second quarters of 2021, bringing our dermatology-facing commercial team to the mid-60s.

The higher personnel costs also reflect expanded headcount in our administrative support functions.

The remainder of the increase was primarily associated with higher travel costs and additional expenses related to conferences and training events.

Stock-based compensation expense included in SG&A expense was $3.5 million for the three months ended September 30, 2021 compared to $1.5 million for the same period in 2020, reflecting both higher post-IPO stock option valuations as well as additional awards outstanding due to growth in headcount.

Amortization of Acquired Intangible Asset

Amortization of acquired intangible asset for the three months ended September 30, 2021 of $0.7 million is related to the developed technology we acquired in May 2021, which is attributable to the myPath Melanoma test.

Other Operating Loss

Other operating loss for the three months ended September 30, 2020 of $1.9 million consists entirely of the reversal of previously recognized income for the automatic payment received from HHS for relief funds pursuant to the CARES Act.

In the second quarter of 2020, based on guidance issued by HHS at the time that stated any reasonable method could be used to calculate lost revenues attributable to COVID-19, we concluded we would qualify to retain the relief funds and recognized the funds received as other operating income during the three months ended June 30, 2020.

On September 19, 2020, HHS issued a notice of reporting requirements that changed the methodology for determining lost revenues to be based on a patient care operating income metric, as defined by HHS.

Due to this change in methodology and uncertainty in its application, we determined we were no longer reasonably assured of keeping the funds.

Therefore, in the three months ended September 30, 2020, we reversed the previously recognized income.

However, in the fourth quarter of 2020, a legislative change was enacted affecting the program, under which we concluded it is reasonably assured we will qualify to retain the funds.

Accordingly, we recognized the income again in the fourth quarter of 2020.

Interest Expense

Interest expense decreased by $0.7 million, or 100.0%, for the three months ended September 30, 2021 compared to the three months ended September 30, 2020.

The decrease is attributable to the repayment of our outstanding debt in full in December 2020.

Stock-Based Compensation Expense

Stock-based compensation expense, which is allocated among cost of sales, research and development expense and SG&A expense, totaled $5.2 million for the three months ended September 30, 2021 compared to $2.1 million for the three months ended September 30, 2020.

We expect material increases in stock-based compensation expense in future periods, reflecting both higher post-IPO stock option valuations as well as additional awards outstanding due to growth in our headcount.

As of September 30, 2021 we had 311 employees compared to 201 as of December 31, 2020.

As of September 30, 2021, the total unrecognized stock-based compensation cost related to outstanding awards was $56.3 million, which is expected to be recognized on a straight-line basis over a weighted-average period of 2.9 years.

We expect to continue granting stock-based compensation awards, which we expect to further contribute to increases in stock-based compensation expense in future periods.

Results of Operations

Comparison of the nine months ended September 30, 2021 and 2020

The following table summarizes our results of operations for the periods indicated (in thousands, except percentages):

Nine Months Ended

September 30, Change

Dermatologic (1)

$ 24,339 $ 20,910 $ 3,429

2,513 1,903 610

Total net revenues $ 26,852 $ 22,813 $ 4,039

(1) Consists of DecisionDx-Melanoma, DecisionDx-SCC and CDO.

(2) Consists primarily of DecisionDx-UM.

The following table presents the calculation of gross margin (in thousands, except percentages):

Three Months Ended

2022 2021 Change

Net revenues $ 26,852 $ 22,813 $ 4,039

Operating expenses:

Cost of sales (exclusive of amortization of acquired intangible asset) 11,225 7,012 4,213 60.1 %

Research and development 20,201 8,675 11,526 132.9 %

Selling, general and administrative 61,578 33,173 28,405 85.6 %

Amortization of acquired intangible asset 950 — 950 NA

Total operating expenses 93,954 48,860 45,094 92.3 %

Operating loss (24,908) (3,510) (21,398) NM

Interest income 51 354 (303) (85.6) %

Interest expense — (2,239) 2,239 100.0 %

Loss before income taxes (24,857) (5,395) (19,462) NM

Income tax expense 5 — 5 NA

Net loss $ (24,862) $ (5,395) $ (19,467) NM

NA = not applicable

NM = not meaningful

The following table indicates the amount of stock-based compensation expense reflected in the line items above (in thousands):

Nine Months Ended

September 30,

Cost of sales (exclusive of amortization of acquired intangible assets) 5,944 3,028 2,916

Amortization of acquired intangible assets 1,648 — 1,648

Gross margin $ 19,260 $ 19,785 $ (525)

Gross margin percentage 71.7 % 86.7 % (15.0) %

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The following table indicates the amount of stock-based compensation expense (non-cash) reflected in the line items above (in thousands):

Three Months Ended

2022 2021 Change

Cost of sales (exclusive of acquired intangible asset amortization) $ 1,480 $ 674 $ 806

Cost of sales (exclusive of amortization of acquired intangible assets) $ 853 $ 510 $ 343

Research and development 1,828 1,058 770

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Total stock-based compensation expense $ 8,419 $ 4,913 $ 3,506

For the nine months ended September 30, 2021 net revenues increased by $23.7 million, or 52.3%, to $69.0 million compared to the nine months ended September 30, 2020 and was primarily attributable to higher DecisionDx-Melanoma and DecisionDx-

UM test revenues.

To a lesser extent, the year-over-year increase also reflects revenues from DecisionDx-SCC, which commercially launched in August 2020.

Overall, the increased revenues reflect higher test report volumes for both DecisionDx-Melanoma and DecisionDx-UM, higher per-unit revenues on these tests and higher positive revenue adjustments related to tests delivered in prior periods.

We believe the higher test report volume for DecisionDx-Melanoma and DecisionDx-UM during the nine months ended September 30, 2021 reflects the relaxing of COVID-19 restrictions, and the related positive impacts on the flow of patient visits, as well as the effects of our sales force expansion.

For the nine months ended September 30, 2021, we experienced a 22.4% increase in total DecisionDx-Melanoma and DecisionDx-UM test reports delivered, compared to the nine months ended September 30, 2020.

For the nine months ended September 30, 2021 and 2020, we recorded net positive revenue adjustments of $4.1 million and $0.2 million, respectively, related to tests delivered in previous periods, associated with changes in estimated variable consideration.

The year-over-year increase is primarily attributable to favorable adjustments related to the settlement and collection during the nine months ended September 30, 2021 of certain groups of receivables from prior years.

Cost of Sales (exclusive of amortization of acquired intangible asset)

Cost of sales (exclusive of amortization of acquired intangible asset) for the nine months ended September 30, 2021 increased by $4.2 million, or 60.1%, compared to the nine months ended September 30, 2020, primarily due to higher personnel costs due to additional headcount in our laboratory testing operations and increased costs for supplies and services, attributable to the higher activity levels.

Net revenues for the three months ended March 31, 2022 increased by $4.0 million, or 17.7%, to $26.9 million compared to the three months ended March 31, 2021, primarily due to $3.4 million higher revenue from dermatologic tests, primarily DecisionDx-Melanoma, and to a lesser extent, higher revenues from our other tests (non-dermatologic) of $0.6 million.

The increase in dermatologic revenue was primarily attributable to a 69% increase in test volumes, with higher test reports delivered across each of our dermatologic offerings, due to a combination of increased patient flow attributable to the easing of COVID-19 restrictions and the effects of our dermatologic sales force expansion during the first half of 2021.

The higher volumes were partially offset by the effect of lower positive revenue adjustments related to tests delivered in previous periods, associated with changes in estimated variable consideration, which were $0.6 million for the three months ended March 31, 2022 compared to $5.3 million for the three months ended March 31, 2021.

The year-over-year decrease is primarily attributable to the effect of favorable adjustments related to the settlement and collection during the three months ended March 31, 2021 of certain groups of receivables from prior years that did not recur during the three months ended March 31, 2022.

The increase in revenue from our other tests (non-dermatologic) of $0.6 million was primarily attributable to higher volume of DecisionDx-UM, which we believe is largely attributable to the easing of COVID-19 restrictions.

Cost of Sales (exclusive of amortization of acquired intangible assets)

Cost of sales (exclusive of amortization of acquired intangible assets) for the three months ended March 31, 2022 increased by $2.9 million, or 96.3%, compared to the three months ended March 31, 2021, primarily due to higher personnel costs, attributable to additional headcount in our laboratory testing operations, including headcount attributable to the addition of Cernostics, as well as increased costs of supplies and services, attributable to the higher activity levels.

Due to the nature of our business, a significant portion of our cost of sales expenses represent fixed costs associated with our testing operations.

Accordingly, our cost of sales expense will not necessarily increase or decrease commensurately with the change in net revenues from period to period.

Stock-based compensation expense included in cost of sales expense was $1.5 million for the nine months ended September 30, 2021 compared to $0.7 million for the same period in 2020, reflecting both higher post-IPO stock option valuations as well as additional awards outstanding due to growth in headcount.

We expect our cost of sales (exclusive of amortization of acquired intangible assets) to continue to increase in future periods as we hire additional laboratory personnel and related resources to support our expected growth in volume for our dermatologic, gastrointestinal, mental health and pipeline tests.

Our gross margin percentage was 71.7% for the three months ended March 31, 2022, compared to 86.7% for the same period in 2021.

The decrease was primarily due to this year’s amortization expense associated with our acquired intangible assets, lower positive revenue adjustments related to tests delivered in previous periods and additional investments in laboratory headcount.

In the near term, we expect that our gross margin percentage will decline, compared to prior periods, as we invest in additional laboratory personnel and related resources to support the anticipated growth in our report volumes for tests in advance of obtaining reimbursement coverage.

Additionally, our gross margin percentage will continue to be negatively impacted by amortization of intangible assets associated with recent acquisitions.

Research and Development

Research and development expenses increased by $11.5 million, or 132.9%, for the nine months ended September 30, 2021, compared to the nine months ended September 30, 2020.

Approximately 61% of the increase was associated with increased personnel costs, which were primarily attributable to additional headcount, with the remainder primarily attributable to increases in other expenses associated with increased clinical study activity.

Stock-based compensation expense included in research and development expense was $3.3 million for the nine months ended September 30, 2021 compared to $0.8 million for the same period in 2020, reflecting both higher post-IPO stock option valuations as well as additional awards outstanding due to growth in headcount.

Research and development expenses increased by $4.9 million, or 82.1%, for the three months ended March 31, 2022, compared to the three months ended March 31, 2021.

Approximately 51% of the increase is attributable to higher personnel costs, primarily due to expansions in headcount in support of our growth, including higher stock-based compensation expense of $0.8 million, and approximately 20% is attributable to higher costs for clinical studies, including costs related to the PERSONALize, CONNECTION and DECIDE studies.

The remainder of the increase is primarily associated with meeting costs and travel expenses.

We expect to continue to increase our research and development expenses as we fund ongoing evidence development for our existing products as well as additional pipeline programs.

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Selling, General and Administrative

SG&A expense increased by $28.4 million, or 85.6%, for the nine months ended September 30, 2021 compared to the nine months ended September 30, 2020.

Approximately 68% of the increase is attributable to higher personnel costs, particularly due to increased headcount.

We expanded our sales organization headcount in the third quarter of 2020 in preparation for the commercial launch of our DecisionDx DiffDx-Melanoma test and further expanded our sales team during the nine months ended September 30, 2021, bringing our dermatology-facing commercial team to the mid-60s.

The higher personnel costs also reflect expanded headcount in our administrative support functions.

The remainder of the increase was primarily associated with additional expenses related to conferences and training events as well as higher travel costs.

Stock-based compensation expense included in SG&A expense was $10.1 million for the nine months ended September 30, 2021 compared to $3.8 million for the same period in 2020, reflecting both higher post-IPO stock option valuations as well as additional awards outstanding due to growth in headcount.

Amortization of Acquired Intangible Asset

Amortization of acquired intangible asset for the nine months ended September 30, 2021 of $1.0 million is related to the developed technology we acquired in May 2021, which is attributable to the myPath Melanoma test.

We estimate that going forward, this amortization will be approximately $2.8 million per year, or $0.7 million per quarter.

Interest Income

Interest income decreased by $0.3 million for the nine months ended September 30, 2021 compared to the nine months ended September 30, 2020.

The decrease is primarily associated with significantly lower interest rates this year, despite our higher average balances of cash and cash equivalents.

Interest Expense

Interest expense decreased by $2.2 million, or 100.0%, for the nine months ended September 30, 2021 compared to the nine months ended September 30, 2020.

The decrease is attributable to the repayment of our outstanding debt in full in December 2020.

The following table provides a breakdown of SG&A expenses (in thousands):

Three Months Ended

2022 2021 Change

Sales and marketing $ 18,221 $ 9,656 $ 8,565

General and administrative 12,232 8,505 3,727

Total selling, general and administrative expense $ 30,453 $ 18,161 $ 12,292

Sales and marketing expenses increased by $8.6 million, or 88.7%, for the three months ended March 31, 2022, compared to three months ended March 31, 2021.

Approximately $5.4 million, or 63%, of the increase is attributable to higher personnel costs including salaries, bonuses and stock-based compensation.

Stock-based compensation expense included in sales and marketing expense was $2.8 million for the three months ended March 31, 2022, compared to $1.5 million for the three months ended March 31, 2021.

Personnel costs have increased through the expansion of our dermatology-facing commercial team headcount to the mid-60s during the first and second quarters of 2021 and through our acquisition of Cernostics in December 2021, where we hired an initial commercial team of approximately 14 outside sales territories, along with commensurate internal sales associates and other personnel, to support our launch of the TissueCypher Barrett’s Esophagus test and to serve as a dedicated team focused on gastroenterology specialists that diagnose and manage patients with BE.

The remainder of the increase in sales and marketing expenses was primarily associated with training events, meetings, travel and other general increases.

The higher expenses for training events and travel reflect both a higher headcount as well a return to more in-person activities resulting from the continued easing of COVID-19 restrictions.

We expect sales and marketing expenses to increase in future periods as we intend to expand our outside sales territories and sales force further during 2022, as discussed under “Overview” above.

General and administrative expenses increased by $3.7 million, or 43.8%, for the three months ended March 31, 2022, compared to three months ended March 31, 2021.

The increase is primarily attributable to $2.6 million in higher personnel costs including salaries, bonuses and stock-based compensation.

Stock-based compensation expense included in general and administrative expense was $2.6 million for the three months ended March 31, 2022, compared to $1.4 million for the three months ended March 31, 2021.

The higher personnel costs reflect expanded headcount in our administrative support functions.

The remainder of the increase in general and administrative expenses was primarily associated with professional fees and other general increases.

Amortization of Acquired Intangible Assets

Amortization of acquired intangible assets was $1.6 million for the three months ended March 31, 2022 and was primarily associated with amortization of developed technology attributable to the acquisitions of Myriad myPath, LLC and Cernostics in May 2021 and December 2021, respectively.

There was no such amortization during the three months ended March 31, 2021.

Change in Fair Value of Contingent Consideration

The change in fair value of contingent consideration for the three months ended March 31, 2022 of $2.6 million is related to the remeasurement of the Earnout Payments associated with our acquisition of Cernostics and primarily reflects the passage of time.

There was no such activity during the three months ended March 31, 2021.

Stock-Based Compensation Expense

Stock-based compensation expense, which is allocated among cost of sales, research and development expense and SG&A expense, totaled $14.9 million for the nine months ended September 30, 2021 compared to $5.3 million for the nine months ended September 30, 2020.

As of September 30, 2021 we had 311 employees compared to 201 as of December 31, 2020.

Stock-based compensation expense, which is allocated among cost of sales, research and development expense and SG&A expense, totaled $8.4 million for the three months ended March 31, 2022, compared to $4.9 million for the three months ended March 31, 2021.

We expect material increases in stock-based compensation expense in future periods, reflecting mainly higher awards outstanding due to growth in our headcount.

As of March 31, 2022, we had 400 employees compared to 242 as of March 31, 2021.

As of March 31, 2022, the total unrecognized stock-based compensation cost related to outstanding awards was $97.1 million, which is expected to be recognized on a straight-line basis over a weighted-average period of 3.1 years.

We expect to continue granting stock-based compensation awards, which we expect to further contribute to increases in stock-based compensation expense in future periods.

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Liquidity and Capital Resources

Sources of Liquidity

Our principal sources of liquidity are our cash and cash equivalents and cash generated from sales of our products.

As of September 30, 2021 and December 31, 2020, we had cash and cash equivalents of $363.2 million and $409.9 million, respectively.

In addition to the revenue generated from the sale of our products, we have financed our operations since July 2019 through the IPO and two follow-on public offerings of common stock in June 2020 and December 2020.

Our principal sources of liquidity are our cash and cash equivalents and cash generated from the sale of our products.

As of March 31, 2022 and December 31, 2021, we had cash and cash equivalents of $309.0 million and $329.6 million, respectively.

In addition to the revenue generated from the sale of our commercial products, we have financed our operations through our IPO in July 2019, two follow-on public offerings of common stock in June 2020 and December 2020, and a $25.0 million secured term loan credit facility, which we repaid in full in December 2020.

On December 14, 2020, we filed an automatically effective shelf registration statement on Form S-3 (File No.

333-251331) with the SEC as a “well-known seasoned issuer.” The registration statement allows us to issue an indeterminate number or amount of common stock, preferred stock, debt securities and warrants from time to time in one or more offerings.

However, there can be no assurance that we will complete any such offerings of securities.

Any future offerings under this registration statement will be dependent upon, among other factors, market conditions, available pricing, our financial condition, investor perception of our prospects, our capital needs and our ability to maintain status as a well-known seasoned issuer.

As mentioned above, we expect to use a portion of these proceeds to further support and accelerate our research and development activities, including the clinical studies noted above.

Medicare Advance Payment

On April 16, 2020, we received an advance payment of $8.3 million, or the Advance Payment, from CMS under its Accelerated and Advance Payment Program, which was expanded to provide increased cash flow to service providers during the COVID-19 pandemic.

Recoupment of the Advance Payment commenced in April 2021.

For the first eleven months of recoupment, CMS will apply 25% of the Medicare payments otherwise owed to us against the balance of the Advance Payment.

After this eleven-month period, CMS will recoup at a rate of 50% of the Medicare payments otherwise owed to us for an additional six months.

If the Advance Payment is not fully recovered by CMS after this recoupment period, we will be required to repay any remaining balance.

Through September 30, 2021, $5.4 million has been applied against the balance of the Advance Payment.

Funding Requirements

Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, clinical research and development services, laboratory operations, equipment and related supplies, legal and other regulatory expenses, general administrative costs and, from time to time, expansion of our facilities in support of our growth.

We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on the commercialization of our existing

products, the development of our future product candidates, the potential commercialization of our product candidates, should their development be successful, and general administrative costs.

We may also, from time to time, consider various strategic opportunities, which may involve using a portion of our capital resources to fund acquisitions of businesses, assets, products or technologies.

In May 2021, we completed the acquisition of the Myriad myPath Laboratory for $32.5 million, which was funded with our existing cash and cash equivalents.

In October 2021, we signed a definitive agreement to acquire Cernostics.

At closing of the transaction, we will pay upfront consideration of approximately $30 million, which may consist entirely of cash or a combination of $20 million in cash and $10 million in shares of our common stock, at our sole discretion.

The transaction is expected to close prior to year-end 2021.

For additional information on each of these transactions, see page 18.

333-251331) (our “Shelf Registration Statement”) with the SEC as a “well-known seasoned issuer.” The Shelf Registration Statement allows us to issue an indeterminate number or amount of common stock, preferred stock, debt securities and warrants from time to time in one or more offerings.

However, there can be no assurance that we will complete any further offerings of securities under our Shelf Registration Statement.

Any future offerings under our Shelf Registration Statement will be dependent upon, among other factors, market conditions, available pricing, our financial condition, investor perception of our prospects, our capital needs and our ability to maintain status as a well-known seasoned issuer.

Our market capitalization as of May 6, 2022 is below the level required to maintain status as well-known seasoned issuer in the future.

As mentioned above, we expect to use a portion of our cash and cash equivalents, including any proceeds from subsequent offerings under our Shelf Registration Statement, to further support and accelerate our research and development activities, including the clinical studies noted above in “Components of the Results of Operations—Research and Development.”

Material Cash Requirements

We anticipate that a substantial portion of our cash requirements in the foreseeable future will relate to the further commercialization of our currently marketed products, the development of our future product candidates in our pipeline and the potential commercialization of these pipeline products, should their development be successful.

In December 2021, we acquired Cernostics for $30.7 million in cash and in April 2022, we acquired AltheaDx, for $32.5 million in cash and $32.5 million in shares of our common stock.

Under the definitive agreement to acquire Cernostics, we also agreed to pay up to an additional $50.0 million of Earnout Payments, based on the achievement of certain commercial milestones relating to the year ending December 31, 2022.

With respect to AltheaDx, we agreed to pay up to an additional $75.0 million, 50% in cash and 50% in common stock, based on the achievement of certain commercial milestones relating to the years ending December 31, 2022, 2023 and 2024.

Our actual liability with respect to these commercial milestone payments from our acquisitions will depend, in part, on our ability to successfully integrate the TissueCypher Barrett’s Esophagus test (acquired from Cernostics) and IDgenetix (acquired from AltheaDx) into our suite of commercial product offerings.

Since our inception, we have generally incurred significant losses and negative cash flows.

For the nine months ended September 30, 2021 we had a net loss of $24.9 million and an accumulated deficit of $87.4 million as of September 30, 2021.

For the year ended December 31, 2021 we had a net loss of $31.3 million and an accumulated deficit of $93.8 million as of December 31, 2021.

For the three months ended March 31, 2022, we had a net loss of $24.6 million and an accumulated deficit of $118.4 million as of March 31, 2022.

Our ability to generate revenue sufficient to achieve profitability will depend heavily on the successful commercialization of our currently marketed products and the products we plan to launch in the future as well as our spending on research and development activities.

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Further, we expect that any acquisitions of businesses, products, assets or technologies will also increase our expenses.

We believe that our existing cash and cash equivalents and anticipated cash generated from sales of our products will be sufficient to fund our operations for the foreseeable future.

We believe that our existing cash and cash equivalents and anticipated cash generated from the sale of our commercial products will be sufficient to fund our operations for the next twelve months.

We believe we will meet longer-term expected cash requirements and obligations through a combination of existing cash and cash equivalents, anticipated cash generated from sales of our products and issuances of equity securities or debt offerings, including through our Shelf Registration Statement.

However, we have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

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• acceptance of new genomic tests by physicians, patients and third-party payors.

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Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate our exact working capital requirements.

Our future funding requirements will depend on and could increase significantly as a result of many factors, including those listed above as well as those listed in Part II, Item 1A., “Risk Factors,” of this Quarterly Report on Form 10-Q.

We do not currently have any committed external source of funds.

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If we are unable to raise additional funds through debt or equity financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our product discovery and development activities or future commercialization efforts.

We have entered into various operating and finance leases, which are primarily associated with our laboratory facilities and office space.

Total undiscounted future minimum payment obligations under our operating leases and finance leases as of March 31, 2022 totaled approximately $10.3 million, of which $1.0 million is payable through the remainder of 2022 and $9.3 million through the end of 2033.

The leases expire on various dates through 2033 and provide certain options to renew for additional periods.

On March 11, 2022, we amended an existing lease agreement to lease additional laboratory space in Phoenix, Arizona.

On April 1, 2022, we entered into a new lease agreement with an initial term of 10.5 years for laboratory and office space located in Pittsburgh, Pennsylvania.

As of March 31, 2022, neither of the two leases had commenced.

Upon commencement, we expect these two leases to increase our undiscounted future minimum payment obligations by a total of approximately $13.8 million.

The following table summarizes our sources and uses of cash and cash equivalents for each of the periods presented (in thousands):

Nine Months Ended

September 30,

Net cash (used in) provided by operating activities $ (16,202) $ 10,295

Three Months Ended

Net cash used in operating activities $ (21,430) $ (3,631)

Net cash used in investing activities (402) (750)

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Operating Activities

Net cash used in operating activities was $16.2 million for the nine months ended September 30, 2021 and was primarily attributable to the net loss of $24.9 million, increases in accounts receivable of $6.1 million and recoupment of the Advance Payment of $5.4 million, partially offset by non-cash stock compensation expense of $14.9 million, increases in accrued compensation of $3.0 million and depreciation and amortization of $2.0 million.

Net cash provided by operating activities was $10.3 million for the nine months ended September 30, 2020 and was primarily attributable to the receipt of the Advance Payment of $8.3 million and the HHS relief funds of $1.9 million described above, stock compensation expense of $5.3 million and decreases in accounts receivable of $1.9 million, partially offset by the net loss of $5.4 million and increases in prepayments and other assets of $1.8 million.

Net cash used in operating activities was $21.4 million for the three months ended March 31, 2022, and was primarily attributable to the net loss of $24.6 million, decreases in accrued compensation of $6.9 million and increases in accounts receivable of $2.7 million, partially offset by non-cash stock compensation expense of $8.4 million, change in fair value of contingent consideration of $2.6 million and depreciation and amortization of $2.2 million.

Net cash used in operating activities was $3.6 million for the three months ended March 31, 2021, and was primarily attributable to the net loss of $4.3 million, decreases in accrued compensation of $3.9 million, increases in accounts receivable of $1.6 million and decreases in other accrued liabilities of $0.3 million, partially offset by stock compensation expense of $4.9 million and decreases in prepayments and other current assets of $1.7 million.

The $17.8 million additional net cash used in operating activities for the three months ended March 31, 2022 compared to the three months ended March 31, 2021 is primarily due to cash requirements associated with the increases in operating expenses, the majority of which were attributable to salaries, bonuses and benefits due to our growth in headcount, as discussed in further

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detail under “Results of Operations—Comparison of the three months ended March 31, 2022 and 2021” above.

The effect of the higher expenses on net cash used in operating activities was partially offset by the higher revenues.

Investing Activities

Net cash used in investing activities for the nine months ended September 30, 2021 consisted primarily of the purchase of Myriad myPath Laboratory of $33.2 million (including transaction costs) and purchases of property and equipment of $2.6 million.

Net cash used in investing activities for the nine months ended September 30, 2020 consisted entirely of purchases of property and equipment of $4.2 million.

Net cash used in investing activities for the three months ended March 31, 2022 and 2021 consisted of purchases of property and equipment in both periods.

Financing Activities

Net cash provided by financing activities was $5.3 million for the nine months ended September 30, 2021 and primarily consisted of $3.9 million in proceeds from the exercise of stock options and $1.8 million in proceeds from contributions to the employee stock purchase plan.

Net cash provided by financing activities was $78.1 million for the nine months ended September 30, 2020 and consisted primarily of $79.5 million in proceeds from our follow-on public offering of common stock (net of underwriting discounts, commissions and offering costs) and cash received associated with our equity compensation plans of $1.9 million, partially offset by principal repayments on our Loan and Security Agreement, dated November 30, 2018, with Oxford Finance LLC and Silicon Valley Bank of $3.3 million.

Critical Accounting Policies and Significant Judgments and Estimates

During the nine months ended September 30, 2021, except as noted below, there were no significant changes to the information discussed under “Critical Accounting Policies and Significant Judgments and Estimates” included in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of our Annual Report on Form 10-K for the year ended December 31, 2020.

Stock-Based Compensation

Previously, because of the limited period of time our stock had been traded in an active market, we calculated expected volatility by using the historical stock prices of a group of similar companies looking back over the estimated life of the option

or the purchase rights under our employee stock purchase plan and averaging the volatilities of these companies.

In the third quarter of 2021, we adjusted this calculation to include our own stock price on a relative basis to the peer group in the calculation of expected volatility, as our common stock has now been traded in an active market for more than two years.

Recent Accounting Pronouncements

Refer to Note 2, ‘‘Summary of Significant Accounting Policies,’’ in the accompanying notes to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for a discussion of recent accounting pronouncements.

JOBS Act Accounting Election

We are an emerging growth company within the meaning of the Jumpstart Our Business Startups Act, as amended, or the JOBS Act.

Section 107(b) of the JOBS Act provides that an emerging growth company can leverage the extended transition period, provided in Section 102(b) of the JOBS Act, for complying with new or revised accounting standards.

Thus, an emerging growth company can delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies.

We have elected to use this extended transition period and, as a result, our consolidated financial statements may not be comparable to companies that comply with public company effective dates.

We have also relied on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of Sarbanes-Oxley.

Because the market value of our common stock held by non-affiliates exceeded $700.0 million as of June 30, 2021, we will no longer be an emerging growth company effective December 31, 2021.

This means that the consolidated financial statements that we include in our next Annual Report on Form 10-K must comply with the public company adoption dates for new or revised accounting standards.

Further, we will be required to comply with the auditor attestation requirements of Section 404(b) of Sarbanes-Oxley regarding our internal control over financial reporting as of December 31, 2021.

Quantitative and Qualitative Disclosures About Market Risk.

As a smaller reporting company, we are not required to provide the information required by this Item.

Net cash provided by financing activities was $1.2 million for the three months ended March 31, 2022, and primarily consisted of $0.9 million in proceeds from contributions to the employee stock purchase plan and $0.4 million in proceeds from the exercise of stock options.

Net cash provided by financing activities was $1.5 million for the three months ended March 31, 2021, and primarily consisted of $1.0 million in proceeds from the exercise of stock options and $0.9 million in proceeds from contributions to the employee stock purchase plan.

Critical Accounting Estimates

During the three months ended March 31, 2022, there were no significant changes to the information discussed under “Critical Accounting Estimates” included in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of our Annual Report on Form 10-K for the year ended December 31, 2021.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

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Item 2. Management’s Discussion and Analysis