flgt-8k_20220223.htm
false 0001674930 0001674930 2022-02-23 2022-02-23

!

 

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 23, 2022

 

FULGENT GENETICS, INC.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

001-37894

81-2621304

(State or other jurisdiction of

incorporation)

(Commission File Number)

(IRS Employer Identification No.)

 

4978 Santa Anita Avenue

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 
(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 February 23, 2022, Fulgent Genetics, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter and year ended December 31, 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 February 23, 2022, 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 (the “Section”) 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

No.

 

Description

 

 

 

99.1

 

Press Release of Fulgent Genetics, Inc., dated February 23, 2022

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: February 23, 2022

FULGENT GENETICS, INC.

 

 

 

 

 

By:

 

/s/ Paul Kim

 

Name:

 

Paul Kim

 

Title:

 

Chief Financial Officer

 

flgt-ex991_6.htm

Exhibit 99.1

 

Fulgent Genetics Reports Fourth Quarter and Full Year 2021 Financial Results

 

Full Year 2021 Total Revenue grows 135% year-over-year to $992.6 million; Q4 Revenue totals $251.7 million

 

Full Year 2021 Core Revenue grows 236% year-over-year to $122.6 million; Q4 Core Revenue grows 234% year-over-year to $40.1 million

 

TEMPLE CITY, CA, February 23, 2022 —Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent Genetics”, “Fulgent”, 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 fourth quarter and full year ended December 31, 2021.

 

Fourth Quarter 2021 Results:

 

Revenue of $251.7 million

 

Billable tests delivered approximately 2.5 million

 

Core Revenue grew 234% year-over-year to $40.1 million

 

GAAP income of $104.3 million, or $3.34 per share

 

Non-GAAP income of $108.7 million, or $3.48 per share

 

Adjusted EBITDA of $159.8 million

 

Cash from operations of $77.1 million

 

Cash, cash equivalents, and investments in marketable securities of $935.5 million as of December 31, 2021

 

Full Year 2021 Results:

 

Total Revenue grew 135% year-over year to $992.6 million

 

Core Revenue grew 236% year-over-year to $122.6 million

 

GAAP income of $507.4 million, or $16.38 per share

 

Non-GAAP income of $516.5 million, or $16.67 per share

 

Adjusted EBITDA of $703.6 million

 

Cash from operations of $538.6 million

 

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 of the Board and Chief Executive Officer, said, “The fourth quarter capped a year of tremendous growth and transformation for Fulgent Genetics. We once again exceeded our guidance in the quarter as both our Core and COVID businesses outperformed our expectations. We are pleased with the early progress we are seeing from the strategic initiatives we pursued in recent quarters, including the acquisition of CSI, partnership with Helio Health, and incremental investment in FF Gene Biotech, which are all contributing to growth of our Core business. We also just announced a strategic investment in Spatial Genomics, which will add Spatial Genemics’ multiomics platform and sequential fluorescence in situ hybridization technology, or seqFISH, to our growing suite of genomic testing solutions. As we look


ahead, we intend to continue investing in our Core business through both the expansion of our existing genomic testing capabilities and through new potential acquisitions and strategic partnerships. We are very excited about the future growth prospects of Fulgent and our strategic opportunities long term.”

 

Paul Kim, Chief Financial Officer, said, “We are pleased with our fourth quarter results which were highlighted by Core revenue growth of 234%, as well as an uptick in our COVID business amid the recent Omicron surge. We continued to see strong cash flow generation in the quarter and finished the year with $935.5 million in cash, cash equivalents and investments in marketable securities, despite the $81.9 million in cash outlays this year for our acquisitions and investments. We remain extremely well positioned with a strong balance sheet to capitalize on additional acquisition and strategic investment opportunities in the future. We are proud of what we accomplished in 2021 to expand our Core business, and we see a meaningful runway ahead to continue driving growth. We will be providing a formal update during our investment community conference call to shortly follow the issuance of this press release.”

 

Outlook:

For the first quarter of 2022, Fulgent Genetics expects:

 

Total Revenue of approximately $245 million

 

Core Revenue including COVID-19 NGS of approximately $32 million, representing growth of 92% year-over-year

 

Core Revenue excluding COVID-19 NGS of approximately $22 million1

For the full year 2022, Fulgent Genetics expects:

 

Total Revenue of approximately $600 million

 

Core Revenue excluding COVID-19 NGS of approximately $120 million1

 

GAAP income of approximately $6.00 per share

 

Non-GAAP income of approximately $7.00 per share

 

Note:

1) COVID-19 NGS testing was included in “Core Revenue” in 2021 and will be excluded from “Core Revenue”, and included in “COVID Revenue”, beginning Q1 2022.

 

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 fourth quarter and full year 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 (888) 394-8218 using the confirmation code 4130266. An audio replay will be available in the Investor Relations section of the Company’s website.

 


 

Note Regarding Non-GAAP Financial Measures

Certain 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, or GAAP, plus amortization of 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 the statutory corporate tax rate on the amortization of 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 next generation sequencing, or 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 first quarter and annual financial results, including revenues, core revenues, GAAP income, and non-GAAP income; evaluations and

 


judgments regarding market position, balance sheet, runway, momentum, reinvestments, acquisition strategies, and the performance of acquired businesses (including CSI Laboratories and FF Gene Biotech), investments and partnerships (including Helio Health and Spatial Genomics), relationships and the Company’s testing services and technology; future growth and the Company’s testing services and technologies; 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, or 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 annual, 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

 

December 31, 2021 and 2020

 

 

 

 

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

ASSETS:

2021

 

 

2020

 

Cash and cash equivalents

$

164,894

 

 

$

87,426

 

Investments in marketable securities

 

770,652

 

 

 

344,443

 

Accounts receivable, net

 

138,912

 

 

 

183,857

 

Property, plant, and equipment, net

 

62,287

 

 

 

40,199

 

Other assets

 

141,975

 

 

 

44,536

 

Total assets

$

1,278,720

 

 

$

700,461

 

 

 

 

 

 

 

 

 

LIABILITIES & EQUITY:

 

 

 

 

 

 

 

Accounts payable, accrued liabilities and other liabilities

$

112,840

 

 

$

131,074

 

Total stockholders' equity

 

1,165,880

 

 

 

569,387

 

Total liabilities & equity

$

1,278,720

 

 

$

700,461

 

 


 


 

 

FULGENT GENETICS, INC.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS DATA

 

 

 

 

 

 

 

 

 

Three and Twelve Months Ended December 31, 2021 and 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands, except per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Twelve Months Ended

 

 

December 31,

 

 

December 31,

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue

$

251,671

 

 

$

294,978

 

 

$

992,584

 

 

$

421,712

 

Cost of revenue (1)

 

62,134

 

 

 

51,772

 

 

 

215,533

 

 

 

89,807

 

     Gross profit

 

189,537

 

 

 

243,206

 

 

 

777,051

 

 

 

331,905

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Research and development (1)

 

7,464

 

 

 

4,576

 

 

 

24,219

 

 

 

11,580

 

     Selling and marketing (1)

 

8,200

 

 

 

5,081

 

 

 

24,439

 

 

 

14,952

 

     General and administrative (1)

 

22,102

 

 

 

7,640

 

 

 

50,732

 

 

 

15,215

 

     Amortization of intangible assets

 

911

 

 

 

 

 

 

1,708

 

 

 

 

Total operating expenses

 

38,677

 

 

 

17,297

 

 

 

101,098

 

 

 

41,747

 

Operating income

 

150,860

 

 

 

225,909

 

 

 

675,953

 

 

 

290,158

 

Interest and other income (loss), net

 

(35

)

 

 

589

 

 

 

1,347

 

 

 

1,526

 

Income before income taxes, gain (loss) on equity-method investments and equity earnings (loss) in investee

 

150,825

 

 

 

226,498

 

 

 

677,300

 

 

 

291,684

 

Provisions for income taxes

 

47,148

 

 

 

58,571

 

 

 

174,795

 

 

 

72,532

 

Income before gain (loss) on equity-method investments and equity earnings (loss) in investee

 

103,677

 

 

 

167,927

 

 

 

502,505

 

 

 

219,152

 

Gain (loss) on equity-method investments

 

 

 

 

(1,763

)

 

 

3,734

 

 

 

(4,354

)

Equity earnings (loss) in investee

 

 

 

 

143

 

 

 

 

 

 

(488

)

Net income from consolidated operations

 

103,677

 

 

 

166,307

 

 

 

506,239

 

 

 

214,310

 

Net loss attributable to noncontrolling interests

 

662

 

 

 

 

 

 

1,125

 

 

 

 

Net income attributable to Fulgent

$

104,339

 

 

$

166,307

 

 

$

507,364

 

 

$

214,310

 

Net income per common share attributable to Fulgent:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Basic

$

3.48

 

 

$

6.55

 

 

$

17.25

 

 

$

9.44

 

     Diluted

$

3.34

 

 

$

6.16

 

 

$

16.38

 

 

$

8.91

 

Weighted average common shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Basic

 

29,964

 

 

 

25,399

 

 

 

29,408

 

 

 

22,694

 

     Diluted

 

31,202

 

 

 

27,015

 

 

 

30,976

 

 

 

24,056

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1)    Equity-based compensation expense was allocated as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

$

1,235

 

 

$

523

 

 

$

3,563

 

 

$

1,452

 

Research and development

 

1,865

 

 

 

1,130

 

 

 

6,326

 

 

 

2,693

 

Selling and marketing

 

774

 

 

 

515

 

 

 

2,513

 

 

 

2,092

 

General and administrative

 

1,146

 

 

 

835

 

 

 

3,480

 

 

 

1,920

 

Total equity-based compensation expense

$

5,020

 

 

$

3,003

 

 

$

15,882

 

 

$

8,157

 

 


 


 

 

FULGENT GENETICS, INC.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Income Reconciliation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three and Twelve Months Ended December 31, 2021 and 2020

 

 

 

 

 

 

 

 

 

(in thousands, except per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Twelve Months Ended

 

 

December 31,

 

 

December 31,

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net income attributable to Fulgent

$

104,339

 

 

$

166,307

 

 

$

507,364

 

 

$

214,310

 

Amortization of intangible assets

 

911

 

 

 

 

 

 

1,708

 

 

 

 

Equity-based compensation expense

 

5,020

 

 

 

3,003

 

 

 

15,882

 

 

 

8,157

 

Non-GAAP tax effect (1)

 

(1,601

)

 

 

(811

)

 

 

(4,749

)

 

 

(2,202

)

(Gain) loss on equity-method investments

 

 

 

 

1,763

 

 

 

(3,734

)

 

 

4,354

 

Equity (earnings) loss in investee

 

 

 

 

(143

)

 

 

 

 

 

488

 

Non-GAAP income attributable to Fulgent

$

108,669

 

 

$

170,119

 

 

$

516,471

 

 

$

225,107

 

Net income per common share attributable to Fulgent:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Basic

$

3.48

 

 

$

6.55

 

 

$

17.25

 

 

$

9.44

 

     Diluted

$

3.34

 

 

$

6.16

 

 

$

16.38

 

 

$

8.91

 

Non-GAAP income per common share attributable to Fulgent:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Basic

$

3.63

 

 

$

6.70

 

 

$

17.56

 

 

$

9.92

 

     Diluted

$

3.48

 

 

$

6.30

 

 

$

16.67

 

 

$

9.36

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Basic

 

29,964

 

 

 

25,399

 

 

 

29,408

 

 

 

22,694

 

     Diluted

 

31,202

 

 

 

27,015

 

 

 

30,976

 

 

 

24,056

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) Tax rates as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Corporate tax rate of 27% for the three and twelve months ended December 31, 2021 and 2020.

 

 


 


 

 

FULGENT GENETICS, INC.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP Adjusted EBITDA Reconciliation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three and Twelve Months Ended December 31, 2021 and 2020

 

 

 

 

 

 

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Twelve Months Ended

 

 

December 31,

 

 

December 31,

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net income attributable to Fulgent

$

104,339

 

 

$

166,307

 

 

$

507,364

 

 

$

214,310

 

Interest income, net

 

(224

)

 

 

(540

)

 

 

(1,737

)

 

 

(1,539

)

Provisions for income taxes

 

47,148

 

 

 

58,571

 

 

 

174,795

 

 

 

72,532

 

Equity-based compensation expense

 

5,020

 

 

 

3,003

 

 

 

15,882

 

 

 

8,157

 

Depreciation and amortization

 

3,491

 

 

 

1,122

 

 

 

11,004

 

 

 

2,962

 

(Gain) loss on equity-method investments

 

 

 

 

1,763

 

 

 

(3,734

)

 

 

4,354

 

Equity (earnings) loss in investee

 

 

 

 

(143

)

 

 

 

 

 

488

 

Adjusted EBITDA

$

159,774

 

 

$

230,083

 

 

$

703,574

 

 

$

301,264

 

 

 

Slide 1

1

Slide 2

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

Slide 3

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

Slide 4

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

Slide 5

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 Acquired controlling ownership of Chinese JV

Slide 6

Well positioned to execute on a growth strategy that includes organic and inorganic initiatives, including: Ramping and integration of capabilities of CSI Labs Scaling partnerships – Helio Health and Spatial Genomics Controlling interest in China JV to grow global presence Potential future acquisitions with a strategy of short and long term ROI, tangible synergies and efficient capital deployment Fulgent is Positioned to Execute on Our Growth Strategy 6 Proprietary technology platform allows for rapid scaling of a broad, flexible test menu 18,400+ Genes | 900+ Panels | Customizable Offerings Next-generation sequencing (NGS) platform complemented with growing portfolio of emerging testing technologies with a focus on oncology

Slide 7

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 Approximately 400 unique tests offered ~165 million covered lives

Slide 8

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 Successful commercial launch in December 2021

Slide 9

Spatial Genomics Investment & Strategic Partnership 9 Spatial Genomics has developed sequential fluorescence in situ hybridization (seqFISH), an advanced biomolecular analysis method that merges imaging with combinatorial molecular barcoding Sophisticated multiplex, multiomic platform that can simultaneously detect tens of thousands of gene expressions, DNA alterations, and proteomic profiling with a subcellular level of spatial information Potential applications include development biology, immunology, cancer genomic and metabolism, biomarker discovery Commercial agreement in process Fulgent Equity Investment Up to $40 Million in Series A

Slide 10

FF Gene Biotech Joint Venture & China Strategy 10 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 international focus is on China, the largest genetic testing market in the world – projected to grow at 30% CAGR to $4.5B in 20301 Fulgent’s current presence in China is a significant competitive advantage vs. other US testing companies Ongoing evaluation of additional international opportunities China Insight Consultancy (CIC)

Slide 11

Target Market Opportunity 11 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 Early Detection / Liquid Biopsy Market size sourced from Frost & Sullivan Market sizes sourced from Wall Street equity research

Slide 12

What Sets Fulgent Apart? Represents genes covered by single-gene tests. For Q4 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. 12 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: $25 (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

Slide 13

Proprietary Technology Platform 13 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

Slide 14

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 14 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

Slide 15

For Q4 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. Fulgent’s Menu is Scalable and Affordable to Customers 15 Large Panel Small Panel Focus Panel Single-Gene / Custom Comprehensive Panel Average Sales Price / Test Whole Genome Whole Exome Q4 ’21 Average Sales Price / Test: ~$103 Q4 ’21 Average COGS / Test: ~$25(1) Clinical Exome GREATER OFFERINGS THAN COMPETITORS CNV+ MANY COMPETITORS DO NOT OFFER Flow Cytometry FISH Histopathology Cytogenetics Molecular

Slide 16

NGS Testing – Offerings 16 Site-Specific Testing Known Mutation Focus (30 Genes) Comprehensive (127 Genes) Somatic Cancer Panels 19 Panels Repeat Expansion 18,400+ Genes Single Gene 900+ Panels Customizable Panels Disease Panels Clinical Exome (4,500+ Genes) Whole Exome Exome Tests

Slide 17

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 17 Focused Comprehensive

Slide 18

Oncology Testing Platforms 18 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 3-5 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

Slide 19

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 19 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

Slide 20

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 20 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

Slide 21

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 21

Slide 22

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 22

Slide 23

Summary Financial Performance 23 $122.6M FY Core Revenue1 as of Q4’21 $539M LTM Operating Cash Flow as of Q4’21 ~372,000 LTM Core Tests as of Q4’21 235.8% growth year-over-year ~413% growth year-over-year ($ in thousands) +235.8% year-over-year Core Revenue in 2021 includes NGS COVID-19 test volume, which is excluded from Core Revenue beginning Q1 2022

Slide 24

Financial Performance: Revenue Profile 24 Core Revenue in 2021 includes NGS COVID-19 test volume, which is excluded from Core Revenue beginning Q1 2022

Slide 25

Figure is not in accordance with GAAP because it does not include equity-based compensation and amortization (1) Financial Performance: Margin Profile 25 (1) (1)

Slide 26

2022 Financial Guidance COVID Core 26 NGS COVID-19 testing was included in “Core” revenue in 2021 and will be included in COVID beginning Q1 2022. “Ex COVID NGS” growth rate excludes the contributions from NGS COVID-19 testing under our CDC contract in 2021 for more accurate year over year comparison purposes.

Slide 27

Balance Sheet 27

Slide 28

Non-GAAP Financial Adjustments 28

Slide 29

Founded in 2011 | Located in Los Angeles, CA | NASDAQ:FLGT