Amgen Announces 2021 Third Quarter Dividend

On July 30, 2021 Amgen (NASDAQ: AMGN) reported that its Board of Directors declared a $1.76 per share dividend for the third quarter of 2021 (Press release, Amgen, JUL 30, 2021, View Source [SID1234585464]). The dividend will be paid on September 8, 2021, to all stockholders of record as of the close of business on August 17, 2021.

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Fresenius raises Group earnings guidance after very strong Q2

On July 30, 2021 Stephan Sturm, CEO of Fresenius, said: "Overall, our interim result for the 2021 business year is very strong (Press release, Fresenius, JUL 30, 2021, View Source [SID1234585463]). We have achieved very healthy sales and earnings growth, despite the ongoing impact of the pandemic . Our businesses are developing well, and we are making good progress on our initiatives for profitable growth and increased efficiency. The increased vaccination rates in many of our important markets are encouraging, but of course the pandemic is not over yet. We must remain vigilant and will continue to monitor the infection situation very closely. Nevertheless, there are reasons for us to be optimistic: Our growth drivers are intact, good health is and will remain of paramount importance to everyone. We will continue the review of our structures, and to drive efficiency measures along with our growth initiatives. The resulting benefits will allow us to sustainably develop our healthcare group even more successfully."

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COVID-19 assumptions for guidance FY/21
Whilst the pandemic exhibited a quite differentiated regional development, negative COVID-effects have – consistent with expectations – generally receded during Q2/21.
Fresenius had projected that the burdens and constraints caused by the pandemic will recede in the second half of the year. Now, however, the currently rising number of COVID-19 cases, the further evolution of COVID-19 virus mutations as well as stalling vaccination progress could all pose a threat to this assumption, and the company remains vigilant.
Whilst the risk of renewed far-reaching containment measures in one or more of Fresenius’ major markets currently appears less likely, it cannot be excluded. Any resulting significant and direct impact on the health care sector without appropriate compensation is not reflected in the Group’s FY/21 guidance. These assumptions are subject to considerable uncertainty.

FY/21 Group earnings guidance raised
Based on the Group’s strong Q2/21 and the progress in the program to improve Group-wide efficiencies, where the company expects first savings already this year, Fresenius raises its 2021 earnings guidance. The Company now projects net income1,2 to grow in a low single-digit percentage range in constant currency. Previously, Fresenius expected an at least broadly stable net income1,2 development in constant currency. The Company continues to project sales growth3 in a low-to-mid single-digit percentage range in constant currency.
Implicitly, net income1 for the Group excluding Fresenius Medical Care is now expected to grow in a high single-digit percentage range in constant currency. Previously, Fresenius expected mid-to-high single-digit percentage growth in constant currency.
The guidance implies ongoing COVID-19 related headwinds in the second half of the year. It reflects negative pricing effects related to tender activity at Fresenius Kabi in China as well as increasingly noticeable cost inflation effects across selected markets.
Fresenius projects net debt/EBITDA4 to be around the top-end of the self-imposed target corridor of 3.0x to 3.5x by the end of FY/21.

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA
2 FY/20 base: €1,796 million, before special items; FY/21: before special items
3 FY/20 base: €36,277 million
4 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures; excluding further potential acquisitions; before special items

For a detailed overview of special items please see the reconciliation table in the PDF document.

Progress on efficiency measures to sustainably improve profitability
To sustainably enhance profitability and operational excellence, Fresenius has launched group-wide efficiency initiatives. These measures are expected to gradually result in cost savings of more than €100 million p.a. after tax and minority interest in 2023, with some potential to increase thereafter.
While an update on the comprehensive operating model review at Fresenius Medical Care is expected to be provided in fall 2021, the three other Fresenius business segments have already identified and launched initiatives in defined areas.
At Fresenius Kabi, these initiatives comprise the optimization of its production network, reduction of product portfolio complexity, centralization of worldwide purchasing and review of organizational and cost structures.
Fresenius Helios will put a focus on its strategic review of the hospital portfolio and ambulatory care network as well as on the reduction of G&A costs.
Fresenius Vamed will implement some dedicated structural and organizational measures, comprising the optimization of its global subsidiary structure, the review of its assets and shareholdings portfolio and the optimization of procurement and G&A costs.
These activities specific to the business segments will be complemented and supported by initiatives on the Fresenius group level, for example, the implementation of new ways of working at the corporate headquarters as well as a group-wide review of the IT operating model.
Achieving these sustainable efficiencies will require significant up-front expenses. For the years 2021 to 2023, those expenses are expected to be more than €100 million p.a. after tax and minority interest on average, with the largest portion currently expected to materialize in 2022. They will be classified as special items, consistent with previous practice.
The company expects significant contributions from all four business segments and from the corporate center in the 2021 to 2023 period. Hence, it is expected that the savings contributed by Fresenius Medical Care will not be overproportional.
For FY/21, initial low double-digit million € savings after tax and minority interest from the Group’s above outlined cost and efficiency measures are expected to support the Group’s profitability. These savings and efficiency gains derive from activities in all four business segments.

Stephan Sturm, CEO of Fresenius, said: "We examine possible cost reductions with great care; and we implement them in a very targeted way, with a sense of proportion. We are saving because we have goals and want to realize them: We want to give ever more people access to ever better medicine. We want to contribute to keeping – or making – people healthy, to helping people enjoy their lives despite an illness. That is why we have a responsibility to use our valuable resources carefully. We will prioritize resources where they can have the biggest impact, remove duplication, and stop activities where results are not satisfying. This fitness program will benefit everyone: Our patients, the healthcare system, our employees and our shareholders."

8% sales increase in constant currency
Group sales increased by 4% (8% in constant currency) to €9,246 million (Q2/20: €8,920 million). Organic growth was 6%. Acquisitions/divestitures contributed net 2% to growth. Currency translation reduced sales growth by 4%. Excluding estimated COVID-19 effects1, Group sales growth would have been 6% to 7% in constant currency. In H1/21, Group sales increased by 1% (6% in constant currency) to €18,230 million (H1/20: €18,055 million). Organic growth was 4%. Acquisitions/divestitures contributed net 2% to growth. Currency translation reduced sales growth by 5%. Excluding estimated COVID-19 effects1, Group sales growth would have been 5% to 6% in constant currency.

20% net income2,3 increase in constant currency
Group EBITDA before special items decreased by 5% (0% in constant currency) to €1,671 million (Q2/20: €1,762 million). Reported Group EBITDA was €1,662 million (Q2/20: €1,762 million).
In H1/21, Group EBITDA before special items decreased by 6% (-1% in constant currency) to €3,302 million (H1/20: €3,517 million). Reported Group EBITDA was €3,290 million (H1/20: €3,517 million).

Group EBIT before special items decreased by 8% (-4% in constant currency) to €1,030 million (Q2/20: €1,123 million). The constant currency decrease is primarily due to COVID-19 related headwinds at Fresenius Medical Care. The EBIT margin before special items was 11.1% (Q2/20: 12.6%). Reported Group EBIT was €1,021 million (Q2/20: €1,123 million).
In H1/21, Group EBIT before special items decreased by 9% (-5% in constant currency) to €2,039 million (H1/20: €2,248 million). The constant currency decrease is primarily due to COVID-19 related headwinds at Fresenius Medical Care. The EBIT margin before special items was 11.2% (Q1/20: 12.5%). Reported Group EBIT was €2,027 million (H1/20: €2,248 million).

1 For estimated COVID-19 effects please see table in the PDF document
2 Before special items
3 Net income attributable to shareholders of Fresenius SE & Co. KGaA

For a detailed overview of special items please see the reconciliation table in the PDF document.

Group net interest before special items and reported net interest improved to -€121 million (Q2/202: -€167 million) mainly due to successful refinancing activities, lower interest rates as well as currency translation effects. In H1/21, Group net interest before special items improved to -€258 million (H1/202: -€341 million). Reported Group net interest improved to -€258 million (H1/20: -€349 million).

Group tax rate before special items was 21.5% (Q2/202: 23.5%) while reported Group tax rate was 21.3% (Q2/20: 23.4%). In H1/21, Group tax rate before special items was 22.1% (H1/202: 23.1%) while reported Group tax rate was 22.0% (H1/20: 23.0%).

Noncontrolling interests before special items were -€240 million (Q2/20: -€321 million) of which 89% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were -€237 million (Q2/20: -€321 million). In H1/21, noncontrolling interests before special items were -€477 million (H1/20: -€592 million) of which 92% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were -€473 million (Q2/20: -€592 million).

Group net income1 before special items increased by 16% (20% in constant currency) to €474 million (Q2/202: €410 million) driven by Helios Spain, Kabi’s Emerging Markets business as well as the favorable net interest development. Excluding estimated COVID-19 effects3, Group net income1 before special items would have grown 10% to 14% in constant currency. Reported Group net income1 increased to €471 million (Q2/20: €411 million).

In H1/21, Group net income1 before special items increased by 4% (8% in constant currency) to €910 million (H1/202: €875 million). Excluding estimated COVID-19 effects3, Group net income1 before special items would have grown 4% to 8% in constant currency. Reported Group net income1 increased to €906 million (H1/20: €870 million).

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA
2 Before special items
3 For estimated COVID-19 effects please see table in the PDF document.

For a detailed overview of special items please see the reconciliation table in the PDF document.

Earnings per share1 before special items increased by 15% (19% in constant currency) to €0.85 (Q2/202: €0.74). Reported earnings per share1 were €0.84 (Q2/20: €0.74). In H1/21, earnings per share1 before special items increased by 4% (8% in constant currency) to €1.63 (H1/202: €1.57). Reported earnings per share1 were €1.62 (H1/20: €1.56).

Continued investment in growth
Spending on property, plant and equipment was €509 million corresponding to 6% of sales (Q2/20: €474 million; 5% of sales). These investments served primarily for the modernization and expansion of dialysis clinics, production facilities as well as hospitals and day clinics. In H1/21, spending on property, plant and equipment was €893 million corresponding to 5% of sales (H1/20: €1,021 million; 6% of sales).

Total acquisition spending was €491 million (Q2/20: €97 million) mainly for the acquisition of Eugin Group at Fresenius Helios which has been consolidated since April 1, 2021, and the acquisition of dialysis clinics at Fresenius Medical Care. In H1/21, total acquisition spending was €640 million (H1/20: €509 million).

Cash flow development
Group operating cash flow decreased to €1,451 million (Q2/20: €3,082 million) with a margin of 15.7% (Q2/20: 34.6%). The decline was mainly due to the U.S. federal government’s payments in Q2/20 under the CARES Act, the start of recoupment of these advanced payments in Q2/21 as well as the timing of certain other expense payments in 2021 at Fresenius Medical Care. Free cash flow before acquisitions and dividends decreased correspondingly to €952 million (Q2/20: €2,606 million). Free cash flow after acquisitions and dividends decreased to -€359 million (Q2/20: €2,374 million).
In H1/21, Group operating cash flow decreased to €2,103 million (H1/20: €3,960 million) with a margin of 11.5% (H1/20: 21.9%). Free cash flow before acquisitions and dividends decreased to €1,193 million (H1/20: €2,911 million). Free cash flow after acquisitions and dividends decreased to -€242 million (H1/20: €2,334 million).

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA
2 Before Special items

Solid balance sheet structure
Group total assets increased by 5% (3% in constant currency) to €69,655 million (Dec. 31, 2020: €66,646 million) given the expansion of business activities and currency effects. Current assets increased by 7% (6% in constant currency) to €16,901 million (Dec. 31, 2020: €15,772 million) mainly driven by the increase of trade accounts receivables, cash and cash equivalents and inventories. Non-current assets increased by 4% (2% in constant currency) to €52,754 million (Dec. 31, 2020: €50,874 million).

Total shareholders’ equity increased by 4% (2% in constant currency) to €27,131 million (Dec. 31, 2020: €26,023 million). The equity ratio was 39.0% (Dec. 31, 2020: 39.0%).

Group debt increased by 5% (4% in constant currency) to €27,289 million (Dec. 31, 2020: € 25,913 million). Group net debt increased by 4% (3% in constant currency) to € 25,039 million (Dec. 31, 2020: € 24,076 million).

As of June 30, 2021, the net debt/EBITDA ratio increased to 3.60×1,2 (Dec. 31, 2020: 3.44×1,2) driven by COVID-19 effects weighing on EBITDA as well as increased net debt.

1 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures
2 Before special items

For a detailed overview of special items please see the reconciliation table in the PDF document.

Business Segments

Fresenius Medical Care (Financial data according to Fresenius Medical Care press release)
Fresenius Medical Care is the world’s largest provider of products and services for individuals with renal diseases. As of June 30, 2021, Fresenius Medical Care was treating approximately 346,000 patients in more than 4,100 dialysis clinics. Along with its core business, the Renal Care Continuum, the company focuses on expanding in complementary areas and in the field of critical care.

• As assumed, COVID-19 pandemic continued to impact organic growth in dialysis and downstream businesses; patient excess mortality rates significantly reduced
• Negative exchange rate effects continue
• Earnings development impacted by phasing and strong prior-year base, as indicated
• Financial targets for FY 2021 confirmed

Sales of Fresenius Medical Care decreased by 5% (increased by 2% in constant currency) to €4,320 million (Q2/20: €4,557 million). Thus, currency translation had a negative effect of 7%. Organic growth was 1%. In H1/21, sales of Fresenius Medical Care decreased by 6% (increased by 2% in constant currency) to €8,530 million (H1/20: €9,045 million). Thus, currency translation had a negative effect of 8%. Organic growth was 1%.

EBIT decreased by 35% (-30% in constant currency) to €424 million (Q2/20: €656 million) resulting in a margin of 9.8% (Q2/20: 14.4%). EBIT before special items declined by 34% to €430 million (-29% in constant currency; Q2/20: €656 million), resulting in a margin of 10.0% (Q2/20: 14.4%). The decrease was mainly due to the adverse impact of the COVID-19 pandemic, including a high prior-year base as a result of government relief funding, the expected phasing and increase in Sales, General and Administrative expense, negative exchange rate effects and higher direct costs. These effects were partially offset in particular by an improved Medicare Advantage payor mix in the U.S.

1 Before special items
2 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA

For a detailed overview of special items please see the reconciliation table in the PDF document.

In H1/21, EBIT decreased by 26% (-20% in constant currency) to €898 million (H1/20: €1,211 million) resulting in a margin of 10.5% (H1/20: 13.4%). EBIT before special items decreased by 25% (-19% in constant currency) to €907 million (Q2/20: €1,211 million) resulting in an EBIT margin excluding special items of 10.6% (H1/20: 13.4%).

Net income1 decreased by 38% (-33% in constant currency) to €219 million (Q2/20: €351 million). Net income1 before special items decreased by 37% (-31% in constant currency) to €223 million (Q2/20: €351 million).

In H1/21, net income1 decreased by 26% (-21% in constant currency) to €468 million (H1/20: €634 million). Net income1 before special items decreased by 25% (-20% in constant currency) to €474 million (H1/20: €634 million).

Operating cash flow was €921 million (Q2/20: €2,319 million) with a margin of 21.3% (Q2/20: 50.9%). The decline was mainly due to the U.S. federal government’s payments in Q2/20 under the CARES Act, the start of recoupment of these advanced payments in Q2/21 as well as the timing of certain other expense payments in 2021. In H1/21, operating cash flow was €1,129 million (H1/20: €2,903 million) with a margin of 13.2% (H1/20: 32.1%).

For FY/21, Fresenius Medical Care confirms its outlook as outlined in February 2021. The Company expects revenue2 to grow at a low-to-mid single-digit percentage range and net income1,3 to decline at a high-teens to mid-twenties percentage range against the 2020 base4. This outlook is based on the assumption of a return to normalized mortality rates in H2/21.

Chugai Continues to be Listed for All ESG Indices Selected by GPIF

On July 30, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has been continuously included as a constituent stock in all indices of the Japanese equities for environmental, social and governance (ESG) investment selected by the Government Pension Investment Fund (GPIF) of Japan (Press release, Chugai, JUL 30, 2021, View Source [SID1234585462]).

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FTSE Blossom Japan Index (commenced investment from July 2017):
An index designed to reflect the performance of Japanese companies demonstrating excellent environmental, social, and governance practices.
MSCI Japan ESG Select Leaders Index (commenced investment from July 2017):
An index created from the stocks of companies with a relatively high ESG rating in each industry from among the top 700 Japanese companies by market capitalization.
MSCI Japan Empowering Women Index (WIN) (commenced investment from July 2017):
An index created from a selection of companies with excellent gender diversity practices in each industry from among the top 700 Japanese companies by market capitalization.
S&P/JPX Carbon Efficient Index (commenced investment from September 2018):
An index designed to measure the performance of companies in the Tokyo Stock Price Index (TOPIX) based on disclosures of environmental information and levels of carbon efficiency.
*Chugai is included in all four ESG indices since the initiation of ESG investment.

The sustainability of Chugai has been highly regarded in terms of ESG practices, as Chugai has been selected as a constituent in the FTSE4Good Index Series for the 19th consecutive year and in the MSCI ESG Leaders Indexes for the 12th consecutive year, both of which are major ESG indices. In addition, we have continued to receive an "AA," rating, the second-highest of the seven levels in the MSCI ESG rating that evaluates ESG risk tolerance, indicating that our risk tolerance to various ESG risks that may occur in the future is relatively high.

Chugai’s basic management policy is "creating shared value between our company and society" and "realize advanced and sustainable medical care centered on patients." This philosophy is also in line with the "Sustainable Development Goals (SDGs)" set by the United Nations. Chugai will continue to strive for appropriate disclosure of information on the SDGs and ESG initiatives, create value for patients and society by leveraging innovation that only Chugai can provide, and contribute to solving social issues and building a sustainable society through our business activities.

Study reveals source of DNA mutations in melanoma

On July 30, 2021 Van Andel Institute reported that The mutations that give rise to melanoma result from a chemical conversion in DNA fueled by sunlight — not just a DNA copying error as previously believed, report a study by Van Andel Institute scientists published today in Science Advances (Press release, Van Andel Institute, JUL 30, 2021, View Source;utm_medium=rss&utm_campaign=pfeifer-melanoma-mutations [SID1234585461]).

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The findings upend long-held beliefs about the mechanisms underlying the disease, reinforce the importance of prevention efforts and offer a path forward for investigating the origins of other cancer types.

Gerd Pfeifer, Ph.D.

"Cancers result from DNA mutations that allow defective cells to survive and invade other tissues. However, in most cases, the source of these mutations is not clear, which complicates development of therapies and prevention methods," said Gerd Pfeifer, Ph.D., a VAI professor and the study’s corresponding author. "In melanoma, we’ve now shown that damage from sunlight primes the DNA by creating ‘premutations’ that then give way to full mutations during DNA replication."

Melanoma is a serious type of skin cancer that begins in pigment-producing skin cells. Although less common than other types of skin cancer, melanoma is more likely to spread and invade other tissues, which significantly reduces patient survival. Previous large-scale sequencing studies have shown that melanoma has the most DNA mutations of any cancer. Like other skin cancers, melanoma is linked to sun exposure, specifically a type of radiation called UVB. Exposure to UVB damages skin cells as well as the DNA within cells.

Most cancers are thought to begin when DNA damage directly causes a mutation that is then copied into subsequent generations of cells during normal cellular replication. In the case of melanoma, however, Pfeifer and his team found a different mechanism that produces disease-causing mutations — the introduction of a chemical base not normally found in DNA that makes it prone to mutation.

DNA comprises four chemical bases that exist in pairs— adenine (A) and thymine (T), and cytosine (C) and guanine (G). Different sequences of these pairs encode all of the instructions for life. In melanoma, the problem occurs when UVB radiation from the sun hits certain sequences of bases — CC, TT, TC and CT — causing them to chemically link together and become unstable. The resulting instability causes a chemical change to cytosine that transforms it into uracil, a chemical base found in the messenger molecule RNA but not in DNA. This change, called a "premutation," primes the DNA to mutate during normal cell replication, thereby causing alterations that underlie melanoma.

These mutations may not cause disease right away; instead, they may lay dormant for years. They also can accumulate as time goes on and a person’s lifetime exposure to sunlight increases, resulting in a tough-to-treat cancer that evades many therapeutic options.

"Safe sun practices are very important. In our study, 10–15 minutes of exposure to UVB light was equivalent to what a person would experience at high noon, and was sufficient to cause premutations," Pfeifer said. "While our cells have built-in safeguards to repair DNA damage, this process occasionally lets something slip by. Protecting the skin is generally the best bet when it comes to melanoma prevention."

The findings were made possible using a method developed by Pfeifer’s lab called Circle Damage Sequencing, which allows scientists to "break" DNA at each point where damage occurs. They then coax the DNA into circles, which are replicated thousands of times using a technology called PCR. Once they have enough DNA, they use next-generation sequencing to identify which DNA bases are present at the breaks. Going forward, Pfeifer and colleagues plan to use this powerful technique to investigate other types of DNA damage in different kinds of cancer.

Other authors include Seung-Gi Jin, Ph.D., Dean Pettinga, Jennifer Johnson and Peipei Li, Ph.D., of VAI.

Research reported in this publication was supported by Van Andel Institute and the National Cancer Institute of the National Institutes of Health under award no. R21CA228089 (Pfeifer). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

XBiotech Announces Payment of Dividend to Holders of Common Stock

On July 30, 2021 XBiotech Inc. (NASDAQ: XBIT) ("XBiotech") reported that it has completed payment to holders of its Common Stock of a previously announced dividend in the amount of USD$75,000,000.00. Based on the number of shares of Common Stock issued and outstanding on the record date for the dividend, each such holder received USD$2.47 per share on July 23, 2021 (Press release, XBiotech, JUL 30, 2021, View Source [SID1234585457]).

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In the past 18 months, XBiotech’s balance sheet strength has enabled the company to offer approximately USD$495 million in cash to shareholders by way of stock repurchase and dividend distribution. The financial strength of the Company owes to the successful development of a pipeline of True Human antibody drug candidates.

John Simard stated that "XBiotech was pleased to be able to reward its shareholders with a $2.47 per share dividend. Our ability to continue to provide opportunities for shareholders to monetize stock in XBiotech, reflects the strength of our fundamental approach to our industry. It begins with a visionary strategy to create a drug pipeline from natural human immunity—which offers an array of exceptional candidate therapeutics. Proprietary manufacturing technology developed at XBiotech has reduced our capital outlays needed for producing drug product, enabling us to build a drug development infrastructure debt-free. Integrating clinical operations has allowed us to conduct our own clinical trials, to test our breakthrough therapies, for a fraction of the cost of the standard industry approach, which involves the use of expensive clinical research contractors. Finally, from our manufacturing technology and clinical operations, we have generated contract revenue that has largely offset operating costs over the past two years. In short, we have stayed the course with our science and pushed the boundaries of industry practices to develop breakthrough therapies, reduce costs and create returns for our shareholders. We have never been more excited about our pipeline and opportunities than we are today."

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.