UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2023
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 001-37894
FULGENT GENETICS, INC.
(Exact name of registrant as specified in its charter)
Delaware
81-2621304
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
4399 Santa Anita Avenue
El Monte, CA
91731
(Address of principal executive offices)
(Zip Code)
(626) 350-0537
(Registrant’s telephone number, including area code)
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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☒
Accelerated filer
☐
Non-accelerated filer
Smaller reporting company
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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of November 1, 2023, there were 29,633,057 outstanding shares of the registrant’s common stock.
Table of Contents
Page
PART I—FINANCIAL INFORMATION
1
Item 1. Financial Statements (Unaudited)
Condensed Consolidated Balance Sheets
Condensed Consolidated Statements of Operations
2
Condensed Consolidated Statements of Comprehensive Income (Loss)
3
Condensed Consolidated Statements of Stockholders’ Equity
4
Condensed Consolidated Statements of Cash Flows
6
Notes to the Condensed Consolidated Financial Statements
7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
20
Item 3. Quantitative and Qualitative Disclosures About Market Risk
26
Item 4. Controls and Procedures
PART II—OTHER INFORMATION
28
Item 1. Legal Proceedings
Item 1A. Risk Factors
Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities
Item 5. Other Information
Item 6. Exhibits
29
Exhibit Index
30
Signatures
31
i
Item 1. Financial Statements.
(in thousands, except par value data)
(unaudited)
September 30,
December 31,
2023
2022
Assets
Current assets
Cash and cash equivalents
$
84,076
79,506
Marketable securities
383,726
446,729
Trade accounts receivable, net of allowance for credit losses of $29,091 and $41,205
49,277
52,749
Other current assets
32,776
48,889
Total current assets
549,855
627,873
Marketable securities, long-term
383,659
326,648
Redeemable preferred stock investment
15,158
12,385
Fixed assets, net
85,265
81,353
Intangible assets, net
144,489
150,643
Goodwill
141,844
143,027
Other long-term assets
38,128
44,124
Total assets
1,358,398
1,386,053
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable
15,772
23,093
Accrued liabilities
21,031
24,981
Contract liabilities
2,586
3,199
Customer deposit
18,861
10,895
Investment margin loan
—
14,999
Notes payable, current portion
2,890
5,639
Other current liabilities
281
5,301
Total current liabilities
61,421
88,107
Unrecognized tax benefits
9,555
9,836
Deferred tax liability
9,833
Other long-term liabilities
15,755
18,235
Total liabilities
96,564
116,178
Commitments and contingencies (Note 8)
Stockholders’ equity
Common stock, $0.0001 par value per share, 50,000 shares authorized, 31,925 and 31,248 shares issued, respectively, and 30,035 and 29,438 shares outstanding, respectively
Preferred stock, $0.0001 par value per share, 1,000 shares authorized, no shares issued or outstanding
Additional paid-in capital
514,262
486,585
Accumulated other comprehensive loss
(16,891
)
(20,903
Retained earnings
761,324
801,000
Total Fulgent stockholders’ equity
1,258,698
1,266,685
Noncontrolling interest
3,136
3,190
Total stockholders’ equity
1,261,834
1,269,875
Total liabilities and stockholders’ equity
The accompanying notes are an integral part of these condensed consolidated financial statements.
(in thousands, except per share data)
Three Months Ended September 30,
Nine Months Ended September 30,
Revenue
84,687
105,655
218,708
551,264
Cost of revenue
44,843
59,560
139,481
197,350
Gross profit
39,844
46,095
79,227
353,914
Operating expenses:
Research and development
10,014
7,507
29,488
20,401
Selling and marketing
10,161
9,859
30,967
28,665
General and administrative
17,498
26,266
57,293
82,281
Amortization of intangible assets
1,957
2,006
5,887
4,487
Restructuring costs
105
3,001
Total operating expenses
39,630
45,743
123,635
138,835
Operating income (loss)
214
352
(44,408
215,079
Interest and other income, net
6,646
1,405
15,519
2,408
Income (loss) before income taxes
6,860
1,757
(28,889
217,487
Provision for income taxes
20,326
414
12,016
51,488
Net (loss) income from consolidated operations
(13,466
1,343
(40,905
165,999
Net loss attributable to noncontrolling interests
359
376
1,229
1,236
Net (loss) income attributable to Fulgent
(13,107
1,719
(39,676
167,235
Net (loss) income per common share attributable to Fulgent:
Basic
(0.44
0.06
(1.33
5.53
Diluted
5.38
Weighted-average common shares:
30,013
30,174
29,789
30,256
30,867
31,107
(in thousands)
Other comprehensive income (loss):
Foreign currency translation loss
(230
(1,925
(2,027
(3,680
Net gain (loss) on available-for-sale debt securities, net of tax
4,017
(2,502
7,214
(22,708
Comprehensive (loss) income from consolidated operations
(9,679
(3,084
(35,718
139,611
Net loss attributable to noncontrolling interest
Foreign currency translation loss (gain) attributable to noncontrolling interest
68
1,242
(1,175
1,545
Comprehensive loss attributable to noncontrolling interest
427
1,618
54
2,781
Comprehensive (loss) income attributable to Fulgent
(9,252
(1,466
(35,664
142,392
Fulgent Stockholders’ Equity
Shares (1)
Amount
Additional Paid-In Capital
Accumulated Other ComprehensiveLoss
Retained Earnings
Noncontrolling Interest
Total Equity
Balance at December 31, 2022
29,438
Equity-based compensation
10,265
Restricted stock awards
280
Common stock withholding for employee tax obligations
(26
(869
Other comprehensive income (loss)
3,707
1,790
5,497
Net income (loss)
(15,340
(509
(15,849
Balance at March 31, 2023
29,692
495,981
(17,196
785,660
1,264,448
4,471
1,268,919
10,323
Exercise of common stock options
8
225
(8
(232
(3,550
(547
(4,097
(11,229
(361
(11,590
Balance at June 30, 2023
29,917
506,075
(20,746
774,431
1,259,763
3,563
1,263,326
10,902
211
(13
(517
Repurchase of common stock
(80
(2,198
3,855
(68
3,787
(359
Balance at September 30, 2023
30,035
(1) As of September 30, 2023, 371,006 shares of the Company's common stock were not issued and were held back by the Company as partial security for the indemnification obligations in connection with the business combination of Fulgent Pharma Holdings, Inc., or Fulgent Pharma, in 2022.
Shares
Balance at December 31, 2021
30,160
501,908
(759
657,597
1,158,749
7,131
1,165,880
5,616
16
172
(494
(11,734
119
(11,615
153,979
(422
153,557
Balance at March 31, 2022
30,327
507,046
(12,493
811,576
1,306,132
6,828
1,312,960
8,030
161
(436
(215
(10,577
Other comprehensive loss
(9,924
(10,346
11,537
(438
11,099
Balance at June 30, 2022
30,266
504,066
(22,417
823,113
1,304,765
5,968
1,310,733
8,972
203
(522
(780
(34,702
(3,185
(1,242
(4,427
(376
Balance at September 30, 2022
29,681
477,814
(25,602
824,832
1,277,047
4,350
1,281,397
5
Cash flow from operating activities:
Adjustments to reconcile net (loss) income to net cash provided by operating activities:
31,490
22,618
Depreciation and amortization
19,610
22,860
Provision for credit losses
(4,331
25,256
Noncash lease expense
4,895
3,311
Loss on disposal of fixed asset
429
300
Amortization of (discount) premium of marketable securities
(2,382
4,230
Deferred taxes
10,964
(4,934
(281
1,101
Net loss on marketable securities
626
Other
(29
(23
Changes in operating assets and liabilities:
Trade accounts receivable
7,596
24,214
Other current and long-term assets
(2,876
3,722
(7,025
(32,331
Income tax payable
(400
Accrued liabilities and other liabilities
(323
(12,905
Operating lease liabilities
(4,762
(3,331
Net cash provided by operating activities
12,070
220,313
Cash flow from investing activities:
Purchase of marketable securities
(343,601
(257,267
Maturities of marketable securities
376,890
131,713
Proceeds from sale of marketable securities
133,407
Purchases of fixed assets
(19,101
(14,053
Proceeds from sale of fixed assets
440
240
Acquisition of businesses, net of cash acquired
(137,755
Investment in private equity securities
(15,000
Contingent consideration payout related to a business acquisition
(10,000
Net cash provided by (used in) investing activities
14,628
(168,715
Cash flow from financing activities:
(45,279
(1,618
(1,452
Repayment of notes payable
(2,429
(367
Repayment of investment margin loan
Principal paid for finance lease
(592
(469
Proceeds from exercise of stock options
19
Net cash used in financing activities
(21,834
(47,548
Effect of exchange rate changes on cash and cash equivalents
(294
(174
Net increase in cash and cash equivalents
4,570
3,876
Cash and cash equivalents at beginning of period
164,894
Cash and cash equivalents at end of period
168,770
Supplemental disclosures of cash flow information:
Income taxes paid
2,698
56,181
Interest Paid
940
Supplemental disclosures of non-cash investing and financing activities:
Purchase of marketable securities in other current liabilities
12,905
Purchases of fixed assets in accounts payable
1,288
1,690
Purchases of fixed assets in notes payable
3,833
Operating lease right-of-use assets obtained in exchange for lease liabilities
2,661
52
Finance lease right-of-use assets obtained in exchange for lease liabilities
573
Finance lease right-of-use assets reduced due to lease modification and termination
696
Operating lease right-of-use assets reduced due to lease modification and termination
66
Note 1. Overview and Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. These financial statements include the assets, liabilities, revenues and expenses of all subsidiaries and entities in which the Company has a controlling financial interest or is deemed to be the primary beneficiary. In determining whether the Company is the primary beneficiary of an entity, the Company applies a qualitative approach that determines whether it has both (i) the power to direct the economically significant activities of the entity and (ii) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. The Company uses the equity method to account for its investments in entities that it does not control, but in which it has the ability to exercise significant influence over operating and financial policies. All intercompany accounts and transactions are eliminated from the accompanying condensed consolidated financial statements.
Nature of the Business
Fulgent Genetics, Inc., together with its subsidiaries and affiliated professional corporations (collectively referred to as the Company, unless otherwise noted or the context otherwise requires), is a technology-based company with a well-established clinical diagnostic business and a therapeutic development business. Its clinical diagnostic business offers molecular diagnostic testing services, comprehensive genetic testing, and high-quality anatomic pathology laboratory services designed to provide physicians and patients with clinically actionable diagnostic information to improve the quality of patient care. Its therapeutic development business is focused on developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of new and existing cancer drugs. The Company aims to transform from a genomic diagnostic business into a fully integrated precision medicine company.
Unaudited Interim Financial Information
The accompanying unaudited interim condensed consolidated financial statements have been prepared on the same basis as the Company’s audited consolidated financial statements as of and for the fiscal year ended December 31, 2022, which are included in the Company’s annual report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 28, 2023, or the 2022 Annual Report, and, in the opinion of management, include all adjustments, which are normal and recurring in nature, necessary for a fair presentation of the Company’s financial position and results of operations. Operating results for interim periods are not necessarily indicative of the results that may be expected for a full fiscal year or any other period. The accompanying Condensed Consolidated Balance Sheet as of December 31, 2022 has been derived from the Company’s audited consolidated financial statements at that date but does not include all of the disclosures required by U.S. GAAP. As such, the information included in this quarterly report on Form 10-Q should be read in conjunction with the Company’s audited consolidated financial statements included in the 2022 Annual Report, including the notes thereto.
Note 2. Summary of Significant Accounting Policies
See the summary of the Company’s significant accounting policies set forth in the notes to its consolidated financial statements included in the 2022 Annual Report.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements, as well as the reported amounts of revenue and expenses during the reporting periods. These estimates, judgments and assumptions are based on historical data and experience available at the date of the accompanying condensed consolidated financial statements, as well as various other factors management believes to be reasonable under the circumstances. The Company’s estimates and assumptions may evolve as conditions change. Actual results could differ significantly from these estimates.
On an on-going basis, management evaluates its estimates, primarily those related to: (i) revenue recognition criteria, (ii) accounts receivable and allowances for credit losses, (iii) the useful lives of fixed assets and intangible assets, (iv) estimates of tax liabilities, (v) valuation of intangible assets and goodwill at time of acquisition and on a recurring basis, and (vi) valuation of investments.
Trade Accounts Receivable and Allowance for Credit Losses
Trade accounts receivable are stated at the amount the Company expects to collect. The Company maintains an allowance for credit losses for expected uncollectible trade accounts receivable, which is recorded as an offset to trade accounts receivable, and changes in allowance for credit losses are classified as a general and administrative expense in the accompanying Condensed Consolidated Statements of Operations. The Company assesses collectability by reviewing trade accounts receivable on a collective basis where similar risk characteristics exist and on an individual basis when it identifies specific customers that have deterioration in credit quality such that they may no longer share similar risk characteristics with the other receivables. In determining the amount of the allowance for credit losses, the Company uses a loss rate model or probability-of-default and loss given default model. Following the loss rate method, expected credit losses are determined based on an estimated historical loss rate. The probability of default method allows the ability to define a point of default and measure credit losses for receivables that have reached the point of default for purposes of calculating the allowance for credit losses. Loss given default represents the likelihood that a receivable that has reached the point of default will not be collected in full. The Company updates its loss rate and factors annually to incorporate the most recent historical data and adjusts the quantitative portion of the reserve through its qualitative reserve overlay. The Company looks at qualitative factors such as general economic conditions in determining expected credit losses. During the three and nine months ended September 30, 2023, the Company recorded an adjustment of $(2.3) million and $(4.3) million, respectively, in provision for credit losses for trade accounts receivable due to decreased allowance for uncollectible accounts. During the three and nine months ended September 30, 2022, the Company recorded $6.5 million and $25.3 million, respectively, of provision for credit losses for trade accounts receivable.
Redeemable Preferred Stock Investment
The redeemable preferred stock investment of $15.2 million as of September 30, 2023 represents the fair value of redeemable preferred stock of a private company that the Company purchased in July 2021. The investment is classified as available-for-sale debt securities. The fair value of available-for-sale debt security is included in the Condensed Consolidated Statement of Balance Sheets. Unrealized gain of $2.3 million and $2.8 million is excluded from earnings and reported in other comprehensive income (loss) in the three and nine months ended September 30, 2023, respectively, and unrealized loss of $748,000 and $10.7 million were excluded from earnings and reported in other comprehensive income (loss) in the three and nine months ended September 30, 2022, respectively. Since the Company intends on holding the preferred stock, and the preferred stock is not redeemable until July 2027, the investment is recorded as a long-term investment.
Foreign Currency Translation and Foreign Currency Transactions
The Company translates the assets and liabilities of its non-U.S. dollar functional currency subsidiaries into U.S. dollars using exchange rates in effect at the end of each period. Expenses for these subsidiaries are translated using rates that approximate those in effect during the period. Gains and losses from these translations are recognized in foreign currency translation included in accumulated other comprehensive income (loss) in the accompanying Condensed Consolidated Statements of Stockholders’ Equity. The Company and its subsidiaries that use the U.S. dollar as their functional currency remeasure monetary assets and liabilities at exchange rates in effect at the end of each period, whereas reagents and supplies, property and nonmonetary assets and liabilities are measured at historical rates. Losses from these remeasurements were $230,000 and $2.0 million in the three and nine months ended September 30, 2023, respectively. Loss from these translations were $1.9 million and $3.7 million in the three and nine months ended September 30, 2022, respectively.
Comprehensive Income (Loss)
Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) consists of net unrealized gain or loss on available-for-sale debt securities, net of tax, and foreign currency translation adjustments from the Company's subsidiaries not using the U.S. dollar as their functional currency. There were no reclassifications from other comprehensive income (loss) to net loss in the three and nine months ended September 30, 2023, and reclassification from other comprehensive income (loss) to net earnings was not significant in the three and nine months ended September 30, 2022. The tax effects related to net unrealized loss on available-for-sale debt securities were $1.2 million and $2.4 million in the three and nine months ended September 30, 2023, respectively. The tax effects related to net unrealized loss on available-for-sale debt securities were $3.6 million and $9.4 million in the three and nine months ended September 30, 2022, respectively.
Concentration of Customers
In certain periods, a small number of customers have accounted for a significant portion of the Company’s revenue. After aggregating customers that are under common control or affiliation, one customer contributed 14% and 11% of the Company's revenue for the three and nine months ended September 30, 2023, respectively. A different customer contributed 13% and 21% of the
Company's revenue for the three and nine months ended September 30, 2022, respectively. No customer comprised 10% or more of total accounts receivable as of September 30, 2023, and one customer comprised 17% of total accounts receivable as of December 31, 2022.
Disaggregation of Revenue
The Company classifies its customers into three payor types: (i) Insurance, including claim reimbursement from the U.S. Health Resources and Services Administration, or HRSA, for uninsured individuals, (ii) Institutional customers, including hospitals, medical institutions, other laboratories, governmental bodies, municipalities, and large corporations, or (iii) Patients who pay directly; as the Company believes these classifications best depict how the nature, amount, timing, and uncertainty of its revenue and cash flows are affected by economic factors. The following table summarizes revenue from contracts with customers by payor type for the three and nine months ended September 30, 2023 and 2022.
Testing Services by payor
Insurance
48,619
63,030
116,231
337,497
Institutional customers
35,164
42,280
100,238
212,980
Patients
904
345
2,239
787
Total Revenue
The insurance revenue category above includes zero and $92.7 million for the three and nine months ended September 30, 2022, respectively, for services related to claims covered by the HRSA COVID-19 Uninsured Program. The Company did not recognize any insurance revenue under HRSA COVID-19 Uninsurance Program for the three and nine months ended September 30, 2023.
$18.9 million variable consideration was recognized in the three months ended September 30, 2023 that related to COVID-19 tests completed in the prior periods due to the recent collection efforts, which was included as revenue from insurance in the table above. During the quarter ended September 30, 2023, the Company experienced a change in estimate related to variable consideration. This change resulted in a cumulative catch-up adjustment of $18.9 million. The Company estimates variable consideration using the expected value method. Any changes in variable consideration estimates that affect transactions are accounted for on a cumulative catch-up basis.
Contract Balances
Receivables from contracts with customers - Receivables from contracts with customers are included within trade accounts receivable on the Condensed Consolidated Balance Sheets. Net receivable from Insurance and Institutional customers represented 41% and 59%, respectively, as of September 30, 2023. Net receivable from Insurance and Institutional customers represented 14% and 86%, respectively, as of December 31, 2022.
Contracts assets and liabilities - Contract assets from contracts with customers associated with contract execution and certain costs to fulfill a contract are included in other current assets in the accompanying Condensed Consolidated Balance Sheets. The Company did not have any contract assets as of September 30, 2023 and December 31, 2022. Contract liabilities are recorded when the Company receives payment prior to completing its obligation to transfer goods or services to a customer. Contract liabilities are included in the Condensed Consolidated Balance Sheets. Revenues of $731,000 and $8.5 million were recognized for the three months ended September 30, 2023 and 2022, respectively, and $2.2 million and $14.4 million were recognized for the nine months ended September 30, 2023 and 2022, respectively, related to contract liabilities at the beginning of the respective periods.
Customer Deposit
Customer deposit in the accompanying Condensed Consolidated Balance Sheets consists of payments received from customers in excess of their outstanding trade accounts receivable balances. These deposits will be offset against future testing receivables or refunded to the customers.
Recent Accounting Pronouncements
9
The Company evaluates all Accounting Standards Updates, or ASUs, issued by the Financial Accounting Standards Board, or FASB, for consideration of their applicability. ASUs not included in the Company’s disclosures were assessed and determined to be either not applicable or are not expected to have a material impact on the Company’s condensed consolidated financial statements.
Note 3. Equity and Debt Securities
The Company’s equity and debt securities consisted of the following:
September 30, 2023
AmortizedCost Basis
UnrealizedGains
UnrealizedLosses
AggregateFair Value
Equity securities:
Long-term
Preferred stock of privately held company
15,000
Total equity securities
Available-for-sale debt securities
Short-term
U.S. government debt securities
165,357
(3,162
162,195
Corporate debt securities
85,674
(1,701
83,973
U.S. agency debt securities
71,498
(742
70,756
U.S. treasury bills
61,756
(18
61,738
Money market accounts
33,318
Municipal bonds
5,117
(53
5,064
Less: Cash equivalents
(33,318
Total debt securities due within 1 year
389,402
(5,676
After 1 year through 5 years
202,084
(3,297
198,793
163,842
(3,910
159,932
16,208
(1,176
15,032
7,517
(149
7,369
Yankee debt securities
752
(84
668
20,000
(4,842
Total debt securities due after 1 year through 5 years
410,403
(13,458
396,952
After 5 years through 10 years
1,905
(40
1,865
Total debt securities due after 5 years through 10 years
Total available-for-sale debt securities
801,710
(19,174
782,543
Total equity and debt securities
816,710
797,543
10
December 31, 2022
189,333
(3,373
185,960
120,480
(2,222
118,258
69,991
(193
69,798
68,411
(342
68,069
27,455
7,371
7,291
2,347
(5
2,342
(32,444
452,944
(6,215
152,435
(6,349
146,088
92,054
(3,435
88,619
80,647
(4,756
75,891
12,065
(217
11,848
753
(85
(7,615
357,954
(22,457
335,499
3,617
(83
3,534
814,515
(28,755
785,762
829,515
800,762
Gross unrealized losses on the Company’s equity and debt securities were $19.2 million and $28.8 million as of September 30, 2023 and December 31, 2022, respectively. The Company did not recognize any credit losses for its available-for-sale debt securities during the three and nine months ended September 30, 2023 and 2022.
Note 4. Fair Value Measurements
The authoritative guidance on fair value measurements establishes a framework with respect to measuring assets and liabilities at fair value on a recurring basis and non-recurring basis. Under the framework, fair value is defined as the exit price, or the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, as of the measurement date. The framework also establishes a three-tier hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use in valuing the asset or liability and are developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors market participants would use in valuing the asset or liability and are developed based on the best information available in the circumstances. The hierarchy consists of the following three levels:
Level 1:
Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity can access at the measurement date.
Level 2:
Inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 3:
Inputs are unobservable for the asset or liability.
11
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis, based on the above three-tier fair value hierarchy:
Total
Level 1
Level 2
Level 3
Equity securities, debt securities and cash equivalents:
360,988
230,688
99,005
14,298
Total equity securities, debt securities and cash equivalents
830,861
95,056
705,647
30,158
332,048
194,149
156,688
22,673
3,010
833,206
97,253
708,568
27,385
The Company’s Level 1 assets include U.S. treasury bills and money market instruments and are valued based upon observable market prices. Level 2 assets consist of U.S. government and U.S. agency debt securities, municipal bonds, corporate debt securities and Yankee debt securities. Level 2 securities are valued based upon observable inputs that include reported trades, broker/dealer quotes, bids and offers. As of September 30, 2023, the Company had preferred stock of a privately held company, which was included in other long-term assets in the accompanying Condensed Consolidated Balance Sheets, and redeemable preferred stock of a private company that were measured using unobservable (Level 3) inputs. The fair value of redeemable preferred stock as of September 30, 2023 and December 31, 2022 was based on valuation performed by a third-party valuation company utilizing the guideline public company method under market approach and the discounted cash flow method under income approach. For the value of the investment in private equity securities, the Company elected to measure it at cost minus impairment, as the preferred stock of the privately held company did not have a readily determinable fair value, and no impairment loss was recorded as of September 30, 2023.
There were no transfers between fair value measurement levels during the three and nine months ended September 30, 2023 and 2022.
12
Note 5. Fixed Assets
Major classes of fixed assets consisted of the following:
Useful Lives
Medical lab equipment
5 months to 12 Years
50,898
53,503
Leasehold improvements
Shorter of lease term or estimated useful life
11,065
11,804
Building
39 Years
9,781
6,731
Computer software
1 to 5 Years
7,739
6,982
Building improvements
6 months to 39 Years
7,703
5,865
Computer hardware
6,485
6,979
Aircraft
7 Years
6,400
Furniture and fixtures
3,751
4,248
Land improvements
5 to 15 Years
Automobile
3 to 7 Years
347
797
General equipment
3 to 5 Years
115
44
Land
8,800
7,500
Assets not yet placed in service
18,385
12,877
132,373
124,634
Less: Accumulated depreciation
(47,108
(43,281
Depreciation expenses on fixed assets totaled $4.3 million and $7.6 million for the three months ended September 30, 2023 and 2022, respectively, and $13.1 million and $17.9 million for the nine months ended September 30, 2023 and 2022, respectively.
Note 6. Other Significant Balance Sheet Accounts
Other current assets consisted of the following:
Prepaid income taxes
14,965
15,434
Prepaid expenses
7,583
6,814
Reagents and supplies
4,877
4,280
Marketable securities interest receivable
4,236
2,525
Other receivable
1,115
19,836
Other receivable as of December 31, 2022 includes $19.1 million of maturities of marketable securities that did not settle until after period-end.
Other long-term liabilities primarily include operating and finance lease liabilities, long-term, see Note 9, Leases, and notes payable, long-term, see Note 8, Debt, Commitments and Contingencies.
Note 7. Reporting Segment and Geographic Information
The Company views its operations and manages its business in one reporting segment. Long-lived assets were primarily located in the United States as of September 30, 2023 and December 31, 2022. Revenue by region during the three and nine months ended September 30, 2023 and 2022 were as follows:
Revenue:
United States
78,974
101,515
204,087
540,801
Foreign
5,713
4,140
14,621
10,463
13
Note 8. Debt, Commitments and Contingencies
Debt
As of September 30, 2023, the Company did not have any outstanding borrowing under its margin account with the custodian of the Company’s marketable debt security investment account, Pershing Advisor Solutions, LLC, a BNY Mellon Company. The related interest expenses for the three and nine months ended September 30, 2023 were zero and $336,000, respectively. The related interest expenses for the three and nine months ended September 30, 2022 were $105,000 and $185,000, respectively.
Notes payable as of September 30, 2023 consisted of $3.4 million of notes payable related to an installment sale contract the Company entered in February 2022 for a building and $2.5 million of notes payable to Xilong Scientific Co., or Xilong Scientific, by Fujian Fujun Gene Biotech Co., Ltd., or FF Gene Biotech. The notes payable related to the installment sale are due in February 2030, and the interest rate is 1.08%. The current portion and noncurrent portion are $408,000 and $3.0 million, respectively, and the noncurrent portion is included in the other long-term liabilities in the accompanying Condensed Consolidated Balance Sheets. The notes payable to Xilong Scientific were extended to and are due on December 31, 2023, and the interest rate on the loan is 4.97%. The related interest expenses for the three and nine months ended September 30, 2023 were $54,000 and $199,000, respectively. The related interest expenses for the three and nine months ended September 30, 2022 were $75,000 and $231,000, respectively.
Operating Leases
See Note 9, Leases, for further information.
Purchase Obligations
The Company entered certain noncancelable purchase commitments with its vendors, which primarily consist of services, reagent and supplies, computer software, and medical lab equipment. As of September 30, 2023, the Company had non-cancelable purchase obligations of $51.1 million, of which $24.0 million is payable within twelve months, and the remainder, $27.1 million, is payable within the next five years.
Contingencies
From time to time, the Company may be subject to legal proceedings and claims arising in the ordinary course of business. In the opinion of management, the outcome of these matters would not have a material effect on the Company’s condensed consolidated financial position, results of operations or cash flows.
The Company has received a Civil Investigative Demand, or CID, issued by the U.S. Department of Justice pursuant to the False Claims Act related to its investigation of allegations of medically unnecessary laboratory testing, improper billing for laboratory testing, and remuneration received or provided in violation of the Anti-Kickback Statute and the Stark Law. Among other things, this CID requests information and records relating to certain of the Company’s customers named in the CID, which represent a small portion of the Company’s revenues. As disclosed in the Company’s prior filings, the U.S. Securities and Exchange Commission, or the SEC is also conducting a non-public formal investigation, which appears to relate to the matters raised in the CID requests and our Exchange Act reports filed for 2018 through 2020. The Company is fully cooperating with the U.S. Department of Justice and the SEC to promptly respond to the requests for information in this CID and investigation and does not presently expect this CID or resulting investigation or the SEC investigation to have a material adverse impact. However, the Company cannot predict when these matters will be resolved, the outcome of these matters, or their potential impact, which may ultimately be greater than what the Company currently expects.
Note 9. Leases
Lessee
The Company is a lessee to various non-cancelable operating leases with varying terms through April 2033 primarily for laboratory and office space and equipment. The Company has options to renew some of these leases after their expirations. On a lease-by-lease basis, the Company considers such options, which may be elected at the Company’s sole discretion, in determining the lease term. The Company also has various finance leases for lab equipment with varying terms through December 2026, some of which were acquired in business combinations. The Company does not have any leases with variable lease payments. The Company’s operating lease agreements do not contain any residual value guarantees, material restrictive covenants, bargain purchase options, or asset retirement obligations.
14
The Company’s headquarters are located in El Monte, California, which is comprised of various corporate offices and a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, and licensed by the State of California Department of Public Health. Other CLIA-certified laboratories are located in Temple City, California; Irving, Texas; Needham, Massachusetts; Phoenix, Arizona; Alpharetta, Georgia; and New York, New York.
The operating and finance lease right-of-use asset, short-term lease liabilities, and long-term lease liabilities as of September 30, 2023 and December 31, 2022 were as follows:
Operating lease ROU asset, net
12,406
14,784
Operating lease liabilities, short term
4,994
6,132
Operating lease liabilities, long term
7,684
8,795
Finance lease ROU asset, net
1,444
2,784
Finance lease liabilities, short term
537
943
Finance lease liabilities, long term
894
1,818
The following were operating and finance lease expenses:
Operating lease cost
1,703
1,770
5,239
3,674
Finance lease cost:
Amortization of ROU assets
136
622
490
Interest on lease liabilities
15
67
Short-term lease cost
453
112
1,460
1,042
Total lease cost
2,307
2,138
7,388
5,272
Supplemental information related to operating and finance leases were the following:
Weighted average remaining lease term - operating leases
4.24 years
Weighted average discount rate - operating leases
4.01
%
Weighted average remaining lease term -finance lease
2.89 years
Weighted average discount rate - finance lease
3.77
The following is a maturity analysis of operating and finance lease liabilities using undiscounted cash flows on an annual basis with renewal periods included:
Finance Lease
Year Ending December 31,
2023 (remaining 3 months)
1,643
96
2024
4,356
579
2025
2,407
467
2026
1,784
366
2027
1,684
2028
541
Thereafter
1,509
Total lease payments
13,924
1,508
Less imputed interest
(1,246
(77
12,678
1,431
Lessor
The Company leases out space in buildings it owns and leases to third-party tenants under noncancelable operating leases. As of September 30, 2023, the remaining lease terms range from 3 months to 15 months, including renewal options and may include rent escalation clauses. Lease income primarily represents fixed lease payments from tenants recognized on a straight-line basis over the application lease term. Variable lease income represents tenant payments for real estate taxes, insurance, and maintenance.
The lease income was included in interest and other income, net, in the accompanying Condensed Consolidated Statements of Operations. Total lease income was as follows:
Lease income
36
48
229
Variable lease income
Total lease income
37
127
241
Future fixed lease payments from tenants for all noncancelable operating leases as of September 30, 2023 are as follows:
Lease Payments
from Tenants
90
126
Note 10. Equity-Based Compensation
The Company has included equity-based compensation expense as part of cost of revenue and operating expenses in the accompanying Condensed Consolidated Statements of Operations as follows:
2,621
2,475
7,374
6,183
3,782
2,687
10,900
7,110
1,189
1,243
3,644
3,148
3,310
2,567
9,572
6,177
Note 11. Income Taxes
The effective tax rate used for interim periods is the estimated annual effective consolidated tax rate, based on the current estimate of full year results, except that taxes related to specific events, if any, are recorded in the interim period in which they occur. The annual effective tax rate is based upon several significant estimates and judgments, including the estimated annual pre-tax income of the Company in each tax jurisdiction in which it operates, and the development of tax planning strategies during the year. In addition, the Company’s tax expense can be impacted by changes in tax rates or laws and other factors that cannot be predicted with certainty. As such, there can be significant volatility in interim tax provisions.
The Company recorded consolidated provision for income taxes of $20.3 million and $12.0 million for the three and nine months ended September 30, 2023, respectively, compared with $414,000 and $51.5 million for the three and nine months ended September 30, 2022, respectively. The Company’s effective tax rate was 296% and (42%) for the three and nine months ended September 30, 2023, respectively, compared to 24% for both the three and nine months ended September 30, 2022. The change in the effective tax rate compared to prior periods is due to the establishment, in the current quarter, of a valuation allowance on the Company's net deferred tax assets.
The Company is under examination by certain tax authorities for the 2020 to 2021 tax years. While the timing of the conclusion of the examination is uncertain, the Company believes that adequate amounts have been reserved for adjustments that may result. During 2023, the statutes of limitations will lapse on the Company’s 2019 federal tax year and certain 2018 and 2019 state tax years. The Company does not believe the federal or state statute lapses or any other event will significantly impact the balance of unrecognized tax benefits in the next twelve months.
Note 12. Income (Loss) per Share
The following table presents the calculation of basic and diluted income (loss) per share for the three and nine months ended September 30, 2023 and 2022:
Net income (loss) attributable to Fulgent
Weighted-average common shares—outstanding, basic
Weighted-average common shares—outstanding, diluted
Net income (loss) per common share, basic
Net income (loss) per common share, diluted
The following securities have been excluded from the calculation of diluted income (loss) per share because their effect would have been anti-dilutive:
Options
215
212
Restricted Stock Units
1,315
1,238
1,196
697
Contingently Issuable Shares
371
The anti-dilutive shares described above were calculated using the treasury stock method. In the three and nine months ended September 30, 2023, the Company had outstanding stock options and restricted stock units and contingently issuable shares for held back related shares to the business combination of Fulgent Pharma that were excluded from the weighted-average share calculation for continuing operations due to the Company’s net loss positions.
Note 13. Related Parties
Linda Marsh, who is a member of the Company’s Board of Directors, or the Board, currently serves as the Senior Executive Vice President of AHMC Healthcare Inc., or AHMC. The Company performs genetic testing and other testing services, on an arms-length basis, for AHMC, and the Company recognized $6,000 and $122,000 in revenue from AHMC in the three and nine months ended September 30, 2023, respectively. The Company recognized $299,000 and $1.3 million in revenue from AHMC in the three and
17
nine months ended September 30, 2022, respectively. As of September 30, 2023 and December 31, 2022, $13,000 and $93,000, respectively, was owed to the Company by AHMC, which is included in trade accounts receivable, net, in the accompanying Condensed Consolidated Balance Sheets, in connection with this relationship.
Ming Hsieh, the Chief Executive Officer and Chairperson of the Board, is on the board of directors and a 20% owner of ANP Technologies, Inc., or ANP, from which the Company purchased COVID-19 antigen rapid test kits and entered into certain drug-related licensing and development service agreements. The President and Chief Scientific Officer of Fulgent Pharma, Ray Yin, is the Founder, President, and Chief Technology Officer of ANP. The Company incurred $368,000 and $1.9 million in expenses, in the three and nine months ended September 30, 2023, respectively, related to the licensing and development services and purchases of equipment and COVID-19 antigen rapid test kits. The Company incurred $120,000 and $280,000 in expenses in the three and nine months ended September 30, 2022, respectively, for COVID-19 antigen rapid test kits. As of September 30, 2023 and December 31, 2022, $255,000 and $607,000, respectively, were owed to ANP by the Company in connection with these relationships. The Company also entered into an employee service agreement with ANP in April 2023, $32,000 and $70,000 were recognized in the three and nine months ended September 30, 2023, respectively, and $70,000 was owed by ANP in connection with the employee service agreement as of September 30, 2023.
Note 14. Goodwill and Acquisition-Related Intangibles
Summaries of goodwill and intangibles balances assets as of September 30, 2023 and December 31, 2022 were as follows:
Weighted-Average Amortization Period
In-process research & development
n/a
64,590
Royalty-free technology
10 Years
5,071
5,364
Less: accumulated amortization
(1,225
(894
Royalty-free technology, net
3,846
4,470
Customer relationships
13 Years
82,686
82,750
(10,976
Customer relationships, net
71,710
76,535
Trade name
8 Years
3,790
(782
(412
Trade name, net
3,008
3,378
In-place lease intangible assets
5 Years
360
(99
(46
In-place lease intangible assets, net
261
314
Laboratory information system platform
1,860
(806
(527
Laboratory information system platform, net
1,054
1,333
Purchased patent
27
(7
(6
Purchased patent, net
23
Total intangible assets, net
18
Acquisition-related intangibles included in the above tables are generally finite-lived and are carried at cost less accumulated amortization, except for In-Process Research and Development, or IPR&D, which is related to a business combination in 2022 and has an indefinite life until research and development efforts are completed or abandoned. All other finite-lived acquisition-related intangibles related to the business combinations in 2022 and 2021 are amortized on a straight-line basis over their estimated lives, which approximates the pattern in which the economic benefits of the intangible assets are expected to be realized.
Changes in the carrying amount of goodwill for the nine months ended September 30, 2023 are as follows:
Amounts
Balance as of January 1, 2023
Accumulated impairment losses
Net foreign currency exchange differences
(1,183
Balance as of September 30, 2023
Based on the carrying value of finite-lived intangible assets recorded as of September 30, 2023, and assuming no subsequent impairment of the underlying assets, the annual amortization expense for intangible assets is expected to be as follows:
1,955
7,822
7,521
7,196
7,161
40,422
79,899
Note 15. Stock Repurchase Program
In March 2022, the Board authorized a $250.0 million stock repurchase program. Under the stock repurchase program, the Company may repurchase shares from time to time in the open market or in privately negotiated transactions. The stock repurchase program has no expiration from the date of authorization.
During the three and nine months ended September 30, 2023, the Company repurchased 80,000 shares of its common stock at an aggregate cost of $2.2 million under the stock repurchase program. During the three months ended September 30, 2022, the Company repurchased 780,000 shares of its common stock at an aggregate cost of $34.7 million. During the nine months ended September 30, 2022, the Company repurchased 995,000 shares of its common stock at an aggregate cost of $45.3 million. As of September 30, 2023, a total of approximately $173.5 million remained available for future repurchases of its common stock under the stock repurchase program.
Note 16. Subsequent Events
In October 2023, the Company repurchased 533,000 shares of its common stock at an aggregate cost of $13.7 million under the stock repurchase program approved in March 2022. See Note 15, Stock Repurchase Program.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read together with our condensed consolidated financial statements and related notes included in this report. Additionally, pursuant to Instruction 2 to paragraph (b) of Item 303 of Regulation S-K promulgated by the U.S. Securities and Exchange Commission, or SEC, in preparing this discussion and analysis, we presume that readers have access to and have read the discussion and analysis of our financial condition and results of operations included in our annual report on Form 10-K for our fiscal year ended December 31, 2022, filed with the SEC on February 28, 2023, or the 2022 Annual Report. As used in this discussion and analysis and elsewhere in this report, unless the context otherwise requires, the terms “Fulgent,” the “Company,” “we,” “us” and “our” refer to Fulgent Genetics, Inc. and its consolidated subsidiaries.
Forward-Looking Statements
The following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or our future performance, and they are based on our current assumptions, expectations and beliefs concerning future developments and their potential effect on our business. The forward-looking statements in this discussion and analysis include statements about, among other things, our future financial and operating performance, our future cash flows and liquidity and our growth strategies, as well as anticipated trends in our business and industry. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, those described under “Item 1A. Risk Factors” in Part I of the 2022 Annual Report. Moreover, we operate in a competitive and rapidly evolving industry and new risks emerge from time to time. It is not possible for us to predict all of the risks we may face, nor can we assess the impact of all factors on our business or the extent to which any factor or combination of factors could cause actual results to differ from our expectations. In light of these risks and uncertainties, the forward-looking events and circumstances described in this discussion and analysis may not occur, and actual results could differ materially and adversely from those described in or implied by any forward-looking statements we make. Although we have based our forward-looking statements on assumptions and expectations we believe are reasonable, we cannot guarantee future results, levels of activity, performance or achievements or other future events. As a result, forward-looking statements should not be relied on or viewed as predictions of future events, and this discussion and analysis should be read with the understanding that actual future results, levels of activity, performance and achievements may be materially different than our current expectations. The forward-looking statements in this discussion and analysis speak only as of the date of this report, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to actual results or to changes in our expectations.
Overview
We are a technology-based company with a well-established clinical diagnostic business and a therapeutic development business. Our clinical diagnostic business offers molecular diagnostic testing services, comprehensive genetic testing, and high-quality anatomic pathology laboratory services designed to provide physicians and patients with clinically actionable diagnostic information to improve the quality of patient care. Our therapeutic development business is focused on developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of new and existing cancer drugs. We aim to transform from a genomic diagnostic business into a fully integrated precision medicine company.
Business Risks and Uncertainties and Other Factors Affecting Our Performance
Our business and prospects are exposed to numerous risks and uncertainties. For more information, see “Item 1A. Risk Factors” in Part I of the 2022 Annual Report. In addition, our performance in any period is affected by a number of other factors. See the description of some of the material factors affecting our performance in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” of the 2022 Annual Report.
Results of Operations
The table below summarizes our results of our continuing operations for each of the periods presented. For a financial overview relating to our results of operations, including general descriptions of the make-up of material line items of our statement of operation data, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” of the 2022 Annual Report.
Three Months Ended
Nine Months Ended
Change
Statement of Operation Data:
(20,968
(20%)
(332,556
(60%)
(14,717
(25%)
(57,869
(29%)
(6,251
(14%)
(274,687
(78%)
2,507
33%
9,087
45%
302
3%
2,302
8%
(8,768
(33%)
(24,988
(30%)
(49
(2%)
1,400
31%
(105
(100%)
(3,001
(6,113
(13%)
(15,200
(11%)
(138
(39%)
(259,487
(121%)
5,241
373%
13,111
544%
5,103
290%
(246,376
(113%)
19,912
4,810%
(39,472
(77%)
(14,809
(1,103%)
(206,904
(125%)
(17
(5%)
(1%)
(14,826
(862%)
(206,911
(124%)
21
Revenue decreased $21.0 million, or 20%, from $105.7 million in the three months ended September 30, 2022 to $84.7 million in the three months ended September 30, 2023, and decreased $332.6 million, or 60%, from $551.3 million in the nine months ended September 30, 2022 to $218.7 million in the nine months ended September 30, 2023. The decreases in revenue between periods were primarily due to decreased orders for our COVID-19 tests.
Revenue from non-U.S. sources increased $1.6 million, or 38%, from $4.1 million in the three months ended September 30, 2022 to $5.7 million in the three months ended September 30, 2023, and increased $4.2 million, or 40%, from $10.5 million in nine months ended September 30, 2022 to $14.6 million in the nine months ended September 30, 2023. The increase in revenue from non-U.S. sources between periods were primarily due to increased sales of our traditional genetic testing services to customers in China through our joint venture in China.
After aggregating customers that are under common control or affiliation, one customer contributed 14% and 11% of the Company’s revenue in the three and nine months ended September 30, 2023, respectively. A different customer contributed 13% and 21%, of the Company’s revenue in the three and nine months ended September 30, 2022, respectively.
Cost of Revenue
Cost of revenue decreased $14.7 million, or 25%, from $59.6 million in the three months ended September 30, 2022 to $44.8 million in the three months ended September 30, 2023. The decrease was primarily due to decreases of $4.3 million in depreciation expenses, $3.4 million in reagent and supply expenses, $3.3 million in consulting and outside labor costs, $726,000 in payroll expenses, $553,000 in shipping expenses, and $420,000 in external customer engagement platform expense related to the decreased tests delivered and orders for our COVID-19 tests, and $1.1 million in allocated facility expense.
Cost of revenue decreased $57.9 million, or 29%, from $197.4 million in the nine months ended September 30, 2022 to $139.5 million in the nine months ended September 30, 2023. The decrease was primarily due to decreases of $30.8 million in consulting and outside labor costs for production, $23.9 million in reagent and supply expenses, $9.3 million in depreciation expenses, $2.2 million in shipping expenses, $1.1 million in meals provided to production teams during pandemic and other travel expense, and $856,000 in external customer engagement platform expense related to the decreased tests delivered and orders for our COVID-19 tests, $1.6 million in allocated facility expense, $750,000 in change in gain or loss on disposal of fixed assets, $663,000 in office and computer expenses, and $334,000 in other state tax, and partially offset by an increase of $13.8 million in personnel costs including equity-based compensation expense related to an entity acquired in the second quarter of 2022.
22
Our gross profit decreased $6.3 million, from $46.1 million in the three months ended September 30, 2022 to $39.8 million in the three months ended September 30, 2023. The decrease in gross profit was primarily due to the decrease in revenue from our COVID-19 tests. Our gross profit as a percentage of revenue, or gross margin, increased from 43.6% to 47.0% due to changes in product mix and revenue recognized for COVID-19 tests completed in prior periods.
Our gross profit decreased $274.7 million, from $353.9 million in the nine months ended September 30, 2022 to $79.2 million in the nine months ended September 30, 2023. The decrease in gross profit was primarily due to the decrease in revenue from our COVID-19 tests. Our gross profit as a percentage of revenue, or gross margin, decreased from 64.2% to 36.2% due to changes in product mix.
Research and Development
Research and development expenses increased $2.5 million, or 33%, from $7.5 million in the three months ended September 30, 2022 to $10.0 million in the three months ended September 30, 2023. The increase was primarily due to increases of $1.6 million in personnel costs including equity-based compensation expense related to increased headcount and equity awards granted post the second quarter of 2022, and $584,000 in reagent and supply expenses related to increased reagent usage for research.
Research and development expenses increased $9.1 million, or 45%, from $20.4 million in the nine months ended September 30, 2022 to $29.5 million in the nine months ended September 30, 2023. The increase was primarily due to increases of $7.2 million in personnel costs including equity-based compensation expense related to increased headcount and equity awards granted post the second quarter of 2022, $681,000 in consulting and outside labor costs, and $611,000 in reagent and supply expenses related to increased reagent usage for research.
Selling and Marketing
Selling and marketing expenses were relatively consistent between periods at $10.2 million and $9.9 million in the three months ended September 30, 2023 and 2022, respectively.
Selling and marketing expenses increased $2.3 million, or 8% from $28.7 million in the nine months ended September 30, 2022 to $31.0 million in the nine months ended September 30, 2023. The increase was primarily due to increases of $2.1 million in software expense, and $1.2 million related to allocated facility expenses, and partially offset by a decrease of $2.0 million in consulting and outside labor costs.
General and Administrative
General and administrative expenses decreased $8.8 million, or 33%, from $26.3 million in the three months ended September 30, 2022 to $17.5 million in the three months ended September 30, 2023. The decrease was primarily due to a decrease of $8.9 million in provisions for credit losses.
General and administrative expenses decreased $25.0 million, or 30%, from $82.3 million in the nine months ended September 30, 2022 to $57.3 million in the nine months ended September 30, 2023. The decrease was primarily due to decreases of $29.6 million in provision for credit losses, $5.2 million in acquisition related costs incurred in the prior period, $2.3 million in legal and professional fees, and $1.7 million in licenses and permits, partially offset by increases of $5.4 million in personnel costs including equity-based compensation expense related to entity acquired in the second quarter of 2022 and equity awards granted post the second quarter of 2022, $4.5 million related to allocated facility expense, and $3.5 million in depreciation expense.
Amortization of Intangible Assets
Amortization of intangible assets represents amortization expenses on the intangible assets arose from the business combinations in 2022 and 2021 and a patent purchased in 2021. Amortization expenses were $2.0 million in the three months ended September 30, 2023 and 2022, respectively, and $5.9 million and $4.5 million in the nine months ended September 30, 2023 and 2022, respectively.
Restructuring Costs
Restructuring expenses represent one-time employee termination benefits provided to employees associated with an entity acquired by the Company who were involuntarily terminated in the prior period.
Interest and Other Income, net
Interest and other income, net, is primarily comprised of net interest income (expenses), which was $6.4 million and $1.5 million in the three months ended September 30, 2023 and 2022, respectively, and $15.2 million and $2.3 million in the nine months ended September 30, 2023 and 2022, respectively. This interest income (expense) related to interest earned on various investments in marketable securities including realized and holding gain (loss) on marketable equity securities, net of interest expenses incurred for our notes payable and margin loan. The increase is primarily due to increases in interest rates on investments relative to the prior comparative periods.
Provision for Income Taxes
Provision for income taxes was $20.3 million and $12.0 million for the three and nine months ended September 30, 2023, respectively, and $414,000 and $51.5 million for the three and nine months ended September 30, 2022, respectively. The effective tax rate was 296% and 24% for the three months ended September 30, 2023 and 2022, respectively. The effective tax rate was (42%) and 24% for the nine months ended September 30, 2023 and 2022, respectively. The change in the effective tax rate for the three and nine months ended September 30, 2023, relative to 2022, was due to the establishment, in the three months ended September 30, 2023, of a valuation allowance on the Company's net deferred tax assets. FASB ASC 740 requires that deferred income tax assets be reduced by a valuation allowance if it is more likely than not that some or all of the deferred income tax assets will not be realized. The Company has evaluated the realizability of any of its deferred tax assets and has concluded that it is more likely than not that the Company may not realize benefit of its deferred tax assets, primarily as a result of operating losses in the nine months ended September 30, 2023, and, accordingly, has provided a full valuation allowance at September 30, 2023.
Net Loss Attributable to Noncontrolling Interest
Net loss attributable to noncontrolling interest represents net loss attributable to the minority shareholders from entities not wholly owned.
Liquidity and Capital Resources
Liquidity and Sources of Cash
We had $851.5 million and $852.9 million in cash, cash equivalents, and marketable securities as of September 30, 2023 and December 31, 2022, respectively. Our marketable securities primarily consist of U.S. government and U.S. agency debt securities, U.S. treasury bills, corporate bonds, municipal bonds, and Yankee debt securities as of September 30, 2023 and December 31, 2022.
Our primary uses of cash are to fund our operations and to fund strategic acquisitions as we continue to invest in and seek to grow our business. Cash used to fund operating expenses is impacted by the timing of our expense payments, as reflected in the changes in our outstanding accounts payable and accrued expenses.
We believe our existing cash, cash equivalent, and short-term marketable securities will be sufficient to meet our anticipated cash requirements for at least the next 12 months. Cash provided by operations significantly contributed to our ability to meet our liquidity needs, including paying for capital expenditures. However, cash provided by our operations fluctuates from period to period, which we expect may continue in the future. These fluctuations can occur because of a variety of factors, including, among others, factors relating to the demand for our tests, the amount and timing of sales, the prices we charge for our tests due to changes in product mix, customer mix, general price degradation for tests, or other factors, the rate and timing of our billing and collections cycles and the timing and amount of our commitments and other payments. Moreover, even if our liquidity expectations are correct, we may still seek to raise additional capital through securities offerings, credit facilities or other debt financings, asset sales or collaborations or licensing arrangements.
If we raise additional funds by issuing equity securities, our existing stockholders could experience substantial dilution. Additionally, any preferred stock we issue could provide for rights, preferences or privileges senior to those of our common stock, and our issuance of any additional equity securities, or the possibility of such an issuance, could cause the market price of our common stock to decline. The terms of any debt securities we issue or borrowings we incur, if available, could impose significant restrictions on our operations, such as limitations on our ability to incur additional debt or issue additional equity or other restrictions that could adversely affect our ability to conduct our business, and would result in increased fixed payment obligations. If we seek to sell assets or enter into collaborations or licensing arrangements to raise capital, we may be required to accept unfavorable terms or relinquish or license to a third party our rights to important or valuable technologies or tests we may otherwise seek to develop ourselves. Moreover, we may incur substantial costs in pursuing future capital, including investment banking, legal and accounting fees, printing and distribution expenses, and other similar costs. Additional funding may not be available to us when needed, on acceptable terms or at all. If we are not able to secure funding if and when needed and on reasonable terms, we may be forced to delay, reduce the scope
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of, or eliminate one or more sales and marketing initiatives, research and development programs, or other growth plans or strategies. In addition, we may be forced to work with a partner on one or more aspects of our tests or market development programs, or initiatives, which could lower the economic value to us of these tests, programs or initiatives. Any such outcome could significantly harm our business, performance, and prospects.
Cash Flows
The following table summarizes our cash flows for each of the periods indicated:
Operating Activities
Cash provided by operating activities in the nine months ended September 30, 2023 was $12.1 million. The difference between net loss and cash provided in operating activities for the period was primarily due to the effects of $31.5 million in equity-based compensation expenses, $19.6 million in depreciation and amortization, $11.0 million in deferred taxes, and $4.9 million in noncash lease expense, partially offset by negative impact of $4.3 million in provisions for credit loss and $2.4 million in amortization of discount on marketable securities. Changes in operating assets and liabilities primarily consisted of decreases of $7.0 million in accounts payable related to the timing of payments, $4.8 million in operating lease liabilities, and an increase of $2.9 million in other current and long-term assets, partially offset by a decrease of $7.6 million in trade accounts receivable due to the timing of collections.
Cash provided by operating activities in the nine months ended September 30, 2022 was $220.3 million. The difference between net income and cash provided by operating activities for the period was primarily due to the effects of $25.3 million in provision for credit losses, $22.9 million in depreciation and amortization, $22.6 million in equity-based compensation expenses, $4.2 million in amortization of premium of marketable securities, $3.3 million in noncash lease expense, $1.1 million in unrecognized tax benefits, and partially offset by a negative impact of $4.9 million increased deferred tax assets. Cash used in operating activities decreased between periods primarily due to decreases of $32.3 million in accounts payable related to timing of payments, $12.9 million in accrued expenses and other liabilities, $3.3 million in operating and finance lease liabilities, and partially offset by decreases of $24.2 million in trade accounts receivable due to timing of collections and $3.7 million in other current and long-term assets primarily reagents and supplies and prepaid expenses.
Investing Activities
Cash provided by investing activities in the nine months ended September 30, 2023 was $14.6 million, which primarily represents proceeds of $376.9 million from maturities of marketable securities, partially offset by $343.6 million for purchases of marketable securities and $19.1 million for purchases of fixed assets, including real estate.
Cash used in investing activities in the nine months ended September 30, 2022 was $168.7 million, which primarily related to $257.3 million purchase of marketable securities and $137.8 million payment related to acquisition of Inform Diagnostics, $15.0 million purchase of preferred stock of a privately held company, purchases of $14.1 million of fixed assets, and $10.0 million contingent consideration payment made in current period related to a business acquisition in 2021, and partially offset by proceeds of $133.4 million from sale of marketable securities and $131.7 million related to maturities of marketable securities.
Financing Activities
Cash used in financing activities in the nine months ended September 30, 2023 was $21.8 million, which primarily related to $15.0 million repayment to the margin loan account, $2.4 million repayment to the notes payable, $2.2 million repurchase of common stock, and $1.6 million common stock withholding for employee tax obligations.
Cash used in financing activities in the nine months ended September 30, 2022 was $47.5 million, which primarily related to $45.3 million repurchase of common stock and $1.5 million related to common stock withholding for employee tax obligations.
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Stock Repurchase Program
During the three and nine months ended September 30, 2023, we repurchased 80,000 shares common stock at an aggregate cost of $2.2 million under the stock repurchase program. During the three months ended September 30, 2022, we repurchased 780,000 shares of our common stock at an aggregate cost of $34.7 million, and during the nine months ended September 30, 2022, we repurchased 995,000 shares of our common stock at an aggregate cost of $45.3 million. As of September 30, 2023, a total of approximately $173.5 million remained available for future repurchases of our common stock under our stock repurchase program.
Critical Accounting Policies and Use of Estimates
There have been no material changes to our critical accounting policies or estimates from the information provided in Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in the 2022 Annual Report.
See Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements included in this report for information about recent accounting pronouncements.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC, that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
For quantitative and qualitative disclosures about market risk, see Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” in our 2022 Annual Report.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. As required by Rule 13a-15(b) under the Exchange Act, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures as of September 30, 2023. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of September 30, 2023.
Changes in Internal Control over Financial Reporting
There have not been any changes in our internal control (as required by Rule 13a-15(b) under the Exchange Act) over the financial reporting during the three months ended September 30, 2023 that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.
Inherent Limitations on Disclosure Controls and Procedures and Internal Control over Financial Reporting
Management recognizes that any controls and procedures, no matter how well-designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the benefits of possible controls and procedures relative to their costs. Because of these inherent limitations, our disclosure and internal controls may not prevent or detect all instances of fraud, misstatements or other control issues. In addition, projections of any evaluation of the effectiveness of disclosure or internal controls to future periods are subject to risks, including, among others, that controls may become inadequate because of changes in conditions or that the degree of compliance with policies or procedures may deteriorate.
Item 1. Legal Proceedings.
From time to time, we may be involved in legal proceedings arising in the ordinary course of our business. As disclosed in Note 8, Debt, Commitments and Contingencies to the Condensed Consolidated Financial Statements, we are engaged in certain legal investigations, and the disclosure set forth in Note 8 relating to these certain legal matters is incorporated herein by reference.
The outcome of litigation is inherently uncertain, and there can be no assurances that favorable outcome will be obtained.
Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity and reputational harm, among other factors.
Item 1A. Risk Factors.
There have been no material changes to the risk factors set forth in Part I, Item 1A, “Risk Factors,” of the 2022 Annual Report.
Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities.
Use of Proceeds from Registered Securities
To date, we have used $121.7 million of the net proceeds from sales of our common stock, of which, $4.5 million was used for contributions to FF Gene Biotech, prior to the FF Gene Biotech acquisition, $101.4 million was used to fund the Company’s operations and a business combination, and $15.8 million was used to pay off the investment margin loan. All other net proceeds from sales of our common stock are invested in investment-grade and interest-bearing securities, such as U.S. government and U.S. agency debt securities, corporate bonds, and municipal bonds. There has been no material change in the planned use of proceeds from the sales of our common stock from that described in the Prospectus.
Information on Share Repurchases
The Company repurchased 80,000 shares common stock during the three and nine months ended September 30, 2023. The number of shares of common stock repurchased by the Company and the average price paid per share are as follows:
Period
(a) Total Number of Shares Purchased
(b) Average Price Paid Per Share (1)
(c) Total Number of Shares Purchased As Part of Publicly Announced Plans or Programs
(d) Maximum Dollar Value that May Yet Be Purchased Under the Plans or Programs
May 2022 (5/1/2022 - 5/31/2022)
30,000
49.56
248,515,000
June 2022 (6/1/2022 - 6/30/2022)
185,000
48.97
239,429,000
August 2022 (8/1/2022 - 8/31/2022)
247,000
47.68
227,657,000
September 2022 (9/1/2022 - 9/30/2022)
533,000
43.04
204,752,000
October 2022 (10/1/2022 - 10/31/2022)
244,000
37.33
195,661,000
November 2022 (11/1/2022 - 11/30/2022)
234,000
35.83
187,276,000
December 2022 (12/1/2022 - 12/31/2022)
337,000
34.32
175,718,000
September 2023 (9/1/2023-9/30/2023)
80,000
27.65
173,522,000
1,890,000
(1) Includes commissions for the shares repurchased under the stock repurchase program.
On October 30, 2023, in accordance with Rule 10D-1 of the Exchange Act, the Board approved the Company’s Amended and Restated Incentive Compensation Recoupment Policy, which allows the Company to recoup certain executive compensation in the event of an accounting restatement resulting from material noncompliance with financial reporting requirements under federal securities laws. The Amended and Restated Incentive Compensation Recoupment Policy has been filed as Exhibit 10.1 of this Quarterly Report on Form 10-Q.
On October 30, 2023, the Compensation Committee of the Board (the “Compensation Committee”) approved the Company’s Amended and Restated Executive Officer Incentive Plan (the “Amended and Restated Incentive Plan”). The Amended and Restated Incentive Plan amended the original Executive Officer Incentive Plan to permit the administrator to, in its discretion, make certain
payments in the form of equity awards. The foregoing summary of the Amended and Restated Incentive Plan does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Amended and Restated Incentive Plan, a copy of which is attached as Exhibit 10.2 to this Quarterly Report on Form 10-Q and incorporated herein by reference.
Item 6. Exhibits.
The information required by this Item 6 is set forth on the Exhibit Index that immediately precedes the signature page to this report and is incorporated herein by reference.
EXHIBIT INDEX
Incorporated by Reference
Exhibit No.
Exhibit Title
Filed with this Form 10-Q
Form
Form No.
Date Filed
3.1
Certificate of Incorporation of the registrant, dated May 13, 2016.
10-Q
001-37894
8/14/2017
3.1.1
Certificate of Amendment to Certificate of Incorporation of the registrant, dated August 2, 2016.
3.1.2
Certificate of Amendment to Certificate of Incorporation of the registrant, dated May 17, 2017.
3.2
Amended and Restated Bylaws of the registrant.
8/4/2023
10.1^#
Amended and Restated Incentive Compensation Recoupment Policy
X
10.2^#
Amended and Restated Executive Officer Incentive Plan
31.1*
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*
Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
* Furnished herewith.
^ Management compensation plan or arrangement.
# Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC.
SIGNATURES
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 thereunto duly authorized.
Date: November 3, 2023
By:
/s/ Ming Hsieh
Ming Hsieh
Chief Executive Officer
(principal executive officer)
/s/ Paul Kim
Paul Kim
Chief Financial Officer
(principal financial and accounting officer)