On July 30, 2020 Fresenius Medical Care reported very strong second quarter results (Press release, Fresenius, JUL 30, 2020, View Source [SID1234562539])

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Rice Powell, Chief Executive Officer of Fresenius Medical Care, said: "As anticipated, we saw the COVID-19 pandemic spread globally in the second quarter and continue to rise in Latin America and the U.S. In this challenging environment, the wide-ranging measures we took at a very early stage to ensure the continuity and quality of care for our patients are continuing to pay off. Together with the tireless efforts of our employees, these steps have given Fresenius Medical Care a strong performance in the first half of the year. This validates our core value proposition and the resiliency of our business model, which is grounded in our vertical integration strategy. Against this background and the anticipated financial net effect from COVID-19, we confirm our outlook for the financial year 2020. We continue to monitor further impacts of the pandemic and potential restrictions in the different markets."

2020 targets confirmed: mid to high single digit growth rates
On the basis of the neutral net impact of COVID-19 in the first six months, Fresenius Medical Care continues to expect both revenue and net income1 to grow at a mid to high single digit rate in 2020. These targets are inclusive of anticipated COVID-19 effects in constant currency, exclude special items3 and are based on the adjusted results 2019 including the effects of the operations of the NxStage acquisition and the IFRS 16 implementation.

1 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
2 For a reconciliation of adjusted figures, please refer to the table at the end of the press release
3 Special items are effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.

Measures to contain COVID-19 continued
Fresenius Medical Care continued its wide-ranging measures to fight COVID-19 in the second quarter. Thanks to the comprehensive protective measures taken at an early stage, Fresenius Medical Care was also able to maintain operations in its more than 4,000 dialysis centers worldwide without significant interruptions and minimizing the impact on patients. This was also made possible thanks to the use of telehealth solutions, which were applied – where necessary – to replace in-person with virtual patient interactions.

The COVID-19 pandemic affected people with advanced kidney disease and the resulting severity of illness generated an increase in hospitalization and mortality rates. In addition, the pandemic caused an interruption in routine medical visits and necessary hospitalization for many patients with advanced Chronic Kidney Disease (CKD) needing to consider renal replacement therapy. These two factors impacted the year-on-year growth for the second quarter.

Expansion in home dialysis
The expansion of home dialysis is a major growth area for Fresenius Medical Care. In the second quarter, the home dialysis offering in the Europe, Middle East and Africa (EMEA) region was expanded. The now-completed integration of the NxStage home dialysis products portfolio in the EMEA region enables Fresenius Medical Care to offer even more patients at-home treatment and a wider choice of treatment methods.

In North America, the number of home dialysis treatments increased by 15% compared to Q2 2019, with home hemodialysis treatments growing by 41%. June 2020 was the strongest month on record with regard to the number of patients being trained for home dialysis. This development will be supported by the rollout of additional 100 transitional care units to assist patients transitioning between modalities or returning to dialysis from transplants.

Patients, Clinics and Employees
As of June 30, 2020, Fresenius Medical Care treated 347,683 patients in 4,036 dialysis clinics worldwide. At the end of the second quarter, the Company had 124,736 employees (full-time equivalents) worldwide, compared to 119,631 employees as of June 30, 2019.

Solid revenue and strong income growth
Revenue increased by 5% to EUR 4,557 million (+5% at constant currency), with organic growth of 4%. Health Care Services revenue rose by 5% to EUR 3,614 million (+4% at constant currency), mainly driven by growth in same market treatments and contributions from acquisitions. Health Care Products revenue grew by 6% and amounted to EUR 943 million (+7% at constant currency). This increase was mainly due to higher sales of products for acute care treatments and disposables for in-center dialysis.

In the first half of 2020 revenue rose by 7% to EUR 9,045 million (+6% at constant currency). Organic growth amounted to 4%. Health Care Services revenue grew by 6% to EUR 7,209 million (5% at constant currency). Health Care Products revenue rose by 8% to EUR 1,836 million (+8% at constant currency).

Operating income increased by 26% to EUR 656 million (+24% at constant currency), resulting in an operating income margin of 14.4% (Q2 2019: 12.0%). Based on a strong, underlying business performance, the increase in margin was largely due to the recovery of COVID-19 related negative effects experienced in the first quarter as well as ongoing cost saving measures.

Operating income for the first half increased by 14% to EUR 1,211 million (+12% at constant currency), resulting in a margin of 13.4% (H1 2019: 12.5%).

Net income1 grew by 38% to EUR 351 million (+36% at constant currency). Adjusted net income increased by 40% (+38% at constant currency). Basic earnings per share (EPS) increased by 43% to EUR 1.20 (+41% at constant currency), driven by the earnings effects described above coupled with a decrease in the average weighted shares outstanding.

In the first half of 2020, net income increased by 21% to EUR 634 million (+18% at constant currency). EPS rose by 25% to EUR 2.15 (+22% at constant currency).

Exceptional cash-flow development
Fresenius Medical Care generated EUR 2,319 million of operating cash flow (Q2 2019: EUR 852 million) resulting in a margin of 50.9% (Q2 2019: 19.6%). The increase was largely driven by the U.S. federal government advanced payments under the CARES Act. In the first half of 2020, operating cash flow increased to EUR 2,903 million (H1 2019: EUR 928 million).

Free cash flow (net cash used in operating activities, after capital expenditures, before acquisitions and investments) amounted to EUR 2,103 million (Q2 2019: EUR 559 million), resulting in a margin of 46.1% (Q2 2019: 12.9%). In the first half of 2020, the company generated a free cash flow of EUR 2,407 million (H1 2019: EUR 435 million).

Regional developments
In North America, revenue increased by 6% to EUR 3,240 million (+4% at constant currency, +4% organic). The increase was supported in particular by organic growth in the Dialysis and Care Coordination business and contributions from acquisitions. For the first half, North America revenue rose by 8% to EUR 6,426 million (+5% constant currency, +4% organic).

Operating income grew by 42% to EUR 609 million (39% at constant currency), resulting in a margin of 18.8 % (Q2 2019: 14.0%). Operating income margin increased mainly due to the recovery of COVID-19 related negative effects experienced in the first quarter, ongoing cost saving measures as well as lower costs for renal pharmaceuticals.

For the first half, operating income rose by 34% to EUR 1,073 million (31% at constant currency), resulting in a margin of 16.7% (H1 2019: 13.5%).

EMEA revenue increased by 6% to EUR 687 million (+8% at constant currency, +7% organic), supported by strong organic growth in the Health Care Products business, including higher sales of products for acute care treatment. For the first half, EMEA revenue rose by 5% to EUR 1,366 million (+6% at constant currency, +5% organic).

Operating income for the EMEA region decreased by 19% to EUR 78 million (-19% at constant currency), resulting in a margin of 11.3% (Q2 2019: 14.9%). The decrease in operating margin was mainly due to an unfavorable impact from an impairment of a license held by the joint venture with Vifor Pharma, based on an unfavorable clinical trial for the drug CCX-140. For the first half, operating income decreased by 24% to EUR 179 million (-23% at constant currency), resulting in a margin of 13.1% (H1 2019: 18.0%).

In Asia-Pacific, revenue decreased by 2% to EUR 450 million (-2% at constant currency, -1% organic). The growth was impacted by the effect of closed or sold clinics and a decrease in organic revenue in the Care Coordination business, driven by COVID-19. For the first half, revenue rose by 1% to EUR 893 million (stable at constant currency, +0% organic).

Operating income decreased by 9% to EUR 63 million (-10% at constant currency), resulting in a margin of 14.1% (Q2 2019: 15.1%). The decrease in margin was mainly due to impacts from the COVID-19 pandemic. For the first half, operating income decreased by 15% to EUR 140 million (-15% at constant currency) resulting in a margin of 15.7% (H1 2019: 18.5%).

Latin America revenue decreased by 2% to EUR 170 million (+24% at constant currency, +18% organic). For the first half, revenue rose by 1% to EUR 338 million (+24% constant currency, +17% organic).
Operating income increased by 85% to EUR 11 million (+110% at constant currency), resulting in a margin of 6.4% (Q2 2019: 3.4%). For the first half, operating income increased by 3% to EUR 18 million (+11% at constant currency), resulting in a margin of 5.3% (H1 2019: 5.2%).

Virtual Annual General Meeting
Fresenius Medical Care has postponed its Annual General Meeting to August 27, 2020. With that, the resolutions regarding the allocation of the distributable profit and the payout of the dividend has also been postponed. The proposed dividend remains unchanged at €1.20 per entitled share.

Conference call
Fresenius Medical Care will host a conference call to discuss the results of the second quarter and first half of 2020 on July 30, 2020 at 3:30 p.m. CEDT (UTC +2) / 09:30 a.m. EDT (UTC -4). Details will be available on the company’s website www.freseniusmedicalcare.com in the "Investors" section. A replay will be available shortly after the call.

On July 30, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") reported that it will release its second quarter 2020 financial results on Tuesday, August 11, 2020, after the markets close (Press release, Aurinia Pharmaceuticals, JUL 30, 2020, View Source [SID1234562537]). Aurinia’s executive team will host a conference call to discuss the Company’s financial results and to provide a general business update.

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The conference call and webcast is scheduled for 4:30 pm EDT on August 11, 2020. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

On July 30, 2020 AstraZeneca’s Tagrisso (osimertinib) reported that it has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent (Press release, AstraZeneca, JUL 30, 2020, View Source [SID1234562536]).

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The Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging early clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.

While up to 30% of patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.1-6

José Baselga, Executive Vice President, Oncology R&D said: "Patients with early-stage EGFRm lung cancer often experience recurrence even after successful surgery and adjuvant chemotherapy, yet there are currently no approved targeted treatments to improve outcomes. The Phase III ADAURA trial with Tagrisso demonstrated an unprecedented level of clinical benefit in these patients, and we are working closely with the FDA to deliver this potentially curative treatment to patients as quickly as possible."

The FDA granted the BTD based on data from the Phase III ADAURA trial, which were also recently presented during the plenary session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program.

In the trial Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the adjuvant treatment of Stage IB-IIIA EGFRm NSCLC patients, reducing the risk of disease recurrence or death by 79% (HR 0.21; 95% CI 0.16-0.28; p<0.0001) in a key secondary endpoint. In April 2020, an Independent Data Monitoring Committee recommended for the trial to be unblinded two years early based on its determination of overwhelming efficacy.

Tagrisso is approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, Japan, China, the EU and many other countries around the world.

Lung cancer

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.7 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.8 The majority of all NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.1-3 A significant portion of patients with resectable NSCLC eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy. Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.9-11 These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors (TKIs) which block the cell-signalling pathways that drive the growth of tumour cells.12

ADAURA

ADAURA is a randomised, double-blinded, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumour resection and adjuvant chemotherapy as indicated. In the experimental arm, patients were treated with Tagrisso 80mg once-daily oral tablets for three years or until disease recurrence. The trial enrolled in more than 200 centres across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East. The primary endpoint DFS in Stage II and IIIA patients and a key secondary endpoint is DFS in Stage IB, II and IIIA patients. The data readout was originally anticipated in 2022. The trial will continue to assess OS.

Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have received approval in the US, Japan, China, the EU and many countries around the world for 1st-line EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being developed in the Stage III, unresectable setting (LAURA), in the neoadjuvant resectable setting (NeoADAURA), in combination with chemotherapy (FLAURA2) and in combination with potential new medicines to address resistance to EGFR-TKIs (SAVANNAH, ORCHARD).

AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action. AstraZeneca aims to address the unmet needs of patients with EGFRm tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and the EU and 30-40% of NSCLC patients in Asia, with the approved medicines Iressa (gefitinib) and Tagrisso, and its ongoing Phase III trials LAURA, NeoADAURA, and FLAURA2.9-11

AstraZeneca is committed to addressing tumour mechanisms of resistance through the ongoing Phase II trials SAVANNAH and ORCHARD which test Tagrisso in combination with savolitinib, a selective inhibitor of c-MET receptor tyrosine kinase, along with other potential new medicines. Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC) is in development for metastatic non-squamous HER2-overexpressing or HER2-mutated NSCLC including trials in combination with other anticancer treatments. In addition, DS-1062, a trophoblast cell-surface antigen 2 (TROP2)-directed ADC, is in early development for advanced NSCLC where TROP2 is overexpressed in the majority of patients.13

An extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a targetable genetic mutation which represents up to three-quarters of all patients with lung cancer.14 Imfinzi, an anti-PDL1 antibody, is in development for patients with advanced disease (Phase III trials POSEIDON and PEARL) and for patients in earlier stages of disease including potentially curative settings (Phase III trials MERMAID-1, AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) both as monotherapy and in combination with tremelimumab and/or chemotherapy. Imfinzi is also in development in the Phase II trials NeoCOAST, COAST and HUDSON in combination with potential new medicines from the early-stage pipeline including Enhertu.

AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On July 30, 2020 Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord), reported that the European Commission (Zer) has Zercepac, a biosimilar trastuzumab for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic stomach cancer (Press release, Henlius Biopharmaceuticals, JUL 30, 2020, View Source [SID1234562532]). The approval was based on a number of robust studies, including comparative quality studies as well as preclinical and clinical studies. The results confirmed the biosimilarity of Zercepac and showed an efficacy and safety comparable to the reference product Herceptin.

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The approval of the drug developed and manufactured by Henlius is an important milestone for both companies. Zercepac is the first monoclonal antibody (mAb) and third biosimilar marketed by Accord in Europe, and it is the first mAb developed by Henlius to be approved in the EU.

Dr. Scott Liu , co-founder and CEO of Henlius , said: "Henlius mission is to improve the lives of patients by providing them with high quality and affordable protein therapeutics through technical innovation and operational excellence. Approval of Zercepac in the EU is a major milestone in our global strategy, and this achievement demonstrates that our biological development and manufacturing capabilities have reached international standards. In the future, Henlius will continue to offer high quality biologicals as new treatments that will benefit patients worldwide. "

Paul Tredwell , VP Specialty Brands of Accord, EMENA, said: "This product is an exciting addition to our growing oncology portfolio that provides patients across Europe with access to more than 30 high quality, affordable oncology treatments. With Zercepac, our first mAb, we have firmly anchored our competence in the market launch of complex medications in order to guarantee an improved patient access and to offer cost-effective alternatives to the overloaded health systems ".

On July 30, 2020 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that it has received preliminary final results from the preclinical toxicology studies being conducted with its FAK inhibitor, AMP945 (Press release, Amplia Therapeutics, JUL 30, 2020, View Source;[email protected] [SID1234561580]). These data, together with those produced from the preclinical toxicology program to date, have not identified any toxicities that are likely to prevent a Phase 1 trial in healthy volunteers from progressing later this year as planned.

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The toxicology studies were conducted under a Good Laboratory Practice (GLP) quality framework and included repeat-dose administration of AMP945 in two species. Data from the repeat-dose studies allows the identification of a No Observed Adverse Effect Level (NOAEL) which can be used to determine the starting dose for the planned Phase 1 clincial trial. The Company is expecting to receive the consolidated report from these studies in late July.

Subject to approval from an independent Human Research Ethics Committee (HREC) and adequate funding, Amplia is planning to conduct the Phase 1 trial under the Australian Clinical Trials Notification (CTN) scheme. The aims of the trial will be to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AMP945 when given as single and multiple doses.

The trial is expected to take 6-9 months from first patient enrolment to collection of final data, with completion expected by mid-2021. Data from the Phase 1 trial will support the progression of AMP945 into a Phase 2 clinical trial program in patients with various solid cancers and/or with fibrotic diseases, such as idiopathic lung fibrosis (IPF), expected to commence in late 2021.

Dr John Lambert, Amplia’s CEO and Managing Director commented "we are very pleased to receive the final piece of key data from the preclinical studies conducted to date. Achieving this milestone marks an important transition for Amplia as we transform the Company into a clinical-stage drug development company."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics