Lineage to Present at the Raymond James 42nd Annual Institutional Investors Conference on March 1, 2021 and the H.C. Wainwright Global Life Sciences Conference on March 9, 2021

On February 23, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that Brian M. Culley, Chief Executive Officer, will be presenting at the Raymond James 42nd Annual Institutional Investors conference on March 1, 2021 at 11:40am Eastern Time / 8:40am Pacific Time (Press release, Lineage Cell Therapeutics, FEB 23, 2021, View Source [SID1234575438]). Mr. Culley will also be presenting at the H.C. Wainwright Global Life Sciences Conference, being held virtually March 9-10, 2021.

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Interested investors can access the live and archived webcasts on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.

Clovis Oncology Announces 2020 Operating Results

On February 23, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter and year ended December 31, 2020, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for 2021 (Press release, Clovis Oncology, FEB 23, 2021, View Source [SID1234575437]).

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"Despite the evident COVID-related challenges of 2020, we are pleased with our overall sales performance and pipeline progress," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Most importantly, we advanced our development programs in 2020, positioning them for important potential achievements in 2021, including the initiation of clinical development for FAP-2286 in the first half of the year, top-line ATHENA monotherapy data in the second half of the year and initial efficacy data for the LIO-1 lucitanib and Opdivo combination trial at medical meetings later this year. While early, we are increasingly enthusiastic about FAP-2286 and our commitment to becoming a leader in the emerging field of targeted radionuclide therapy."

Fourth Quarter and Year-End 2020 Financial Results

Clovis reported global net product revenues for Rubraca of $43.3 million for the fourth quarter of 2020, which included U.S. product revenues of $36.4 million and ex-U.S. product revenues of $6.9 million, respectively. This represents a 10 percent increase year-over-year compared to Q4 2019 net product revenues of $39.3 million, which included U.S. net product revenues of $36.1 million and ex-U.S. net product revenues of $3.2 million.

Rubraca global net product revenues for 2020 were $164.5 million, which included $146.3 million in the U.S. and $18.2 million in ex-U.S. product revenues, respectively. This represents a 15 percent increase year-over-year compared to 2020 net product revenues of $143.0 million, which included $137.2 million in the U.S. and ex-U.S. net product revenues of $5.8 million.

Research and development expenses totaled $56.7 million for Q4 2020 and $257.7 million for FY 2020, down 22 percent and 9 percent, respectively, compared to $72.5 million and $283.1 million for the comparable periods in 2019. Research and development expenses decreased for the quarter and year compared to the same periods in the prior year due primarily to lower spending on Rubraca clinical trials. We expect research and development expenses to be lower in the full year 2021 compared to 2020.

Selling, general and administrative expenses totaled $40.8 million for Q4 2020 and $163.9 million for FY 2020, both down 10 percent compared to $45.2 million and $182.8 million for the comparable periods in 2019. Selling, general and administrative expenses decreased during the quarter and year compared to the same periods in the prior year with savings due to the COVID-19 situation globally and overall cost reduction efforts. We expect selling, general and administrative expenses to decrease in the full year 2021 compared to 2020.

Clovis reported a net loss for the fourth quarter of 2020 of $99.0 million, or ($1.02) per share, and a net loss of $369.2 million, or ($4.38) per share, for FY 2020. Net loss for Q4 2019 was $99.5 million, or ($1.81) per share, and $400.4 million, or a net loss of ($7.43) per share, for FY 2019. Net loss for Q4 and FY 2020 included share-based compensation expense of $12.0 million and $50.8 million, compared to $12.6 million and $54.3 million for the comparable periods of 2019.

Clovis had $240.2 million in cash and cash equivalents as of December 31, 2020, which is expected to fund the Company’s operating plan into early 2023 based on current revenue and expense forecasts.

As of December 31, 2020, the Company had drawn approximately $100 million under the Sixth Street Partners, LLC ATHENA clinical trial financing and had up to $75 million available to draw under the agreement to fund the expenses of the ATHENA trial.

Net cash used in operating activities was $56.1 million for the fourth quarter of 2020, down from $70.1 million reported in the fourth quarter of 2019. Similarly, net cash used in operating activities for FY 2020 was $252.7 million, compared with $323.6 million for FY 2019. Cash burn in Q4 2020 was $40.9 million, down 27 percent from the Q4 2019 quarter cash burn of $56.3 million. Cash burn for the twelve months ended December 31, 2020 was $195.6M million, down 36 percent from the twelve months ended 2019 cash burn of $304.7 million. We expect this trend of lower cash burn to continue in 2021.

Clovis Oncology Pipeline Highlights

Rubraca ARIEL4 Study Met Primary Endpoint of Improved PFS Compared to Chemotherapy

In December, Clovis announced the top line results of the ARIEL4 randomized Phase 3 study of Rubraca versus standard-of-care chemotherapy, in which Rubraca met the primary endpoint of significantly improving progression-free survival (PFS) in later-line ovarian cancer patients with a BRCA mutation. The safety observed in the study was highly consistent with both the U.S. and European labels. These results were submitted as a late-breaking abstract and accepted as an oral presentation at the upcoming Society for Gynecologic Oncology Virtual Annual Meeting in March. Completion of ARIEL4 is a post-marketing commitment in the U.S. and Europe.

Anticipated Rubraca Pipeline Events in 2021

Top-line data from the ATHENA Phase 3 study in first-line maintenance treatment ovarian cancer setting evaluating Rubraca monotherapy versus placebo are expected in the second-half of 2021, contingent on achieving sufficient PFS events. Data from the combination arm of Rubraca plus Opdivo versus Rubraca monotherapy are expected a year or more later.

LODESTAR, the Company’s Phase 2 trial of Rubraca in patients with solid tumors with deleterious mutations in homologous recombination repair (HRR) genes is currently enrolling. This study may be registration-enabling with a potential regulatory filing by the end of 2021 or first-half 2022.

LuMIERE Phase 1/2 Study of FAP-2286 Expected to Begin 1H 2021

FAP-2286 is Clovis Oncology’s peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) and represents its lead candidate in the PTRT development program. Clovis intends to initiate the Phase 1/2 LuMIERE clinical study of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286) to determine the dose and tolerability of the FAP-targeting therapeutic agent (Phase 1), with expansion cohorts planned in multiple tumor types (Phase 2). FAP-2286 labelled with gallium-68 (68Ga-FAP-2286) will be utilized as a diagnostic to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. The LuMIERE study is expected to begin in the first half of 2021, pending acceptance by the FDA of gallium-68 CMC data from clinical sites.Other studies of FAP-2286 linked to an alpha-particle emitting radionuclide and combination studies are also being planned.

Interim LIO-1 data of Lucitanib and Opdivo in Combination Expected in 2021

The Phase 2 part of the LIO-1 study of lucitanib in combination with Opdivo continues to enroll patients with gynecologic cancers, and Clovis Oncology intends to present initial data at 2021 medical meetings, which are expected to include interim results from the ovarian and endometrial cancer expansion cohorts.

Conference Call Details

Clovis will hold a conference call to discuss Q4/FY 2020 results this morning, February 23, at 8:30am ET. The conference call will be simultaneously webcast on the Clovis Oncology web site www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 5869256.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is approved in the U.S. for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

About Lucitanib

Lucitanib is an investigational angiogenesis inhibitor, which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis holds global rights for lucitanib excluding China.

Lucitanib is an unlicensed medical product.

About FAP-2286

FAP-2286 is a preclinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two parts; a peptide that binds to FAP and a linker and site that can be used to attach radiation for imaging and therapeutic use. FAP is highly expressed in many epithelial cancers, including more than 90 percent of breast, lung, colorectal and pancreatic carcinomas. Clovis holds U.S. and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Peptide-Targeted Radionuclide Therapy

Peptide-targeted radionuclide therapy (PTRT) is a form of targeted radiotherapy that is emerging as a new treatment option for patients with cancer.These therapies consist of a small amount of a radioactive isotope, known as a radionuclide, linked to a cell-targeting peptide that binds to a cancer specific protein which selectively directs the radionuclide to tumors.Following binding, the radionuclide warhead emits ionizing radiation causing DNA damage and cell death to neighboring tumor cells.

Fresenius achieves 2020 targets and expects healthy business development in 2021 despite ongoing COVID-19 impact

On February 23, 2021 Stephan Sturm, CEO of Fresenius reported The pandemic year 2020 showed emphatically the importance of forward-thinking, effective and efficient healthcare (Press release, Fresenius, FEB 23, 2021, View Source [SID1234575436]). Fresenius is making a vital contribution here, in many different areas of medicine. This year, the pandemic will again present us with a number of challenges, making it even more important that we increase efficiency in order to improve our cost base. Beyond our established businesses, we will also expand in important growth areas including biosimilars, digital healthcare, home dialysis and fertility medicine. By doing so, we are laying the foundations for more dynamic growth in the coming years. Even though the pandemic and its consequences are keeping us busy right now, we are already looking ahead and setting the course for the medicine of the future. In this way, we are also securing our company’s sustainable economic success."

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FY/21 Group guidance
For FY/21, Fresenius projects sales growth1 in a low to mid-single-digit percentage range and at least broadly stable net income2,3 year-over-year, both in constant currency. Implicitly, net income2 for the Group excluding Fresenius Medical Care is expected to grow in a mid-to high single digit percentage range in constant currency. 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.

COVID-19 assumptions for guidance FY/21
COVID-19 will continue to impact Fresenius’ operations in 2021. Current burdens and constraints caused by COVID-19 are expected to recede only in H2/21. The expected improvement in the Group’s relevant business environment from H2/21 is heavily dependent on continuously increasing levels of vaccination coverage in Fresenius’ relevant markets. These assumptions are subject to considerable uncertainty.
Fresenius closely monitors the development of COVID-19 case numbers, and the associated various containment measures being enacted in many of the Company’s relevant markets. A possible significant deterioration of the situation associated with further containment measures that could have a significant and direct impact on the health care sector without any appropriate compensation is not reflected in the Group’s FY/21 guidance.

1 FY/20 base: €36,277 million
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/20 base: €1,796 million; before special items; FY/21: before special items
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 tables in the PDF document.

Efficiency and cost saving programs
COVID-19 has led and will lead to a shortfall relative to our original expectations in FY/20 and FY/21 as well as to ongoing incremental uncertainty. Fresenius is hence planning to launch group-wide strategic efficiency initiatives to further safeguard the confirmed medium-term targets and sustainably enhance profitability. These initiatives are expected to consist of operational excellence and cost-saving measures, targeted strengthening of future growth areas and portfolio optimizations. The operational excellence and cost-saving measures are targeted to result in cost savings of at least €100 million p.a. after tax and minority interest in 2023 with some further potential to increase thereafter. We anticipate that achieving these sustainable efficiencies will require significant up-front expenses. On average for the years 2021 to 2023, those expenses are expected to be in the order of magnitude of €100 million p.a. after tax and minority interest. They will be classified as special items. Further information will be provided during our Q1 earnings call on May 6, 2021.

Growth targets for 2020 – 2023 confirmed
Fresenius continues to expect Group sales to grow organically with a compounded annual growth rate (CAGR) of 4% to 7% during 2020 to 2023. Group net income1,2 is projected to increase organically with a CAGR of 5% to 9% during 2020 to 2023. Fresenius expects its sales growth and efficiency improvement initiatives as well as Fresenius Kabi’s biosimilars business to drive an acceleration of Group earnings growth over that period. Small and medium-sized acquisitions are expected to contribute an incremental CAGR of approx. 1%-point to both sales and net income growth.

28th consecutive dividend increase proposed
The Management Board of Fresenius will propose to the Supervisory Board a dividend increase of 5% to €0.88 per share for FY/20 (FY/19: €0.84). Provided the proposal is approved by the Supervisory Board and the Annual General Meeting, this will be the 28th consecutive dividend increase.

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA
2 Before special items
For a detailed overview of special items please see the reconciliation tables in the PDF document.

5% sales growth in constant currency
Group sales remained on prior year’s level (increased by 5% in constant currency) at €9,304 million (Q4/19: €9,311 million). Organic growth was 2%. Acquisitions/ divestitures contributed net 3% to growth. Currency translation reduced sales growth by 5%. Excluding estimated COVID-19 effects1, Group sales growth would have been 7% to 8% in constant currency.
In FY/20, Group sales increased by 2% (5% in constant currency) to €36,277 million (FY/19: €35,409 million). Organic growth was 3%. Acquisitions/divestitures contributed net 2% to sales growth. Currency translation reduced sales growth by 3%. Excluding estimated COVID-19 effects1, Group sales growth would have been 7% to 8% in constant currency.

2% net income2,3 growth in constant currency
Group EBITDA before special items decreased by 3% (increased by 3% in constant currency) to €1,886 million (Q4/192: €1,937 million). Reported Group EBITDA was €1,854 million (Q4/19: €1,937 million).
In FY/20, Group EBITDA before special items remained on prior year’s level (increased by 2% in constant currency) at €7,132 million (FY/192: €7,104 million). Reported Group EBITDA was €7,100 million (FY/19: €7,083 million).

Group EBIT before special items decreased by 3% (increased by 2% in constant currency) to €1,251 million (Q4/192: €1,287 million). The constant currency increase is due to the positive development at Fresenius Medical Care and Fresenius Helios. Missing contributions from elective procedures, volume headwinds leading to underutilized production capacities, headwinds at Fresenius Kabi North America, COVID-19 related project delays at Fresenius Vamed as well as Group-wide incremental COVID-19 related expenses weighed on EBIT. The EBIT margin before special items was 13.4% (Q4/192: 13.8%). Reported Group EBIT was €1,024 million (Q4/19: €1,269 million). In FY/20, Group EBIT before special items decreased by 2% (0% in constant currency) to €4,612 million (FY/192: €4,688 million). The EBIT margin before special items was 12.7% (FY/192: 13.2%). Higher levels of investments in recent years triggered incremental depreciation charges. Reported Group EBIT was €4,385 million (FY/19: €4,631 million).

Group net interest before special items improved to -€159 million (Q4/192: -€182 million) mainly due to successful refinancing activities, lower interest rates as well as currency translation effects. Reported Group net interest improved to -€156 million (Q4/19: -€184 million).

1 For estimated COVID-19 effects in Q4/20 and FY/20 please see table on page 18 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 tables in the PDF document.

In FY/20, Group net interest before special items improved to -€654 million (FY/191: – €714 million) while reported Group net interest improved to -€659 million (FY/19: -€719 million).

The Group tax rate before special items was 24.1% (Q4/191: 23.8%) and the reported Group tax rate was 29.4% (Q4/19: 23.0%). The increase is due to a not tax deductible €195 million impairment of goodwill and tradenames in the Latin America segment at Fresenius Medical Care. In FY/20, the Group tax rate before special items was 23.1% (FY/191: 23.3%) and the reported Group tax rate was 24.2% (FY/19: 22.6%).

Noncontrolling interests before special items were €335 million (Q4/191: €336 million) of which 93% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were €203 million (Q4/19 reported: €320 million). In FY/20, noncontrolling interests before special items were €1,248 million (FY/191: €1,170 million) of which 96% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were €1,116 million (FY/19 reported: €1,146 million).

Group net income2 before special items decreased by 2% (increased by 2% in constant currency) to €494 million (Q4/19: €506 million). Excluding estimated COVID-19 effects3, Group net income2 before special items would have grown 3% to 7% in constant currency. Reported Group net income2 decreased to €410 million (Q4/19: €515 million). The decrease is mainly due to an impairment of goodwill and tradenames in the Latin America segment at Fresenius Medical Care and the increased valuation of the biosimilars contingent purchase price liabilities at Fresenius Kabi. In FY/20, Group net income2 before special items decreased by 4% (-3% in constant currency) to €1,796 million (FY/191: €1,879 million). Excluding estimated COVID-19 effects3, Group net income2 before special items would have grown 2% to 6% in constant currency. Reported Group net income2 decreased to €1,707 million (FY/19: €1,883 million).

Earnings per share2 before special items decreased by 2% (increased by 2% in constant currency) to €0.88 (Q4/191: €0.90). Reported earnings per share2 were €0.73 (Q4/19: €0.92). In FY/20, earnings per share2 before special items decreased by 4% (-3% in constant currency) to €3.22 (FY/191: €3.37). Reported earnings per share2 were €3.06 (FY/191: €3.38).

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 For estimated COVID-19 effects in Q4/20 and FY/20 please see table on page 18 in the PDF document.
For a detailed overview of special items please see the reconciliation tables in the PDF document.

Continued investment in growth
Spending on property, plant and equipment was €856 million corresponding to 9% of sales (Q4/19: €871 million; 9% of sales). These investments served primarily for the modernization and expansion of dialysis clinics, production facilities as well as hospitals and day clinics. Despite the COVID-19 pandemic, Fresenius has been largely able to continue its investment programs. In FY/20, spending on property, plant and equipment was €2,398 million corresponding to 7% of sales (FY/19: €2,463 million; 7% of sales).

Total acquisition spending was €251 million (Q4/19: €331 million). In FY/20, total acquisition spending was €902 million, mainly for the purchase of hospitals by Fresenius Helios in Germany and Colombia (FY/19: €2,623 million, mainly for the acquisition of NxStage by Fresenius Medical Care).

Good cash flow development
Group operating cash flow increased to €1,390 million (Q4/19: €1,286 million) with a margin of 14.9% (Q4/19: 13.8%). Free cash flow before acquisitions and dividends increased to €590 million (Q4/19: €442 million). Free cash flow after acquisitions and dividends increased to €329 million (Q4/19: €89 million).

In FY/20, Group operating cash flow increased to €6,549 million (FY/19: €4,263 million) with a margin of 18.1% (FY/19: 12.0%). The increase was largely driven by Fresenius Medical Care due to the U.S. federal relief funding and advanced payments under the Coronavirus Aid, Relief and Economic Security Act (CARES Act) as well as by the shorter payment periods of the COVID-19 governmental compensation and reimbursement scheme for Helios Germany. Also excluding these COVID-19 effects, Group operating cash flow would have grown year-over-year. Free cash flow before acquisitions and dividends increased to €4,183 million (FY/19: €1,830 million). Free cash flow after acquisitions and dividends increased to €2,478 million (FY/19: -€1,545 million, driven by Fresenius Medical Care’s acquisition of NxStage).

Solid balance sheet structure
Group total assets decreased by 1% (increased by 5% in constant currency) to €66,646 million (Dec. 31, 2019: €67,006 million). The decrease is mainly due to currency translation effects outweighing the expansion of business activities. Current assets increased by 3% (10% in constant currency) to €15,772 million (Dec. 31, 2019: €15,264 million), mainly driven by the increase of cash and cash equivalents. Non-current assets decreased by 2% (increased by 3% in constant currency) to €50,874 million (Dec. 31, 2019: €51,742 million).

Total shareholders’ equity decreased by 2% (increased by 6% in constant currency) to €26,023 million (Dec. 31, 2019: €26,580 million). The equity ratio was 39.0% (Dec. 31, 2019: 39.7%).

Group debt decreased by 5% (-2% in constant currency) to €25,913 million (Dec. 31, 2019: € 27,258 million). Group net debt decreased by 6% (-4% in constant currency) to € 24,076 million (Dec. 31, 2019: € 25,604 million), driven by the exceptional cash flow development.

As of December 31, 2020, the net debt/EBITDA ratio improved to 3.44×1,2 (Dec. 31, 2019: 3.61×1,2) driven by the exceptional cash flow development, despite COVID-19 effects weighing on EBITDA.

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 tables on pages 20-22 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 December 31, 2020, Fresenius Medical Care was treating 346,553 patients in 4,092 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.

Sales of Fresenius Medical Care decreased by 4% (increased by 4% in constant currency) to €4,400 million (Q4/19: €4,580 million). Thus, currency translation had a negative effect of 8%. Organic growth was 1%. Acquisitions/divestitures contributed net 3% to growth. In FY/20, Fresenius Medical Care increased sales by 2% (5% in constant currency) to €17,859 million (FY/19: €17,477 million). Thus, currency translation had a negative effect of 3%. Organic growth was 3%. Acquisitions/divestitures contributed net 2% to growth.

Reported EBIT decreased by 25% (-18% in constant currency) to €462 million (Q4/19: €616 million). The decrease was mainly due to a macro-economic driven impairment of goodwill and tradenames in the Latin America segment, unfavorable COVID-19 effects and a lower reimbursement for calcimimetics. The reported EBIT margin was 10.5% (Q4/19: 13.5%). EBIT on an adjusted basis decreased by 1% (increased by 5% in constant currency) to €657 million (Q4/19: €663 million). The EBIT margin on an adjusted basis was 14.9% (Q4/19: 14.5%).

In FY/20, reported EBIT increased by 2% (4% in constant currency) to €2,304 million (FY/19: €2,270 million). The reported EBIT margin was 12.9% (FY/19: 13.0%). EBIT on an adjusted basis increased by 6% (8% in constant currency) to €2,499 million (FY/19: €2,356 million). The EBIT margin on an adjusted basis was 14.0% (FY/19: 13.5%).

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 tables on pages 20-22 in the PDF document.

Reported net income1 decreased by 48% (-43% in constant currency) to €177 million (Q4/19: €343 million) and increased on an adjusted basis by 1% (6% in constant currency) to €372 million (Q4/19: €368 million). In FY/20, reported net income1 decreased by 3% (-1% in constant currency) to €1,164 million (FY/19: €1,200 million) and increased on an adjusted basis by 10% (12% in constant currency) to €1,359 million (FY/19: €1,236 million).

Operating cash flow was €584 million (Q4/19: €771 million) with a margin of 13.3% (Q4/19: 16.8%). In FY/20, operating cash flow was €4,233 million (FY/19: €2,567 million) with a margin of 23.7% (FY/19: 14.7%). The increase was largely driven by the U.S. federal relief funding and advanced payments under the CARES Act and other COVID-19 relief, as well as working capital improvements driven by cash collections.

For FY/21, Fresenius Medical Care 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 higher than expected 2020 base4.

For further information, also on the FME25 program, please see Fresenius Medical Care’s press release at www.freseniusmedicalcare.com.

1 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
2 FY/20 base: €17,859 million
3 FY/20 base: €1,359 million, before special items; FY/21: before special items
4 These targets are based on the 2020 results excluding the impairment of goodwill and trade names in the Latin America Segment of €195 million. They are inclusive of anticipated COVID-19 effects, in constant currency and exclude special items. Special items include costs related to FME25 and other effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

Fresenius Kabi
Fresenius Kabi offers intravenously administered generic drugs, clinical nutrition and infusion therapies for seriously and chronically ill patients in the hospital and outpatient environments. The company is also a leading supplier of medical devices and transfusion technology products. In the biosimilars business, Fresenius Kabi develops products with a focus on oncology and autoimmune diseases.

Sales increased by 3% (8% in constant currency) to €1,815 million (Q4/19: €1,766 million). Organic growth was 7%. Negative currency translation effects of 5% were mainly related to weakness of the US dollar, the Brazilian real and the Argentinian peso. Estimated COVID-19 effects made a slight positive contribution to sales growth. In FY/20, sales increased by 1% (4% in constant currency) to €6,976 million (FY/19: €6,919 million). Organic growth was 4%. Negative currency translation effects of 3% were mainly related to the weakness of the US dollar, the Brazilian real and the Argentinian peso. Estimated COVID-19 effects slightly reduced sales growth.

Sales in North America decreased by 10% (organic growth: -3%) to €549 million (Q4/19: €609 million). The decrease was driven by fewer elective treatments, supply constraints for certain products due to temporary manufacturing issues and competitive pressure, which outweighed extra demand for COVID-19 related products. In FY/20, sales in North America decreased by 2% (organic growth: 0%) to €2,376 million (FY/19: €2,424 million). Sales in Europe increased by 13% (organic growth: 9%) to €680 million (Q4/19: €604 million) mainly due to increased demand for COVID-19 related products. In FY/20, sales in Europe increased by 6% (organic growth: 6%) to €2,458 million (FY/19: €2,313 million). Sales in Asia-Pacific increased by 11% (organic growth: 14%) to €428 million (Q4/19: €385 million). While China saw a solid recovery based on increasing elective procedures, other Asian markets were lagging behind. In FY/20, sales in Asia-Pacific decreased by 1% (organic growth: 1%) to €1,497 million (FY/19: €1,506 million). Sales in Latin America/Africa decreased by 6% (organic growth: 16%) to €158 million (Q4/19: €168 million). In FY/20, sales in Latin America/Africa decreased by 5% (organic growth: 17%) to €645 million (FY/19: €676 million).

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

EBIT before special items decreased by 17% (-10% in constant currency) to €236 million (Q4/191: €285 million) with an EBIT margin before special items of 13.0% (Q4/191:16.1%). The decline is driven by headwinds leading to some underutilized production capacities in the US, coupled with selective supply constraints due to temporary manufacturing issues, incremental COVID-19 related expenses, competitive pressure, a negative effect due to the bankruptcy of a customer as well as planned SG&A spending ahead of the launch of the company’s first US biosimilar. Lower corporate costs due to travel restrictions and phasing of projects partially offset the decline. Estimated COVID-19 effects had a moderate negative impact on EBIT growth in Q4/20. In FY/20, EBIT before special items decreased by 9% (-6% in constant currency) to €1,095 million (FY/191: €1,205 million) with an EBIT margin before special items of 15.7% (FY/191: 17.4%). Estimated COVID-19 effects had an insignificant impact on EBIT growth in FY/20.

Net income1,2 decreased by 19% (-11% in constant currency) to €148 million (Q4/191: €183 million). In FY/20, net income1,2 decreased by 8% (-5% in constant currency) to €730 million (FY/191: €797 million).

Operating cash flow increased to €307 million (Q4/19: €291 million) with a margin of 16.9% (Q4/19: 16.5%). In FY/20, operating cash flow increased by 11% to €1,143 million (FY/19: €1,028 million) with a margin of 16.4% (FY/19: 14.9%) due to the favorable working capital development.

For FY/21, Fresenius Kabi expects organic sales3 growth in a low to mid-single digit percentage range. Constant currency EBIT4 is expected to show a stable development up to low single digit percentage growth. Both sales and EBIT outlook include expected COVID-19 effects.

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/20 base: €6,976 million
4 FY/20 base: €1,095 million, before special items, FY/21: before special items
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

Fresenius Helios
Fresenius Helios is Europe’s leading private hospital operator. The company comprises Helios Germany and Helios Spain (Quirónsalud). Helios Germany operates 89 hospitals, ~130 outpatient centers and 6 prevention centers. Quirónsalud operates 46 hospitals, 70 outpatient centers and around 300 occupational risk prevention centers. In addition, the company is active in Latin America with 6 hospitals and as a provider of medical diagnostics.

Sales increased by 13% (13% in constant currency) to €2,637 million (Q4/19: €2,344 million). Organic growth was 9%. Acquisitions contributed 4% to sales growth. COVID-19 effects had an insignificant effect on organic growth. In FY/20, sales increased by 6% (7% in constant currency) to €9,818 million (FY/19: €9,234 million). Organic growth was 4%. Acquisitions contributed 3% to sales growth. COVID-19 effects had a slight negative impact on organic growth.

Sales of Helios Germany increased by 11% (organic growth: 8%) to €1,637 million (Q4/19: €1,475 million). In FY/20, sales of Helios Germany increased by 7% (organic growth: 6%) to €6,340 million (FY/19: €5,940 million). COVID-19 effects were mitigated by government financial support and hence had only a slight negative impact on organic growth in both Q4/20 and FY/20.

Sales of Helios Spain increased by 15% (17% in constant currency) to €999 million (Q4/19: €867 million). Organic growth of 11% was driven by a strong recovery of elective procedures and a consistently high level of outpatient treatments. Thus, COVID-19 effects had a moderate positive impact on organic growth in Q4. The hospital acquisitions in Colombia contributed 6% to sales growth. In FY/20, sales of Helios Spain increased by 6% (7% in constant currency) to €3,475 million (FY/19: €3,292 million). Organic growth was 2%. Acquisitions contributed 5% to sales growth. COVID-19 effects had a significant negative impact on organic sales growth.

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA

EBIT of Fresenius Helios increased by 12% (13% in constant currency) to €328 million (Q4/19: €294 million) with an EBIT margin of 12.4% (Q4/19: 12.5%). COVID-19 effects, in particular due to the strong recovery of elective procedures in Spain, had a significant positive effect on EBIT growth in Q4. In FY/20, EBIT of Fresenius Helios remained on prior year’s level (0% in constant currency) at €1,025 million (FY/19: €1,025 million) with an EBIT margin of 10.4% (FY/19: 11.1%). COVID-19 effects had a moderate negative impact on EBIT growth.

EBIT of Helios Germany increased by 10% to €157 million (Q4/19: €143 million) with an EBIT margin of 9.6% (Q4/19: 9.7%). Financial support provided by the German government under revised regulations focusing on regions with high COVID incidences broadly offset additional headwinds as Helios Germany continued to play a crucial role in treating COVID-19 patients. In FY/20, EBIT of Helios Germany increased by 4% to €602 million (FY/19: €577 million) with an EBIT margin of 9.5% (FY/19: 9.7%). Due to the comprehensive financial support provided by the German government, COVID-19 effects had an overall insignificant impact on the EBIT development.

EBIT of Helios Spain increased by 17% (19% in constant currency) to €159 million (Q4/19: €136 million) with an EBIT margin of 15.9% (Q4/19: 15.7%). The growth is driven by a recovery of elective procedures following the government-ordered postponement of planned surgical procedures in Q2, where medically justifiable. Thus, COVID-19 effects had a significant positive effect on EBIT growth in Q4. In FY/20, EBIT of Helios Spain decreased by 5% (-5% in constant currency) to €420 million (FY/19: €443 million) with an EBIT margin of 12.1% (FY/19: 13.5%). COVID-19 effects had a very significant negative impact on EBIT growth with missing or delayed elective procedures and higher expenses amid the comprehensive efforts to combat the pandemic.

Net income1 increased by 14% to €225 million (Q4/19: €197 million). In FY/20, net income1 remained on prior year’s level at €666 million (FY/19: €664 million).

Operating cash flow increased to €434 million (Q4/19: €226 million) with a margin of 16.5% (Q4/19: 9.6%), driven by phasing of payments under the German law to ease the financial burden on hospitals. In FY/20, operating cash flow increased to €1,149 million (FY/19: €733 million) with a margin of 11.7% (FY/19: 7.9%).

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA

For FY/21, Fresenius Helios expects organic sales1 growth in a low to mid-single digit percentage range and constant currency EBIT2 growth in a mid to high single digit percentage range. Both sales and EBIT outlook include expected COVID-19 effects.

1 FY/20 base: €9,818 million
2 FY/20 base: €1,025 million; FY/21 before special items

Fresenius Vamed
Fresenius Vamed manages projects and provides services for hospitals and other health care facilities worldwide and is a leading post-acute care provider in Central Europe. The portfolio ranges along the entire value chain: from project development, planning, and turnkey construction, via maintenance and technical management to total operational management.

Sales decreased by 22% (-22% in constant currency) to €577 million (Q4/19: €737 million). Organic growth was -22%. Acquisitions did not contribute to growth. Estimated COVID-19 effects had a very significant negative impact on growth. In FY/20, sales decreased by 6% (-6% in constant currency) to €2,068 million (FY/19: €2,206 million). Organic growth was -8%. Acquisitions contributed 2% to growth. Estimated COVID-19 effects had a very significant negative impact on growth.

Sales in the service business decreased by 1% to €372 million (Q4/19: €374 million).
Sales in the project business decreased by 44% to €205 million (Q4/19: €363 million), driven by postponements and cancellations of projects. In FY/20, sales in the service business grew by 3% to €1,435 million (FY/19: €1,399 million). Sales in the project business decreased by 22% to €633 million (FY/19: €807 million).

1 Net income attributable to shareholders of VAMED AG

EBIT decreased by 42% (-42% in constant currency) to €39 million (Q4/19: €67 million) with an EBIT margin of 6.8% (Q4/19: 9.1%). Estimated COVID-19 effects had a very significant negative impact on EBIT. Capacities in the post-acute care clinics were left partially empty given a generally lower intake of elective surgery patients from acute-care hospitals. Authority-instigated restrictions or even closures of individual facilities also had a negative effect. In the project business, project delays and global supply chain restraints triggered incremental expenses. In FY/20, EBIT decreased by 78% (-79% in constant currency) to €29 million (FY/19: €134 million) with an EBIT margin of 1.4% (FY/19: 6.1%). Estimated COVID-19 effects had a very significant negative impact on EBIT.

Net income1 decreased to €25 million (Q4/19: €44 million). In FY/20, net income1 decreased to €2 million (FY/19: €83 million).

Order intake was €648 million in Q4/20 (Q4/19: €576 million) and €1,010 million in FY/20 (FY/19: €1,314 million). As of December 31, 2020, order backlog was at €3,055 million (December 31, 2019: €2,865 million). Order intake and order backlog were marked by COVID-19 related cancellations and project delays.

Operating cash flow increased to €74 million (Q4/19: €0 million) with a margin of 12.8% (Q4/19: 0%), driven by a favorable working capital development mainly related to pre-payments. In FY/20, operating cash flow increased to €78 million (FY/19: -€17 million) with a margin of 3.8% (FY/19: -0.8%).

For FY/21, Fresenius Vamed expects organic sales2 growth in a mid to high single digit percentage range and EBIT3 to grow to a high double-digit euro million amount. Both sales and EBIT outlook include expected negative COVID-19 effects.

1 Net income attributable to shareholders of VAMED AG
2 FY/20 base: €2,068 million
3 FY/20 base: €29 million; FY/21 before special items

Conference Call
As part of the publication of the results for FY 2020, a conference call will be held on February 23, 2021 at 1:30 p.m. CET (7:30 a.m. EST). All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com/investors. Following the call, a replay will be available on our website.

Continued survival benefit in Targovax’s ONCOS-102 trial in mesothelioma at the 21-month follow-up

On February 23, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that 21-month follow-up data from the randomized phase I/II trial of ONCOS-102 in combination with standard of care chemotherapy in malignant pleural mesothelioma (MPM) (Press release, Targovax, FEB 23, 2021, View Source [SID1234575430]).

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The trial is an open label, exploratory phase I/II trial adding ONCOS-102 to standard of care (SoC) chemotherapy (pemetrexed/cisplatin) in first and second (and later) line MPM to assess safety, immune activation and clinical efficacy vs SoC only. In total, 31 patients have been treated in the trial, with 20 patients in the experimental group receiving the ONCOS-102 and chemotherapy combination, and 11 patients in a control group receiving chemotherapy only. The 31 patients have now completed the 21-month follow-up. Immunological data and 12-month survival rate were reported in June 2020 (see link here), and 18-month survival follow-up in November 2020 (see link here).

At the 21-month follow-up, half of the patients in the first-line ONCOS-102-treated group of the randomized part of the trial were still alive, and mOS was not yet reached. Based on current survival data mOS will be 20.5 months or longer. For the first-line SoC-only control group mOS is 13.5 months, which is similar to outcomes from previously reported trials where patients received the same chemotherapy treatment1.

Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, said: "It is most encouraging that survival continues to track so well in the ONCOS-102-treated first line group. We have earlier seen and reported how ONCOS-102 drives profound remodeling of the tumor microenvironment. It is now becoming clear that this is translating into long-term survival benefit. The survival data also holds up well to the recently FDA-approved ipilimumab and nivolumab combination, confirming the relevance of immunotherapy in mesothelioma and strongly suggesting combining ONCOS-102 with checkpoint inhibition could further boost efficacy in this highly malignant and difficult-to-treat cancer."

Sutro Biopharma to Participate in the Cowen 41st Annual Healthcare Conference

On February 23, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that Bill Newell, Chief Executive Officer, will participate in the Ovarian Cancer Panel discussion at the Cowen 41st Annual Healthcare Conference on Tuesday, March 2, 2021, at 12:50 p.m. ET / 9:50 a.m. PT and, along with members of Sutro’s senior management team, will conduct one-on-one meetings with members of the investment community (Press release, Sutro Biopharma, FEB 23, 2021, View Source [SID1234575429]). The Ovarian Cancer Panel will stream live on the Cowen conference website.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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