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Phase 3 Trial Shows REGEN-COV™ (casirivimab with imdevimab) Antibody Cocktail Reduced Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients

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TARRYTOWN, N.Y., March 23, 2021 /PRNewswire/ — 

REGEN-COV also significantly shortened the duration of symptoms by 4 days

All doses (8,000 mg, 2,400 mg and 1,200 mg) had similar efficacy across all endpoints

Companion dose-ranging Phase 2 trial showed significant and comparable viral reductions for all REGEN-COV doses tested, including as low as 300 mg

FDA recently updated U.S. EUA fact sheets for all authorized monoclonal antibody treatments, indicating that REGEN-COV is the only one to retain potency against key emerging variants

Regeneron will share new data with regulatory authorities immediately and request that a lower 1,200 mg dose be added to EUA

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalized patients (n=4,567). This definitive Phase 3 outcomes trial in high-risk non-hospitalized COVID-19 patients (“outpatients”) met its primary endpoint, showing the investigational REGEN-COV™ (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared to placebo.

“This is a landmark moment in the fight against COVID-19 as this large well-controlled trial provides conclusive results demonstrating that REGEN-COV can dramatically reduce the risk of hospitalization and death in the outpatient setting,” said Suraj Saggar, D.O., trial investigator and Chief of Infectious Disease at Holy Name Medical Center in Teaneck, New Jersey. “With so many people still getting infected, as well as recent data showing that REGEN-COV addresses emerging variants, these data underscore the need to rapidly adopt REGEN-COV as standard-of-care to offer high-risk patients their best chance to reduce serious consequences like hospitalization or death.”

REGEN-COV also met all secondary endpoints in the Phase 3 outcomes trial, including the ability to reduce symptom duration. In addition, a companion Phase 2 trial showed that even the lowest doses tested (IV: 300 mg; subcutaneous [SC]: 600 mg) had significant viral load reductions over the first 7 study days, comparable to the 2,400 mg and 1,200 mg IV doses.

“With approximately 60,000 newly diagnosed individuals in the U.S. every day and 40,000 still in the hospital because of COVID-19, we are committed to working with the government, healthcare providers and others to support rapid and widespread adoption of REGEN-COV in appropriate patients,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. “We will discuss the new data with regulatory authorities and request that the 1,200 mg dose be rapidly added to the U.S. Emergency Use Authorization, in order for the anticipated REGEN-COV supply to be available to treat even more patients. These Phase 3 data will also form the basis of a full Biologics License Application.”

TABLE 1: Key Results from Phase 3 Outpatient Trial1-3



1,200 mg
IV

Placebo

2,400 mg
IV

Placebo

n=736

n=748

n=1,355

n=1,341

Patients with ³1 COVID-19-related hospitalization or death through day 29

Risk reduction

70%

(p=0.0024)

71%

(p<0.0001)

# of patients with events

7 (1.0%)

24 (3.2%)

18 (1.3%)

62 (4.6%)

Time to COVID-19 symptom resolution

Median (days)

10

14

10

14

Median reduction (days)

4

(p<0.0001)

4

(p<0.0001)

1.

Based on the modified Full Analysis Set population, which includes all randomized patients with a positive
SARS-CoV-2 RT-qPCR test from nasopharyngeal swabs at randomization and ³1 risk factor for severe
COVID-19.

2.

The formal hierarchical analysis first evaluated the 2,400 mg dose vs. concurrent placebo and then
evaluated the 1,200 mg dose vs. concurrent placebo.

3.

Based on Phase 1/2 analyses showing that the 8,000 mg and 2,400 mg doses were indistinguishable, the
Phase 3 protocol was amended to compare the 2,400 mg and 1,200 mg doses vs. placebo, and the 8,000
mg data were converted to a descriptive analysis.

A safety assessment was conducted on all available patient data up to day 169, and identified no new safety signals. Serious adverse events (SAEs) were largely related to COVID-19 and occurred in 1.1% of patients in the 1,200 mg group, 1.3% in the 2,400 mg group and 4.0% in the placebo group. There was 1 death in the 1,200 mg group (n=827), 1 death in the 2,400 mg group (n=1,849) and 5 deaths in the placebo groups (n=1,843).

All patients in this analysis had at least one risk factor, including obesity (58%), age ³50 years (51%) and cardiovascular disease, including hypertension (36%). Approximately 35% of patients were Latino/Hispanic, 5% were Black/African American and the median age was 50 years (range: 18-96 years).

Dose-ranging Virology Trial
A companion dose-ranging Phase 2 trial of 803 outpatient COVID-19 patients was conducted to evaluate the antiviral effect of several different REGEN-COV doses (IV: 2,400 mg, 1,200 mg, 600 mg and 300 mg; SC: 1,200 mg and 600 mg). All tested doses met the primary endpoint, rapidly and significantly reducing patients’ viral load (log10 copies/mL) compared to placebo (p£0.001). Each dose demonstrated similar efficacy, including the lowest doses tested (IV: 300 mg; SC: 600 mg).

“These encouraging results confirm the rapid and significant antiviral effects of REGEN-COV, even at much lower and subcutaneous doses,” said David Weinreich, M.D., Executive Vice President and Head of Global Clinical Development at Regeneron. “We are grateful to all patients and investigators who participated in these and other ongoing REGEN-COV trials. We will share both our Phase 3 outcomes data and our Phase 2 virology data with regulatory authorities to discuss next steps, including the possibility of utilizing lower doses and more convenient subcutaneous administration.”

Detailed results from both trials will be shared with regulatory authorities and submitted for peer review as soon as possible. REGEN-COV continues to be evaluated in clinical trials in multiple settings for COVID-19: in non-hospitalized and certain hospitalized patients, including the open-label RECOVERY trial of hospitalized patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals. As of March 2021, more than 25,000 people have participated in clinical trials involving REGEN-COV.

The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.

FDA Updates to Fact Sheets
To address SARS-CoV-2 variants, last week the U.S. Food and Drug Administration (FDA) authorized revisions to the fact sheets for monoclonal antibodies currently under emergency use authorization (EUA). The REGEN-COV fact sheet (see table below), notes that it retains potency against the main variants of concern known to be circulating within the U.S. In contrast, multiple variant strains had reduced susceptibility to the other two FDA-authorized monoclonal antibodies (fact sheets are available here and here).

TABLE 2: Pseudovirus Neutralization Data for SARS-CoV-2 Variant Substitutions with casirivimab and imdevimab Together

 

Lineage with Spike Protein
Substitution

Key Substitutions Tested

Fold Reduction in
Susceptibility

B.1.1.7 (UK origin)

N501Ya

no changec

B.1.351 (South Africa origin)

K417N, E484K, N501Yb

no changec

P.1 (Brazil origin)

K417T + E484K

no changec

B.1.427/B.1.429 (California origin)

L452R

no changec

B.1.526 (New York origin)d

E484K

no changec

a.  

Pseudovirus expressing the entire variant spike protein was tested. The following changes from wild-type
spike protein are found in the variant: del69-70, del145, N501Y, A570D, D614G, P681H, T716I, S982A,
D1118H.

b.  

Pseudovirus expressing the entire variant spike protein was tested. The following changes from wild-type
spike protein are found in the variant: D80Y, D215Y, del241-243, K417N, E484K, N501Y, D614G, A701V.

c.  

No change: < 2-fold reduction in susceptibility.

d.  

Not all isolates of the New York lineage harbor the E484K substitution (as of February 2021).

Supply and Distribution Update
REGEN-COV is available throughout the U.S. without restriction – information on availability in your area is available from the Department of Health and Human Services and the National Infusion Center Association.

Regeneron anticipates recording approximately $260 million in REGEN-COV U.S. net product sales to the U.S. government in the first quarter of 2021, representing final deliveries from the initial agreement with the U.S. government. Sales under the second U.S. government agreement are now expected to begin in the second quarter of 2021. The company expected to provide approximately 750,000 doses at the 2,400 mg dose level, but now anticipates being able to provide approximately 1.25 million doses if the 1,200 mg dose is added to the EUA. Due to the pandemic, many organizations are currently utilizing the same limited manufacturing resources including external fill and finish capacity, and this may impact the timing of final delivery of doses. The government is obligated to purchase all finished doses supplied by June 30, 2021, up to 1.25 million doses total, and may accept doses after this date at its discretion.

Roche, which is responsible for REGEN-COV outside the U.S., continues to work with the European Medicines Agency, governments and other health authorities across the globe to bring this antibody cocktail to as many patients as possible.

About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab with imdevimab) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987) that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron’s proprietary VelocImmune® and VelociSuite® technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

Under an EUA issued by the FDA, REGEN-COV is currently available in the U.S. to treat mild-to-moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

REGEN-COV is currently authorized and available in a 2,400 mg IV dose, with infusion times as short as 20 minutes. The criteria for ‘high-risk’ patients are described in the Fact Sheet for Healthcare Providers. In the U.S., REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.

Regeneron is collaborating with Roche to increase global supply of REGEN-COV. Regeneron is responsible for development and distribution of the treatment in the U.S., and Roche is primarily responsible for development and distribution outside the U.S. The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.

About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN-COVTM (casirivimab with imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza™ (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION

Authorized Emergency Use
REGEN-COV, (casirivimab with imdevimab to be administered together) is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. [see Limitations of Authorized Use]

  • REGEN-COV has not been approved, but has been authorized for emergency use by FDA
  • This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
  • Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of REGEN-COV and mandatory requirements of the EUA and must comply with the requirements of the EUA. The FDA Letter of Authorization is available for reference, as well as the Dear Healthcare Provider Letter and Patient Fact Sheet

Limitations of Authorized Use

  • REGEN-COV (casirivimab with imdevimab) is not authorized for use in patients
    • who are hospitalized due to COVID-19, OR
    • who require oxygen therapy due to COVID-19, OR
    • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
  • Benefit of treatment with REGEN-COV has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

Definition of High-Risk Patients
High-risk is defined as patients who meet at least one of the following criteria:

  • Have a body mass index (BMI) ≥35
  • Have chronic kidney disease
  • Have diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Are ≥65 years of age
  • Are ≥55 years of age AND have
    • cardiovascular disease, OR
    • hypertension, OR
    • chronic obstructive pulmonary disease/other chronic respiratory disease.
  • Are 12 – 17 years of age AND have
    • BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm,OR
    • sickle cell disease, OR
    • congenital or acquired heart disease, OR
    • neurodevelopmental disorders (e.g., cerebral palsy), OR
    • a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
    • asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.

Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Healthcare providers should review the Antiviral Resistance information in Section 15 of the Fact Sheet for details regarding specific variants and resistance, and refer to the CDC website (https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html) as well as information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions. 

IMPORTANT SAFETY INFORMATION
REGEN-COV (casirivimab with imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use.

Warnings and Precautions:

  • Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions: There is a potential for serious hypersensitivity reaction, including anaphylaxis, with administration of REGEN-COV. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy. Infusion-related reactions have been observed with administration of REGEN-COV.
    • Signs and symptoms of infusion related reactions may include fever, difficulty breathing, reduced oxygen saturation, chills, nausea, arrythmia (e.g., atrial fibrillation, tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, fatigue and diaphoresis. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.
  • Clinical Worsening After REGEN-COV Administration: Clinical worsening of COVID-19 after administration of REGEN-COV has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to REGEN-COV use or were due to progression of COVID-19.
  • Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19: Benefit of treatment with REGEN-COV has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. Therefore, REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

Adverse Reactions:

  • Serious adverse events (SAEs) were reported in 4 (1.6%) patients in REGEN-COV 2,400 mg group, 2 (0.8%) patients in REGEN-COV 8,000 mg group and 6 (2.3%) patients in the placebo group. None of the SAEs were considered to be related to study drug. SAEs that were reported as Grade 3 or 4 adverse events were pneumonia, hyperglycemia, nausea and vomiting (2,400 mg REGEN-COV), intestinal obstruction and dyspnea (8,000 mg REGEN-COV) and COVID-19, pneumonia and hypoxia (placebo). REGEN-COV is not authorized at the 8,000 mg dose (4,000 mg casirivimab and 4,000 mg imdevimab).
  • One anaphylactic reaction was reported in the clinical program. The event began within 1 hour of completion of the infusion, and required treatment including epinephrine. The event resolved. Infusion-related reactions, of Grade 2 or higher severity, were reported in 4 subjects (1.5%) in the 8,000 mg (4,000 mg casirivimab and 4,000 mg imdevimab) arm. These infusion-related reactions events were moderate in severity; and include pyrexia, chills, urticaria, pruritus, abdominal pain, and flushing. One infusion-related reaction (nausea) was reported in the placebo arm and none were reported in the 2,400 mg (1,200 mg casirivimab and 1,200 mg imdevimab) arm. In two subjects receiving the 8,000 mg dose of REGEN-COV, the infusion-related reactions (urticaria, pruritus, flushing, pyrexia, shortness of breath, chest tightness, nausea, vomiting) resulted in permanent discontinuation of the infusion. All events resolved.

Patient Monitoring Recommendations: Clinically monitor patients during infusion and observe patients for at least 1 hour after infusion is complete.

Use in Specific Populations:

  • Pregnancy: There is currently limited clinical experience in the use of REGEN-COV in COVID-19 patients who are pregnant. REGEN-COV therapy should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
  • Lactation: There is currently no clinical experience in use of REGEN-COV in COVID-19 patients who are breastfeeding. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for REGEN-COV and any potential adverse effects on the breastfed child from REGEN-COV or from the underlying maternal condition.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

Regeneron Forward-Looking Statements and Use of Digital Media 
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue to conduct research and clinical programs, Regeneron’s ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators (collectively, “Regeneron’s Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron’s Products and product candidates and research and clinical programs now underway or planned, including without limitation the development program relating to REGEN-COVTM (casirivimab with imdevimab) antibody cocktail; how long the Emergency Use Authorization (“EUA”) granted by the U.S. Food and Drug Administration (the “FDA”) for REGEN-COV will remain in effect and whether the EUA is revoked by the FDA based on its determination that the underlying health emergency no longer exists or warrants such authorization or other reasons; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s product candidates (such as REGEN-COV) and new indications for Regeneron’s Products; whether the 1,200 mg dose of REGEN-COV will be added the EUA for REGEN-COV based on the data discussed in this press release or otherwise; the amount of net product sales of REGEN-COV under Regeneron’s agreements with the U.S. government and timing of recognition of any such sales; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and product candidates (including REGEN-COV) and the impact of the foregoing on Regeneron’s ability to supply its Products and product candidates (including REGEN-COV); the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products and product candidates (such as REGEN-COV) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and product candidates in clinical trials; uncertainty of market acceptance and commercial success of Regeneron’s Products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) (including the study discussed in this press release) on any potential regulatory approval (including with respect to REGEN-COV) and/or the commercial success of Regeneron’s Products and product candidates; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and product candidates, including without limitation REGEN-COV; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and product candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), as well as Regeneron’s collaboration with Roche relating to REGEN-COV, to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), Praluent® (alirocumab), and REGEN-COV), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2020. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).

SOURCE Regeneron Pharmaceuticals, Inc.

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Williams Homes Announces Promotion And Hiring Of Three Key Executive Leadership Posts

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LOS ANGELES, May 6, 2021 /PRNewswire/ — Williams Homes, one of the largest, privately held residential builders and developers in the Western United States with operations in six markets spanning four states and growing, today announced the promotions of two key executives and a new hire. The announcement comes as the company celebrates its 25th anniversary and has its sights set on further expansion throughout the Western United States.

Company executives promoted include Michael Brunette to the position of Director of Sales, and Patrice Quishenberry expanding her role to serve as Director of Marketing and Community Outreach, and industry veteran Kathleen Magner hired as Southern California Sales Manager.

“Michael, Patrice and Kathleen are genuine attributes to our executive management team,” said Lance Williams, Williams Homes’ chairman and CEO. “As the company continues to grow, we are only as good as the vision, work ethic and leadership of those around us. I am confident that Michael, Patrice and Kathleen are equipped with all of the tools needed to help take Williams Homes to the next level.”

Michael Burnette

Brunette, who joined Williams Homes in 2017, has been promoted to Director of Sales having previously served as Southern California Sales Manager since October 2019. In his expanded role Brunette will implement his expertise in development and execution of strategic plans to achieve sales goals and communicate progress of those goals to upper management, oversee division sales manages, sales team development and training, and ongoing understanding of industry-specific trends and landscapes that affect strategic direction and budgeting.

Patrice Quishenberry

As Director of Marketing and Community Outreach, Quishenberry will serve as the strategic leader in development of the Williams Homes brand throughout all divisions. Quishenberry’s focus will be on further advancing Williams Homes’ marketing department structure and processes, while supporting performance goals. Quishenberry brings more than 25 years of experience in new home real estate and development including sales, marketing, general management, and business development.

Kathleen Magner

As Southern California Sales Manager, Magner will utilize her 20-plus years of experience and knowledge of new home sales and marketing management to oversee Williams Homes’ Southern California operations. She previously served as the Sales and Marketing Director at Watt Communities and most recently Area Sales Manager for Tri Pointe Homes.

About Williams Homes

Williams Homes is a residential homebuilder based in Los Angeles, California that specializes in building high-quality new homes for families.  Founded in 1996, the privately-owned company has built thousands of homes throughout California during the last two decades and has recently begun out-of-state operations in Montana, Idaho, and Texas.  Committed to insightful design and superior craftsmanship, Williams Homes continues to set a new standard in homebuilding and ultimately, the customer experience. For more information, visit www.williamshomes.com.

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Lisa Silagy
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310.755.8999 / [email protected]

SOURCE Williams Homes, Inc.

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Veeva lance une solution de contenu modulaire pour aider les entreprises à accélérer la diffusion de contenu numérique à grande échelle

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BARCELONE, Espagne, 7 mai 2021 /PRNewswire/ — Veeva Systems (NYSE : VEEV) a annoncé aujourd’hui de nouvelles fonctionnalités de contenu modulaire dans Veeva Vault PromoMats pour aider les spécialistes du marketing en sciences de la vie à accélérer la création, l’examen et la diffusion de contenu dans tous les canaux. Les nouvelles améliorations apportées à la plateforme de contenu commercial comprennent des fonctionnalités et des connecteurs qui permettent aux marques de diffuser rapidement du contenu conforme à grande échelle.

Les données de Veeva Pulse montrent que les entreprises de l’industrie des sciences de la vie ont créé 3,5 fois plus de contenu numérique que de contenu imprimé au cours de l’année écoulée, avec un cycle d’approbation moyen de 21 jours,1 ce qui souligne la nécessité d’avoir plus de contenu, plus rapidement. L’utilisation de modules de contenu pré-approuvés pour créer des ressources de vente et de marketing permet aux équipes d’accélérer les examens juridiques, médicaux et réglementaires (MLR).

« La solution de contenu modulaire de Veeva nous aide à générer un contenu promotionnel conforme qui résonne profondément auprès des publics clés, afin que nous puissions créer des expériences numériques de premier ordre », a déclaré Cédric Grand-Pierre, responsable mondial de l’expérience client et de l’engagement chez Organon, le projet de scission de Merck. « Vault PromoMats nous permet d’agir plus rapidement, d’accroître la réutilisation du contenu sur tous les canaux et d’accélérer le processus d’examen. »

Au cours de l’année 2021, Veeva ajoutera les fonctionnalités suivantes à sa solution de contenu modulaire dans Vault PromoMats :

  • Modules de contenu PromoMats Vault : dès aujourd’hui, les clients peuvent créer et stocker des modules directement dans leur bibliothèque de contenu Veeva Vault. Le système sert désormais de source unique de vérité pour les blocs de texte, d’images ou de déclarations réutilisables, ainsi que pour les règles associées qui régissent l’utilisation de chaque module.
  • Connecteurs de création omnicanale : les modules de contenu de Vault PromoMats peuvent également être partagés via les API de Veeva. Dans les mois à venir, les clients seront en mesure d’intégrer une gamme d’outils de création spécifiques aux canaux, notamment Anthill Activator, la plateforme eWizard de Viseven et d’autres, dans la solution de contenu modulaire de Veeva. Les équipes peuvent utiliser leurs outils préférés pour assembler des modules préexistants, puis renvoyer les ressources finies dans Vault PromoMats pour approbation.
  • Examen MLR modulaire : une fois qu’une ressource est prête pour approbation, les spécialistes du marketing peuvent lancer les flux de travail natifs de conformité MLR dans Veeva Vault. Plus tard cette année, le système ajoutera des points saillants visuels pour indiquer lesquels des modules assemblés sont déjà approuvés, en attente ou examinés pour la première fois.

« Le contenu modulaire soutient le passage rapide de l’industrie à l’engagement numérique grâce à un changement marqué dans la façon dont les équipes de la marque rédigent, examinent et distribuent le contenu », a déclaré Pooja Ojala, vice-président du contenu commercial chez Veeva. « Notre solution s’appuie sur notre solide patrimoine en matière de MLR et de gestion des ressources numériques pour créer un système flexible et modulaire de création de contenu, réduisant les cycles d’examen de plus de 20 % et augmentant la vitesse de mise sur le marché de plus de 50 %. »

Pour permettre aux équipes de la marque de distribuer rapidement des modules de contenu via différents canaux, Veeva s’associe également pour mettre en place un vaste écosystème d’outils de création. « En collaborant avec Veeva pour automatiser le cycle de production de contenu, nous aidons les clients à fournir des contenus personnalisés plus rapidement et à moindre coût », a déclaré Nataliya Andreychuk, PDG de Viseven. Et Rasmus Kalms, responsable produits chez Anthill, d’ajouter : « Avec Veeva, nous pouvons donner aux entreprises de l’industrie des sciences de la vie les moyens d’améliorer la création, la réutilisation et l’agilité du contenu à chaque étape du processus. »

Pour plus d’informations sur les meilleures pratiques en matière de contenu modulaire, inscrivez-vous au prochain sommet Veeva Commercial & Medical North America Summit Connect le 10 juin 2021. Cet événement virtuel d’une journée et en direct est ouvert aux professionnels de l’industrie des sciences de la vie.

Informations complémentaires
Pour en savoir plus sur Veeva Vault ProductName, visitez le site : veeva.com/PromoMats
Rejoignez Veeva sur LinkedIn : linkedin.com/company/veeva-systems
Suivez @veeva_eu sur Twitter : twitter.com/veeva_eu 

À propos de Veeva Systems
Veeva est le leader mondial des logiciels en nuage pour l’industrie des sciences de la vie. Engagée en faveur de l’innovation, de l’excellence des produits et de la réussite des clients, Veeva compte plus de 975 clients, allant des plus grands laboratoires pharmaceutiques du monde aux biotechnologies émergentes. En tant que société d’intérêt public, Veeva s’engage à équilibrer les intérêts de toutes les parties prenantes, y compris les clients, les employés, les actionnaires et les industries qu’elle sert. Pour plus d’informations, visitez le site veeva.com/eu.

Déclarations prospectives
Le présent communiqué contient des déclarations prospectives, notamment sur la demande et l’acceptation par le marché des produits et services de Veeva, les résultats de l’utilisation des produits et services de Veeva et les conditions commerciales générales (y compris l’impact continu de la COVID-19), en particulier dans l’industrie des sciences de la vie. Toutes les déclarations prospectives contenues dans ce communiqué de presse sont basées sur les performances historiques de Veeva et sur ses plans, estimations et attentes actuels, et ne constituent pas une déclaration selon laquelle ces plans, estimations ou attentes se réaliseront. Ces déclarations prospectives représentent les attentes de Veeva à la date de cette annonce de presse. Des événements ultérieurs peuvent faire évoluer ces prévisions, et Veeva décline toute obligation de mettre à jour les déclarations prospectives à l’avenir. Ces déclarations prospectives sont soumises à des risques et à des incertitudes connus et inconnus qui peuvent entraîner des différences importantes entre les résultats réels. D’autres risques et incertitudes susceptibles d’affecter les résultats financiers de Veeva sont inclus dans les rubriques « Facteurs de risque » et « Commentaires et analyse de la direction sur la situation financière et les résultats d’exploitation » dans le formulaire 10-K déposé par l’entreprise pour la période se terminant le 31 janvier 2021. Il est disponible sur le site web de l’entreprise à l’adresse veeva.com dans la section Investisseurs, et sur le site web de la SEC à l’adresse sec.gov. De plus amples informations sur les risques probables qui pourraient affecter les résultats réels seront incluses dans d’autres dépôts que Veeva effectue périodiquement auprès de la SEC.

1 Veeva Pulse data 2020

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SOURCE Veeva Systems

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Veeva bringt modulare Content-Lösung auf den Markt, um Unternehmen bei der schnellen Bereitstellung digitaler Inhalte in großem Umfang zu unterstützen

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BARCELONA, Spanien, 7. Mai 2021 /PRNewswire/ — Veeva Systems (NYSE: VEEV) kündigte heute neue modulare Content-Funktionen in Veeva Vault PromoMats an, die Life-Sciences-Vermarkter bei der schnellen Erstellung, Überprüfung und Verteilung von Inhalten über verschiedene Medien unterstützen. Zu den neuen Erweiterungen der kommerziellen Content-Plattform gehören Funktionen und Konnektoren, die es Marken ermöglichen, schnell und in großem Umfang konforme Inhalte bereitzustellen.

Die Daten von Veeva Pulse zeigen, dass Life-Sciences-Unternehmen im vergangenen Jahr 3,5-mal mehr digitale Inhalte als gedruckte erstellt haben, mit einem durchschnittlichen Genehmigungszyklus von 21 Tagen1, was den Bedarf an mehr und schnellerem Inhalt unterstreicht. Durch die Verwendung von vorab genehmigten Inhaltsmodulen für den Aufbau von Vertriebs- und Marketing-Assets können Teams die rechtlichen, medizinischen und regulatorischen (MLR) Prüfungen beschleunigen.

„Die modulare Content-Lösung von Veeva hilft uns, konforme Werbeinhalte zu generieren, die bei den wichtigsten Zielgruppen auf große Resonanz stoßen, so dass wir erstklassige digitale Erlebnisse schaffen können”, sagte Cedric Grand-Pierre, Global Customer Experience and Engagement Lead bei Organon, dem geplanten Spin-off von Merck. „Vault PromoMats ermöglicht es uns, schneller zu handeln, die Wiederverwendung von Inhalten über Kanäle hinweg zu erhöhen und den Überprüfungsprozess zu beschleunigen.”

Im Laufe des Jahres 2021 wird Veeva seine modulare Content-Lösung in Vault PromoMats um die folgenden Funktionen erweitern:

  • Vault PromoMats Inhaltsmodule – Ab heute können Kunden Module direkt in ihrer Veeva Vault Inhaltsbibliothek erstellen und speichern. Das System dient nun als „Single Source of Truth” für wiederverwendbare Text-, Bild- oder Claims-Blöcke zusammen mit den zugehörigen Regeln für die Verwendung der einzelnen Module.
  • Omnichannel Authoring Connectors – Vault PromoMats Content-Module sind nun auch über die APIs von Veeva teilbar. In den kommenden Monaten werden Kunden in der Lage sein, eine Reihe von kanalspezifischen Authoring-Tools – darunter Anthill Activator, die eWizard-Plattform von Viseven und andere – in die modulare Content-Lösung von Veeva zu integrieren. Teams können ihre bevorzugten Tools verwenden, um bereits vorhandene Module zusammenzustellen, und dann die fertigen Assets zur Freigabe zurück in Vault PromoMats schieben.
  • Modulare MLR-Überprüfung – Sobald ein Asset zur Genehmigung bereit ist, können Marketer native MLR-Compliance-Workflows in Veeva Vault starten. Später in diesem Jahr wird das System visuelle Hervorhebungen hinzufügen, um anzuzeigen, welche der zusammengestellten Module bereits genehmigt, in Bearbeitung oder zum ersten Mal geprüft sind.

„Modularer Content unterstützt den rasanten Wandel der Branche hin zu digitalem Engagement durch eine deutliche Veränderung der Art und Weise, wie Markenteams Inhalte entwerfen, überprüfen und verteilen”, so Pooja Ojala, Vice President of Commercial Content bei Veeva. „Unsere Lösung baut auf unserer starken Tradition im Bereich MLR und Digital Asset Management auf, um ein flexibles und modulares System für die Erstellung von Inhalten zu schaffen, das die Prüfzyklen um mehr als 20 Prozent reduziert und die Markteinführungsgeschwindigkeit um mehr als 50 Prozent erhöht.”

Um den Markenteams die schnelle Verteilung von Inhaltsmodulen über verschiedene Kanäle zu erleichtern, bietet Veeva außerdem ein breites Ökosystem von Autorentools an. „Durch die Zusammenarbeit mit Veeva zur Automatisierung des Lebenszyklus der Content-Produktion helfen wir unseren Kunden, personalisierte Inhalte schneller und kostengünstiger zu liefern”, sagt Nataliya Andreychuk, CEO bei Viseven. Rasmus Kalms, Chief Product Officer bei Anthill, fügte hinzu: „Gemeinsam mit Veeva können wir Unternehmen aus dem Bereich Life Sciences in die Lage versetzen, die Erstellung, Wiederverwendung und Agilität von Inhalten bei jedem Schritt zu verbessern.”

Für weitere Informationen zu den Best Practices für modulare Inhalte können Sie sich für die kommende Veeva Commercial & Medical North America Summit Connect am 10. Juni 2021 anmelden. Die eintägige virtuelle Live-Veranstaltung richtet sich an Fachleute aus der Life-Science-Branche.

Zusätzliche Informationen

Weitere Informationen zu Veeva Vault ProductName finden Sie unter: veeva.com/PromoMats
Verbinden Sie sich mit Veeva auf LinkedIn: linkedin.com/unternehmen/veeva-systeme
Folgen Sie @veeva_eu auf Twitter: twitter.com/veeva_eu 

Informationen zu Veeva Systems

Veeva ist der weltweit führende Anbieter von Cloud-Software für die Life-Science-Branche. Veeva hat sich der Innovation, der Produktqualität und dem Erfolg seiner Kunden verschrieben und bedient mehr als 975 Kunden, von den weltweit größten Pharmaunternehmen bis hin zu aufstrebenden Biotech-Unternehmen. Als gemeinnützige Gesellschaft ist Veeva verpflichtet, die Interessen aller Stakeholder, einschließlich der Kunden, Mitarbeiter, Aktionäre und der Branchen, für die das Unternehmen tätig ist, in Einklang zu bringen. Für weitere Informationen besuchen Sie veeva.com/eu.

Zukunftsgerichtete Aussagen

Diese Mitteilung enthält zukunftsgerichtete Aussagen, einschließlich der Marktnachfrage nach den Produkten und Dienstleistungen von Veeva und deren Akzeptanz, der Ergebnisse aus der Nutzung der Produkte und Dienstleistungen von Veeva sowie der allgemeinen Geschäftsbedingungen (einschließlich der anhaltenden Auswirkungen von COVID-19), insbesondere in der Life-Science-Branche. Alle in dieser Pressemitteilung enthaltenen zukunftsgerichteten Aussagen basieren auf der historischen Performance von Veeva sowie auf den aktuellen Plänen, Schätzungen und Erwartungen des Unternehmens und stellen keine Zusicherung dar, dass diese Pläne, Schätzungen oder Erwartungen auch tatsächlich erreicht werden. Diese zukunftsgerichteten Aussagen stellen die Erwartungen von Veeva zum Zeitpunkt der Veröffentlichung dieser Pressemitteilung dar. Spätere Ereignisse können dazu führen, dass sich diese Erwartungen ändern, und Veeva lehnt jede Verpflichtung ab, die zukunftsgerichteten Aussagen in der Zukunft zu aktualisieren. Diese zukunftsgerichteten Aussagen unterliegen bekannten und unbekannten Risiken und Unsicherheiten, die dazu führen können, dass die tatsächlichen Ergebnisse erheblich abweichen. Weitere Risiken und Ungewissheiten, die sich auf die Finanzergebnisse von Veeva auswirken könnten, sind unter den Überschriften „Risk Factors” und „Management’s Discussion and Analysis of Financial Condition and Results of Operations” in der Einreichung des Unternehmens auf Formular 10-K für den Zeitraum bis zum 31. Januar 2021 enthalten. Dieser ist auf der Website des Unternehmens unter veeva.com im Bereich „Investoren” und auf der Website der SEC unter sec.gov zu finden. Weitere Informationen zu potenziellen Risiken, die sich auf die tatsächlichen Ergebnisse auswirken könnten, werden in anderen Unterlagen enthalten sein, die Veeva von Zeit zu Zeit bei der SEC einreicht.

1 Veeva Pulse data 2020

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SOURCE Veeva Systems

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Con Edison Reports 2021 First Quarter Earnings

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NEW YORK, May 6, 2021 /PRNewswire/ — Consolidated Edison, Inc. (Con Edison) (NYSE: ED) today reported 2021 first quarter net income for common stock of $419 million or $1.23 a share compared with $375 million or $1.13 a share in the 2020 first quarter. Adjusted earnings were $491 million or $1.44 a share in the 2021 period compared with $451 million or $1.35 a share in the 2020 period. Adjusted earnings and adjusted earnings per share in the 2021 period exclude the impact of the impairment loss related to Con Edison’s investment in Stagecoach Gas Services, LLC (Stagecoach). Adjusted earnings and adjusted earnings per share in the 2021 and 2020 periods exclude the effects of hypothetical liquidation at book value (HLBV) accounting for tax equity investments in certain renewable and sustainable electric production projects of Con Edison Clean Energy Businesses, Inc. (the Clean Energy Businesses) and the net mark-to-market effects of the Clean Energy Businesses.

“Con Edison is leading the way to a clean energy future with its investments in renewable energy, electric vehicle infrastructure, and energy efficiency,” said Timothy P. Cawley, the company’s president and chief executive officer. “Delivering energy safely and reliably is always a top priority, and our workforce continues to provide value for shareholders and all New Yorkers during this challenging time.”

For the year of 2021, Con Edison reaffirmed its previous forecast of adjusted earnings per share to be in the range of $4.15 to $4.35 per share.  Adjusted earnings per share exclude the impact of the impairment loss related to Con Edison’s investment in Stagecoach (($0.35) a share after-tax), the effects of HLBV accounting for tax equity investments in certain renewable and sustainable electric production projects of the Clean Energy Businesses (approximately $0.23 a share after-tax) and the net mark-to-market effects of the Clean Energy Businesses, the amount of which will not be determinable until year end.

See Attachment A to this press release for a reconciliation of Con Edison’s reported earnings per share to adjusted earnings per share and reported net income for common stock to adjusted earnings for the three months ended March 31, 2021 and 2020. See Attachment B for the estimated effect of major factors resulting in variations in earnings per share and net income for common stock for the three months ended March 31, 2021 compared to the 2020 period.

The company’s 2021 First Quarter Form 10-Q is being filed with the Securities and Exchange Commission. A first quarter 2021 earnings release presentation will be available at www.conedison.com. (Select “For Investors” and then select “Press Releases.”)

This press release contains forward-looking statements that are intended to qualify for the safe-harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are statements of future expectations and not facts. Words such as “forecasts,” “expects,” “estimates,” “anticipates,” “intends,” “believes,” “plans,” “will,” “target,” “guidance” and similar expressions identify forward-looking statements. The forward-looking statements reflect information available and assumptions at the time the statements are made, and accordingly speak only as of that time.

Actual results or developments might differ materially from those included in the forward-looking statements because of various factors such as those identified in reports Con Edison has filed with the Securities and Exchange Commission, including that Con Edison’s subsidiaries are extensively regulated and are subject to penalties; its utility subsidiaries’ rate plans may not provide a reasonable return; it may be adversely affected by changes to the utility subsidiaries’ rate plans; the failure of, or damage to, its subsidiaries’ facilities could adversely affect it; a cyber-attack could adversely affect it; the failure of processes and systems and the performance of employees and contractors could adversely affect it; it is exposed to risks from the environmental consequences of its subsidiaries’ operations, including increased costs related to climate change; a disruption in the wholesale energy markets or failure by an energy supplier or customer could adversely affect it; it has substantial unfunded pension and other postretirement benefit liabilities; its ability to pay dividends or interest depends on dividends from its subsidiaries; it requires access to capital markets to satisfy funding requirements; changes to tax laws could adversely affect it; its strategies may not be effective to address changes in the external business environment; it faces risks related to health epidemics and other outbreaks, including the COVID-19 pandemic; and it also faces other risks that are beyond its control. Con Edison assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release also contains financial measures, adjusted earnings and adjusted earnings per share, that are not determined in accordance with generally accepted accounting principles in the United States of America (GAAP). These non-GAAP financial measures should not be considered as an alternative to net income for common stock or net income per share, respectively, each of which is an indicator of financial performance determined in accordance with GAAP. Adjusted earnings and adjusted earnings per share exclude from net income for common stock and net income per share, respectively, certain items that Con Edison does not consider indicative of its ongoing financial performance such as the impairment loss related to Con Edison’s investment in Stagecoach, the effects of the Clean Energy Businesses’ HLBV accounting for tax equity investors in certain renewable and sustainable electric production projects and mark-to-market accounting. Management uses these non-GAAP financial measures to facilitate the analysis of Con Edison’s financial performance as compared to its internal budgets and previous financial results and to communicate to investors and others Con Edison’s expectations regarding its future earnings and dividends on its common stock. Management believes that these non-GAAP financial measures are also useful and meaningful to investors to facilitate their analysis of Con Edison’s financial performance.

Consolidated Edison, Inc. is one of the nation’s largest investor-owned energy-delivery companies, with approximately $12 billion in annual revenues and $62 billion in assets. The company provides a wide range of energy-related products and services to its customers through the following subsidiaries: Consolidated Edison Company of New York, Inc. (CECONY), a regulated utility providing electric service in New York City and New York’s Westchester County, gas service in Manhattan, the Bronx, parts of Queens and parts of Westchester, and steam service in Manhattan; Orange and Rockland Utilities, Inc. (O&R), a regulated utility serving customers in a 1,300-square-mile-area in southeastern New York State and northern New Jersey; Con Edison Clean Energy Businesses, Inc., the second-largest solar developer in the United States and the seventh-largest worldwide, which, through its subsidiaries develops, owns and operates renewable and sustainable energy infrastructure projects and provides energy-related products and services to wholesale and retail customers; and Con Edison Transmission, Inc., which falls primarily under the oversight of the Federal Energy Regulatory Commission and through its subsidiaries invests in electric transmission projects supporting its parent company’s effort to transition to clean, renewable energy. Con Edison Transmission manages, through joint ventures, both electric and gas assets while seeking to develop electric transmission projects that will bring clean, renewable electricity to customers, focusing on New York, New England, the Mid-Atlantic states and the Midwest.

Attachment A



For the Three Months Ended


March 31,


Earnings

per Share

Net Income for
Common Stock

(Millions of Dollars)


2021

2020

2021

2020

Reported earnings per share (basic) and net income for common stock (GAAP basis)

$1.23

$1.13

$419

$375






Impairment loss related to investment in Stagecoach (pre-tax)

0.51

172

Income taxes (a)

(0.16)

(52)

Impairment loss related to investment in Stagecoach (net of tax)

0.35

120

HLBV effects of the Clean Energy Businesses (pre-tax)

0.06

1

17

Income taxes (b)

(0.02)

(4)

HLBV effects of the Clean Energy Businesses (net of tax)

0.04

1

13

Net mark-to-market effects of the Clean Energy Businesses (pre-tax)

(0.19)

0.25

(65)

83

Income taxes (b)

0.05

(0.07)

16

(20)

Net mark-to-market effects of the Clean Energy Businesses (net of tax)

(0.14)

0.18

(49)

63






Adjusted earnings per share and adjusted earnings (non-GAAP basis)

$1.44

$1.35

$491

$451










(a) 

The amount of income taxes was calculated using a combined federal and state income tax rate of 30% for the three months ended March 31, 2021.

(b) 

The amount of income taxes was calculated using a combined federal and state income tax rate of 25% and 24% for the three months ended March 31, 2021 and 2020, respectively.




Attachment B

Variation for the Three Months Ended March 31, 2021 vs. 2020


Earnings

per Share

Net Income
for
Common
Stock
(Millions of
Dollars)


CECONY (a)




Changes in rate plans

$0.29

$98

Primarily reflects higher electric and gas net base revenues of $0.16 a share and $0.15 a share, respectively,
due to electric and gas base rate increases in January 2021 under the company’s rate plans.

Weather impact on steam revenues

0.06

22

Reflects the impact of colder winter weather in 2021.

Operations and maintenance expenses

(0.09)

(29)

Reflects higher costs for pension and other postretirement benefits of $(0.08) a share, which are reconciled
under the rate plans, and higher storm-related costs of $(0.06) a share, offset in part by the timing of
compensation costs of $0.03 a share, a lower reserve for uncollectibles associated with the Coronavirus
Disease 2019 (COVID-19) pandemic of $0.01 a share and lower incremental costs associated with the COVID-
19 pandemic of $0.01 a share.

Depreciation, property taxes and other tax matters

(0.18)

(60)

Reflects higher property taxes of $(0.12) a share and higher depreciation and amortization expense of $(0.06) a share, both of which are recoverable under the rate plans.

Other

0.06

28

Primarily reflects lower costs associated with components of pension and other postretirement benefits other than service cost of $0.08 a share, unbilled amounts due to the suspension of customers’ late payment charges and certain other fees associated with the COVID-19 pandemic of $(0.03) a share and the dilutive effect of Con Edison’s stock issuances of $(0.03) a share.

Total CECONY

0.14

$59


O&R (a)




Changes in rate plans

2


Operations and maintenance expenses

(0.01)

(4)

Primarily reflects higher storm-related costs.

Depreciation, property taxes and other tax matters

(1)


Other

(1)


Total O&R

(0.01)

(4)


Clean Energy Businesses




Operating revenues less energy costs

0.13

43

Primarily reflects higher revenue from renewable and sustainable electric production projects of $0.09 a share
and higher wholesale revenues of $0.05 a share.

Operations and maintenance expenses

(0.10)

(33)

Primarily reflects an increase in operating expenses from renewable and sustainable electric production
projects.

Net interest expense

0.33

112

Primarily reflects lower unrealized losses on interest rate swaps in the 2021 period.

HLBV effects

0.04

12

Primarily reflects lower losses from tax equity projects in the 2021 period.

     Other

(0.02)

(3)

Primarily reflects lower income attributable to non-controlling interest of $(0.01) a share and a non-recurring tax benefit in 2020 allowed under the CARES Act signed into law in March 2020 of $(0.01) a share.

Total Clean Energy Businesses

0.38

131


Con Edison Transmission

(0.39)

(136)

Primarily reflects the impairment loss related to the investment in Stagecoach of $(0.36) a share and foregoing Allowance for Funds Used During Construction income starting in January 2021 until significant construction resumes on the Mountain Valley Pipeline of $(0.03) a share.

Other, including parent company expenses

(0.02)

(6)

Primarily reflects lower consolidated state income tax benefits.

Total Reported (GAAP basis)

$0.10

$44


Impairment loss related to investment in Stagecoach

0.35

120


HLBV effects of the Clean Energy Businesses

(0.04)

(12)


Net mark-to-market effects of the Clean Energy Businesses

(0.32)

(112)

Primarily reflects unrealized gains on interest rate swaps.

Total Adjusted (non-GAAP basis)

$0.09

$40






a.  Under the revenue decoupling mechanisms in the Utilities’ New York electric and gas rate plans and the weather-normalization clause applicable to their gas businesses, revenues are generally not affected by changes in delivery volumes from levels assumed when rates were approved. In general, the Utilities recover on a current basis the fuel, gas purchased for resale and purchased power costs they incur in supplying energy to their full-service customers. Accordingly, such costs do not generally affect Con Edison’s results of operations.

SOURCE Consolidated Edison, Inc.

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