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INFORMATION STATEMENT
Menlo Park, California 94025
We are sending you this Information Statement in connection with Illumina, Inc. s partial spin-off
of its wholly owned subsidiary, GRAIL, LLC, or GRAIL. GRAIL must be held and operated separately and independently from Illumina pursuant to the transitional measures ordered by the European Commission, following the prohibition of
Illumina s acquisition of GRAIL on September 6, 2022. Immediately prior to the completion of the spin-off, GRAIL will be converted into a Delaware corporation and will be renamed GRAIL, Inc. To effect the
spin-off, Illumina, Inc., or Illumina, will distribute at least 85.5% of the shares of GRAIL s common stock owned by Illumina as of the close of business on June 13, 2024, which is the
record date for the distribution, on a pro rata basis to the holders of Illumina common stock. Immediately after the distribution becomes effective, Illumina may retain up to 14.5% of GRAIL s common stock.
We intend that the distribution of GRAIL common stock will be tax-free to Illumina stockholders for
U.S. federal income tax purposes, except for cash that stockholders receive in lieu of fractional shares and subject to the discussion below under The Spin-Off Material U.S. Federal Income Tax
Consequences of the Spin-Off Consequences to Holders of Illumina Common Stock. You should consult your own tax advisor as to the tax consequences of the distribution to you, including potential
tax consequences under state, local and non-U.S. tax laws.
If you are a record holder of Illumina
common stock as of the record date, for every six shares of Illumina common stock you hold on that date, you will be entitled to receive one share of GRAIL common stock. Illumina will distribute the shares of GRAIL common stock in book-entry form,
which means that we will not issue physical stock certificates. The distribution agent will not distribute any fractional shares of GRAIL common stock. Instead, the distribution agent will aggregate fractional shares into whole shares, sell the
whole shares in the open market at prevailing market prices and distribute the aggregate cash proceeds of the sales, net of brokerage fees and other costs, pro rata to each holder (net of any required withholding for taxes applicable to each holder)
who would otherwise have been entitled to receive a fractional share in the distribution. As discussed in the section entitled The Spin-Off Trading Prior to the Distribution Date beginning on
page 113 of this Information Statement, if you sell your Illumina common stock in the regular-way market after the record date and on or before the distribution date, you also will be selling
your right to receive shares of GRAIL common stock in connection with the distribution.
We expect that the distribution will be effective
as of 12:01 a.m., New York City time, on June 24, 2024. Immediately after the distribution becomes effective, GRAIL will be an independent, publicly traded company.
Illumina s stockholders are not required to vote on or take any other action in connection with the
spin-off. We are not asking you for a proxy, and request that you do not send us a proxy. Illumina s stockholders will not be required to pay any consideration for the shares of GRAIL common stock
they receive in the spin-off, and they will not be required to surrender or exchange their common stock of Illumina or take any other action in connection with the
Illumina currently owns all outstanding shares of GRAIL common stock. Accordingly, no
public trading market for GRAIL common stock currently exists. We expect, however, that a limited trading market for GRAIL common stock, commonly known as a when-issued trading market, will develop on or shortly before the record date
for the distribution, and we expect regular-way trading of GRAIL common stock will begin on the first trading day after the distribution date. We intend to list the GRAIL common stock on the Nasdaq
Global Select Market under the ticker symbol GRAL. Following the distribution, Illumina will continue to trade on the Nasdaq Global Select Market under the ticker symbol ILMN.
We are an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012.
In reviewing this Information Statement, you should carefully consider the matters described in the section entitled Risk
Factors beginning on page 31 of this Information Statement.
Neither the Securities and Exchange Commission nor any
state securities commission has approved or disapproved these securities or determined if this Information Statement is truthful or complete. Any representation to the contrary is a criminal offense.
This Information Statement is not an offer to sell, or a solicitation of an offer to buy, any securities.
The date of this Information Statement is June 3, 2024.
This Information Statement will be made publicly available on or about June 3, 2024. Notice of this Information Statement s
availability will be first sent to Illumina stockholders on or about June 3, 2024.
| Page | ||||
| INDUSTRY AND MARKET DATA | 1 | |||
| TRADEMARKS AND COPYRIGHTS | 1 | |||
| BASIS OF FINANCIAL PRESENTATION | 1 | |||
| SUMMARY | 2 | |||
| RISK FACTORS | 31 | |||
| CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS | 101 | |||
| THE SPIN-OFF | 102 | |||
| DIVIDEND POLICY | 115 | |||
| CAPITALIZATION | 116 | |||
| SELECTED HISTORICAL FINANCIAL DATA | 117 | |||
| UNAUDITED PRO FORMA CONDENSED CONSOLIDATED FINANCIAL STATEMENTS | 119 | |||
| BUSINESS | 125 | |||
| MANAGEMENT S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 186 | |||
| MANAGEMENT | 213 | |||
| EXECUTIVE COMPENSATION | 219 | |||
| SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT | 231 | |||
| CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS | 233 | |||
| DESCRIPTION OF OUR CAPITAL STOCK | 238 | |||
| WHERE YOU CAN FIND MORE INFORMATION | 244 | |||
| INDEX TO CONSOLIDATED FINANCIAL STATEMENTS | F-1 |
INDUSTRY AND MARKET DATA
Unless otherwise indicated, information contained in this Information Statement concerning our industry and the markets in which we operate,
including our general expectations and market position, market opportunity, and market size, is based on information from various sources on assumptions that we have made that are based on such information and other, similar sources and on our
knowledge of, and expectations about, the markets for our products. This information involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. While we believe the market position, market
opportunity, and market size information included in this Information Statement is generally reliable, such information is inherently imprecise. In addition, projections, assumptions, and estimates of our future performance and the future
performance of the industry in which we operate is necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section entitled Risk Factors and elsewhere in this Information
Statement. These and other factors could cause results to differ materially from those expressed in the estimates made by independent third parties and by us.
TRADEMARKS AND COPYRIGHTS
GRAIL, the GRAIL logos, Galleri and other trade names, trademarks or service marks of GRAIL appearing in this
Information Statement are the property of GRAIL. GRAIL also owns or has the rights to copyrights that protect the content of its products. Other trade names, trademarks, service marks or copyrights appearing in this Information Statement are the
property of their respective holders. Solely for convenience, trade names, trademarks, service marks, and copyrights referred to in this Information Statement appear without the , , SM, and symbols, but those references are not intended to indicate, in any way,
that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trade names, trademarks, service marks, and copyrights.
BASIS OF FINANCIAL PRESENTATION
Illumina acquired the common stock of GRAIL that it did not own and completed its acquisition of GRAIL on August 18, 2021. Our
consolidated balance sheets as of December 31, 2023 and January 1, 2023, and our consolidated statements of operations, comprehensive loss, and cash flows for the period from January 2, 2022 to January 1, 2023, the period from January 2, 2023 to
December 31, 2023, and the period from August 19, 2021 to January 2, 2022 (the Successor ) reflect the new basis of accounting established in connection with the acquisition of GRAIL on August 18, 2021 and for the period from January
1, 2021 to August 18, 2021 (the Predecessor ) reflect the predecessor activity of GRAIL prior to the acquisition. A black line distinguishes the periods before and after the acquisition of GRAIL because these periods are not
Prior to the acquisition, we had a fiscal year end of December 31, which we will revert back to upon the closing of the
Spin-Off. Illumina, and, by proxy, us following the acquisition and prior to the Spin-Off, use a 52-53 week fiscal year-end calendar that ends on the Sunday closest to the quarter-end, so the exact year-end
date may change from year to year. In this Information Statement when we discuss our financial results:
The Company s fiscal year is the 52 or 53 weeks ending the Sunday closest to December 31, with quarters of 13 or 14 weeks ending the
Sunday closest to March 31, June 30, September 30, and December 31. References to Q1 2024 and Q1 2023 refer to the three months ended March 31, 2024 and April 2, 2023, respectively, which were both 13 weeks.
This summary highlights selected information from this Information Statement and provides an overview of our company, our separation from
Illumina and Illumina s distribution of our common stock to its stockholders. For a more complete understanding of our business and the spin-off, you should read the entire Information Statement
carefully, particularly the discussion of Risk Factors and Management s Discussion and Analysis of Financial Condition and Results of Operations beginning on pages 31 and 186, respectively, of this Information
Statement, and our historical consolidated financial statements and the notes to those financial statements appearing elsewhere in this Information Statement.
In this Information Statement, unless the context otherwise requires:
Our mission is to detect cancer early, when it can be cured.
We are an innovative commercial-stage healthcare company focused on saving lives and shifting the paradigm in early cancer detection. We
believe screening individuals for many types of cancer with a single test represents a significant opportunity to reduce the global burden of cancer. Our Galleri test is a commercially available screening test for early detection of multiple types
of cancer, which we termed multi-cancer early detection ( MCED ). We believe Galleri is clinically validated based on the results of its clinical studies completed to date, including the results of its foundational case-control Circulating
Cell-free Genome Atlas ( CCGA ) study and interventional PATHFINDER study, which together enrolled more than 21,000 participants. In these studies, Galleri demonstrated an ability to detect a shared cancer signal across more than 50 types
of cancer, accurately predict the specific organ or tissue type where the cancer signal originated, and yield high positive predictive values and low false positive rates, all from a simple blood draw. See Business Our Products: Galleri
and Beyond and Our Clinical Studies. Galleri results can help guide next steps for a diagnosis of cancer by healthcare providers in required follow-up diagnostic testing. Galleri is not a diagnostic test and has not been
approved or cleared by the U.S. Food and Drug Administration (the FDA ). We launched Galleri in the United States in mid-2021. As of March 31, 2024, we have sold more than 180,000 commercial
tests and established over 100 commercial partnerships, including leading healthcare systems, employers, payors, and life insurance providers. Commercial use of Galleri has detected some of the most aggressive cancers in early stages including,
among others, endometrial, esophageal, gastrointestinal stromal, head and neck, liver, pancreatic, and rectal cancers.
public health crisis. It is the second leading cause of death both in the United States and worldwide. Most cancers that result in death are diagnosed too late, in advanced stages when they are most challenging to treat. We estimate that more than
60% of cancer deaths result from cancers that have no recommended screening guidelines. In the United States, we consider standard of care screening for cancer to consist of the grade A and B recommendations published by the United States Preventive
( USPSTF ), which currently recommend broad population screening for only four types of cancer using single-cancer screening tests (breast, cervical, colorectal, and lung cancer), and
prostate cancer screening, which is USPSTF grade C and is widely implemented in the United States. Grade A and B recommendations are services that USPSTF most highly recommends for preventative care and that have a high or moderate net benefit for
patients. Grade C recommendations are services that USPSTF recommends selectively offering or providing to patients based on individual circumstances and that have a moderate certainty of a small net benefit for patients. According to data in the
American Cancer Society s Cancer Facts & Figures 2024, cancers for which there are grade A and B recommendations published by the USPSTF (breast, cervical, colorectal, and lung cancer) are expected to result in approximately 225,000
deaths out of approximately 612,000 cancer-related deaths in the United States in 2024, and prostate cancer is expected to resulted in approximately 35,000 additional deaths. We believe that expanding upon these current guidelines to screen
individuals for many types of cancer with a single test represents a significant opportunity to reduce cancer mortality and the cost of cancer care. In 2021, we published modeling data in Cancer Epidemiology, Biomarkers & Prevention
(Cancer Epidemiol Biomarkers Prev. 2021; 30:460 8) that estimated the potential impact of MCED testing on mortality reduction based on test performance in our CCGA-2 study and using 2006 to 2015 data from the Surveillance, Epidemiology, and End
Results Program of the U.S. National Cancer Institute ( SEER ) for ages 50-79. Based on this model, we estimate that by adding Galleri to the five standard of care single-cancer screening tests (breast, cervical, colorectal, lung cancer,
and prostate), there is potential to detect many more cancers at an earlier stage, which could translate into the potential to avert approximately 100,000 deaths per year in the United States as measured by five-year survival. We believe this model
provides helpful context regarding the potential benefits of screening for multiple cancers at once with a singular screening test, like Galleri, in addition to the five standard of care single-cancer screening tests; however, there can be no
assurance when or even if Galleri will be added to the USPSTF guidelines or standard of care screening. In addition, an analysis published in Data (Data. 2017; 2(30):2 16) estimated that diagnosing cancer early could result in
$26 billion in annual cost-savings in the United States.
We designed Galleri to detect cancer early. If cancer is detected early, it
is more amenable to curative treatment. According to the American Cancer Society, the ability to cure cancer depends on the type and stage of cancer, the type of treatment the patient receives, and other factors. While there is not one cure for
cancer and not all cancers may be cured, according to the World Health Organization many cancers can be cured if detected early and treated effectively and some of the most common cancer types, such as breast cancer, cervical cancer, oral cancer,
and colorectal cancer, have high cure probabilities when detected early and treated according to best practices. Galleri works by detecting DNA fragments shed into the bloodstream by tumor cells. In cancerous cells, methylation, a natural biological
process that determines which sections of DNA to turn on or off and that drives tissue differentiation, becomes abnormal. As a result, DNA from cancer has specific methylation patterns that can be used to both identify a general cancer signal and
localize that signal to a specific organ or tissue type. In our CCGA study, Galleri identified a shared cancer signal across more than 50 types of cancer, often at an early stage. If a cancer signal is detected, Galleri can accurately predict the
tissue type or organ associated with the cancer signal (the cancer signal origin). In our PATHFINDER study, Galleri correctly predicted the first or second cancer signal origins in 22 of 25 participants with a cancer diagnosis following a cancer
signal detected (positive) test result (i.e., participants with true positive test results), demonstrating a high cancer signal origin prediction accuracy of 88%. For additional information, see Business Our Products: Galleri and
Beyond and Our Clinical Studies. Galleri s screening test results can be used by healthcare providers to guide required follow-up diagnostic testing for a diagnosis of cancer.
As an early proponent of MCED testing, we have established strong relationships within the cancer and primary care community, including
through partnerships with academic and community medical centers, key opinion leaders, and governmental policy and advocacy partners. We have shared evidence supporting our MCED testing at renowned medical conferences, such as the American
Association of Cancer Research ( AACR ), American Society of Clinical Oncology ( ASCO ), European Society of Medical Oncology