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Business Culture

B&G Foods issues voluntary allergy alert for undeclared egg and milk in a limited number of boxes of Back to Nature® Cheddalicious® Cheese Flavored Crackers mistakenly containing animal shaped crackers

PARSIPPANY, N.J. — (BUSINESS WIRE) — B&G Foods announced today it is voluntarily recalling 1,855 cases of a single date code of 6 oz. Back to Nature Cheddalicious Cheese Flavored Crackers, with a “best by” date of SEP 05 2022, after learning that a limited number of the cracker boxes were inadvertently filled with foil wrapped pouches of animal shaped crackers, which contain egg and milk, allergens that are not declared on the box label. People who have an allergy or severe sensitivity to egg or milk run the risk of serious or life-threatening allergic reaction if they consume the animal shaped crackers contained in the recalled boxes. There is no health risk associated with this product for individuals without an allergy to egg or milk.


This recall affects only 1,855 cases of the following product, which may have been distributed in retail stores nationwide:

 

Description

Consumer UPC #

Size

Best By Date

Back to Nature Cheddalicious

Cheese Flavored Crackers

8-19898-01491-0

6 oz.

SEP 05 2022

(The “best by” date is located on the top of the box.)

 

This recall does not apply to any other “best by” dates, sizes or varieties of Back to Nature products.

No allergic reactions related to this matter have been reported to date. This recall was initiated in cooperation with the FDA and the third party co-packer that produced the product.

 

B&G Foods discovered this issue when it received a consumer complaint that a foil pouch within a single box of Back to Nature Cheddalicious Cheese Flavored Crackers contained animal shaped crackers. The third-party co-packer that produces the product inadvertently filled a limited number of Back to Nature Cheddalicious Cheese Flavored Crackers product boxes with another food company’s animal shaped crackers.

 

Out of an abundance of caution, B&G Foods is recalling all 1,855 cases with this particular “best by” date. Product with this particular “best by” date was shipped and distributed to customer warehouses located in Arizona, California, Colorado, Connecticut, Florida, Georgia, Indiana, Maryland, Maine, New Jersey, New York, Tennessee and Wisconsin.

 

Consumers who have purchased the recalled product can return it to the place of purchase for a full refund. Consumers seeking a refund or additional information may also contact B&G Foods by calling 855.346.2225 Monday through Friday from 8:30 a.m. to 6:00 p.m. Eastern time or submitting a contact at https://backtonaturefoods.com/contact-us.

Contacts

Media Relations:

ICR, Inc.

Matt Lindberg

203.682.8214

Categories
Business Lifestyle

Stonepeak successfully completes $3.0 billion equity recapitalization of portfolio company Cologix

NEW YORK & DENVER — (BUSINESS WIRE) — Stonepeak, a leading alternative investment firm specializing in infrastructure and real assets, today announced the successful closing of its previously announced equity recapitalization of Cologix, the largest private interconnection and hyperscale edge platform in North America. At $3.0 billion in equity value, the transaction represents the largest single asset continuation vehicle raised in digital infrastructure to date. Cologix also completed a $1.65 billion asset-backed securitization earlier this year to support continued growth.

The recapitalization was effectuated as a sale of Cologix by Stonepeak Infrastructure Fund II LP and co-investors (Fund II) to Stonepeak-managed vehicles comprising a combination of existing Fund II investors who have chosen to reinvest in the business in partnership with a number of new third-party investors.

 

Cyrus Gentry, Managing Director at Stonepeak, said, “We are excited to extend and deepen our partnership with the Cologix team through this transaction and look forward to supporting Bill and team as they continue to build out Cologix’s leading North American interconnection and hyperscale edge platform in the years ahead.”

 

“With this transaction, we are accelerating our investments to match the growing demand from cloud services and network providers as well as digital enterprises,” added Cologix Chairman and CEO Bill Fathers. “We will build and acquire ScalelogixSM hyperscale edge data centers in current and new markets to complement and expand our network dense digital edge business.”

 

Cologix is North America’s leading network-neutral interconnection and hyperscale edge data center company with a carrier-dense ecosystem of more than 600 networks, 300+ cloud providers and 29 onramps across its platform. The company provides colocation and connectivity solutions to more than 1,600 customers through its operations that span 40+ digital edge and Scalelogix hyperscale edge data centers in 11 North American markets. Cologix maintains a strong focus on environmental, social and governance efforts across its business and to date has undertaken various sustainability initiatives, including the use of hydropower, optimizing water usage and installing the most efficient uninterruptible power supplies in the industry.

 

Fund II acquired a majority stake in Cologix in March of 2017 and subsequently partnered with Mubadala Investment Company (who have exited their position as part of this recapitalization) for an incremental growth capital investment in January 2020. Since 2017, Cologix has invested $1 billion of incremental capital in building out the company’s footprint through various organic and inorganic initiatives.

 

Goldman Sachs & Co. LLC acted as financial advisor to Stonepeak. RBC Capital Markets, LLC acted as financial advisor to Fund II. Simpson Thacher & Bartlett LLP acted as legal counsel to Stonepeak.

 

About Stonepeak

Stonepeak is a leading alternative investment firm specializing in infrastructure and real assets with approximately $46 billion of assets under management. Through its investment in defensive, hard-asset businesses globally, Stonepeak aims to create value for its investors and portfolio companies, and to have a positive impact on the communities in which it operates. Stonepeak sponsors investment vehicles focused on private equity and credit. The firm provides capital, operational support, and committed partnerships to sustainably grow investments in its target sectors, which include communications, water, energy transition, power and renewable energy, and transport and logistics. Stonepeak is headquartered in New York with offices in Austin, Hong Kong, Houston, London and Sydney. For more information, please visit www.stonepeak.com.

 

About Cologix

Cologix provides carrier and cloud neutral hyperscale edge data centers and services across North America. Cologix is the interconnection hub for cloud service providers, carriers and a rich ecosystem of partners who want to deploy applications at the very edge across Canada and the U.S. With a growing portfolio of next generation facilities that meet the unique requirements for hyperscale growth with deep connectivity, Cologix offers massive scale and tailor-made data center solutions to accelerate customers’ digital transformation. For on-demand connectivity for scale and control, Cologix Access Marketplace provides fast, reliable, self-service provisioning. For a tour of one of our data centers in Ashburn, Columbus, Dallas, Jacksonville, Lakeland, Minneapolis, Montreal, New Jersey, Silicon Valley, Toronto or Vancouver visit www.cologix.com or email sales@cologix.com. Follow Cologix on LinkedIn and Twitter.

 

About Mubadala Investment Company

Mubadala Investment Company is a sovereign investor managing a global portfolio, aimed at generating sustainable financial returns for the Government of Abu Dhabi.

 

Mubadala’s $243.4 billion (AED 894 billion) portfolio spans six continents with interests in multiple sectors and asset classes. We leverage our deep sectoral expertise and long-standing partnerships to drive sustainable growth and profit, while supporting the continued diversification and global integration of the economy of the United Arab Emirates.

 

Mubadala’s Digital Infrastructure unit, headed by Mounir Barakat, invests in physical assets around the world underpinning the global trend of digitalization and increasing demand for connectivity, data storage and compute power.

 

Headquartered in Abu Dhabi, Mubadala has offices in London, Rio de Janeiro, Moscow, New York, San Francisco and Beijing. For more information about Mubadala Investment Company, please visit: www.mubadala.com.

Contacts

Stonepeak
Kate Beers

beers@stonepeak.com
+1 646-540-5225

Cologix
Krista Shepard

krista.shepard@cologix.com
+1 720-739-5396

Categories
Business Science

Bayer presents new subgroup analyses for KERENDIA® (finerenone) for chronic kidney disease associated with type 2 diabetes with or without history of atherosclerotic cardiovascular disease

  • Late-breaking data from prespecified subgroup analyses of FIDELITY evaluate KERENDIA® (finerenone) on cardiovascular (CV) and kidney outcomes, including patients with stages 1-4 chronic kidney disease (CKD) associated with type 2 diabetes (T2D), with or without a history of atherosclerotic cardiovascular disease1
  • FIDELITY, a prespecified exploratory pooled analysis of the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest Phase III cardiorenal outcomes clinical trial program to evaluate the risk of progression of kidney disease as well as fatal and nonfatal CV events in >13,000 patients with CKD associated with T2D1,2

 

WHIPPANY, N.J. — (BUSINESS WIRE) — Bayer announced today late-breaking data from prespecified exploratory subgroup analyses of FIDELITY, a prespecified pooled analysis of the Phase III FIDELIO-DKD and FIGARO-DKD trials. These analyses investigated KERENDIA® (finerenone) versus placebo on composite cardiovascular (CV) and kidney outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), with and without a history of atherosclerotic cardiovascular disease (ASCVD).1 The subgroup analyses were presented today at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22).

Out of the 13,026 patients included in the FIDELITY full analysis, 5935 (45.6%) had a history of ASCVD at baseline.1 Over a median follow-up of 3 years, patients with ASCVD versus those without had the following composite CV outcome of time to CV death, nonfatal myocardial infarction (MI), nonfatal stroke and hospitalization for heart failure (HHF; incident rate [IR]/100 patient-years [PY] 6.9 vs. 3.0; hazard ratio [HR] 2.09; 95% confidence interval [CI] 1.89–2.30), composite outcome of time to CV death or HHF (IR/100 PY, 4.51 vs. 1.92; HR: 2.12; 95% CI 1.88–2.40) and composite kidney outcome (IR/100 PY 2.1 vs. 2.4; HR: 0.96; 95% CI 0.83–1.10).1

 

KERENDIA was approved in the United States on July 9, 2021, based on the results of FIDELIO-DKD, to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, CV death, nonfatal MI and HHF in adult patients with CKD associated with T2D.3 The KERENDIA label contains a Warning and Precaution that KERENDIA can cause hyperkalemia.3 For more information, see “Important Safety Information” and the FIDELIO-DKD study results below.

 

The prespecified exploratory subgroup analyses of FIDELITY showed that the treatment effect of finerenone, when compared to placebo, was consistent in patients with or without history of ASCVD for the composite CV outcome of time to CV death, nonfatal MI, nonfatal stroke or HHF (HR: 0.83; 95% CI 0.74–0.94; HR: 0.91; 95% CI 0.78–1.06; P-value for interaction=0.38, respectively). The treatment effect, when compared to placebo, was also consistent in patients with or without history of ASCVD for the composite outcome of CV death or HHF (HR: 0.82; 95% CI 0.71–0.94; HR: 0.86; 95% CI 0.71–1.04; P-value for interaction: 0.68, respectively).1

 

Regarding the effects of finerenone on the composite kidney outcome of time to kidney failure, sustained ≥57% decrease in eGFR or kidney-related death, the treatment effect was consistent in patients with or without a history of ASCVD (HR: 0.71; 95% CI 0.57–0.88; HR: 0.81; 95% CI 0.68–0.97; P-value for interaction: 0.33, respectively).1

 

“In patients with chronic kidney disease associated with type 2 diabetes, cardiovascular complications are among the most frequent causes of death.4,5 However, there is limited data on how the risk of cardiovascular events could be reduced in these patients,” said Javed Butler, MD, MPH, MBA, president of the Baylor Scott & White Research Institute and senior vice president for Baylor Scott & White Health, and distinguished professor of medicine at the University of Mississippi. “These subgroup analyses investigate outcomes in patients suffering from chronic kidney disease associated with type 2 diabetes, with or without a history of atherosclerotic cardiovascular disease. The analyses show us that in both cases, there’s a need to treat patients irrespective of where they are on the atherosclerotic cardiovascular disease spectrum.”

 

“Patients with chronic kidney disease and type 2 diabetes are three times more likely to die from a cardiovascular event than those with type 2 diabetes alone.6 That said, the severity of kidney impairment correlates with a higher incidence of cardiovascular events,” said Dr. Christian Rommel, member of the executive committee of Bayer AG’s pharmaceutical division and head of research and development.5 “The latest prespecified subgroup analyses of FIDELITY add to our growing body of data on the renal and CV outcomes of finerenone in adults with chronic kidney disease associated with type 2 diabetes.”

 

About KERENDIA (finerenone)

INDICATION:

  • KERENDIA is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)3

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

  • Concomitant use with strong CYP3A4 inhibitors3
  • Patients with adrenal insufficiency3

WARNINGS AND PRECAUTIONS:

  • Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5.0 mEq/L3

    Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium3

MOST COMMON ADVERSE REACTIONS:

  • Adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo: hyperkalemia (18.3% vs. 9%), hypotension (4.8% vs. 3.4%), and hyponatremia (1.4% vs. 0.7%)3

DRUG INTERACTIONS:

  • Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice3
  • Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor and adjust KERENDIA dosage as appropriate3
  • Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers3

USE IN SPECIFIC POPULATIONS:

  • Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment3
  • Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B)3

Please read the Prescribing Information for KERENDIA.

About Finerenone Phase III Clinical Trials Program

Having randomized more than 13,000 patients with CKD associated with T2D around the world, the Phase III program with finerenone in CKD associated with T2D comprises two studies, evaluating the effect of finerenone versus placebo on top of standard of care (SoC) on both renal and CV outcomes.7

The FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) study was a randomized, double-blind, placebo-controlled, multicenter study in adult patients with CKD associated with T2D, defined as either having an uACR of 30 to 300 mg/g, eGFR 25 to 60 mL/min/1.73 m2 and diabetic retinopathy, or as having an uACR of ≥300 mg/g and an eGFR of 25 to 75 mL/min/1.73 m2.3,8 The trial excluded patients with known significant nondiabetic kidney disease and a clinical diagnosis of chronic heart failure with reduced ejection fraction and persistent symptoms (NYHA class II to IV).3 All patients were to have a serum potassium ≤4.8 mEq/L at screening and be receiving standard of care background therapy, including a maximum tolerated labeled dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).3 A total of 5,674 patients were randomized to receive finerenone (N=2,833) or placebo (N=2,841) and were followed for a median of 2.6 years.3 The mean age of the study population was 66 years, and 70% of patients were male.3 The trial population was 63% white, 25% Asian, and 5% Black.3

Finerenone reduced the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥40%, kidney failure, or renal death (HR 0.82 [95% CI, 0.73-0.93; P=0.001]).3 The treatment effect reflected a reduction in a sustained decline in eGFR of ≥40% and progression to kidney failure.3 There were few renal deaths during the trial.3

Finerenone also reduced the incidence of the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or hospitalization for heart failure (HR 0.86 [95% CI, 0.75-0.99; P=0.034]).3 The treatment effect reflected a reduction in cardiovascular death, nonfatal myocardial infarction and hospitalization for heart failure.3

The most frequently reported adverse reaction was hyperkalemia (18.3% KERENDIA vs. 9% placebo).3 Hospitalization due to hyperkalemia for the KERENDIA group was 1.4% versus 0.3% in the placebo group.3 Hyperkalemia led to permanent discontinuation of treatment in 2.3% of patients receiving KERENDIA versus 0.9% of patients receiving placebo.3

FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease), a randomized, double-blind, placebo-controlled trial, randomly assigned 7,352 participants to finerenone (N=3686) or placebo (N=3666) on top of standard of care, including a maximum tolerated labeled dose of ACEis or ARBs.9 Patients had UACR ≥30–<300 mg/g and eGFR ≥25–≤90 mL/min/1.73m2 or UACR ≥300–≤5000 mg/g and eGFR ≥60 mL/min/1.73m2.9 This data is under review with the FDA.

KERENDIA significantly reduced the risk of the composite primary endpoint of time to first occurrence of CV death or nonfatal CV events (myocardial infarction, stroke or heart failure hospitalization) by 13% (relative risk reduction, HR 0.87 [95% CI, 0.76-0.98; P=0.0264]) over a median duration of follow-up of 3.4 years when added to maximum tolerated labeled dose of ACEi or ARB in adults with CKD associated with T2D.9 The reduction in the CV composite outcome was primarily driven by hospitalization due to heart failure.9

The incidence of the secondary endpoint, a composite of time to kidney failure, a sustained decrease of eGFR ≥40% from baseline over a period of at least four weeks, or renal death, was lower with finerenone than with placebo, affecting 350 (9.5%) and 395 (10.8%) patients, respectively.9 However, the difference was not statistically significant (HR 0.87 [95% CI, 0.76-1.01; P=0.0689]) over a median duration of follow-up of 3.4 years.9

Overall, hyperkalemia-related adverse events occurred more often in patients receiving finerenone compared with placebo (10.8% and 5.3%, respectively).9 Hospitalization due to hyperkalemia for the finerenone group was 0.6% versus <0.1% in the placebo group, and there was no hyperkalemia-related death in either treatment group. Treatment was discontinued due to hyperkalemia in 1.2% of patients treated with finerenone compared to 0.4% in the placebo group.9

Bayer also recently announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study that will investigate finerenone compared to placebo in more than 5,500 symptomatic heart failure patients (NYHA class II-IV) with a left ventricular ejection fraction of ≥40%.10 The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure events (defined as hospitalizations for heart failure or urgent heart failure visits).10

About Chronic Kidney Disease Associated With Type 2 Diabetes

Patients with CKD associated with T2D are three times more likely to die from a CV-related cause than those with T2D alone.6 CKD is a serious and progressive condition that is generally underrecognized.11 CKD is a frequent complication arising from T2D and is also an independent risk factor of CV disease.12-14 Approximately 40% of all patients with T2D develop CKD.14 Despite guideline-directed therapies, patients with CKD associated with T2D remain at high risk of CKD progression and CV events.12,13,15,16 T2D is the leading cause of end-stage kidney disease, which requires dialysis or a kidney transplant to stay alive.17-19

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.

Find more information at www.pharma.bayer.com
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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

  1. Filippatos G, et al. Finerenone and cardiorenal outcomes by history of cardiovascular disease in patients with type 2 diabetes and chronic kidney disease: FIDELITY analyses. Oral presentation at: ACC.22. April 4, 2022. Washington, D.C. https://www.abstractsonline.com/pp8/#!/10461/presentation/22134
  2. Agarwal R, Filippatos G, Pitt B, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J. 2022;43(6):474-484.
  3. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; July 2021.
  4. Einarson TR, Acs A, Ludwig C, Panton UH. Prevalence of cardiovascular disease in type 2 diabetes: a systematic literature review of scientific evidence from across the world in 2007-2017. Cardiovasc Diabetol. 2018;17:83.
  5. Fox CS, Matsushita K, Woodward M, et al. Associations of kidney disease measures with mortality and end-stage renal disease in individuals with and without diabetes: a meta-analysis [published correction appears in Lancet. 2013 Feb 2;381(9864):374]. Lancet. 2012;380(9854):1662-1673.
  6. Afkarian M, Sachs MC, Kestenbaum B, et al. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013;24(2):302-308..
  7. Ruilope LM, et al. Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial. Am J Nephrol. 2019;50(5)345-356.
  8. Bakris G, et al. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. 2020. 2020;383:2219-2229.
  9. Pitt B, et al. Cardiovascular events with finerenone in kidney disease and type 2 diabetes. N Engl J Med. 2021;10.1056/NEJMoa2110956. doi:10.1056/NEJMoa2110956.
  10. ClinicalTrials.gov. Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity & Mortality in Participants with Heart Failure and Left Ventricular Ejection Fraction Greater or Equal to 40% (FINEARTS-HF). 2020. Accessed November 2021. https://clinicaltrials.gov/ct2/show/NCT04435626
  11. Breyer MD, et al. Developing treatments for chronic kidney disease in the 21st Century. Semin Nephrol. 2016. 2016;36(6):436-447.
  12. Anders HJ, et al. CKD in diabetes: diabetic kidney disease versus nondiabetic kidney disease. Nat Rev Nephrol. 2018;14:361-377.
  13. Thomas MC, et al. Diabetic kidney disease. Nat Rev Dis Primers. 2015;1:1-20.
  14. Bailey R, et al. Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging. BMC Res Notes. 2014;7(1):415. doi:10.1186/1756-0500-7-415.
  15. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2013;3:1-150.
  16. American Diabetes Association standards of medical care in diabetes – 2021. Diabetes Care. 2021;44(1):1-244.
  17. National diabetes statistics report 2020: estimates of diabetes and its burden in the United States. Centers for Disease Control and Prevention. Accessed July 9, 2021. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
  18. Stages of CKD. American Kidney Fund. Accessed May 11, 2021. https://www.kidneyfund.org/kidney-disease/chronic-kidney-disease-ckd/stages-of-chronic-kidney-disease/
  19. United States Renal Data System. USRDS Annual data report. Volume 1: Chronic kidney disease. Chapter 6: Healthcare expenditures for persons with CKD. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. 2020. Accessed November 2021. https://adr.usrds.org/2020/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd

Contacts

Media:

Elaine Colón

Tel. +1 732-236-1587

Email: elaine.colon@bayer.com

Categories
Business Lifestyle

Apriori Network System’s innovative Optical Fiber Hack-Proof Solution a better value proposition than Quantum Encryption

BEDMINSTER, N.J. — (BUSINESS WIRE) — During the most recent, annual, international Optical Fiber Communications Conference (OFC 2022) in San Diego, at the expert panel session entitled, “Will Quantum Always Remain Basic Research or is it Ready to Power Great Products?”, the world-renowned telecommunications expert, Dr. Peter Winzer, stated categorically that “Quantum key distribution (QKD) … has yet to yield practical products that solve real-world problems….QKD only strives to provide a secure key, typically at kbps to mbps rates, which is unsuitable for today’s massive traffic needs. Significantly higher speed physical-layer security systems exist, including Apriori Network System’s method for secure, high-capacity optical data transmission.”

There has been a raging debate as to whether QKD will solve the problem of the vulnerability of optical fibers to physical hacking. Despite much research into QKD technology, there remains a lot of skepticism. A United Kingdom National Cyber Security Centre1 (NCSC) white paper referring to QKD, states that “it does not endorse its use in government or military applications…” and the NSA2 asserts QKD, “suffers from limitations and implementation challenges that make it impractical for use in National Security System (NSS) operational networks.”

 

The U.S. Government’s Committee on National Security Systems3 (CNSS) specified a product that monitors fibers for breaches using more conventional technology.

 

Gary Weiner, CEO of Apriori, points out that the CNSS4 solutions are designed to detect fiber hacks, but the emphasis is on detection of tampering and not prevention of fiber hacking or dealing with the tapping problem. Mr. Weiner contends, “the ability of a person-in-the-middle hacker accessing transmission data to monitor, influence and control critical infrastructure could be devastating financially, security-wise, and even impact lives. The sooner service providers recognize this risk and act on it, the better we will all be.”

 

The Apriori PrivaC™ fiber links guarantee privacy-asssured transmission service by intrinsically defending itself from eavesdropper attacks over an entire protected fiber span.

 

About Apriori Network Systems

Apriori Network Systems, as a privately held N.J. company, is positioned to be the world leader in cost-effective, privacy-assuring, efficient, practical prevention of physical hacking of optical fiber communications systems. Apriori’s first product, the PrivaC™ fiber platform, based on a patented solution, is presently in final development and available for demonstrations.

 

Links

1United Kingdom: https://www.ncsc.gov.uk/whitepaper/quantum-security-technologies

2https://www.apriorinetwork.com/complementary-to-quantum-key-distribution/

2https://www.nsa.gov/Press-Room/News-Highlights/Article/Article/2394053/nsa-cybersecurity-perspectives-on-quantum-key-distribution-and-quantum-cryptogr/

3 CNSS https://en.wikipedia.org/wiki/Committee_on_National_Security_Systems

4 CNSSI https://www.dcsa.mil/Portals/91/documents/ctp/nao/CNSSI_7003_PDS_September_2015.pdf

Contacts

Media:

Gary Weiner, 1-877-807-7482

Gary.Weiner@Apriori-NET.com

Categories
Business

Hayward announces planned retirement of Don Smith, senior vice president, chief supply chain officer

BERKELEY HEIGHTS, N.J. — (BUSINESS WIRE) — Hayward Holdings, Inc. (NYSE: HAYW) (“Hayward”), a global designer, manufacturer and marketer of a broad portfolio of pool equipment and technology, today announced that Don Smith, Senior Vice President, Chief Supply Chain Officer, plans to retire from Hayward after more than 15 years with the company. He will remain with the company through the transition of his successor, who will be announced at a later date.

“Don has been an integral part of the Hayward senior leadership team for over 15 years and has been a driving force in shaping Hayward into the company it is today,” said Kevin Holleran, CEO of Hayward. “He has built a high-performance culture in our manufacturing, supply chain and distribution organizations around the world, which continues to meet challenges and deliver growth for the company. We thank Don for his years of leadership and wish him well as he moves into this next chapter of his life.”

 

Smith said, “It has been my honor to lead Hayward’s Operations and Supply Chain through its development into a global leader in swimming pool original equipment. Our operational expansion and transformation into a vertically integrated, lean, global operation was a vision I shared with our many team members and stakeholders. I am beyond proud of the world-class enterprise we’ve all built together. Hayward’s operational teams are strong, experienced and skilled in the leadership of world-class operations. These teams have my unwavering confidence to execute Hayward’s growth and profitability strategies with great effect and efficiency. I am looking forward to working with my successor to ensure a seamless transition to maintain exceptional performance for Hayward’s global supply chain.”

 

Smith joined Hayward in 2007 as a member of its senior leadership. During his tenure, Smith led a number of enterprise-changing initiatives focused on enhancing Hayward’s production and distribution capabilities, including the successful opening and growth of Hayward’s manufacturing facility in Wuxi, China. The facility enabled the expansion of Hayward’s capacity for high-demand products across the globe. Most recently, Smith led the transition of manufacturing from Pomona, CA to Clemmons, NC and Wuxi, China, and the establishment of Hayward’s West Coast distribution center in Phoenix, AZ.

 

Over the last two years, Smith spearheaded efforts to increase Hayward’s global production capacity by more than 75 percent since the onset of the global pandemic, a remarkable accomplishment given the supply chain bottlenecks, logistics challenges and labor shortages during this period.

 

Smith also led numerous initiatives which will leave a legacy of excellence at Hayward. These include establishing a Centers of Excellence architecture across Hayward manufacturing facilities, instituting a new product development process, and implementing Hayward’s global distribution network.

 

About Hayward Holdings, Inc.

Hayward Holdings, Inc. (NYSE:HAYW) is a leading global designer and manufacturer of pool equipment and technology all key to the SmartPad™ conversion strategy designed to provide a superior outdoor living experience. Hayward offers a full line of innovative, energy-efficient and sustainable residential and commercial pool equipment, including a complete line of advanced pumps, filters, heaters, automatic pool cleaners, LED lighting, internet of things (IoT) enabled controls, alternate sanitizers and water features.

Contacts

Investor Relations:
Hayward Investor Relations

908.288.9706

investor.relations@hayward.com

Media Relations:
Tanya McNabb

tmcnabb@hayward.com

Categories
Business Lifestyle

Fortune International acquires D’Artagnan, leader in ‘Farm to Table’ movement and purveyor to top restaurants and retailers

– Acquisition to expand food distribution into Northeast, add new relationships with major retailers

– Founder Ariane Daguin to remain with Fortune

 

BENSENVILLE, Ill. & UNION, N.J. — (BUSINESS WIRE) — Fortune International, LLC, the country’s leading processor, distributor and importer of quality seafood, meats, and gourmet products, today announced the acquisition of D’Artagnan, Inc., a leader in popularizing the sustainable “farm to table” movement over last 35 years and purveyor of free-range meat and all-natural organic poultry, game, foie gras, mushrooms and truffles to the United States’ most renowned restaurants and retailers. Terms of the transaction were not disclosed.

Fortune’s acquisition of D’Artagnan as a preferred supplier of food and gourmet products expands the Company’s geographic footprint into D’Artagnan’s markets, as well as adds new relationships with leading retailers. In addition, the acquisition provides an opportunity for Fortune to offer new products to consumers directly as part of D’Artagnan’s successful and fast-growing e-commerce business.

 

Founded in 1985 by Ariane Daguin, D’Artagnan has been redefining the meat industry, distributing organic, antibiotic and hormone-free meats many years ahead of consumer demand for “clean label” and farm-to-table offerings. Since its inception, D’Artagnan has grown from a one-truck and two-employee business to a nationally recognized food brand by developing a network of independent farmers and ranchers that abide by the strictest standards to deliver the highest quality, best tasting, conscientiously raised meat possible. Headquartered in Union, New Jersey, the company has approximately 260 employees and over 80 trucks working from five primary operations located in Colorado, Georgia, Illinois, New Jersey, and Texas.

 

Today, D’Artagnan remains dedicated to putting only the finest meats on the tables of American gastronomes and is widely recognized for its superior quality and uncompromising standards. The top chefs and restauranteurs in America have relied on D’Artagnan for their daily deliveries, including Grant Achatz, Daniel Boulud, David Chang, Barbara Lynch, Danny Meyer, and the late Anthony Bourdain, who named his daughter Ariane in tribute to his friend. Recognized as a leader in sustainable and humane production practices, Ariane was inducted into James Beard Foundation’s “Who’s Who in Food & Beverage” in 1994, received the “Lifetime Achievement Award” from Bon Appetit Magazine in 2005, and awarded “Forbes Small Giants” in 2018.

 

Ariane will remain with D’Artagnan, continuing her life’s work as a devoted advocate for natural, sustainable, and humane production, at the forefront of America’s organic movement as well as continue to develop The D’Artagnan Farms Foundation. D’Artagnan will continue to operate as a subsidiary of Fortune Fish & Gourmet.

 

“We are excited to welcome Ariane and her talented team to our platform as the preferred supplier to top restaurants and retailers in the U.S.,” said Sean J. O’Scannlain, Fortune’s President and CEO. “In joining together, we combine Fortune’s strength in fresh seafood with D’Artagnan’s in free-range meat, offering customers their protein needs across virtually any market. We also look forward to building upon D’Artagnan’s successful direct-to-consumer e-commerce services. Ariane and her team have created a spectacular business and a best-in-class brand in our industry, and we are honored she has elected to join our growing Fortune family.”

 

Ariane Daguin, founder, owner, and CEO of D’Artagnan, commented, “I am excited to partner with and join Fortune, which is a company as committed to its customers and uncompromising service as we have always been. We have come a long way from our humble beginnings, 38 years ago. I am extremely excited for D’Artagnan’s future and want to thank our customers and vendors for their support through all these years.”

 

D’Artagnan represents Fortune International’s 13th transaction since launching its acquisition strategy in 2012, which has accelerated since entering into a partnership in 2020 with Investcorp, a leading global alternative asset manager. Fortune’s previous acquisitions include: JDY Gourmet (2012); Chef Martin Old World Butcher Shop (2014); Coastal Seafoods (2016); Morey’s Seafood International of Missouri, Classic Provisions Inc., and Jubilee Seafoods (2019); Seattle Fish of Missouri (2020), EuroGourmet, and Neesvig’s (2020); and C.C.T. Logistics, Inc., Meat Processors Inc., and Ocean Harvest Wholesale (2021).

 

Fortune International, LLC

Fortune International, LLC, is the parent operating company of Fortune Fish & Gourmet, a full-service processor and distributor providing white-tablecloth restaurants, private clubs, elegant hotels and gourmet retail stores with the finest quality fresh, live, and frozen seafood and gourmet foods. The company handles more than 10,000 seafood and gourmet products daily, selected to exceed the high standards embraced by its quality focused customer base. Fortune currently services more than 10,000 customers throughout the Central and Southeastern United States with a fleet of refrigerated vehicles and nationally through FedEx and common carriers. For more information, please visit www.fortunefishco.net.

Contacts

For Fortune International, LLC

Doug Donsky or Joe Crisci (ICR, Inc.)

P: (646) 277-1200

Email: doug.donsky@ICRinc.com or joe.crisci@ICRinc.com

For D’Artagnan

Linlee Hermann

P: 973-344-0565 ext. 200

Email: linleeh@dartagnan.com

Categories
Business

Zoetis to host webcast and conference call on first quarter 2022 financial results

PARSIPPANY, N.J. — (BUSINESS WIRE) — $ZTS #animalhealth—Zoetis Inc. (NYSE:ZTS) will host a webcast and conference call at 8:30 a.m. (ET) on Thursday, May 5, 2022. Chief Executive Officer Kristin Peck and Executive Vice President and Chief Financial Officer Wetteny Joseph will review first quarter 2022 financial results and respond to questions from financial analysts during the call.

Investors and the public may access the live webcast by visiting the Zoetis website at http://investor.zoetis.com/events-presentations. Information on accessing and pre-registering for the webcast is available beginning today. A replay of the webcast will be made available on May 5, 2022.

 

About Zoetis

As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After 70 years innovating ways to predict, prevent, detect, and treat animal illness, Zoetis continues to stand by those raising and caring for animals worldwide – from livestock farmers to veterinarians and pet owners. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics, and technologies make a difference in over 100 countries. A Fortune 500 company, Zoetis generated revenue of $7.8 billion in 2021 with approximately 12,100 employees. For more, visit www.zoetis.com.

ZTS-COR

ZTS-IR

Contacts

Media Contacts:

Bill Price

1-973-443-2742 (o)

william.price@zoetis.com

Kristen Seely

1-973-443-2777 (o)

kristen.seely@zoetis.com

Investor Contact:

Steve Frank

1-973-822-7141 (o)

steve.frank@zoetis.com

Categories
Business

AM Best affirms Credit Ratings for members of Donegal Insurance Group and Donegal Group Inc.

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has affirmed the Financial Strength Rating (FSR) of A (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICR) of “a” (Excellent) of the members of Donegal Insurance Group (Donegal Group). Concurrently, AM Best has affirmed the Long-Term ICR of “bbb” (Good) of the publicly traded holding company, Donegal Group Inc. (Delaware) [NASDAQ: DGICA and DGICB]. The outlook of these Credit Ratings (ratings) is stable. (See below for a detailed listing of the member companies.)

The ratings reflect Donegal Group’s balance sheet strength, which AM Best assesses as very strong, as well as its adequate operating performance, neutral business profile and appropriate enterprise risk management (ERM).

 

Donegal Group’s balance sheet strength assessment reflects its risk-adjusted capitalization at the strongest level, as measured by Best’s Capital Adequacy Ratio (BCAR), and its sound liquidity position, conservative investment portfolio, a comprehensive reinsurance program and stabilized loss reserving trends, which are partially offset by elevated underwriting leverage and modest stockholders’ dividend payments.

 

Although the individual members within Donegal Group play a specific role in the organization’s overall business plan, and their operating performances vary, each contributes favorably to the group’s risk-adjusted capitalization. In addition, each member supports the corporate business strategy and benefits from shared senior management, intercompany reinsurance and the added financial flexibility of Donegal Group Inc. to raise capital through debt or equity offerings during favorable investment markets.

 

Donegal Group’s adequate operating performance assessment reflects improved operating performance in recent years (2019-2021), primarily driven by a number of initiatives implemented by management to help improve its underwriting performance, including significant rate actions, the transfer of unprofitable accounts and investing in new technology. However, the group’s five-year combined ratio average slightly lags the property/casualty insurance industry’s composite average.

 

Donegal Group’s neutral business profile assessment reflects its geographic and product line diversification, effective use of technology in the independent agency distribution channel, and a history of successful expansion through strategic acquisitions and affiliations.

 

Donegal Group’s appropriate ERM is demonstrated through a formal risk management process, which provides assurances that the organization’s key compliance, financial and operational risks are addressed in meeting organizational objectives. Additionally, Donegal Group purchases various excess of loss and per risk reinsurance treaties from high quality reinsurers to protect surplus, reduce volatility and increase capacity.

 

The affirmation of the Long-Term ICR of Donegal Group Inc. recognizes the overall financial strength of its property/casualty insurance operations, its modest amount of financial leverage and the subordination of its creditors to the insurance companies’ policyholders.

 

The FSR of A (Excellent) and the Long Term ICRs of “a” (Excellent) have been affirmed, with stable outlooks for the following members of Donegal Insurance Group:

  • Atlantic States Insurance Company
  • Donegal Mutual Insurance Company
  • Michigan Insurance Company
  • Mountain States Commercial Insurance Company
  • Mountain States Indemnity Company
  • Peninsula Indemnity Company
  • Peninsula Insurance Company
  • Southern Insurance Company of Virginia
  • Southern Mutual Insurance Company

 

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

 

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

 

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

Contacts

Adib Nassery
Senior Financial Analyst
+1 908 439 2200, ext. 5205
adib.nassery@ambest.com

Christopher Sharkey

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

Brian O’Larte
Director
+1 908 439 2200, ext. 5138
brian.o’larte@ambest.com

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

Categories
Business Education Healthcare Local News

NJ Health Dept. issue emergency recall on school milk

PRODUCT RECALL — The New Jersey Department of Health — Public Health and Food Protection Program, is requesting all local health departments to check each public school’s cafeterias for the presence of Guida’s brand milk, of any type, size, and code date.

 

Schools will need to issue an embargo or otherwise prohibit the distribution of the milk.

 

This happened after at least 25 children have been hospitalized due to the presence of peroxyacetic sanitizer in Guida’s 1% Lowfat Milk, code dated 09-183 Apr 11 B2.

 

Other code dates of Guida’s milk may be affected as well.

 

Please notify Alan Talarsky, Dairy, Juice, Bottled Water, and Recalls Project at alan.talarsky@doh.nj.gov with the locations and quantities, if found.

Categories
Business Sports & Gaming

Profitable GameTech Company Novibet to combine with Nasdaq-listed Artemis Strategic Investment Corporation and to pursue high growth iGaming and online sports betting opportunities in Europe and the Americas

Novibet is a Fast-Growing GameTech Operator that Offers iGaming and Online Sports Betting and Features an Internationally Recognized Brand, Efficient Digital Marketing Strategy and a Proprietary Vertically Integrated Technology Platform

 

Novibet Expects to Generate $156 Million in Net Gaming Revenue and EBITDA of $20 Million in 2022 from iGaming and OSB Operations in Four Regulated European Markets

 

Novibet Achieved Average New User Breakeven in Less than Two Months in 2021

 

Poised to Begin Leveraging Track Record of New Market Entry in North America by the end 2022; Entered into a Market Access Agreement for Pennsylvania and Negotiating Market Access Agreements for Six Additional States

 

Expected to Have Approximately $135 Million of Unrestricted Cash at Closing (assuming no redemptions) as well as Continued Positive Cash Flow from Existing Operations to Drive Global Expansion

 

Novibet Pre-Transaction Enterprise Value of $625 Million

 

PHOENIX & VALLETTA, Malta — (BUSINESS WIRE) — Artemis Strategic Investment Corporation (Nasdaq: ARTE) (“Artemis”), a publicly traded special purpose acquisition company, and Logflex MT Holding Limited (doing business as “Novibet”), an established and profitable technology-enabled operator, jointly announced today that the companies entered into a definitive agreement for a business combination, whereby Artemis will merge into a new wholly-owned subsidiary of Novibet in a transaction based on Novibet’s pre-transaction enterprise valuation of $625 million. Following completion of the transaction, Novibet’s ordinary shares will be listed on the Nasdaq Stock Market. Artemis founders and existing Novibet stakeholders will hold approximately 75% of the combined company at close.1

Founded in 2010, Novibet currently operates iGaming and online sports betting actively across four regulated European markets: Greece, Ireland, Italy, and Malta. Over the last four years, Novibet has grown gross gaming revenue at a compound annual rate of approximately 107% for the full year ended December 31, 2021, with EBITDA during this period increasing at a compound annual rate of approximately 182%.

 

Novibet’s current operations and offerings include:

  • An iCasino platform that offers one of the largest online slots portfolios in the global gaming industry, including more than 5,000 casino games and 180 progressive jackpot games;
  • An online sports book platform that has strong brand awareness across its markets, with an opportunity to establish a differentiated brand in North America based in part on an internal team that covers more than 400,000 events across more than 20 sports;
  • A scalable and flexible technology offering that positions Novibet to efficiently address future growth with emerging iCasino verticals such as live games; and,
  • A proprietary platform for customer relationship management and technology.

________________

1 Assumes no redemptions from Artemis stockholders and $50 million of cash consideration paid to Novibet’s sole shareholder

Note: Novibet’s reporting currency is Euros. The exchange rate provided for US dollars is 1.1828 (due to fluctuating currency exchange, this rate is provided for convenience only and is based on the average for 2021)

 

Multi-Pronged Growth Strategy

The proceeds from the business combination and expected ongoing positive cash flow growth from existing operations are expected to favorably position Novibet to execute on a multi-pronged growth strategy that will grow its presence in the total addressable market (TAM). Novibet’s near-term strategic growth initiatives include:

 

  • Leveraging its strong operations and proprietary technology to continue to grow market share in existing core markets and enter additional European markets
    • European markets represent an estimated $29+ billion 2026 regional TAM opportunity: In addition to continued growth in Greece, Italy and Ireland, Novibet has developed a multi-phase European expansion plan to enter Sweden, the Netherlands, Romania, Belgium, Hungary, Germany, France and Spain via a joint venture partnership or strategic, accretive M&A
  • Deploying its ability to enter into new markets to enter emerging and regulated iGaming markets in North America and multiple Latin American markets
    • U.S. and Canada represent an estimated $37+ billion 2026 regional TAM opportunity: Novibet has entered into market access agreements for iGaming in Pennsylvania and is finalizing market access agreements for six additional U.S. States, while seeking a direct license to operate in Ontario and in other Canadian provinces as they become regulated
    • Latin America represents an estimated $4+ billion 2026 regional TAM opportunity: Novibet believes it is close to finalizing a market access agreement for Mexico with a land-based operator and is seeking to enter additional Latin American markets (Peru, Chile, Brazil, Colombia and Argentina) via a joint venture partnership or through strategic, accretive M&A
  • Pursuing a return-focused acquisition strategy to acquire complementary iGaming operators to further diversify its markets and sources of revenue and grow cash flow
    • Novibet is reviewing several pipeline targets in key new regulated markets that can increase its scale and reach, provide technology synergies, and/or provide new licenses in locally regulated markets

 

Initial execution against these multi-year growth initiatives is expected to help drive growth in full year 2023 projected net gaming revenue to approximately $200 million and EBITDA to approximately $37 million.

 

Management Commentary

“Novibet has a strong record of success developing a superior technical platform to address the global iGaming opportunity in a manner that delivers profitable financial performance and positive cash flow. This record, combined with its demonstrated ability to successfully and profitably enter new markets as well as the significant opportunity to leverage its competitive advantages in new markets, including in North America, aligns with our original investment thesis and makes Novibet an ideal partner for Artemis,” said Holly Gagnon, Chairperson and Co-Chief Executive Officer of Artemis. “Novibet’s innovative and wholly-owned technology platform and expansive suite of iCasino games and products have helped establish it as a successful iGaming and sports betting operator in the fast-growing Greece market and is helping to drive profitable market share growth in its other markets. Over the last three years, Novibet has consistently grown iGaming and sports betting users while also increasing the number of bets or hands played per user, resulting in a nearly 69% increase in the twelve-month value of each user to $617 in 2021 when compared to 2019.

 

“We expect the available growth capital and ongoing positive cash flow growth from Novibet’s current operations, coupled with our own substantial industry expertise, will provide a significant benefit to Novibet’s efforts to continue to grow share in its existing markets and simultaneously address new markets, including the large North American iGaming and sports betting opportunity along with the Latin American market. We are confident that Novibet’s proven, efficient, digital-focused customer acquisition strategy and depth of content offerings will enable it to deliver continued profitable growth as it launches its North American offerings beginning early next year.”

 

“Novibet has always focused on generating revenue growth that delivers positive cash flow,” said George Athanasopoulos, Chief Executive Officer of Novibet. “As we move closer to launching in additional markets where we can leverage our product and technology advantages, that focus will not waver. Our proposed combination with Artemis will enable us to both accelerate growth in our existing markets and efficiently enter newer markets. We see a significant growth opportunity in North America as our planned launch of operations in the U.S., Canada and Mexico will significantly grow our TAM with our expected initial market access agreements for seven states enabling us to reach 14% of the U.S. population. Furthermore, with approximately $135 million of expected unrestricted cash (assuming no redemptions) and positive cash flow from operations, we will be well-positioned to opportunistically pursue accretive acquisitions that can further grow our revenue and profitability. We believe our execution on these strategies will result in consistent cash flow growth which, combined with our new access to the U.S. financial markets, will help us to continue to invest in growth opportunities and drive significant long-term shareholder value.”

 

Transaction Highlights

  • Pro forma for the transaction, the implied enterprise valuation is approximately $696 million (assuming no redemptions from Artemis stockholders)
  • Approximately $205 million of SPAC cash-in-trust (assuming no redemptions from Artemis stockholders)
  • Artemis founders and existing Novibet stakeholder will hold approximately 75% of the combined company at close2
  • Novibet’s shareholder will roll at least 92% of their equity into ordinary shares of the combined company
  • Rodolfo Odoni, current owner of Novibet will be named Chairman of Novibet; George Athanasopoulos, Chief Executive Officer of Novibet, to remain CEO
  • Artemis will appoint two representatives to the Novibet Board of Directors

 

________________

2Novibet’s sole shareholder has the option to receive cash in exchange for up to $50 million of its Novibet shares, subject to there being at least $100 million of transaction proceeds after redemptions

 

Novibet Business Highlights

  • Novibet is a profitable GameTech operator that currently derives its revenue from four regulated online sports book (OSB) and iGaming markets in Europe: Greece, Ireland, Italy, and Malta
  • Approximately 68% of 2021 net gaming revenue was derived from iGaming operations with the balance derived from online sports betting
  • Novibet owns its state-of-the art, vertically integrated technology platform which has a seamless fusion with the Company’s iGaming products and digital acquisition tools, leading to higher customer entertainment, engagement and retention
    • User retention in Greece after twelve months from first time deposit has improved to 37% in 2021 from 11.5% pre-2019
    • 2.5x average monthly increase in active users from 2020 to 2021
      • More than 350,000 annual unique active customers in 2021
    • Approximately 69% first month retention rate in 2021
    • Average twelve-month Revenue per User growth of 96% over the last two years
  • Novibet’s return-focused digital marketing engine drives strong ROI on customer acquisition spend
    • New user breakeven time from first deposit of cost of acquisition has improved to 43 days in 2021 from 146 days pre-2019, despite a simultaneous increase in marketing spend
  • Novibet is poised to enter and capture share in the North American iGaming market beginning by the end of 2022
    • Entered or in process of finalizing iGaming and/or online sportsbook (OSB) market access agreements in seven U.S. states
      • Pennsylvania: entered into an agreement for iGaming; expects to launch operations in 2Q 2023
      • New Jersey: finalizing agreements for iGaming and OSB; expects to launch operations in the first half of 2023
      • Finalizing agreements with an operator for Indiana (iGaming and OSB), Louisiana, (iGaming), Iowa (iGaming and OSB), Missouri (OSB), and Mississippi (OSB); expects to launch initial operations in 2023 or 2024
    • Expects to launch iGaming and OSB operations in Canada through its own license, beginning with Ontario in Q4 2022
    • Expects to launch iGaming and OSB operations in Mexico through a partnership with a land-based operator beginning in Q3 2022

 

Timing and Approvals

The proposed transaction has been unanimously approved by the Boards of Directors of both companies and is expected to close in the second half of 2022, subject to approval by Artemis’ shareholders and other customary closing conditions.

 

Advisors

Oakvale Capital LLP acted as exclusive financial advisor to Novibet. Barclays acted as exclusive financial and capital markets advisor to Artemis. White & Case LLP acted as lead legal advisor to Artemis and Wiggin LLP assisted with gaming regulatory legal advice to Artemis. Harris Beach PLLC acted as lead legal advisor to Novibet.

 

Management Presentation Information

Interested parties may access an investor presentation and listen to a pre-recorded presentation regarding the proposed business combination beginning today at 4:30 p.m. ET at https://investor.novibet.com/ (Select Investor Relations and then Events and Presentations). The pre-recorded presentation will be available until March 30, 2023. The investor presentation will also be filed with the SEC as an exhibit to a Current Report on Form 8-K.

 

####

About Artemis Strategic Investment Corporation

Artemis is a special purpose acquisition company formed in 2021 and listed on Nasdaq in September 2021. Artemis was formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. Artemis is focused on partnering with companies in the gaming, sports and entertainment sectors as well as the technology and services that are associated with these verticals. Its Class A common stock, units, and warrants trade on Nasdaq under the symbols “ARTE”, “ARTEU”, and “ARTEW”, respectively. Artemis’ management team is led by Holly Gagnon, Philip Kaplan, Thomas Granite and Scott Shulak who each have decades of experience operating, advising and creating value for the owners and investors of leading businesses and entities.

 

About Novibet

Novibet is an established GameTech company operating in several countries across Europe through its headquarters in Malta, offices in Greece and employees in Isle of Man and Italy. Licensed and regulated by HGC, MGA, ADM, and Irish Revenue Commissioners, Novibet is committed to delivering the best sports betting and gaming experience to an expanding customer base. Since 2010, Novibet has offered online sports betting and casino entertainment in several competitive European markets.

 

The exciting online gaming experience begins with providing the most popular online casino games and, to that end, Novibet has teamed up with some of the world’s leading online casino content providers. With over 5,000 online casino games available to its experienced Casino Management Team, Novibet delivers slots, casino table, live-action, and many more game types across desktop, mobile, and tablet devices.

 

Novibet has its own proprietary betting platform that integrates world leading official data providers; with its own algorithms generating an extensive Betting Offer that includes In Play and Minute markets, in house developed Automatic and Hybrid Cash-Out, quick settlement of bets, and unparalleled excitement to sports enthusiasts.

 

As an innovative and adaptable operator, Novibet has a product offering that is constantly interacting with demand to meet and exceed existing and upcoming trends. In close partnership with Microsoft, Novibet is fully hosted in the Azure Cloud, providing scalability, high availability, redundancy, and economies of scale that are unrivaled in the industry.

 

For more information: https://investor.novibet.com/.

 

Important Information About the Proposed Business Combination and Where to Find It

In connection with the proposed Business Combination, Artemis, Novibet, and Novibet PLC (“PubCo”) intend to prepare, and PubCo intends to file with the SEC, a registration statement on Form F-4 (“Registration Statement”) which will include the proxy statement of Artemis and the prospectus of PubCo (as amended or supplemented from time to time, the “Proxy Statement/Prospectus”) and one or more amendments to the Registration Statement, and, after the Registration Statement is declared effective, Artemis will mail the definitive Proxy Statement/Prospectus included therein to the holders of Artemis’s common stock in connection with Artemis’s solicitation of proxies for the vote by Artemis stockholders with respect to the Business Combination and other matters described in the Registration Statement. Artemis urges its stockholders and other interested persons to read, when available, the Registration Statement, the amendments thereto, and the documents incorporated by reference therein, as well as other documents filed by Artemis with the SEC in connection with the Business Combination, as these materials will contain important information about Artemis, Novibet, and the Business Combination. Stockholders of Artemis will also be able to obtain copies of such documents, when available, free of charge through the website maintained by the SEC at www.sec.gov or by directing a written request to Artemis Strategic Investment Corporation, 3310 East Corona Avenue, Phoenix, AZ 85040.

 

Participants in the Solicitation

Under SEC rules, Artemis, Novibet, PubCo, and each of their respective officers and directors may be deemed to be participants in the solicitation of Artemis’s stockholders in connection with the Business Combination. Stockholders of Artemis may obtain more detailed information regarding the names, affiliations, and interests of Artemis’s directors and officers in Artemis’s prospectus for its initial public offering, filed with the SEC on October 1, 2021 (the “IPO Prospectus”) and the Registration Statement, when available. The interests of Artemis’s directors, officers, and others in the Business Combination may, in some cases, be different than those of Artemis’s stockholders generally. Information about such interests will be set forth in the Registration Statement when it becomes available. You may obtain free copies of these documents as described in the preceding paragraph.

 

Forward-Looking Statements

This press release includes historical information as well as “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to matters such as the future results of operations and financial position of PubCo and its subsidiaries; planned products and services; Novibet’s business strategy, including Novibet’s planned launch in the United States and the Americas; objectives of Novibet’s management for future operations; market size and potential growth opportunities; competitive position; expectations and timings related to commercial launches; potential benefits of the proposed business combination; and technological and market trends and other future conditions.

 

Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “future,” “anticipate,” “assume,” “intend,” “plan,” “may,” “will,” “could,” “should,” “would,” “believes,” “predicts,” “potential,” “strategy,” “opportunity,” “continue,” and similar expressions are intended to identify such forward-looking statements. Accordingly, such forward-looking statements are not guarantees and are subject to inherent risks, uncertainties, and changes in circumstance that are difficult to predict and may be outside of PubCo’s, Artemis’s and Novibet’s control. PubCo’s, Artemis’s and Novibet’s actual results may differ materially from their expectations, estimates and projections due to a variety of factors and consequently, you should not place undue reliance on these forward-looking statements as predictions of future events. Although it is impossible to identify all factors that may cause such differences, they include, but are not limited to: (1) the level of redemptions by Artemis’s shareholders in connection with a business combination and the outcome of any legal proceedings that may be instituted against Artemis or Novibet following the announcement of the Business Combination; (2) the inability to complete the Business Combination; (3) the risk that the Business Combination disrupts current plans and operations of Novibet as a result of the announcement and consummation of the Business Combination; (4) the inability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably, maintain relationships with customers and suppliers and retain its key employees; (5) costs related to the Business Combination; (6) changes in laws or regulations applicable to Novibet’s business; (7) the possibility that PubCo may be adversely affected by other economic, business, and/or competitive factors; (8) the impact of the global COVID-19 pandemic; (9) the risk factors which will be set forth under the heading “Risk Factors” in the Registration Statement; and (10) the risks and uncertainties described in the “Risk Factors” section of Artemis’s IPO Prospectus and Artemis’s subsequent filings with the SEC.

 

The foregoing list of factors is not exclusive. There may be additional risks that Artemis and Novibet do not presently know or that they currently believe are immaterial that could cause actual results to differ materially from those contained in the forward-looking statements. All information set forth herein speaks only as of the date hereof in the case of information about Artemis and Novibet or the date of such information in the case of information from persons other than Artemis and Novibet, and PubCo, Artemis and Novibet expressly disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release or to reflect any changes in their expectations or any change in events, conditions or circumstances on which any statement is based.

 

No Offer or Solicitation

This press release is for informational purposes only and shall neither constitute an offer to sell nor the solicitation of an offer to buy any securities, nor a solicitation of a proxy, vote, consent or approval in any jurisdiction in connection with the Business Combination, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdictions. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act, or an exemption therefrom.

 

INVESTMENT IN ANY SECURITIES DESCRIBED HEREIN HAS NOT BEEN APPROVED OR DISAPPROVED BY THE SEC OR ANY OTHER REGULATORY AUTHORITY NOR HAS ANY AUTHORITY PASSED UPON OR ENDORSED THE MERITS OF THE OFFERING OR THE ACCURACY OR ADEQUACY OF THE INFORMATION CONTAINED HEREIN. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

 

Financial and Other Information

All of Novibet’s financial information presented in this press release is presented in U.S. Dollars, except as otherwise indicated. Novibet’s functional currency is the Euro and its financial statements are reported in Euros. Certain amounts reported in Euros have been converted to U.S. Dollars at the exchange rates stated herein. Novibet’s financial statements have been prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”). IFRS differs in certain material respects from U.S. generally accepted accounting principles (“U.

Contacts

Investor Contacts:
Joseph Jaffoni, Richard Land and James Leahy

JCIR

(212) 835-8500

novibet@jcir.com

Thomas Granite

Artemis Strategic Investment Corporation

info@artemisspac.com

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