On July 22, 2021 Eli Lilly and Company (NYSE: LLY) reported its second-quarter 2021 financial results on Tuesday, August 3, 2021 (Press release, Eli Lilly, JUL 22, 2021, View Source [SID1234585074]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On July 22, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Friday, August 6, 2021, at 8:00 a.m. ET to discuss a corporate update and financial results for the second quarter 2021 (Press release, Oncolytics Biotech, JUL 22, 2021, View Source [SID1234585073]).

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Conference Call & Webcast

A webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using reference code: 148-191#.

On July 22, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that clinicians have treated the first patient in a Phase 1b/2 study evaluating the company’s lead drug candidate, uproleselan, added to cladribine plus low dose cytarabine (LDAC) in patients with treated secondary AML (ts-AML) (Press release, GlycoMimetics, JUL 22, 2021, View Source [SID1234585072]). The investigator-sponsored trial is being led by Tapan Kadia, M.D., associate professor of Leukemia at The University of Texas MD Anderson Cancer Center.

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According to Eric Feldman, M.D., GlycoMimetics’ Chief Medical Officer, "Patients with treated secondary AML have an extremely poor prognosis. Despite new drug approvals in the field, subgroups of patients with limited options still exist, especially those whose disease has progressed following treatment with a hypomethylating agent. Our previous preclinical and clinical research supports the potential for these patients to benefit from the addition of uproleselan. If the new study demonstrates that targeting E-selectin with uproleselan could help to overcome resistance to other therapies, this would be a significant achievement that underscores the broad potential of our drug candidate."

About the Phase 1b/2 Clinical Trial

The Phase 1b/2 single-arm trial is enrolling patients 18 years or older, with a diagnosis of ts-AML who have not received therapy for their AML. Considered a distinct high-risk subset of AML with an adverse prognosis, ts-AML is defined as AML arising from a previously treated antecedent myeloid neoplasm (myelodysplastic syndrome or myeloproliferative neoplasm). Clinicians plan to enroll approximately 25 patients in the trial.

GlycoMimetics is providing uproleselan for the investigator-sponsored trial. The study is designed to evaluate both the safety and tolerability of the combination therapy, as well as to identify a recommended Phase 2 dose of the uproleselan triple combination approach in patients with ts-AML. Among the trial’s secondary objectives are efficacy assessments including overall response rate, complete response, complete response without blood count recovery, and other measures. The rate of minimal residual disease negativity will also be evaluated by flow cytometry at response. Exploratory endpoints include examination of biomarkers of response and resistance and the correlation of the expression of E-selectin ligand-forming glycosylation genes of leukemic blasts with clinical outcome.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration and the Chinese Health authority for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance.

On July 22, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that financial results for the second quarter ended June 30, 2021 (Press release, Quest Diagnostics, JUL 22, 2021, View Source [SID1234585064]).

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"We had another strong quarter, with a faster than expected recovery in our base business," said Steve Rusckowski, Chairman, CEO and President. "This was the first quarter since 2019 that organic base testing revenues grew in the quarter, driven by contributions from new hospital lab management contracts as well as people returning to the healthcare system. We are well-positioned to continue our momentum and support the return to health care in the coming months, which is reflected in the outlook we have provided for the remainder of 2021."

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

The sum of reported and adjusted diluted EPS for the first two quarters of 2021 did not equal the totals for the six months ended June 30, 2021 due to both quarterly fluctuations in the company’s earnings and in the weighted average common shares outstanding throughout the period as a result of the impact of accelerated share repurchase agreements ("ASRs") that the company entered into during April 2021.

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, costs associated with donations, contributions, and other financial support through Quest for Health Equity, the company’s initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities, a gain on sale of an ownership interest in a joint venture, 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, from approximately 10:30 a.m. Eastern Time on July 22, 2021 until midnight Eastern Time on August 5, 2021, by phone at 866-360-3307 for domestic callers or 203-369-0162 for international callers. 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 22, 2021 Hoffmann-La Roche reported that (Press release, Hoffmann-La Roche, JUL 22, 2021, View Source [SID1234585063])

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Group sales up 8%1 at constant exchange rates (CER); 5% in Swiss francs
Pharmaceuticals Division sales decline 3%; sales grow 4% in the second quarter, following a first-quarter decrease of 9%; newly launched medicines (+30%) compensate for the continued impact from biosimilars
Diagnostics Division sales grow 51% due to high demand for COVID-19 tests and strong momentum in routine testing
IFRS net income increases by 2% (-3% in Swiss francs), while core earnings per share up 6%
Highlights in the second quarter:
Pipeline: Positive study results for immunotherapy Tecentriq in early lung cancer; encouraging data strengthen Roche’s portfolio in neurosciences and hard-to-treat blood cancers
EU approvals: Tecentriq (specific type of metastatic non-small cell lung cancer), Venclyxto-based combinations (acute myeloid leukaemia) and Enspryng (neuromyelitis optica spectrum disorder, a rare autoimmune disease of the CNS)
GenMark Diagnostics: Acquisition, completed in April, broadens Roche’s molecular lab portfolio and reinforces our commitment to fight infectious diseases and antibiotic resistance
COVID-19: Additional positive study results for antibody combination Ronapreve (co-developed with Regeneron) and AT-527 (co-developed with Atea); Japan becomes first country to approve Ronapreve for the treatment of mild to moderate COVID-19; FDA Emergency Use Authorization for Actemra/RoActemra; launch of further tests reinforces Roche’s position as a global leader in COVID-19 diagnostics
Outlook for 2021 confirmed

Commenting on the Group’s performance in the first six months, Roche CEO Severin Schwan said: "We have achieved good results in the first half, primarily thanks to the demand for our new medicines and COVID-19 tests. The Pharma Division began to grow again in the second quarter. The base diagnostics business shows strong momentum. As expected, demand for COVID-19 tests peaked in the second quarter. I’m particularly excited about the significant progress we made in our product pipeline, including very promising study results for Tecentriq in early-stage lung cancer, as well as additional positive data for Evrysdi in spinal muscular atrophy and for COVID-19 medicines. Based on the good results of the first half of 2021, we confirm the outlook for the full year."

Outlook confirmed for 2021
Despite the continued strong impact of biosimilars, sales are expected to grow in the low- to mid-single digit range, at constant exchange rates. Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to increase its dividend in Swiss francs further.

Group results
In the first half of the year, Group sales rose 8% (5% in CHF) to CHF 31 billion. IFRS net income increased 2% (-3% in CHF), while core earnings per share up by 6%. The appreciation of the Swiss franc against most currencies had a negative impact on the results expressed in Swiss francs compared to constant exchange rates.

Sales in the Pharmaceuticals Division were CHF 22 billion, a decrease of 3%. However, while sales in the first quarter were still strongly affected by COVID-19 (-9%), the second quarter showed signs of recovery in some regions (+4%). The ongoing impact from biosimilars, particularly in the US, resulted in a sales decrease of CHF 2.8 billion.

The new medicines (launched since 20122) continued their strong growth (+30%, or +CHF 2.6 billion). In the first six months, they generated sales of over CHF 11 billion, thus already contributing more than 50% to the division’s total sales.

In the United States, sales decreased by 8%, due to the launches of biosimilars for the cancer medicines MabThera/Rituxan, Avastin and Herceptin (combined -49% or CHF 1.7 billion) and the pandemic. This decline was partially compensated for by the new medicines – mainly Ocrevus (multiple sclerosis), Hemlibra (haemophilia), Evrysdi (spinal muscular atrophy) and Tecentriq (cancer immunotherapy). Here too, business is showing signs of recovery: after -14% in the first quarter, sales in the second quarter were stable, i.e. at the previous year’s level.

Sales in Europe grew by 4%, with new product sales more than compensating for the impact from biosimilars and the pandemic. Ronapreve, the antibody combination against COVID-19, was the key growth driver, mainly in Germany, Italy and France.

In Japan, sales were stable. Growth of recently launched medicines, such as Tecentriq and Enspryng, was offset by the impact from biosimilars and government price cuts.

Sales in the International region grew by 2%. Growth in China (+3%) was mainly due to strong sales of Perjeta, Alecensa, Tecentriq and Herceptin, partly offset by biosimilar competition for Avastin and MabThera/Rituxan. Excluding China, sales increased by 1%, mainly due to orders for Ronapreve in India, again partially offset by the impact from biosimilars, mainly in Canada and Brazil.

The Diagnostics Division achieved very strong sales growth of 51% to CHF 9 billion. The base business (i.e. routine diagnostics), which was heavily impacted by the pandemic in 2020, grew strongly: +17% in the first quarter and +31% in the second quarter. Roche’s industry-leading portfolio of COVID-19 tests contributed total sales of CHF 2.5 billion (CHF 0.7 billion in 2020); the demand for COVID-19 tests is likely to decrease in the second half of 2021.

The division recorded high sales growth in all regions: Europe, Middle East and Africa +70%, Asia-Pacific +44%, North America +25% and Latin America +77%.

In April, Roche acquired the US company GenMark Diagnostics for USD 1.9 billion. GenMark’s novel technology detects a wide range of pathogens from a single patient sample. It broadens Roche’s molecular lab portfolio, and reinforces our commitment to help control infectious diseases and antibiotic resistance.

Roche’s response to the COVID-19 pandemic
Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, more treatment options are still needed. In the second quarter, Roche and/or its partners shared positive news:

Antibody combination Ronapreve (co-developed with Regeneron): Preliminary phase III data from a University of Oxford-led trial demonstrated that the antibody combination casirivimab/imdevimab reduced the risk of death when given to patients hospitalised with severe COVID-19 who had not mounted a natural antibody response of their own. In July, Japan became the first country to approve Ronapreve for the treatment of patients with mild to moderate COVID-19.
AT-527 (co-developed with Atea): Interim results from a phase II trial indicated rapid and sustained antiviral activity against SARS-CoV-2 in hospitalised COVID-19 patients. AT-527 continues to be evaluated for the treatment and prevention of COVID-19.
Actemra/RoActemra:3 Roche’s intravenous anti-inflammation medicine received FDA Emergency Use Authorization (EUA) for the treatment of severe COVID-19 in hospitalised adults and children.
Manufacturing: Roche is currently ramping up its production capacity for AT-527, which requires a complex manufacturing process, as much as possible. For Actemra, Roche has already increased its own production capacity significantly and has been working with external manufacturers on transferring its technologies to increase the global supply further.
Roche has also reinforced its position as a world-leading supplier of COVID-19 diagnostics. In June, the SARS-CoV-2 Antigen Self Test Nasal obtained the CE mark,4 and the cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System was granted first FDA EUA for PCR testing of both symptomatic and asymptomatic individuals at the point of care (with results within 20 minutes).