vcyt-20230222
FALSE000138410100013841012023-02-222023-02-22
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): February 22, 2023
VERACYTE, INC.
(Exact name of registrant as specified in its charter)
| | | | | | | | | | | | | | |
Delaware | | 001-36156 | | 20-5455398 |
(State or other jurisdiction of incorporation) | | Commission File Number | | (IRS Employer Identification No.) |
| | | | | | | | |
6000 Shoreline Court, Suite 300, South San Francisco, California | | 94080 |
(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 |
Common Stock, par value $0.001 per share | | VCYT | | The Nasdaq Stock Market LLC |
| | |
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 February 22, 2023, Veracyte, Inc. issued a press release announcing its financial results for the quarter and year ended December 31, 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.
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Dated: | February 22, 2023 | | |
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| | VERACYTE, INC. |
| | | |
| | By: | /s/ Rebecca Chambers |
| | Name: | Rebecca Chambers |
| | Title: | Chief Financial Officer |
| | | Principal Financial Officer |
Document
Exhibit 99.1
Veracyte Announces Fourth Quarter and Full-Year 2022 Financial Results
Grew Fourth Quarter Revenue to $80.3 Million
Grew 2022 Total Revenue to $296.5 Million
Conference Call and Webcast Today at 4:30 p.m. ET
SOUTH SAN FRANCISCO, Calif., February 22, 2023 --- Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the fourth quarter and full year ended December 31, 2022.
“We had an outstanding fourth quarter, driving record revenue and operating cash flows, achieving the best quarter ever for both our Decipher prostate and Afirma thyroid tests,” said Marc Stapley, Veracyte’s chief executive officer. “Moreover, throughout 2022, we invested in our long-term growth drivers to deliver on our promise of empowering clinicians with high-value insights to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Moving into 2023, we have a clear strategy, strong financial position, and significant momentum to advance our vision of transforming cancer care for patients all over the world.”
Key Business Highlights:
•Grew total test volume to 28,001 in the fourth quarter and 102,524 for the full-year 2022, an increase of 26% and 30%, respectively, compared to the prior year.
•Launched an updated Decipher Genomics Resource for Intelligent Discovery (GRID) patient report, providing physicians who order the Decipher Prostate Genomic Classifier with expanded precision-medicine insights, on a Research Use Only basis.
•Submitted the Envisia Genomic Classifier to the Notified Body for CE marking in the European Union, ahead of schedule.
•Published data in the International Journal of Radiation Oncology, Biology, Physics demonstrating that the Decipher Prostate Genomic Classifier can improve risk stratification among men with clinically high-risk prostate cancer.
•Published a meta-analysis of 13 independent studies for the Afirma Genomic Sequencing Classifier in the Journal of Clinical Endocrinology & Metabolism, confirming the test’s strong real-world performance in informing thyroid nodule diagnosis.
•Published data in Frontiers in Endocrinology suggesting that insights derived from Veracyte’s comprehensive thyroid nodule database of whole-transcriptome sequencing may help personalize care for patients with thyroid nodules.
•Generated $9.7 million in cash from operating activities in the fourth quarter and $7.5 million for the full-year 2022. Ended the fourth quarter of 2022 with cash, cash equivalents and short-term investments of $178.9 million, compared to $177.2 million at the beginning of 2022.
•Promoted Annie McGuire to General Counsel and Chief People Officer.
Fourth Quarter 2022 Financial Results
Total revenue for the fourth quarter of 2022 was $80.3 million, an increase of 19% compared to $67.3 million in the fourth quarter of 2021. Testing revenue was $70.3 million, an increase of 32% compared to $53.4 million in the fourth quarter of 2021 driven primarily by the strong performance of our Decipher and Afirma tests. Product revenue was $3.2 million, an increase of 17% compared to $2.8 million in the fourth quarter of 2021. Biopharmaceutical and other revenue was $6.8 million, a decrease of 39% compared to $11.2 million, driven primarily by a milestone payment received in the prior year period.
Total gross margin for the fourth quarter of 2022, including the amortization of acquired intangible assets, was 61%, compared to 59% in the fourth quarter of 2021. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 67% compared to 66% in the fourth quarter of 2021.
Operating expenses, excluding cost of revenue, were $58.9 million, an increase of 4% compared to the fourth 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 $46.2 million in the fourth quarter of 2021.
Net loss for the fourth quarter of 2022 was $3.8 million, an improvement of 63% compared to the fourth quarter of 2021. Basic and diluted net loss per common share was $0.05, an improvement of 67% compared to the fourth quarter of 2021.
Full Year 2022 Financial Results
Total revenue for 2022 was $296.5 million, an increase of 35% compared to $219.5 million in 2021. Testing revenue was $250.5 million, an increase of 33% compared to $188.2 million in 2021 driven primarily by the strong performance of our Decipher and Afirma tests. Product revenue was $12.6 million, an increase of 10% compared to $11.5 million in 2021. Biopharmaceutical and other revenue was $33.4 million, an increase of 68% compared to $19.9 million in 2021, driven primarily by the contribution of the HalioDx acquisition.
Total gross margin for the full year 2022, including the amortization of acquired intangible assets, was 59%, compared to 60% in 2021. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 66%, flat to 2021.
Operating expenses, excluding cost of revenue, were $236.0 million, an increase of 4% compared to 2021. Non-GAAP operating expenses, excluding cost of revenue, amortization of acquired intangible assets, other acquisition related expenses and other restructuring costs, were $200.3 million compared to $158.4 million in 2021.
Net loss for the full year 2022 was $36.6 million, an improvement of 52% compared to 2021. Basic and diluted net loss per common share was $0.51, an improvement of 54% compared to 2021. Net cash provided by operating activities in 2022 was $7.5 million, an improvement of $39.2 million compared to 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."
2023 Financial Outlook
Veracyte is initiating 2023 annual total revenue guidance of $325 million to $335 million, assuming currency rates as of February 22, 2023. This range includes mid-teens year-over-year growth of testing and product revenue, and a decline in Biopharmaceutical and other revenue for fiscal 2023 compared to fiscal 2022.
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/6vvggrow. 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/BIbe54a1af06be4083968e88a7edfb6679
About Veracyte
Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our high-performing tests enable clinicians to make more confident diagnostic, prognostic and treatment decisions for some of the most challenging diseases such as thyroid, prostate, breast, bladder and lung cancers, as well as interstitial lung diseases. We help patients avoid unnecessary procedures and speed time to diagnosis and appropriate treatment. In addition to making our tests available in the U.S. through our central laboratories, we also aim to deliver our tests to patients worldwide through a distributed
model to 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 for 2023 and our plans, objectives, expectations (financial and otherwise) or intentions with respect to our tests and products. 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 war in Ukraine on European economies and energy supply, as well as our facilities in France; the impact of the COVID-19 pandemic and its variants on our business and general economic conditions; the impact of foreign currency fluctuations, increasing interest rates 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 Quarterly Report on Form 10-Q for the three months ended September 30, 2022, filed on November 3, 2022, and our Annual Report on Form 10-K to be filed for the year ended December 31, 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.
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VERACYTE, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
(Unaudited) |
(In thousands of dollars, except share and per share amounts) |
| | | | | | | |
| Three Months Ended December 31, | | Twelve Months Ended December 31, |
| 2022 | | 2021 | | 2022 | | 2021 |
Revenues: | | | | | | | |
Testing revenue | $ | 70,269 | | | $ | 53,414 | | | $ | 250,544 | | | $ | 188,182 | |
Product revenue | 3,231 | | | 2,758 | | | 12,632 | | | 11,464 | |
Biopharmaceutical and other revenue | 6,797 | | | 11,164 | | | 33,360 | | | 19,868 | |
Total revenue | 80,297 | | | 67,336 | | | 296,536 | | | 219,514 | |
| | | | | | | |
Operating expenses (1): | | | | | | | |
Cost of testing revenue | 19,394 | | | 16,366 | | | 75,317 | | | 58,860 | |
Cost of product revenue | 2,618 | | | 1,583 | | | 7,820 | | | 5,887 | |
Cost of biopharmaceutical and other revenue | 4,819 | | | 4,933 | | | 18,445 | | | 9,653 | |
Research and development | 11,287 | | | 10,252 | | | 40,603 | | | 29,843 | |
Selling and marketing | 24,127 | | | 22,212 | | | 97,560 | | | 79,840 | |
General and administrative | 18,208 | | | 18,849 | | | 76,518 | | | 101,353 | |
Intangible asset amortization | 5,264 | | | 5,474 | | | 21,354 | | | 15,981 | |
Total operating expenses | 85,717 | | | 79,669 | | | 337,617 | | | 301,417 | |
Loss from operations | (5,420) | | | (12,333) | | | (41,081) | | | (81,903) | |
Other income, net | 1,979 | | | 1,016 | | | 4,654 | | | 254 | |
Loss before income taxes | (3,441) | | | (11,317) | | | (36,427) | | | (81,649) | |
Income tax provision (benefit) | 403 | | | (789) | | | 133 | | | (6,086) | |
Net loss | $ | (3,844) | | | $ | (10,528) | | | $ | (36,560) | | | $ | (75,563) | |
Net loss per common share, basic and diluted | $ | (0.05) | | | $ | (0.15) | | | $ | (0.51) | | | $ | (1.11) | |
Shares used to compute net loss per common share, basic and diluted | 71,825,754 | | | 71,064,467 | | | 71,549,204 | | | 67,890,328 | |
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 December 31, | | Twelve Months Ended December 31, |
| 2022 | | 2021 | | 2022 | | 2021 |
Cost of revenue | $ | 408 | | | $ | 354 | | | $ | 1,355 | | | $ | 835 | |
Research and development | 1,332 | | | 1,555 | | | 6,132 | | | 4,747 | |
Selling and marketing | 1,297 | | | 1,197 | | | 6,018 | | | 4,638 | |
General and administrative | 3,997 | | | 3,708 | | | 13,951 | | | 12,748 | |
Total stock-based compensation expense | $ | 7,034 | | | $ | 6,814 | | | $ | 27,456 | | | $ | 22,968 | |
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VERACYTE, INC. |
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME (LOSS) |
(Unaudited) |
(In thousands) |
| | | | | | | |
| Three Months Ended December 31, | | Twelve Months Ended December 31, |
| 2022 | | 2021 | | 2022 | | 2021 |
Net loss | $ | (3,844) | | | $ | (10,528) | | | $ | (36,560) | | | $ | (75,563) | |
Other comprehensive loss: | | | | | | | |
Change in currency translation adjustments | 22,720 | | | (6,943) | | | (16,263) | | | (15,083) | |
| | | | | | | |
Net comprehensive income (loss) | $ | 18,876 | | | $ | (17,471) | | | $ | (52,823) | | | $ | (90,646) | |
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VERACYTE, INC. |
CONSOLIDATED BALANCE SHEETS |
(In thousands) |
| | | |
| December 31, | | December 31, |
| 2022 | | 2021 |
| (Unaudited) | | (See Note 1) |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 154,247 | | | $ | 173,197 | |
Short-term investments | 24,605 | | | 3,964 | |
Accounts receivable | 44,021 | | | 41,461 | |
Supplies and inventory | 14,294 | | | 11,225 | |
Prepaid expenses and other current assets | 11,469 | | | 13,255 | |
Total current assets | 248,636 | | | 243,102 | |
Property and equipment, net | 17,702 | | | 15,098 | |
Right-of-use assets, operating leases | 13,160 | | | 16,043 | |
Intangible assets, net | 174,866 | | | 202,731 | |
Goodwill | 695,891 | | | 707,904 | |
Restricted cash | 749 | | | 749 | |
Other assets | 5,418 | | | 2,198 | |
Total assets | $ | 1,156,422 | | | $ | 1,187,825 | |
Liabilities and Stockholders’ Equity | | | |
Current liabilities: | | | |
Accounts payable | $ | 11,911 | | | $ | 12,360 | |
Accrued liabilities | 37,774 | | | 39,475 | |
Current portion of long-term debt | — | | | 1,127 | |
Current portion of deferred revenue | 2,613 | | | 4,646 | |
Current portion of acquisition-related contingent consideration | 6,060 | | | 2,682 | |
Current portion of operating lease liabilities | 4,070 | | | 3,630 | |
Current portion of other liabilities | 186 | | | 231 | |
Total current liabilities | 62,614 | | | 64,151 | |
Deferred revenue, net of current portion | — | | | 343 | |
Deferred tax liabilities | 4,531 | | | 5,592 | |
Acquisition-related contingent consideration, net of current portion | 2,498 | | | 5,722 | |
Operating lease liabilities, net of current portion | 10,648 | | | 14,096 | |
Other liabilities | 931 | | | 1,407 | |
Total liabilities | 81,222 | | | 91,311 | |
Total stockholders’ equity | 1,075,200 | | | 1,096,514 | |
Total liabilities and stockholders’ equity | $ | 1,156,422 | | | $ | 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. |
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VERACYTE, INC. |
CONSOLIDATED STATEMENTS OF CASH FLOWS |
(Unaudited) |
(in thousands of dollars) |
| | | |
| Twelve Months Ended |
| 2022 | | 2021 |
Operating activities | | | |
Net loss | $ | (36,560) | | | $ | (75,563) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Depreciation and amortization | 25,928 | | | 19,593 | |
Loss on disposal of property and equipment | 206 | | | — | |
Stock-based compensation | 26,734 | | | 22,519 | |
Provision for (benefit from) income taxes | 133 | | | (6,258) | |
Interest on end-of-term debt obligation | 161 | | | 216 | |
Noncash lease expense | 3,320 | | | 1,632 | |
Revaluation of acquisition-related contingent consideration | 154 | | | 810 | |
Effect of foreign currency on operations | 522 | | | 1,211 | |
Impairment of intangible assets | 3,318 | | | — | |
Changes in operating assets and liabilities: | | | |
Accounts receivable | 1,096 | | | (8,571) | |
Supplies and inventory | (3,011) | | | (1,464) | |
Prepaid expenses and other current assets | (4,201) | | | (3,316) | |
Other assets | (3,049) | | | (216) | |
Operating lease liabilities | (3,448) | | | (1,794) | |
Accounts payable | 152 | | | 5,155 | |
Accrued liabilities and deferred revenue | (3,920) | | | 14,425 | |
Net cash provided by (used in) operating activities | 7,535 | | | (31,621) | |
Investing activities | | | |
Acquisition of Decipher Biosciences, net of cash acquired | — | | | (574,411) | |
Acquisition of HalioDx, net of cash acquired | — | | | (162,419) | |
Purchase of short-term investments | (33,519) | | | — | |
Proceeds from maturity of short-term investments | 12,681 | | | — | |
Proceeds from sale of equity securities | — | | | 3,000 | |
| | | |
Purchases of property and equipment | (8,549) | | | (5,376) | |
Net cash used in investing activities | (29,387) | | | (739,206) | |
Financing activities | | | |
Proceeds from the issuance of common stock in a public offering, net of issuance costs | — | | | 593,821 | |
Payment of long-term debt | (1,281) | | | — | |
Payment of taxes on vested restricted stock units | (3,167) | | | (9,029) | |
Proceeds from the exercise of common stock options and employee stock purchases | 7,942 | | | 11,528 | |
Net cash provided by financing activities | 3,494 | | | 596,320 | |
Decrease in cash, cash equivalents and restricted cash | (18,358) | | | (174,507) | |
Effect of foreign currency on cash, cash equivalents and restricted cash | (592) | | | (1,514) | |
Net decrease in cash, cash equivalents and restricted cash | (18,950) | | | (176,021) | |
Cash, cash equivalents and restricted cash at beginning of period | 173,946 | | | 349,967 | |
Cash, cash equivalents and restricted cash at end of period | $ | 154,996 | | | $ | 173,946 | |
| | | |
| | | | | | | | | | | |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
(Unaudited) |
(In thousands of dollars) |
| | | |
| December 31, | | December 31, |
| 2022 | | 2021 |
Cash and cash equivalents | $ | 154,247 | | | $ | 173,197 | |
Restricted cash | 749 | | | 749 | |
Total cash, cash equivalents and restricted cash | $ | 154,996 | | | $ | 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 December 31, 2022 | | | | | | | | |
Total revenue | $ | 80,297 | | | $ | — | | | $ | — | | | $ | — | | | $ | 80,297 | |
Cost of testing revenue | 19,394 | | | 50 | | | — | | | — | | | 19,344 | |
Cost of product revenue | 2,618 | | | — | | | — | | | — | | | 2,618 | |
Cost of biopharmaceutical and other revenue | 4,819 | | | 64 | | | — | | | — | | | 4,755 | |
Intangible asset amortization (2) | 4,747 | | | — | | | 4,747 | | | — | | | — | |
Gross margin $ | 48,719 | | | 114 | | | 4,747 | | | — | | | 53,580 | |
Gross margin % | 61 | % | | | | | | | | 67 | % |
| | | | | | | | | |
Research and development | 11,287 | | | 232 | | | — | | | — | | | 11,055 | |
Selling and marketing | 24,127 | | | 917 | | | — | | | — | | | 23,210 | |
General and administrative | 18,208 | | | 1,368 | | | — | | | — | | | 16,840 | |
Intangible asset amortization | 517 | | | — | | | 517 | | | — | | | — | |
Total operating expenses excluding cost of revenue (3) | 54,139 | | | 2,517 | | | 517 | | | — | | | 51,105 | |
Income (loss) from operations | $ | (5,420) | | | $ | 2,631 | | | $ | 5,264 | | | $ | — | | | $ | 2,475 | |
| | | | | | | | | |
Three Months Ended December 31, 2021 | | | | | | | | |
Total revenue | $ | 67,336 | | | $ | — | | | $ | — | | | $ | — | | | $ | 67,336 | |
Cost of testing revenue | 16,366 | | | 55 | | | — | | | — | | | 16,311 | |
Cost of product revenue | 1,583 | | | — | | | — | | | — | | | 1,583 | |
Cost of biopharmaceutical and other revenue | 4,933 | | | 165 | | | — | | | — | | | 4,768 | |
Intangible asset amortization (2) | 4,936 | | | — | | | 4,936 | | | — | | | — | |
Gross margin $ | 39,518 | | | 220 | | | 4,936 | | | — | | | 44,674 | |
Gross margin % | 59 | % | | | | | | | | 66 | % |
| | | | | | | | | |
Research and development | 10,252 | | | 667 | | | — | | | — | | | 9,585 | |
Selling and marketing | 22,212 | | | 1,046 | | | — | | | — | | | 21,166 | |
General and administrative | 18,849 | | | 3,399 | | | — | | | — | | | 15,450 | |
Intangible asset amortization | 538 | | | — | | | 538 | | | — | | | — | |
Total operating expenses excluding cost of revenue (3) | 51,851 | | | 5,112 | | | 538 | | | — | | | 46,201 | |
Loss from operations | $ | (12,333) | | | $ | 5,332 | | | $ | 5,474 | | | $ | — | | | $ | (1,527) | |
| | | | | | | | | |
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 ($26.8 and $22.9 million) and the amortization of intangible assets which would have been allocated to the cost of revenue ($4.7 and $4.9 million) for Q4 2022 and 2021 respectively. |
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 |
Twelve Months Ended December 31, 2022 | | | | | | | | |
Total revenue | $ | 296,536 | | | $ | — | | | $ | — | | | $ | — | | | $ | 296,536 | |
Cost of testing revenue | 75,317 | | | 203 | | | — | | | 18 | | | 75,096 | |
Cost of product revenue | 7,820 | | | — | | | — | | | 3 | | | 7,817 | |
Cost of biopharmaceutical and other revenue | 18,445 | | | 325 | | | — | | | — | | | 18,120 | |
Intangible asset amortization (2) | 19,273 | | | — | | | 19,273 | | | — | | | — | |
Gross margin $ | 175,681 | | | 528 | | | 19,273 | | | 21 | | | 195,503 | |
Gross margin % | 59 | % | | | | | | | | 66 | % |
| | | | | | | | | |
Research and development | 40,603 | | | 1,418 | | | — | | | — | | | 39,185 | |
Selling and marketing | 97,560 | | | 3,914 | | | — | | | 493 | | | 93,153 | |
General and administrative | 76,518 | | | 5,245 | | | — | | | 3,318 | | | 67,955 | |
Intangible asset amortization | 2,081 | | | — | | | 2,081 | | | — | | | — | |
Total operating expenses excluding cost of revenue (3) | 216,762 | | | 10,577 | | | 2,081 | | | 3,811 | | | 200,293 | |
Loss from operations | $ | (41,081) | | | $ | 11,105 | | | $ | 21,354 | | | $ | 3,832 | | | $ | (4,790) | |
| | | | | | | | | |
Twelve Months Ended December 31, 2021 | | | | | | | | |
Total revenue | $ | 219,514 | | | $ | — | | | $ | — | | | $ | — | | | $ | 219,514 | |
Cost of testing revenue | 58,860 | | | 81 | | | — | | | — | | | 58,779 | |
Cost of product revenue | 5,887 | | | — | | | — | | | — | | | 5,887 | |
Cost of biopharmaceutical and other revenue | 9,653 | | | 217 | | | — | | | — | | | 9,436 | |
Intangible asset amortization (2) | 14,491 | | | — | | | 14,491 | | | — | | | — | |
Gross margin $ | 130,623 | | | 298 | | | 14,491 | | | — | | | 145,412 | |
Gross margin % | 60 | % | | | | | | | | 66 | % |
| | | | | | | | | |
Research and development | 29,843 | | | 1,027 | | | — | | | — | | | 28,816 | |
Selling and marketing | 79,840 | | | 1,755 | | | — | | | — | | | 78,085 | |
General and administrative | 101,353 | | | 49,814 | | | — | | | — | | | 51,539 | |
Intangible asset amortization | 1,490 | | | — | | | 1,490 | | | — | | | — | |
Total operating expenses excluding cost of revenue (3) | 212,526 | | | 52,596 | | | 1,490 | | | — | | | 158,440 | |
Loss from operations | $ | (81,903) | | | $ | 52,894 | | | $ | 15,981 | | | $ | — | | | $ | (13,028) | |
| | | | | | | | | |
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 ($101.6 and $74.4 million) and the amortization of intangible assets which would have been allocated to the cost of revenue ($19.3 and $14.5 million) for the full year 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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