UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 2, 2022
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | Commission File Number | (IRS Employer Identification No.) | ||||||||||||
(Address of principal executive offices) | (Zip Code) | |||||||
Registrant’s telephone number, including area code: (650 ) 243-6300
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: | |||||
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
| Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934. | ||
Emerging growth company | ||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ | ||
Item 2.02. Results of Operations and Financial Condition.
On November 2, 2022, Veracyte, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2022. The full text of the press release is furnished as Exhibit 99.1 to this report.
The information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: | November 2, 2022 | ||||||||||
VERACYTE, INC. | |||||||||||
By: | /s/ Rebecca Chambers | ||||||||||
Name: | Rebecca Chambers | ||||||||||
Title: | Chief Financial Officer | ||||||||||
| Principal Financial Officer | |||||||||||
Exhibit 99.1
Veracyte Announces Third Quarter 2022 Financial Results
Grew Total Revenue to $75.6 million, an Increase of 25%
Conference Call and Webcast Today at 4:30 p.m. ET
SOUTH SAN FRANCISCO, Calif., November 2, 2022 --- Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the third quarter ended September 30, 2022.
“Our third quarter results were robust given test adoption growth across our key products, new reimbursement contracts and expanded clinical evidence for our tests,” said Marc Stapley, Veracyte’s chief executive officer. “We continue to invest in our long-term growth drivers, while maintaining our firm focus on financial discipline. I’m delighted with our team’s progress as we pursue our global vision of improving outcomes for patients all over the world through our exceptional diagnostic tests.”
Key Business Highlights:
•Increased third quarter total revenue by 25% to $75.6 million, compared to the third quarter of 2021.
•Grew total test volume to 26,374, an increase of 26% compared to the third quarter of 2021.
•Bolstered commercial reimbursement:
◦Received positive coverage decisions for the Decipher Prostate Genomic Classifier from three commercial payers representing over 20 million members, bringing the total number of covered lives for the test to 195 million; and
◦Signed four new commercial payer contracts for the Afirma Genomic Sequencing Classifier, bolstering the test’s in-network coverage to over 230 million health plan members.
•Further reinforced the value and utility of our portfolio offerings through guideline inclusion and expanded clinical evidence:
◦Received a “Level 1” evidence designation in the National Comprehensive Cancer Network® (NCCN®)’s update to the 2023 prostate cancer guidelines, making the Decipher Prostate Genomic Classifier the first and only prostate cancer gene expression test to achieve this status;
◦Published data from a prospective, multi-site, Phase 2 clinical study in the Journal of the National Cancer Institute suggesting that the Decipher Prostate test may help identify African American men with early, localized prostate cancer who are most likely to harbor aggressive disease;
◦Shared data from Phase 3 of the multi-center, randomized STAMPEDE trial at the European Society for Medical Oncology (ESMO) conference, which confirm the Decipher Prostate test’s ability to identify men with advanced prostate cancer who are more likely to benefit from intensified treatment, potentially expanding the test’s use;
◦Presented data at the American Thyroid Association’s annual meeting suggesting that Veracyte’s Afirma thyroid database and whole-transcriptome capabilities may enable identification of genomic signatures to help predict tumor behavior in thyroid cancer;
◦Presented data at the European Respiratory Society and American College of Chest Physicians (CHEST 2022) annual meetings suggesting the Envisia Genomic Classifier’s ability to provide prognostic information for people with suspected interstitial lung disease;
◦Published a study in Nature Medicine examining the predictive and prognostic potential of Veracyte’s immuno-oncology biomarkers and insight into factors associated with response to CAR T-cell therapy among patients with large B-cell lymphoma; and
◦Presented preliminary clinical utility data at the CHEST meeting for the Percepta Nasal Swab test, which suggest that the noninvasive genomic test may classify more lung nodule patients as low-risk
or high-risk for lung cancer, as compared to the standard-of-care approach, which consists of a physician’s own assessment of clinical factors along with CT imaging.
•Appointed Eliav Barr, M.D., to our Board of Directors and named John Leite, Ph.D. as general manager for Pulmonology and Market Access.
•Generated $7.0 million in cash from operating activities and ended the third quarter of 2022 with cash, cash equivalents and short-term investments of $170.1 million, compared to $164.0 million at the end of the second quarter of 2022.
Third Quarter 2022 Financial Results
Total revenue for the third quarter of 2022 was $75.6 million, an increase of 25% compared to $60.4 million in the third quarter of 2021. Testing revenue was $64.6 million, an increase of 27% compared to $50.9 million in the third quarter of 2021 driven primarily by the strong performance of our Decipher and Afirma tests. Product revenue was $3.3 million, an increase of 12% compared to $3.0 million in the third quarter of 2021. Biopharmaceutical and other revenue was $7.7 million, an increase of 18% compared to $6.5 million in the third quarter of 2021, driven primarily by the contribution of the HalioDx acquisition.
Total gross margin for the third quarter of 2022, including the amortization of acquired intangible assets, was 59%, compared to 57% in the third quarter of 2021. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 66%, compared to 64% in the third quarter of 2021.
Operating expenses, excluding cost of revenue, were $54.6 million, an increase of 5% compared to the third quarter of 2021. Non-GAAP operating expenses, excluding cost of revenue, amortization of acquired intangible assets, other acquisition related expenses and other restructuring costs, were $51.1 million compared to $42.4 million in the third quarter of 2021.
Net loss for the third quarter of 2022 was $8.7 million, an improvement of 38% compared to the third quarter of 2021. Basic and diluted net loss per common share was $0.12, an improvement of 40% compared to the third quarter of 2021. Net cash used by operating activities in the first nine months of 2022 was $2.2 million, an improvement of $37.9 million compared to the same period in 2021.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."
2022 Financial Outlook
The company is raising full-year 2022 total revenue expectations to $288 million to $293 million, representing year-over-year growth of 31% to 33%, assuming currency rates as of November 2, 2022. This represents an improved outlook compared to our prior guidance of $272 million to $280 million.
Conference Call and Webcast Details
Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company's financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: https://edge.media-server.com/mmc/p/iigzqcix. The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at https://investor.veracyte.com/events-presentations.
The conference call dial-in can be accessed by registering at the following link: https://register.vevent.com/register/BIdd8a25033ce74acb8bf03d2ed76733f0
About Veracyte
Veracyte (Nasdaq: VCYT) is a global diagnostics company that improves patient care by answering important clinical questions to inform diagnosis and treatment decisions. Our growing menu of advanced diagnostic tests help patients avoid risky, costly procedures and interventions, and reduce time to appropriate treatment. In addition to making our tests available in the United States through our central laboratories, our exclusive license to our best-in-class diagnostics instrument (nCounter Analysis System) positions us to deliver our tests to patients worldwide
through laboratories that can perform them locally. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, our statements related to our expected total revenue and other financial and operating results for 2022 and our plans, objectives, expectations (financial and otherwise) or intentions with respect to our Prosigna, Afirma, Percepta, Envisia, LymphMark, Decipher Prostate, Percepta Nasal Swab, Percepta Genomic Atlas and Decipher Bladder tests and products, including our biopharma atlas, for use in diagnosing and treating diseases, Medicare coverage, and our commercial organization. Forward-looking statements can be identified by words such as: “appears,” "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will," “positioned,” “designed” and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to: our ability to launch, commercialize and receive reimbursement for our products; to demonstrate the validity and utility of our genomic tests and biopharma offerings to continue to integrate and expand the HalioDx and Decipher businesses and execute on our business plans; to continue to scale our global operations and enhance our internal control environment; the impact of the COVID-19 pandemic and its variants on our business and general economic conditions; the impact of foreign currency fluctuations and inflation; and the performance and utility of our tests in the clinical environment. Additional factors that may impact these forward-looking statements can be found under the caption “Risk Factors” in our Annual Report on Form 10-K filed on February 28, 2022, and our Quarterly Report on Form 10-Q to be filed for the three months ended September 30, 2022. Copies of these documents, when available, may be found in the Investors section of our website at www.investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.
Veracyte, the Veracyte logo, Decipher, Decipher GRID, Afirma, Percepta, Envisia, Prosigna, Lymphmark, TMExplore, Brightplex, Immunosign, “Know by Design” and “More about You” are registered trademarks of Veracyte, Inc. and its subsidiaries in the U.S. and selected countries. Immunoscore IC® is a trademark of Veracyte SAS registered in France. Immunoscore is a registered trademark of Inserm used by Veracyte under license. nCounter is the registered trademark of NanoString Technologies used by Veracyte under license.
Note Regarding Use of Non-GAAP Financial Measures
In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), this press release and the accompanying tables contain, and reference certain non‐GAAP results including non-GAAP gross margin, non-GAAP operating expenses, and non-GAAP loss from operations. These measures are not meant to be considered superior to or a substitute for financial measures calculated in accordance with GAAP, and investors are cautioned that there are material limitations associated with the use of non-GAAP financial measures as an analytical tool.
We use non-GAAP measures to internally evaluate and analyze financial results. We believe these non-GAAP financial measures provide investors with useful supplemental information about the financial performance of our business, enable comparison of financial results between periods where certain items may vary independent of business performance, and enable comparison of our financial results with other public companies, many of which present similar non-GAAP financial measures. However, the non-GAAP measures we present may be different from those used by other companies.
We exclude amortization of acquired intangible assets, acquisition-related expenses relating to our acquisitions of Decipher Biosciences and HalioDx and certain costs related to restructuring from certain of our non-GAAP measures. Management has excluded the effects of these items in non-GAAP measures to help investors gain a better understanding of the core operating results and future prospects of the company, consistent with how management measures and forecasts the company's performance, especially when comparing such results to previous periods or forecasts. The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non‐GAAP information and the reconciliation between these presentations, to more fully understand its business.
Reconciliations between our GAAP results and non‐GAAP financial measures are presented in the tables of this release.
| VERACYTE, INC. | |||||||||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||
| (In thousands of dollars, except share and per share amounts) | |||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
| Testing revenue | $ | 64,577 | $ | 50,897 | $ | 180,275 | $ | 134,768 | |||||||||||||||
| Product revenue | 3,314 | 2,959 | 9,401 | 8,706 | |||||||||||||||||||
| Biopharmaceutical and other revenue | 7,701 | 6,514 | 26,563 | 8,704 | |||||||||||||||||||
| Total revenue | 75,592 | 60,370 | 216,239 | 152,178 | |||||||||||||||||||
| Operating expenses (1): | |||||||||||||||||||||||
| Cost of testing revenue | 19,816 | 16,073 | 55,923 | 42,494 | |||||||||||||||||||
| Cost of product revenue | 1,981 | 1,491 | 5,202 | 4,304 | |||||||||||||||||||
| Cost of biopharmaceutical and other revenue | 4,211 | 4,079 | 13,626 | 4,720 | |||||||||||||||||||
| Research and development | 10,773 | 8,006 | 29,316 | 19,591 | |||||||||||||||||||
| Selling and marketing | 25,678 | 21,670 | 73,433 | 57,628 | |||||||||||||||||||
| General and administrative | 17,600 | 20,749 | 58,310 | 82,504 | |||||||||||||||||||
| Intangible asset amortization | 5,213 | 4,983 | 16,090 | 10,507 | |||||||||||||||||||
| Total operating expenses | 85,272 | 77,051 | 251,900 | 221,748 | |||||||||||||||||||
| Loss from operations | (9,680) | (16,681) | (35,661) | (69,570) | |||||||||||||||||||
| Other income (loss), net | 805 | 1,202 | 2,675 | (762) | |||||||||||||||||||
| Loss before income taxes | (8,875) | (15,479) | (32,986) | (70,332) | |||||||||||||||||||
| Income tax benefit | (152) | (1,350) | (270) | (5,297) | |||||||||||||||||||
| Net loss | $ | (8,723) | $ | (14,129) | $ | (32,716) | $ | (65,035) | |||||||||||||||
| Net loss per common share, basic and diluted | $ | (0.12) | $ | (0.20) | $ | (0.46) | $ | (0.97) | |||||||||||||||
| Shares used to compute net loss per common share, basic and diluted | 71,656,694 | 69,743,733 | 71,456,008 | 66,820,654 | |||||||||||||||||||
1. Cost of revenue, research and development, sales and marketing and general and administrative expenses include the following stock-based compensation related expenses:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Cost of revenue | $ | 290 | $ | 193 | $ | 947 | $ | 481 | |||||||||||||||
| Research and development | 1,692 | 1,276 | 4,801 | 3,191 | |||||||||||||||||||
| Selling and marketing | 2,015 | 1,804 | 4,721 | 3,441 | |||||||||||||||||||
| General and administrative | 3,445 | 4,961 | 9,954 | 9,041 | |||||||||||||||||||
| Total stock-based compensation expense | $ | 7,442 | $ | 8,234 | $ | 20,423 | $ | 16,154 | |||||||||||||||
| VERACYTE, INC. | |||||||||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS | |||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||
| (In thousands) | |||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Net loss | $ | (8,723) | $ | (14,129) | $ | (32,716) | $ | (65,035) | |||||||||||||||
| Other comprehensive loss: | |||||||||||||||||||||||
| Change in currency translation adjustments | (16,016) | (8,140) | (38,983) | (8,140) | |||||||||||||||||||
| Net comprehensive loss | $ | (24,739) | $ | (22,269) | $ | (71,699) | $ | (73,175) | |||||||||||||||
| VERACYTE, INC. | |||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||
| (In thousands) | |||||||||||
| September 30, | December 31, | ||||||||||
| 2022 | 2021 | ||||||||||
| (Unaudited) | (See Note 1) | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 170,112 | $ | 173,197 | |||||||
| Short-term investments | — | 3,964 | |||||||||
| Accounts receivable | 40,068 | 41,461 | |||||||||
| Supplies and inventory | 13,798 | 11,225 | |||||||||
| Prepaid expenses and other current assets | 14,538 | 13,255 | |||||||||
Total current assets | 238,516 | 243,102 | |||||||||
| Property and equipment, net | 17,237 | 15,098 | |||||||||
| Right-of-use assets, operating leases | 13,885 | 16,043 | |||||||||
| Intangible assets, net | 176,542 | 202,731 | |||||||||
| Goodwill | 676,885 | 707,904 | |||||||||
| Restricted cash | 749 | 749 | |||||||||
| Other assets | 2,143 | 2,198 | |||||||||
| Total assets | $ | 1,125,957 | $ | 1,187,825 | |||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 11,114 | $ | 12,360 | |||||||
| Accrued liabilities | 32,137 | 39,475 | |||||||||
| Current portion of long-term debt | 1,187 | 1,127 | |||||||||
| Current portion of deferred revenue | 3,863 | 4,646 | |||||||||
| Current portion of acquisition-related contingent consideration | 5,913 | 2,682 | |||||||||
| Current portion of operating lease liabilities | 3,958 | 3,630 | |||||||||
| Current portion of other liabilities | 180 | 231 | |||||||||
Total current liabilities | 58,352 | 64,151 | |||||||||
| Deferred revenue, net of current portion | — | 343 | |||||||||
| Deferred tax liabilities | 4,342 | 5,592 | |||||||||
| Acquisition-related contingent consideration, net of current portion | 2,411 | 5,722 | |||||||||
| Operating lease liabilities, net of current portion | 11,527 | 14,096 | |||||||||
| Other liabilities | 1,148 | 1,407 | |||||||||
Total liabilities | 77,780 | 91,311 | |||||||||
| Total stockholders’ equity | 1,048,177 | 1,096,514 | |||||||||
| Total liabilities and stockholders’ equity | $ | 1,125,957 | $ | 1,187,825 | |||||||
| 1. The condensed consolidated balance sheet at December 31, 2021 has been derived from the audited financial statements at that date included in the Company's Form 10-K filed with the Securities and Exchange Commission dated February 28, 2022. | |||||||||||
| VERACYTE, INC. | |||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||
| (Unaudited) | |||||||||||
| (in thousands of dollars) | |||||||||||
| Nine Months Ended September 30, | |||||||||||
| 2022 | 2021 | ||||||||||
| Operating activities | |||||||||||
| Net loss | $ | (32,716) | $ | (65,035) | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Depreciation and amortization | 19,372 | 13,189 | |||||||||
| Loss on disposal of property and equipment | 72 | — | |||||||||
| Stock-based compensation | 19,867 | 15,787 | |||||||||
| Benefit from income taxes | (270) | (5,297) | |||||||||
| Interest on end-of-term debt obligation | 161 | 161 | |||||||||
| Noncash lease expense | 2,487 | 1,566 | |||||||||
| Revaluation of acquisition-related contingent consideration | (80) | 303 | |||||||||
| Effect of foreign currency on operations | 1,563 | 1,601 | |||||||||
| Impairment of intangible assets | 3,318 | — | |||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Accounts receivable | (4,356) | (6,285) | |||||||||
| Supplies and inventory | (2,841) | 4 | |||||||||
| Prepaid expenses and other current assets | (25) | (1,905) | |||||||||
| Other assets | 160 | 353 | |||||||||
| Operating lease liabilities | (2,570) | (1,710) | |||||||||
| Accounts payable | (325) | 3,872 | |||||||||
| Accrued liabilities and deferred revenue | (6,026) | 3,329 | |||||||||
| Net cash used in operating activities | (2,209) | (40,067) | |||||||||
| Investing activities | |||||||||||
| Acquisition of Decipher Biosciences, net of cash acquired | — | (574,411) | |||||||||
| Acquisition of HalioDx, net of cash acquired | — | (163,645) | |||||||||
| Purchase of short-term investments | (8,972) | — | |||||||||
| Proceeds from maturity of short-term investments | 12,696 | — | |||||||||
| Proceeds from sale of equity securities | — | 3,000 | |||||||||
| Purchases of property and equipment | (6,677) | (4,535) | |||||||||
| Net cash used in investing activities | (2,953) | (739,591) | |||||||||
| Financing activities | |||||||||||
| Proceeds from the issuance of common stock in a public offering, net of issuance costs | — | 593,821 | |||||||||
| Payment of long-term debt | (94) | — | |||||||||
| Payment of taxes on vested restricted stock units | (2,639) | (8,307) | |||||||||
| Proceeds from the exercise of common stock options and employee stock purchases | 6,134 | 10,633 | |||||||||
| Net cash provided by financing activities | 3,401 | 596,147 | |||||||||
| Decrease in cash, cash equivalents and restricted cash | (1,761) | (183,511) | |||||||||
| Effect of foreign currency on cash, cash equivalents and restricted cash | (1,324) | (1,678) | |||||||||
| Net decrease in cash, cash equivalents and restricted cash | (3,085) | (185,189) | |||||||||
| Cash, cash equivalents and restricted cash at beginning of period | 173,946 | 349,967 | |||||||||
| Cash, cash equivalents and restricted cash at end of period | $ | 170,861 | $ | 164,778 | |||||||
| CASH, CASH EQUIVALENTS AND RESTRICTED CASH | |||||||||||
| (Unaudited) | |||||||||||
| (In thousands of dollars) | |||||||||||
| September 30, | December 31, | ||||||||||
| 2022 | 2021 | ||||||||||
| Cash and cash equivalents | $ | 170,112 | $ | 173,197 | |||||||
| Restricted cash | 749 | 749 | |||||||||
| Total cash, cash equivalents and restricted cash | $ | 170,861 | $ | 173,946 | |||||||
| Reconciliation of U.S. GAAP to Non-GAAP Financial Measures | |||||||||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||||||||
| (In thousands of dollars) | |||||||||||||||||||||||||||||
| Identified Expenses | |||||||||||||||||||||||||||||
| GAAP | Acquisition Related Expenses (1) | Intangible Assets Amortization Expense | Other (4) | Total Non-GAAP Measure | |||||||||||||||||||||||||
| Three Months Ended September 30, 2022 | |||||||||||||||||||||||||||||
| Total revenue | $ | 75,592 | $ | — | $ | — | $ | — | $ | 75,592 | |||||||||||||||||||
| Cost of testing revenue | 19,816 | 49 | — | 18 | 19,749 | ||||||||||||||||||||||||
| Cost of product revenue | 1,981 | — | — | 3 | 1,978 | ||||||||||||||||||||||||
| Cost of biopharmaceutical and other revenue | 4,211 | 62 | — | — | 4,149 | ||||||||||||||||||||||||
| Intangible asset amortization (2) | 4,703 | — | 4,703 | — | — | ||||||||||||||||||||||||
| Gross margin $ | 44,881 | 111 | 4,703 | 21 | 49,716 | ||||||||||||||||||||||||
| Gross margin % | 59 | % | 66 | % | |||||||||||||||||||||||||
| Research and development | 10,773 | 251 | — | — | 10,522 | ||||||||||||||||||||||||
| Selling and marketing | 25,678 | 923 | — | 493 | 24,262 | ||||||||||||||||||||||||
| General and administrative | 17,600 | 1,272 | — | — | 16,328 | ||||||||||||||||||||||||
| Intangible asset amortization | 510 | — | 510 | — | — | ||||||||||||||||||||||||
| Total operating expenses excluding cost of revenue (3) | 54,561 | 2,446 | 510 | 493 | 51,112 | ||||||||||||||||||||||||
| Loss from operations | $ | (9,680) | $ | 2,557 | $ | 5,213 | $ | 514 | $ | (1,396) | |||||||||||||||||||
| Three Months Ended September 30, 2021 | |||||||||||||||||||||||||||||
| Total revenue | $ | 60,370 | $ | — | $ | — | $ | — | $ | 60,370 | |||||||||||||||||||
| Cost of testing revenue | 16,073 | 26 | — | — | 16,047 | ||||||||||||||||||||||||
| Cost of product revenue | 1,491 | — | — | — | 1,491 | ||||||||||||||||||||||||
| Cost of biopharmaceutical and other revenue | 4,079 | 52 | — | — | 4,027 | ||||||||||||||||||||||||
| Intangible asset amortization (2) | 4,517 | — | 4,517 | — | — | ||||||||||||||||||||||||
| Gross margin $ | 34,210 | 78 | 4,517 | — | 38,805 | ||||||||||||||||||||||||
| Gross margin % | 57 | % | 64 | % | |||||||||||||||||||||||||
| Research and development | 8,006 | 359 | — | — | 7,647 | ||||||||||||||||||||||||
| Selling and marketing | 21,670 | 641 | — | — | 21,029 | ||||||||||||||||||||||||
| General and administrative | 20,749 | 7,047 | — | — | 13,702 | ||||||||||||||||||||||||
| Intangible asset amortization | 466 | — | 466 | — | — | ||||||||||||||||||||||||
| Total operating expenses excluding cost of revenue (3) | 50,891 | 8,047 | 466 | — | 42,378 | ||||||||||||||||||||||||
| Loss from operations | $ | (16,681) | $ | 8,125 | $ | 4,983 | $ | — | $ | (3,573) | |||||||||||||||||||
| 1. Includes transaction related expenses as well as post-combination compensation expenses. For 2021, adjustments consist primarily of transaction-related expenses associated with the acquisition of Decipher Biosciences. For 2022, adjustments consist primarily of post-combination compensation expenses associated with the acquisition of HalioDx. | |||||||||||||||||||||||||||||
| 2. Includes only amortization of intangible assets identified as developed technology assets through purchase accounting transactions, which otherwise would have been allocated to cost of revenue. | |||||||||||||||||||||||||||||
| 3. Includes only amortization of intangible assets, which otherwise would have been allocated to research and development, selling and marketing or general and administrative expense and excludes the cost of revenue ($26.0 and $21.6 million) and the amortization of intangible assets which would have been allocated to the cost of revenue ($5.2 and $5.0 million) for Q3 2022 and 2021 respectively. | |||||||||||||||||||||||||||||
| 4. Includes $0.5 million expense related to restructuring costs | |||||||||||||||||||||||||||||
| Reconciliation of U.S. GAAP to Non-GAAP Financial Measures | |||||||||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||||||||
| (In thousands of dollars) | |||||||||||||||||||||||||||||
| Identified Expenses | |||||||||||||||||||||||||||||
| GAAP | Acquisition Related Expenses (1) | Intangible Assets Amortization Expense | Other (4) | Total Non-GAAP Measure | |||||||||||||||||||||||||
| Nine Months Ended September 30, 2022 | |||||||||||||||||||||||||||||
| Total revenue | $ | 216,239 | $ | — | $ | — | $ | — | $ | 216,239 | |||||||||||||||||||
| Cost of testing revenue | 55,923 | 153 | — | 18 | 55,752 | ||||||||||||||||||||||||
| Cost of product revenue | 5,202 | — | — | 3 | 5,199 | ||||||||||||||||||||||||
| Cost of biopharmaceutical and other revenue | 13,626 | 261 | — | — | 13,365 | ||||||||||||||||||||||||
| Intangible asset amortization (2) | 14,526 | — | 14,526 | — | — | ||||||||||||||||||||||||
| Gross margin $ | 126,962 | 414 | 14,526 | 21 | 141,923 | ||||||||||||||||||||||||
| Gross margin % | 59 | % | 66 | % | |||||||||||||||||||||||||
| Research and development | 29,316 | 1,186 | — | — | 28,130 | ||||||||||||||||||||||||
| Selling and marketing | 73,433 | 2,997 | — | 493 | 69,943 | ||||||||||||||||||||||||
| General and administrative | 58,310 | 3,877 | — | 3,318 | 51,115 | ||||||||||||||||||||||||
| Intangible asset amortization | 1,564 | — | 1,564 | — | — | ||||||||||||||||||||||||
| Total operating expenses excluding cost of revenue (3) | 162,623 | 8,060 | 1,564 | 3,811 | 149,188 | ||||||||||||||||||||||||
| Loss from operations | $ | (35,661) | $ | 8,474 | $ | 16,090 | $ | 3,832 | $ | (7,265) | |||||||||||||||||||
| Nine Months Ended September 30, 2021 | |||||||||||||||||||||||||||||
| Total revenue | $ | 152,178 | $ | — | $ | — | $ | — | $ | 152,178 | |||||||||||||||||||
| Cost of testing revenue | 42,494 | 26 | — | — | 42,468 | ||||||||||||||||||||||||
| Cost of product revenue | 4,304 | — | — | — | 4,304 | ||||||||||||||||||||||||
| Cost of biopharmaceutical and other revenue | 4,720 | 52 | — | — | 4,668 | ||||||||||||||||||||||||
| Intangible asset amortization (2) | 9,555 | — | 9,555 | — | — | ||||||||||||||||||||||||
| Gross margin $ | 91,105 | 78 | 9,555 | — | 100,738 | ||||||||||||||||||||||||
| Gross margin % | 60 | % | 66 | % | |||||||||||||||||||||||||
| Research and development | 19,591 | 360 | — | — | 19,231 | ||||||||||||||||||||||||
| Selling and marketing | 57,628 | 709 | — | — | 56,919 | ||||||||||||||||||||||||
| General and administrative | 82,504 | 46,415 | — | — | 36,089 | ||||||||||||||||||||||||
| Intangible asset amortization | 952 | — | 952 | — | — | ||||||||||||||||||||||||
| Total operating expenses excluding cost of revenue (3) | 160,675 | 47,484 | 952 | — | 112,239 | ||||||||||||||||||||||||
| Loss from operations | $ | (69,570) | $ | 47,562 | $ | 10,507 | $ | — | $ | (11,501) | |||||||||||||||||||
| 1. Includes transaction related expenses as well as post-combination compensation expenses. For 2021, adjustments consist primarily of transaction-related expenses associated with the acquisition of Decipher Biosciences. For 2022, adjustments consist primarily of post-combination compensation expenses associated with the acquisition of HalioDx. | |||||||||||||||||||||||||||||
| 2. Includes only amortization of intangible assets identified as developed technology assets through purchase accounting transactions, which otherwise would have been allocated to cost of revenue. | |||||||||||||||||||||||||||||
| 3. Includes only amortization of intangible assets, which otherwise would have been allocated to research and development, selling and marketing or general and administrative expense and excludes the cost of revenue ($74.8 and $51.5 million) and the amortization of intangible assets which would have been allocated to the cost of revenue ($14.5 and $9.6 million) for the first nine months of 2022 and 2021 respectively | |||||||||||||||||||||||||||||
| 4. Includes $3.3 million expense related to the impairment charge associated with certain developed technology intangible assets and $0.5 million related to restructuring costs | |||||||||||||||||||||||||||||
# # #
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