On July 29, 2019 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the second quarter of fiscal year 2019 (Press release, Illumina, JUL 29, 2019, View Source [SID1234537843]).

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Second quarter 2019 results:

•Revenue of $838 million, a 1% increase compared to $830 million in the second quarter of 2018
•GAAP net income attributable to Illumina stockholders for the quarter of $296 million, or $1.99 per diluted share, compared to $209 million, or $1.41 per diluted share, for the second quarter of 2018
•Non-GAAP net income attributable to Illumina stockholders for the quarter of $200 million, or $1.35 per diluted share, compared to $212 million, or $1.43 per diluted share, for the second quarter of 2018. Non-GAAP net income excludes a $92 million unrealized gain from a strategic investment that completed an initial public offering (see the table entitled "Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)
•Cash flow from operations of $143 million compared to $295 million in the second quarter of 2018. Cash flow from operations for the second quarter of 2019 included an $84 million payment of the accreted debt discount related to the conversion of our 2019 Notes
•Free cash flow (cash flow from operations less capital expenditures) of $96 million for the quarter compared to $218 million in the second quarter of 2018. Free cash flow for the second quarter of 2019 included the convertible notes payment, referenced above

Gross margin in the second quarter of 2019 was 68.4% compared to 69.3% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 69.5% for the second quarter of 2019 compared to 70.3% in the prior year period.

Research and development (R&D) expenses for the second quarter of 2019 were $166 million compared to $151 million in the prior year period. R&D expenses as a percentage of revenue were 19.8% compared to 18.2% in the prior year period.

Selling, general and administrative (SG&A) expenses for the second quarter of 2019 were $202 million compared to $197 million in the prior year period. Excluding acquisition-related expenses, non-GAAP SG&A expenses as a percentage of revenue were 23.1% compared to 23.7% in the prior year period.

Depreciation and amortization expenses were $49 million and capital expenditures for free cash flow purposes were $47 million during the second quarter of 2019. At the close of the quarter, the company held $3.2 billion in cash, cash equivalents and short-term investments, compared to $3.5 billion as of December 30, 2018.

"While our second quarter results clearly fell short of our expectations, we remain committed to leading innovation in genomics, and to enabling our global community of 6,300 customers who unlock more of the human genome each day in an effort to improve human health and, in many cases, save lives," said Francis deSouza, President and CEO. "In addition to continued sequencing consumables growth, we are encouraged by the sequential and year-over-year growth in shipments across our high, mid, and low-throughput sequencing system portfolio, including a record number of NextSeq Dx systems, reflecting the growing clinical opportunity."

Updates since our last earnings release:

•Launched Veriseq NIPT v2, enabling a genome-wide screen which almost doubles the detection of chromosomal abnormalities
•Partnered with AnchorDx, a molecular diagnostics company, to develop clinical oncology products for the Chinese market
•Expanded Illumina Accelerator to Cambridge, UK, further catalyzing the rapidly growing genomics industry in Europe and surrounding markets
•Repaid $632 million of 2019 Convertible Notes that matured on June 15, 2019, leaving $1.3 billion of convertible debt outstanding due in 2021 and 2023

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. 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 2019, the company expects year over year revenue growth of approximately 6%, and now expects GAAP earnings per diluted share attributable to Illumina stockholders of $6.41 to $6.51 and non-GAAP earnings per diluted share attributable to Illumina stockholders of $6.00 to $6.10.

Except for acquisition-related expenses incurred during the first half of 2019 which are reflected in our GAAP guidance, this guidance excludes any impact from the pending acquisition of Pacific Biosciences, which we now expect to close in Q4 2019.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Monday, July 29, 2019. 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) 647-5490, or 1 (615) 247-0295 outside North America, both with conference ID 3469888.
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.

On July 29, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $199.9 million and screened approximately 415,000 people with Cologuard during the quarter ended June 30, 2019 (Press release, Exact Sciences, JUL 29, 2019, View Source [SID1234537842]). Second-quarter 2019 revenue and test volume grew 94 percent and 93 percent, respectively, from the same period of 2018.

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"The Exact Sciences team delivered another strong quarter, bringing us closer to our goal of capturing at least 40-percent share of the U.S. colorectal cancer screening market with Cologuard, from about 6 percent today," said Kevin Conroy, chairman and CEO of Exact Sciences. "The foundation we’ve built with our team, infrastructure, and commercial scale positions Exact Sciences well for continued growth."

Second-Quarter 2019 Financial Results

For the three-month period ended June 30, 2019, as compared to the same period of 2018 (where applicable):

Revenue was $199.9 million, an increase of 94 percent, and test volume was 415,000, an increase of 93 percent
Average Cologuard recognized revenue per test was unchanged at $479
Average Cologuard cost per test was $123, an improvement of $2 per test
Gross margin was 74 percent, an increase of 30 basis points
Operating expenses were $182.1 million, an increase of 68 percent
Net loss was $38.4 million, or $0.30 per share, compared to $36.4 million, or $0.30 per share
Non-cash interest expense related to convertible debt was $19.8 million, or $0.16 per share
Cash utilization was $43.3 million, compared to $45.3 million
Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter
More than 13,000 healthcare providers ordered their first Cologuard test during the second quarter, and nearly 174,000 have ordered since the test was launched
2019 Outlook

The company anticipates revenue of $800-$810 million during 2019, an increase from prior guidance of $725-$740 million. The company’s updated guidance does not include the impact of the pending combination with Genomic Health.
The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Forward-Looking Statements" section of this news release.

Second-Quarter and Genomic Health Combination Conference Call & Webcast

In light of the combination with Genomic Health announced separately today, Exact Sciences will not hold its previously announced earnings conference call that had been scheduled for July 30, 2019. The two companies will host a joint conference call today at 8:00 a.m. ET to discuss the transaction as well as each companies’ second-quarter 2019 financial results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 8288326. The webcast, conference call, and replay are open to all interested parties.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals, including those with a history of colorectal cancer and advanced adenoma, a family history of colorectal cancer, IBD or certain hereditary syndromes. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On July 29, 2019 Exact Sciences Corp. (NASDAQ: EXAS) and Genomic Health, Inc. (NASDAQ: GHDX) reported that the companies have entered into a definitive agreement under which Exact Sciences will combine with Genomic Health for $72.00 per share in a cash and stock transaction valued at $2.8 billion (Press release, Exact Sciences, JUL 29, 2019, View Source [SID1234537841]). The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to be completed by the end of 2019.

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Together, Exact Sciences and Genomic Health will create a leading global cancer diagnostics company. The combined company will offer two of the strongest and fastest growing brands in cancer diagnostics, Cologuard and Oncotype DX, providing a robust platform for continued growth. With this enhanced platform, including a commercial presence in more than 90 countries, the combined company expects to continue to increase adoption of current tests, and to bring new innovative cancer diagnostics to patients throughout the world.

On a pro forma basis, the combined company expects to generate revenue of approximately $1.6 billion and gross profit of approximately $1.2 billion in 2020. Additionally, the combination is expected to generate annualized cost synergies of approximately $25 million within the third full year following close, primarily through reducing public company costs and purchasing optimization.

"Uniting the best minds and molecular diagnostics capabilities will advance the fight against cancer. Combining industry pioneers Exact Sciences and Genomic Health is a pivotal step toward building the leading cancer diagnostics company in the world," said Kevin Conroy, chairman and CEO of Exact Sciences. "Exact Sciences is continuing to grow sales and expand adoption of Cologuard at a rapid pace, and Genomic Health’s Oncotype DX is the global standard of care to inform treatment decisions for women with breast cancer. Together, with our collective resources and broader platform, we will be able to provide our existing tests to more people, while also accelerating the development and launch of future cancer diagnostic tests. We are excited to join together two teams who are united in their dedication to making a positive impact on patients’ lives."

"We are very pleased to join forces with Exact Sciences, a company and team with which we have a shared vision to revolutionize the way cancer is diagnosed and treated," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "Genomic Health has achieved incredible success over nearly two decades in pioneering cancer diagnostics, and the recent landmark TAILORx trial results set a new standard of care for the use of the Oncotype DX test for women with early-stage invasive breast cancer. This transaction provides immediate value to Genomic Health stockholders through an upfront cash payment, as well as ownership in a combined company with enhanced financial strength and the commercial and R&D capabilities to continue to drive significant growth into the future."

Combining Talented Teams with Proven Capabilities to Create a Leading Cancer Diagnostics Company

Joins two of the strongest brands in cancer diagnostics into one entity and provides platform for continued growth: Cologuard and Oncotype DX, the companies’ leading brands, will respectively continue to help detect colorectal cancer and inform treatment decisions in colorectal, breast and prostate cancer, which collectively represent approximately 40% of all solid tumor incidence.

Exact Sciences’ Cologuard has a total available U.S. screening market of $15 billion, with an additional potential $3 billion opportunity among people ages 45-491. To date, Cologuard has captured less than 6% of the large addressable market of people over 50 years old, and is rapidly building on its 174,000 health care provider customer base, with a goal of reaching 40% share of the market over the long-term. In the second quarter of 2019, Cologuard revenue grew 94% year-over-year.

Genomic Health’s Oncotype IQ portfolio has guided personalized treatment decisions for more than one million cancer patients worldwide, and delivered more than 19% year-over-year overall revenue growth in the second quarter of 2019. Genomic Health estimates that its Oncotype DX suite of products in oncology and urology have a total available market of $2 billion.

Forms best-in-class commercial, R&D and clinical organization, with enhanced scale and scope in cancer diagnostics: The transaction will create a combined R&D team with extensive clinical capabilities and a robust evidence generation engine, complemented by proven regulatory expertise, and key relationships with oncologists. The combined commercial organization will have more than 1,000 team members inclusive of sales, marketing and reimbursement teams. The combined company will have the financial strength to support a high level of investment in R&D. This will support the development of innovative products across the diagnostic paradigm, including the ongoing work to identify proprietary biomarkers across the world’s 15 deadliest cancers, while continuing to advance the adoption of current products.

Provides global infrastructure to accelerate the ability to provide new innovative cancer diagnostics to patients: The combined company will have a commercial presence in more than 90 countries and expanded reach across primary care, oncology, OB/GYN, gastroenterology, and urology to support growth of existing and future cancer tests. The combined company will build upon Genomic Health’s presence in the San Francisco Bay Area, providing lab infrastructure in a state where the Medicare Administrative Contractor participates in the MolDx program, which may facilitate reimbursement of future liquid biopsy products.
Transaction Terms

Under the terms of the agreement, for each share of Genomic Health common stock they own, Genomic Health stockholders will receive $27.50 in cash and $44.50 in shares of Exact Sciences stock, subject to a 10% collar centered on Exact Sciences’ volume-weighted average price for the 45 trading days ended July 26, 2019.

Based on the parties’ closing stock prices as of July 26, 2019, the last trading day prior to today’s announcement, the total per-share consideration represents a premium of approximately 19% to Genomic Health’s volume-weighted average price ("VWAP") for the last 30 trading days. Upon closing, Exact Sciences shareholders are expected to own approximately 91% of the combined company, and Genomic Health stockholders are expected to own approximately 9%.

Transaction Approvals

The transaction is subject to customary closing conditions and regulatory approvals, including the approval of stockholders of Genomic Health. Felix and Julian Baker and certain funds advised by entities with whom they are affiliated, which collectively own approximately 25.3% of the outstanding shares of Genomic Health common stock, have entered into agreements to vote in favor of the transaction.

Advisors

Centerview Partners and XMS Capital Partners are serving as financial advisors to Exact Sciences and Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor. Goldman Sachs & Co. LLC is serving as financial advisor to Genomic Health and Sullivan & Cromwell LLP and Pillsbury Winthrop Shaw Pittman LLP are serving as legal advisors.

Conference Call Information and Transaction Website

Associated presentation materials and an infographic regarding the transaction will be available on the investor relations section of each company’s website at View Source and View Source as well as a joint transaction website at www.leadingcancerdiagnostics.com.

The two companies will host a joint conference call today at 8:00 a.m. ET to discuss this transaction. The call will include a slide presentation and participants are encouraged to view the presentation via webcast at View Source

Date:

Monday, July 29, 2019

Time:

8 a.m. ET, 7 a.m. CT, 5 a.m. PT

Webcast:

The live webcast can be accessed at www.exactsciences.com and
www.genomichealth.com

Domestic callers, dial 877-201-0168

International callers, dial +1 647-788-4901

Access code for both domestic and international callers: 8288326

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay is 8288326. The webcast, conference call and replay are open to all interested parties.

Exact Sciences and Genomic Health Second Quarter 2019 Earnings Results

In separate news releases, Exact Sciences and Genomic Health today both announced their financial results for the second quarter of 2019, ended June 30, 2019. Exact Sciences and Genomic Health will address any questions regarding their earnings on the joint transaction call at 8 a.m. ET. Exact Sciences and Genomic Health have cancelled their previously scheduled earnings calls on July 30, 2019, and August 1, 2019, respectively.

On July 29, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that the European Commission (EC) has granted unconditional approval of Bristol-Myers Squibb’s pending acquisition of Celgene Corporation (NASDAQ:CELG) (Press release, Bristol-Myers Squibb, JUL 29, 2019, View Source [SID1234537840]).

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"Clearance from the European Commission is an important milestone toward completing our combination with Celgene and moves us one step closer to creating a leading biopharma company that is well positioned to develop and deliver innovative, meaningful medicines to patients," said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb.

The transaction remains subject to additional customary closing conditions and other regulatory approvals. Bristol-Myers Squibb intends to close the Celgene transaction at the earliest possible date, which it currently expects to be by the end of 2019 or the beginning of 2020.

On July 29, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system to fight cancer, reported that the VA North Texas Health Care System and its non-profit affiliate, the Dallas VA Research Corporation, have joined Anixa’s ongoing prostate cancer Cchek study (Press release, Anixa Biosciences, JUL 29, 2019, View Source [SID1234537839]). Study enrollment will be led by Dr. Manoj Reddy, Radiation Oncologist, and Dr. Jeffrey Gahan, Chief of Robotic Surgery.

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"We are pleased to see the continued expansion in Cchek collaboration partners to now include the VA North Texas Health Care System. We look forward to working with Dr. Reddy and Dr. Gahan as we further the development of our artificial intelligence based prostate cancer diagnostic test," stated Dr. Amit Kumar, CEO of Anixa.