On April 29, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will present at the 2021 Bank of America Healthcare Conference on Thursday, May 13, 2021 at 5:00 p.m. Eastern Time (Press release, Personalis, APR 29, 2021, View Source [SID1234578839]).

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On April 29, 2021 City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, reported that now recruiting patients for a Phase 2 clinical trial to investigate whether pills containing white button mushroom extract could regulate the immune system, affecting prostate-specific antigen (PSA) levels to either remain stable or decline (Press release, City of Hope, APR 29, 2021, View Source [SID1234578838]). Heightened levels of PSA in men may indicate the existence of prostate tumors.

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Shiuan Chen, Ph.D., the Lester M. and Irene C. Finkelstein Chair in Biology, has been investigating the potential beneficial effects of white button mushroom (Agaricus bisporus) at City of Hope for about 20 years. His translational preclinical and clinical research has found that this "bioactive food" available in most supermarkets might prevent or slow the spread of prostate and breast cancers. The common fungus appears to block the activity of dihydrotestosterone (DHT), a strong form of the male hormone.

"White button mushroom — like green tea, turmeric, soybean, rosemary and tomato — has been considered a ‘superfood’ with positive effects on human health," said Chen, co-investigator of the clinical trial. "What we’re trying to do is scientifically prove whether the hype is true. If white button mushroom can slow the progression of prostate cancer, we want to know what the active agent is and what biological mechanisms are at work."

City of Hope in Duarte, California, is leading the multisite Phase 2 clinical trial, which will also recruit patients at City of Hope community locations (South Pasadena, West Covina, Rancho Cucamonga) and at John Wayne Cancer Institute in Santa Monica. This National Cancer Institute-funded study will seek to recruit 132 male participants who have recurrent prostate cancer following local therapy or who are undergoing active surveillance and have not yet received any therapy.

"This trial may reveal a possible alternative to or may obviate or delay the need for local or salvage treatments for prostate cancer. These standard-of-care therapies may cause significant short-term and long-term side effects such as incontinence and erectile dysfunction, or weight gain, hot flashes and osteoporosis," said Clayton Lau, M.D., the Pauline & Martin Collins Family Chair in Urology and director of City of Hope’s Prostate Cancer Program. Lau is principal investigator of the trial.

Results from the Phase 1 white button mushroom trial indicated that white button mushroom extract is safe and potentially effective against prostate cancer. About 36% of study participants had some decline in PSA levels after three months of white button mushroom tablet intake, and no dose-limiting toxicities were observed. There were no negative side effects. Androgen deprivation therapy, on the other hand, is an approved therapy with side effects including fatigue, weight gain, muscle weakness, hot flashes, loss of libido, increased risk of diabetes and cardiovascular problems — all these side effects, yet androgen deprivation therapy is not curative.

White button mushroom consumption seemed to stimulate the immune system into action and limited the growth of prostate cancer cells. Upon further research in the laboratory, City of Hope scientists found that white button mushrooms contain chemicals that can block the activity of the androgen receptor in animal models, indicating this common fungus could reduce PSA levels. This research was recently published in The Journal of Nutritional Biochemistry.

The objective of the Phase 2 trial is to assess if recurrent prostate cancer patients experience any PSA reduction at three months. The experimental groups will consume 14 grams of the mushroom-powder tablet per day — roughly 2/3 of a container of white button mushrooms purchased from the supermarket. Tablets will be prepared from freeze-dried powder of white button mushrooms. Those in the control group (observation only) will be able to receive the mushroom tablet after three months.

In addition, for 12 months, the scientists will assess the relative change in PSA levels in men under active surveillance who have not received any localized prostate cancer treatment. Furthermore, scientists will look at biopsy material to identify what molecular changes are linked to intake of white button mushrooms.

On April 29, 2021 Illumina, Inc. (NASDAQ: ILMN) reported that it has filed an action in the General Court of the European Union asking for annulment of the European Commission’s decision asserting jurisdiction to review Illumina’s acquisition of GRAIL (Press release, Illumina, APR 29, 2021, View Source [SID1234578837]). The Commission asserted jurisdiction to review the acquisition under Article 22 of the EU Merger Regulation on April 19, 2021, seven months after the deal was announced.

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"The European Commission’s unprecedented and untimely decision to review this procompetitive acquisition without proper engagement with the parties leaves businesses uncertain as to how the EU Merger Regulation will be applied," said Charles Dadswell, Senior Vice President and General Counsel for Illumina. "The Commission’s actions will stifle innovation, fail patients and increase healthcare costs by needlessly delaying this transaction. The acquisition will allow Illumina to bring GRAIL’s lifesaving testing to more patients, more quickly and at a lower cost."

While the Court process is ongoing, Illumina will continue to work with the European Commission’s Directorate-General for Competition to bring the review to a conclusion as quickly as possible.

On April 29, 2021 Labcorp (NYSE: LH), a leading life sciences company, reported results for the first quarter ended March 31, 2021 and raised 2021 guidance (Press release, LabCorp, APR 29, 2021, View Source [SID1234578816]).

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"We delivered very strong results in the first quarter driven by revenue growth across both our Diagnostics and Drug Development businesses," said Adam H. Schechter, chairman and CEO, Labcorp. "Overall revenue in our base business grew 14.6% as people continued to return to their pre-pandemic healthcare routines and our biopharmaceutical clients resumed their important research and development. Our drug development pipeline remained robust, with a book-to-bill of 1.47 on a trailing twelve-month basis driven by strong demand across major therapeutic areas."

In the quarter, Labcorp continued to bring science and technology innovations to market quickly to improve health and improve lives. The company opened a fully automated kit production facility in Belgium to support its Central Lab customers, ultimately improving access and cost efficiency for biopharma and clinical trial clients across Europe, the Middle East and Africa. In the fight against COVID-19, Labcorp expanded its work with the CDC to identify variants to the virus, and now offers Pixel by Labcorp COVID-19 home collection kits in thousands of pharmacies across the United States.

"We are pleased with our strong first quarter performance and improved outlook, and are raising our full year adjusted EPS guidance range to between $20.00 and $24.00. I am proud of our more than 70,000 employees and their commitment to our patients and customers during this pandemic and the difference they are making in the lives of people around the world," said Schechter.

Consolidated Results

First Quarter Results
Revenue for the quarter was $4.16 billion, an increase of 47.4% over $2.82 billion in the first quarter of 2020. The increase in revenue was due to organic growth of 45.0%, acquisitions of 0.9%, and favorable foreign currency translation of 1.4%. The 45.0% increase in organic revenue includes a 32.9% contribution from PCR and antibody testing (COVID-19 Testing) and a 12.2% increase in the company’s organic Base Business. Base Business includes Labcorp’s business operations except for COVID-19 Testing.

Operating income for the quarter was $1,057.9 million, or 25.4% of revenue, compared to ($192.6) million, or (6.8%), in the first quarter of 2020. The increase in operating income and margin was primarily due to COVID-19 Testing, organic Base Business growth, acquisitions, and LaunchPad savings, partially offset by higher personnel costs. The company recorded amortization, restructuring charges, and special items, which together totaled $124.0 million in the quarter, compared to $558.5 million during the same period in 2020. This decrease was primarily due to the goodwill impairment recorded in the first quarter of 2020. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $1,181.9 million, or 28.4% of revenue, compared to $365.9 million, or 12.9%, in the first quarter of 2020.

Net earnings (losses) for the quarter were $769.6 million, compared to ($317.2) million in the first quarter of 2020. Diluted EPS were $7.82 in the quarter, up from ($3.27) in the same period in 2020. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $8.79 in the quarter, up from $2.37 in the first quarter of 2020.

Operating cash flow for the quarter was $1,157.6 million, compared to $203.8 million in the first quarter of 2020. The increase in operating cash flow was due to higher cash earnings and lower working capital. Capital expenditures totaled $95.4 million, down from $106.6 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $1,062.2 million, up from $97.2 million in the first quarter of 2020.

At the end of the quarter, the company’s cash balance and total debt were $1.9 billion and $5.4 billion, respectively. During the quarter, the company invested $34.1 million on acquisitions, repurchased $68.5 million of stock representing approximately 0.3 million shares, and paid down $375.0 million of debt. As of March 31, 2021, the company had $731.5 million of authorization remaining under its share repurchase program.
3

First Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics
Revenue for the quarter was $2.76 billion, an increase of 62.0% over $1.70 billion in the first quarter of 2020. The increase in revenue was primarily due to organic growth of 60.8%, acquisitions of 0.9%, and favorable foreign currency translation of 0.4%. The increase in organic revenue was due to a 54.5% contribution from COVID-19 Testing and a 6.3% increase in the Base Business, which includes the unfavorable impact of weather of approximately (2.0%).

Total volume (measured by requisitions) increased by 27.3% as organic volume increased by 26.6% and acquisition volume contributed 0.7%. The organic volume growth was due to a 27.9% contribution from COVID-19 Testing demand, partially offset by a (1.3%) reduction in organic Base Business, which includes the unfavorable impact from weather of approximately (2.0%). Price / mix increased by 34.7% primarily due to COVID-19 Testing of 26.6% and organic Base Business of 7.5%.

Adjusted operating income for the quarter was $991.6 million, or 36.0% of revenue, compared to $254.2 million, or 14.9%, in the first quarter of 2020. The increase in adjusted operating income and adjusted operating margin were primarily due to the increase in COVID-19 Testing, organic Base Business growth and LaunchPad savings, partially offset by higher personnel costs. The company remains on track to deliver approximately $200 million of net savings from its three-year Diagnostics LaunchPad initiative by the end of 2021.

Drug Development
Revenue for the quarter was $1.44 billion, an increase of 25.7% over $1.14 billion in the first quarter of 2020. The increase in revenue was due to organic growth of 21.9%, acquisitions of 1.0%, and favorable foreign currency translation of 2.9%. The increase in organic revenue was due to a 19.7% increase in the Base Business and a 2.2% contribution from COVID-19 Testing performed through its Central Laboratories business. Drug Development benefited from broad-based demand across businesses, including COVID-19 vaccine and therapeutic work.

4

Adjusted operating income for the quarter was $234.1 million, or 16.3% of revenue, compared to $150.8 million, or 13.2%, in the first quarter of 2020. The increase in adjusted operating income and adjusted operating margin were primarily due to organic Base Business growth, COVID-19 Testing, and LaunchPad savings, partially offset by higher personnel costs. The company continues to develop and execute new LaunchPad programs to support profitable growth in Drug Development.

Net orders and net book-to-bill during the trailing twelve months were $7.61 billion and 1.47, respectively. Backlog at the end of the quarter was $13.97 billion, compared to $13.76 billion last quarter, and the company expects approximately $4.62 billion of its backlog to convert into revenue in the next twelve months.

5

Outlook for 2021

Labcorp is raising its 2021 full year guidance to reflect the improved recovery in the Diagnostics and Drug Development base businesses, while the COVID-19 Testing contribution remains within the original guidance range provided. The following guidance assumes foreign exchange rates effective as of March 31, 2021 for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions and share repurchases.

(Dollars in billions, except per share data) Previous Updated Results 2021 Guidance 2021 Guidance 2020 Low High Low High Revenue
Total Labcorp Enterprise (1)(2)
$ 13.98 (1.0%) 4.5% 2.0% 6.5%
Base Business (2)
$ 11.19 11.0% 13.5% 13.5% 16.0%
COVID-19 Testing (2)
$ 2.78 (50.0%) (35.0%) (50.0%) (35.0%)
Total Diagnostics (3)
$ 9.25 (7.5%) (0.5%) (5.0%) 0.0% Base Business $ 6.47 11.0% 14.0% 13.5% 16.0% COVID-19 Testing $ 2.78 (50.0%) (35.0%) (50.0%) (35.0%)
Total Drug Development (4)
$ 4.88 8.0% 10.5% 12.0% 14.0% Base Business $ 4.76 9.5% 12.0% 14.0% 16.0% Adjusted EPS $ 23.94 $ 19.00 $ 23.00 $ 20.00 $ 24.00
Free Cash Flow (5)
$ 1.75 $ 1.70 $ 1.90 $ 1.80 $ 2.00 (1) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.7%, Previous 2021 Guidance was 0.9% (2) Enterprise level revenue is presented net of intersegment transaction eliminations, including Drug Development COVID-19 Testing revenue (3) 2021 Updated Guidance includes a benefit from foreign currency translation of 0.3%, Previous 2021 Guidance was 0.1% (4) 2021 Updated Guidance includes a benefit from foreign currency translation of 1.4%, Previous 2021 Guidance was 2.2% (5) Free Cash Flow consists of operating cash flow less capital expenditures

6Use of Adjusted Measures

The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company’s operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company’s financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release.

The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company’s website at View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing Labcorp’s quarterly results will be held today at 9:00 a.m. ET and is available by dialing 877-898-8036 (720-634-2811 for international callers). The conference ID is 6566853. A telephone replay of the call will be available through May 13, 2021, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The conference ID for the replay is 6566853. A live online broadcast of Labcorp’s quarterly conference call on April 29, 2021, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through April 15, 2022.

On April 29, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will be participating in the upcoming BofA Securities 2021 Healthcare Conference (Press release, Guardant Health, APR 29, 2021, View Source [SID1234578836]).

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Guardant Health’s management is scheduled to participate in a fireside chat on Wednesday, May 12 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. Interested parties may access a live and archived webcast of the presentation on the "Investors" section of the company website at: www.guardanthealth.com.