What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2023-05-03 compared with 2022-11-02 · 287 added, 400 removed, 188 unchanged (79% of the section changed)

11 unchanged sentences

Castle Biosciences is applying innovative diagnostics to inform disease management and improve patient outcomes.

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 (or risk stratification) tests provide.

Our Test Portfolio

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

We also offer a proprietary pharmacogenomic (“PGx”) test to guide optimal drug treatment for patients suffering from depression, anxiety and other mental health conditions following our acquisition of AltheaDx, Inc.

We currently offer five proprietary multi-analyte assays with algorithmic analysis (“MAAA”) tests for use in the dermatologic, ocular and gastroenterology fields.

We also offer a proprietary pharmacogenomics (“PGx”) 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.

Business Overview

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 (“U.S.”), representing an estimated U.S.

Currently, our revenue is primarily generated by our DecisionDx-Melanoma risk stratification test for cutaneous melanoma, our DecisionDx-SCC risk stratification test for cutaneous squamous cell carcinoma (“SCC”), our TissueCypher risk stratification test for Barrett’s esophagus (“BE”) and our DecisionDx-UM risk stratification test for uveal melanoma (“UM”).

Test Overview

Our Dermatologic Tests

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 a typical year, we estimate approximately 130,000 patients are diagnosed with invasive cutaneous melanoma in the United States, representing an estimated U.S.

total addressable market (“TAM”) of approximately $540 million.

We launched DecisionDx-Melanoma in May 2013.

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).

We estimate 20% of SCC patients, or 200,000 annually in the United States, are classified as high risk, representing an estimated U.S.

DecisionDx‑SCC is our proprietary GEP test for use in patients with SCC, with one or more risk factors (also referred to as “high-risk” SCC).

We estimate 20% of SCC patients, or 200,000 annually in the United States, are

classified as high risk, representing an estimated U.S.

TAM of approximately $820 million.

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

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 DiffDx-Melanoma test.

Today, we offer both our MyPath Melanoma test and our DiffDx-Melanoma test under an offering that we refer to as our Diagnostic GEP offering.

We believe we have demonstrated that offering both tests can lead to an improvement in actionable test results for patients with difficult-to-diagnose melanocytic lesions.

We launched DecisionDx-SCC in August 2020.

Initially, we offered both our MyPath Melanoma test and our DiffDx-Melanoma test under an offering that we referred to as our Diagnostic GEP offering for use in patients with a melanocytic lesion and uncertainty related to the malignancy of the lesion.

Of the two million suspicious pigmented lesions biopsied annually in the United States, we estimate approximately 300,000 of those present a difficult-to-diagnose melanocytic lesion, representing an estimated U.S.

TAM of approximately $600 million associated with these two tests.

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.

In 2021, we initiated a 4,800 patient, prospective, multi-center clinical study (our “IDENTITY Study”), to develop and validate this pipeline test and have 55 committed sites and approximately 337 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.

We launched DiffDx-Melanoma in November 2020 and began to offer MyPath Melanoma following our acquisition of Myriad myPath, LLC (“Myriad MyPath Laboratory”) from Myriad Genetics, Inc.

Our internal data indicates that we have improved the technical performance of MyPath Melanoma such that it is now comparable to the technical performance of DiffDx-Melanoma.

As such, following an internal assessment of the clinical value of offering both tests, we made the decision to suspend the clinical offering of DiffDx-Melanoma in February 2023.

Our Gastroenterology Test

The TissueCypher Barrett’s Esophagus Test is the world’s first precision medicine test designed to predict future development of high-grade dysplasia (“HGD”) and/or esophageal cancer in patients with non-dysplastic (“ND”), indefinite dysplasia (“IND”) or low-grade dysplasia (“LGD”) BE.

We estimate approximately 415,000 patients annually undergo an endoscopic biopsy with a subsequent diagnosis of ND, IND or LGD BE, representing an estimated U.S.

TAM of approximately $1 billion.

We began offering the TissueCypher Barrett’s Esophagus Test following our acquisition of Cernostics, Inc.

(“Cernostics”) in December 2021.

Our Uveal Melanoma Test

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-UM, which represents approximately 50% of the addressable patient population for this test.

We estimate approximately 2,000 patients in the United States are diagnosed annually with UM, representing an estimated U.S.

TAM of approximately $10 million.

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 estimate approximately 415,000 patients annually undergo an endoscopic biopsy with a subsequent diagnosis of non-dysplastic, indefinite or low-grade dysplastic BE, representing an estimated U.S.

TAM of approximately $1 billion.

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

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 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, 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.

The number of test reports delivered by us during the nine months ended September 30, 2022 and 2021 and for the year ended December 31, 2021 are presented in the table below:

Proprietary Dermatologic GEP Tests

Melanoma DecisionDx-SCC Diagnostic GEP offering (1)

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

IDgenetix (3)

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

Q2 2022 7,125 1,344 955 9,424 431 352 827 11,034

Q3 2022 7,354 1,636 834 9,824 392 690 1,208 12,114

For the nine months ended September 30, 2022

20,502 4,122 2,739 27,363 1,279 1,098 2,035 31,775

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

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

Q3 2021 5,505 934 913 7,352 375 — — 7,727

For the nine months ended September 30, 2021

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

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

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

(1) Includes DiffDx-Melanoma and MyPath Melanoma.

We began offering MyPath Melanoma following our acquisition of the Myriad MyPath Laboratory on May 28, 2021.

We offer both MyPath Melanoma and DiffDx-Melanoma under our Diagnostic GEP offering.

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

(3) We began offering the IDgenetix test on April 26, 2022, following our acquisition of AltheaDx.

Includes both single-gene and multi-gene tests.

For the three and nine months ended September 30, 2022, our dermatologic test report volume increased by 33.6% and 46.4%, respectively, compared to the prior period in 2021, largely driven by continued growth from our DecisionDx-Melanoma and DecisionDx-SCC tests.

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 second quarter of 2021, we expanded our dermatologic commercial team, bringing our dermatologic sales force to the mid-60s.

In September 2022, we established a new commercial sales team dedicated to our Diagnostic GEP offering, with the current dermatologic commercial team shifting to focus solely on DecisionDx-Melanoma and DecisionDx-SCC.

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 Assay.

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

In September 2022, we added additional outside territories for our TissueCypher Barrett’s Esophagus Assay.

Similar to our dermatologic commercial team, we will continue to assess market response in determining further commercial expansions.

AltheaDx, which we acquired in late April 2022, has a commercial team covering approximately 20 outside sales territories.

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

For the three months ended September 30, 2022, we saw 601 new ordering clinicians for our dermatologic tests compared to 536 during the same period of 2021.

For the nine months ended September 30, 2022 and 2021, we saw 1,801 and 1,408, respectively, new ordering clinicians for our dermatologic tests.

Total ordering clinicians for our dermatologic tests were 6,763 and 4,979 for the nine months ended September 30, 2022 and 2021, respectively, and 1,102 and 1,100 for the three months ended September 30, 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 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 nine months ended September 30, 2022, approximately 75% of all clinicians ordering DecisionDx-SCC had also ordered our DecisionDx-Melanoma test during that same period.

We launched DecisionDx-UM in January 2010.

Our Mental Health Test

IDgenetix is a PGx test for depression, anxiety and other mental health conditions.

IDgenetix is designed to provide important genetic information to clinicians to help guide personalized treatment plans for their patients, with the potential to help patients achieve a faster therapeutic response and improve their chances of remission by identifying appropriate medications more efficiently than the standard of care trial-and-error approach.

We estimate a U.S.

TAM of approximately $5 billion associated with this test.

We began offering the IDgenetix test following our acquisition of AltheaDx in April 2022.

Commercial Expansion Efforts

In late April 2022, we acquired AltheaDx which has a commercial team covering approximately 20 outside sales territories.

In September 2022, we added additional outside territories for our TissueCypher Barrett’s Esophagus Test and established a new commercial sales team dedicated to our Diagnostic GEP offering, with the current dermatologic commercial team shifting to focus primarily on DecisionDx-Melanoma and DecisionDx-SCC.

We expect the new sales teams to be fully integrated into our commercial operations by the second quarter of 2023.

We will continue to assess market response in determining further commercial expansions.

Reimbursement

The primary source of revenue for our products is reimbursement from third-party payors, which includes government payors, such as Medicare, and commercial payors, such as insurance companies.

Achieving broad coverage and reimbursement of our current products by third-party payors and continued Medicare coverage are key components of our financial success.

De novo coverage by government and third-party payors for our pipeline tests will be important over time.

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 (“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.

We have received Medicare coverage for our DecisionDx-Melanoma, DecisionDx-SCC, MyPath Melanoma, DecisionDx-UM, TissueCypher and IDgenetix tests which meet certain criteria for Medicare and Medicare Advantage beneficiaries, representing approximately 60 million covered lives.

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

Medicare coverage and payment for the TissueCypher Barrett’s Esophagus Assay was established through Novitas in early 2020, prior to our acquisition of Cernostics.

The payment rate for TissueCypher is published in the CMS Clinical Laboratory Fee Schedule (“CLFS”) for the test.

Effective March 24, 2022, we received Advanced Diagnostic Laboratory Test (“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.

The Medicare rates discussed below are prior to giving effect to applicable sequestration in effect from time to time as described in further detail under “Government Regulation and Product Approval—Healthcare Reform” included in Item 1, Business, of our Annual Report on Form 10-K for the year ended December 31, 2022.

DecisionDx-Melanoma

Palmetto GBA MolDX (“Palmetto”), the Medicare Administrative Contractor (“MAC”) responsible for administering MolDX, the program that assesses molecular diagnostic technologies, issued a final expanded local coverage determination (“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 (“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.

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 included commentary about two publications regarding the clinical utility of GEP tests and included 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 August 8, 2021.

Palmetto issued a final LCD on May 19, 2022 with Noridian issuing the same on June 16, 2022.

More recently, Palmetto converted the DecisionDx-Melanoma test-specific LCD to a “foundational” LCD.

This LCD was issued as final May 19, 2022 with Noridian issuing the same on June 16, 2022.

The final LCDs did not result in any change in coverage.

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.

Noridian’s 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, the Centers for Medicare & Medicaid Services (“CMS”) determined that DecisionDx-UM meets the criteria for “existing ADLT” status.

Since 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 2022 continues to be at $7,776, 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.

Initially, the Medicare reimbursement rate was equal to the initial list price of $7,193.

Since 2022, the rate is set annually based upon the median private payor rate for the first half of the second preceding calendar year.

Our rate for 2022 continues 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 is $1,950, based on the median private payor rate.

For 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.

Our TissueCypher test is processed 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 rate 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 payor rates received between April 1, 2022 and August 31, 2022.

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

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

The Medicare coverage includes depression and 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.

The dossier was accepted as complete in the third quarter of 2020.

On May 17, 2019, Centers for Medicare & Medicaid Services (“CMS”) determined that DecisionDx-Melanoma meets the criteria for “new Advanced Diagnostic Laboratory Test (“ADLT”)” status.

Beginning in 2022, the rate for DecisionDx-Melanoma is 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 was set using median private payor rate data from January 1, 2021 to June 30, 2021.

Our rate for 2022 was $7,193 per test and continues to be $7,193 per test for 2023.

DecisionDx-UM

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.

Similar to cutaneous melanoma, the median age at diagnosis for UM is estimated at 58-62 years old.

The Medicare eligible population represents close to 45% of the addressable market.

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

Our rate is 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 was set using median private payor rate data from January 1, 2021 to June 30, 2021.

Our rate for 2022 was $7,776 per test and our rate for 2023 remains at $7,776 per test.

Diagnostic GEP Offering

MyPath Melanoma

MyPath Melanoma is currently covered under a MolDX LCD policy through Noridian that became effective in June 2019.

MyPath Melanoma was approved as a new ADLT in September 2019.

The rate for 2022 was $1,950 per test.

Our 2023 rate is set at $1,755 per test, based on data submitted by the predecessor owner of the Myriad MyPath Laboratory relating to the first half of 2021.

Rates for our MyPath Melanoma test continues to be set annually based upon the median private payor rate for the first half of the second preceding calendar year.

DiffDx-Melanoma

In early 2021, we submitted our technical assessment dossier for DiffDx-Melanoma.

1 unchanged sentence

In June 2022, Palmetto and Noridian each posted a draft LCD that would provide coverage criteria for DiffDx-Melanoma, and each of the comment periods closed during the third quarter of 2022.

We believe the LCD for DiffDx-Melanoma will be finalized by the end of the second quarter of 2023.

We believe the LCD for DiffDx-Melanoma will be finalized near the end of the second quarter of 2023.

However, 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.

Regarding DecisionDx-SCC, no draft LCD has been posted by Palmetto or Noridian to date.

In the second quarter of 2022, we obtained a Proprietary Laboratory Analyses (“PLA”) code for DiffDx-Melanoma.

In late September 2022, CMS reviewed our DiffDx-Melanoma test price and released a draft CLFS for 2023.

Based on the draft CLFS, the reimbursement rate for DiffDx-Melanoma would be crosswalked to our MyPath Melanoma rate.

In the second quarter of 2022, following the completion of a requested medical review and pricing of our DecisionDx-SCC test by Novitas, we obtained a PLA code and began receiving reimbursement from Novitas for DecisionDx-SCC at a rate of approximately $3,800 per test.

In late September 2022, CMS reviewed our DecisionDx-SCC test price and released a draft CLFS for 2023.

Based on the draft CLFS, the reimbursement rate for DecisionDx-SCC would be crosswalked to our MyPath Melanoma rate.

We have interacted with CMS and submitted our recommendation.

We expect CMS to communicate a final determination on our 2023 rate in the fourth quarter of 2022.

DiffDx-Melanoma is going through CMS’s gapfill pricing process in 2023, which we expect to conclude in late 2023.

The gapfill process consists of several steps throughout the calendar year.

First, individual MACs develop gapfill rates and report them to CMS.

Using this information, CMS then posts preliminary rates and commences a public comment period.

After evaluating public comments, CMS posts updated rates and begins accepting requests to reconsider these rates, known as reconsideration requests.

After CMS processes any reconsideration requests, the gapfill rates are considered final.

In April 2023, CMS posted a preliminary determination of a gapfill rate for DiffDx-Melanoma of $1,950 per test, which is subject to a public comment period and any reconsideration requests.

We cannot predict at this time what the final gapfill rate will be.

DecisionDx‑SCC

In the first quarter of 2022, we requested that Novitas Solutions (“Novitas”) conduct a medical review of our DecisionDx-SCC test.

That review was completed towards the end of that quarter.

On June 9, 2022, Novitas posted a draft oncology biomarker LCD that proposes to rely upon evidentiary reviews sourced from three databases for all oncology biomarker tests:

ClinGen, OncoKB and National Comprehensive Cancer Network (“NCCN”).

Two of the databases do not review gene expression profile tests and NCCN has not yet, to our knowledge, reviewed DecisionDx-SCC.

We believe the purpose of the proposals in this draft LCD are to streamline future reviews.

Two of the databases do not review GEP tests and NCCN has not yet, to our knowledge, reviewed DecisionDx-SCC.

If finalized as proposed, then DecisionDx-SCC would not be included as a covered test in the associated billing and coding article.

1 unchanged sentence

We cannot predict whether this draft LCD will be finalized as proposed or what the timing of any final LCD might be.

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, marketable investment securities 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.

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, the effects of acquisitions and the timing of revenue recognition under Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”).

In November 2022, CMS set our rate of reimbursement for DecisionDx-SCC at $3,873 per test.

DecisionDx-SCC is going through CMS’s gapfill pricing process in 2023, which we expect to conclude in late 2023.

The gapfill process consists of several steps throughout the calendar year, as discussed above.

In April 2023, CMS posted a preliminary determination of a gapfill rate for DecisionDx-SCC of $3,159 per test, which is subject to a public comment period and any reconsideration requests.

We expect our current rate of $3,873 per test to be maintained through the gapfill process and for the final gapfill rate to go into effect on January 1, 2024, although we cannot predict at this time what the final gapfill rate will be.

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

The dossier was accepted as complete in the third quarter of 2020.

To date, neither Palmetto nor Noridian has posted a draft LCD for DecisionDx-SCC.

TissueCypher is processed in our Pittsburgh, Pennsylvania laboratory and falls under the Medicare jurisdiction managed by Novitas which previously reviewed TissueCypher.

We receive payments for claims according to the published Clinical Laboratory Fee Schedule (“CLFS”) rate.

For 2022, the published CLFS payment rate was $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.

Effective January 1, 2023, the published CLFS rate for TissueCypher is $4,950, which will remain effective through December 31, 2024.

This rate is based on the median private payor rates received between April 1, 2022 and August 31, 2022.

Our IDgenetix test was processed in our San Diego laboratory until the lab's closure in December 2022, at which time we began processing the test in our Arizona laboratory.

As previously discussed, Noridian is the MAC responsible for administering claims for laboratory services performed in Arizona and California laboratories.

IDgenetix is currently covered under an LCD policy through MolDX and an accompanying billing and coding article through Noridian.

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

schizophrenia, bipolar disorder, anxiety disorders, social phobia, 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 per test.

IDgenetix has historically been billed to Medicare using a multi-test unspecified Current Procedural Terminology (“CPT”) code along with the IDgenetix test-specific MolDX Z-code (the “IDgenetix Z-Code”).

In February 2023,

MolDX notified us that as part of its annual CPT code updates IDgenetix should shift billing to a different multi-test generic gene sequencing CPT code and continue using the IDgenetix Z-Code beginning in March 2023.

The New CPT Code is currently contractor priced at $917 while it goes through CMS’s gapfill pricing process in 2023.

The New CPT Code does not describe all of the components of the IDgenetix test.

We, therefore, do not believe the New CPT Code, in conjunction with the IDgenetix Z-Code, provides additional specificity and thus we believe the New CPT Code is not appropriate for IDgenetix.

Delivered Test Reports

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

The number of test reports delivered by us during the three months ended March 31, 2023 and 2022 and for the year ended December 31, 2022 are presented in the table below:

Proprietary Dermatologic GEP Tests

Melanoma DecisionDx-SCC Diagnostic GEP offering (1)

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

Q1 2023 7,583 2,411 980 10,974 409 1,383 2,150 14,916

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

Q2 2022 7,125 1,344 955 9,424 431 352 827 11,034

Q3 2022 7,354 1,636 834 9,824 392 690 1,208 12,114

Q4 2022 7,301 1,845 822 9,968 432 1,030 1,214 12,644

For year ended December 31, 2022 27,803 5,967 3,561 37,331 1,711 2,128 3,249 44,419

(1) Includes MyPath Melanoma and DiffDx-Melanoma.

We offered both MyPath Melanoma and DiffDx-Melanoma under our Diagnostic GEP offering until February 2023 when we suspended the offering of DiffDx-Melanoma, as discussed above.

(2) We began offering the IDgenetix test on April 26, 2022, following our acquisition of AltheaDx.

Includes both single-gene and multi-gene tests.

For the three months ended March 31, 2023, we delivered 14,916 total test reports, an increase of 72.9% compared to 8,627 in the same period of 2022.

Our dermatologic test report volume increased by 35.2% compared to the prior period in 2022 largely driven by continued growth from our DecisionDx-Melanoma and DecisionDx-SCC tests.

Other tests (non-dermatologic) contributed to the overall total test reports increase from our TissueCypher and IDgenetix tests.

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

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

For the three months ended March 31, 2023 and 2022, we saw approximately 539 and 592, respectively, new ordering clinicians for our dermatologic tests.

Total ordering clinicians for our dermatologic tests were approximately 4,525 and 3,629 for the three months ended March 31, 2023 and 2022, respectively.

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

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

For example, we found that for the three months ended March 31, 2023, approximately 56% of all clinicians ordering DecisionDx-SCC had also ordered our DecisionDx-Melanoma test during that same period.

Information About Certain Metrics

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

Test reports delivered 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 Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”).

We use this metric to evaluate the growth in adoption of our tests and to measure against our internal performance objectives.

We believe this metric is useful to investors in evaluating the volume of our business activity from period-to-period that may not be discernible from our reported revenues under ASC 606.

New Ordering Clinicians

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.

Our dermatologic tests consist of DecisionDx-Melanoma, DecisionDx-SCC, MyPath Melanoma and DiffDx-Melanoma.

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 suite of dermatologic tests.

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 revenue was recognized.

Impact of Macroeconomic Conditions

Macroeconomic conditions, including uncertainties associated with the COVID-19 pandemic, the invasion of Ukraine by Russia, economic slowdowns, labor shortages, recessions or market corrections, supply chain disruptions, inflation and monetary policy shifts, bank failures or other disruptions in in the banking system or financing markets, rising interest rates and tightening of credit markets resulting from the conflict or other evolving macroeconomic developments, continue to have direct and indirect impacts on our business and could in the future materially impact our results of operations and financial condition.

We continue to actively monitor the impact of these macroeconomic factors on our results of operations, financial condition and cash flows.

The extent of the impact of these factors on our operational performance and financial condition, including our ability to execute our business strategies and initiatives in the expected timeframe, will depend on future developments, which are uncertain and cannot be predicted;

however, any continued or renewed disruption resulting from these factors could negatively impact our business.

Our Financial Results

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

4 unchanged sentences

• hire additional scientific and research and development staff;

• complete acquisitions of businesses, assets, products or technologies;

• add additional operational, financial and management information systems and personnel.

Impact of Hurricane Ian

Hurricane Ian made landfall at the Southwestern Florida coast in late September 2022, causing significant damage within the state.

Historically, a significant number of orders for our skin cancer tests have come from clinicians and healthcare providers based in Florida, and we are still assessing the expected impact of Hurricane Ian on our delivered test report volumes and financial results for the fourth quarter of 2022, which will depend on future developments that cannot be predicted at this time.

Accordingly, we are unable to predict the extent to which our future test report volumes, and our results of operations, financial condition and cash flows, will ultimately be impacted by Hurricane Ian.

Impact of Other Macroeconomic Conditions

Global economic and business activities continue to face widespread macroeconomic uncertainties, including labor shortages, inflation and monetary supply shifts, recession risks and potential disruptions from the Russia-Ukraine conflict.

We continue to actively monitor the impact of these macroeconomic factors on our results of operations, financial condition and cash flows.

The extent of the impact of these factors on our operational and financial performance, including our ability to execute our business strategies and initiatives in the expected timeframe, will depend on future developments, which are uncertain and cannot be predicted;

however, any continued or renewed disruption resulting from these factors could negatively impact our business.

Impact of COVID-19 Pandemic

We are continuing to monitor our compliance with state and local government mandates to protect the health and safety of our workforce.

Although state and local government restrictions put in place to slow the spread of the virus have been eased in most 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, which could negatively impact our results of operations, financial condition and cash flows.

We believe the volumes of in-person sales calls have returned to our pre-COVID-19 levels and we expect to continue to maintain uninterrupted business operations.

Factors Affecting Our Performance

1 unchanged sentence

• Report volume.

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.

We believe that the number of reports we deliver to clinicians 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.

Our report volume could be negatively impacted by developments related to the COVID-19 pandemic or other evolving macroeconomic developments, as discussed above.

Our performance depends on our ability to retain and broaden

adoption with existing prescribing clinicians, as well as attract new clinicians.

Our report volume could be negatively impacted by developments related to evolving macroeconomic developments, 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.

Our revenue depends on our ability to demonstrate the value of our diagnostic and prognostic tests to these payors.

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

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

• Gross margin.

1 unchanged sentence

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

• Expansion of our sales force and marketing programs.

We believe the expansion of our direct sales force and marketing organization to educate clinicians and pathologists on the value of our molecular diagnostic testing products will significantly impact our performance.

• Integrating acquisitions.

Revenue growth, operational results and advances to our business strategy depends on our ability to integrate any acquisitions into our existing business and effectively scale their operations.

The integration of acquired assets may impact our revenue growth, increase the cost of operations or may require management resources that otherwise would be available for ongoing development of our existing business.

• New product development.

A significant aspect of our business is our investment in research and development activities, including activities related to the development of new products.

In addition to the development of new product candidates, we believe these studies are critical to gaining physician adoption of new products and driving favorable coverage decisions by payors for such products.

Information About Certain Metrics

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, MyPath Melanoma/DiffDx-Melanoma, DecisionDx-UM, TissueCypher and IDgenetix represents the number of completed test reports delivered by us during the reporting period indicated.

We use this metric to evaluate the growth in adoption of our tests and to measure against our internal performance objectives.

We believe this metric is useful to investors in evaluating the volume of our business activity from period-to-period that may not be discernible from our reported revenues under ASC 606.

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 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.

Our dermatologic tests consist of DecisionDx-Melanoma, DecisionDx-SCC, MyPath Melanoma and DiffDx-Melanoma.

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 either a test report was delivered or revenue was recognized.

In addition to the development of new product candidates, we believe these studies are critical to gaining clinician adoption of new products and driving favorable coverage decisions by payors for such products.

Components of the Results of Operations

We generate revenues from the sale of our products.

Currently, our revenues are primarily derived from the sale of DecisionDx-Melanoma and DecisionDx-UM.

Currently, our revenues are primarily derived from the sale of DecisionDx-Melanoma, DecisionDx-SCC, TissueCypher and DecisionDx-UM.

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

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.

We have determined that our contracts contain variable consideration under ASC 606 because the amounts paid by third-party payors may be paid at less than our standard rates or not paid at all, with such differences considered implicit price concessions.

1 unchanged sentence

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 or otherwise, including those claims undergoing appeal, is deemed to be fully constrained due to factors outside our influence (e.g., 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 Medicare, including those claims undergoing appeal, is deemed to be fully constrained due to factors outside our influence (e.g., 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.

5 unchanged sentences

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.

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.

1 unchanged sentence

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 and tests acquired through acquisitions.

For example, we expect to commence operations in a new expanded laboratory facility in Pittsburgh, Pennsylvania in the second quarter of 2023.

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

See the tables in “Results of Operations—Comparison of the three months ended September 30, 2022 and 2021” and “Results of Operations—Comparison of the nine months ended September 30, 2022 and 2021” for details.

See the table in “Results of Operations—Comparison of the three months ended March 31, 2023 and 2022” for details.

Research and Development

5 unchanged sentences

The first is the CONNECTION study, which is collecting long-term outcomes for up to 10,000 patients who have been tested with DecisionDx-Melanoma.

The second 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, in 2021, we initiated our IDENTITY Study, a 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.

The second is the DECIDE study, which is designed to determine the association of GEP test results with sentinel lymph node biopsy (“SLNB”) surgical decisions in patients eligible for SLNB as well as to track outcomes for patients who did and did not undergo SLNB.

In February 2023, we announced the publication of data from the DECIDE study presenting DecisionDx-Melanoma test results influenced 85% of clinicians’ decisions regarding the SLNB surgical procedure.

Additionally, use of the tests’ results within current guideline recommendations led to a significant reduction in SLNB procedures performed, demonstrating the clinical value of the test to guide risk-aligned patient care.

Also, in 2021, we initiated our IDENTITY Study, a 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.

As of March 31, 2023, we have 55 committed sites and 632 patients enrolled in our IDENTITY study.

We previously funded the PERSONALize study, which was evaluating the use of DecisionDx-Melanoma in patients eligible for adjuvant therapy.

1 unchanged sentence

These studies have shown statistically and clinically significant risk stratification separation.

Based upon this currently available and anticipated future data, we have decided to close the PERSONALize study.

Based upon this currently available and anticipated future data, in the second quarter of 2022 we decided to close the PERSONALize study.

Selling, General and Administrative

Selling, general and administrative (“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 (“Nasdaq”).

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

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

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 Assets

Amortization of acquired intangible assets are primarily associated with developed technology obtained through acquisitions, such as our acquisitions of the Myriad MyPath Laboratory in May 2021, Cernostics in December 2021 and AltheaDx in April 2022.

Amortization of acquired intangible assets is primarily associated with developed technology obtained through acquisitions, such as our acquisitions of the Myriad MyPath Laboratory in May 2021, Cernostics in December 2021 and AltheaDx in April 2022.

Change in Fair Value of Contingent Consideration

Change in fair value of contingent consideration is associated with our acquisitions of Cernostics and AltheaDx and the related additional consideration of up to $50.0 million and $75.0 million, respectively, that may become payable based on the achievement of certain commercial milestones relating to the year ending December 31, 2022 in the case of Cernostics, and the years ending December 31, 2022, 2023 and 2024, in the case of AltheaDx (collectively, the “Earnout Payments”).

Change in fair value of contingent consideration is associated with our acquisitions of Cernostics and AltheaDx and the related contingent consideration of up to $50.0 million and $75.0 million, respectively, payable based on the

achievement of certain commercial milestones relating to the year ending December 31, 2022 in the case of Cernostics, and the years ending December 31, 2022, 2023 and 2024, in the case of AltheaDx.

No amounts were paid relating to the year ended December 31, 2022 for Cernostics and AltheaDx since the applicable commercial milestones were not achieved.

As of March 31, 2023 and December 31, 2022, our contingent consideration liability for AltheaDx was zero.

Interest Income

4 unchanged sentences

Income Tax (Benefit) Expense

In connection with our acquisition of AltheaDx in April 2022, and taking into consideration the additional deferred tax liabilities resulting from such acquisition, we determined that a portion of our valuation allowance should be reduced, which is reflected in our income tax benefit for the three and nine months ended September 30, 2022.

Our consolidated financial statements do not reflect any federal or state income tax benefits attributable to the pre-tax losses we have incurred, due to the uncertainty of realizing a benefit from those items.

As of December 31, 2021, we had federal net operating loss carryforwards of $99.4 million, of which $43.5 million will begin to expire in 2030 if not utilized to offset federal taxable income, and $55.9 million may be carried forward indefinitely.

Also, as of December 31, 2021, we had state net operating loss carryforwards of $67.5 million, which begin to expire in 2028 if not utilized to offset state taxable income.

As of December 31, 2022, we had federal net operating loss (“NOL”) carryforwards of $207.2 million, of which $106.1 million will begin to expire in 2029 if not utilized to offset federal taxable income, and $101.1 million may be carried forward indefinitely.

Also, as of December 31, 2022, we had state NOL carryforwards of $114.0 million, which begin to expire in 2028 if not utilized to offset state taxable income.

Results of Operations

Comparison of the three months ended September 30, 2022 and 2021

Comparison of the Three Months Ended March 31, 2023 and 2022

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 $ 42,037 $ 26,852 $ 15,185 56.6 %

Operating expenses and other operating income

Operating expenses

Cost of sales (exclusive of amortization of acquired intangible assets) 10,182 5,944 4,238 71.3 %

2 unchanged sentences

Amortization of acquired intangible assets 2,222 1,648 574 34.8 %

Change in fair value of contingent consideration (151) — (151) NA

Change in fair value of contingent consideration — 2,562 (2,562) (100.0) %

Total operating expenses, net 73,559 51,368 22,191 43.2 %

1 unchanged sentence

Interest income 2,336 30 2,306 NM

Interest expense (6) — (6) NA

Interest expense (4) (3) (1) (33.3) %

Loss before income taxes (29,190) (24,489) (4,701) (19.2) %

Income tax (benefit) expense — — — NM

Income tax expense

14 134 (120) (89.6) %

Net loss $ (29,204) $ (24,623) $ (4,581) (18.6) %

NA = Not applicable

NM = Not meaningful

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

Three Months Ended

September 30,

2022 2021 Change

Dermatologic (1)

$ 33,924 $ 21,593 $ 12,331

3,087 1,882 1,205

Total net revenues $ 37,011 $ 23,475 $ 13,536

(1) Consists of DecisionDx-Melanoma, DecisionDx-SCC and our Diagnostic GEP offering.

(2) Consists primarily of DecisionDx-UM.

Also includes TissueCypher and IDgenetix.

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

Three Months Ended

September 30,

2022 2021 Change

Net revenues $ 37,011 $ 23,475 $ 13,536

Cost of sales (exclusive of amortization of acquired intangible assets) 8,859 4,500 4,359

Amortization of acquired intangible assets 2,306 694 1,612

Gross margin $ 25,846 $ 18,281 $ 7,565

Gross margin percentage 69.8 % 77.9 % (8.1) %

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

Three Months Ended

September 30,

2023 2022 Change

3 unchanged sentences

Total stock-based compensation expense $ 13,525 $ 8,419 $ 5,106

Net revenues for the three months ended September 30, 2022 increased by $13.5 million, or 57.7%, to $37.0 million compared to the three months ended September 30, 2021, primarily due to a $12.3 million increase in revenue from our dermatologic tests, primarily DecisionDx-Melanoma and DecisionDx-SCC.

The increase in dermatologic revenue was primarily attributable to a 33.6% increase in total test report volumes for our dermatologic offerings, due to a combination of the effects of our dermatologic sales force expansion during the second quarter of 2021 and increased patient flow potentially attributable to the easing of COVID-19 restrictions.

The higher revenues also reflect Medicare payments on DecisionDx-SCC, as discussed above, partially offset by the effect of higher negative revenue adjustments related to tests delivered in previous periods, associated with changes in estimated variable consideration, which were $0.3 million for the three months ended September 30, 2022 compared to $0.1 million for the three months ended September 30, 2021.

The increase in revenue from our other tests (non-dermatologic) of $1.2 million was primarily attributable to TissueCypher and IDgenetix.

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 September 30, 2022 increased by $4.4 million, or 96.9%, compared to the three months ended September 30, 2021, primarily due to higher personnel costs and increased costs of supplies and third-party services.

Personnel costs have increased with additions in headcount in our laboratory testing operations, including headcount attributable to our acquisitions of Cernostics and AltheaDx.

The increased personnel costs also reflect higher salaries and wages for existing employees.

Supply and services expense have increased due to higher laboratory activity, which is attributable to higher test volumes.

Due to the nature of our business, a significant portion of our cost of sales expenses represents 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.

We expect our cost of sales expenses (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 69.8% for the three months ended September 30, 2022, compared to 77.9% for the same period in 2021.

The decrease was primarily due to this year’s additional investments in laboratory headcount, higher rates of pay and higher amortization expense associated with our acquired intangible assets.

In the near term, we expect that our gross margin percentage will be lower, compared to prior periods, as we invest in additional laboratory personnel and related resources to support the anticipated growth in our test report volumes 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 $3.4 million, or 45.4%, for the three months ended September 30, 2022, compared to the three months ended September 30, 2021.

Approximately 62.3% of the increase is attributable to higher personnel costs, primarily due to expansions in headcount in support of our growth, higher rates of pay, and higher stock-based compensation expense.

The remainder of the increase is primarily attributable to higher inventory usage to support research and development activities, higher travel and meeting costs, and higher costs for clinical studies, including costs related to the IDENTITY, CONNECTION and DECIDE studies.

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.

Selling, General and Administrative

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

Three Months Ended

September 30,

2022 2021 Change

Sales and marketing $ 22,388 $ 13,241 $ 9,147

General and administrative 14,238 9,354 4,884

Total selling, general and administrative expense $ 36,626 $ 22,595 $ 14,031

Sales and marketing expenses increased by $9.1 million, or 69.1%, for the three months ended September 30, 2022, compared to three months ended September 30, 2021.

Approximately $5.9 million, or 65.0%, of the increase is attributable to higher personnel costs including salaries, stock-based compensation and bonuses.

Personnel costs have increased through our acquisitions of Cernostics in December 2021 and AltheaDx in April 2022, and through the expansion of our outside sales territories and sales force in September 2022, as discussed under “Overview—Business Overview” above.

In addition to increases through sales force expansion, higher personnel costs also reflect salary increases for members of our existing sales force.

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

The higher expenses for travel and training events reflect an increase in our sales and commercial operations related to our expanded headcount and expanded test offerings, as well a return to more in-person activities resulting from the continued easing of COVID-19 restrictions.

Stock-based compensation expense included in sales and marketing expense was $3.1 million for the three months ended September 30, 2022, compared to $1.6 million for the three months ended September 30, 2021.

General and administrative expenses increased by $4.9 million, or 52.2%, for the three months ended September 30, 2022, compared to three months ended September 30, 2021.

The increase is primarily attributable to $3.2 million in higher personnel costs including salaries, bonuses and stock-based compensation.

The higher personnel costs reflect expanded headcount in our administrative support functions, including that related to the acquisitions of Cernostics and AltheaDx, as well as higher rates of salaries and wages.

Stock-based compensation expense included in general and administrative expense was $3.2 million for the three months ended September 30, 2022, compared to $1.9 million for the three months ended September 30, 2021.

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 increased by $1.6 million for the three months ended September 30, 2022, compared to the three months ended September 30, 2021.

The increase is primarily associated with amortization of developed technology attributable to the acquisitions of Cernostics and AltheaDx in December 2021 and April 2022, respectively.

Change in Fair Value of Contingent Consideration

The change in fair value of contingent consideration for the three months ended September 30, 2022 of $0.2 million, a net gain, is primarily related to the remeasurement of the Earnout Payments associated with our acquisition of AltheaDx and reflects changes in management’s projections regarding attainment of certain commercial milestones.

There was no such activity during the three months ended September 30, 2021.

Interest Income

Interest income increased by $1.3 million for the three months ended September 30, 2022, compared to the three months ended September 30, 2021, primarily as a result of higher interest rates and our purchases of marketable investment securities.

Stock-Based Compensation Expense

Stock-based compensation expense, which is allocated among cost of sales, research and development expense and SG&A expense, totaled $9.2 million for the three months ended September 30, 2022, compared to $5.2 million for the three months ended September 30, 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 September 30, 2022, we had 517 employees compared to 311 as of September 30, 2021.

As of September 30, 2022, the total unrecognized stock-based compensation cost related to outstanding awards was $94.4 million, which is expected to be recognized on a straight-line basis over a weighted-average period of 2.8 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.

Comparison of the nine months ended September 30, 2022 and 2021

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

Nine Months Ended

September 30, Change

Net revenues $ 98,701 $ 69,046 $ 29,655 42.9 %

Operating expenses and other operating income

Cost of sales (exclusive of amortization of acquired intangible assets) 22,489 11,225 11,264 100.3 %

Research and development 33,594 20,201 13,393 66.3 %

Selling, general and administrative 104,577 61,578 42,999 69.8 %

Amortization of acquired intangible assets 6,051 950 5,101 536.9 %

Change in fair value of contingent consideration (17,987) — (17,987) NA

Total operating expenses, net 148,724 93,954 54,770 58.3 %

Operating loss (50,023) (24,908) (25,115) (100.8) %

Interest income 1,693 51 1,642 NM

Interest expense (13) — (13) NA

Loss before income taxes (48,343) (24,857) (23,486) (94.5) %

Income tax (benefit) expense (1,823) 5 (1,828) NM

Net loss $ (46,520) $ (24,862) $ (21,658) (87.1) %

NA = Not applicable

NM = Not meaningful

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

Nine Months Ended

September 30,

Three Months Ended

2023 2022 Change

1 unchanged sentence

$ 35,911 $ 24,339 $ 11,572

Non-Dermatologic (2)

6,126 2,513 3,613

1 unchanged sentence

(1) Consists of DecisionDx-Melanoma, DecisionDx-SCC and Diagnostic GEP offering.

(2) Consists primarily of DecisionDx-UM.

Also includes TissueCypher and IDgenetix.

(2) Consists of TissueCypher, DecisionDx-UM and IDgenetix.

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

Nine Months Ended

September 30,

Three Months Ended

2023 2022 Change

4 unchanged sentences

Gross margin percentage 70.5 % 71.7 % (1.2) %

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

Nine Months Ended

September 30,

2022 2021 Change

Cost of sales (exclusive of amortization of acquired intangible assets) $ 2,725 $ 1,480 $ 1,245

Research and development 5,607 3,266 2,341

Selling, general and administrative 18,066 10,143 7,923

Total stock-based compensation expense $ 26,398 $ 14,889 $ 11,509

Net revenues for the nine months ended September 30, 2022 increased by $29.7 million, or 42.9%, to $98.7 million compared to the nine months ended September 30, 2021, primarily due to a $27.3 million increase in revenue from our dermatologic tests, primarily DecisionDx-Melanoma and DecisionDx-SCC, and to a lesser extent, a $2.4 million increase in revenue from our other tests (non-dermatologic).

The increase in dermatologic revenue was primarily attributable to a 46.4% increase in test volumes, with higher test reports delivered across each of our dermatologic offerings, due to a combination of the effects of our dermatologic sales force expansion during the second quarter of 2021 and increased patient flow potentially attributable to the easing of COVID-19 restrictions.

The higher revenues also reflect Medicare payments on DecisionDx-SCC, as discussed above.

The higher volumes were partially offset by the effect of variations in positive (negative) revenue adjustments related to tests delivered in previous periods, associated with changes in estimated variable consideration, which were $(1.9) million for the nine months ended September 30, 2022 compared to $4.1 million for the nine months ended September 30, 2021.

The year-over-year decrease is primarily attributable to the effect of favorable adjustments related to the settlement and collection during the nine months ended September 30, 2021 of certain groups of receivables from prior years that did not recur during the nine months ended September 30, 2022.

The increase in revenue from our other tests (non-dermatologic) of $2.4 million was primarily attributable to TissueCypher and IDgenetix.

Net revenues for the three months ended March 31, 2023 increased by $15.2 million, or 56.6%, to $42.0 million compared to the three months ended March 31, 2022, due to a $11.6 million increase in revenue from our dermatologic tests and a $3.6 million increase in revenue from our non-dermatologic tests.

The increase from our dermatologic tests was primarily due to a 25.9% increase in DecisionDx-Melanoma test report volumes, the effect of receiving Medicare coverage for DecisionDx-SCC beginning in the second quarter of 2022 and a 111.1% increase in DecisionDx-SCC test report volumes.

The increase in revenue from our non-dermatologic tests of $3.6 million was primarily attributable to increased TissueCypher test report volumes in the first quarter of 2023 compared to initial test report volumes in the first quarter of 2022, after we first began offering the test in December 2021, and the effect of the increase in the Medicare reimbursement rate.

Also contributing to the increase in non-dermatologic revenues was our IDgenetix test, which we acquired with AltheaDx in April 2022.

The increases in total net revenues were partially offset by the effect of variations in revenue adjustments related to tests delivered in previous periods, associated with changes in estimated variable consideration, which were $1.3 million of net negative revenue adjustments for the three months ended March 31, 2023, compared to $0.6 million of net positive revenue adjustments for the three months ended March 31, 2022.

These amounts include (i) adjustments for actual collections versus estimated amounts and (ii) cash collections and the related recognition of revenue in current period for tests delivered in prior periods due to the release of the constraint on variable consideration.

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

Cost of sales (exclusive of amortization of acquired intangible assets) for the nine months ended September 30, 2022 increased by $11.3 million, or 100.3%, compared to the nine months ended September 30, 2021, primarily due to higher personnel costs and increased costs of supplies and third-party services.

Personnel costs have increased with additions in headcount in our laboratory testing operations, including headcount attributable to our acquisitions of Cernostics and AltheaDx.

Cost of sales (exclusive of amortization of acquired intangible assets) for the three months ended March 31, 2023 increased by $4.2 million, or 71.3%, compared to the three months ended March 31, 2022, primarily due to higher personnel costs and increased expenditures on supplies, third-party services and rent.

Personnel costs increased primarily due to headcount associated with our increase in testing and volume, including headcount increases attributable to our acquisition of AltheaDx.

The increased personnel costs also reflect higher salaries and wages for existing employees.

3 unchanged sentences

Our gross margin percentage was 71.1% for the nine months ended September 30, 2022, compared to 82.4% for the nine months ended September 30, 2021.

The decrease was primarily due to higher personnel costs attributable to investments in laboratory headcount as well as higher rates of pay, variations in revenue adjustments related to tests delivered in previous periods and higher amortization expense associated with our acquired intangible assets.

In the near term, we expect that our gross margin percentage will be lower, 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.

Our gross margin percentage was 70.5% for the three months ended March 31, 2023, compared to 71.7% for the same period in 2022.

The decrease was primarily due to higher personnel costs attributable to increases in laboratory headcount as well as higher rates of pay, higher amortization expense associated with our acquired intangible assets and variations in revenue adjustments related to tests delivered in previous periods.

Research and Development

Research and development expenses increased by $13.4 million, or 66.3%, for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021.

Approximately 53.7% of the increase is attributable to higher personnel costs, primarily due to expansions in headcount in support of our growth, higher pay rates and higher stock-based compensation expense, and approximately 17.9% is attributable to higher costs for clinical studies, including costs related to the IDENTITY, 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.

Research and development expenses increased by $3.6 million, or 33.8%, for the three months ended March 31, 2023, compared to the three months ended March 31, 2022.

Approximately 70.6% of the increase was attributable to higher personnel costs, primarily due to expansions in headcount in support of our growth, higher pay rates and higher stock-based compensation expense, and approximately 25.7% is attributable to higher costs for clinical studies, partially offset by decreases in advisory costs.

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

Selling, General and Administrative

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

Nine Months Ended

September 30,

Three Months Ended

2023 2022 Change

2 unchanged sentences

Total selling, general and administrative expense $ 46,762 $ 30,453 $ 16,309

Sales and marketing expenses increased by $27.4 million, or 78.9%, for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021.

Sales and marketing expenses increased by $11.7 million, or 64.3%, for the three months ended March 31, 2023, compared to three months ended March 31, 2022.

Approximately $7.0 million, or 59.8%, of the increase is attributable to higher personnel costs including salaries, stock-based compensation and bonuses.

Personnel costs have increased through the expansion of our dermatology-facing commercial team headcount to the mid-60s during the second quarter of 2021, through our acquisitions of Cernostics in December 2021 and AltheaDx in April 2022, and through the expansion of our outside sales territories and sales force in September 2022, as discussed under “Overview—Business Overview” above.

In addition to increases through sales force expansion, higher personnel costs also reflect salary increases for members of our existing sales force.

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 an increase in our sales and commercial operations related to our expanded headcount and expanded test offerings, as well a return to more in-person activities resulting from the continued easing of COVID-19 restrictions.

Stock-based compensation expense included in sales and marketing expense was $8.7 million for the nine months ended September 30, 2022, compared to $4.7 million for the nine months ended September 30, 2021.

General and administrative expenses increased by $15.6 million, or 58.1%, for the nine months ended September 30, 2022, compared to nine months ended September 30, 2021.

The increase is primarily attributable to $9.4 million in higher personnel costs including salaries, bonuses and stock-based compensation.

Stock-based compensation expense included in general and administrative expense was $9.3 million for the nine months ended September 30, 2022, compared to $5.4 million for the nine months ended September 30, 2021.

Furthermore, we incurred $1.7 million of transaction costs associated with our acquisition of AltheaDx during the nine months ended September 30, 2022.

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

Personnel costs have increased through the expansions of our dermatology-facing and non-dermatology-facing commercial teams and outside sales forces, including increases associated with our acquisition of AltheaDx in April 2022.

In addition, higher personnel costs also reflect salary increases for members of our existing sales force.

The remainder of the increase in sales and marketing expenses was primarily associated with travel, training events and conferences fees.

The higher expenses for training events and travel reflect an increase in our sales and commercial operations related to our expanded headcount.

Stock-based compensation expense included in sales and marketing was $4.9 million for the three months ended March 31, 2023, compared to $2.8 million for the three months ended March 31, 2022.

General and administrative expenses increased by $4.6 million, or 37.5%, for the three months ended March 31, 2023, compared to three months ended March 31, 2022.

The increase is primarily attributable to $3.4 million in higher personnel costs including stock-based compensation, salaries, and bonuses.

The higher personnel costs reflect expanded headcount in our administrative support functions, including that related to the acquisition of AltheaDx, as well as higher rates of salaries and wages.

Stock-based compensation expense included in general and administrative expense was $4.7 million for the three months ended March 31, 2023, compared to $2.9 million for the three months ended March 31, 2022.

The remainder of the increase in general and administrative expenses was primarily associated with general increases across various categories.

Amortization of Acquired Intangible Assets

Amortization of acquired intangible assets increased by $5.1 million for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021.

The increase is primarily associated with amortization of developed technology attributable to the acquisitions of the Myriad MyPath Laboratory, Cernostics, and AltheaDx in May 2021, December 2021 and April 2022, respectively.

Amortization of acquired intangible assets increased by $0.6 million for the three months ended March 31, 2023, compared to the three months ended March 31, 2022.

The increase is primarily associated with amortization of developed technology attributable to the acquisition of AltheaDx in April 2022.

Change in Fair Value of Contingent Consideration

The change in fair value of contingent consideration for the nine months ended September 30, 2022 of $18.0 million, a net gain, is primarily related to the remeasurement of the Earnout Payments associated with our acquisition of Cernostics and reflects changes in management’s projections regarding attainment of certain commercial milestones.

There was no such activity during the nine months ended September 30, 2021.

In the first quarter of 2022 the fair value of the contingent consideration associated with our acquisition of Cernostics increased by $2.6 million with no similar activity in the first quarter of 2023 .

Interest Income

Interest income increased by $1.6 million for the nine months ended September 30, 2022 , compared to the nine months ended September 30, 2021 , primarily as a result of higher interest rates and our purchases of marketable investment securities.

Income Tax (Benefit) Expense

Our income tax benefit was $1.8 million for the nine months ended September 30, 2022, and was primarily attributable to a reduction of $1.8 million in our valuation allowance on net deferred tax assets resulting from our acquisition of AltheaDx in April 2022.

Specifically, we took into consideration the additional deferred tax liabilities resulting from the acquisition and determined that a portion of our existing valuation allowance should be reduced.

Other than this item, we recorded minimal amounts in income tax benefit because in both the nine months ended September 30, 2022 and 2021, the income tax benefit of the pre-tax loss was largely offset by corresponding changes in the valuation allowance on net deferred tax assets, as we have determined that it is more likely than not that these benefits will not be realized.

Interest income increased by $2.3 million for the three months ended March 31, 2023, compared to the three months ended March 31, 2022, primarily as a result of higher interest rates and our purchases of marketable investment securities beginning in the third quarter of 2022.

Stock-Based Compensation Expense

Stock-based compensation expense, which is allocated among cost of sales, research and development expense and SG&A expense, totaled $26.4 million for the nine months ended September 30, 2022, compared to $14.9 million for the nine months ended September 30, 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 September 30, 2022, we had 517 employees compared to 311 as of September 30, 2021.

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.

Stock-based compensation expense, which is allocated among cost of sales, research and development expense and SG&A expense, totaled $13.5 million for the three months ended March 31, 2023, compared to $8.4 million for

the three months ended March 31, 2022.

The increase is primarily due to the effect of our annual grant of awards in December 2022.

We expect material increases in stock-based compensation expense in future periods, attributable to both existing awards outstanding and anticipated additional grants to our current and future employees.

As of March 31, 2023, we had 562 employees compared to 400 as of March 31, 2022.

As of March 31, 2023, the total unrecognized stock-based compensation cost related to outstanding awards was $118.4 million, which is expected to be recognized over a weighted-average period of 2.8 years.

Liquidity and Capital Resources

2 unchanged sentences

All of our marketable investment securities are considered investment grade, are readily available for use in current operations and have contractual maturities of one year or less.

As of September 30, 2022, we had marketable investment securities of $131.8 million, and we had no such balance as of December 31, 2021.

As of September 30, 2022 and December 31, 2021, we had cash and cash equivalents of $134.2 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) (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.

As of October 26, 2022, our non-affiliate market capitalization was below $700 million, and if our non-affiliate market capitalization does not meet or exceed $700 million during any date within 60 days prior to the filing of our Annual Report on Form 10-K for the fiscal year ending December 31, 2022, we may lose our well-known seasoned issuer status.

If that were to occur, we would no longer be able to take advantage of the benefits of being a well-known seasoned issuer, including the ability to file automatically effective shelf registration statements allowing us to issue an indeterminate number or amount of securities from time to time in one or more offerings, which could restrict our ability to timely access the capital markets.

As mentioned above, we expect to use a portion of our cash and cash equivalents and marketable investment securities, 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.”

As of March 31, 2023 and December 31, 2022, we had marketable investment securities of $117.2 million and $135.7 million, respectively.

As of March 31, 2023 and December 31, 2022, we had cash and cash equivalents of $114.8 million and $122.9 million, respectively.

Since becoming a public company, our liquidity has been primarily derived from the revenue generated from the sale of our products, proceeds from our initial public offering of common stock on July 29, 2019 (the “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, marketable investment securities and anticipated cash generated from sales of our products will be sufficient to fund our operations for at least the next 12 months and for the foreseeable future.

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

As mentioned above, we expect to use a portion of our cash and cash equivalents and marketable investment securities 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

1 unchanged sentence

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 $30.5 million in cash and $17.1 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.

In each case, the number of shares of our common stock that may be issued in connection with the Earnout Payments is subject to limitations, as discussed in Notes 6 and 11 to the unaudited condensed consolidated financial statements.

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 Assay (acquired from Cernostics) and IDgenetix (acquired from AltheaDx) into our suite of commercial product offerings and the timing thereof.

In April 2022, we acquired AltheaDx, for $30.5 million in cash and $17.1 million in shares of our common stock.

We agreed to pay contingent consideration of up $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.

The portion associated with the commercial milestones for the year ended December 31, 2022 was not paid since the applicable commercial milestones were not met.

This portion represented $35.0 million of the $75.0 million total potential payment obligation, exclusive of a potential catch-up payment in 2023 of $17.5 million which will become payable if all 2023 commercial milestones are fully met.

Therefore, a potential payment obligation of up to $57.5 million with respect to the remaining commercial milestones for 2023 and 2024 remains as of March 31, 2023.

In each case, the number of shares of our common stock that may be issued in connection with the commercial milestone payments is subject to limitations, as discussed in Note 10 to the unaudited condensed consolidated financial statements.

Our actual liability with respect to these commercial milestone payments from our acquisition will depend, in part, on our ability to successfully integrate IDgenetix (acquired from AltheaDx) into our suite of commercial product offerings and the timing thereof.

See Note 6 of the unaudited condensed consolidated financial statements for additional information on recent acquisitions.

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

For the year ended December 31, 2022 we had a net loss of $67.1 million and an accumulated deficit of $160.9 million as of December 31, 2022.

For the nine months ended September 30, 2022, we had a net loss of $46.5 million and an accumulated deficit of $140.3 million as of September 30, 2022.

For the three months ended March 31, 2023, we had a net loss of $29.2 million and an accumulated deficit of $190.1 million as of March 31, 2023.

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.

We expect to incur additional expenses and losses in the future as we invest in the commercialization of our existing products, the development of our future product candidates and the commercialization of our product candidates.

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, marketable investment securities 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, marketable investment securities, anticipated cash generated from sales of our products and issuances of equity securities or debt offerings, including through our Shelf Registration Statement.

We expect to incur additional expenses and losses in the future as we invest in the commercialization of our existing products and the development and commercialization of our current pipeline products and future product candidates.

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

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

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.

3 unchanged sentences

• the development and validation of genomic classifiers;

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

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

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.

5 unchanged sentences

Any disruptions to, or volatility in, the credit and financial markets or any deterioration in overall economic conditions may make any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive.

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.

If we are unable to raise additional funds through debt or equity financing 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.

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.

Total undiscounted future minimum payment obligations under our operating leases and finance leases as of September 30, 2022 totaled approximately $23.6 million, of which $0.3 million is payable through the remainder of 2022 and $23.3 million through the end of 2033.

Total undiscounted future minimum payment obligations under our operating leases and finance leases as of March 31, 2023 totaled approximately $23.1 million, of which $1.5 million is payable through the remainder of 2023 and $21.6 million is payable through the end of 2033.

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

On April 18, 2023, we amended an existing lease agreement to lease additional laboratory space in Phoenix, Arizona.

Upon us occupying the additional laboratory space, we expect this lease to increase our undiscounted future minimum payment obligations by a total of approximately $1.7 million.

We expect our lease obligations may increase in the future as we expand our facilities, operations and headcount in support of the anticipated growth in our portfolio of commercial products and pipeline tests.

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,

Three Months Ended

Net cash used in operating activities $ (25,439) $ (21,430)

Net cash used in investing activities (162,063) (35,768)

Net cash provided by (used in) investing activities 16,584 (402)

Net cash provided by financing activities 728 1,216

3 unchanged sentences

Operating Activities

Net cash used in operating activities was $35.7 million for the nine months ended September 30, 2022, and was primarily attributable to the net loss of $46.5 million, the change in fair value of contingent consideration of $18.0 million, increases in accounts receivable of $5.7 million and deferred income taxes of $1.8 million, partially offset by non-cash stock-based compensation expense of $26.4 million, depreciation and amortization of $7.7 million and the increase in accrued compensation of $3.7 million.

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 $5.4 million of an advance payment from CMS under its Accelerated and Advance Payment Program, partially offset by non-cash stock-based compensation expense of $14.9 million, increases in accrued compensation of $3.0 million and depreciation and amortization of $2.0 million.

The $19.5 million additional net cash used in operating activities for the nine months ended September 30, 2022 compared to the nine months ended September 30, 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 detail under “Results of Operations—Comparison of the nine months ended September 30, 2022 and 2021” above.

Net cash used in operating activities was $25.4 million for the three months ended March 31, 2023, and was primarily attributable to the net loss of $29.2 million, decreases in accrued compensation of $11.6 million, increases in accounts receivable of $4.4 million, increases in accretion of discounts on marketable investment securities of $1.2 million and increases in prepaid expenses and other current assets of $0.7 million, partially offset by non-cash stock-based compensation expense of $13.5 million, change in accounts payable of $3.9 million, depreciation and amortization of $2.9 million and a change in other accrued and current liabilities of $1.0 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-based 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.

The $4.0 million additional net cash used in operating activities for the three months ended March 31, 2023 compared to the three months ended March 31, 2022 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 detail under “Results of Operations—Comparison of the three months ended March 31, 2023 and 2022” above.

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

First quarter 2023 cash use reflects payout of employee annual cash bonuses as well as certain health care benefit payments totaling $17.7 million, that are not expected to recur during the remainder of 2023.

In comparison, we paid $11.6 million during the same period in 2022 towards annual cash bonuses and certain health care benefits.

Investing Activities

Net cash used in investing activities was $162.1 million for the nine months ended September 30, 2022 and consisted primarily of purchases of marketable investment securities of $131.8 million, the cash portion of the AltheaDx purchase consideration of $27.0 million (net of cash and cash equivalents acquired) and purchases of property and equipment of $3.8 million.

Net cash used in investing activities was $35.8 million for the nine months ended September 30, 2021 and resulted primarily from the purchase of Myriad MyPath Laboratory for $33.2 million (including transaction costs) and purchases of property and equipment of $2.6 million.

Net cash provided by investing activities was $16.6 million for the three months ended March 31, 2023 and consisted primarily of the maturity of marketable investment securities of $50.0 million, partially offset by purchases of marketable investment securities of $30.1 million and purchases of property and equipment of $3.3 million.

Net cash used in investing activities was $0.4 million for the three months ended March 31, 2022 and resulted from the purchases of property and equipment of $0.4 million.

Financing Activities

Net cash provided by financing activities was $2.3 million for the nine months ended September 30, 2022, and primarily consisted of $1.8 million in proceeds from contributions to the employee stock purchase plan and $0.7 million in proceeds from the exercise of stock options.

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.

In 2021, the rate of inflation in the United States began to increase and has since risen to levels not experienced in over 40 years.

We are experiencing inflationary pressures, primarily in personnel costs, and we anticipate impacts on other cost areas within the next twelve months.

The extent of any future impacts from inflation on our business and our results of operations will be dependent upon how long the elevated inflation levels persist and the extent to which the rate of inflation further increases, if at all, neither of which we are able to predict.

If elevated levels of inflation were to persist or if the rate of inflation were to accelerate, the purchasing power of our cash and cash equivalents and marketable investment securities may be diminished, our expenses could increase faster than anticipated and we may utilize our capital resources sooner than expected.

Net cash provided by financing activities was $0.7 million for the three months ended March 31, 2023, and consisted primarily of $1.0 million of proceeds from contributions to our 2019 Employee Stock Purchase Plan (the “ESPP”), $0.1 million of proceeds from exercise of common stock options, partially offset by the $0.3 million payment of employee taxes attributable to the vesting of Restricted Stock Units (“RSUs”).

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 ESPP and $0.4 million in proceeds from the exercise of stock options.

In 2021, the rate of inflation in the United States began to increase and then rose to levels not experienced in over 40 years, but began subsiding in the second half of 2022.

We are experiencing inflationary pressures, primarily in increased personnel costs and price increases for certain lab supplies.

We anticipate possible inflationary impacts on other cost areas in the future.

The extent of any future impacts from inflation on our business and our results of operations will be dependent upon how long the elevated inflation levels persist and the extent to which the rate of inflation were to further increase, if at all, neither of which we are able to predict.

If elevated levels of inflation were to persist or if the rate of inflation were to accelerate, the purchasing power of our cash and cash equivalents and marketable investment securities may be further diminished, our expenses could increase faster than anticipated and we may utilize our capital resources sooner than expected.

Further, given the complexities of the reimbursement landscape in which we operate, our payors may be unwilling or unable to increase reimbursement rates to compensate for inflationary impacts.

1 unchanged sentence

Critical Accounting Estimates

During the nine months ended September 30, 2022, except as noted below, 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.

The following is an updated discussion of our critical accounting estimates related to contingent consideration.

During the three months ended March 31, 2023, except as noted below, 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, 2022.

The following is an updated discussion of our critical accounting estimates related to the determination of the requisite service period with respect to stock-based compensation.

This information should be read in conjunction with our other information on critical accounting estimates included in our Annual Report on Form 10-K for the year ended December 31, 2022.

Contingent Consideration

Under the terms of business combinations or asset acquisitions, we may be required to pay additional consideration if specified future events occur or if certain conditions are met.

In a business combination, in accordance with to ASC Topic 805, Business Combinations, contingent consideration is recorded at fair value as of the acquisition date and classified as liabilities or equity based on applicable accounting principles generally accepted in the United States of America (“U.S.

For contingent consideration classified as liabilities, we remeasure the contingent consideration at fair value each period with changes in fair value recorded in the statements of operations each period.

For contingent consideration in transactions that are not business combinations, we apply applicable U.S.

With respect to the additional consideration that may be payable in connection with the acquisition of Cernostics, an asset acquisition we completed on December 3, 2021, we account for the contingent consideration as liability in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”), under the guidance for obligations that must or may be settled by issuance of a variable number of shares.

In accordance with ASC 480, we record the contingent consideration initially and subsequently at fair value with changes in fair value recorded in the condensed consolidated statements of operations each period.

Liabilities for contingent consideration are classified as a “Level 3” fair value measurements (as defined in Note 11 to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q) due to the use of significant unobservable inputs and a Monte Carlo simulation to determine its fair value.

The Monte Carlo simulation uses projections of the commercial milestones for the applicable period as well as the corresponding targets and approximate timing of payment based on the terms of the arrangement.

The analysis also uses assumptions for expected volatility of the financial metrics and a risk-adjusted discount rate.

The assumptions and estimates we use in the Monte Carlo simulation require considerable judgment and may change in future periods as a result of new information.

For example, during the three months ended June 30, 2022, as a result of a change in management’s projections regarding the outcome of certain commercial milestones associated with our acquisition of Cernostics, the fair value of the related contingent consideration liability decreased by $20.8 million.

Stock-Based Compensation—Requisite Service Period

For awards with graded vesting and only service conditions, we recognize compensation costs on a straight-line basis over the requisite service period of the awards.

For options and RSUs, the requisite service period is generally the awards’ vesting period (typically four years).

Performance-based restricted stock units (“PSUs”) vest upon the achievement of certain performance conditions and the provision of service with us through a specified period.

Accruals of compensation cost for PSUs are based on the probable outcome of the performance conditions and are reassessed each reporting period.

We recognize compensation cost for PSUs separately for each vesting tranche on a ratable basis over the requisite service period.

The requisite service period for PSUs is based on an analysis of vesting requirements and performance conditions for the particular award.

Certain employees are entitled to acceleration of vesting of a portion of their awards upon retirement, subject to age, years of service and notice requirements.

In these cases, the requisite service period takes into consideration the employee’s retirement eligibility, and is reassessed at each reporting date.

For the ESPP, the requisite service period is generally the period of time from the offering date to the purchase date.

Quantitative and Qualitative Disclosures About Market Risk.

1 unchanged sentence

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.

What changed 10-Q

Item 2. Management’s Discussion and Analysis