On July 23, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the second quarter ended June 30, 2020, which are consistent with the preliminary results reported on July 13, 2020 (Press release, Quest Diagnostics, JUL 23, 2020, View Source [SID1234562270]).

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"In one of the most challenging periods in our history, Quest Diagnostics stepped up and rapidly expanded COVID-19 testing for the country and delivered stronger-than-expected performance in the second quarter," said Steve Rusckowski, Chairman, CEO and President, Quest Diagnostics. "Our base testing volume declined versus 2019 because of the pandemic and was partially offset by COVID-19 testing. I am proud of Quest’s employees who have been on the frontlines of healthcare, answering the call in fighting the COVID-19 pandemic."

Mr. Rusckowski concluded: "Looking forward to the rest of the year, we will continue to expand COVID-19 testing capacity while also continuing to serve our customers as they continue to recover from the pandemic. We have re-established our financial outlook for the remainder of the year with a broad range that reflects uncertainty caused by the pandemic."

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Three Months Ended June 30,

Operating income as a percentage of net revenues

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, income from continuing operations attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Outlook Reinstated for full year 2020

The company reinstated its financial outlook for full year 2020 after withdrawing it in April 2020. Current estimates for full year 2020 results are as follows:

Outlook ranges for full year 2020 reflect a number of assumptions that are subject to change based on uncertainties related to the impact of the COVID-19 pandemic. The company intends to provide further detail regarding these assumptions on its quarterly conference call today.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on the company’s website at www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 888-566-0435 for domestic callers or 402-998-0605 for international callers. No passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on July 23, 2020 until midnight Eastern Time on August 6, 2020. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On July 23, 2020 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the second-quarter 2020 and updated full-year 2020 financial guidance (Press release, West Pharmaceutical Services, JUL 23, 2020, View Source [SID1234562268]).

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Second-Quarter 2020 Summary (comparisons to prior-year period)

Net sales of $527.2 million grew 12.2%; organic sales growth was 14.3%.
Reported-diluted EPS of $1.21 increased 38%.
Adjusted-diluted EPS of $1.25 increased 40%.
Company is raising full-year 2020 net sales guidance to a new range of between $2.035 billion and $2.055 billion.
Company is raising full-year 2020 adjusted-diluted EPS guidance to a new range of between $4.15 and $4.25.
"Adjusted-diluted EPS" and "organic sales growth" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"Our second quarter results reflect the strength and resiliency of our business in today’s environment," said Eric M. Green, President and Chief Executive Officer. "We continue to see underlying demand growth in our existing business for our high-value products and in high adoption rates from customers who are developing therapeutics and vaccines to address the COVID-19 pandemic."

Mr. Green continued, "The outlook for the balance of 2020 remains robust; and with our One West philosophy, broad range of innovative solutions and the ability to flex our global operating network, we are well positioned. I am extremely proud of our colleagues’ response to the challenging landscape and the dedicated focus on delivering high-quality components and solutions to our customers."

Proprietary Products Segment
Net sales grew by 10.9% to $399.5 million. Organic sales growth was 13.3%, with currency translation decreasing sales growth by 240 basis points. High-value products (HVP) represented 65% of segment sales and generated double-digit organic sales growth.

Our Biologics market unit had double-digit organic sales growth, led by customer purchases of film-coated components (Flurotec and Daikyo), self-injection platforms, Westar and Crystal Zenith components. Our Generics market unit posted double-digit organic sales growth, and our Pharma market unit grew organic sales by low-single digits. Both Generics and Pharma market units were led by sales of film-coated and Westar components.

Contract-Manufactured Products Segment
Net sales grew by 16.8% to $127.8 million. Organic sales growth was 17.8% with currency translation decreasing sales growth by 100 basis points. Segment performance was led by strong sales of healthcare-related injection and diagnostic devices.

Financial Highlights (first six months of 2020)
Operating cash flow was $205.2 million, an increase of 34%. Capital expenditures were $69.2 million. Free cash flow (operating cash flow minus capital expenditures) was $136.0 million, an increase of 42%.

Full-Year 2020 Financial Guidance

Full-year 2020 net sales guidance is expected to be in a range of between $2.035 billion and $2.055 billion, compared to a prior range of between $1.95 billion and $1.97 billion.
Organic sales growth is expected to be approximately 12%, compared to a prior guidance range of 8%.
Net sales guidance includes an estimated full-year headwind of $26 million for the full-year 2020 based on current foreign exchange rates, unchanged from prior guidance.
Full-year 2020 adjusted-diluted EPS is expected to be in a range of between $4.15 and $4.25, compared to a prior range of between $3.52 and $3.62.
Full-year adjusted-diluted EPS guidance includes an estimated headwind of approximately $0.07 based on current foreign currency exchange rates, unchanged from prior guidance.
The revised guidance includes a $0.16 EPS impact from tax benefits from stock-based compensation in the first six months of 2020.
For the remainder of the year, our EPS guidance range assumes a tax rate of 24% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in the first six months of 2020 would provide a positive adjustment to our full-year EPS guidance.
Second-Quarter 2020 Conference Call
The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 7789173.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, July 30, 2020, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 7789173.

On July 23, 2020 Synaffix B.V., a biotechnology company focused on enabling antibody-drug conjugates (ADCs) with superior therapeutic index based on its proprietary ADC technology platform, reported that ADC Therapeutics SA has expanded its existing collaboration to explore additional applications, including DAR1, of Synaffix’ site-specific conjugation technologies (Press release, Synaffix, JUL 23, 2020, View Source [SID1234562267]).

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Under the expanded collaboration, ADC Therapeutics has been granted non-exclusive rights for two additional programs, which brings the total number of programs using Synaffix’ ADC technologies to five. ADC Therapeutics also gains access to the latest innovative extensions of Synaffix’ proprietary GlycoConnect platform, including DAR1 technology that enables stable attachment of just a single drug per antibody.

Synaffix is eligible to receive upfront, milestone and royalty payments tied to each program. Further financial details are not disclosed.

Peter van de Sande, CEO of Synaffix said:

"We are very pleased to see the rapid progression of ADC Therapeutics’ programs that have been developed using our GlycoConnect ADC technology platform, and the multiple collaboration expansions that have followed our original agreement.

"We look forward to continuing to work closely with the ADC Therapeutics team as they translate more product candidates using GlycoConnect into the clinic."

Synaffix entered into the original commercial license agreement with ADC Therapeutics in October 2016. ADC Therapeutics is responsible for the research, development, manufacturing and commercialization of any resulting ADC products, and Synaffix is responsible for the manufacturing of components specifically related to its proprietary ADC technologies.

On July 23, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, reported that it has opened its trial of 67Cu-SARTATE for paediatric patients with neuroblastoma at Memorial Sloan Kettering Cancer Center (MSK) in New York City and recruitment has commenced (Press release, Clarity Pharmaceuticals, JUL 23, 2020, View Source [SID1234562244]).

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"We are very excited to commence recruitment for our trial in this very important patient population" commented Dr Alan Taylor, Clarity’s Executive Chairman. "The opening of the trial and commencement of recruitment comes shortly after the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation status for both the diagnostic and therapeutic applications of SARTATE in neuroblastoma. Achieving these milestones despite the challenging conditions presented by the coronavirus pandemic signifies strong support from the FDA, MSK and Clarity’s collaborators and importantly our team which relates to the importance of progressing the development of SARTATE in this vulnerable patient population."

67Cu-SARTATE trial is a Peptide Receptor Radionuclide Therapy (PRRT) administered to paediatric patients with high-risk neuroblastoma. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a theranostic clinical trial at MSK.1 MSK is the world’s oldest and largest private cancer centre. It has devoted more than 135 years to exceptional patient care, innovative research, and outstanding educational programs.

Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality.2 High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.3

Dr Taylor said: "At this time, children with high-risk neuroblastoma have poor prognosis as current treatment strategies have limited effect in patients with late-stage disease where cancer has metastasised. It is evident that the development of new treatment approaches and strategies is crucial to improving treatment outcomes for this patient population. We are looking forward to progressing the development of SARTATE and getting closer to our ultimate goal of better treatment of children and adults with cancer."

On July 22, 2020 G1 Therapeutics, a clinical-stage oncology company, reported a license agreement for lerociclib to EQRx, a biopharmaceutical company focused on making innovative medicines at dramatically lower prices for the benefit of people and society (Press release, G1 Therapeutics, JUL 22, 2020, View Source [SID1234634609]). Under the terms of the agreement, EQRx gains exclusive rights for lerociclib in the U.S., Europe, Japan and all other global markets, excluding the Asia-Pacific region (except Japan). G1 will receive an upfront cash payment of $20 million and will be eligible to receive development and commercial milestone payments of up to $290 million, plus tiered royalties ranging from mid-single digits to mid-teens based on annual net sales of lerociclib.

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"We are excited to partner with EQRx to further development of lerociclib, a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies," said Mark Velleca, M.D., Ph.D., Chief Executive Officer of G1. "This is the third strategic collaboration we have executed this year. Collectively, these partnerships have advanced our goal to provide global access to our promising oncology therapies and extend our financial runway so that we can continue our efforts to bring novel treatments to patients with cancer."

Discovered and developed by G1, lerociclib has demonstrated clinical proof-of-concept and a differentiated profile in a Phase 1/2 trial in patients with ER+, HER2- breast cancer. Earlier this year, G1 licensed development and commercialization rights in the Asia-Pacific region (excluding Japan) to Genor Biopharma.

About Lerociclib
Lerociclib is a differentiated oral CDK4/6 inhibitor being developed for use in combination with other targeted therapies in certain types of breast and lung cancer. Preliminary clinical data in estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer have demonstrated proof-of-concept of the differentiated clinical profile of lerociclib versus currently marketed CDK4/6 inhibitors, with improved tolerability and less neutropenia. Neutropenia is one of the main toxicities associated with CDK4/6 inhibition. Current treatments require frequent blood testing for neutropenia. Less monitoring would mean fewer office visits and blood draws, improving the experience for patients and reducing the burden on physician offices and costs to the healthcare system.