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AM Best withdraws Credit Ratings of American Millennium Insurance Company and Citadel Reinsurance Company Limited

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has removed from under review with developing implications and downgraded the Financial Strength Rating (FSR) to D (Poor) from C- (Weak) and the Long-Term Issuer Credit Rating (Long-Term ICR) to “c” (Poor) from “cc” (Very Weak) of American Millennium Insurance Company (AMIC) (Bridgewater, NJ), a wholly owned subsidiary of Citadel Reinsurance Company Limited (Citadel Re) (Hamilton, Bermuda). The outlook assigned to these Credit Ratings (ratings) is negative.

Additionally, AM Best has removed from under review with developing implications and downgraded the FSR to C+ (Marginal) from B (Fair) and the Long-Term ICR to “b-” (Marginal) from “bb” (Fair) of Citadel Re. The outlook assigned to these ratings is negative. Concurrently, AM Best has withdrawn the ratings of AMIC and Citadel Re as the companies have requested to no longer participate in AM Best’s interactive rating process.

 

The ratings of AMIC reflect its balance sheet strength, which AM Best assesses as very weak, as well as its weak operating performance, limited business profile and marginal enterprise risk management (ERM).

 

The ratings of Citadel Re reflect its balance sheet strength, which AM Best assesses as weak, as well as its marginal operating performance, limited business profile and marginal ERM.

 

Prior to these rating actions, AM Best downgraded the ratings of AMIC and Citadel Re in February 2021, and maintained the under review with negative implications status, resulting from persistent underwriting losses that negatively impacted the risk-adjusted capitalization of both companies. The under review status was pending due to a planned recapitalization of AMIC and Citadel Re to raise capital from outside investors.

 

In August 2021, Citadel Re completed its recapitalization of AMIC with a $6.2 million cash injection, raising the risk-based capital ratio to above 300% to the satisfaction of AMIC’s regulator, the Department of Banking and Insurance of New Jersey. However, management’s planned capital raise was not successful, as the transaction failed to get approval from the Bermuda Monetary Authority (BMA).

 

The failed transaction also led to Citadel Re having to return a portion of its capital to the outside investor and causing Citadel Re’s capital to fall below Bermuda’s Solvency Capital Requirement (SCR); consequently, the BMA ordered Citadel Re to stop writing any new and renewal business.

 

The downgrading of Citadel Re’s ratings reflects its weakened balance sheet strength, as well as a lower assessment of its business profile due to its run-off status. The downgrading of AMIC’s ratings is mainly due to it no longer receiving lift from Citadel Re, because of Citadel Re’s diminished capital position. The negative outlooks on both entities reflect the uncertainty surrounding their future business prospects and the challenges associated with the regulatory and capital requirements imposed on Citadel Re by the BMA.

 

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 © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

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Jieqiu Fan
Associate Director
+1 908 439 2200, ext. 5372
jieqiu.fan@ambest.com

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

Daniel Ryan
Senior Director

+1 908 439 2200, ext. 5325
daniel.ryan@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

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Traverse City Whiskey Co. nominated as a ‘Best in Class’ finalist, awarded three double gold medals at the 2023 San Francisco World Spirits Competition

Amongst Thousands of Entries, TCWC’s Barrel Proof Bourbon Once Again Selected as a Top Three Finalist For “Best Small Batch Bourbon,” Which it Won in 2019

 

TRAVERSE CITY, Mich. — (BUSINESS WIRE) — #barrellproofryeTraverse City Whiskey Co. (TCWC), a true small batch distillery handcrafting a portfolio of premium whiskies and bourbons in Up North Michigan, announced that three of its signature products – Barrel Proof Bourbon Whiskey, Barrel Proof Rye Whiskey and Sherry Barrel Finished Bourbon – were awarded Double Gold medals at the prestigious 2023 San Francisco World Spirits Competition. Additionally, TCWC’s Barrel Proof Bourbon was named a Finalist for “Best Small Batch Bourbon,” an award which it won in 2019.


TCWC’s Barrel Proof Bourbon Whiskey has quickly become a must have for premium bourbon lovers. It has a truly exhilarating taste, like hugging a bear, but way less dangerous. It contains a mashbill of 75% corn, 21% rye and 4% malted barley that was aged for 10 years and bottled at 120.2 proof (60.1% ABV). The bourbon presents a deep, oaky body with sweet and nutty flavors of burnt caramel and dark chocolate, a smooth and creamy mouthfeel, and a long finish. SRP $80.

 

The company’s Barrel Proof Rye is the newest addition to the company’s already impressive lineup. Imagine a red-bearded pirate crying tears of joy after seeing land for the first time in 10 years. That’s the feeling whiskey lovers can expect when drinking it. The expression has a mashbill of 95% rye and 5% malted barley. The expression was aged for six years and bottled at 116.6 proof (58.3% ABV). The whiskey showcases a classic rye spice alongside a rich oak flavor, an effervescent aroma of baking spices, notes of allspice, black peppercorns and sage, and a warm buttery finish. SRP $80.

 

The Sherry Barrel Finished Bourbon tastes like a classy Cinco de Mayo party in your mouth. It is part of TCWC’s new “Finishing Series” that features a unique high-rye bourbon whiskey with a mashbill of 60% corn, 36% rye and 4% malted barley. The whiskey was aged for five years in new American Oak barrels and then rested in Pedro Ximenez sherry wine casks for nearly 12 months and bottled at 95 proof (47.5% ABV). It exemplifies notes of caramel, sassafras, cinnamon, raisins, and vanilla bean, with a mild finish of toasted rye bread and tobacco. SRP $60.

 

“It’s an absolute thrill to have our signature Barrel Proof Bourbon and Rye whiskeys receive Double Gold, and an honor to be a finalist for ‘Best Small Batch Bourbon’ for the second time,” said Chris Fredrickson, Co-founder, TCWC. “We’re also thrilled that our Sherry Barrel Finished whiskey, one of our newest products, also earned Double Gold.”

 

TCWC draws upon its early family roots in the distilled spirits industry dating back to the late 1800s, sourcing their grains from the Midwest. The distilling team, led by Chris Fredrickson, strives to make quality products, inspired by patented distilling techniques invented by Fredrickson’s great grandfather that were approved by the US PTO during the prohibition era.

 

TCWC products are available in 750ml bottles at both on- and off-premise establishments in the following markets: Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, Washington, Washington DC, Wisconsin. Retail prices may vary by market.

 

For more information, please visit www.tcwhiskey.com and follow the brand on Facebook, Twitter, and Instagram @tcwhiskey.

 

About Traverse City Whiskey Co.

Traverse City Whiskey Co. is a family-owned distilled spirits company that is known for crafting premium whiskeys that are unmistakably Up North. The harsh winters and hot summers of Traverse City, Michigan, produce exceptional whiskeys forged by the elements. Up North whiskey is said to be both strong and delicate, like a lumberjack with an understanding gaze. TCWC’s early family roots are in the distilled spirits industry dating back to the late 1800’s, sourcing all grains from the Midwest.

 

Traverse City Whiskey Co. is a proud member of the Distilled Spirits Council of the United States (DISCUS).

Contacts

Aaron Brost | Ro-Bro Marketing & PR

312.576.5315 | aaron@ro-bro.com

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Healthcare Lifestyle Science

Blue Earth Diagnostics announces additional results from phase 3 SPOTLIGHT trial of investigational PET imaging agent 18F-rhPSMA-7.3 in biochemical recurrence of prostate cancer

Results at the American Urological Association’s 2023 Annual Meeting (AUA2023)

 

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced additional results from its completed Phase 3 SPOTLIGHT trial of 18F-rhPSMA-7.3 in recurrent prostate cancer, among a subgroup of patients who had undergone primary treatment with radiation therapy only.

 

It evaluated the overall Detection Rates (DRs) of 18F-rhPSMA-7.3 at patient level and stratified by anatomical region, Gleason score, baseline Prostate Specific Antigen (PSA) levels and PSA doubling time. 18F-rhPSMA-7.3 is an investigational high affinity radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent. The results were reported in a moderated poster presentation at the American Urological Association’s 2023 Annual Meeting (AUA2023), in Chicago, Ill.


“The ability to determine the extent and location of recurrent prostate cancer to inform appropriate clinical management for these men is key for physicians and their patients, because up to 50% of patients who undergo radiation therapy will develop local or distant recurrences within 10 years,” said Brian T. Helfand, MD, Chief of Division of Urology, NorthShore University HealthSystem, Evanston, Ill., on behalf of the SPOTLIGHT Study Group.

 

“The utility of conventional imaging for the localization of recurrence is limited, and relapse after curative-intent radiation therapy remains a considerable clinical burden. Precise imaging techniques are required to identify areas of involvement in order to facilitate delivery of optimized management for patients. These findings from the Phase 3 SPOTLIGHT subgroup study showed high detection rates by majority read for 18F-rhPSMA-7.3 across all regions. In particular, the finding that 43% (33/76) of men had distant extra-pelvic recurrences has important implications for clinical management, as procedures such as salvage prostatectomy would be futile in those cases.”

 

“These results from the Phase 3 SPOTLIGHT trial in biochemically recurrent prostate cancer are included in our New Drug Application for 18F-rhPSMA-7.3 PET imaging currently under review by the U.S. Food and Drug Administration, and we are pleased that they are being presented to the urology community at AUA 2023,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “18F-rhPSMA-7.3 represents a new class of PSMA-targeted PET radiopharmaceuticals, with early studies showing a high binding affinity for PSMA, together with biodistribution data suggesting the potential for low bladder activity. The compound is part of Blue Earth Diagnostics’ comprehensive prostate cancer portfolio, which includes other compounds and this investigational rhPSMA compound for potential use in diagnostic PET imaging and targeted radiopharmaceutical therapy.”

 

The findings presented at AUA included analyses of clinical factors impacting DRs for 18F-rhPSMA-7.3 as evaluated by three blinded central readers: DRs, overall patient-level detection rate, and regional-level analyses, stratified by Gleason score, baseline PSA levels and PSA doubling time. For example, results showed that among the subgroup (n=76) of patients in the Evaluable PET Scan Population who had undergone primary treatment with radiation therapy for prostate cancer, the overall patient-level DR was 99% (75/76) and consistently high across the three independent readers (range 93-99%). Recurrence by region was 76% (58/76) for the prostate, 25% (19/76) for pelvic lymph nodes and 43% (33/76) for extra-pelvic recurrences. As noted previously, no serious adverse reactions were attributed to 18F-rhPSMA-7.3 PET in the SPOTLIGHT study. Of the 391 patients who received 18F-rhPSMA-7.3 in the SPOTLIGHT study, 16 (4.1%) patients had at least one treatment-emergent adverse event that was considered possibly related/related to 18F-rhPSMA-7.3. The most frequently reported events were: hypertension: 1.8% (n=7); diarrhea: 1.0% (n=4); injection site reaction: 0.5% (n=2), and headache: 0.5% (n=2).

 

The SPOTLIGHT trial (NCT04186845) was a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Key results for 18F-rhPSMA-7.3 PET were previously presented at ASCO GU in February 2022,1 with additional results announced at AUA in April 20222, at SNMMI in June 20223 and at ASTRO in October 20224.

 

The findings were discussed in a moderated poster presentation at AUA 2023 on April 29, 2023, “18F-rhPSMA-7.3 Detection Rates in Patients with Recurrence of Prostate Cancer Following Primary Treatment with Radiation Therapy: Results SPOTLIGHT Study,” by Brian T. Helfand, MD, NorthShore University HealthSystem, Evanston, Ill., on behalf of the SPOTLIGHT Study Group. Full session details and the abstract are available in the AUA online program HERE.

 

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: (“SPOTLIGHT,” NCT04186845), in men with recurrent disease and (“LIGHTHOUSE,” NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

 

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

 

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com.

 

1Schuster, DM, SPOTLIGHT Study Group, J. Clin. Onc. 2022; 40 (6_suppl):9-9.

2Fleming, MT, SPOTLIGHT Study Group, J. Urol. 2022; 207 (5_suppl):31047.

3Kuo, P, SPOTLIGHT Study Group, J. Nucl. Med. 2022; 63 (2_suppl):2539.

4Lowentritt, B, SPOTLIGHT Study Group, Int. J. Radiat. Oncol. Biol. Phys. 2022; 114(3):S130-S131.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)
Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0) 7917 536939

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

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Business Healthcare Lifestyle Science

Teva and MedinCell announce FDA approval of UZEDY™ (risperidone) extended-release injectable suspension, a long-acting subcutaneous atypical antipsychotic injection, for the treatment of schizophrenia in adults

  • This new treatment provides adults living with schizophrenia a long-acting formulation that offers flexible 1- and 2-month dosing intervals1
  • In a Phase 3 clinical trial, UZEDY demonstrated up to 80% reduction in risk of schizophrenia relapse versus placebo1
  • UZEDY is a subcutaneous injection from a pre-filled syringe with a 21-gauge needle

 

PARSIPPANY, N.J. & TEL AVIV & PARIS — (BUSINESS WIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced today that the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults.

 

UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.1

“UZEDY embodies Teva’s commitment to bringing innovative advances to patients and to providing people living with schizophrenia an important new treatment option that was designed to address certain treatment challenges and may decrease the risk of relapse,” said Richard Francis, President and CEO of Teva. “The approval of UZEDY is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market. This milestone is a testament to advancing our robust biopharmaceutical pipeline of innovative medicines that aim to support more people living with mental health disorders and neurological diseases in the coming years.”

 

Approximately 80% of patients with schizophrenia experience multiple relapses over the first five years of treatment,2 most commonly due to suboptimal adherence to treatment with oral antipsychotics. Each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.3,4

Schizophrenia is a chronic, progressive and severely debilitating mental health disorder that affects how one thinks, feels and acts.5 This approval is based on data from two Phase 3 trials evaluating UZEDY in patients with schizophrenia: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia).

 

“The approval of the first product formulated with our technology is a pivotal moment for MedinCell and for the many patients who will benefit,” said Christophe Douat, CEO of MedinCell. “We are committed to supporting patients through innovative therapy options. It continues to be a wonderful journey with Teva, an ideal partner to harness the full potential of UZEDY. Our technology reaching commercial stage marks the start of an exciting new era for MedinCell and we are extremely proud to share this very special moment with all our employees and shareholders.”

 

The use of novel SteadyTeq technology in UZEDY controls the release of risperidone over time. The initiation of treatment requires no loading dose or oral supplementation. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.1

 

“Treatments for schizophrenia are largely prescribed as daily oral medications, which can present challenges with adherence due to missed doses. Lack of adherence to treatment with oral antipsychotics is the most common cause of relapse in schizophrenia,6 so there’s a role for therapies that are dosed in one- or two-month dosing intervals to help prevent relapse,” said Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, Hempstead, NY. “As a clinician, I am excited to now have a new treatment option that reduces the risk of relapse1 for this complex disease and helps address some of the barriers around receiving schizophrenia treatment.”

 

CLICK HERE TO ACCESS THE COMPLETE PRESS RELEASE

 

About Schizophrenia

Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts. Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability. Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 3.5 million people in the U.S. are currently diagnosed with the condition. Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women. The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization. Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology. Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.

 

About UZEDY

UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use rather than intramuscular use, is indicated for the treatment of schizophrenia in adults. In clinical trials, UZEDY reduced the risk of relapse by up to 80%. UZEDY administers risperidone through copolymer technology under license from MedinCell that allows for absorption and sustained release in the first subcutaneous injection. UZEDY is the only long-acting, subcutaneous formulation of risperidone available in both one- and two-month dosing intervals.1 For full prescribing information, visit https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf.

 

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products. Learn more at www.tevapharm.com.

 

About MedinCell

MedinCell is an innovative pharmaceutical company with a portfolio of long-acting injectable products, from development to market, in various therapeutic areas. MedinCell proprietary technology BEPO® (licensed to Teva under the name SteadyTeq) makes it possible to control the delivery of a drug at a therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options. Based in Montpellier, MedinCell currently employs more than 140 people representing over 25 different nationalities. www.medincell.com

 

1 UZEDY™ (risperidone) extended-release injectable suspension, for subcutaneous injection Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.

2 Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric disease and treatment, 14, 205–223.

3 Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.

4 Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The American journal of psychiatry, 170(6), 609–615.

5 Patel, K. R., Cherian, J., Gohil, K., & Atkinson, D. (2014). Schizophrenia: overview and treatment options. P & T: a peer-reviewed journal for formulary management, 39(9), 638–645..

6 Kane JM, Correll CU. Optimizing treatment choices to improve adherence and outcomes in schizophrenia. J Clin Psychiatry. 2019;80(5):IN18031AH1C. doi:10.4088/JCP.IN18031AH1C.

Contacts

IR Contacts

Ran Meir, +1 (267) 468-4475

Yael Ashman, +972 (3) 914 8262

Sanjeev Sharma, +1 (973) 658 2700

PR Contacts

Kelley Dougherty, 1 (973) 832-2810

Eden Klein, +972 (3) 906 2645

MedinCell France

David Heuzé (Head of Communication), +33 (0) 6 83 25 21 86

david.heuze@medincell.com

Louis-Victor Delouvrier (NewCap – IR), +33 (0) 1 44 71 98 53

medincell@newcap.eu

Nicolas Merigeau (NewCap – Media Relations), +33 (0) 1 44 71 94 98

medincell@newcap.eu

Categories
Business Healthcare Science

Seres Therapeutics and Nestlé Health Science announce FDA approval of VOWSTTM (fecal microbiota spores, live-brpk) for prevention of recurrence of C. difficile infection in adults following antibacterial treatment for recurrent CDI

– First and only FDA-approved orally administered microbiota-based therapeutic, validating Seres’ microbiome platform –

– Phase 3 ECOSPOR III study demonstrated that 88% of treated individuals were recurrence-free at 8 weeks –

– Opportunity to address prevention of recurrence of C. difficile infection in adults with rCDI, including first recurrence, following antibacterial treatment –

– VOWST product availability expected in June –

– Conference call at 8:30 a.m. ET tomorrow –

 

CAMBRIDGE, Mass. & HOBOKEN, N.J. — (BUSINESS WIRE) — Seres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science  announced Thursday  the U.S. Food and Drug Administration (FDA) approval of VOWSTTM (fecal microbiota spores, live-brpk), formerly called SER-109, an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). VOWST is not indicated for the treatment of CDI.


“Since being founded by Flagship Pioneering over a decade ago, Seres has led the development of microbiome therapeutics, and today’s FDA approval of VOWST as the first orally administered microbiota-based therapeutic for the prevention of recurrent C. difficile infection marks a tremendous milestone for the patient community, and for Seres. We are deeply grateful to the patients, caregivers, clinical investigators, and employees who contributed to the discovery, development, and approval of VOWST,” said Eric Shaff, President and Chief Executive Officer at Seres. “With VOWST, we and Nestlé Health Science have the opportunity to prevent recurrence in a broad group of adult rCDI patients, including those who have experienced a first recurrence.”

 

“Our strategic collaboration with Seres is part of Nestlé Health Science’s ongoing commitment to advancements in the gastrointestinal space to address unmet patient needs,” said Greg Behar, Chief Executive Officer, Nestlé Health Science. “Our teams have vast experience in gastrointestinal disorders and are poised to engage with healthcare professionals to start addressing this critical need for patients. We expect VOWST to be available in June and look forward to helping patients.”

 

Recurrent CDI represents significant unmet need and is a leading cause of hospital-acquired infection that can result in severe illness and death.1 Based on data from the U.S. Centers for Disease Control and Prevention (CDC), the companies estimate 156,000 episodes in the U.S. in 2023.

 

“Recurrent C. difficile infection is a highly debilitating and life-threatening disease, and antibiotics alone do not address the underlying cause of rCDI, dysbiosis of the gut microbiome,” said Carl Crawford M.D., Assistant Professor of Clinical Medicine at Weill Cornell Medical College. “The approval of VOWST provides an important new oral treatment option for this disease, and I am pleased to now be able to offer this medicine to recurrent CDI patients.”

 

“Recurrent C. difficile infection significantly impacts patients’ quality of life, both physically and emotionally, leaving many living in tremendous fear of future recurrences. Patients have been waiting for new treatment options that address a key concern: prevention of an additional CDI recurrence,” said Christian John Lillis, Executive Director at Peggy Lillis Foundation for C. diff Education and Advocacy.

 

VOWST Phase 3 Study Data

The FDA approval of VOWST was supported by a robust Phase 3 development program that included the ECOSPOR III and ECOSPOR IV studies. VOWST was previously granted Breakthrough Therapy and Orphan Drug Designations by the FDA.

 

ECOSPOR III was a multicenter, randomized, placebo-controlled study in individuals with rCDI, the results of which were published in the New England Journal of Medicine.2 The study’s primary objective was to demonstrate the reduction of CDI recurrence with VOWST. In ECOSPOR III, VOWST was shown to reduce CDI recurrence at eight weeks, with approximately 88% of individuals recurrence-free at eight weeks post-treatment, compared to 60% in participants who received placebo.2 In addition, at six months post-treatment, 79% of the VOWST group were demonstrated to be recurrence-free, compared to 53% in the placebo group.3 No treatment-related serious adverse events were observed in the active arm and the frequency of treatment-related adverse events was similar between the VOWST and placebo arms. The most common adverse reactions through eight weeks in VOWST treated participants versus placebo were solicited events of abdominal distention (31.1% VOWST versus 29.3% placebo), fatigue (22.2% VOWST versus 21.7% placebo), constipation (14.4% VOWST versus 10.9% placebo), chills (11.1% versus 7.6% placebo), and unsolicited event of diarrhea (10.0% versus 4.3% placebo).4

 

ECOSPOR IV was an open-label, single arm study evaluating VOWST in 263 adult participants with rCDI. Study results were published in the JAMA Network Open.5 The ECOSPOR IV study results contributed to the VOWST safety database and supported product approval.

 

Seres and Nestlé Health Science are committed to helping appropriate patients who have been prescribed VOWST obtain access. Additional details about VOWST access programs will be available at launch.

 

Joint Commercialization Agreement

In July 2021, Seres and Nestlé Health Science entered into an agreement to jointly commercialize VOWST in the U.S. and Canada. Nestlé Health Science is leveraging its global pharmaceutical business and assuming the role of lead commercialization party, including the utilization of its existing infrastructure, gastrointestinal sales force and payer access team.

 

Seres is due to receive a $125 million milestone payment from Nestlé Health Science associated with the FDA approval of VOWST. Upon VOWST commercialization, each company will be entitled to share equally in commercial profits and losses.

 

Conference Call Information

Seres’ management will host a conference call tomorrow, April 27, 2023, at 8:30 a.m. ET. Accompanying slides will be posted on the Seres website prior to the call. To access the conference call, please dial 773-305-6867 (domestic) or 866-400-0049 (international) and reference Conference ID 1937506. To join the live webcast, please visit the “Investors and News” section of the Seres website at www.serestherapeutics.com.

 

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

 

INDICATION AND IMPORTANT SAFETY INFORMATION FOR VOWST

INDICATION

VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).

Limitation of Use: VOWST is not indicated for treatment of CDI.

 

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Transmissible infectious agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.

 

Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.

 

ADVERSE REACTIONS

The most common adverse reactions (reported in ≥5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).

 

To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.

 

DRUG INTERACTIONS

Do not administer antibacterials concurrently with VOWST.

 

Please see Full Prescribing Information and Patient Information

About Recurrent C. difficile Infection (rCDI)

Recurrent C. difficile infection is a gastrointestinal infection caused by C. difficile bacteria. rCDI is linked to dysbiosis of the gastrointestinal microbiome and is associated with increased mortality. CDI has been characterized as an Urgent Health Threat by the Centers for Disease Control and Prevention (CDC). rCDI results in a substantial burden on the healthcare system1 with the average rCDI-related annual costs per patient at approximately $43K.6

 

About Seres Therapeutics

Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage company developing novel microbiome therapeutics for serious diseases. Seres’ lead program, VOWSTTM, obtained U.S. FDA approval in April 2023 as the first orally administered microbiota-based therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI and is being commercialized in collaboration with Nestlé Health Science. Seres is also developing a novel class of multifunctional fermented bacterial consortia designed to functionally interact with host cells and tissues to treat disease. For more information, please visit www.serestherapeutics.com.

 

About Nestlé Health Science

Nestlé Health Science, a leader in the science of nutrition, is a globally managed business unit of Nestlé. We are committed to redefining the management of health, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Our extensive research network provides the foundation for products that empower healthier lives through nutrition. Headquartered in Switzerland, we have more than 12,000 employees around the world, with products available in more than 140 countries. For more information, please visit www.nestlehealthscience.us.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the timing of commercial launch, the availability of VOWST, the commercial success of VOWST; and other statements which are not historical fact.

 

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; the impact of the COVID-19 pandemic; our unproven approach to therapeutic intervention; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates and develop and commercialize our product candidates, if approved; the unknown degree and competing factors of market acceptance for VOWST; the competition we will face; our ability to protect our intellectual property; and our ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), on March 7, 2023, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

 

References:
  1. Rodrigues R, Barber GE, Ananthakrishnan AN. A Comprehensive Study of Costs Associated With Recurrent Clostridium difficile Infection. Infect Control Hosp Epidemiol. 2016;38:196-202. DOI: 10.1017/ice.2016.246
  2. Feuerstadt P, Louie TJ, Lashner B, et al. SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection. N Engl J Med. 2022;386:220-9. DOI: 10.1056/nejmoa2106516
  3. Cohen SH, Louie TJ, Sims M, et al. Extended Follow-up of Microbiome Therapeutic SER-109 Through 24 Weeks for Recurrent Clostridioides difficile Infection in a Randomized Clinical Trial. JAMA. 2022;328:2062. DOI: 10.1001/jama.2022.16476
  4. VOWSTTM.Prescribing Information. Seres Therapeutics, Inc.; 2023.
  5. Sims MD, Khanna S, Feuerstadt P, et al. Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection: A Phase 3, Open-Label, Single-Arm Trial. JAMA Network Open. 2023;6(2):e2255758. DOI: 10.1001/jamanetworkopen.2022.55758
  6. U.S. Bureau of Labor Statistics. CPI Inflation Calculator. U.S. Bureau of Labor Statistics. Published 2022. https://www.bls.gov/data/inflation_calculator.htm. CPI inflation adjusted to March 2023.

Contacts

Seres IR and PR Contact:
Carlo Tanzi, Ph.D.

ctanzi@serestherapeutics.com

Nestlé Health Science PR Contact:
Lindsay Yanek

lindsay.yanek@us.nestle.com

Categories
Business Economics Environment Lifestyle Special/Sponsored Content

American Water reports strong first quarter 2023 results; affirms 2023 guidance and long-term targets

  • First quarter 2023 earnings of $0.91 per share, compared to $0.87 per share in 2022
  • 2023 earnings per share guidance range of $4.72 to $4.82 affirmed, long-term targets also affirmed
  • Invested $538 million in the first three months of the year; total capital plan on track to invest approximately $2.9 billion in 2023
  • Sold 12,650,000 shares of common stock on March 3, 2023, for net proceeds of approximately $1.7 billion
  • Announced agreements to purchase the assets related to the wastewater system of Towamencin Municipal Authority in Pennsylvania for a purchase price of $104 million and the wastewater treatment plant from Granite City in Illinois for a purchase price of $83 million
  • Published the 2022 Environmental, Social and Governance Data Summary and the Inclusion, Diversity & Equity Summary, part of the Company’s commitment to data transparency and sharing timely information on key ESG and diversity metrics

 

CAMDEN, N.J. — (BUSINESS WIRE) — American Water Works Company, Inc. (NYSE: AWK) today reported results for the quarter ended March 31, 2023, of $0.91 per share, compared to $0.87 per share in 2022.

 

“We’re off to a great start to the year,” said M. Susan Hardwick, president and CEO of American Water. “Our investments in infrastructure and our success signing new purchase agreements for regulated acquisitions has set the stage well for achieving our expected growth in 2023 and beyond.”

 

“We also successfully executed the 2023 planned equity issuance in March. In total $1.7 billion was issued, reflecting an upsized offering made possible by very strong demand for our securities. We are very pleased with the interest by investors in the company, both existing and new shareholders. Having the issue completed allows us to be very focused on executing on our plan. With this action and solid first quarter results, we are on track to meet our 2023 objectives,” said Hardwick.

 

2023 EPS Guidance and Long-Term Financial Targets Affirmed

The Company affirms its 2023 earnings per share guidance range of $4.72 to $4.82. The Company also affirms its long-term financial targets for the 2023-2027 period announced in Nov. 2022, including its long-term EPS and dividend growth rate targets of 7-9%. The Company’s earnings forecasts are subject to numerous risks and uncertainties, including, without limitation, those described under “Cautionary Statement Concerning Forward-Looking Statements” below and under “Risk Factors” in its annual, quarterly, and current reports filed with the Securities and Exchange Commission (“SEC”). All statements related to earnings and earnings per share refer to diluted earnings and earnings per share.

 

Consolidated Results

For the three months ended March 31, 2023, earnings per share were $0.91, compared to $0.87 per share in the same period in 2022. These increases were primarily driven by the implementation of new rates in the Regulated Businesses for the recovery of capital and acquisition investments, offset somewhat by impacts from inflationary pressures on production costs and higher interest costs since mid-2022. Approximately 75% of the estimated impact of inflation on chemicals, power and other fuel, and from higher pension costs and interest rates, are reflected in higher revenues in 2023 from rate cases recently completed.

 

The Company is on track to meet its capital investment plan for the year with investments of $538 million in the first three months of 2023, including $532 million for infrastructure improvements and replacements in the Regulated Businesses. The Company plans to invest a total of approximately $2.9 billion across its footprint in 2023, including approximately $0.4 billion for acquisitions. As of March 31, 2023, the Company had $481 million of acquisitions under agreement, including Pennsylvania American Water’s agreement announced in March 2023 to purchase the wastewater system assets of Towamencin Township for $104 million. In addition, in April 2023, Illinois American Water announced an agreement to purchase the assets of the wastewater treatment plant from Granite City for $83 million, adding further to the Company’s acquisitions under agreement.

 

Regulated Businesses

In the first quarter of 2023, Regulated Businesses’ net income was $174 million, compared to $160 million for the same period in 2022.

 

Operating revenues increased $82 million for the three months ended March 31, 2023, as compared to 2022. The increase in operating revenues was primarily a result of authorized revenue increases from completed general rate cases and infrastructure proceedings for the recovery of incremental capital and acquisition investments.

 

To date, the Company has been authorized additional annualized revenues of approximately $229 million from general rate cases in 2023. Further, approximately $50 million of additional annualized revenues from infrastructure surcharges have been authorized and are effective in 2023. The Company has general rate cases in progress in three jurisdictions, and has filed for infrastructure surcharges in two jurisdictions, reflecting a total annualized revenue request of approximately $144 million.

 

Operation and maintenance (“O&M”) expenses were higher by $15 million for the three months ended March 31, 2023, as compared to 2022, primarily due to increases in production costs from inflationary pressures that began to accelerate in mid-2022. Depreciation expense was higher by $14 million in the same period due to the growing capital investment. Also, interest expense was higher by $17 million due to additional long-term debt and higher rates on short-term debt.

 

For the 12-month period ended March 31, 2023, the Company’s adjusted regulated O&M efficiency ratio (a non-GAAP financial measure) was 33.6%, compared to 33.9% for the 12-month period ended March 31, 2022. The ratio reflects an increase in operating revenues for the Regulated Businesses, after considering the adjustment for the amortization of the excess accumulated deferred income taxes (“EADIT”) shown in the table below, as well as the continued focus on operating costs.

 

Dividends

On March 1, 2023, the Company paid a quarterly cash dividend of $0.6550 per share to shareholders of record as of February 7, 2023.

On April 26, 2023, the Company’s Board of Directors declared a quarterly cash dividend payment of $0.7075 per share of common stock, an 8.0% increase over the prior quarterly dividend, payable on June 1, 2023, to shareholders of record as of May 9, 2023.

 

2023 First Quarter Earnings Conference Call

The conference call to discuss first quarter 2023 earnings will take place on Thursday, April 27, 2023, at 9 a.m. Eastern Daylight Time. Interested parties may listen to an audio webcast through a link on the Company’s Investor Relations website at ir.amwater.com. Presentation slides that will be used in conjunction with the earnings conference call will also be made available online in advance at ir.amwater.com. The Company recognizes its website as a key channel of distribution to reach public investors and as a means of disclosing material non-public information to comply with its obligations under SEC Regulation FD.

 

Following the earnings conference call, a replay of the audio webcast will be available for one year on American Water’s investor relations website at ir.amwater.com/events.

 

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.

 

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 6,500 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, 2023 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, 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, 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, 2022, 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; 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 and energy, such as may result from conservation efforts, or otherwise; a loss of one or more large industrial or commercial customers due to adverse economic conditions, 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, data and consumer privacy, security and protection, 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 and have delivered adequate and cost-effective supplies of pipe, equipment (including personal protective equipment), chemicals, power and other fuel, water and other raw materials and to address or mitigate supply chain constraints that may result in delays or shortages in, as well as increased costs of, supplies, products and materials that are critical to or used in 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, the Company’s Military Services Group entering into new military installation contracts, price redeterminations and other agreements and contracts with the U.S. government, and realizing anticipated benefits and synergies from new acquisitions; risks and uncertainties following the completion of the sale of the Company’s former Homeowner Services Group (“HOS”), including the Company’s ability to receive contingent consideration provided for in the HOS sale as well as amounts due, payable and owing to the Company under the seller note when due, and the ability of the Company to redeploy successfully and timely the net proceeds of this transaction into the Company’s Regulated Businesses; 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; the ability of energy providers, state governments and other third parties to achieve or fulfill their greenhouse gas emission reduction goals, including without limitation through state renewable portfolio standards and carbon transition plans; changes in general economic, political, business and financial market conditions; access to sufficient debt and/or equity capital on satisfactory terms and as needed to support operations and capital expenditures; fluctuations in inflation or interest rates and the Company’s ability to address or mitigate the impacts thereof; 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, or assumptions and estimates related to, its benefit plan assets and liabilities, including with respect to its pension and other post-retirement benefit plans, that could increase expenses and plan funding requirements; changes in federal or state general, income and other tax laws, including (i) future significant tax legislation or regulations; and (ii) the availability of, or the Company’s compliance with, the terms of applicable tax credits and tax abatement programs; migration of customers into or out of the Company’s service territories and changes in water and energy consumption resulting therefrom; 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, changes in fair value and other adjustments related to the Company’s goodwill or the value of its other assets; labor actions, including work stoppages and strikes; the Company’s ability to retain and attract highly qualified and skilled employees and/or diverse talent; 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 (Unaudited)

(In millions, except per share data)

For the Three Months Ended March 31,

2023

2022

Operating revenues

$

938

$

842

Operating expenses:

Operation and maintenance

393

364

Depreciation and amortization

172

158

General taxes

78

74

Total operating expenses, net

643

596

Operating income

295

246

Other income (expense):

Interest expense

(115

)

(100

)

Interest income

14

13

Non-operating benefit costs, net

9

19

Other, net

11

15

Total other (expense) income

(81

)

(53

)

Income before income taxes

214

193

Provision for income taxes

44

35

Net income attributable to common shareholders

$

170

$

158

Basic earnings per share:

Net income attributable to common shareholders

$

0.91

$

0.87

Diluted earnings per share:

Net income attributable to common shareholders

$

0.91

$

0.87

Weighted-average common shares outstanding:

Basic

186

182

Diluted

186

182

American Water Works Company, Inc. and Subsidiary Companies

Consolidated Balance Sheets (Unaudited)

(In millions, except share and per share data)

March 31, 2023

December 31, 2022

ASSETS

Property, plant and equipment

$

30,214

$

29,736

Accumulated depreciation

(6,582

)

(6,513

)

Property, plant and equipment, net

23,632

23,223

Current assets:

Cash and cash equivalents

213

85

Restricted funds

29

32

Accounts receivable, net of allowance for uncollectible accounts of $55 and $60, respectively

318

334

Income tax receivable

96

114

Unbilled revenues

289

275

Materials and supplies

103

98

Other

290

312

Total current assets

1,338

1,250

Regulatory and other long-term assets:

Regulatory assets

1,004

990

Seller promissory note from the sale of the Homeowner Services Group

720

720

Operating lease right-of-use assets

83

82

Goodwill

1,143

1,143

Other

366

379

Total regulatory and other long-term assets

3,316

3,314

Total assets

$

28,286

$

27,787

American Water Works Company, Inc. and Subsidiary Companies

Consolidated Balance Sheets (Unaudited)

(In millions, except share and per share data)

March 31, 2023

December 31, 2022

CAPITALIZATION AND LIABILITIES

Capitalization:

Common stock ($0.01 par value; 500,000,000 shares authorized; 200,058,247 and 187,200,539 shares issued, respectively)

$

2

$

2

Paid-in-capital

8,519

6,824

Retained earnings

1,437

1,267

Accumulated other comprehensive loss

(23

)

(23

)

Treasury stock, at cost (5,414,795 and 5,342,477 shares, respectively)

(388

)

(377

)

Total common shareholders’ equity

9,547

7,693

Long-term debt

10,485

10,926

Redeemable preferred stock at redemption value

2

3

Total long-term debt

10,487

10,929

Total capitalization

20,034

18,622

Current liabilities:

Short-term debt

1,175

Current portion of long-term debt

727

281

Accounts payable

193

254

Accrued liabilities

561

706

Accrued taxes

74

49

Accrued interest

114

91

Other

223

255

Total current liabilities

1,892

2,811

Regulatory and other long-term liabilities:

Advances for construction

321

316

Deferred income taxes and investment tax credits

2,483

2,437

Regulatory liabilities

1,568

1,590

Operating lease liabilities

70

70

Accrued pension expense

215

235

Other

192

202

Total regulatory and other long-term liabilities

4,849

4,850

Contributions in aid of construction

1,511

1,504

Commitments and contingencies

Total capitalization and liabilities

$

28,286

$

27,787

Contacts

Investor Contact:
Aaron Musgrave

Vice President, Investor Relations

856-955-4029

aaron.musgrave@amwater.com

Media Contact:
Maureen Duffy

Senior Vice President, Communications and External Affairs

856-955-4163

maureen.duffy@amwater.com

Read full story here

Categories
Business

Best’s Special Report: U.S. Life/Annuity Benchmarking analysis shows link between quality of assets, unrealized loss impacts

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best benchmarking analysis of rated U.S. life/annuity (L/A) insurance companies showed that those insurers with higher quality investments fared better in uncertain market conditions during the first three quarters of 2022 that saw a sharp increase in unrealized losses.

The Best’s Special Report, “Life/Annuity Benchmarking: 2022 Unrealized Losses Exceed Early Pandemic,” states that insurers whose quality of assets were assessed as negative under the balance sheet strength assessment experienced a higher percentage of unrealized losses to surplus. Unrealized losses came to 5.3% of surplus for companies with a quality of assets assessment of negative, while companies whose quality of assets was assessed as positive saw unrealized losses come to less than 1% of surplus.

 

“Unrealized losses underscore the importance of favorable liquidity and asset-liability matching,” said Helen Andersen, industry analyst, AM Best. “During the prolonged low interest rate environment, L/A insurers extended the maturities of their bond portfolios to bolster yields. However, longer maturities are now a disadvantage as interest rates rise, because insurers must wait longer to reinvest the proceeds at the new higher rates.”

 

Benchmarking is an essential element in AM Best’s rating process, as it allows for comparisons of the performance of a rating unit to its peers, composites and the industry. AM Best uses a variety of benchmarking techniques to view companies from different perspectives, allowing for comparisons of absolute results and volatility levels across the industry. In noting that life insurance premiums, which grew to pandemic-driven historical highs, were now normalizing, the report states that life premium growth in 2021 was not uniform and could be viewed through rated insurers’ operating performance assessment results. According to the analysis, those insurers with an operating performance assessment of very strong saw the highest growth rates in 2021.

 

“Those companies with operating performance assessments of strong or better had advantages during the pandemic that aided in growth, such as nationwide distribution or more abilities in selling in a remote lockdown environment. Companies with worse operating performance assessments already were experiencing worse mortality and cutbacks on production,” said Andersen.

 

To access the full copy of this special report, please visit http://www3.ambest.com/bestweek/purchase.asp?record_code=330876.

 

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 © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Helen Andersen
Industry Analyst
+1 908 439 2200, ext. 5722

helen.andersen@ambest.com

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

christopher.sharkey@ambest.com

Al Slavin

Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Business Economics Environment Lifestyle

American Water increases dividend 8.0 percent

CAMDEN, N.J. — (BUSINESS WIRE) — American Water Works Company, Inc. (NYSE: AWK) announced today that its board of directors declared a quarterly cash dividend payment of $0.7075 per share of common stock, an increase of 8.0 percent.

 

“American Water continues to be an industry leader in dividend growth, which is a result of our continued successful execution of key strategic initiatives and the strength of our financial outlook,” said M. Susan Hardwick, president and chief executive officer of American Water. “We recognize the value of our dividend growth and the role it has played in delivering exceptional shareholder value.”

 

The company expects to continue its dividend growth within a 7 to 9 percent range over the long term, with a target dividend payout ratio of between 55 and 60 percent of earnings. The company has paid dividends at a compound annual growth rate of nearly 9.7 percent over the last five years.

 

The increased quarterly dividend will be payable on June 1, 2023, to all shareholders of record as of May 9, 2023.

 

American Water offers a dividend reinvestment and direct stock purchase plan called American Water Stock Direct (the “Plan”), which enables shareholders to reinvest cash dividends and purchase additional shares of American Water common stock without any brokerage commissions or service charges. Shareholders and other persons may obtain a copy of the Plan prospectus and an enrollment form by contacting American Stock Transfer & Trust Company (“AST”) at 888-556-0423, visiting AST’s website at www.astfinancial.com, contacting American Water’s Investor Relations department at 856-566-4005 or by visiting the Investor Relations webpage located at ir.amwater.com.

 

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities. The offer is being made solely through the Plan prospectus.

 

About American Water

With a history dating back to 1886, American Water (NYSE: AWK) is the largest and most geographically diverse U.S. publicly traded water and wastewater utility company. The company employs approximately 6,500 dedicated professionals who provide regulated and regulated-like drinking water and wastewater services to an estimated 14 million people in 24 states. American Water provides safe, clean, affordable, and reliable water services to our customers to help keep their lives flowing. For more information, visit amwater.com and diversityataw.com. Follow American Water on Twitter, Facebook and LinkedIn.

AWK-IR

Contacts

Investor Contact:
Aaron Musgrave

Vice President, Investor Relations

(856) 955-4029

aaron.musgrave@amwater.com

Media Contact:
Maureen Duffy

Senior Vice President, Communications and External Affairs

(856) 955-4163

maureen.duffy@amwater.com

Categories
Business Healthcare Lifestyle Science Technology

Johnson & Johnson to participate in the Bernstein 39th Annual Strategic Decisions Conference

NEW BRUNSWICK, N.J. — (BUSINESS WIRE) — Johnson & Johnson (NYSE: JNJ) will participate in the Bernstein 39th Annual Strategic Decisions Conference on Wednesday, May 31st, at the New York Hilton Midtown in New York.

 

Joaquin Duato, Chairman of the Board and Chief Executive Officer will represent the Company in a session scheduled at 10:00 a.m. (Eastern Time).

This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

 

A webcast replay will be available approximately 48-hrs after the live webcast.

Contacts

Investor:
RA-JJCUS-InvestorRel@ITS.JNJ.com

Media:
media-relations@its.jnj.com

Categories
Business Lifestyle Special/Sponsored Content

1st Colonial Bancorp, Inc. reports first quarter 2023 net income

Income Statement Highlights include:

  • Net income was $1.5 million, for the first quarter of 2023 compared to net income of $1.7 million for the first quarter of 2022.
  • Net interest income for the quarter ended March 31, 2023 was $6.5 million, an increase of $720 thousand, or 12%, from the same period in 2022.
  • Net interest margin for the quarter ended March 31, 2023 was 3.53%, a 2% increase over the same period in 2022, and down from 3.92% for the quarter ended December 31, 2022.
  • Provision for credit losses for loans was ($197) thousand for the first quarter of 2023, compared to $350 thousand in the fourth quarter of 2022. The first quarter 2023 net recovery was related to the payoff of a non-performing commercial loan.
  • Non-interest expense for the quarter ended March 31, 2023 was $4.9 million, as compared to $4.8 million for the quarter ended December 31, 2022 and includes $0.3 million of one-time expenses due to the separation of employment with a former executive.
  • For the first quarter of 2023, diluted earnings per share was $0.31, compared to $0.34 per diluted share for the first quarter of 2022.

 

Balance Sheet Highlights include:

  • Total assets grew $18.9 million, or 2%, to $800.9 million as of March 31, 2023 from $782.0 million as of December 31, 2022.
  • Total loans grew $15.8 million, or 3%, to $619.4 million as of March 31, 2023 from $603.6 million as of December 31, 2022.
  • Total deposits declined $8.8 million, or 1%, from $671.1 million as of December 31, 2022 to $662.3 million as of March 31, 2023, which reflects normal and anticipated cyclical changes in client balances.
  • Book value per share increased 2% to $13.01 as of March 31, 2023 from $12.76 as of December 31, 2022.

 

MOUNT LAUREL, N.J. — (BUSINESS WIRE) — 1st Colonial Bancorp, Inc. (FCOB), holding company of 1st Colonial Community Bank, Tuesday reported net income of $1.5 million, or $0.31 per diluted share, for the three months ended March 31, 2023, compared to net income of $1.7 million, or $0.34 per diluted share, for the three months ended March 31, 2022.

 

Robert White, President and Chief Executive Officer, commented, “We are pleased to report our first quarter results, which reflect our continued financial strength and resilience during challenging times in the banking industry. We continue to deliver upon our commitment to be a leading provider of deposit interest pricing for all interest-bearing accounts. We anticipated and planned for the impact of rising rates on our interest margin and we continue to remain focused on delivering high quality, value added products and services to our clients.”

 

“Our non-interest income was down in the first quarter as a result of lower loan sale activity in our residential lending unit. The lack of inventory in the housing market and rising interest rates are having an impact on new loan volume, which is likely to continue in the near term. Commercial loan demand has leveled off, as the rise in debt costs has caused many companies to re-evaluate growth plans and capital expenditures. In addition, we have made some organizational changes to support our sales efforts and to ensure that our sound credit discipline is maintained for new credits and our portfolio management practices. We continue to remain focused on our asset quality metrics and continue to look for early signs of distress within our customer base. We are also closely monitoring and managing our operating costs to account for the expected increase in funding costs, along with the continued impact of high inflation on our bottom line.”

 

“Our team is committed to executing our strategic priorities and delivering exceptional products and services through multiple distribution channels to support the ongoing needs of our customers.”

 

Operating Results

Net Interest Income

Net interest income for the three months ended March 31, 2023 and 2022 was $6.5 million and $5.8 million, respectively. The increase in net interest income was primarily attributable to a $2.4 million increase in interest income on average loans outstanding. For the first quarter of 2023, average loan balances increased $90.3 million to $604.1 million from $513.8 million for the first quarter of 2022. Additionally, approximately 27% of the loan portfolio is tied to the Wall Street Journal (“WSJ”) prime rate and re-prices at various times when that rate changes. The 450 basis point increase in the WSJ prime rate over the last twelve months has had a positive impact on interest income. When compared to the fourth quarter of 2022, net interest income declined $760 thousand from $7.3 million and was related to a $1.2 million increase in interest expense.

 

For the first quarter of 2023, interest expense was $2.6 million, an increase of $1.9 million from $650 thousand for the first quarter of 2022. For the first quarter of 2023, average interest-bearing deposits increased $51.1 million from the first quarter of 2022 and included $32 million in average municipal interest-checking balances. As a result of the cumulative increases in the Federal Funds Rate during 2022, we began increasing our deposit rates in the third quarter of 2022, which resulted in an increase of $1.6 million in deposit interest expense in the first quarter of 2023 compared to the first quarter of 2022. To fund our interest-earning asset growth, our average borrowings increased $30.3 million in the first quarter of 2023 compared to the same period in 2022 and contributed $368 thousand to the overall increase in interest expense of $1.9 million in the first quarter of 2023. When compared to the fourth quarter of 2022, interest expense increased $1.2 million from $1.4 million.

 

The net interest margin was 3.53% for the first quarter of 2023 compared to 3.46% for the first quarter of 2022. The average yield on interest-earning assets grew 109 basis points from 3.85% for the quarter ended March 31, 2022 to 4.94% for the quarter ended March 31, 2023. The average rate paid on average interest-bearing liabilities increased 119 basis points from 0.48% for the first quarter of 2022 to 1.67% for the first quarter of 2023. When compared to the fourth quarter of 2022, the first quarter 2023 net interest margin declined 39 basis points from 3.92% and was mainly related to a 75 basis point increase in the average rate paid on average interest-bearing liabilities.

 

Provision for Credit Losses

For the three months ended March 31, 2023, the provision for credit losses was ($174) thousand. In the first quarter of 2023 we adopted Accounting Standards Update 2016-13 “Financial Instruments-Credit Losses” (“CECL”). With the adoption of CECL the 2023 provision includes ($197) thousand for loans and $23 thousand for off balance sheet (“OBS”) commitments. Prior to the adoption of CECL, the provision for OBS commitments was included in non-interest expense. The provision for loan losses was $300 thousand for the three months ended March 31, 2022. The 2023 decline in provision for loans was due to a $445 thousand decrease in specific reserves on impaired loans due to a loan payoff. The loan loss provision was $350 thousand for the fourth quarter of 2022. Net recoveries were $32 thousand for the first quarter of 2023 compared to $137 thousand for the first quarter of 2022.

 

Non-interest Income

Non-interest income for the first quarter of 2023 was $454 thousand, a decrease of $628 thousand, or 58%, from $1.1 million for the first quarter of 2022. Income from the origination and sales of residential mortgages declined $306 thousand, or 62%, from the first quarter in 2022 due to a $27.4 million, or 54%, decline in originations. Mortgage activity has been challenging due to a drop in refinancing transactions and a lack of inventory in the purchase market. We have been originating adjustable-rate residential mortgages and have retained them in our loan portfolio. Retained mortgage loans accounted for 54% of the total residential mortgage originations in the first quarter of 2023 compared to 42% for the same period in 2022. During the first quarter of 2023, we earned $12 thousand in gains on the sale of SBA loans compared to $347 thousand for the comparable 2022 period. The higher interest rates have tempered new SBA loan origination volume.

 

When compared to the fourth quarter of 2022, non-interest income for the first quarter of 2023 declined $194 thousand from $648 thousand. Income from sales of residential mortgages and the sales of SBA loans declined $59 thousand and $54 thousand, respectively, from their amounts for the fourth quarter of 2022. Additionally, the fourth quarter of 2022 included a nontaxable bank owned life insurance (“BOLI”) death benefit of $98 thousand related to a former employee. There was no nontaxable death benefit in the first quarter of 2023.

 

Non-interest Expense

Non-interest expense was $4.9 million for the quarter ended March 31, 2023, and increased $677 thousand, or 16.2%, from $4.2 million for the quarter ended March 31, 2022. Salaries and benefits and data processing and technology expenses increased $330 thousand and $90 thousand, respectively, and were the main contributors to the increase in non-interest expense. The rise in salaries and benefits was mainly related to the recognition of severance that was negotiated with a former executive.

 

When compared to the fourth quarter of 2022, non-interest expense for the first quarter of 2023 increased $314 thousand from $4.6 million. Salaries and benefits increased $466 thousand and was related to the aforementioned negotiated severance with a former executive.

 

Income Taxes

For the first quarter of 2023, income tax expense was $726 thousand compared to $707 thousand for the first quarter of 2022 and $682 thousand for the fourth quarter of 2022. During the first quarter of 2023, we surrendered a low yielding BOLI policy and reinvested the proceeds at a significantly higher yield. As a result of the surrender, we recorded $113 thousand in tax expense which included a 10% penalty. We expect to earn back the $113 thousand in less than two years.

 

Financial Condition

Assets

As of March 31, 2023, total assets were $800.9 million and grew $18.9 million from $782.0 million as of December 31, 2022.

 

Total loans were $619.4 million as of March 31, 2023, an increase of $15.8 million, or 2.6%, from $603.6 million as of December 31, 2022. During the first quarter, residential mortgages and home equity loans and lines of credit increased $11.7 million and $5.7 million, respectively. Construction loans declined by $2.4 million. Loans held for sale were $2.0 million as of March 31, 2023, compared to $6.7 million as of December 31, 2022.

 

Investments decreased $1.9 million to $127.2 million as of March 31, 2023 from $129.1 million as of December 31, 2022. The unrealized loss improved $1.0 million from $8.1 million as of December 31, 2022 to $7.1 million as of March 31, 2023.

 

Asset Quality

As mentioned previously, we adopted CECL on January 1, 2023. This accounting standard requires that credit losses for financial assets and off-balance-sheet credit commitments be measured based on expected credit losses, rather than on incurred credit losses as in prior periods. As a result of the adoption of CECL, the allowance for credit losses (“ACL”) increased by $1.6 million and included $1.2 million for the ACL on loans and $436 thousand for the ACL on OBS commitments. As a result of the CECL adjustment, retained earnings decreased by $1.1 million.

 

As of March 31, 2023, the ACL for loans was $9.3 million, or 1.50% of total loans. Non-performing assets as of March 31, 2023, were $4.2 million compared to $4.6 million as of December 31, 2022. The ACL to non-accrual loans was 223.7% as of March 31, 2023, compared to the allowance for loan losses to non-accrual loans of 182.5% as of December 31, 2022. As of March 31, 2023, the ratio of non-performing assets to total assets was 0.52% compared to 0.58% as of December 31, 2022.

 

Liabilities

Total deposits were $662.3 million as of March 31, 2023, and declined $8.8 million, or 1.3%, from $671.1 million as of December 31, 2022. Municipal interest checking declined $30.9 million to $248.1 million as of March 31, 2023. During the first quarter of 2023, we consolidated and improved our business deposit products. Approximately $37.0 million migrated from business money market and savings products into business interest-checking products. Total interest-checking accounts increased $45.0 million, while money markets, savings, and demand accounts decreased $24.1 million, $12.7 million and $3.4 million, respectively. Brokered certificates of deposit increased $18.7 million. Short-term borrowings increased $25.8 million to supplement our funding requirements.

 

Shareholder’s Equity

Total shareholders’ equity was $60.9 million as of March 31, 2023, compared to $59.6 million as of December 31, 2022. During the first quarter of 2023, we recorded a charge to retained earnings of $1.1 million related to the adoption of CECL. Accumulated comprehensive loss improved from $5.9 million as of December 31, 2022 to $5.1 million as of March 31, 2023. The accumulated comprehensive loss is related to the unrealized loss in our investment portfolio. Tangible book value per share increased $0.26, or 2.0%, from $12.76 as of December 31, 2022 to $13.01 as of March 31, 2023.

 

Consolidated Financial Statements and Other Highlights:

1st COLONIAL BANCORP, INC.

CONSOLIDATED INCOME STATEMENTS

(Unaudited, dollars in thousands, except per share data)

For the three months ended

Mar 31,

Dec 31,

Mar 31,

2023

2022

2022

Interest income

$

9,079

$

8,666

$

6,421

Interest expense

2,588

1,415

650

Net Interest Income

6,491

7,251

5,771

Provision for credit losses

(174)

350

300

Net interest income after provision for credit losses

6,665

6,901

5,471

Non-interest income

454

648

1,082

Non-interest expense

4,864

4,550

4,187

Income before taxes

2,255

2,999

2,366

Income tax expense

726

682

707

Net Income

$

1,529

$

2,317

$

1,659

Earnings Per Share – Basic

$

0.33

$

0.50

$

0.35

Earnings Per Share – Diluted

$

0.31

$

0.48

$

0.34

SELECTED PERFORMANCE RATIOS:

For the three months ended

Mar 31,

Dec 31,

Mar 31,

2023

2022

2022

Return on Average Assets

0.80%

1.21%

0.96%

Return on Average Equity

10.49%

15.86%

11.69%

Book value per share

$

13.01

$

12.76

$

12.01

As of March 31, 2023

As of December 31, 2022

Bank Capital ratios:

Tier 1 Leverage

9.65%

9.75%

Total Risk Based Capital

13.97%

14.14%

Common Equity Tier 1

12.72%

12.89%

1st COLONIAL BANCORP, INC.

CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands)

As of March 31, 2023

As of December 31, 2022

Cash and cash equivalents

$

28,186

$

20,399

Total investments

127,171

129,131

Mortgage loans held for sale

1,954

6,710

Total loans

619,404

603,609

Less ACL-loans

(9,318)

(8,331)

Loans, net

610,086

595,278

Bank owned life insurance

17,488

14,458

Premises and equipment, net

1,838

1,845

Accrued interest receivable

3,076

2,779

Other assets

11,094

11,273

Total Assets

$

800,893

$

781,963

Total deposits

$

662,301

$

671,052

Other borrowings

60,600

34,788

Subordinated debt

10,577

10,559

Other liabilities

6,535

5,926

Total Liabilities

740,013

722,325

Total Shareholders’ Equity

60,880

59,638

Total Liabilities and Shareholders’ Equity

$

800,893

$

781,963

1st COLONIAL BANCORP, INC.

NET INTEREST INCOME AND MARGIN

(Unaudited, in thousands, except percentages)

For the three months ended

March 31, 2023

December 31, 2022

March 31, 2022

Average

Balance

Interest

Yield/

Rate

Average

Balance

Interest

Yield/

Rate

Average

Balance

Interest

Yield/

Rate

Cash and cash equivalents

$

8,840

$

63

2.89%

$

10,204

$

65

2.52%

$

41,227

$

15

0.15%

Investment securities

127,843

659

2.09%

128,354

632

1.95%

110,342

378

1.39%

Loans held for sale

5,025

48

3.87%

5,496

52

3.79%

11,016

81

2.98%

Loans

604,088

8,309

5.58%

589,869

7,917

5.32%

513,770

5,947

4.69%

Total interest-earning assets

745,796

9,079

4.94%

733,923

8,666

4.68%

676,355

6,421

3.85%

Non-interest earning assets

27,616

25,809

22,633

Total average assets

$

773,412

$

759,732

$

698,988

Interest-bearing deposits

Interest checking accounts

$

361,598

$

900

1.01%

$

340,834

$

401

0.47%

$

283,404

$

86

0.12%

Savings and money markets

86,247

208

0.98%

127,839

222

0.69%

129,219

92

0.29%

Time deposits

138,825

915

2.67%

112,172

417

1.47%

122,900

275

0.91%

Total interest-bearing deposits

586,670

2,023

1.40%

580,845

1,040

0.71%

535,523

453

0.34%

Borrowings

40,851

565

5.61%

27,264

375

5.46%

10,535

197

7.58%

Total interest-bearing liabilities

627,521

2,588

1.67%

608,109

1,415

0.92%

546,058

650

0.48%

Non-interest bearing deposits

80,488

88,230

91,335

Other liabilities

6,275

5,433

4,026

Total average liabilities

714,284

701,772

641,419

Shareholders’ equity

59,128

57,960

57,569

Total average liabilities and equity

$

773,412

$

759,732

$

698,988

Net interest income

$

6,491

$

7,251

$

5,771

Net interest margin

3.53%

3.92%

3.46%

Net interest spread

3.26%

3.76%

3.37%

 

1st Colonial Bancorp, Inc, is a Pennsylvania corporation headquartered in Mount Laurel, New Jersey, and the parent company of 1st Colonial Community Bank (the “Bank”). The Bank provides a range of business and consumer financial services, placing emphasis on customer service and access to decision makers. Headquartered in Collingswood, New Jersey, the Bank has branches in Westville, New Jersey and Limerick, Pennsylvania. The bank also has administrative offices in Mount Laurel, New Jersey. To learn more, call (877) 785-8550 or visit www.1stcolonial.com.

 

In addition to historical information, this press release may contain “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements with respect to 1st Colonial Bancorp, Inc.’s strategies, goals, beliefs, expectations, estimates, intentions, capital raising efforts, financial condition and results of operations, future performance, and business. Statements preceded by, followed by, or that include the words “may,” “could,” “should,” “pro forma,” “looking forward,” “would,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” or similar expressions generally indicate a forward-looking statement. These forward-looking statements involve risks and uncertainties that are subject to change based on various important factors (some of which, in whole or in part, are beyond 1st Colonial Bancorp, Inc.’s control). Numerous competitive, economic, regulatory, legal and technological factors, risks and uncertainties that could cause actual results to differ materially include, without limitation, the impact of the ongoing pandemic and government responses thereto; on the U.S. economy, including the markets in which we operate; actions that we and our customers take in response to these factors and the effects such actions have on our operations, products, services and customer relationships; increased competitive pressures; changes in the interest rate environment; changes in general economic conditions and conditions within the securities markets; legislative and regulatory changes; and the effects of inflation, a potential recession, among others, could cause 1st Colonial Bancorp, Inc.’s financial performance to differ materially from the goals, plans, objectives, intentions and expectations expressed in such forward-looking statements. 1st Colonial Bancorp, Inc. cautions that the foregoing factors are not exclusive, and neither such factors nor any such forward-looking statement takes into account the impact of any future events. All forward-looking statements and information set forth herein are based on management’s current beliefs and assumptions as of the date hereof and speak only as of the date they are made. 1st Colonial Bancorp, Inc. does not undertake to update any forward-looking statement whether written or oral, that may be made from time to time by 1st Colonial Bancorp, Inc. or by or on behalf of 1st Colonial Community Bank.

Contacts

For more information, contact

Mary Kay Shea at 856‑885‑2391