8-K
Fulgent Genetics, Inc. (FLGT)
!
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 9, 2021
FULGENT GENETICS, INC.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-37894 | 81-2621304 |
|---|---|---|
| (State or other jurisdiction of<br><br><br>incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 4978 Santa Anita Avenue<br><br><br>Temple City, California | 91780 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
(626) 350-0537
(Registrant’s telephone number, including area code)
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 $0.0001 per share | FLGT | The Nasdaq Stock Market <br>(Nasdaq Global Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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 2.02Results of Operations and Financial Condition.
On November 9, 2021, Fulgent Genetics, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2021. A copy of the Company’s press release containing this information is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 7.01Regulation FD Disclosure
From time to time, the Company presents and/or distributes slides and presentations to the investment community to provide updates and summaries of its business. On November 9, 2021, the Company updated its investor presentation, which is available on the “Investor Relations” section of the Company’s website at https://fulgentgenetics.com/. This presentation is also furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information in Items 2.02 and 7.01, including Exhibits 99.1 and 99.2, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01Financial Statements and Exhibits.
(d)Exhibits.
| Exhibit<br><br><br>No. | Description |
|---|---|
| 99.1 | Press Release of Fulgent Genetics, Inc., dated November 9, 2021 |
| 99.2 | Corporate Presentation of Fulgent Genetics, Inc. |
| 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.
| Date: November 9, 2021 | FULGENT GENETICS, INC. | |
|---|---|---|
| By: | /s/ Paul Kim | |
| Name: | Paul Kim | |
| Title: | Chief Financial Officer |
flgt-ex991_6.htm
Exhibit 99.1
Fulgent Genetics Reports Third Quarter Financial Results
| • | Revenue grows 124% year-over-year to $227.9 million |
|---|---|
| • | Core Revenue grows 292% year-over-year to $40.1 million |
| --- | --- |
| • | Raises Full Year Revenue guidance to $930 million from $800 million, given recent strength in core and COVID-19 business |
| --- | --- |
TEMPLE CITY, CA, November 9, 2021 —Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent Genetics” or the “company”), a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, today announced financial results for its third quarter ended September 30, 2021.
Third Quarter 2021 Results:
| • | Revenue of $227.9 million, growing 124% year-over-year |
|---|---|
| • | Billable tests delivered approximately 2.2 million, or more than twice the volume of third quarter of 2020 |
| --- | --- |
| • | Gross Margin improved approximately 7 percentage points year-over-year |
| --- | --- |
| • | Core Revenue grew 292% year-over-year to $40.1 million |
| --- | --- |
| • | GAAP income of $122.5 million, or $3.93 per share |
| --- | --- |
| • | Non-GAAP income of $126.3 million, or $4.05 per share |
| --- | --- |
| • | Adjusted EBITDA of $167.3 million |
| --- | --- |
| • | Cash from operations of $152.2 million; Cash, cash equivalent, and investments in marketable securities of $877.3 million as of September 30, 2021 |
| --- | --- |
Non-GAAP income (loss) and adjusted EBITDA are described below under “Note Regarding Non-GAAP Financial Measures” and are reconciled to the most directly comparable GAAP financial measure, GAAP income (loss), in the accompanying tables.
Ming Hsieh, Chairman and Chief Executive Officer, said, “We demonstrated great execution across our business in the third quarter and significantly exceeded our guidance for both core and COVID-19 revenue. The investments we have made in CSI Laboratories, Helio Health and FF Gene Biotech are already contributing nicely to our growth, while our core next generation sequencing (“NGS”) business continues to do well. We see a meaningful runway ahead with a number of opportunities that have expanded our genomic test menu and commercial reach, and we have continued to build out our operational infrastructure and personnel to support our growth. We remain optimistic that our differentiated approach to the genomic testing market positions us well for continued momentum.”
Paul Kim, Chief Financial Officer, said, “We had a very strong third quarter, driven by outperformance across both our core NGS and RT-PCR COVID-19 testing businesses, which grew 292% and 105% year-over-year, respectively. Our core business has been seeing strong momentum with the addition of CSI and integration of FF Gene Biotech, and we are continuing to make investments to drive our post-COVID growth strategy. At the same time, the spread of the contagious Delta variant drove a meaningful increase in our RT-PCR COVID-19 testing in the quarter, while we also saw strong demand for our NGS based COVID-19 testing solutions. We are pleased to be raising our guidance for the year and will be providing
a formal update during our investment community conference call to shortly follow the issuance of this press release.”
Outlook:
For the fourth quarter of 2021, Fulgent Genetics expects:
| • | Total Revenue of approximately $189 million |
|---|---|
| • | Core Revenue of approximately $32 million, representing growth of 166% year-over-year |
| --- | --- |
For the full year 2021, Fulgent Genetics expects:
| • | Total Revenue of approximately $930 million versus previous guidance of $800 million |
|---|---|
| • | Core Revenue of approximately $115 million versus previous guidance of $110 million, representing growth of 215% year-over-year |
| --- | --- |
| • | GAAP income of approximately $15.50 per share |
| --- | --- |
| • | Non-GAAP income of approximately $16.00 per share |
| --- | --- |
Conference Call Information
Fulgent Genetics will host a conference call for the investment community today at 4:30 PM ET (1:30 PM PT) to discuss its third quarter 2021 results. Press and industry analysts are invited to attend in listen-only mode.
The call can be accessed through a live audio webcast in the Investor Relations section of the company’s website, http://ir.fulgentgenetics.com, and through a live conference call by dialing (800) 367-2403 using the confirmation code 3277675. An audio replay will be available in the Investor Relations section of the company’s website.
Note Regarding Non-GAAP Financial Measures
Certain of the information set forth in this press release, including non-GAAP income (loss), non-GAAP income (loss) per share and adjusted EBITDA, are non-GAAP financial measures. Fulgent Genetics believes this information is useful to investors because it provides a basis for measuring the performance of the company’s business excluding certain income or expense items that management believes are not directly attributable to the company’s core operating results. Fulgent Genetics defines non-GAAP income (loss) as income (loss) calculated in accordance with accounting principles generally accepted in the United States of America (“GAAP”), plus amortization of acquisition-related intangible assets, plus equity-based compensation expenses, plus or minus the non-GAAP tax effect, plus or minus (loss) gain on equity-method investments, plus or minus equity (loss) earnings in investee, and plus or minus other charges or gains, as identified, that management believes are not representative of the company’s core operations. The non-GAAP tax effect is calculated by applying statutory corporate tax rate on amortization of acquisition-related intangible assets and equity-based compensation expenses. Fulgent Genetics defines adjusted EBITDA as GAAP income (loss) plus or minus interest (expense) income, plus or minus provisions (benefits) for income taxes, plus depreciation and amortization, plus equity-based compensation expenses, plus or minus (loss) gain on equity-method investments, plus or minus equity (loss) earnings in investee, and plus or minus other charges or gains, as identified, that management believes are not representative of the company’s core operations.
Fulgent Genetics may continue to incur expenses similar to the items added to or subtracted from GAAP income (loss) to calculate non-GAAP income (loss) and adjusted EBITDA; accordingly, the exclusion of these items in the presentation of these non-GAAP financial measures should not be construed as an implication that these items are unusual, infrequent or non-recurring. Management uses these non-GAAP financial measures along with the most directly comparable GAAP financial measure of income (loss) in evaluating the company's operating performance. Non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information presented in conformity with GAAP, and non-GAAP financial measures as reported by Fulgent Genetics may not be comparable to similarly titled metrics reported by other companies.
About Fulgent Genetics
Fulgent Genetics is a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health. Fulgent Genetics’ proprietary technology platform has created a broad, flexible test menu and the ability to continually expand and improve its proprietary genetic reference library while maintaining accessible pricing, high accuracy, and competitive turnaround times. Combining NGS with its technology platform, the company performs full-gene sequencing with deletion/duplication analysis in an array of panels that can be tailored to meet specific customer needs. A cornerstone of the company’s business is its ability to provide expansive options and flexibility for all clients’ unique testing needs through a comprehensive technology offering including cloud computing, pipeline services, record management, web portal services, clinical workflow, sequencing as a service and automated laboratory services.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: guidance regarding expected fourth quarter and annual financial results, including revenues, core revenues, GAAP income and Non-GAAP income ; evaluations and judgments regarding market position, runway, momentum, acquisitions and acquired businesses (including CSI Laboratories and FF Gene Biotech), investments and partnerships (including Helio Health), relationships and the company’s testing services and technology; the timing, commercial success and impact on the company’s results of new product launches and other initiatives; the company’s identification and evaluation of opportunities and its ability to capitalize on opportunities, capture market share or to expand its presence in certain markets; and the company’s ability to continue to grow its business.
Forward-looking statements are statements other than historical facts and relate to future events or circumstances or the company’s future performance, and they are based on management’s current assumptions, expectations and beliefs concerning future developments and their potential effect on the company’s business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the ongoing impacts of the COVID-19 pandemic, including the preventive public health measures that may continue to impact demand for its tests and the pandemic’s effects on the global supply chain; the market potential for, and the rate and degree of market adoption of, the company’s tests, including its newly-developed tests for COVID-19 and genetic testing generally; the company’s ability to capture a sizable share of the developing market for genetic and COVID-19 testing and to compete successfully in these markets,
including its ability to continue to develop new tests that are attractive to its various customer markets, its ability to maintain turnaround times and otherwise keep pace with rapidly changing technology; the company’s ability to maintain the low internal costs of its business model, particularly as the company makes investments across its business; the company’s ability to maintain an acceptable margin on sales of its tests, particularly in light of increasing competitive pressures and other factors that may continue to reduce the company’s sale prices for and margins on its tests; risks related to volatility in the company’s results, which can fluctuate significantly from period to period; risks associated with the composition of the company’s customer base, which can fluctuate from period to period and can be comprised of a small number of customers that account for a significant portion of the company’s revenue; the company’s ability to grow and diversify its customer base and increase demand from existing and new customers; the company’s investments in its infrastructure, including its sales organization and operational capabilities, and the extent to which these investments impact the company’s business and performance and enable it to manage any growth it may experience in future periods; the company’s level of success in obtaining coverage and adequate reimbursement and collectability levels from third-party payors for its tests; the company’s level of success in establishing and obtaining the intended benefits from partnerships, strategic investments, joint ventures, acquisitions or other relationships; the company’s compliance with the various evolving and complex laws and regulations applicable to its business and its industry; risks associated with the company’s international operations; the company’s ability to protect its proprietary technology platform; and general industry, economic, political and market conditions. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events.
The forward-looking statements made in this press release speak only as of the date of this press release, and the company assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law.
The company’s reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including its annual report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 8, 2021 and the other reports it files from time to time, including subsequently filed quarterly and current reports, are made available on the company’s website upon their filing with the SEC. These reports contain more information about the company, its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this press release.
Investor Relations Contact:
The Blueshirt Group
Nicole Borsje, 415-217-2633, nicole@blueshirtgroup.com
| FULGENT GENETICS, INC. | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CONDENSED CONSOLIDATED BALANCE SHEET DATA | ||||||||||||
| September 30, 2021 and December 31, 2020 | ||||||||||||
| (in thousands) | ||||||||||||
| September 30, | December 31, | |||||||||||
| ASSETS: | 2021 | 2020 | ||||||||||
| Cash and cash equivalents | $ | 214,877 | $ | 87,426 | ||||||||
| Investments in marketable securities | 662,386 | 344,443 | ||||||||||
| Accounts receivable, net | 120,822 | 183,857 | ||||||||||
| Property, plant, and equipment, net | 60,166 | 40,199 | ||||||||||
| Other assets | 146,417 | 44,536 | ||||||||||
| Total assets | $ | 1,204,668 | $ | 700,461 | ||||||||
| LIABILITIES & EQUITY: | ||||||||||||
| Accounts payable, accrued liabilities and other liabilities | $ | 160,215 | $ | 131,074 | ||||||||
| Total stockholders' equity | 1,044,453 | 569,387 | ||||||||||
| Total liabilities & equity | $ | 1,204,668 | $ | 700,461 | ||||||||
| FULGENT GENETICS, INC. | ||||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | ||
| CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS DATA | ||||||||||||
| Three and Nine Months Ended September 30, 2021 and 2020 | ||||||||||||
| (in thousands, except per share data) | ||||||||||||
| (unaudited) | ||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||
| September 30, | September 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Revenue | $ | 227,868 | $ | 101,716 | $ | 740,913 | $ | 126,734 | ||||
| Cost of revenue (1) | 43,466 | 26,261 | 153,399 | 38,035 | ||||||||
| Gross profit | 184,402 | 75,455 | 587,514 | 88,699 | ||||||||
| Operating expenses: | ||||||||||||
| Research and development (1) | 6,021 | 3,177 | 16,755 | 7,004 | ||||||||
| Selling and marketing (1) | 6,012 | 5,014 | 16,239 | 9,871 | ||||||||
| General and administrative (1) | 12,299 | 3,741 | 28,630 | 7,575 | ||||||||
| Amortization of acquisition-related intangible assets | 797 | — | 797 | — | ||||||||
| Total operating expenses | 25,129 | 11,932 | 62,421 | 24,450 | ||||||||
| Operating income | 159,273 | 63,523 | 525,093 | 64,249 | ||||||||
| Interest and other income, net | 496 | 421 | 1,382 | 937 | ||||||||
| Income before income taxes, gain (loss) on<br><br><br>equity method investments and equity loss in investee | 159,769 | 63,944 | 526,475 | 65,186 | ||||||||
| Provisions for income taxes | 37,545 | 14,526 | 127,647 | 13,961 | ||||||||
| Income before gain (loss) on equity method investments<br><br><br>and equity loss in investee | 122,224 | 49,418 | 398,828 | 51,225 | ||||||||
| Gain (loss) on equity-method investments | — | (2,591 | ) | 3,734 | (2,591 | ) | ||||||
| Equity loss in investee | — | (189 | ) | — | (631 | ) | ||||||
| Net income from consolidated operations | 122,224 | 46,638 | 402,562 | 48,003 | ||||||||
| Net loss attributable to noncontrolling<br><br><br>interests | 298 | — | 463 | — | ||||||||
| Net income attributable to Fulgent | $ | 122,522 | $ | 46,638 | $ | 403,025 | $ | 48,003 | ||||
| Net income per common share attributable to Fulgent: | ||||||||||||
| Basic | $ | 4.13 | $ | 2.11 | $ | 13.79 | $ | 2.20 | ||||
| Diluted | $ | 3.93 | $ | 1.98 | $ | 13.04 | $ | 2.07 | ||||
| Weighted average common shares: | ||||||||||||
| Basic | 29,673 | 22,062 | 29,221 | 21,793 | ||||||||
| Diluted | 31,170 | 23,539 | 30,906 | 23,135 | ||||||||
| (1) Equity-based compensation expense was allocated as follows: | ||||||||||||
| Cost of revenue | $ | 962 | $ | 428 | $ | 2,328 | $ | 929 | ||||
| Research and development | 1,757 | 887 | 4,461 | 1,563 | ||||||||
| Selling and marketing | 693 | 1,184 | 1,739 | 1,577 | ||||||||
| General and administrative | 962 | 651 | 2,334 | 1,085 | ||||||||
| Total equity-based compensation expense | $ | 4,374 | $ | 3,150 | $ | 10,862 | $ | 5,154 | ||||
| FULGENT GENETICS, INC. | ||||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Non-GAAP Income Reconciliation | ||||||||||||
| Three and Nine Months Ended September 30, 2021 and 2020 | ||||||||||||
| (in thousands, except per share data) | ||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||
| September 30, | September 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Net income attributable to Fulgent | $ | 122,522 | $ | 46,638 | $ | 403,025 | $ | 48,003 | ||||
| Amortization of acquisition-related intangible assets | 797 | — | 797 | — | ||||||||
| Equity-based compensation expense | 4,374 | 3,150 | 10,862 | 5,154 | ||||||||
| Non-GAAP tax effect (1) | (1,396 | ) | (851 | ) | (3,148 | ) | (1,392 | ) | ||||
| Gain (loss) on equity-method investments | — | 2,591 | (3,734 | ) | 2,591 | |||||||
| Equity loss in investee | — | 189 | — | 631 | ||||||||
| Non-GAAP income attributable to Fulgent | $ | 126,297 | $ | 51,717 | $ | 407,802 | $ | 54,987 | ||||
| Net income per common share attributable to Fulgent: | ||||||||||||
| Basic | $ | 4.13 | $ | 2.11 | $ | 13.79 | $ | 2.20 | ||||
| Diluted | $ | 3.93 | $ | 1.98 | $ | 13.04 | $ | 2.07 | ||||
| Non-GAAP income per common share attributable to Fulgent: | ||||||||||||
| Basic | $ | 4.26 | $ | 2.34 | $ | 13.96 | $ | 2.52 | ||||
| Diluted | $ | 4.05 | $ | 2.20 | $ | 13.19 | $ | 2.38 | ||||
| Weighted average common shares: | ||||||||||||
| Basic | 29,673 | 22,062 | 29,221 | 21,793 | ||||||||
| Diluted | 31,170 | 23,539 | 30,906 | 23,135 | ||||||||
| (1) Tax rates as follows: | ||||||||||||
| Corporate tax rate of 27% for the three and nine months ended September 30, 2021. | ||||||||||||
| Corporate tax rate of 27% for the three and nine months ended September 30, 2020. | ||||||||||||
| FULGENT GENETICS, INC. | ||||||||||||
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Non-GAAP Adjusted EBITDA Reconciliation | ||||||||||||
| Three and Nine Months Ended September 30, 2021 and 2020 | ||||||||||||
| (in thousands) | ||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||
| September 30, | September 30, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| Net income attributable to Fulgent | $ | 122,522 | $ | 46,638 | $ | 403,025 | $ | 48,003 | ||||
| Interest income, net | (357 | ) | (424 | ) | (1,513 | ) | (999 | ) | ||||
| Provisions for income taxes | 37,545 | 14,526 | 127,647 | 13,961 | ||||||||
| Equity-based compensation expense | 4,374 | 3,150 | 10,862 | 5,154 | ||||||||
| Depreciation and amortization | 3,173 | 722 | 7,513 | 1,840 | ||||||||
| Gain (loss) on equity-method investments | — | 2,591 | (3,734 | ) | 2,591 | |||||||
| Equity loss in investee | — | 189 | — | 631 | ||||||||
| Adjusted EBITDA | $ | 167,257 | $ | 67,392 | $ | 543,800 | $ | 71,181 |
Founded in 2011 | Located in Los Angeles, CA | NASDAQ:FLGT 1 Exhibit 99.2 November 2021
Disclaimer Forward-Looking Statements and Market Data
This presentation contains forward-looking statements, which are statements other than those of historical facts and which represent the estimates and expectations of Fulgent Genetics, Inc. (the “Company”) about future events based on current views and assumptions. Examples of forward-looking statements made in this presentation include, among others, those related its anticipated growth and positioning, the Company’s mission and strategies, the success of its business model and strategy, anticipated future revenue and guidance, evaluations and judgments regarding the Company’s business, products, technologies, competitive landscape, scalability, plans regarding development and launch of potential future products, and any businesses the Company may seek to acquire or has acquired, including statements regarding CSI Laboratories and Helio Health. The Company’s views and assumptions on which these forward-looking statements are based may prove to be incorrect. As a result, matters discussed in any forward-looking statements are subject to risks, uncertainties and changes in circumstances that may cause actual results to differ materially from those discussed or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those implied by forward-looking statements are disclosed under “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s reports filed with the Securities and Exchange Commission ("SEC"), including its annual report on Form 10-K filed on March 8, 2021, and other reports it files from time to time. Because of these factors, you should not rely upon forward-looking statements as predictions of future events. The forward-looking statements in this presentation are made only as of the date hereof, and, except as required by law, the Company assumes no obligation to update any forward-looking statements in the future. The company’s reports filed with the SEC, including its annual report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 8, 2021 and the other reports it files from time to time, including subsequently filed quarterly and current reports, are made available on the company’s website upon their filing with the SEC. These reports contain more information about the company, its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this press release.
This presentation also includes market data and forecasts with respect to the industry in which the Company operates. In some cases the Company relies upon and refers to market data and certain industry forecasts that have been obtained from third-party surveys, market research, consultant surveys, publicly available information and industry publications that the Company believes to be reliable. These data and estimates involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.
Non-GAAP Financial Measures
This presentation contains certain supplemental financial measures that are not calculated pursuant to U.S. generally accepted accounting principles (“GAAP”). These non-GAAP measures are in addition to, not a substitute for or superior to, measures of financial performance prepared in accordance with GAAP. A reconciliation of non-GAAP measures to GAAP measures is contained in this presentation. 2
Mission, Core Values, and Strategy 3 Mission Develop flexible and affordable genomic testing that improves the everyday lives of those around us Core Values Innovation Customer service and commitment Quality Efficiency Strategy Leverage our proprietary NGS platform for broad application Operational excellence Disciplined M&A We are a premier global, technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health
Leadership Team 4 Esteemed background in molecular science and pathology
Most recently Chief Medical Officer at NeoGenomics; prior senior role at Clarient.
Chairman Emeritus of Pathology at City of Hope National Medical Center Brandon Perthuis Chief Commercial Officer Dr. Lawrence Weiss Chief Medical Officer Ming Hsieh Chief Executive Officer Dr. Harry Gao Lab Director and Chief Scientific Officer James Xie Chief Operating Officer Paul Kim Chief Financial Officer Extensive experience leading genetic testing commercialization programs since 2003
Previously VP of Sales and Marketing of the Medical Genetics Laboratory at Baylor College of Medicine
Prior to Baylor, held senior roles at PerkinElmer and Spectral Genomics
B.S. in Biomedical Science Responsible for managing all global operations, product vision and product engineering
Served as an SVP of Cogent
B.A. in Engineering, M.S. in Industrial Engineering and an M.S. in Computer Science Experienced financial leader and Certified Public Accountant
Previously CFO of Cogent Systems; sold to 3M for $943M in 2010
B.A. in Economics from University of California at Berkeley Previously Lab Director at City of Hope
Clinical molecular genetics training fellowship and post-doctoral fellowship at Harvard Medical School
M.S. in Immunology, and M.D. and Ph.D. in Microbiology, Immunology, and Medical Genetics Experienced operational leader, entrepreneur and philanthropist
Previously CEO, President, and Chairman of Cogent Systems
Member of the National Academy of Engineering; Fellow of the National Academy of Inventors; Trustee of USC
Dr. Larry Weiss Ming Hsieh Paul Kim James Xie Dr. Harry Gao History of Fulgent Genetics 5 Expansion with organic growth and strategic deployment of capital
Strengthen positioning as holistic genetic testing platform
Leverage expertise of seasoned leadership team with disciplined operational focus 2011 2017-2019 2020 2021 & Onwards 2015-2016 Founded with initial focus on pediatric rare disease Women’s health and prenatal testing added Launched Picture, at-home genetic test offering Launched JV with Xi Long in China Nasdaq IPO Tests for oncology, cardiovascular, and neurological disorders added Combined technology approach from Cogent with genetics expertise from the City of Hope Launched COVID-19 testing Opened lab in Houston, TX CSI Labs acquired, expanding footprint and offerings Rapid Expansion enabled by proprietary technology platform Awarded CDC contract to study variants Awarded multiple testing contracts from a variety of States Brandon Perthuis Acquired controlling ownership of Chinese JV
Fulgent is well positioned to execute on a targeted growth strategy. Near term initiatives include: CSI Labs acquisition to expand capabilities Controlling interest in China JV to grow global presence Fulgent is Positioned to Execute on Our Growth Strategy 6 Proprietary technology platform allows for broad, flexible test menu and rapid scaling that is affordable 18,400+ Genes | 900+ Panels | Customizable Offerings Utilizes next-generation sequencing (NGS) to perform an array of tailorable panels with focus on oncology
CSI Laboratories Acquisition 7 Leading cancer testing and diagnostics laboratory acquired in August 2021 Headquarters & Main Laboratory 2580 Westside Pkwy. Alpharetta, GA 30004 South Florida Laboratory 2141 Alternate A1A, South Jupiter, FL 33477 Accelerates Fulgent’s goal of becoming a large player in the molecular diagnostic field with focus on oncology, with the goal of leveraging the NGS platform Profitable with quality customers, reimbursement contracts, and established service offerings in molecular diagnostics, Flow, FISH, Cytogenetics, and Histology Key CSI Highlights Founded in 1997 400+ unique tests offered ~165 million covered lives
Fulgent Equity Investment: $20 Million Helio Health Investment & Strategic Partnership 8 Emerging liquid biopsy company for early detection of cancer with proven management team USA Office 9950 Research Drive Irvine, CA 92618 China Office No. 1908, Building 10, Jianguo Rd Chaoyang District, Beijing, 100022 +86 10 58208807 Fulgent enters the early detection liquid biopsy space, and Helio benefits from the operational capabilities and establishment of Fulgent Exclusive commercial agreement LDT US & Canada Poised to access both the US and China markets
Competitive Landscape 9 Cancer Diagnostics Reproductive Health Genes & Panels Known Mutation Genomic Testing Hereditary Cancer Tumor Profiling Newborn Genetics Carrier Screens Sequencing Service $18B market2 $80B market2 $7B market1 Market size sourced from Frost & Sullivan Market sizes sourced from Wall Street equity research Early Detection / Liquid Biopsy
What Sets Fulgent Apart? (1) Represents genes covered by single-gene tests. (2) For Q3 2021. Includes all tests available for sale (e.g., Whole Exome, Whole Genome, Large Panels, Small Panels, Comprehensive and Focus Cancer Panels and Single-Gene Tests, COVID-19 Tests, and vaccines). Also excludes stock-based compensation. See GAAP reconciliation. 10 Technology Platform A New Approach to NGS Proprietary probes and engineered chemistry Comparison and Suppression Algorithms Comprehensive analytics powered by AI and ML Extensive Test Menu Superior Cost Structure And a Better Cost Structure Average COGS per Test: $20 (2) Lab efficiencies, automation and scale have translated to a sustainable cost structure Partnerships create leverage with sales and marketing Process 100% of volume without the need for outsourcing Leads to a Broader Test Menu 18,400+ single-gene tests (1) 900+ panels Whole Genome and Exome Flexibility enables custom tests for any genes or conditions Preset panels have grown 350%+ since IPO in 2016
Proprietary Technology Platform 11 Differentiated Technology... Engineered genetic biochemistry, including reagents and probes Data suppression and comparison algorithms Adaptive learning software Automated reporting
…Provides a Multitude of Advantages Broadest test menu Ability to rapidly develop and launch new tests Customizable test offerings Lower costs per billable test High efficiency
Commercialized COVID-19 Testing Commercialized COVID-19 Testing
Specialized Oncology Testing Next Generation Sequencing Opportunities Specialized Oncology Testing Core NGS
Recent Traction with: Hereditary Cancer Cardiovascular Genetics Reproductive Health Neurodegenerative Genetics
Newly launched pharmacogenetic test
Aggressively expanding sales and commercial organization Wide Array of Technologies
Services Include: Flow cytometry Cytogenetic analysis Fluorescence in-situ hybridization (FISH) Immunohistochemistry Molecular genetics Consultations in the areas of hematopathology and surgical pathology NGS Fulgent’s Broad Capabilities COVID NGS
Research driven platform working with local and federal government on genomic studies
CDC contract awarded Fulgent worth up to $47M to study SARS-CoV-2 using Fulgent’s NGS platform
Capacity of 10,000 NGS tests per day
Used to identify new strains and mutations 12 Primarily RT-PCR Based Testing
Contracts with: School systems Nursing homes Athletic organizations Specialty health clinics Travel organizations Government agencies
Offered through: Drive through sites Picture at-home kits Managed on-site programs
Next Generation Sequencing Opportunities
Fulgent’s Menu is Scalable and Affordable to Customers 13 Large Panel Small Panel Focus Panel Single-Gene / Custom Comprehensive Panel Average Sales Price / Test Whole Genome Whole Exome Q3 ’21 Average Sales Price / Test: ~$105 Q3 ’21 Average COGS / Test: ~$20(1) Clinical Exome GREATER OFFERINGS THAN COMPETITORS CNV+ MANY COMPETITORS DO NOT OFFER Flow Cytometry FISH Histopathology Cytogenetics Molecular (1) For Q3 2021. Includes all tests available for sale (e.g., Whole Exome, Whole Genome, Large Panels, Small Panels, Comprehensive and Focus Cancer Panels and Single-Gene Tests, COVID-19 Tests, and vaccines). Also excludes stock-based compensation. See GAAP reconciliation.
NGS Testing – Offerings 14 Site-Specific Testing Known Mutation Focus (30 Genes) Comprehensive (127 Genes) Somatic Cancer Panels 20 Panels Repeat Expansion 18,400+ Genes Single Gene 900+ Panels Customizable Panels Disease Panels Clinical Exome (4,500+ Genes) Whole Exome Exome Tests
NGS Testing – Oncology Test Menu Customizable: Add additional cancer genes or panels at no charge Coverage: 99% at 50x Del/Dup ≥ 1 Exon TAT: 2 – 3 Weeks Customizable: Add additional cancer genes or panels at no charge Coverage: 99% at 50x Del/Dup ≥ 1 Exon TAT: 2 – 3 Weeks 15 Focused Comprehensive
Oncology Testing Platforms 16 Expansive heme and solid tumor menu Promyelocytic Leukemia/Retinoic Acid Receptor Alpha test: 4-hour turnaround time Genius Multiple Myeloma Assessment Protocol (using CD138 isolation marker) for plasma cell enrichment 4-6 Day turnaround time 225+ stains Platforms Ventana Ultra/Dako Link 48 Aperio ScanScope Three levels of service Programmed death-ligand (PD-L1), Mismatch Repair and Microsatellite Instability 12-36 hour turnaround time Hematology and solid tumor menu 90% of assays performed in-house Microarray and NGS available 5-7 day turnaround time Oncology and constitutional >20% abnormality detection rate Mitogen stimulation/dual culture DSP30 (detection of B-Cell disorders) Interleukin 4 for Multiple Myeloma Phytohemagglutinin and Interleukin 2 (detection of T-Cell disorders) Children’s Oncology Group approved 5-7 Day turnaround time
The Focus Carrier screen is a pan-ethnic screen that looks for pathogenic mutations known to cause autosomal recessive and X-linked disorders
Gene Count: 30 The Ashkenazi Jewish carrier screens for pathogenic carrier variants known to cause recessive genetic disorders
Gene Count: 43 The ACOG/ACMG panel screens for common genetic disorders seen in the general population
Gene Count: 6 The Expanded Panel with “opt-in” genes, these 9 genes are associated with mild or adult-onset presentation disease
Gene Count: 410 The Expanded Panel screens for more than 400 recessive and X-linked conditions that covers people of all ethnic backgrounds
Gene Count: 401 NGS Testing – Panel Deep Dive 17 Beacon ACOG / ACMG Guidelines Panel Beacon Ashkenazi Jewish Panel Beacon Focus Panel Beacon Expanded Panel Beacon Expanded + Opt-in Genes Fulgent Beacon Carrier Screening Tests Are the Most Comprehensive Ever Offered
NGS Testing – Women’s Health: PGT-A Increased Chance of Pregnancy Embryos with a normal number of chromosomes have a better chance of resulting in successful pregnancy More Confidence in Transferring a Single Embryo Avoid health risks associated with twin or triplet pregnancies that can occur from multiple embryo implantation Reduced Risk of Miscarriage Embryos with an abnormal number of chromosomes (aneuploid) typically do not result in successful pregnancy or may result in birth defects Fewer Number of Embryo Transfer Cycles Needed Reduce the amount of time to pregnancy and the costs of additional IVF cycles PGT-A Can Expand a Patient’s Prospects of a Successful Pregnancy Preimplantation Genetic Testing for Aneuploidy (PGT-A) can identify potentially abnormal embryos for transfer in IVF, thereby expanding a patient’s prospects of a successful pregnancy 18 Women 35+ Who is PGT-A testing for? Those who have experienced miscarriages Those who want to reduce the likelihood of having multiples Couples experiencing male factor infertility Those who have experienced IVF failure
NGS Testing – Rapid Whole Genome for Newborns Screens for over 200 health conditions Identifies potential health risks before symptoms arise Early detection known to have a positive impact Simple cheek swab collection for your baby : No pricks, sticks, or tears necessary Newborn Genetic Screening Goes Beyond Standard Newborn Screening Multiple congenital anomalies Inborn errors of metabolism Immunodeficiency Respiratory distress Epilepsy Ideal for Infants Experiencing: In a Retrospective Analysis of Diagnostic and Clinical Finding with 35 Acutely Ill Infants (2015): TAT of 7 - 10 Days Designed for critically ill infants in the NICU or PICU to rapidly diagnose genetic disorders 19
Consumer Initiated Tests – Picture Genetics Targeting the Large Consumer Market with Picture Genetics Launched in 2019 with significant growth amid COVID-19 A consumer-focused offering that merges clinical utility with accuracy of an accredited lab Extends Fulgent’s NGS capabilities to a broader market Validated by successfully scaling to several million billable tests performed within months for COVID-19, after receiving an EUA Performs a complete sequencing (vs genotyping) analysis for better, more accurate results Patient-friendly with easy to use “order from home” model – no doctor visits or insurance necessary, though many tests are eligible for reimbursement Full service offering that includes analysis and genetic counseling support
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China Strategy 21 FF Gene Biotech Joint Venture Joint venture between Fulgent, Xi Long Scientific, and Fuzhou Jinqiang Investment Partnership (FJIP) Fulgent owns controlling interest Brings Fulgent’s NGS capabilities to the Chinese genetic testing market Fulgent will increase testing capacity and expand the sales organization in China Currently ~100 employees on the ground Test menu mirrors Fulgent’s existing capabilities in the US Primary focus today is on China, the largest genetic testing market in the world – projected to grow at 30% CAGR to $4.5B in 20301 Ongoing evaluation of additional international opportunities Physical presence in China is a significant competitive advantage vs. US testing companies 1 Source: China Insight Consultancy (CIC)
Summary Financial Performance 22 $94.5M LTM Core Revenue as of Q3’21 $596M LTM Operating Cash Flow as of Q3’21 ~265,000 LTM Core Tests as of Q3’21 187% growth year-over-year ~334% growth year-over-year (in thousands)
Financial Performance: Revenue Profile 23
(1) Figure is not in accordance with GAAP because it does not include equity-based compensation Financial Performance: Margin Profile 24 (1) (1)
2021 Financial Guidance 25 COVID CORE Key Takeaways: Guidance categories remain “Core” and “COVID” “Core” revenue includes NGS testing plus contribution from CSI Laboratories “COVID” revenue includes RT-PCR COVID-19 testing 25 $110 M +201% y/y $115 M +215% y/y
Balance Sheet 26
Non-GAAP Financial Adjustments 27
Founded in 2011 | Located in Los Angeles, CA | NASDAQ:FLGT 28