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Illumina Reports Financial Results for Fourth Quarter and Fiscal Year 2021

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SAN DIEGO, Feb. 10, 2022 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN) today announced its financial results for the fourth quarter and fiscal year 2021, which include the consolidated financial results of GRAIL.

Fourth quarter consolidated results:

  • Revenue of $1,198 million, a 26% increase compared to the prior year period

  • GAAP net income for the quarter of $112 million, or $0.71 per diluted share, compared to $257 million, or $1.75 per diluted share, for the prior year period

  • Non-GAAP net income for the quarter of $117 million, or $0.75 per diluted share, compared to $179 million, or $1.22 per diluted share, for the prior year period (see the "Consolidated Reconciliation Between GAAP and Non-GAAP Net Income" table for a reconciliation of these GAAP and non-GAAP financial measures)

  • Cash flow from operations of $282 million compared to $406 million in the prior year period

  • Free cash flow (cash flow from operations less capital expenditures) of $212 million for the quarter compared to $344 million in the prior year period

"We are seeing strength across our business as a growing number of patients around the world are accessing the life-saving benefits of genomics, from oncology therapy selection to genetic disease testing and pathogen surveillance," said Francis deSouza, Chief Executive Officer. "Opportunities are also expanding across new markets like proteomics, infectious disease and drug discovery. In addition, momentum for GRAIL's groundbreaking multi-cancer early detection blood test continues to accelerate. We are also making great progress on exciting new innovations, like our breakthrough Chemistry X and our Infinity long-read technology, to help clinicians and scientists make discoveries that improve patient care."

Gross margin in the fourth quarter of 2021 was 68.2% compared to 66.1% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 71.5% for the fourth quarter of 2021 compared to 66.9% in the prior year period.

Research and development (R&D) expenses for the fourth quarter of 2021 were $350 million compared to $200 million in the prior year period. Non-GAAP R&D expenses as a percentage of revenue were 29.2% compared to 20.9% in the prior year period.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2021 were $426 million compared to $298 million in the prior year period. Excluding acquisition-related expenses, fair value adjustments on contingent consideration liabilities and amortization of acquired intangible assets, non-GAAP SG&A expenses as a percentage of revenue were 30.1% compared to 25.1% in the prior year period.

Depreciation and amortization expenses were $90 million and capital expenditures for free cash flow purposes were $70 million during the fourth quarter of 2021. At the close of the quarter, the company held $1.3 billion in cash, cash equivalents and short-term investments, compared to $3.5 billion as of January 3, 2021.

Fourth quarter segment results:

Following the acquisition of GRAIL on August 18, 2021, we have two reportable segments, Core Illumina and GRAIL. GRAIL financial results are reflected for the period after the acquisition.


Core Illumina



GAAP


Non-GAAP (a)

In millions

Q4 2021


Q4 2020


Q4 2021


Q4 2020

Revenue (b)

$ 1,193


$ 953





Gross margin

71.0%


66.1%


71.6%


66.9%

Research and development expense

$ 274


$ 200


$ 274


$ 200

Selling, general and administrative expense

$ 351


$ 298


$ 306


$ 239

Operating profit

$ 222


$ 132


$ 274


$ 199

Operating margin

18.6%


13.9%


22.9%


20.9%


(a) See the "Core Illumina Itemized Reconciliation Between GAAP and Non-GAAP Results of Operations as a Percent of Revenue" table for a reconciliation of these GAAP and non-GAAP financial measures.

(b) Amount for Q4 2021 includes intercompany revenue of $5 million, which is eliminated in consolidation.



GRAIL



GAAP


Non-GAAP (a)

In millions

Q4 2021


Q4 2020


Q4 2021


Q4 2020

Revenue

$ 10






Operating loss

$ (182)



$ (128)



(a) See the "GRAIL Itemized Reconciliation Between GAAP and Non-GAAP Results of Operations" table for a reconciliation of these GAAP and non-GAAP financial measures.


Fiscal year 2021 consolidated results:

  • Revenue of $4,526 million, a 40% increase compared to $3,239 million in fiscal 2020

  • GAAP net income of $762 million, or $5.04 per diluted share, which included an $899 million gain from our previously held investment in GRAIL and $654 million in GRAIL acquisition-related compensation expense. This compared to $656 million, or $4.45 per diluted share, in fiscal 2020

  • Non-GAAP net income of $892 million, or $5.90 per diluted share, compared to $664 million, or $4.50 per diluted share, in fiscal 2020 (see the "Consolidated Reconciliation Between GAAP and Non-GAAP Net Income" table for a reconciliation of these GAAP and non-GAAP financial measures)

  • Cash flow from operations of $545 million compared to $1,080 million in fiscal 2020, with the year-over-year decrease primarily attributable to expenses related to the GRAIL acquisition, as well as GRAIL's operating loss for the period after the acquisition

  • Free cash flow (cash flow from operations less capital expenditures) of $337 million, compared to $891 million in fiscal 2020

Gross margin for fiscal 2021 was 69.7% compared to 68.0% in the prior year. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 71.3% for fiscal 2021 compared to 69.0% in the prior year period.

R&D expenses for fiscal 2021 were $1,185 million compared to $682 million in the prior year. Excluding GRAIL acquisition-related compensation expense, non-GAAP R&D expenses as a percentage of revenue were 21.9% compared to 21.0% in the prior year period.

SG&A expenses for fiscal 2021 were $2,092 million compared to $941 million in the prior year period. Excluding GRAIL acquisition-related compensation expense and other acquisition-related expenses, fair value adjustments on contingent consideration liabilities, expenses and income related to COVID-19, gain on litigation and amortization of acquired intangible assets, non-GAAP SG&A expenses as a percentage of revenue were 25.2% compared to 24.6% in the prior year period.

Fiscal year 2021 segment results:

Following the acquisition of GRAIL on August 18, 2021, we have two reportable segments, Core Illumina and GRAIL. GRAIL financial results are reflected for the period after the acquisition.


Core Illumina



GAAP


Non-GAAP (a)

In millions

2021


2020


2021


2020

Revenue (b)

$ 4,519


$ 3,239





Gross margin

70.7%


68.0%


71.3%


69.0%

Research and development expense

$ 885


$ 682


$ 885


$ 681

Selling, general and administrative expense

$ 1,502


$ 941


$ 1,064


$ 796

Operating profit

$ 808


$ 580


$ 1,273


$ 758

Operating margin

17.9%


17.9%


28.2%


23.4%


(a) See the "Core Illumina Itemized Reconciliation Between GAAP and Non-GAAP Results of Operations as a Percent of Revenue" table for a reconciliation of these GAAP and non-GAAP financial measures.

(b) Amount for 2021 includes intercompany revenue of $5 million, which is eliminated in consolidation.



GRAIL



GAAP


Non-GAAP (a)

In millions

2021


2020


2021


2020

Revenue

$ 12






Operating loss

$ (931)



$ (177)



(a) See the "GRAIL Itemized Reconciliation Between GAAP and Non-GAAP Results of Operations" table for a reconciliation of these GAAP and non-GAAP financial measures.


Announcements since Illumina's last earnings release:

Core Illumina

  • Key oncology studies utilizing our TruSight Oncology 500 panel, including:

  • Expansion of oncology testing partnerships, including:

  • Participation in Our Future Health, the largest-ever research program in the U.K., with up to 5 million volunteers

  • Updates on groundbreaking innovations, including:

  • Collaborations in large, emerging spaces of genomics, including:

  • The 2022 Illumina Genomics Forum will take place in person and online Sept. 28Oct. 1, 2022 in San Diego

A full list of recent Illumina announcements can be found in the company's News Center

GRAIL

  • A collaboration with the Knight Cancer Institute at Oregon Health & Science University to offer Galleri®, GRAIL's multi-cancer early detection blood test

  • A collaboration with Premier, Inc.'s PINC AI™, an advanced technology and services platform that provides artificial intelligence-enabled clinical performance improvement technologies, to support patient access to Galleri®

  • A partnership with Alignment Health Plan, a national Medicare Advantage health plan from Alignment Healthcare (NASDAQ: ALHC), to provide its Medicare Advantage members access to Galleri®

A full list of recent GRAIL announcements can be found in the company's Newsroom

Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance, including our Core Illumina and GRAIL segments. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2022, the company expects consolidated revenue growth in the range of 14% to 16%, GAAP earnings per diluted share of $3.04 to $3.24, and non-GAAP earnings per diluted share of $4.00 to $4.20. The company expects Core Illumina revenue growth in the range of 13% to 15%. GRAIL revenue is expected to be in the range of $70 million to $90 million.

Conference call information

The conference call will begin at 2 p.m. Pacific Time (5 p.m. Eastern Time) on Thursday, February 10, 2022. Interested parties may access the live teleconference through the Investor Info section of Illumina's website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1.844.200.6205 or 1.929.526.1599 outside North America, both using conference ID 018314.

A replay of the conference call will be posted on Illumina's website after the event and will be available for at least 30 days following.

Statement regarding use of non-GAAP financial measures

The company reports non-GAAP results for diluted net income per share, net income, gross margins, operating expenses, including research and development expenses and selling general and administrative expenses, operating income (loss), operating margins, gross profit, other income (expense), and free cash flow (on a consolidated and, as applicable, segment basis for our Core Illumina and GRAIL segments) in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company's financial measures under GAAP include substantial charges such as amortization of acquired intangible assets, non-cash interest expense associated with the company's convertible debt instruments that may be settled in cash, and others that are listed in the itemized reconciliations between GAAP and non-GAAP financial measures included in this press release. Management has excluded the effects of these items in non-GAAP measures to assist investors in analyzing and assessing past and future operating performance, including in the non-GAAP measures relating to our Core Illumina and GRAIL segments. Additionally, non-GAAP net income and diluted earnings per share are key components of the financial metrics utilized by the company's board of directors to measure, in part, management's performance and determine significant elements of management's compensation.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

Use of forward-looking statements

This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) the impact to our business and operating results of the COVID-19 pandemic; (ii) changes in the rate of growth in the markets we serve; (iii) the volume, timing and mix of customer orders among our products and services; (iv) our ability to adjust our operating expenses to align with our revenue expectations; (v) our ability to manufacture robust instrumentation and consumables; (vi) the success of products and services competitive with our own; (vii) challenges inherent in developing, manufacturing, and launching new products and services, including expanding or modifying manufacturing operations and reliance on third-party suppliers for critical components; (viii) the impact of recently launched or pre-announced products and services on existing products and services; (ix) our ability to further develop and commercialize our instruments, consumables, and products, including Galleri, the cancer screening test developed by GRAIL, to deploy new products, services, and applications, and to expand the markets for our technology platforms; (x) the risks and costs associated with the integration of, and our ability to integrate, GRAIL's business successfully to achieve anticipated synergies, including the restrictions on integration during any hold separate period or any delay in integration following any hold separate period; (xi) the risk that disruptions from the consummation of our recent acquisition of GRAIL or any associated legal or regulatory proceedings or obligations will harm our business, including current plans and operations; (xii) potential adverse reactions or changes to business relationships resulting from the consummation of our recent acquisition of GRAIL; (xiii) our ability to obtain approval by third-party payors to reimburse patients for our products; (xiv) our ability to obtain regulatory clearance for our products from government agencies; (xv) our ability to successfully partner with other companies and organizations to develop new products, expand markets, and grow our business; (xvi) our ability to successfully identify and integrate acquired technologies, products, or businesses; (xvii) the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments and (xviii) legislative, regulatory and economic developments, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit www.illumina.com and connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube.

About GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a wholly-owned subsidiary of Illumina, which is currently being held and operated separately in order to comply with the interim measures order imposed by the European Commission during the pendency of its ongoing merger review. For more information, please visit www.grail.com.

Investors:
Salli Schwartz
+1.858.291.6421
ir@illumina.com

Media:
Sarah Shew
+1.330.353.2512
sshew@illumina.com



Illumina, Inc.

Condensed Consolidated Balance Sheets

(In millions)



January 2,


January 3,


2022


2021

ASSETS

(unaudited)



Current assets:




Cash and cash equivalents

$ 1,232


$ 1,810

Short-term investments

107


1,662

Accounts receivable, net

648


487

Inventory

431


372

Prepaid expenses and other current assets

295


152

Total current assets

2,713


4,483

Property and equipment, net

1,024


922

Operating lease right-of-use assets

672


532

Goodwill

7,113


897

Intangible assets, net

3,250


142

Other assets

445


609

Total assets

$ 15,217


$ 7,585





LIABILITIES AND STOCKHOLDERS' EQUITY




Current liabilities:




Accounts payable

$ 332


$ 192

Accrued liabilities

761


541

Convertible senior notes, current portion


511

Total current liabilities

1,093


1,244

Operating lease liabilities

774


671

Term notes

993


Convertible senior notes

702


673

Other long-term liabilities

915


303

Stockholders' equity

10,740


4,694

Total liabilities and stockholders' equity

$ 15,217


$ 7,585




Illumina, Inc.

Condensed Consolidated Statements of Income

(In millions, except per share amounts)

(unaudited)



Three Months Ended


Year Ended


January 2,

2022


January 3,

2021


January 2,

2022


January 3,

2021

Revenue:








Product revenue

$ 1,065


$ 831


$ 3,968


$ 2,735

Service and other revenue

133


122


558


504

Total revenue

1,198


953


4,526


3,239

Cost of revenue:








Cost of product revenue (a)

277


254


1,060


788

Cost of service and other revenue (a)

64


62


241


220

Amortization of acquired intangible assets

40


7


71


28

Total cost of revenue

381


323


1,372


1,036

Gross profit

817


630


3,154


2,203

Operating expense:








Research and development (a)

350


200


1,185


682

Selling, general and administrative (a)

426


298


2,092


941

Total operating expense

776


498


3,277


1,623

Income (loss) from operations

41


132


(123)


580

Other income, net

45


166


1,007


276

Income before income taxes

86


298


884


856

(Benefit) provision for income taxes

(26)


41


122


200

Net income

$ 112


$ 257


$ 762


$ 656

Earnings per share:








Basic

$ 0.72


$ 1.76


$ 5.07


$ 4.48

Diluted

$ 0.71


$ 1.75


$ 5.04


$ 4.45

Shares used in computing earnings per common share:








Basic

157


146


150


147

Diluted

157


147


151


148


(a) Includes stock-based compensation expense for stock-based awards:




Three Months Ended


Year Ended


January 2,

2022


January 3,

2021


January 2,

2022


January 3,

2021

Cost of product revenue

$ 1


$ 8


$ 23


$ 21

Cost of service and other revenue

1


1


4


4

Research and development

33


26


276


74

Selling, general and administrative

62


44


638


95

Stock-based compensation expense before taxes

$ 97


$ 79


$ 941


$ 194




Illumina, Inc.

Condensed Consolidated Statements of Cash Flows

(In millions)

(unaudited)



Three Months Ended


Year Ended


January 2,

2022


January 3,

2021


January 2,

2022


January 3,

2021

Net cash provided by operating activities

$ 282


$ 406


$ 545


$ 1,080

Net cash used in investing activities


(33)


(1,069)


(554)

Net cash used in financing activities

(129)


(331)


(51)


(766)

Effect of exchange rate changes on cash and cash equivalents

(1)


7


(3)


8

Net increase (decrease) in cash and cash equivalents

152


49


(578)


(232)

Cash and cash equivalents, beginning of period

1,080


1,761


1,810


2,042

Cash and cash equivalents, end of period

$ 1,232


$ 1,810


$ 1,232


$ 1,810









Calculation of free cash flow:








Net cash provided by operating activities

$ 282


$ 406


$ 545


$ 1,080

Purchases of property and equipment

(70)


(62)


(208)


(189)

Free cash flow (a)

$ 212


$ 344


$ 337


$ 891


(a) Free cash flow, which is a non-GAAP financial measure, is calculated as net cash provided by operating activities reduced by purchases of property and equipment. Free cash flow is useful to management as it is one of the metrics used to evaluate our performance and to compare us with other companies in our industry. However, our calculation of free cash flow may not be comparable to similar measures used by other companies.




Illumina, Inc.

Results of Operations - Non-GAAP

(In millions, except per share amounts)

(unaudited)


CONSOLIDATED RECONCILIATION BETWEEN GAAP AND NON-GAAP EARNINGS PER SHARE:



Three Months Ended


Year Ended


January 2,

2022


January 3,

2021


January 2,

2022


January 3,

2021

GAAP earnings per share - diluted

$ 0.71


$ 1.75


$ 5.04


$ 4.45

Cost of revenue (b)

0.25


0.05


0.47


0.21

Research and development costs (b)



1.30


0.01

Selling, general and administrative costs (b)

0.41


0.40


6.30


0.98

Other income, net (b)

(0.34)


(0.99)


(6.78)


(1.60)

Incremental non-GAAP tax expense (c)

(0.23)


0.07


(0.31)


0.02

Income tax benefit (d)

(0.05)


(0.06)


(0.12)


(0.18)

Tax expense related to increase in valuation allowance (e)




0.42

Tax expense related to cost-sharing arrangement (f)




0.19

Non-GAAP earnings per share - diluted (a)

$ 0.75


$ 1.22


$ 5.90


$ 4.50



CONSOLIDATED RECONCILIATION BETWEEN GAAP AND NON-GAAP NET INCOME:



Three Months Ended


Year Ended


January 2,

2022


January 3,

2021


January 2,

2022


January 3,

2021

GAAP net income

$ 112


$ 257


$ 762


$ 656

Cost of revenue (b)

40


8


71


32

Research and development costs (b)



196


1

Selling, general and administrative costs (b)

65


59


952


145

Other income, net (b)

(53)


(146)


(1,024)


(236)

Incremental non-GAAP tax expense (c)

(38)


10


(47)


3

Income tax benefit (d)

(9)


(9)


(18)


(27)

Tax expense related to increase in valuation allowance (e)




62

Tax expense related to cost-sharing arrangement (f)




28

Non-GAAP net income (a)

$ 117


$ 179


$ 892


$ 664


All amounts in tables are rounded to the nearest millions, except as otherwise noted. As a result, certain amounts may not recalculate using the rounded amounts provided.


(a) Non-GAAP net income and diluted earnings per share exclude the effect of the pro forma adjustments as detailed above. Non-GAAP net income and diluted earnings per share are key components of the financial metrics utilized by the company's board of directors to measure, in part, management's performance and determine significant elements of management's compensation. Management has excluded the effects of these items in these measures to assist investors in analyzing and assessing our past and future operating performance.

(b) Refer to our Itemized Reconciliations between GAAP and Non-GAAP Results of Operations below for the components of these amounts.

(c) Incremental non-GAAP tax expense reflects the tax impact of the non-GAAP adjustments listed.

(d) Amounts represent tax deductions taken in excess of stock-based compensation cost.

(e) Amounts represent discrete tax expense related to the valuation allowance established in 2020 against the deferred tax asset for California research and development credits.

(f) Amounts represent discrete tax expense related to the finalization of the Altera court case in 2020 which determined stock-based compensation must be included in intercompany cost sharing payments.




Illumina, Inc.

Results of Operations - Non-GAAP (continued)

(Dollars in millions)

(unaudited)


CONSOLIDATED ITEMIZED RECONCILIATION BETWEEN GAAP AND NON-GAAP RESULTS OF OPERATIONS AS A PERCENT OF REVENUE:



Three Months Ended


Year Ended


January 2,
2022


...