On May 6, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the first quarter ended March 31, 2021, and provided a corporate update (Press release, BioCryst Pharmaceuticals, MAY 6, 2021, View Source [SID1234579378]).

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

                  Schedule Your 30 min Free Demo!

"Our commercial team is off to an outstanding start with the U.S. launch of ORLADEYO. In this highly competitive market, we are demonstrating what we have known for some time now, HAE patients have been waiting to switch to an oral, once-daily therapy to reduce their attacks and burden of therapy," said Jon Stonehouse, president and chief executive officer of BioCryst.

"Our early launch performance is the latest piece of evidence that BioCryst’s differentiated strategy to discover, develop and, now, successfully commercialize unique oral medicines for rare diseases has the potential to create greater and greater value. We are doing this first in HAE and will next apply what we have learned to patients suffering from complement-mediated diseases," Stonehouse added.

Program Updates and Key Milestones

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

ORLADEYO net revenue in the first quarter of 2021, the first full quarter of launch in the United States, was $10.9 million.

The majority of ORLADEYO revenue in the first quarter of 2021 came from new patients who switched to ORLADEYO from either injectable/infused prophylactic medications or from acute-only treatment. The remainder came from patients transitioning from clinical trials and the company’s early access program.
European Approvals and Launches

On April 30, 2021, the company announced that the European Commission (EC) had approved oral, once-daily ORLADEYO for the prevention of recurrent hereditary angioedema (HAE) attacks in HAE patients 12 years and older. The EC approval of ORLADEYO is applicable to all European Union member states plus Iceland, Norway and Liechtenstein.

BioCryst has its European commercial team in place and expects to launch ORLADEYO in the second quarter in Germany, with launches in other European markets to follow. HAE patients in France currently have access to ORLADEYO through an Autorisation Temporaire d’Utilisation de cohorte (cohort ATU).

On March 2, 2021, the company announced the submission of a marketing authorization application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) seeking approval of ORLADEYO for the prevention of recurrent HAE attacks in HAE patients 12 years and older. The MAA was submitted under the MHRA’s new European Commission Decision Reliance Procedure. If approved, ORLADEYO would be the first oral, once-daily therapy in the United Kingdom to treat patients with HAE.
Japanese Approval and Launch

On January 22, 2021, the company announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan had granted marketing and manufacturing approval for oral, once-daily ORLADEYO 150 mg for prophylactic treatment of HAE in adults and pediatric patients 12 years and older.

On April 14, 2021, the company announced that the Japanese National Health Insurance System (NHI) approved the addition of oral, once-daily ORLADEYO (berotralstat) to the NHI drug price list on April 21, 2021. This triggered a $15 million milestone payment to BioCryst from Torii Pharmaceutical Co., Ltd., the company’s commercial partner in Japan.

ORLADEYO is the first and only prophylactic HAE medication approved in Japan. Torii launched ORLADEYO in Japan on April 23, 2021. BioCryst will receive tiered royalties ranging from 20 percent to 40 percent of Japanese net sales.
Complement Oral Factor D Inhibitor Program – BCX9930

BioCryst has reached agreement with the U.S. Food and Drug Administration (FDA) that the primary endpoint for the upcoming pivotal trials in paroxysmal nocturnal hemoglobinuria (PNH) is change from baseline in hemoglobin. On March 22, 2021 the company announced that BCX9930 increased hemoglobin from baseline by a mean of 3.3 g/dL in C5 inadequate response (no prior treatment with C5 inhibitors) patients and 3.5 g/dL in treatment-naïve patients and reduced transfusions in an ongoing dose-ranging trial in PNH patients. BCX9930 was safe and generally well-tolerated in the trial.

In the second half of 2021, the company plans to advance directly into PNH pivotal trials with oral BCX9930, at a dose of 500 mg bid, in patients naïve to C5 inhibitors, and patients with an inadequate response to C5 inhibitors. The goal of the pivotal trials is to achieve a broad indication for BCX9930 to treat PNH as oral monotherapy. Also in the second half of 2021, the company plans to initiate a proof of concept trial of oral BCX9930 (500 mg bid) in renal complement-mediated diseases.
Additional Updates

On February 3, 2021, the company announced that the FDA had approved a supplemental new drug application for RAPIVAB (peramivir injection) expanding the patient population of RAPIVAB for the treatment of acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. Prior to this approval, RAPIVAB had been indicated for patients two years and older.

On March 19, 2021, the company announced the appointment of Helen Thackray, M.D., FAAP, to the newly created position of chief research and development officer.
First Quarter 2021 Financial Results

For the three months ended March 31, 2021, total revenues were $19.1 million, compared to $4.8 million in the first quarter of 2020. The increase was primarily due to $10.9 million in ORLADEYO net revenue in the first quarter of 2021.

Research and development (R&D) expenses for the first quarter of 2021 increased to $42.4 million from $29.9 million in the first quarter of 2020, primarily due to increased investment in the development of BCX9930 as well as other research, preclinical and development costs, offset by a reduction in spend on the ORLADEYO program following our commercial launch in December 2020.

Selling, general and administrative (SG&A) expenses for the first quarter of 2021 increased to $22.1 million, compared to $15.9 million in the first quarter of 2020. The increase was primarily due to increased investment in to support the U.S. commercial launch of ORLADEYO and expanded international operations.

Interest and other income in the first quarter of 2021 was $6.4 million lower than the first quarter of 2020, primarily due to the partial arbitration award in the first quarter of 2020 related to our Seqirus dispute.

Interest expense was $12.9 million in the first quarter of 2021, compared to $3.0 million in the first quarter of 2020. The increase was due to service on the royalty and debt financings which were completed in December 2020.

Net loss for the first quarter of 2021 was $64.3 million, or $0.36 per share, compared to a net loss of $37.6 million, or $0.24 per share, for the first quarter of 2020.

Cash, cash equivalents, restricted cash and investments totaled $244.4 million at March 31, 2021, compared to $114.6 million at March 31, 2020. Operating cash use for the first quarter of 2021 was $60.0 million.

Financial Outlook for 2021

In the launch period for ORLADEYO, the company is not providing specific revenue or operating expense guidance. Based on our expectations for revenue, operating expenses, and our option to access an additional $75 million from our existing credit facility, we believe our current cash runway takes us into 2023.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 2660434. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 2660434.

On May 6, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported its operational and financial results for the quarter ended March 31, 2021 (Press release, Autolus, MAY 6, 2021, View Source [SID1234579395]).

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

                  Schedule Your 30 min Free Demo!

"We have had a productive first quarter and are on track for multiple clinical read outs during the remainder of this year and into 2022," said Dr. Christian Itin, chief executive officer of Autolus. "We are excited by the unique characteristics of AUTO1 and encouraged by what we believe is the significant clinical benefit AUTO1 can offer for patients with relapsed/refractory (r/r) Acute Lymphoblastic Leukemia (ALL). AUTO1 is being evaluated in the P1b/2 FELIX study in adult ALL patients with data expected in 2022. In addition, AUTO1 is being explored in patients with B-NHL and in primary CNS lymphoma, and we are also evaluating AUTO1/22 in pediatric ALL patients. Finally, several programs are expected to enter the clinic in 2021, including our next generation program AUTO6NG in Neuroblastoma, setting up clinical news flow for 2022 and beyond."

Key Pipeline Updates:

AUTO1 in relapsed / refractory (r/r) adult B-Acute Lymphocytic Leukemia (ALL).
The International Nonproprietary Name (INN) name (obecabtagene autoleucel, or obe-cel) was published.
Autolus received PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA) for AUTO1 being investigated in the ongoing FELIX Phase 1b/2 clinical trial in ALL. This designation is designed to accelerate the review of a promising therapy targeting unmet medical need. Data from this potentially pivotal program is expected in 2022, which, if positive, could enable us to file for accelerated approval.

AUTO1 in indolent B cell Non-Hodgkin Lymphoma (NHL) (cohort 1), high grade B-NHL (cohort 2) and chronic lymphocytic leukemia (CLL) (cohort 3).
The trial is progressing well and Autolus will present updated data at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June 2021.

AUTO4 in Peripheral T Cell Lymphoma (PTCL).
Autolus received innovative licensing and access pathway (ILAP) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for AUTO4, which is currently being studied in a Phase 1 clinical trial in PTCL. As with the AUTO1 PRIME designation, this is intended to accelerate the review of a promising therapy targeting unmet medical need. Autolus expects to provide a next data update in the second half of 2021.

Partnerable Coronavirus Disease (COVID-19) Project. Autolus’ research team has developed a potentially universal SARS-CoV2 decoy receptor with virus neutralizing activity against SARS-CoV2 and its variants and also active against SARS-CoV1.
Operational Highlights:

In the first quarter of 2021, Autolus sold an aggregate of 1,718,506 ADSs in offerings under its Open Market Sales AgreementSM with Jefferies LLC, for net proceeds of approximately $15.3 million.

Successful closing of a follow-on public offering raising net proceeds to Autolus, after underwriting discounts and offering expenses, of $106.9 million in February 2021, taking total net cash raised in Q1 2021 to approximately $122.2 million.

As announced in Autolus’ business update in January 2021, Autolus has realigned its research and development resources to prioritize the AUTO1 program and plans to partner the AUTO3 program before progressing it into the next phase of development.

Also announced in Autolus’ business update in January 2021, the company adjusted its workforce and infrastructure footprint, including an overall reduction in headcount of approximately 20%. Autolus expects to realize cash savings, on an annualized basis, of approximately $15 million with the operational changes fully implemented.

In March 2021, Autolus announced it was establishing global commercial launch manufacturing capacity in the UK, enabling the company to leverage the expertise and skill base of its U.K. employees. As a result, future commercial supply will be provided by a combination of the existing clinical trial manufacturing facility at The Cell and Gene Therapy Catapult (CGTC) facility and a new Autolus facility. This revised strategy aims to deliver a less capital-intensive commercial manufacturing infrastructure at a lower cost base. In conjunction, Autolus announced the termination of its lease for the manufacturing and office facility in, Rockville, MD, resulting in a cash payment to Autolus of $2.0 million.

Dr Muhammad Al-Hajj, Senior Vice President, Translational Sciences, left the Company in April 2021. The company would like to thank Dr. Al-Hajj for his contributions and wishes him well in the future.

Post the period end, Dr Martin Murphy was appointed non-executive chairman of Autolus.
Key Upcoming Clinical Milestones:

AUTO1 updates in 2021 on ALLCAR19 in patients with r/r B-NHL and longer term follow up of the fully enrolled r/r aALL cohort.

AUTO1 – Currently enrolling a potentially pivotal Phase 1b/2 clinical trial (FELIX) in r/r adult ALL patients with data expected in 2022.

Updates on Phase 1 programs AUTO1/22 in pediatric ALL, as well as AUTO4 in TRBC1+ Peripheral TCL, in 2021.

Phase 1 trials are expected to be initiated in 2021 with AUTO1 in Primary CNS Lymphoma, AUTO5 in TRBC2+ Peripheral TCL, AUTO6NG in Neuroblastoma, and AUTO8 in Multiple Myeloma.

First exploratory allogeneic program expected to enter the clinic in 2021.
Financial Results for the Quarter Ended March 31, 2021

Cash at March 31, 2021 totaled $239.0 million, as compared to $153.3 million at December 31, 2020. In January 2021, the company sold 1.7 million ADSs under its Open Market Sales AgreementSM with Jefferies LLC as sales agent, resulting in net proceeds of $15.3 million and in February 2021, the company sold 16.4 million ADSs representing 16.4 million ordinary shares in a follow-on, public offering, including the exercise in full by the underwriters of their option to purchase an additional 2.1 million ADSs, at a public offering price of $7.00 per ADS, yielding net proceeds of $106.9 million.

Net total operating expenses for the three months ended March 31, 2021 were $39.9 million, net of grant income of $0.3 million, as compared to net operating expenses of $38.6 million, net of grant income of $0.3 million, for the same period in 2020.

Research and development expenses decreased to $30.7 million for the three months ended March 31, 2021 from $31.3 million for the three months ended March 31, 2020. Cash costs, which exclude depreciation and amortization as well as share-based compensation, increased to $30.7 million from $25.6 million. The increase in research and development cash costs of $5.1 million consisted primarily of (i) an increase in compensation and employment related costs, net of lower travel costs (as a result of restricted travel due to the ongoing COVID-19 pandemic), of $3.5 million due to a combination of an increase in employee headcount to support the advancement of our product candidates in clinical development and severance payments related to the reduction in workforce that began to take place during the quarter, (ii) an increase of $2.2 million in facilities costs related to the continued scaling of manufacturing operations, and (iii) an increase of $0.4 million related to cell logistics, which is offset by decreases in purchased materials in the amount of $0.6 million and project expenses of $0.4 million.

Non-cash R&D costs decreased to $36,000 for the three months ended March 31, 2021 from $5.7 million for the three months ended March 31, 2020. The decrease is primarily related to share-based compensation expense included in research and development expenses, which decreased by $6.2 million as a result of forfeitures of incentive share options related to employees affected by the reduction in workforce. This was offset by an increase in depreciation of $0.5 million.

General and administrative expenses increased to $8.7 million for the three months ended March 31, 2021 from $7.6 million for the three months ended March 31, 2020. Cash costs, which exclude depreciation expense as well as share-based expense compensation increased to $7.6 million from $5.9 million. The increase in general and administrative cash costs of $1.7 million related to an increase of (i) $0.4 million in facilities cost, (ii) an increase of $0.6 million in legal fees and audit fees, (iii) an increase of $0.3 million of expenses related to preparations for becoming a commercial stage company, and (iv) an increase of $0.4 million in compensation and employment related costs due to an increase in headcount, and severance payments related to the reduction in workforce that began to take place during the quarter.

Non-cash general and administrative costs decreased to $1.1 million for the three months ended March 31, 2021 from $1.7 million for the three months ended March 31, 2020. The decrease is attributed to share-based compensation expense as a result of the lower fair value of stock options recognized during the period. Loss on disposal of leasehold improvements of $0.7 million related to the leasehold improvements no longer being utilized in the facility in White City, London.

Interest income decreased by $0.5 million for three months ended March 31, 2021 due to lower interest rates for cash held on deposit. Other income decreased by $3.7 million for the three months ended March 31, 2021 from other income of $4.5 million for the three months ended March 31, 2020 to $0.8 million. There was a decrease of $5.6 million primarily due to the weakening of the U.S. dollar exchange rate relative to the pound sterling during the three months ended March 31, 2021 as compared to the three months ended March 31, 2020, offset by gains on lease terminations of $2.0 million, net of the related expenses.

Income tax benefit increased to $5.7 million for the three months ended March 31, 2021 from $3.7 million for the three months ended March 31, 2020 due to increased research and development credits. As research and development credits grew at a faster rate than our net loss before income tax, this led to a higher effective tax rate. Research and development credits are obtained at a maximum rate of 33.35% of our qualifying research and development expenses, and the increase in the net credit was primarily attributable to an increase in our eligible research and development expenses.

Net loss attributable to ordinary shareholders was $33.3 million for the three months ended March 31, 2021, compared to $29.9 million for the same period in 2020. The basic and diluted net loss per ordinary share for the three months ended March 31, 2021 totaled $(0.53) compared to a basic and diluted net loss per ordinary share of $(0.60) for the three months ended March 31, 2020.

Autolus estimates that its current cash on hand will provide the Company with a cash runway into the first half of 2023.

Conference Call

Management will host a conference call and webcast today at 8:30 am ET/1:30 pm BST to discuss the company’s financial results and provide a general business update. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 7756178. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 7756178.

On May 6, 2021 Asieris Pharmaceuticals ("Asieris") and BeiGene, Ltd. ("BeiGene") reported that they have entered into a clinical collaboration agreement to evaluate the safety and efficacy of oral APL-1202 in combination with tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC) (Press release, Asieris Pharmaceuticals, MAY 6, 2021, View Source [SID1234579412]). Asieris plans to submit INDs in China and United States for an open-label, multi-center Phase I/II clinical study with primary objectives including: to evaluate the safety in MIBC patients; determine the RP2D (recommended phase 2 dose), and efficacy as neoadjuvant therapy for MIBC.

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

                  Schedule Your 30 min Free Demo!

APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in phase III/pivotal clinical trials in China as single agent for the first-line treatment of non-muscle invasive for the second-line treatment of NMIBC. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It has been approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with high expression of PD-L1 who have failed to receive platinum-based chemotherapy, including neoadjuvant or adjuvant chemotherapy that has progressed within 12 months.

"We are excited to collaborate with BeiGene to further explore the potential of APL-1202," said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris. "We found that synergistic effects of APL-1202 and immunotherapies have been shown in orthotopic prostate cancer and MIBC efficacy animal models. Based on these preclinical data, we hope that this clinical trial will prove the concept of APL-1202’s activity in modulating tumor microenvironment, and believe that APL-1202 in combination with tislelizumab could be an effective neoadjuvant therapy for patients with MIBC."

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

                  Schedule Your 30 min Free Demo!

On May 6, 2021 Rice Powell, Chief Executive Officer of Fresenius Medical Care, reported: "The COVID-19 pandemic continues to plague our societies and especially our vulnerable patients (Press release, Fresenius, MAY 6, 2021, View Source [SID1234579317]). We are very grateful that we are increasingly allowed to directly vaccinate our dialysis patients in our clinics. By doing so, we can support healthcare systems, contribute to saving lives and overcoming this health crisis as fast as possible. While we have seen significant progress in the roll-out and adoption of vaccinations globally, COVID-19 infection rates in several countries remain high. This will, unfortunately, continue to affect many of our patients. Consequently, this will also continue to impact our organic growth and weigh on our earnings development throughout the year. As the underlying development in the first three months was in line with our expectations, we confirm our guidance for the full year 2021."

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

                  Schedule Your 30 min Free Demo!

1 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA

COVID-19 impact on organic growth continues to accumulate as expected

The adverse COVID-19 impact on organic growth in the Health Care Services business amounted to around 350 basis points in the first quarter. While monthly excess mortality continuously declined since February, it is expected to further accumulate and peak in the second quarter.

Besides Fresenius Medical Care’s comprehensive measures to reduce infection risks and maintain safe operations in its dialysis centers, vaccinations are crucial for containing the COVID-19 pandemic. In several countries, Fresenius Medical Care has made its dialysis clinics available for the direct vaccination of patients and, where requested, the general public. At the end of March, the U.S. government agreed to directly allocate COVID-19 vaccine to dialysis centers nationwide. At Fresenius Medical Care’s U.S. facilities, more than 64% of patients and 47% of dialysis center staff have been at least partially vaccinated. The Company is making further progress every day. On a global basis, about 51 percent of Fresenius Medical Care’s patients have received at least one vaccination.

Outlook

Fresenius Medical Care confirms its outlook for FY 2021 as outlined on February 23, 2021. The Company expects revenue to grow at a low- to mid-single digit percentage rate and net income to decline at a high-teens to mid-twenties percentage rate against the 2020 base.2

2 These targets are based on the 2020 results excluding the impairment of goodwill and trade names in the Latin America Segment of EUR 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.

The Company continues to monitor closely the latest COVID-19-related developments in respect to additional variants of the virus and potential surges in different regions.

Fresenius Medical Care will experience an adverse earnings effect due to the U.S. government delaying the CKCC models (Comprehensive Kidney Care Contracting) by nine months to January 1, 2022. This effect will be offset by the further extension of the U.S. Medicare sequestration relief from April 1, 2021 until the end of 2021.

To support its 2025 strategy, further strengthen profitability and compensate for the negative earnings effects of the COVID-19 pandemic, Fresenius Medical Care has initiated the FME25 program. The Company is currently undergoing a detailed review of its global operating model and will provide an update in the second half of 2021.

Driving value-based care

Fresenius Medical Care aims to build sustainable partnerships with payors to support the transition from a fee-for-service to a pay-for-performance healthcare system. This applies equally to reimbursement models of commercial and public insurers. In the U.S., Fresenius Medical Care recently extended its value-based arrangement with Aetna, Inc., a provider of health insurance and related services and subsidiary of CVS Health Corporation, to include patients enrolled in Medicare Advantage. In late 2020, Fresenius Medical Care expanded its cooperation with health insurer Humana and thereby implemented the existing clinical network contract as a value-based payment model.

Revenue and earnings impacted by COVID-19 and exchange rate effects

Revenue declined by 6% to EUR 4,210 million (+1% at constant currency). Organic growth amounted to 1%.

Health Care Services revenue decreased by 7% to EUR 3,325 million (+1% at constant currency, +1% organic). The decline was mainly due to a negative exchange rate effect, the absence of a prior-year partial reversal of a revenue recognition adjustment, the impact from COVID-19 and lower reimbursement for calcimimetics.

Health Care Products revenue declined by 1% to EUR 885 million (+4% at constant currency, +5% organic). Headwinds from exchange rates and lower sales of acute care products as well as in-center disposables were partially offset by higher sales of machines for chronic treatment, peritoneal dialysis products and home hemodialysis products.

Operating income decreased by 15% to EUR 474 million (-8% at constant currency), resulting in a margin of 11.3% (Q1 2020: 12.4%). The decrease was mainly driven by effects from COVID-19 across all regions, higher personnel expenses and a significant negative exchange rate effect. In addition, operating income was negatively affected by a positive prior-year effect from the divestiture of cardiovascular clinics and a prior-year partial reversal of a revenue recognition adjustment. These negative effects were partially offset by an improved payor mix, mainly driven by Medicare Advantage, and expected lower SG&A expense, which are anticipated to reverse in the remainder of the year.

Net income1 declined by 12% to EUR 249 million (-6% at constant currency). Besides the above-mentioned operating earnings effects, net income was supported by a 27% decrease of net interest expense to EUR 76 million (Q1 2020: EUR 104 million).

The first quarter 2020 included negative COVID-19 effects that reversed in Q2 2020, including the compensation received under the CARES Act, and therewith increase the base for the second quarter 2021. These base effects impact the phasing of net income growth in 2021.

Basic earnings per share (EPS) decreased by 10% to EUR 0.85 (-4% at constant currency). The decline as a result of the above-mentioned earnings effects was partially offset by a decrease in the average weighted number of shares outstanding due to the redemption of shares following the completed share buyback program.

Cash flow development

Fresenius Medical Care generated EUR 208 million of operating cash flow (Q1 2020: EUR 584 million), resulting in a margin of 4.9% (Q1 2020: 13.0%). The decline was driven by the seasonality in invoicing and periodic delays in payment of public health care organizations.

Free cash flow3 amounted to EUR 29 million (Q1 2020: EUR 304 million), resulting in a margin of 0.7% (Q1 2020: 6.8%).

3 Net cash used in operating activities, after capital expenditures, before acquisitions, investments and dividends

Regional developments

In North America, revenue declined by 9% to EUR 2,899 million (-1% at constant currency, -1% organic). Besides a sizable negative exchange rate effect, this was mainly due to a substantial negative impact of COVID-19 on the Services business and lower reimbursement for calcimimetics.

Operating income in North America declined by 14% to EUR 399 million (-6% at constant currency), resulting in a margin of 13.7% (Q1 2020: 14.5%). The decrease was mainly due to the effects of COVID-19, higher personnel expense, headwinds from exchange rates, a positive prior-year effect from the divestiture of cardiovascular clinics, a prior-year partial reversal of a revenue recognition adjustment and a lower contribution from calcimimetics. This was mitigated by an improved payor mix, mainly driven by an increased Medicare Advantage share, contributions from acquisitions and lower SG&A expense due to favorable phasing.

Revenue in EMEA decreased by 1% and amounted to EUR 670 million (+1% at constant currency, +1% organic). This was mainly driven by the unfavorable effects of COVID-19 and negative exchange rate effects.

Operating income in the EMEA region declined by 21% to EUR 80 million (-21% at constant currency), resulting in a margin of 11.9% (Q1 2020: 14.9%). The prior-year base benefitted from the revaluation of an investment. In addition, the decline was mainly driven by an unfavorable country mix in the Products business, a decrease in dialysis days as well as higher cost for personnel and supplies in certain countries. This was partially offset by lower bad debt expense.

In Asia-Pacific, revenue increased by 6% to EUR 471 million (+10% at constant currency, +11% organic), mainly due to organic growth in the Services and Product businesses as well as contributions from acquisitions. This was partially offset by the effect of clinics closed or sold in the prior year.

Operating income grew by 11% to EUR 85 million (+14% at constant currency), resulting in a margin of 18.1% (Q1 2020: 17.3%). The prior-year base benefited from a gain from the deconsolidation of clinics. The increase was mainly driven by business growth and a favorable impact from manufacturing.

Including a very significant headwind from exchange rates and a negative effect from COVID-19, Latin America revenue decreased by 5% to EUR 159 million (+17% at constant currency, +15% organic). Operating income in Latin America declined by 3% to EUR 7 million (+3% at constant currency), resulting in a margin of 4.2% (Q1: 2020: 4.1%).

Patients, Clinics and Employees

As of March 31, 2021, Fresenius Medical Care treated 344,476 patients in 4,110 dialysis clinics worldwide. At the end of the first quarter, the Company had 124,995 employees (full-time equivalents) worldwide, compared to 121,403 employees as of March 31, 2020.

Conference call

Fresenius Medical Care will host a conference call to discuss the results of the first quarter of 2021 on May 6, 2021 at 3:30 p.m. CET / 9:30 a.m. ET. 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.

Please refer to our statement of earnings included in the PDF-file for a complete overview of the results of the first quarter of 2021. Our 6-K disclosure provides more details.