On October 21, 2020 ICON plc (NASDAQ: ICLR), a global provider of outsourced drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations, reported its financial results for the third quarter ended September 30, 2020 (Press release, ICON, OCT 21, 2020, View Source [SID1234568748]).

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CEO Dr. Steve Cutler commented, "Driven by positive market demand in conjunction with our ability to win COVID-19 related opportunities we delivered a new record $990 million of net business wins during quarter three. This represented a quarterly book to bill of 1.41 and resulted in our backlog growing to $9.4 billion, an increase of 12% year over year. Our financial position remains robust with a strong balance sheet supplemented further by solid quarterly cash collections helping to improve days sales outstanding to 45 days.

We remain well placed to face the challenges of COVID-19 and take advantage of opportunities into the future. We are therefore increasing our 2020 revenue guidance from a range of $2,650 million – $2,750 million to $2,750 million – $2,810 million and narrowing our earnings guidance from a range of $6.00 – $6.50 to a range of $6.35 – $6.50."

Third Quarter 2020 Results

Gross business wins in the third quarter were $1.2 billion and cancellations were $190 million. This resulted in net business wins of $990 million and a book to bill of 1.41.

Reported revenue for Quarter 3 was $701.7 million. This represents a year on year decrease of 1.2% or 1.9% on a constant currency basis.

Reported income from operations in the quarter was $108.4 million or 15.4% of revenue compared to $110.0 million or 15.5% of revenue for Quarter 3 2019.

Reported net income attributable to the Group for the quarter was $91.6 million or 13.1% of revenue compared with $94.8 million or 13.3% of revenue in Quarter 3 2019.

Adjusted earnings per share attributable to the Group on a diluted basis was $1.72, compared to $1.74 per share for Quarter 3 2019. GAAP earnings per share attributable to the Group on a diluted basis was $1.72, compared to $1.72 per share for Quarter 3 2019.

On a comparative basis, non-GAAP days sales outstanding were 45 days at September 30, 2020, compared with 53 days at the end of June 2020 and 56 Days at the end of September 2019.

Cash generated from operating activities for the quarter was $112.0 million and capital expenditure was $6.9 million. As a result, at September 30, 2020, the Group had net cash of $359.8 million, compared to net cash of $244.0 million at June 30, 2020 and net cash of $121.7 million at the end of September 2019.

During the quarter the company completed the successful refinance of the existing private placement of $350 million senior notes maturing on December 15, 2020. The transaction has been successfully priced over three and five year tenors at a blended rate of 2.41% compared to the current private placement blended rate of 3.37%. The drawdown of funds will coincide with the maturity of the senior notes in December 2020.

Year to date 2020 Results

Gross business wins year to date were $3.3 billion and cancellations were $520 million. This resulted in net business wins of $2.8 billion and a book to bill of 1.36.

Year to date reported revenue was $2,037 million. This represents a year on year decrease of 2.1% or 2.0% on a constant currency basis.

Reported income from operations* year to date was $289.7 million or 14.2% of revenue compared to $318.1 million or 15.3% of revenue for the equivalent prior year period.

Reported net income* attributable to the Group year to date was $246.9 million or 12.1% of revenue compared with $275.0 million or 13.2% of revenue for the equivalent prior year period.

Adjusted earnings per share* attributable to the Group on a diluted basis was $4.63, compared to $5.06 per share for the equivalent prior year period.

During the year the company recorded a charge of $18.1 million in relation to restructuring costs. US GAAP income from operations year to date amounted to $271.6 million or 13.3% of revenue. US GAAP net income attributable to the Group year to date was $231.1 million or $4.25 per diluted share, compared to $5.03 per share for the equivalent prior year period.

*before non-recurring charges.

COVID-19 Update

ICON continues to closely monitor and assess the evolving pandemic situation. The welfare and safety of ICON’s employees, customers and patients remains the Company’s highest priority. ICON is taking guidance from global health authorities, such as World Health Organisation (WHO) and Centers for Disease Control and Prevention (CDC), as well as regional health authorities and governments to ensure that ICON protects the safety and welfare of employees and abides by government directives in various jurisdictions.

COVID-19 continues to affect our global business. However, the impact has reduced in recent months as sites reopened and patient recruitment gradually improved. Where on-site monitoring is not possible we continue to use alternative approaches including remote and risk based monitoring and ‘at home’ services delivered through our Symphony Clinical Research group.

Since February, ICON has mobilised its vaccine resources to address the COVID-19 global threat, including its ability to conduct home-based trials to minimise infection. The company is currently providing clinical monitoring and safety oversight on more than 100 COVID-19 trials for both the private and government sectors.

Other Information

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), this press release contains certain non-GAAP financial measures, including non-GAAP operating and net income and non-GAAP diluted earnings per share. While non-GAAP financial measures are not superior to or a substitute for the comparable GAAP measures, ICON believes certain non-GAAP information is useful to investors for historical comparison purposes.

Adjusted earnings per share attributable to the Group (Non-GAAP) has been computed by dividing non-GAAP net income attributable to the Group by the weighted average number of shares outstanding. GAAP earnings per share attributable to the Group has been computed by dividing net income attributable to the Group plus a GAAP charge associated with non-controlling interest in MeDiNova Research ("MeDiNova") by the weighted average number of shares outstanding. ICON purchased a majority shareholding in MeDiNova on May 23, 2019. ICON exercised its call on the outstanding shares in MeDiNova and derecognized the non-controlling interest effective from March 2020.

The Company entered into an agreement with a third party to jointly establish Oncacare. Oncacare will operate a specialized oncology site network in the US and EMEA regions. The Company holds a 49% interest in the voting share capital of Oncacare. The Company’s investment in Oncacare is accounted for under the equity method and records its pro rata share of the earnings/losses of this investment in Share of equity method investments in the Condensed Consolidated Statement of Operations.

ICON will hold its third quarter conference call tomorrow, October 22nd, 2020 at 9:00 EDT [14:00 Ireland & UK]. This call and linked slide presentation can be accessed live from our website at View Source A recording will also be available on the website for 90 days following the call. In addition, a calendar of company events, including upcoming conference presentations, is available on our website, under "Investors". This calendar will be updated regularly.

On October 21, 2020 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, reported the successful outcome of its October 14, 2020 meeting with FDA (Press release, Guided Therapeutics, OCT 21, 2020, View Source [SID1234568746]). The purpose of the meeting was to finalize the protocol (procedure) for its new clinical study in support of its Premarketing Application for the LuViva Advanced Cervical Scan (i.e., FDA approval). The Company filed the minutes from this meeting with FDA yesterday, which the agency will review and provide any final comments on the meeting and study protocol.

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Currently, women are screened for cervical cancer using one or more laboratory-based tests that require a tissue sample. Women who test positive on these screening tests are referred to biopsy of the suspect cervical tissue. Unfortunately, because of limitations in current imaging technology, 40- 50% of the time the disease is not detected when it is actually present. In addition, the screening tests may generate up to 80% false positives. LuViva does not require a tissue sample and produces an immediate result, so that treatment can begin sooner. Previous clinical studies that included two year follow up showed that LuViva detected a significant number of these missed cases. The Company has received broad agreement from the FDA on the new study’s methodology and patient population in order to demonstrate LuViva’s ability to significantly improve the early detection of cervical cancer. The study is expected to take a few months once enrollment begins and will include approximately 300 to 600 patients.

"Reaching agreement with FDA on the intended use of LuViva and the study to support that intended use is a major milestone for us," said Gene Cartwright, CEO. "We look forward to filing the protocol with the participating clinical sites and beginning the study as soon as practicable."

On October 21, 2020 Boundless Bio, a biotechnology company developing innovative therapeutics directed to extrachromosomal DNA (ecDNA) in aggressive cancers, reported it will present a poster at the 2020 American Society of Human Genetics (ASHG) Annual Meeting, which is being held in a virtual format this year due to COVID-19 (Press release, Boundless Bio, OCT 21, 2020, View Source [SID1234568745]).

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Presentation details are as follows:

Poster Title: A robust imaging and single-cell sequencing platform to characterize tumor extrachromosomal DNA (ecDNA) in response to therapeutic intervention
Session: 202 – Cancer
Poster #: 2251
Date: October 26, 2020
Time: 6:00 a.m. – 11:59 p.m. ET

About ecDNA

Extrachromosomal DNA, or ecDNA, are distinct circular units of DNA containing functional genes, including oncogenes, that are separated from tumor cell chromosomes. ecDNA rapidly replicate within cancer cells, causing high numbers of oncogene copies and can be passed to daughter cells asymmetrically during cell division, driving tumor heterogeneity. Cancer cells have the ability to increase or decrease copy number of select oncogenes located on ecDNA to enable survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment resistance. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

On October 21, 2020 Henry Schein, Inc. (Nasdaq: HSIC) reported that it will again support nonprofit organizations dedicated to the fight against cancer through its Practice Pink program (Press release, Henry Schein, OCT 21, 2020, View Source [SID1234568743]). Now in its 14th year, Henry Schein has donated more than $1.7 million through the program towards promoting early cancer detection, improving access to care, and supporting research and prevention efforts. Practice Pink, an international effort, is an initiative of Henry Schein Cares, the Company’s global corporate social responsibility program.

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Along with non-governmental organizations and supplier partners across North America and Europe, Henry Schein is helping dental and medical health care professionals raise awareness and support for a cure for breast cancer and other cancers by offering its customers a range of pink products, including health care consumables, practice supplies, and apparel. Customers can obtain more information about these products in the Henry Schein Dental and Medical catalogs.

"As part of Henry Schein Cares’ mission, we are dedicated to helping catalyze public-private partnerships and mobilize the resources needed to promote wellness and prevention," said Stanley M. Bergman, Chairman of the Board and Chief Executive Officer of Henry Schein. "Thanks to our dedicated customers and valued supplier partners who have played a large role in making Practice Pink a success, we have collectively helped promote early cancer detection, improved access to care, and provided financial support to further advance the goals of the organizations we support."

The Practice Pink program supports U.S.-based organizations such as the American Cancer Society, Cohen Children’s Medical Center of Northwell Health, Stony Brook Children’s Hospital, and the Memorial Sloan Kettering/Henry Schein Cares Women’s Health Center. In Europe, the program supports organizations such as the Italian League for the Fight Against Cancer (LILT), Germany-based Brustkrebs Deutschland e.V., and Federacja Stowarzyszeń Amazonki in Poland.

For more information about Practice Pink and Henry Schein Cares, please visit www.henryschein.com/PracticePink.

About Henry Schein Cares

Henry Schein Cares stands on four pillars: engaging Team Schein Members to reach their potential, ensuring accountability by extending ethical business practices to all levels within Henry Schein, promoting environmental sustainability, and expanding access to health care for underserved and at-risk communities around the world. Health care activities supported by Henry Schein Cares focus on three main areas: advancing wellness, building capacity in the delivery of health care services, and assisting in emergency preparedness and relief.

Firmly rooted in a deep commitment to social responsibility and the concept of enlightened self-interest championed by Benjamin Franklin, the philosophy behind Henry Schein Cares is a vision of "doing well by doing good." Through the work of Henry Schein Cares to enhance access to care for those in need, the Company believes that it is furthering its long-term success. To learn more about how Henry Schein Cares is making a difference, please visit: www.henryschein.com/socialresponsibility.

On October 21, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it will host an investor webcast on Oct. 28, 2020, at 4:30 p.m. Eastern time, to highlight the planned launch of the ConfirmDx-Melanoma test, which will be commercially available in the fourth quarter of 2020 (Press release, Castle Biosciences, OCT 21, 2020, View Source [SID1234568742]). ConfirmDx-Melanoma is designed for use in patients with difficult-to-diagnose suspicious pigmented (melanocytic), lesions.

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Castle’s ConfirmDx-Melanoma test is designed to aid dermatopathologists in characterizing difficult-to-diagnose pigmented lesions. Of the 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. ConfirmDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of malignant melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, ConfirmDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists, while helping dermatologists better understand the clinical implications for more informed patient care.

Conference call and webcast details can be found below:

Title:

Castle Biosciences ConfirmDx-Melanoma Investor Webcast

Date:

October 28, 2020

Time:

4:30 p.m. ET

Dial-in:

US/Canada Participant Toll-Free Dial-in number: (877) 282-2581

US/Canada Participant International Dial-in number: (470) 495-9137

Conference ID:

4091207

The webcast will include Sarah I. Estrada, M.D., FACP, laboratory director, Affiliated Dermatology, as a guest speaker. There will be a brief Question & Answer session following management commentary.

A live webcast of the conference call can be accessed here View Source or via the webcast link on the Investor Relations page of the Company’s website (www.castlebiosciences.com). Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until Nov.18, 2020.

About Suspicious Pigmented Lesions

In the U.S., approximately 2 million skin biopsies of pigmented or melanocytic lesions are performed annually, leading to the diagnosis of an estimated 130,000 invasive melanoma cases and more than 96,000 in situ melanoma cases. These biopsies are typically pigmented lesions for which the healthcare provider suspects melanoma. The majority of these biopsies receive a definitive diagnosis by the dermatopathologist using traditional microscopic analyses. However, approximately 300,000 biopsies are considered difficult-to-diagnose using this traditional method and require additional testing to clarify the likelihood that this lesion is benign or malignant. And though there are several options for further testing, Castle believes there is a need for improvements in objective tests to resolve this diagnostic dilemma.