Tag: Business

Categories
Business Regulations & Security

SPWR Shareholder Alert: Bronstein, Gewirtz & Grossman, LLC, a leading class action firm, notifies SunPower Corporation investors of class action and encourages investors to contact the fcirm

NEW YORK — (BUSINESS WIRE) — Attorney Advertising–Bronstein, Gewirtz & Grossman, LLC notifies investors that a class action lawsuit has been filed against SunPower Corporation (“SunPower” or the “Company”) (NASDAQ: SPWR) and certain of its officers, on behalf of shareholders who purchased or otherwise acquired SunPower securities between August 3, 2021 and January 20, 2022, both dates inclusive (the “Class Period”). Such investors are encouraged to join this case by visiting the firm’s site: www.bgandg.com/spwr.

This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1934.

 

The complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that certain connectors used by SunPower suffered from cracking issues; (2) that, as a result, the Company was reasonably likely to incur costs to remediate the faulty connectors; (3) that, as a result of the foregoing, SunPower’s financial results would be adversely impacted; and (4) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

 

A class action lawsuit has already been filed. If you wish to review a copy of the Complaint you can visit the firm’s site: www.bgandg.com/spwr or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss in SunPower you have until April 18, 2022, to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff.

 

Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm’s expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.

Contacts

Bronstein, Gewirtz & Grossman, LLC

Peretz Bronstein or Yael Nathanson

212-697-6484 | info@bgandg.com

Categories
Healthcare Science

ENHERTU® significantly improved both progression-free and overall survival in DESTINY-Breast04 trial in patients with HER2 low metastatic breast cancer

  • First HER2 low metastatic breast cancer phase 3 results for Daiichi Sankyo and AstraZeneca’s ENHERTU offer potential to redefine how the disease is classified and treated
  • Plans for global regulatory submissions are underway

 

TOKYO & MUNICH & BASKING RIDGE, N.J. — (BUSINESS WIRE) — Positive topline results from the pivotal DESTINY-Breast04 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2 low unresectable and/or metastatic breast cancer regardless of hormone receptor (HR) status versus physician’s choice of chemotherapy, which is the current standard of care. ENHERTU is a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).


All patients in the trial received a HER2 test and the results were centrally confirmed. HER2 low status was defined as an immunohistochemistry (IHC) score of 1+ or IHC2+ with a negative in-situ hybridization (ISH) score.

 

HER2 expression is currently defined as either positive or negative.1 HER2 positive cancers are defined as IHC 3+ or IHC 2+/ISH+ and HER2 negative cancers are defined as IHC 0, IHC 1+ or IHC 2+/ISH-.1 Up to 55% of all patients with breast cancer have tumors with a HER2 IHC score of 1+ or a HER2 IHC score of 2+ in combination with a negative ISH test, an expression level not currently eligible for HER2 targeted therapy.2,3 Low HER2 expression occurs in both hormone receptor (HR) positive and HR negative disease.4

 

HER2 testing is well-established to determine an appropriate treatment strategy in metastatic breast cancer. Targeting the lower range of HER2 expression may offer another approach to delay disease progression and extend survival in patients with metastatic breast cancer.5 Currently, chemotherapy remains the only treatment option both for patients with HR positive tumors following progression on endocrine (hormone) therapy and for those who are HR negative.6

 

DESTINY-Breast04 met its primary endpoint where ENHERTU demonstrated superior PFS in previously-treated patients with HR positive, HER2 low metastatic breast cancer compared to the standard of care chemotherapy. The trial met the key secondary endpoint of PFS in patients with HER2 low metastatic breast cancer regardless of HR status (HR positive or HR negative). The trial also met other key secondary endpoints of OS in patients with HR positive disease and patients regardless of HR status at interim analysis.

 

The safety profile of ENHERTU was consistent with previous clinical trials with no new safety concerns identified. Overall interstitial lung disease (ILD) rates were consistent with that observed in late-line HER2 positive breast cancer trials of ENHERTU with a lower rate of grade 5 ILD observed, as determined by an independent adjudication committee.

 

“ENHERTU continues to redefine the treatment of HER2 targetable cancers. DESTINY-Breast04 is the first ever phase 3 trial of a HER2 directed therapy in patients with HER2 low metastatic breast cancer to show a statistically significant and clinically meaningful benefit in progression-free and overall survival compared to standard treatment,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We look forward to sharing the detailed findings of DESTINY-Breast04 with the medical community and initiating discussions with regulatory agencies globally with the goal of potentially bringing ENHERTU to patients with metastatic breast cancer previously considered to be HER2 negative.”

 

“Today’s historic news from DESTINY-Breast04 could reshape how breast cancer is classified and treated,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “A HER2 directed therapy has never before shown a benefit in patients with HER2 low metastatic breast cancer. These results for ENHERTU are a huge step forward and could potentially expand our ability to target the full spectrum of HER2 expression, validating the need to change the way we categorize and treat breast cancer.”

 

The data will be presented at an upcoming medical meeting and shared with global health authorities.

 

About DESTINY-Breast04

DESTINY-Breast04 is a global, randomized, open-label, pivotal phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel) in patients with HR positive (n=480) or HR negative (n=60), HER2 low unresectable and/or metastatic breast cancer previously treated with one or two prior lines of chemotherapy. Patients were randomized 2:1 to receive either ENHERTU or chemotherapy.

 

The primary endpoint of DESTINY-Breast04 is PFS in patients with HR positive disease based on blinded independent central review (BICR). Key secondary endpoints include PFS based on BICR in all randomized patients (regardless of HR status), OS in patients with HR positive disease and OS in all randomized patients (regardless of HR status). Other secondary endpoints include PFS based on investigator assessment, objective response rate based on BICR and on investigator assessment, duration of response based on BICR and safety.

 

DESTINY-Breast04 enrolled approximately 540 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

 

About Breast Cancer and HER2 Expression

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide.7 More than two million cases of breast cancer were diagnosed in 2020 resulting in nearly 685,000 deaths globally.7

 

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers, and is one of many biomarkers expressed in breast cancer tumors.1 HER2 expression is currently defined as either positive or negative, and is determined by an IHC test which measures the amount of HER2 protein in a cancer cell, and/or an ISH test, which counts the copies of the HER2 gene in cancer cells. 1,8 HER2 positive cancers are defined as IHC 3+, IHC 2+/ISH+ and HER2 negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.1 Up to 55% of all patients with breast cancer have tumors with a HER2 IHC score of 1+, or a HER2 IHC score of 2+ in combination with a negative ISH test, an expression level not currently eligible for HER2 targeted therapy.2,3 Low HER 2 expression occurs in both hormone receptor (HR) positive and HR negative disease.4

 

HER2 testing is well-established to determine an appropriate treatment strategy in metastatic breast cancer. Targeting the lower range of HER2 expression may offer another approach to delay disease progression and extend survival in patients with metastatic breast cancer.5 Currently, chemotherapy remains the only treatment option both for patients with HR positive tumors following progression on endocrine (hormone) therapy and for those who are HR negative.6

 

About ENHERTU

ENHERTU® (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

 

ENHERTU (5.4 mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens based on the results from the DESTINY-Breast01 trial.

 

ENHERTU (6.4 mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

 

ENHERTU is approved in the U.S. with Boxed WARNINGS for Interstitial Lung Disease and Embryo-Fetal Toxicity. For more information, please see the accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

 

About the ENHERTU Clinical Development Program

A comprehensive global development program is underway evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

 

Regulatory applications for ENHERTU are currently under review in Europe, Japan, US and several other countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen based on the results from the DESTINY-Breast03 trial. ENHERTU also is currently under review in Europe for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2 based regimen based on the DESTINY-Gastric01 and DESTINY-Gastric02 trials.

 

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan (Dato-DXd) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan.

 

U.S. Important Safety Information for ENHERTU

Indications

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

  • Unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

    This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

  • Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY

  • Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms.
  • Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

Contraindications

None.

Warnings and Precautions

Interstitial Lung Disease / Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.

Metastatic Breast Cancer

In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, ILD occurred in 9% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 2.6% of patients treated with ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to 8.3).

Locally Advanced or Metastatic Gastric Cancer

In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21.0).

Neutropenia

Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU.

Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for more than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one level.

Metastatic Breast Cancer

In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU 5.4mg/kg, a decrease in neutrophil count was reported in 62% of patients. Sixteen percent had Grade 3 or 4 decrease in neutrophil count. Median time to first onset of decreased neutrophil count was 23 days (range: 6 to 547). Febrile neutropenia was reported in 1.7% of patients.

Locally Advanced or Metastatic Gastric Cancer

In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients.

Left Ventricular Dysfunction

Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. In the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF decrease were reported. In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.

Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure.

Embryo-Fetal Toxicity

ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.

Additional Dose Modifications

Thrombocytopenia

For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less. Reduce dose by one level.

Adverse Reactions

Metastatic Breast Cancer

The safety of ENHERTU was evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast01 and Study DS8201-A-J101. ENHERTU was administered by intravenous infusion once every three weeks. The median duration of treatment was 7 months (range: 0.7 to 31).

Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were interstitial lung disease, pneumonia, vomiting, nausea, cellulitis, hypokalemia, and intestinal obstruction. Fatalities due to adverse reactions occurred in 4.3% of patients including interstitial lung disease (2.6%), and the following events occurred in one patient each (0.4%): acute hepatic failure/acute kidney injury, general physical health deterioration, pneumonia, and hemorrhagic shock.

ENHERTU was permanently discontinued in 9% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 33% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, thrombocytopenia, leukopenia, upper respiratory tract infection, fatigue, nausea, and ILD. Dose reductions occurred in 18% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, and neutropenia.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (79%), white blood cell count decreased (70%), hemoglobin decreased (70%), neutrophil count decreased (62%), fatigue (59%), vomiting (47%), alopecia (46%), aspartate aminotransferase increased (41%), alanine aminotransferase increased (38%), platelet count decreased (37%), constipation (35%), decreased appetite (32%), anemia (31%), diarrhea (29%), hypokalemia (26%), and cough (20%).

Locally Advanced or Metastatic Gastric Cancer

The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma in DESTINY‑Gastric01. Patients intravenously received at least one dose of either ENHERTU (N=125) 6.4 mg/kg once every three weeks or either irinotecan (N=55) 150 mg/m2 biweekly or paclitaxel (N=7) 80 mg/m2 weekly for 3 weeks. The median duration of treatment was 4.6 months (range: 0.7 to 22.3) in the ENHERTU group and 2.8 months (range: 0.5 to 13.1) in the irinotecan/paclitaxel group.

Serious adverse reactions occurred in 44% of patients receiving ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients who received ENHERTU were decreased appetite, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of patients: disseminated intravascular coagulation, large intestine perforation, and pneumonia occurred in one patient each (0.8%).

ENHERTU was permanently discontinued in 15% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 62% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, decreased appetite, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, upper respiratory tract infection, diarrhea, and hypokalemia. Dose reductions occurred in 32% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were neutropenia, decreased appetite, fatigue, nausea, and febrile neutropenia.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (75%), white blood cell count decreased (74%), neutrophil count decreased (72%), lymphocyte count decreased (70%), platelet count decreased (68%), nausea (63%), decreased appetite (60%), anemia (58%), aspartate aminotransferase increased (58%), fatigue (55%), blood alkaline phosphatase increased (54%), alanine aminotransferase increased (47%), diarrhea (32%), hypokalemia (30%), vomiting (26%), constipation (24%), blood bilirubin increased (24%), pyrexia (24%), and alopecia (22%).

Use in Specific Populations

  • Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months following the last dose of ENHERTU.
  • Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.
  • Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 7 months following the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months following the last dose. Infertility: ENHERTU may impair male reproductive function and fertility.
  • Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients.
  • Geriatric Use: Of the 234 patients with HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, 26% were ≥65 years and 5% were ≥75 years. No overall differences in efficacy were observed between patients ≥65 years of age compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged ≥65 years (53%) as compared to younger patients (42%).

Contacts

Global:
Victoria Amari

Daiichi Sankyo, Inc.

vamari@dsi.com
+1 908 900 3010 (mobile)

US:
Don Murphy

Daiichi Sankyo, Inc.

domurphy@dsi.com
+1 917 817 2649 (mobile)

Japan:
Masashi Kawase

Daiichi Sankyo Co., Ltd.

kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

EU:
Lydia Worms

Daiichi Sankyo Europe GmbH

lydia.worms@daiichi-sankyo.eu
+49 (89) 7808751 (office)

+49 176 11780861 (mobile)

Read full story here

Categories
Business Entertainment News

Paul McCartney GOT BACK Tour 2022 coming to MetLife Stadium June 16

Tickets On Sale Friday, February 25 at 10am

 

McCartney Has Home Field Advantage With End Zone Takeover at MetLife Stadium

 

paulmccartneygotback.com

Paul McCartney Announces First Live Shows Since 2019

 

“I said at the end of the last tour that I’d see you next time. I said I was going to get back to you. Well, I got back!”—Paul McCartney

 

EAST RUTHERFORD, N.J. — (BUSINESS WIRE) — Following more than a year of speculation, Paul McCartney today announces the GOT BACK Tour, a 13-city return to U.S. stages, kicking off April 28 with Paul’s first ever show in Spokane, WA and running through to June 16 in East Rutherford, NJ, where Paul will play MetLife Stadium for the first time since 2016. The MetLife Stadium show is produced by AEG Presents.

“We are honored to have one of the world’s most influential artists come back to New Jersey for another spectacular concert at MetLife Stadium,” said Ron VanDeVeen, MetLife Stadium President and CEO. “To celebrate Sir Paul McCartney’s return to MetLife Stadium, we are extending an unprecedented tribute by painting his name in our end zones. PAUL McCARTNEY will be emblazoned on our field in 20-foot-tall letters.”

 

The process to paint the end zones began this morning and will continue throughout the day. Each end zone will have PAUL McCARTNEY in 20-foot-tall white letters against a black background. GOT BACK and JUNE 16 will be on the 50-yard-line and #PAULMcCARTNEYGOTBACK on each sideline. MetLife Stadium will offer three open sessions next week for fans to come in and take their own photos to commemorate this tribute. Sessions are Tuesday, Feb. 22, 12pm-2pm; Wednesday, Feb. 23, 5:30pm – 7:30pm; and Thursday, Feb. 24, time TBD. More information will be posted on metlifestadium.com.

 

GOT BACK will see Paul’s live debuts in Hollywood, FL; Knoxville, TN; and Winston-Salem, NC; his first Fort Worth, TX and Baltimore, MD shows since 1976 with Wings and 1964 with The Beatles, respectively, and his first Oakland, CA date in 20 years. The tour will also include stops in cities where Paul has put in more recent yet no less unforgettable performances, including Boston, MA; Los Angeles, CA; Orlando, FL; Seattle, WA; and Syracuse, NY.

 

Tickets for all GOT BACK tour dates will be on sale to the public beginning Friday, February 25 at 10am local time. American Express® Card Members can purchase tickets before the general public beginning Tuesday, February 22 at 10am local time through Thursday, February 24 at 10pm local time. For a full itinerary, see below or check paulmccartneygotback.com.

 

GOT BACK marks Paul’s first series of live shows since his FRESHEN UP Tour wrapped in July 2019–its 39-date 12-country odyssey concluding with a triumphant sold-out show at Dodger Stadium in Los Angeles—a performance that instantly attained legendary status, generating rave reviews and Best of 2019 notices including:

 

“… Wow. After several decades now of writing about music and facing the perpetual challenge of translating what is beyond words into understandable language, that’s the best I can muster. Here in the heady aftermath of Paul McCartney’s final show of his Freshen Up tour at Dodger Stadium along with 50,000 of my fellow Angelenos on July 13, 2019 — Wow.”—AMERICAN SONGWRITER

 

“The perfect display of the philosophy McCartney has embodied over his 60-year career in music… the perfect bow to tie up the perfect show, with the final lyric of the night an ever-appropriate one: ‘And in the end, the love you take is equal to the love you make.’”—BILLBOARD

 

“Macca continues to put artists half his age and younger to shame with epic shows featuring his crackerjack band and a jukebox of hits.”—ENTERTAINMENT WEEKLY Best Live Music Performances of 2019

 

“The best thing about a McCartney show is how many generations of people leave with the broadest smile upon their face. Whether it’s the first time they’ve seen him or the tenth, he never, ever, disappoints.”—FLAUNT

 

“McCartney was in top form, his voice effortlessly climbing to the heights it always hit so easily back in the day…”—THE LOS ANGELES TIMES

 

“The total and complete immersion into MaccaLand was colorful and loud, rocking and rolling, nostalgic and present, and, above all, in the truest sense, marvelous… And, in the end, the love McCartney has taken for 60 years was equal to the love he’s made for generations.”—RELIX

 

“Definitely We’re Amazed by Paul McCartney’s Blowout Dodger Stadium Show… McCartney remains a show-stopping entertainer of the highest order.”—VARIETY

 

With songs like ‘Hey Jude’, ‘Live and Let Die’, ‘Band on the Run’, ‘Let It Be’ and so many more, the Paul McCartney live experience is everything any music lover could ever want from a rock show: Hours of the greatest moments from the last 60 years of music — dozens of songs from Paul’s solo, Wings and of course Beatles catalogues that have formed the soundtracks of our lives. Paul and his band have performed in an unparalleled range of venues and locations throughout the Americas, the UK, Europe, Japan, Australia, New Zealand and all points between: outside the Coliseum in Rome, Moscow’s Red Square, Buckingham Palace, The White House, a free show in Mexico for over 400,000 people, the last ever show at San Francisco’s Candlestick Park where The Beatles played their final concert in 1966, a 2016 week in the California desert that included two headline sets at the historic Desert Trip festival and a jam-packed club gig for a few hundred lucky fans at Pappy & Harriet’s Pioneertown Palace, and even one performance broadcast live into Space! Featuring Paul’s longtime band – Paul “Wix” Wickens (keyboards), Brian Ray (bass/guitar), Rusty Anderson (guitar) and Abe Laboriel Jr (drums) – and constantly upgraded state-of-the-art audio and video technology that ensures an unforgettable experience from every seat in the house, a Paul McCartney concert is never anything short of life-changing.

 

For approved artist images and videos for media use, please download HERE.

 

PAUL McCARTNEY

GOT BACK

Tour 2022

Thursday, April 28

Spokane, WA

Spokane Arena

Monday, May 2

Seattle, WA

Climate Pledge Arena

Tuesday, May 3

Seattle, WA

Climate Pledge Arena

Friday, May 6

Oakland, CA

Oakland Arena

Friday, May 13

Los Angeles, CA

SoFi Stadium

Tuesday, May 17

Fort Worth, TX

Dickies Arena

Saturday, May 21

Winston-Salem, NC

Truist Field

Wednesday, May 25

Hollywood, FL

Hard Rock Live

Saturday, May 28

Orlando, FL

Camping World Stadium

Tuesday, May 31

Knoxville, TN

Thompson-Boling Arena

Saturday, June 4

Syracuse, NY

Carrier Dome

Tuesday, June 7

Boston, MA

Fenway Park

Sunday, June 12

Baltimore, MD

Oriole Park

Thursday, June 16

East Rutherford, NJ

MetLife Stadium

 

About AEG Presents

Combining the power of the live event with a focus on true artist development, AEG Presents is a world leader in the music and entertainment industries. Operating across three continents, the company has an unparalleled commitment to artistry, creativity, and community. Its tentpole festivals and multi-day music events — which include the iconic Coachella Valley Music & Arts Festival, the legendary New Orleans Jazz & Heritage Festival, British Summer Time at Hyde Park, Stagecoach, Hangout Festival, Electric Forest, and Firefly — continue to set the bar for the live music experience alongside such renowned clubs and theaters as Webster Hall, Eventim Apollo, Mission Ballroom, The Roxy and Forest Hills Stadium, to name a few. AEG Presents promotes global tours for such artists as Justin Bieber, Kenny Chesney, Celine Dion, Elton John, Paul McCartney, Katy Perry, The Rolling Stones, Ed Sheeran, and Taylor Swift, in addition to creating and developing an unmatched infrastructure for artist development and audience reach through its network of clubs, theatres, arenas, stadiums, renowned wholly owned brands Concerts West and Goldenvoice, and partner brands Messina Touring Group, The Bowery Presents, PromoWest Productions, Marshall Arts, and Zero Mile Presents. More information can be found at www.aegpresents.com.

Contacts

Dennis Dennehy

ddennehy@aegpresents.com

Categories
Business Environment

American Water 2021 results in line with expectations; results include gain on sale of Homeowner Services; affirms 2022 guidance and long-term targets

  • 2021 full-year results of $6.95 per share compared to 2020 results of $3.91 per share
    • 2021 results reflect earnings of $4.25 per share, up 8.7% compared to earnings of $3.91 per share in 2020, before the gain on the sale of Homeowner Services Group (HOS) in Dec. 2021
    • 2021 results reflect gain of $2.70 per share on sale of HOS, after reflecting $0.19 per share contribution to the American Water Charitable Foundation out of proceeds
  • Completed the sale of our regulated subsidiaries in New York and Michigan in early Jan. 2022 and early Feb 2022, respectively
  • 2022 diluted earnings per share guidance range of $4.39 to $4.49 affirmed
  • Long-term financial targets announced in Nov. 2021 affirmed, including long-term EPS growth target of 7-9%
  • Continued ESG leadership as evidenced by recent exceptional ranking from Corporate Knights

 

CAMDEN, N.J. — (BUSINESS WIRE) — American Water Works Company, Inc. (NYSE: AWK) today reported results for the fourth quarter 2021, of $3.55 per share, compared to $0.80 per share in 2020, and full year results of $6.95 per share compared to $3.91 per share in 2020. Full year and fourth quarter 2021 results include a gain of $2.70 per share, which reflects the completion of the sale of HOS in December, reduced by the $0.19 per share contribution to the American Water Charitable Foundation from the proceeds on the sale. Full year and fourth quarter 2021 results were $4.25 per share and $0.85 per share, respectively, before the gain on the sale of HOS.

“American Water fully executed on the strategy in 2021, continuing our record of significant earnings growth and delivering on our plan, including the completion of the sale of HOS in 2021 and the sales of our regulated subsidiaries in New York and Michigan in early 2022,” said Susan Hardwick, president and CEO of American Water.

 

“We invested $1.9 billion in our regulated business, delivered greater efficiencies in our operations and successfully completed 23 regulated acquisitions during the year. We are also proud that 2021 marked one of our best years of safety performance and a continued recognition of our work to integrate our core values of diversity, inclusion, equity and environmental leadership into everything we do at American Water,” added Hardwick. “We are excited about this positive momentum as we continue to execute on the long-term strategies and targets that we shared late last year.”

 

2022 Earnings Guidance and Long-Term Financial Targets Affirmed

The Company affirms its 2022 earnings guidance range of $4.39 to $4.49 per share. The Company also affirms its long-term financial targets for the 2022-2026 period announced in Nov. 2021, including its long-term EPS compound annual growth rate target range of 7-9% and its long-term dividend growth expectation at the high end of a 7-10% range. The Company’s earnings forecasts are subject to numerous risks and uncertainties, including, without limitation, those described under “Forward-Looking Statements” below and under “Risk Factors” in its annual, quarterly and current reports filed with the Securities and Exchange Commission (“SEC”).

 

Closing of HOS, New York, and Michigan Transactions

On December 9, 2021 the Company announced the close of the sale of its Homeowner Services Group to a wholly owned subsidiary of funds advised by Apax Partners LLP. The sale agreement was announced on October 29, 2021, with a transaction value of approximately $1.275 billion, plus an applicable working capital adjustment.

 

Under the agreement, American Water received at closing, as part of the purchase price, $480 million in cash plus working capital adjustments, and a $720 million secured Seller Note bearing a 7.00% annual interest rate with a five-year term. In addition, the transaction includes a delayed payment to American Water of $75 million if certain milestones are met by December 31, 2023. The structure of the transaction enables initial cash proceeds to be redeployed into the regulated water and wastewater business to fund near-term incremental capital investments, while interest on the Seller Note will provide a stream of earnings over the term of the note. Upon maturity, the proceeds from the repayment of the Seller Note are expected to be used to fund a continually growing capital investment in the regulated business.

 

On January 3, 2022 the Company announced the close of the sale of its regulated operations in New York to a subsidiary of Liberty Utilities Co., the regulated utility operating subsidiary of parent company Algonquin Power & Utilities Corp., for a purchase price of $608 million in cash.

 

On February 4, 2022, the Company announced the close of the sale of its operations in Michigan to Ullico, Inc.’s infrastructure business, through its portfolio company, Triton Utilities, Inc., for a purchase price of $6 million in cash.

 

These transactions are part of American Water’s strategy to continue to operate in states where it can best serve customers and drive efficiencies, thereby creating value for its customers, employees, and shareholders.

 

Consolidated Results

For the three months ended December 31, 2021, earnings per share were $3.55, an increase of $2.75 compared to the same period in 2020. This increase reflects the gain on the sale of HOS and continued growth in the Regulated Businesses from infrastructure investment and acquisitions, partially offset by higher operating costs and lower HOS results year over year as a result of the sale.

 

For the twelve months ended December 31, 2021, earnings per share were $6.95, an increase of $3.04 compared to the same period in 2020. This increase reflects the gain on the sale of HOS and a $0.40 increase in the Regulated Businesses as earnings grew from infrastructure investment, acquisitions and organic growth. The increase was partially offset by an estimated $0.05 per share impact from cooler and wetter weather in 2021 compared to 2020. Before the gain on the HOS sale, on a weather normalized basis, diluted earnings for 2021 and 2020 were $4.23 and $3.84 per share, respectively, an increase of 10.2%.

 

In 2021, the Company made capital investments of $1.9 billion, including $1.8 billion primarily for infrastructure improvements in the Regulated Businesses and $135 million for regulated acquisitions.

 

Regulated Businesses

In the fourth quarter of 2021, the Regulated Businesses’ net income was $166 million, compared to $154 million for the same period in 2020. Regulated revenue increased approximately $41 million due to increases from additional authorized revenues from infrastructure investments and acquisitions. Excluding revenue reductions for the amortization of excess accumulated deferred income tax (“EADIT”) of $11 million, which is offset with a like amount as lower tax expense, revenue increased $52 million. Results also reflect higher O&M expenses of $16 million to support growth in the Regulated Businesses and increased depreciation of $7 million, mainly related to infrastructure investment growth.

 

For the full year 2021, the Regulated Businesses’ net income was $789 million, compared to $715 million in 2020. Regulated revenue increased approximately $129 million from additional authorized revenues from infrastructure investments, acquisitions and organic growth, partially offset by lower demand due to weather. Excluding agreed-to revenue reductions for the amortization of EADIT of $79 million, which is offset with a like amount as lower tax expense, revenue increased $208 million. Results also reflect higher O&M expenses of $67 million to support growth in the Regulated Businesses and increased depreciation of $39 million, mainly related to infrastructure investment growth.

 

To date, the Company has been authorized additional annualized revenues, excluding agreed-to reductions for EADIT, of approximately $135 million from general rate cases, with $115 million effective in 2021 and $20 million effective in 2022. In addition, approximately $83 million of additional annualized revenues from infrastructure surcharges have been authorized. The Company has general rate cases in progress in six jurisdictions and filed for infrastructure surcharges in two jurisdictions, reflecting a total annualized revenue request of approximately $242 million.

 

For the full year 2021, the Company’s adjusted regulated O&M efficiency ratio (a non-GAAP financial measure) was 34.1%, compared to 34.3% for 2020. The improvement in this ratio reflects the continued focus on operating costs, as well as an increase in operating revenues for the Regulated Businesses after considering the adjustment for the amortization of the EADIT shown below.

 

Market-Based Businesses

In the fourth quarter of 2021, net income for the Market-Based Businesses was $491 million, compared to a net income of $23 million for the same period in 2020.

 

Net income in the Market-Based Businesses in 2021 was $550 million, compared to a net income of $91 million for the same period in 2020. The increase resulted from the gain on the sale of HOS of $478 million, partially offset by lower operating results for HOS primarily as a result of the timing of the sale.

 

In addition to the gain on the sale of HOS within the Market-Based Businesses, Parent and Other results reflect a $13 million net income benefit from the revaluation of state net operating losses that can now be utilized as a result of the sale.

 

Dividends

On December 9, 2021, the Company’s board of directors declared a quarterly cash dividend payment of $0.6025 per share of common stock payable on March 1, 2022, to all shareholders of record as of February 8, 2022.

 

Non-GAAP Financial Measures

This press release includes a presentation of adjusted regulated O&M efficiency ratio, a “non-GAAP financial measure” under SEC rules, which excludes from its calculation estimated purchased water revenues and purchased water expenses, reductions for the amortization of EADIT, and the allocable portion of non-O&M support services costs, mainly depreciation and general taxes. These items were excluded from the O&M efficiency ratio calculation as they do not reflect management’s ability to increase the efficiency of the Regulated Businesses. This item is derived from American Water’s consolidated financial information but is not presented in its financial statements prepared in accordance with GAAP. This non-GAAP financial measure supplements and should be read in conjunction with the Company’s GAAP disclosures and should be considered as an addition to, and not a substitute for, any GAAP measure.

 

Management evaluates its operating performance using this ratio and believes that this non-GAAP financial measure is useful to the Company’s investors because it directly measures improvement in the operating performance and efficiency of the Company’s Regulated Businesses. The Company’s adjusted regulated O&M efficiency ratio (i) is not an accounting measure that is based on GAAP; (ii) is not based on a standard, objective industry definition or method of calculation; (iii) may not be comparable to other companies’ operating measures; and (iv) should not be used in place of the GAAP information provided elsewhere in this press release.

 

Set forth in this release is a table that calculates the Company’s adjusted regulated O&M efficiency ratio and reconciles each of the components used to calculate this ratio to the most directly comparable GAAP financial measure. Management is unable to present a reconciliation of adjustments to the components of the forward-looking regulated O&M efficiency ratio without unreasonable effort because management cannot reliably predict the nature, amount or probable significance of all of the adjustments for future periods; however, these adjustments may, individually or in the aggregate, cause the non-GAAP financial measure component of the forward-looking ratio to differ significantly from the most directly comparable GAAP financial measure.

 

About American Water

With a history dating back to 1886, American Water is the largest and most geographically diverse U.S. publicly-traded water and wastewater utility company. The Company employs approximately 6,400 dedicated professionals who provide regulated and market-based drinking water, wastewater and other related services to over 14 million people in 24 states. More information can be found by visiting amwater.com and follow American Water on Twitter, Facebook and LinkedIn.

 

Throughout this press release, unless the context otherwise requires, references to the “Company” and “American Water” mean American Water Works Company, Inc. and all of its subsidiaries, taken together as a whole.

 

Cautionary Statement Concerning Forward-Looking Statements

Certain statements in this press release including, without limitation, 2022 earnings guidance, the Company’s long-term financial, growth and dividend targets, future capital needs, the ability to achieve the Company’s strategies and goals, including with respect to its ESG focus and related to the sale of HOS, the Company’s receipt of contingent consideration, the repayment of the seller note and the redeployment of the net proceeds from its divestitures, the outcome of the Company’s pending acquisition activity, the amount and allocation of projected capital expenditures; and estimated revenues from rate cases and other government agency authorizations, are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. In some cases, these forward-looking statements can be identified by words with prospective meanings such as “intend,” “plan,” “estimate,” “believe,” “anticipate,” “expect,” “predict,” “project,” “propose,” “assume,” “forecast,” “outlook,” “likely,” “uncertain,” “future,” “pending,” “goal,” “objective,” “potential,” “continue,” “seek to,” “may,” “can,” “will,” “should” and “could” and or the negative of such terms or other variations or similar expressions. These forward-looking statements are predictions based on American Water’s current expectations and assumptions regarding future events. They are not guarantees or assurances of any outcomes, financial results of levels of activity, performance or achievements, and readers are cautioned not to place undue reliance upon them. The forward-looking statements are subject to a number of estimates and assumptions, and known and unknown risks, uncertainties and other factors. Actual results may differ materially from those discussed in the forward-looking statements included in this press release as a result of the factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, and subsequent filings with the SEC, and because of factors such as: the decisions of governmental and regulatory bodies, including decisions to raise or lower customer rates and regulatory responses to the COVID-19 pandemic; the timeliness and outcome of regulatory commissions’ and other authorities’ actions concerning rates, capital structure, authorized return on equity, capital investment, system acquisitions and dispositions, taxes, permitting, water supply and management, and other decisions; changes in customer demand for, and patterns of use of, water, such as may result from conservation efforts, impacts of the COVID-19 pandemic, or otherwise; a loss of one or more large industrial or commercial customers due to adverse economic conditions, the COVID-19 pandemic, or other factors; limitations on the availability of the Company’s water supplies or sources of water, or restrictions on its use thereof, resulting from allocation rights, governmental or regulatory requirements and restrictions, drought, overuse or other factors; changes in laws, governmental regulations and policies, including with respect to the environment, health and safety, water quality and water quality accountability, contaminants of emerging concern, public utility and tax regulations and policies, and impacts resulting from U.S., state and local elections and changes in federal, state and local executive administrations; the Company’s ability to collect, distribute, use, secure and store consumer data in compliance with current or future governmental laws, regulation and policies with respect to data and consumer privacy, security and protection; weather conditions and events, climate variability patterns, and natural disasters, including drought or abnormally high rainfall, prolonged and abnormal ice or freezing conditions, strong winds, coastal and intercoastal flooding, pandemics (including COVID-19) and epidemics, earthquakes, landslides, hurricanes, tornadoes, wildfires, electrical storms, sinkholes and solar flares; the outcome of litigation and similar governmental and regulatory proceedings, investigations or actions; the risks associated with the Company’s aging infrastructure, and its ability to appropriately improve the resiliency of, or maintain and replace, current or future infrastructure and systems, including its technology and other assets, and manage the expansion of its businesses; exposure or infiltration of the Company’s technology and critical infrastructure systems, including the disclosure of sensitive, personal or confidential information contained therein, through physical or cyber attacks or other means; the Company’s ability to obtain permits and other approvals for projects and construction of various water and wastewater facilities; changes in the Company’s capital requirements; the Company’s ability to control operating expenses and to achieve operating efficiencies; the intentional or unintentional actions of a third party, including contamination of the Company’s water supplies or the water provided to its customers; the Company’s ability to obtain adequate and cost-effective supplies of pipe, equipment (including personal protective equipment), chemicals, electricity, fuel, water and other raw materials and to address or mitigate supply chain constraints impacting the Company’s business operations; the Company’s ability to successfully meet its operational growth projections, either individually or in the aggregate, and capitalize on growth opportunities, including, among other things, with respect to acquiring, closing and successfully integrating regulated operations and market-based businesses, the Company’s Military Services Group entering into new contracts, price redeterminations and other agreements and contracts, and realizing anticipated benefits and synergies from new acquisitions; risks and uncertainties following the completion of the sale of HOS and the Company’s New York subsidiary; risks and uncertainties associated with contracting with the U.S. government, including ongoing compliance with applicable government procurement and security regulations; cost overruns relating to improvements in or the expansion of the Company’s operations; the Company’s ability to successfully develop and implement new technologies and to protect related intellectual property; the Company’s ability to maintain safe work sites; the Company’s exposure to liabilities related to environmental laws and similar matters resulting from, among other things, water and wastewater service provided to customers; changes in general economic, political, business and financial market conditions, including without limitation conditions and collateral consequences associated with COVID-19; access to sufficient debt and/or equity capital on satisfactory terms and when and as needed to support operations and capital expenditures; fluctuations in inflation or interest rates; the ability to comply with affirmative or negative covenants in the current or future indebtedness of the Company or any of its subsidiaries, or the issuance of new or modified credit ratings or outlooks or other communications by credit rating agencies with respect to the Company or any of its subsidiaries (or any current or future indebtedness thereof), which could increase financing costs or funding requirements and affect the Company’s or its subsidiaries’ ability to issue, repay or redeem debt, pay dividends or make distributions; fluctuations in the value of benefit plan assets and liabilities that could increase the Company’s cost and funding requirements; changes in federal or state general, income and other tax laws, including (i) future significant tax legislation; (ii) the availability of, or the Company’s compliance with, the terms of applicable tax credits and tax abatement programs; and (iii) the Company’s ability to utilize its state income tax net operating loss carryforwards; migration of customers into or out of the Company’s service territories; the use by municipalities of the power of eminent domain or other authority to condemn the systems of one or more of the Company’s utility subsidiaries, or the assertion by private landowners of similar rights against such utility subsidiaries; any difficulty or inability to obtain insurance for the Company, its inability to obtain insurance at acceptable rates and on acceptable terms and conditions, or its inability to obtain reimbursement under existing or future insurance programs and coverages for any losses sustained; the incurrence of impairment charges related to the Company’s goodwill or other assets; labor actions, including work stoppages and strikes; the Company’s ability to retain and attract qualified employees; civil disturbances or unrest, or terrorist threats or acts, or public apprehension about future disturbances, unrest, or terrorist threats or acts; and the impact of new, and changes to existing, accounting standards.

 

These forward-looking statements are qualified by, and should be read together with, the risks and uncertainties set forth above and the risk factors included in American Water’s annual, quarterly and other SEC filings, and readers should refer to such risks, uncertainties and risk factors in evaluating such forward-looking statements. Any forward-looking statements American Water makes speak only as of the date of this press release. American Water does not have or undertake any obligation or intention to update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, except as otherwise required by the federal securities laws. New factors emerge from time to time, and it is not possible for the Company to predict all such factors. Furthermore, it may not be possible to assess the impact of any such factor on the Company’s businesses, either viewed independently or together, or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. The foregoing factors should not be construed as exhaustive.

 

AWK-IR

American Water Works Company, Inc. and Subsidiary Companies

Consolidated Statements of Operations

(In millions, except per share data)

For the Three Months Ended
December 31,

For the Years Ended

December 31,

2021

2020

2021

2020

(Unaudited)

Operating revenues

$

951

$

923

$

3,930

$

3,777

Operating expenses:

Operation and maintenance

491

429

1,777

1,622

Depreciation and amortization

160

153

636

604

General taxes

80

78

321

303

Total operating expenses, net

731

660

2,734

2,529

Operating income

220

263

1,196

1,248

Other income (expense):

Interest expense

(103

)

(99

)

(403

)

(397

)

Interest income

4

—

4

2

Non-operating benefit costs, net

19

12

78

49

Gain or (loss) on sale of businesses

747

—

747

—

Other, net

7

5

18

22

Total other income (expense)

674

(82

)

444

(324

)

Income before income taxes

894

181

1,640

924

Provision for income taxes

249

36

377

215

Net income attributable to common shareholders

$

645

$

145

$

1,263

$

709

Basic earnings per share: (a)

Net income attributable to common shareholders

$

3.56

$

0.80

$

6.96

$

3.91

Diluted earnings per share: (a)

Net income attributable to common shareholders

$

3.55

$

0.80

$

6.95

$

3.91

Weighted-average common shares outstanding:

Basic

182

181

182

181

Diluted

182

181

182

182

Contacts

Investors:
Aaron Musgrave

Senior Director, Investor Relations

856-955-4029

aaron.musgrave@amwater.com

Media:
Maureen Duffy

Senior Vice President, Communications and External Affairs

856-955-4163

maureen.duffy@amwater.com

Read full story here

Categories
Business

AdvanSix announces fourth quarter and full year 2021 financial results

Record annual sales, earnings and cash flow in 2021

 

4Q21 Sales of $424 million; EPS of $0.80; Cash Flow from Operations of $33 million

 

Agreement to acquire U.S. Amines, a leading North American producer of intermediates used in agrochemicals, pharmaceuticals and other applications

 

Board authorizes $0.125 per share quarterly dividend payable March 15, 2022

 

Targeting significant earnings growth in 2022 supported by expected strong execution and robust ammonium sulfate fertilizer performance

 

PARSIPPANY, N.J. —  (BUSINESS WIRE) — AdvanSix (NYSE: ASIX) today announced its financial results for the fourth quarter and full year ending December 31, 2021. In 2021, the Company generated record annual sales, earnings and cash flow as a public company reflecting strong execution amid improving end market demand and tight industry supply conditions. The Company also announced it has agreed to acquire U.S. Amines in an all-cash transaction for an estimated net purchase price of approximately $100 million. U.S. Amines is a leading North American producer of alkyl and specialty amines serving high-value end markets such as agrochemicals and pharmaceuticals.

Full Year 2021 Summary

  • Sales up approximately 45% versus prior year driven by 20% favorable impact of market-based pricing, 18% higher raw material pass-through pricing and 7% higher volume
  • Net Income of $139.8 million, an increase of $93.7 million versus the prior year
  • EBITDA of $255.5 million, an increase of $131.8 million versus the prior year
  • EBITDA Margin of 15.2%, up 450 bps versus the prior year
  • Cash Flow from Operations of $218.8 million, an increase of $107.0 million versus the prior year
  • Capital Expenditures of $56.8 million, a decrease of $26.1 million versus the prior year
  • Free Cash Flow of $162.0 million, an increase of $133.1 million versus the prior year

 

Summary full year 2021 financial results for the Company are included below:

 

($ in Thousands, Except Earnings Per Share)

FY 2021

FY 2020

Sales

$1,684,625

$1,157,917

Net Income

139,791

46,077

Diluted Earnings Per Share

$4.81

$1.64

EBITDA (1)

255,479

123,657

EBITDA Margin % (1)

15.2%

10.7%

Cash Flow from Operations

218,849

111,847

Free Cash Flow (1)(2)

162,038

28,929

(1) See “Non-GAAP Measures” included in this press release for non-GAAP reconciliations

(2) Net cash provided by operating activities less capital expenditures

“In 2021, we once again differentiated our performance by delivering outstanding results and supporting our customers, all while continuing to successfully navigate the ongoing Covid-19 pandemic, significant industry supply chain disruptions, and an inflationary cost environment,” said Erin Kane, president and CEO of AdvanSix. “We achieved a post-spin record annual EBITDA and Free Cash Flow, executed our first acquisition, initiated a quarterly dividend, entered into a new revolving credit facility and significantly reduced our debt levels to provide optionality for further value creation. Our strong results reflect the resilience and strength of our execution and business model as well as our leadership positions across our diverse product portfolio.”

 

Fourth Quarter 2021 Summary

  • Sales up approximately 25% versus prior year driven by 25% favorable impact of market-based pricing and 12% higher raw material pass-through pricing, partially offset by 12% lower volume
  • Net Income of $23.6 million, a decrease of $3.2 million versus the prior year
  • EBITDA of $49.3 million, an increase of $0.8 million versus the prior year including an approximately $16 million net unfavorable impact of planned plant turnarounds year-over-year
  • Cash Flow from Operations of $33.3 million, a decrease of $14.4 million versus the prior year
  • Capital Expenditures of $19.3 million, an increase of $4.0 million versus the prior year
  • Free Cash Flow of $14.0 million, a decrease of $18.4 million versus the prior year

Summary fourth quarter 2021 financial results for the Company are included below:

($ in Thousands, Except Earnings Per Share)

4Q 2021

4Q 2020

Sales

$424,064

$340,272

Net Income

23,587

26,764

Diluted Earnings Per Share

$0.80

$0.94

EBITDA (1)

49,287

48,499

EBITDA Margin % (1)

11.6%

14.3%

Cash Flow from Operations

33,326

47,761

Free Cash Flow (1)(2)

13,986

32,406

(1) See “Non-GAAP Measures” included in this press release for non-GAAP reconciliations

(2) Net cash provided by operating activities less capital expenditures

Sales of $424.1 million in the quarter increased approximately 25% versus the prior year. Market-based pricing was favorable by 25% compared to the prior year driven by higher pricing across our ammonium sulfate and nylon product lines. Raw material pass-through pricing was favorable by 12% following a net cost increase in benzene and propylene (inputs to cumene which is a key feedstock to our products). Sales volume in the quarter decreased approximately 12% driven primarily by the impact of the planned plant turnaround in the fourth quarter of 2021 as well as robust operational performance in the prior year period.

Sales by product line and approximate percentage of total sales are included below:

($ in Thousands)

FY 2021

FY 2020

Sales

% of Total

Sales

% of Total

Nylon

$

422,897

25%

$

284,701

24%

Caprolactam

316,132

19%

216,268

19%

Chemical Intermediates

544,504

32%

369,130

32%

Ammonium Sulfate

401,092

24%

287,818

25%

$

1,684,625

100%

$

1,157,917

100%

($ in Thousands)

4Q 2021

4Q 2020

Sales

% of Total

Sales

% of Total

Nylon

$

105,288

25%

$

79,959

23%

Caprolactam

73,673

17%

63,674

19%

Chemical Intermediates

127,862

30%

118,831

35%

Ammonium Sulfate

117,241

28%

77,808

23%

$

424,064

100%

$

340,272

100%

EBITDA of $49.3 million in the quarter increased $0.8 million versus the prior year primarily due to higher market-based pricing, net of increased raw material costs, partially offset by approximately $16 million net unfavorable impact of planned plant turnarounds year-over-year and lower production volume.

Earnings per share of $0.80 decreased $0.14 versus the prior year driven by a higher effective tax rate in the quarter versus the prior year primarily due to an approximately $3.8 million energy tax credit associated with our natural gas boilers investment in the prior year period, which more than offset the factors discussed above.

Cash flow from operations of $33.3 million in the quarter decreased $14.4 million versus the prior year primarily due to the unfavorable impact of changes in working capital and lower net income. This includes the strategic absence of our typical ammonium sulfate pre-buy cash advances in the fourth quarter of 2021 reflecting the dynamic raw material and end market environment. Capital expenditures of $19.3 million in the quarter increased $4.0 million versus the prior year.

Dividend

The Company’s Board of Directors declared a quarterly cash dividend of $0.125 per share on the Company’s common stock, payable on March 15, 2022 to stockholders of record as of the close of business on March 1, 2022.

Agreement to Acquire U.S. Amines

According to the terms of the agreement, the Company will acquire U.S. Amines in an all-cash transaction for an estimated net purchase price of approximately $100 million. The acquisition is expected to close in the first quarter of 2022, subject to customary closing conditions, and is expected to be accretive to 2022 earnings.

Aligned to our M&A framework, our strategic rationale to acquire U.S. Amines includes:

  • Value chain integration – enhances advantaged position through internal supply of products and raw materials
  • Platform for broader expansion – unique platform in agrochemicals space and supports further penetration into high-value applications (electronics, pharmaceuticals, water treatment)
  • Leverages AdvanSix core strengths – complementary business model with long-tenured customer relationships and formula pricing mechanisms; Operational excellence to enable sales synergies and unlock incremental value
  • Strengthens North America position – adjacent to both our ammonium sulfate adjuvant and solvent businesses with ability to leverage regional scale
  • Bolt-on, robust cash and margin profile – strong free cash flow conversion and margins accretive to Intermediates portfolio

“U.S. Amines is a complementary and cohesive fit with our existing portfolio and supports further penetration in high-value end markets and applications. We will leverage our core strengths across its unique manufacturing capabilities to enable sales synergies and unlock incremental value. We see robust opportunities for incremental growth through increased utilization of assets, new market opportunities and high-return organic investments,” said Kane.

“The transaction will have minimal impact to our debt leverage and we are confident in our ability to attain strong returns. Today’s announcement marks another step as we evolve and enhance our capital allocation strategy to support sustainable and robust shareholder returns over the long-term. We are eager to welcome the U.S. Amines team to AdvanSix and look forward to their contributions to our continued growth,” added Kane.

U.S. Amines employs approximately 50 people in the United States at manufacturing locations in Bucks, AL and Portsmouth, VA. Estimated 2022 revenue for the business is approximately $70 million.

Outlook

  • Targeting significant earnings growth in 2022 supported by expected strong execution and robust ammonium sulfate fertilizer performance
  • Expect strong North America demand for nylon and chemical intermediates to continue
  • Successful integration of U.S. Amines expected to deliver year one earnings accretion
  • Continue to expect Capital Expenditures to be $95 to $105 million in 2022 reflecting scope of planned plant turnarounds and timing of project execution
  • Expect pre-tax income impact of planned plant turnarounds to be approximately $33 to $38 million in 2022

“2022 is shaping up to be another exciting year for AdvanSix. We are targeting significant earnings growth as we continue to execute on our strategic priorities including superior operational excellence, differentiated product growth and being strong and disciplined stewards of capital. Demand is expected to remain strong across our nylon and chemical intermediates product lines and we are in the midst of the strongest fertilizer environment that we’ve seen in over a decade. We are gaining momentum for our next chapter and remain confident that AdvanSix is well positioned to deliver robust performance and returns over the long-term,” concluded Kane.

Conference Call Information

AdvanSix will discuss its results during its investor conference call today starting at 9:00 a.m. ET. To participate on the conference call, dial (844) 855-9494 (domestic) or (412) 858-4602 (international) approximately 10 minutes before the 9:00 a.m. ET start, and tell the operator that you are dialing in for AdvanSix’s fourth quarter 2021 earnings call. The live webcast of the investor call as well as related presentation materials can be accessed at http://investors.advansix.com. Investors can hear a replay of the conference call from 12 noon ET on February 18 until 12 noon ET on February 25 by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international). The access code is 3624672.

About AdvanSix

AdvanSix plays a critical role in global supply chains, innovating and delivering essential products for our customers in a wide variety of end markets and applications that touch people’s lives, such as building and construction, fertilizers, plastics, solvents, packaging, paints, coatings, adhesives and electronics. Our reliable and sustainable supply of quality products emerges from the vertically integrated value chain of our three U.S.-based manufacturing facilities. AdvanSix strives to deliver best-in-class customer experiences and differentiated products in the industries of nylon solutions, chemical intermediates, and plant nutrients, guided by our core values of Safety, Integrity, Accountability and Respect. More information on AdvanSix can be found at http://www.advansix.com.

Forward Looking Statements

This release contains certain statements that may be deemed “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, that address activities, events or developments that our management intends, expects, projects, believes or anticipates will or may occur in the future are forward-looking statements. Forward-looking statements may be identified by words such as “expect,” “anticipate,” “estimate,” “outlook,” “project,” “strategy,” “intend,” “plan,” “target,” “goal,” “may,” “will,” “should” and “believe” and other variations or similar terminology and expressions. Although we believe forward-looking statements are based upon reasonable assumptions, such statements involve known and unknown risks, uncertainties and other factors, many of which are beyond our control and difficult to predict, which may cause the actual results or performance of the Company to be materially different from any future results or performance expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: general economic and financial conditions in the U.S. and globally, including the impact of the coronavirus (COVID-19) pandemic and any resurgences; the scope, shape and pace of recovery of the pandemic; the timing of the distribution and efficacy of vaccines or treatments for COVID-19 that are currently available or may be available in the future and related vaccination rates; the severity and transmissibility of newly identified strains of COVID-19; governmental, business and individuals’ actions in response to the pandemic, including our business continuity and cash optimization plans that have been, and may in the future be, implemented; the impact of social and economic restrictions and other containment measures taken to combat virus transmission; the effect on our customers’ demand for our products and our suppliers’ ability to manufacture and deliver our raw materials, including implications of reduced refinery utilization in the U.S.; our ability to sell and provide our goods and services, including as a result of travel and other COVID-19-related restrictions; the ability of our customers to pay for our products; and any closures of our and our customers’ offices and facilities; risks associated with increased phishing, compromised business emails and other cybersecurity attacks and disruptions to our technology infrastructure; risks associated with employees working remotely or operating with a reduced workforce; risks associated with our indebtedness including compliance with financial and restrictive covenants, and our ability to access capital on reasonable terms, at a reasonable cost or at all due to economic conditions resulting from COVID-19 or otherwise; the failure to satisfy conditions to the acquisition of U.S. Amines on the proposed terms and within the proposed timeframe, the inability to realize the anticipated benefits of the transaction in amounts or in the timeframe anticipated, and the costs or difficulties relating to integration matters and material adverse changes to anticipated operations or earnings; the impact of scheduled turnarounds and significant unplanned downtime and interruptions of production or logistics operations as a result of mechanical issues or other unanticipated events such as fires, severe weather conditions, natural disasters and pandemics; price fluctuations, cost increases and supply of raw materials; our operations and growth projects requiring substantial capital; growth rates and cyclicality of the industries we serve including global changes in supply and demand; failure to develop and commercialize new products or technologies; loss of significant customer relationships; adverse trade and tax policies; extensive environmental, health and safety laws that apply to our operations; hazards associated with chemical manufacturing, storage and transportation; litigation associated with chemical manufacturing and our business operations generally; inability to acquire and integrate businesses, assets, products or technologies; protection of our intellectual property and proprietary information; prolonged work stoppages as a result of labor difficulties or otherwise; cybersecurity, data privacy incidents and disruptions to our technology infrastructure; failure to maintain effective internal controls; our ability to declare and pay quarterly cash dividends and the amounts and timing of any future dividends; our ability to repurchase our common stock and the amount and timing of any future repurchases; disruptions in supply chain, transportation and logistics; potential for uncertainty regarding qualification for tax treatment of our spin-off; fluctuations in our stock price; and changes in laws or regulations applicable to our business. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Such forward-looking statements are not guarantees of future performance, and actual results, developments and business decisions may differ from those envisaged by such forward-looking statements. We identify the principal risks and uncertainties that affect our performance in our filings with the Securities and Exchange Commission (SEC), including the risk factors in Part 1, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020, as updated in subsequent reports filed with the SEC.

Non-GAAP Financial Measures

This press release includes certain non-GAAP financial measures intended to supplement, not to act as substitutes for, comparable GAAP measures. Reconciliations of non-GAAP financial measures to GAAP financial measures are provided in this press release. Investors are urged to consider carefully the comparable GAAP measures and the reconciliations to those measures provided. Non-GAAP measures in this press release may be calculated in a way that is not comparable to similarly-titled measures reported by other companies.

AdvanSix Inc.

Consolidated Balance Sheets

(Unaudited)

(Dollars in thousands, except share and per share amounts)

December 31,

2021

December 31,

2020

ASSETS

Current assets:

Cash and cash equivalents

$

15,100

$

10,606

Accounts and other receivables – net

178,140

123,554

Inventories – net

149,570

180,085

Taxes receivable

947

12,289

Other current assets

6,097

6,969

Total current assets

349,854

333,503

Property, plant and equipment – net

767,964

765,469

Operating lease right-of-use assets

136,207

114,484

Goodwill

17,592

15,005

Other assets

40,382

34,946

Total assets

$

1,311,999

$

1,263,407

LIABILITIES

Current liabilities:

Accounts payable

$

221,234

$

190,227

Accrued liabilities

49,712

41,152

Operating lease liabilities – short-term

36,127

29,279

Deferred income and customer advances

2,749

26,379

Total current liabilities

309,822

287,037

Deferred income taxes

133,330

125,575

Operating lease liabilities – long-term

100,580

85,605

Line of credit – long-term

135,000

275,000

Postretirement benefit obligations

18,243

39,168

Other liabilities

13,834

6,899

Total liabilities

710,809

819,284

STOCKHOLDERS’ EQUITY

Common stock, par value $0.01; 200,000,000 shares authorized;

31,755,430 shares issued and 28,139,954 outstanding at

December 31, 2021; 31,627,139 shares issued and 28,033,227

outstanding at December 31, 2020

318

316

Preferred stock, par value $0.01; 50,000,000 shares authorized and 0

shares issued and outstanding at December 31, 2021 and December 31, 2020

—

—

Treasury stock at par (3,615,476 shares at December 31, 2021;

3,593,912 shares at December 31, 2020)

(36

)

(36

)

Additional paid-in capital

195,931

184,732

Retained earnings

411,516

275,243

Accumulated other comprehensive loss

(6,539

)

(16,132

)

Total stockholders’ equity

601,190

444,123

Total liabilities and stockholders’ equity

$

1,311,999

$

1,263,407

AdvanSix Inc.

Consolidated Statements of Operations

(Unaudited)

(Dollars in thousands, except share and per share amounts)

Three Months Ended

December 31,

Twelve Months Ended

December 31,

2021

2020

2021

2020

Sales

$

424,064

$

340,272

$

1,684,625

$

1,157,917

Costs, expenses and other:

Costs of goods sold

369,538

287,664

1,410,503

1,024,169

Selling, general and administrative expenses

20,873

20,042

82,985

70,870

Interest expense, net

927

1,965

5,023

7,792

Other non-operating expense, net

648

(162

)

998

53

Total costs, expenses and other

391,986

309,509

1,499,509

1,102,884

Income before taxes

32,078

30,763

185,116

55,033

Income tax expense

8,491

3,999

45,325

8,956

Net income

$

23,587

$

26,764

$

139,791

$

46,077

Earnings per common share

Basic

$

0.84

$

0.95

$

4.97

$

1.64

Diluted

$

0.80

$

0.94

$

4.81

$

1.64

Weighted average common shares outstanding

Basic

28,201,439

28,081,709

28,152,876

28,048,726

Diluted

29,417,713

28,349,870

29,045,186

28,157,062

AdvanSix Inc.

Consolidated Statements of Cash Flows

(Unaudited)

(Dollars in thousands)

Three Months Ended

December 31,

Twelve Months Ended

December 31,

2021

2020

2021

2020

Cash flows from operating activities:

Net income

$

23,587

$

26,764

$

139,791

$

46,077

Adjustments to reconcile net income to net cash provided by operating activities:

Depreciation and amortization

16,282

15,771

65,340

60,832

Loss on disposal of assets

869

553

1,711

696

Deferred income taxes

(6,533

)

5,716

4,702

17,611

Stock-based compensation

2,693

1,399

11,299

4,902

Accretion of deferred financing fees

253

141

677

553

Changes in assets and liabilities, net of business acquisitions:

Accounts and other receivables

(7,223

)

(26,435

)

(53,772

)

(18,990

)

Inventories

(6,658

)

(6,212

)

31,227

(8,375

)

Taxes receivable

(610

)

1,518

11,342

(10,242

)

Accounts payable

(1,654

)

8,602

25,393

(1,337

)

Accrued liabilities

8,236

6,116

14,654

13,892

Deferred income and customer advances

(389

)

21,976

(23,630

)

8,456

Other assets and liabilities

4,473

(8,148

)

(9,885

)

(2,228

)

Net cash provided by operating activities

33,326

47,761

218,849

111,847

Cash flows from investing activities:

Expenditures for property, plant and equipment

(19,340

)

(15,355

)

(56,811

)

(82,918

)

Acquisition of business

—

—

(9,523

)

—

Other investing activities

(253

)

(287

)

(1,228

)

(1,185

)

Net cash used for investing activities

(19,593

)

(15,642

)

(67,562

)

(84,103

)

Cash flows from financing activities:

Borrowings from line of credit

42,500

95,500

176,000

364,000

Payments of line of credit

(42,500

)

(133,500

)

(316,000

)

(386,000

)

Payment of line of credit facility fees

(2,442

)

—

(2,442

)

(425

)

Principal payments of finance leases

(201

)

(176

)

(735

)

(710

)

Dividend payments

(3,518

)

—

(3,518

)

—

Purchase of treasury stock

(63

)

(23

)

(652

)

(1,055

)

Issuance of common stock

352

—

554

2

Net cash used for financing activities

(5,872

)

(38,199

)

(146,793

)

(24,188

)

Net change in cash and cash equivalents

7,861

(6,080

)

4,494

3,556

Cash and cash equivalents at beginning of year

7,239

16,686

10,606

7,050

Cash and cash equivalents at the end of year

$

15,100

$

10,606

$

15,100

$

10,606

Supplemental non-cash investing activities:

Capital expenditures included in accounts payable

$

11,720

$

6,178

Contacts

Media
Debra Lewis

(973) 526-1767

debra.lewis@advansix.com

Investors
Adam Kressel

(973) 526-1700

adam.kressel@advansix.com

Read full story here

Categories
Business

NICE Reports 19% growth in total revenue for the fourth quarter and 17% growth for the full year 2021

2021 Full-Year Cloud Revenue Exceeds $1 Billion, Increasing 31% Compared to Full-Year 2020

Provides 2022 Guidance of 12% Total Revenue Growth and Expects 27% or Greater Growth for 2022 Cloud Revenue

 

HOBOKEN, N.J. —  (BUSINESS WIRE) — NICE (NASDAQ: NICE) today announced results for the fourth quarter and full year ended December 31, 2021.

Fourth Quarter 2021 Financial Highlights

GAAP

Non-GAAP

Revenue of $515 million, growth of 18.6% year-over-year

Revenue of $515 million, growth of 17.6% year-over-year

Cloud revenue of $285 million, growth of 30.2% year-over-year

Cloud revenue of $285 million, growth of 28.1% year-over-year

Gross margin of 67.9% compared to 66.4% last year

Gross margin of 73.0% compared to 72.2% last year

Operating income of $65 million compared to $65 million last year

Operating income of $146 million compared to $132 million last year, growth of 10.5% year-over-year

Operating margin of 12.6% compared to 15.0% last year

Operating margin of 28.2%, compared to 30.1% last year

Diluted EPS of $0.76 versus $0.83 last year

Diluted EPS of $1.73 versus $1.61 last year, growth of 7.5%

Full Year 2021 Financial Highlights

GAAP

Non-GAAP

Revenue of $1,921 million, growth of 16.6% year-over-year

Revenue of $1,926 million, growth of 16.2% year-over-year

Cloud revenue of $1,019 million, growth of 31.0% year-over-year

Cloud revenue of $1,023 million, growth of 30.1% year-over-year

Gross margin of 67.5% compared to 65.9% last year

Gross margin of 72.6% compared to 71.3% last year

Operating income of $264 million compared to $242 million last year

Operating income of $544 million compared to $470 million last year, growth of 15.6% year-over-year

Operating margin of 13.7% compared to 14.7% last year

Operating margin of 28.2% compared to 28.4% last year

Diluted EPS of $2.98 versus $2.98 last year

Diluted EPS of $6.52 versus $5.73 last year, 13.8% growth year-over-year

“We ended 2021 on a high note and with great momentum. NICE is a fast growing, agile market leader at scale combined with blue-chip profitability,” said Barak Eilam, CEO of NICE.

Mr. Eilam continued, “Fourth quarter financial results reflected outstanding execution across the board that led to 19% growth in total revenue, double-digit growth in every region and continued strength in profitability. Fueling this growth is our continued excellent performance in the cloud. Cloud revenue increased 30% in the quarter, which propelled our annual cloud revenue over the $1 billion mark, further establishing NICE as the clear cloud leader in our industry.”

“The strong fourth quarter results echo our success throughout 2021 as we reported double-digit total revenue growth in every quarter, further drove our international expansion, gained massive scale in digital and transformed NICE from an analytics leader to an AI powerhouse with a fivefold increase in AI bookings.

“As we head into 2022 and beyond, we believe we are in the best competitive position in our history with the strategic assets firmly in place to achieve further success.”

GAAP Financial Highlights for the Fourth Quarter and Full Year Ended December 31:

Revenues: Fourth quarter 2021 total revenues increased 18.6% to $515.5 million compared to $434.6 million for the fourth quarter of 2020.

Full year 2021 total revenues increased 16.6% to $1,921.2 million compared to $1,648.0 million for the full year 2020.

Gross Profit: Fourth quarter 2021 gross profit was $350.2 million compared to $288.5 million for the fourth quarter of 2020. Fourth quarter 2021 gross margin was 67.9% compared to 66.4% for the fourth quarter of 2020.

Full year 2021 gross profit increased to $1,296.7 million compared to $1,086.1 million for the full year 2020. Full year 2020 gross margin was 67.5% compared to 65.9% for the full year 2020.

Operating Income: Fourth quarter 2021 operating income was $65.1 million compared to $65.1 million for the fourth quarter of 2020. Fourth quarter 2021 operating margin was 12.6% compared to 15.0% for the fourth quarter of 2020.

Full year 2021 operating income increased to $263.9 million compared to $242.0 million for the full year 2020. Full year 2020 operating margin was 13.7% compared to 14.7% for the full year 2020.

Net Income: Fourth quarter 2021 net income was $51.2 million compared to $55.0 million for the fourth quarter of 2020. Fourth quarter 2021 net income margin was 9.9% compared to 12.6% for the fourth quarter of 2020.

Full year 2021 net income was $199.2 million compared to $196.3 million. Full year 2021 net income margin was 10.4% compared to 11.9% for the full year 2020.

Fully Diluted Earnings Per Share: Fully diluted earnings per share for the fourth quarter of 2021 was $0.76 compared to $0.83 in the fourth quarter of 2020.

Fully diluted earnings per share for the full year 2021 were $2.98 compared to $2.98 for the full year 2020.

Operating Cash Flow and Cash Balance: Fourth quarter 2021 operating cash flow was $112.7 million and full year operating cash flow was $461.8 million.

In the fourth quarter, $24.3 million were used for share repurchases and for the full year of 2021, $73.2 million were used for share repurchases. As of December 31, 2021, total cash and cash equivalents, short and long term investments were $1,424.8 million. Our debt, net of a hedge instrument, was 532 million dollars, resulting in net cash and investments of 893 million dollars.

Non-GAAP Financial Highlights for the Fourth Quarter and Full Year Ended December 31:

Revenues: Fourth quarter 2021 Non-GAAP total revenues increased to $515.5 million, up 17.6% from $438.4 million for the fourth quarter of 2020.

Non-GAAP total revenues for the full year 2021 increased 16.2% to $1,925.7 million compared to $1,657.1 million for the full year 2020.

Gross Profit: Fourth quarter 2021 Non-GAAP gross profit increased to $376.4 million compared to $316.7 million for the fourth quarter of 2020. Fourth quarter 2021 Non-GAAP gross margin was 73.0% compared to 72.2% for the fourth quarter of 2020.

Full year 2021 Non-GAAP gross profit increased to $1,397.6 million compared to $1,181.6 million for the full year 2020. Full year 2021 Non-GAAP gross margin was 72.6%, compared to 71.3% for full year 2020.

Operating Income: Fourth quarter 2021 Non-GAAP operating income increased to $145.6 million compared to $131.7 million for the fourth quarter of 2020. Fourth quarter 2021 Non-GAAP operating margin was 28.2% compared to 30.1% for the fourth quarter of 2020.

Full year 2021 Non-GAAP operating income increased to $543.9 million compared to $470.4 million for the full year 2020. Full year 2021 Non-GAAP operating margin was 28.2% compared to 28.4% for the full year 2020.

Net Income: Fourth quarter 2021 Non-GAAP net income increased to $116.7 million compared to $106.9 million for the fourth quarter of 2020. Non-GAAP net income margin totaled 22.6% compared to 24.4% for the fourth quarter of 2020.

Full year 2021 Non-GAAP net income increased to $436.3 million compared to $378.2 million for the full year 2020.

Full year 2021 Non-GAAP net income margin totaled 22.7% compared to 22.8% for the full year 2020.

Fully Diluted Earnings Per Share: Fourth quarter 2021 Non-GAAP fully diluted earnings per share increased 7.5% to $1.73 compared to $1.61 for the fourth quarter of 2020.

Full year 2021 Non-GAAP fully diluted earnings per share increased 13.8% to $6.52 compared to $5.73 for the full year 2020.

First Quarter and Full Year 2022 Guidance:

First Quarter 2022:

First quarter 2022 Non-GAAP total revenues are expected to be in a range of $505 million to $515 million.

First quarter 2022 Non-GAAP fully diluted earnings per share are expected to be in a range of $1.65 to $1.75.

Full Year 2022:

Full year 2022 Non-GAAP total revenues are expected to be in a range of $2,140 million to $2,160 million, representing 12% growth at the midpoint compared to full year 2021.

Full year 2022 Non-GAAP fully diluted earnings per share are expected to be in a range of $7.07 to $7.27, representing 10% growth at the midpoint compared to full year 2021.

Quarterly Results Conference Call

NICE management will host its earnings conference call today February 17th, 2022 at 8:30 AM ET, 13:30 GMT, 15:30 Israel, to discuss the results and the company’s outlook. To participate in the call, please dial into the following numbers: United States 1-877-407-4018 or +1-201-689-8471, United Kingdom 0-800-756-3429, Israel 1-809-406-247.

The call will be webcast live on the Company’s website at https://www.nice.com/investor-relations/upcoming-event.

Explanation of Non-GAAP measures

Non-GAAP financial measures are included in this press release. Non-GAAP financial measures consist of GAAP financial measures adjusted to exclude share-based compensation, amortization of acquired intangible assets, acquisition related expenses, amortization of discount on debt and loss from extinguishment of debt and the tax effect of the Non-GAAP adjustments. The Company early adopted ASU 2021-08, Business Combinations, effective January 1, 2021. The amendments in ASU 2021-08 require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination. The Company applied the new guidance retrospectively to all business combinations for which the acquisition date occurred on or after January 1, 2021, therefore comparative financials were not adjusted. Through December 31, 2020 business combination accounting rules required the recognition of a legal performance obligation related to a revenue arrangement of an acquired entity as a liability. The amount assigned to such liability was based on its fair value at the date of acquisition. Comparative financials Non-GAAP adjustment for a revenue arrangement is intended to reflect the full amount of such revenue. The Company believes that these Non-GAAP financial measures, used in conjunction with the corresponding GAAP measures, provide investors with useful supplemental information about the financial performance of our business. We believe Non-GAAP financial measures are useful to investors as a measure of the ongoing performance of our business. Our management regularly uses our supplemental Non-GAAP financial measures internally to understand, manage and evaluate our business and to make financial, strategic and operating decisions. These Non-GAAP measures are among the primary factors management uses in planning for and forecasting future periods. Our Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read only in conjunction with our consolidated financial statements prepared in accordance with GAAP. These Non-GAAP financial measures may differ materially from the Non-GAAP financial measures used by other companies. Reconciliation between results on a GAAP and Non-GAAP basis is provided in a table immediately following the Consolidated Statements of Income. The Company provides guidance only on a Non-GAAP basis. A reconciliation of guidance from a GAAP to Non-GAAP basis is not available due to the unpredictability and uncertainty associated with future events that would be reported in GAAP results and would require adjustments between GAAP and Non-GAAP financial measures, including the impact of future possible business acquisitions. Accordingly, a reconciliation of the guidance based on Non-GAAP financial measures to corresponding GAAP financial measures for future periods is not available without unreasonable effort.

About NICE

NICE (Nasdaq: NICE) is the worldwide leading provider of both cloud and on-premises enterprise software solutions that empower organizations to make smarter decisions based on advanced analytics of structured and unstructured data. NICE helps organizations of all sizes deliver better customer service, ensure compliance, combat fraud and safeguard citizens. Over 25,000 organizations in more than 150 countries, including over 85 of the Fortune 100 companies, are using NICE solutions. www.nice.com.

Trademark Note: NICE and the NICE logo are trademarks or registered trademarks of NICE. All other marks are trademarks of their respective owners. For a full list of NICE’ marks, please see: http://www.nice.com/nice-trademarks.

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements may be identified by words such as “believe,” “expect,” “seek,” “may,” “will,” “intend,” “should,” “project,” “anticipate,” “plan,” and similar expressions. Forward-looking statements are based on the current beliefs, expectations and assumptions of the Company’s management regarding the future of the Company’s business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Examples of forward-looking statements include guidance regarding the Company’s revenue and earnings and the growth of our cloud, analytics and artificial intelligence business.

Forward looking statements are inherently subject to significant economic, competitive and other uncertainties and contingencies, many of which are beyond the control of management. The Company cautions that these statements are not guarantees of future performance, and investors should not place undue reliance on them. There are or will be important known and unknown factors and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements. These factors, include, but are not limited to, risks associated with changes in economic and business conditions, competition, successful execution of the Company’s growth strategy, success and growth of the Company’s cloud Software-as-a-Service business, difficulties in making additional acquisitions or effectively integrating acquired operations, products, technologies and personnel, the Company’s dependency on third-party cloud computing platform providers, hosting facilities and service partners, rapidly changing technology, cyber security attacks or other security breaches against the Company, privacy concerns and legislation impacting the Company’s business, changes in currency exchange rates and interest rates, the effects of additional tax liabilities resulting from our global operations, uncertainty related to COVID-19 and various other factors and uncertainties discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”).

You are encouraged to carefully review the section entitled “Risk Factors” in our latest Annual Report on Form 20-F and our other filings with the SEC for additional information regarding these and other factors and uncertainties that could affect our future performance. The forward-looking statements contained in this presentation speak only as of the date hereof, and the Company undertakes no obligation to update or revise them, whether as a result of new information, future developments or otherwise, except as required by law.

###

NICE LTD. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

December 31,

December 31,

2021

2020

Unaudited

Audited

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

$ 378,656

$ 442,267

Short-term investments

1,046,095

1,021,613

Trade receivables

395,583

303,100

Prepaid expenses and other current assets

436,495

175,340

Total current assets

2,256,829

1,942,320

LONG-TERM ASSETS:

Property and equipment, net

145,654

137,785

Deferred tax assets

48,900

32,735

Other intangible assets, net

295,378

366,003

Operating lease right-of-use assets

85,055

97,162

Goodwill

1,606,756

1,503,252

Other long-term assets

224,445

153,660

Total long-term assets

2,406,188

2,290,597

TOTAL ASSETS

$ 4,663,017

$ 4,232,917

LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES:

Trade payables

$ 36,121

$ 33,132

Deferred revenues and advances from customers

330,459

311,851

Current maturities of operating leases

19,514

22,412

Debt

348,551

259,881

Accrued expenses and other liabilities

487,547

417,174

Total current liabilities

1,222,192

1,044,450

LONG-TERM LIABILITIES:

Deferred revenues and advances from customers

66,606

36,295

Operating leases

81,185

92,262

Deferred tax liabilities

7,429

32,109

Debt

429,267

421,337

Other long-term liabilities

18,379

17,980

Total long-term liabilities

602,866

599,983

SHAREHOLDERS’ EQUITY

Nice Ltd’s equity

2,825,085

2,563,910

Non-controlling interests

12,874

24,574

Total shareholders’ equity

2,837,959

2,588,484

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

$ 4,663,017

$ 4,232,917

NICE LTD. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF INCOME

U.S. dollars in thousands (except per share amounts)

Quarter ended

Year to date

December 31,

December 31,

2021

2020

2021

2020

Unaudited

Unaudited

Unaudited

Audited

Revenue:

Cloud

$ 285,201

$ 219,036

$ 1,018,624

$ 777,331

Services

166,376

174,003

660,083

687,532

Product

63,896

41,542

242,443

183,153

Total revenue

515,473

434,581

1,921,150

1,648,016

Cost of revenue:

Cloud

112,127

91,357

410,671

339,985

Services

47,341

49,245

191,137

199,803

Product

5,777

5,453

22,648

22,164

Total cost of revenue

165,245

146,055

624,456

561,952

Gross profit

350,228

288,526

1,296,694

1,086,064

Operating expenses:

Research and development, net

75,332

56,163

271,187

218,182

Selling and marketing

149,662

121,819

536,192

445,102

General and administrative

60,167

45,421

225,406

180,733

Total operating expenses

285,161

223,403

1,032,785

844,017

Operating income

65,067

65,123

263,909

242,047

Financial and other expense, net

7,696

2,600

23,290

4,859

Income before tax

57,371

62,523

240,619

237,188

Taxes on income

6,210

7,549

41,396

40,842

Net income

$ 51,161

$ 54,974

$ 199,223

$ 196,346

Earnings per share:

Basic

$ 0.81

$ 0.87

$ 3.15

$ 3.13

Diluted

$ 0.76

$ 0.83

$ 2.98

$ 2.98

Weighted average shares outstanding:

Basic

63,382

62,967

63,189

62,710

Diluted

67,245

66,600

66,896

65,956

NICE LTD. AND SUBSIDIARIES

CONSOLIDATED CASH FLOW STATEMENTS

U.S. dollars in thousands

Quarter ended

Year to date

Dec 31,

Dec 31,

2021

2020

2021

2020

Unaudited

Unaudited

Unaudited

Audited

Operating Activities

Net income

$ 51,161

$ 54,974

$ 199,223

$ 196,346

Depreciation and amortization

47,350

46,893

184,092

182,026

Stock based compensation

49,968

32,828

153,030

101,667

Amortization of premium and discount and accrued interest on marketable securities

1,855

157

11,867

(633)

Deferred taxes, net

(2,768)

(16,588)

(32,970)

(33,241)

Changes in operating assets and liabilities:

Trade Receivables

(40,149)

(5,343)

(85,778)

22,245

Prepaid expenses and other assets

(49,751)

(49,028)

(85,970)

(80,665)

Trade payables

9,254

(1,137)

(389)

4,094

Accrued expenses and other current liabilities

41,578

51,459

64,179

14,875

Operating lease right-of-use assets, net

2,758

5,241

15,075

18,167

Deferred revenue

(2,276)

48,585

30,770

63,202

Operating lease liabilities

(3,206)

(5,272)

(18,011)

(19,569)

Amortization of discount on debt

2,946

5,352

14,469

13,297

Loss in respect of extinguishment of debt

5,893

–

13,969

–

Other

(1,955)

(1,251)

(1,740)

(1,505)

Net cash provided by operating activities

112,658

166,870

461,816

480,306

Investing Activities

Purchase of property and equipment

(3,658)

(2,519)

(24,771)

(24,186)

Purchase of Investments

(40,233)

(277,038)

(322,129)

(583,115)

Proceeds from Investments

44,681

45,444

270,645

328,593

Capitalization of software development costs

(10,453)

(10,322)

(42,440)

(39,098)

Payments for business and asset acquisitions, net of cash acquired

360

–

(142,804)

(147,261)

Net cash used in investing activities

(9,303)

(244,435)

(261,499)

(465,067)

Financing Activities

Proceeds from issuance of shares upon exercise of share options

942

688

4,426

8,865

Purchase of treasury shares

(24,272)

(20,671)

(73,180)

(48,272)

Dividends paid to noncontrolling interest

(953)

–

(1,754)

–

Capital Lease payments

–

–

–

(177)

Purchase of subsidiaries shares from non-controlling interest

(14,000)

–

(14,000)

–

Proceeds from issuance of exchangeable notes

–

(48)

–

451,421

Repayment of debt

(83,993)

(215,000)

(177,308)

(215,000)

Net cash provided by/(used in) financing activities

(122,276)

(235,031)

(261,816)

196,837

Effect of exchange rates on cash and cash equivalents

(119)

1,747

(2,112)

1,868

Net change in cash and cash equivalents

(19,040)

(310,849)

(63,611)

213,944

Cash and cash equivalents, beginning of period

$ 397,696

$ 753,116

$ 442,267

$ 228,323

Cash and cash equivalents, end of period

$ 378,656

$ 442,267

$ 378,656

$ 442,267

NICE LTD. AND SUBSIDIARIES

RECONCILIATION OF GAAP TO NON-GAAP RESULTS

U.S. dollars in thousands (except per share amounts)

Quarter ended

Year to date

December 31,

December 31,

2021

2020

2021

2020

GAAP revenues

$ 515,473

$ 434,581

$ 1,921,150

$ 1,648,016

Valuation adjustment on acquired deferred cloud revenue

–

3,679

4,372

8,866

Valuation adjustment on acquired deferred services revenue

–

149

175

230

Non-GAAP revenues

$ 515,473

$ 438,409

$ 1,925,697

$ 1,657,112

GAAP cost of revenue

$ 165,245

$ 146,055

$ 624,456

$ 561,952

Amortization of acquired intangible assets on cost of cloud

(18,796)

(18,012)

(72,015)

(66,434)

Amortization of acquired intangible assets on cost of services

(669)

(1,225)

(4,228)

(4,566)

Amortization of acquired intangible assets on cost of product

(277)

(1,073)

(1,130)

(4,467)

Valuation adjustment on acquired deferred cost of cloud

21

194

97

931

Cost of cloud revenue adjustment (1)

(2,661)

(1,457)

(7,949)

(4,058)

Cost of services revenue adjustment (1)

(3,597)

(2,593)

(10,513)

(7,550)

Cost of product revenue adjustment (1)

(185)

(131)

(595)

(336)

Non-GAAP cost of revenue

$ 139,081

$ 121,758

$ 528,123

$ 475,472

GAAP gross profit

$ 350,228

$ 288,526

$ 1,296,694

$ 1,086,064

Gross profit adjustments

26,164

28,125

100,880

95,576

Non-GAAP gross profit

$ 376,392

$ 316,651

$ 1,397,574

$ 1,181,640

GAAP operating expenses

$ 285,161

$ 223,403

$ 1,032,785

$ 844,017

Research and development (1)

(9,980)

(4,324)

(25,221)

(11,877)

Sales and marketing (1,2)

(14,495)

(10,769)

(42,021)

(30,392)

General and administrative (1,2)

(19,403)

(13,775)

(70,776)

(52,014)

Amortization of acquired intangible assets

(10,538)

(9,719)

(41,308)

(38,670)

Valuation adjustment on acquired deferred commission

54

89

215

195

Non-GAAP operating expenses

$ 230,799

$ 184,905

$ 853,674

$ 711,259

NICE LTD. AND SUBSIDIARIES

RECONCILIATION OF GAAP TO NON-GAAP RESULTS (continued)

U.S. dollars in thousands (except per share amounts)

Quarter ended

Year to date

December 31,

December 31,

2021

2020

2021

2020

GAAP financial and other expense, net

$ (7,696)

$ (2,600)

$ (23,290)

$ (4,859)

Amortization of discount and loss of extinguishment on debt

8,874

5,353

28,279

13,297

Non-GAAP financial and other income, net

$ 1,178

$ 2,753

$ 4,989

$ 8,438

GAAP taxes on income

$ 6,210

$ 7,549

$ 41,396

$ 40,842

Tax adjustments re non-GAAP adjustments

23,898

20,056

71,157

59,757

Non-GAAP taxes on income

$ 30,108

$ 27,605

$ 112,553

$ 100,599

GAAP net income

$ 51,161

$ 54,974

$ 199,223

$ 196,346

Valuation adjustment on acquired deferred revenue

–

3,828

4,547

9,096

Valuation adjustment on acquired deferred cost of cloud revenue

(21)

(194)

(97)

(931)

Amortization of acquired intangible assets

30,280

30,029

118,681

114,137

Valuation adjustment on acquired deferred commission

(54)

(89)

(215)

(195)

Share-based compensation (1)

50,321

33,049

154,213

102,304

Acquisition related expenses (2)

–

–

2,862

3,923

Amortization of discount and loss of extinguishment on debt

8,874

5,353

28,279

13,297

Tax adjustments re non-GAAP adjustments

(23,898)

(20,056)

(71,157)

(59,757)

Non-GAAP net income

$ 116,663

$ 106,894

$ 436,336

$ 378,220

GAAP diluted earnings per share

$ 0.76

$ 0.83

$ 2.98

$ 2.98

Non-GAAP diluted earnings per share

$ 1.73

$ 1.61

$ 6.52

$ 5.73

Shares used in computing GAAP diluted earnings per share

67,245

66,600

66,895

65,956

Shares used in computing non-GAAP diluted earnings per share

67,245

66,600

66,895

65,956

Contacts

Investors
Marty Cohen, +1 551 256 5354, ir@nice.com, ET

Omri Arens, +972 3 763-0127, ir@nice.com, CET

Media Contact
Chris Irwin-Dudek, +1 (551) 256-5140, Chris.Irwin-Dudek@nice.com

Read full story here

Categories
Business Science

Legend Biotech announces preliminary results for the year ended December 31, 2021

SOMERSET, N.J. — (BUSINESS WIRE) — $LEGN–Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, today in conjunction with an announcement to be issued by Legend Biotech’s majority shareholder, GenScript Biotech Corporation, pursuant to the rules of The Stock Exchange of Hong Kong Limited, announced preliminary, unaudited financial results for the year ended December 31, 2021.

For the year ended December 31, 2021, Legend Biotech expects to record a loss for the year of approximately US$365.3 million to US$397.4 million and an adjusted loss for the year of approximately US$335.8 million to US$364.7 million, in each case, including research and development expenses of approximately US$297.9 million to US$321.8 million, which was mainly caused by the continuous investment into its lead product candidate, ciltacabtagene autoleucel (cilta-cel), and other product candidates in Legend Biotech’s pipeline, and selling and marketing expenses of approximately US$95.3 million to US$106.2 million, which was mainly caused by the increase of costs associated with commercial preparation activities for cilta-cel. See “Use of Non-IFRS Financial Measures” below for a reconciliation of Loss for the year to Adjusted loss for the year.

 

In addition, Legend Biotech expects to report a non-cash fair value loss of approximately US$5.7 million to US$6.4 million caused by the changes of fair value of Legend Biotech’s warrant liability. On May 13, 2021, Legend Biotech entered into a subscription agreement with an institutional investor relating to the offer and sale of 20,809,850 ordinary shares of the Company, par value US$0.0001 per share, in a private placement at a purchase price of US$14.41625 per ordinary share (the “PIPE Offering”). Pursuant to the subscription agreement, the Company also agreed to issue and sell concurrently with the PIPE offering a warrant (the “Warrant”) exercisable for up to an aggregate of 10,000,000 ordinary shares (such transaction together with the PIPE Offering, the “Transactions”). The Transactions closed on May 21, 2021(the “Closing Date”). The Warrant is exercisable, in whole or in part, at an exercise price of US$20.00 per ordinary share, until the two-year anniversary of the Closing Date. The Warrant is accounted for as a financial liability because the Warrant may be net share settleable at the holder’s option.

 

As of December 31, 2021, Legend Biotech had approximately US$688.9 million of cash and cash equivalents, approximately US$168.2 million of time deposits and approximately $29.9 million of financial assets measured at amortized cost.

 

The financial information contained in this press release is preliminary and is based on the latest estimated unaudited management accounts for the year ended December 31, 2021. Because Legend Biotech has not yet completed its financial closing procedures for the year ended December 31, 2021, Legend Biotech has provided a range for the preliminary results described above. Such information is not a comprehensive statement of Legend Biotech’s results for, and as of, this year, and are subject to the completion of management’s and Legend Biotech’s audit committee’s reviews and other financial closing processes and potential adjustments. Accordingly, Legend Biotech’s actual results as of, and for, the year ended December 31, 2021 may differ materially from the preliminary estimated data presented in this press release. As a result, it is possible that Legend Biotech’s final results will not be within the ranges presented.

The information contained in this press release has not been, and is not based on information that has been, audited, or reviewed by Legend Biotech’s independent auditor. Investors are cautioned not to place undue reliance on these preliminary estimates.

 

This preliminary estimated data should not be considered a substitute for the audited financial results for the year ended December 31, 2021, to be filed with the Securities and Exchange Commission (the “SEC”) on Form 20-F, which Legend Biotech expects to occur before the end of March 2022.

 

Use of Non-IFRS Financial Measures

We report certain financial information using non-IFRS financial measures, as we believe that these measures provide information that is useful to investors in understanding our performance. These non-IFRS financial measures do not have any standardized meaning and may not be comparable to similar measures used by other companies. For certain non-IFRS financial measures, there are no directly comparable amounts under IFRS. These non-IFRS financial measures should not be viewed as alternatives to measures of financial performance determined in accordance with IFRS.

 

The following table provides a reconciliation of Legend Biotech’s Loss for the year to Adjusted loss for the year:

 

Year ended

(in millions, US$)

December 31, 2021

Loss for the year

(365.3)~(397.4)

Equity-settled share-based compensation expense

18.9~20.8

Service fees for follow-on public offering

0.4

Exchange differences, net

4.5~5.1

Fair value loss of warrant liability

5.7~6.4

Adjusted loss for the year

(335.8)~(364.7)

Adjusted loss for the year is a non-IFRS financial measure. Legend Biotech is reporting Adjusted loss for the year because this financial measure is to be reported as part of a Profit Warning announcement issued by Legend Biotech’s majority shareholder, GenScript Biotech Corporation, pursuant to Rule 13.09 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited. Adjusted loss for the year has limitations in that it does not reflect all expense items that affect Legend Biotech’s results.

 

Non-IFRS measures are not meant to be considered in isolation or as a substitute for financial information presented in accordance with IFRS and should be viewed as supplemental and in addition to Legend Biotech’s financial information presented in accordance with IFRS.

About Cilta-cel

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the United States and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In addition to a Breakthrough Therapy Designation (BTD) granted in the United States in December 2019, cilta-cel received a Priority Medicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. Food and Drug Administration (FDA) in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.

 

About Legend Biotech

Legend Biotech is a global, clinical-stage biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

 

We are currently engaged in a strategic collaboration to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. Applications seeking approval of cilta-cel for the treatment of patients with RRMM are currently under regulatory review by several health authorities around the world, including the U.S. Food and Drug Administration and the European Medicines Agency.

 

Learn more at www.legendbiotech.com and follow us on Twitter and LinkedIn.

Cautionary Statement

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to future milestone payments under our collaboration agreement with Janssen. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial or preclinical study results, including as a result of additional analysis of existing data or unexpected new data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the US litigation process; competition in general; government, industry, and general public pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 2, 2021. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated or expected. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

Investor:
Joanne Choi, Senior Manager, Investor Relations, Legend Biotech

Joanne.choi@legendbiotech.com

Crystal Chen, Manager, Investor Relations, Legend Biotech

crystal.chen@legendbiotech.com

Press:
Tina Carter, Corporate Communications Lead, Legend Biotech

tina.carter@legendbiotech.com
(908) 331-5025

Categories
Business

AM Best affirms credit ratings of PMG Assurance Ltd.

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has affirmed the Financial Strength Rating of A (Excellent) and the Long-Term Issuer Credit Rating of “a+” (Excellent) of PMG Assurance Ltd. (PMG) (Bermuda). The outlook of these Credit Ratings (ratings) is stable.

The ratings reflect PMG’s balance sheet strength, which AM Best assesses as very strong, as well as its strong operating performance, limited business profile and appropriate enterprise risk management. The company also receives rating enhancement provided by its ultimate parent, Sony Group Corporation (Sony) [NYSE: SONY].

 

The ratings also benefit from PMG’s strategic role as Sony’s only captive insurance company. PMG is an integral part of Sony’s enterprise risk management, whose role is to meet the global insurance requirements of the parent while also providing risk management services to Sony group members.

 

PMG’s balance sheet strength is assessed as very strong, and is supported by risk-adjusted capitalization at the strongest level, as measured by Best’s Capital Adequacy Ratio (BCAR), excellent liquidity and conservative investment strategy. Operating performance reflects consistent combined and operating ratios that continue to outperform industry averages. A critical function of PMG is to cover the parent for potential low frequency, high severity claims; PMG mitigates this risk through its comprehensive reinsurance program.

 

Importantly, PMG exhibits strengths that are derived from its keen underwriting focus, conservative operational strategy and emphasis on risk management controls, which are well-integrated with those of its parent. PMG writes predominantly commercial property and marine coverages, and employee benefits coverage for Sony employees located outside of Japan. PMG’s surplus growth has enabled it to retain higher net risk exposures on its marine business, in addition to offering new lines of business such as cyber, which it began offering in 2019.

 

AM Best remains the leading rating agency of alternative risk transfer entities, with more than 200 such vehicles rated in the United States and throughout the world. For current Best’s Credit Ratings and independent data on the captive and alternative risk transfer insurance market, please visit www.ambest.com/captive.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Robert Gabriel
Financial Analyst
+1 908 439 2200, ext. 5725
robert.gabriel@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159

christopher.sharkey@ambest.com

Dan Teclaw
Associate Director
+1 908 439 2200, ext. 5394

dan.teclaw@ambest.com

Jim Peavy
Director, Communications
+1 908 439 2200, ext. 5644

james.peavy@ambest.com

Categories
Business

AM Best downgrades Issuer Credit Rating of Mutual of America Life Insurance Company, affirms financial strength rating

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has downgraded the Long-Term Issuer Credit Rating (Long-Term ICR) to “a” (Excellent) from “a+” (Excellent) and affirmed the Financial Strength Rating (FSR) of A (Excellent) of Mutual of America Life Insurance Company (MofA) (New York, NY). The outlook of the Long-Term ICR has been revised to stable from negative, while the FSR is stable.

These Credit Ratings (ratings) reflect MofA’s balance sheet strength, which AM Best assesses as very strong, as well as its marginal operating performance, favorable business profile and appropriate enterprise risk management (ERM).

 

The rating downgrade of the Long-Term ICR reflects AM Best’s view of the company’s operating performance assessment as marginal, and considers the continuing deterioration and recent volatility in Mutual of America’s operating performance. Furthermore, the company’s Long-Term ICR also reflects the continued weakness in its balance sheet strength assessment, driven by market volatility and continued declines in risk-adjusted capitalization with increased losses.

 

The stable outlooks reflect AM Best’s expectation that MofA will continue to execute on the necessary steps to curb volatility, improve its overall operating performance and its strategic business profile in the near future. MofA’s business profile has experienced some additional weakness, but not enough deterioration to drive the FSR down further.

 

The company’s risk-adjusted capitalization has continued to decline a bit over the past few years, and is projected to be at the very strong level, as measured by Best’s Capital Adequacy Ratio (BCAR). Surplus has declined a bit as well. The company’s investment portfolio maintained a good credit quality through the COVID-19 pandemic and was without financial leverage, but this will be changing toward privately managed investments in the near future. The company’s net income has declined significantly in recent years, mainly due to general account margin compression, realized losses from impairments and significantly higher operating expenses, including additional costs related to business transformation initiatives. The company’s return-on-equity (ROE) ratio remains lower than the industry average, despite MofA not having a tax liability.

 

The company has a competitive position in its target market of providing pension products to nonprofit organizations and small for-profit businesses, although almost all of general account reserves are interest-sensitive, and more than half of the total assets are separate account assets. MofA is continuing to invest heavily in technology to enhance its infrastructure, sales efforts and margins as it still expects to gain market share in the near future.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Igor Bass
Senior Financial Analyst
+1 908 439 2200, ext. 5109
igor.bass@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Michael Porcelli
Senior Director
+1 908 439 2200, ext. 5548
michael.porcelli@ambest.com

Jim Peavy
Director, Communications
+1 908 439 2200, ext. 5644
james.peavy@ambest.com

Categories
Local News Science

Bristol Myers Squibb presents interim results from long-term study reinforcing maintenance of response and safety profile of Zeposia (ozanimod) in patients with moderately to severely active ulcerative colitis

The percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142

 

Zeposia is the first and only oral sphingosine 1-phosphate (S1P) receptor modulator approved to treat patients with ulcerative colitis

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ECCO2022—Bristol Myers Squibb (NYSE: BMY) today announced interim results from the True North open-label extension study evaluating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with moderately to severely active ulcerative colitis (UC). Findings show that the percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142. No new safety signals emerged in the study. These data (Presentation #DOP44) will be presented at the 17th Congress of the European Crohn’s and Colitis Organisation (ECCO), taking place February 16-19, 2022.

“For clinicians treating patients with this serious, chronic disease, results from the True North extension study provide an understanding of long-term therapeutic outcomes and help to identify an appropriate treatment approach for their patients with ulcerative colitis,” said Silvio Danese, M.D., Director, Gastroenterology and Endoscopy, IRCCS, San Raffaele Hospital and University Vita-Salute San Raffaele in Milan. “These findings demonstrate important and clinically meaningful responses across multiple key endpoints and build upon our current knowledge of the efficacy and safety profile of Zeposia.”

 

In the True North extension study, data from an interim analysis of patients (n=823) who had previously participated in the Phase 3 True North Zeposia clinical trial were examined. At Weeks 46, 94 and 142, 45% (203/452), 51% (109/213) and 45% (39/87) of participants, respectively, were in clinical remission, and 80% (352/441), 84% (176/209) and 86% (73/85) achieved clinical response, respectively. The efficacy of Zeposia in those who entered the long-term study as responders on Day 1 was higher compared to the total population, with 70% (107/152) and 69% (42/61) achieving clinical remission at Weeks 46 and 94, respectively, and 95% (145/152) and 98% (60/61) achieving clinical response at Weeks 46 and 94, respectively. At the time of this analysis, of the 823 patients from the Phase 3 True North trial who entered the open-label extension study, 64% subsequently completed Week 46, 34% completed Week 94, and 14% completed Week 142. The most common reason for discontinuation was lack of efficacy (21%). No new safety signals were seen with longer-term Zeposia use in the 1,158 patients within the pooled population, including patients from the Phase 2 Touchstone study and the Phase 3 True North study.

 

Additional Bristol Myers Squibb-sponsored abstracts presented at the ECCO 2022 Congress can be accessed online here.

 

“These data reinforce the growing body of evidence demonstrating the long-term efficacy and safety of Zeposia and showcase its role as an important therapeutic option before biologic and Janus kinase inhibitor treatments in patients with moderately to severely active ulcerative colitis,” said Jonathan Sadeh, M.D., MSc., senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb. “With our heritage in transformational science for immune-mediated diseases – and our commitment to inflammatory bowel disease research – we are seeking to find solutions that have the goal of redefining treatment outcomes and elevating standards of care for the gastroenterology community.”

 

Visit this page on BMS.com for more information on Bristol Myers Squibb’s scientific approach and resources on gastrointestinal immune-mediated diseases.

 

About True North

True North is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial assessing the efficacy and safety of Zeposia 0.92 mg in patients with moderately to severely active ulcerative colitis (UC) who had an inadequate response or were intolerant to any of the following: oral aminosalicylates, corticosteroids, immunomodulators or a biologic. Patients were to be receiving treatment with oral aminosalicylates and/or corticosteroids prior to and during the induction period. A total of 30% of patients had previously failed or were intolerant to tumor necrosis factor (TNF) blockers. Of these patients, 63% received at least two biologics including TNF blockers. At study entry, mean age was 42 years, 60% were male and mean disease duration was 7 years; patient characteristics were well balanced across treatment groups. In the 10-week induction study (UC Study 1), a total of 645 patients were randomized 2:1 to receive Zeposia (n=429) or placebo (n=216), of whom 94% and 89%, respectively, completed the induction study. No new safety signals were observed in the induction phase.

 

In maintenance study (UC Study 2) a total of 457 patients who received Zeposia in either UC Study 1 or in an open-label arm and achieved clinical response at Week 10 were re-randomized 1:1 and were treated with either Zeposia 0.92 mg (n=230) or placebo (n=227) for 42 weeks, for a total of 52 weeks of treatment. Concomitant aminosalicylates were required to remain stable through Week 52. Patients on concomitant corticosteroids were to taper their dose upon entering the maintenance study. Of these, 80% and 54.6% of patients who received Zeposia and placebo, respectively, completed the study. In the maintenance phase, the overall safety profile was consistent with the known safety profile for Zeposia and patients with moderate to severe UC. More information about the True North trial can be found on www.clinicaltrials.gov, NCT02435992.

 

For the True North open-label extension (OLE) study, eligible patients who completed the maintenance UC Study 2 were rolled into the OLE study, which is ongoing and designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active UC. Patients were also eligible to enter the OLE study if they completed UC Study 1 and did not achieve a clinical response or if they experienced a disease relapse during UC Study 2. Among patients who entered the trial, clinical remission, clinical response, endoscopic improvement and symptomatic remission were generally maintained through Week 142. No new safety concerns were identified in this study extension in patients with ulcerative colitis. More information about the open-label extension trial can be found on www.clinicaltrials.gov, NCT02531126.

 

Bristol Myers Squibb thanks the patients and investigators involved in the True North clinical trial.

 

About Ulcerative Colitis

Ulcerative colitis, a chronic inflammatory bowel disease (IBD), is characterized by an irregular, chronic immune response that creates inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon) or rectum. Symptoms include bloody stools, severe diarrhea and frequent abdominal pain. Ulcerative colitis has a major impact on patients’ health-related quality of life, including physical functioning, social and emotional well-being and ability to go to work/school. Many patients have an inadequate response or do not respond at all to currently available therapies. It is estimated that approximately 12.6 million people worldwide are living with IBD.

 

About Zeposia (ozanimod)

Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia reduces the capacity of lymphocytes to migrate from lymphoid tissue, reducing the number of circulating lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in ulcerative colitis (UC) is unknown but may involve the reduction of lymphocyte migration into the intestines.

 

Bristol Myers Squibb is continuing to evaluate Zeposia in the ongoing True North open-label extension trial, designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active UC. The company is also investigating Zeposia for the treatment of moderately to severely active Crohn’s disease in the ongoing Phase 3 YELLOWSTONE clinical trial program.

 

The European Commission approved Zeposia for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features in May 2020 and for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent in November 2021. The U.S. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020 and adults with moderately to severely active UC on May 27, 2021.

 

U.S. FDA APPROVED INDICATIONS

ZEPOSIA (ozanimod) is indicated for the treatment of:

1. Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

2. Moderately to severely active ulcerative colitis (UC) in adults.

IMPORTANT SAFETY INFORMATION

Contraindications:

  • Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure or have the presence of Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker
  • Patients with severe untreated sleep apnea
  • Patients taking a monoamine oxidase (MAO) inhibitor

Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS or UC therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA

  • Herpes zoster was reported as an adverse reaction in ZEPOSIA-treated patients. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA
  • Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another S1P receptor modulator. If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated
  • Progressive Multifocal Leukoencephalopathy (PML) is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. PML has been reported in patients treated with S1P receptor modulators and other MS and UC therapies and has been associated with some risk factors. If PML is suspected, withhold ZEPOSIA and perform an appropriate diagnostic evaluation. If confirmed, treatment with ZEPOSIA should be discontinued
  • In the MS and UC clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for treatment of MS and UC. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects
  • Use of live attenuated vaccines should be avoided during and for 3 months after treatment with ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA

Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of ZEPOSIA without dose escalation may result in greater decreases in heart rate. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals:

  • with significant QT prolongation
  • with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs
  • with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension
  • with a history of Mobitz type II second-degree or higher AV block, sick sinus syndrome, or sino-atrial heart block

Liver Injury: Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain liver function tests, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes checked and ZEPOSIA should be discontinued if significant liver injury is confirmed. Caution should be exercised when using ZEPOSIA in patients with history of significant liver disease

Fetal Risk: There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA

Increased Blood Pressure: Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately. Certain foods that may contain very high amounts of tyramine could cause severe hypertension in patients taking ZEPOSIA. Patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA

Respiratory Effects: ZEPOSIA may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated

Macular edema: S1P modulators have been associated with an increased risk of macular edema. Patients with a history of uveitis or diabetes mellitus are at increased risk. Patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation and regular follow-up examinations. An ophthalmic evaluation is recommended in all patients at any time if there is a change in vision. Continued use of ZEPOSIA in patients with macular edema has not been evaluated; potential benefits and risks for the individual patient should be considered if deciding whether ZEPOSIA should be discontinued

Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued

Unintended Additive Immunosuppressive Effects From Prior Immunosuppressive or Immune-Modulating Drugs: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended

Severe Increase in Disability After Stopping ZEPOSIA: Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment so patients should be monitored upon discontinuation

Immune System Effects After Stopping ZEPOSIA: After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days with approximately 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA

Most Common Adverse Reactions that occurred in the MS clinical trials of ZEPOSIA-treated patients (≥ 4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension

In the UC clinical trials, the most common adverse reactions that occurred in ≥4% of ZEPOSIA-treated patients and greater than in patients who received placebo were upper respiratory infection, liver test increased, and headache

For additional safety information, please see the full Prescribing Information and Medication Guide.

Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives

Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and neurology. We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission – and perhaps even cures – in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, whether results of future post-marketing studies will be consistent with the results of this study, whether Zeposia (ozanimod) for the indication described in this release will be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of such treatment for such indication described in this release may be contingent upon verification and description of clinical benefit in additional confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent Quarterly Reports on Form 10‑Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

corporatefinancial-news

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Nina Goworek

908-673-9711

nina.goworek@bms.com