Category: Business

Merck announces First-Quarter 2021 financial results

Post author By Michelle Dryden
Post date April 29, 2021
No Comments on Merck announces First-Quarter 2021 financial results

First-Quarter 2021 Sales Were $12.1 Billion, In-Line with First-Quarter 2020; Excluding the Impact from Foreign Exchange, Sales Declined 1%
First-Quarter 2021 Sales Reflect Strong Underlying Performance of KEYTRUDA, Lynparza, BRIDION and Animal Health, Which Was Offset by COVID-19 Pandemic Impacts to Patient Access, Particularly for Vaccines
First-Quarter 2021 GAAP EPS Was $1.25; First-Quarter Non-GAAP EPS Was $1.40
Entered into HIV Collaboration with Gilead Sciences, Inc. and Completed Acquisition of Pandion Therapeutics, Inc.
Merck Will Host an Investor Event Featuring Organon on May 3; Organon Spinoff is Expected to be Completed on June 2, with First Day of Trading Scheduled for June 3
2021 Financial Outlook
- Continues to Expect Sales Growth of 8% to 12%; Full-Year 2021 Sales Estimated to be Between $51.8 Billion and $53.8 Billion, Including a Positive Impact from Foreign Exchange of Less Than 2%, Assuming Organon is Part of Merck for the Full Year
- Expects Full-Year 2021 GAAP EPS to be Between $5.05 and $5.25; Continues to Expect Non-GAAP EPS to be Between $6.48 and $6.68, Including a Positive Impact from Foreign Exchange of Less Than 3%, Assuming Organon is Part of Merck for the Full Year
- Assuming the Completion of the Organon Spinoff, Expects Full-Year 2021 Sales from Continuing Operations to be Between $45.8 Billion and $47.8 Billion

KENILWORTH, N.J. — (BUSINESS WIRE) — #earnings–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2021.

“While our results this quarter were impacted by the pandemic, the underlying demand for our innovative products remains strong and we remain confident in our future growth prospects,” said Kenneth C. Frazier, chairman and CEO, Merck. “We are also taking the right steps to evolve Merck’s operating model to continue to create value for patients, shareholders and society.”

“As I transition into the CEO role, one of my immediate priorities is to ensure that our experienced leadership team continues to build on our solid foundation,” said Robert M. Davis, president, Merck. “Our company is well positioned for strong long-term performance, with scientific innovation remaining the source of our company’s energy and value creation.”

Financial Summary

$ in millions, except EPS amounts	First Quarter
$ in millions, except EPS amounts	2021	2020	Change	Change Ex- Exchange
Sales	$12,080	$12,057	0%	-1%
GAAP net income¹	3,179	3,219	-1%	-3%
Non-GAAP net income that excludes certain items^1,2*	3,556	3,851	-8%	-9%
GAAP EPS	1.25	1.26	-1%	-3%
Non-GAAP EPS that excludes certain items²*	1.40	1.51	-7%	-9%
*Refer to table on page 11.

GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) was $1.25 for the first quarter of 2021. Non-GAAP EPS of $1.40 for the first quarter of 2021 excludes acquisition- and divestiture-related costs, restructuring costs, income and losses from investments in equity securities and certain other items.

Oncology Pipeline Highlights

Merck continued to advance the development programs for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy; Lynparza (olaparib), a PARP inhibitor being co-developed and co-commercialized with AstraZeneca; and Lenvima (lenvatinib mesylate), an orally available tyrosine kinase inhibitor being co-developed and co-commercialized with Eisai Co., Ltd. (Eisai), in addition to other notable developments as follows:

Merck announced the following regulatory actions for KEYTRUDA:
- Approval by the U.S. Food and Drug Administration (FDA) in combination with platinum- and fluropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation, based on results from the Phase 3 KEYNOTE-590 trial.
- Approval by the European Commission (EC) for the treatment of adult and pediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option, based on results from the Phase 3 KEYNOTE-204 trial.
- Approval by the EC for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient colorectal cancer based on results from the Phase 3 KEYNOTE-177 trial.
- A Complete Response Letter was received from the FDA regarding Merck’s supplemental Biologics License Application for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC), in combination with chemotherapy as neoadjuvant (pre-operative) treatment, then continuing as a single agent as adjuvant (post-operative) treatment after surgery.
- A voluntary withdrawal in the United States for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This withdrawal does not affect other indications for KEYTRUDA.
Merck announced that an interim analysis from the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA met its primary endpoint of disease-free survival for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) following nephrectomy or following nephrectomy and resection of metastatic lesions. Data will be presented at the 2021 American Society for Clinical Oncology (ASCO) Annual Meeting.
Merck announced that the FDA has accepted and granted priority review for a New Drug Application (NDA) for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, belzutifan, a novel investigational candidate in Merck’s oncology pipeline, for the potential treatment of certain patients with von Hippel-Lindau (VHL) disease-associated RCC, not requiring immediate surgery. The FDA has set a PDUFA date of Sept. 15, 2021.
Merck and Eisai announced the first presentation of new investigational data from the pivotal Phase 3 CLEAR study (KEYNOTE-581/Study 307) at the 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine. The combination of KEYTRUDA plus Lenvima significantly improved the primary endpoint of progression-free survival (PFS) and key secondary endpoint of overall survival (OS) versus sunitinib in first-line treatment of patients with advanced RCC.
Merck and Eisai announced the first presentation of investigational data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting. The combination of KEYTRUDA plus Lenvima significantly improved the dual primary endpoints of PFS and OS versus chemotherapy for the treatment of patients with advanced endometrial cancer following one prior platinum-based regimen in any setting.
Merck and AstraZeneca announced that the Phase 3 OlympiA trial for Lynparza will move to early primary analysis and reporting following a recommendation from the Independent Data Monitoring Committee (IDMC). Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival versus placebo in the adjuvant treatment of germline BRCA-mutated (gBRCAm), high-risk human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer following definitive local treatment and neoadjuvant or adjuvant chemotherapy. The trial will continue to evaluate the key secondary endpoints of OS and distant disease-free survival. Data will be presented at the 2021 ASCO Annual Meeting.
Merck began enrollment for the Phase 3 study evaluating vibostolimab, its investigational anti-TIGIT antibody, in combination with KEYTRUDA in non-small cell lung cancer patients whose tumors express PD-L1.

Business Development and Other Pipeline Highlights

Merck and Gilead Sciences, Inc. (Gilead) announced that they have entered into an agreement to co-develop and co-commercialize long-acting treatments in HIV that combine Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), islatravir, into a two-drug regimen in oral and injectable formulations with the potential to provide new, meaningful treatment options for people living with HIV.
Merck acquired Pandion Therapeutics, Inc. (Pandion), a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases, on April 1, 2021.
Merck announced that a Phase 2/3 trial of molnupiravir (EIDD-2801/MK-4482), an investigational oral antiviral agent being developed in collaboration with Ridgeback Biotherapeutics, for the treatment of outpatients diagnosed with COVID-19, will proceed to Phase 3. Interim results from Phase 2/3 studies evaluating molnupiravir in both outpatients and inpatients will be shared with the scientific community at an upcoming medical meeting.
Merck announced results from a Phase 1 study evaluating the safety, tolerability and pharmacokinetics (PK) of the company’s investigational subdermal drug-eluting implant with potential for extended administration of islatravir, an investigational NRTTI, for pre-exposure prophylaxis (PrEP) of HIV-1 infection. Study results demonstrated that the implant achieved active drug concentrations above the pre-specified PK threshold at 12 weeks across the three doses of islatravir studied (48 mg, 52 mg and 56 mg), and is projected to provide drug concentrations likely above threshold for one year at the 56 mg dose. Based on these findings, Merck plans to initiate a Phase 2 trial to further explore the potential of a subdermal implant containing islatravir as a long-acting option for PrEP for up to 12 months.
Merck announced that the FDA has accepted for review the company’s NDA for gefapixant, an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory chronic cough or unexplained chronic cough in adults based on results from the COUGH-1 and COUGH-2 studies. This application for gefapixant will be discussed at an upcoming advisory committee meeting. The FDA has set a PDUFA date of Dec. 21, 2021.
Merck announced that supply for VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) in the United States will be available in June 2021. Developed as part of a joint-partnership between Sanofi and Merck, VAXELIS is the first and only hexavalent combination vaccine approved in the United States to help protect infants and children 6 weeks through 4 years of age against diseases caused by six infectious agents: diphtheria, tetanus, pertussis (whooping cough), poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type b.

Organon Highlights

Merck filed a Form 10 registration statement with the United States Securities and Exchange Commission (SEC) in connection with the intended spinoff of its women’s health, biosimilars and established brands businesses into a standalone, publicly-traded company, Organon & Co. (Organon).
In April 2021, Organon Finance 1 LLC issued senior secured notes of €1.25 billion aggregate principal amount of 2.875% senior secured notes due 2028, $2.1 billion aggregate principal amount of 4.125% senior secured notes due 2028 and $2.0 billon aggregate principal amount of 5.125% senior unsecured notes due 2031, in connection with the intended spinoff of Organon from Merck.
Merck announced a definitive agreement pursuant to which, after the intended spinoff of Organon, Organon will acquire Alydia Health. Alydia Health is a commercial-stage medical device company focused on preventing maternal morbidity and mortality caused by postpartum hemorrhage or abnormal postpartum uterine bleeding.
Merck will host an investor event featuring Organon on May 3. The Organon spinoff is expected to be completed on June 2, with first day of trading scheduled for June 3.

Corporate Developments

Merck announced goals to achieve carbon neutrality in its operations (Scopes 1 & 2 emissions) by 2025 through ongoing innovation to increase efficiency and reduce carbon emissions, applying sustainable building standards and continuing to transition away from fossil fuel use. Remaining Scope 1 emissions will be offset each year with a portfolio of high-quality carbon credits, including carbon removals. Merck has also set a goal of achieving a 30% reduction in its value chain emissions by 2030 (Scope 3 emissions).

First-Quarter Revenue Performance

The following table reflects sales of the company’s top pharmaceutical products, as well as sales of animal health products.

$ in millions	First Quarter
	2021	2020	Change	Change Ex-Exchange
Total Sales	$12,080	$12,057	0%	-1%
Pharmaceutical	10,675	10,655	0%	-3%
KEYTRUDA	3,899	3,284	19%	16%
JANUVIA / JANUMET	1,295	1,277	1%	-2%
GARDASIL / GARDASIL 9	917	1,097	-16%	-20%
PROQUAD, M-M-R II and VARIVAX	449	435	3%	2%
BRIDION	340	299	14%	11%
Lynparza* SIMPONI	228 214	145 215	57% 0%	51% -8%
ISENTRESS / ISENTRESS HD	209	245	-15%	-15%
PNEUMOVAX 23 ROTATEQ	171 158	256 222	-33% -29%	-36% -29%
Animal Health	1,418	1,214	17%	15%
Livestock	819	739	11%	9%
Companion Animals	599	475	26%	24%
Other Revenues**	(13)	188	-107%	-21%
*Alliance revenue for this product represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.
**Other revenues are comprised primarily of third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities. The revenue hedging activities resulted in negative revenue in the first quarter of 2021.

Pharmaceutical Revenue

First-quarter pharmaceutical sales of $10.7 billion were in-line with the first quarter of 2020. Excluding the favorable effect of foreign exchange, sales declined by 3%. Sales performance reflects underlying strength in the business, offset by negative impacts of the COVID-19 pandemic, and the ongoing impacts of the loss of market exclusivity for several products. With respect to the COVID-19 pandemic, the estimated negative impact to Merck’s first quarter pharmaceutical revenue was approximately $600 million. Continued reduced access to health care providers, combined with the prioritization of COVID-19 vaccines has negatively impacted the sales of certain products, notably vaccines in the United States.

Pharmaceutical revenue reflects growth in oncology, largely driven by higher sales of KEYTRUDA, which rose 19% to $3.9 billion in the quarter, although the COVID-19 pandemic had a dampening effect on growing demand due to a decline in the number of new patients starting treatment. Global sales growth of KEYTRUDA reflects continued strong momentum from the non-small-cell lung cancer indications as well as continued uptake in other indications, including adjuvant melanoma, RCC, bladder, head and neck squamous cell carcinoma (HNSCC) and MSI-H cancers, as well as uptake following the recent launch of the 400mg every 6 weeks adult dosing regimen in the United States, partially offset by pricing pressure in Europe and Japan. Also contributing to growth in oncology was 57% growth in Lynparza alliance revenue, reflecting continued uptake in approved indications in the United States, Europe and China.

The decline in vaccine sales was primarily driven by GARDASIL (Human Papillomavirus Quadrivalent [Types 6,11,16 and 18] Vaccine, Recombinant)/GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), vaccines to prevent certain cancers and other diseases caused by HPV, primarily attributable to buying patterns in the United States and the timing of shipments in China, which in total negatively affected the year over year GARDASIL/GARDASIL 9 sales comparison by approximately $230 million. The COVID-19 pandemic also negatively affected sales for GARDASIL/GARDASIL 9, particularly in the United States and Europe.

Also contributing to the decline in vaccine sales were lower sales of PNEUMOVAX 23 (pneumococcal vaccine polyvalent), a vaccine to help prevent pneumococcal disease, primarily reflecting the impact of the COVID-19 pandemic on demand in the United States, partially offset by higher volumes in international markets.

Vaccines sales were also negatively affected by lower sales of ROTATEQ (Rotavirus Vaccine, Live Oral, Pentavalent), a vaccine to help protect against rotavirus gastroenteritis in infants and children, largely due to the timing of shipments in China and lower demand in the United States.

Pharmaceutical sales in the quarter were negatively affected by the ongoing impacts from the loss of market exclusivity, including for ZETIA (ezetimibe) and NOXAFIL (posaconazole), as well as certain products in diversified brands.

Performance in hospital acute care primarily reflects the decline in sales of ZERBAXA (ceftolozane and tazobactam) for injection, a combination cephalosporin antibacterial and beta-lactamase inhibitor for the treatment of adults with certain bacterial infections due to the temporary suspension of sales and product recall in the fourth quarter of 2020. Hospital acute care performance also reflects higher demand globally for BRIDION (sugammadex) Injection 100 mg/mL, a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults undergoing surgery; and the continued uptake of PREVYMIS (letermovir), a medicine for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

Animal Health Revenue

Animal Health sales totaled $1.4 billion for the first quarter of 2021, an increase of 17% compared with the first quarter of 2020; excluding the favorable effect from foreign exchange, Animal Health sales grew 15%. Sales growth reflects higher demand globally for companion animal products, including parasiticide lines of products, primarily BRAVECTO (fluralaner), as well as higher sales of companion animal vaccines. Sales growth in livestock products reflects higher demand in international markets for ruminant, poultry and swine products, as well as higher demand globally for Animal Intelligence products.

First-Quarter Expense, EPS and Related Information

The tables below present selected expense information.

$ in millions First-Quarter 2021	GAAP	Acquisition- and Divestiture- Related Costs³	Restructuring Costs	(Income) Loss from Investments in Equity Securities	Certain Other Items	Non- GAAP²
Cost of sales	$3,670	$517	$27	$−	$188	$2,938
Selling, general and administrative	2,633	218	3	−	−	2,412
Research and development	2,465	18	7	−	−	2,440
Restructuring costs	298	−	298	−	−	−
Other (income) expense, net	(448)	(28)	−	(561)	−	141

First-Quarter 2020
Cost of sales	$3,312	$407	$68	$−	$−	$2,837
Selling, general and administrative	2,555	278	11	−	−	2,266
Research and development	2,209	40	17	−	−	2,152
Restructuring costs	72	−	72	−	−	−
Other (income) expense, net	71	(11)	–	(87)	−	169

GAAP Expense, EPS and Related Information

Gross margin was 69.6% for the first quarter of 2021 compared to 72.5% for the first quarter of 2020. The decrease reflects higher costs associated with COVID-19 development programs, including a charge related to the discontinuation of certain COVID-19 development programs, as well as higher acquisition- and divestiture-related costs, and pricing pressure, partially offset by favorable product mix.

Selling, general and administrative expenses were $2.6 billion in the first quarter of 2021, an increase of 3% compared to the first quarter of 2020. The increase primarily reflects higher promotion and administrative costs, the unfavorable effects of foreign exchange and higher costs related to the company’s planned spinoff of Organon, partially offset by lower selling costs due in part to the COVID-19 pandemic.

Research and development expenses were $2.5 billion in the first quarter of 2021, an increase of 12% compared with the first quarter of 2020. The increase was primarily driven by higher expenses related to clinical development, including investment in COVID-19 development programs, as well as increased investment in discovery research and early drug development, partially offset by lower licensing costs.

Other (income) expense, net, was $448 million of income in the first quarter of 2021 compared to $71 million of expense in the first quarter of 2020, primarily reflecting higher income from investments in equity securities in 2021 compared with 2020.

The effective income tax rate of 8.0% for the first quarter of 2021 reflects a net tax benefit of $237 million related to the settlement of certain federal income tax matters.

GAAP EPS was $1.25 for the first quarter of 2021 compared with $1.26 for the first quarter of 2020.

Non-GAAP Expense, EPS and Related Information

Non-GAAP gross margin was 75.7% for the first quarter of 2021 compared to 76.5% for the first quarter of 2020. The decrease in non-GAAP gross margin reflects higher costs associated with COVID-19 development programs, as well as pricing pressure, partially offset by favorable product mix.

Non-GAAP selling, general and administrative expenses were $2.4 billion in the first quarter of 2021, an increase of 6% compared to the first quarter of 2020. The increase primarily reflects higher promotion and administrative costs and the unfavorable effects of foreign exchange, partially offset by lower selling costs due in part to the COVID-19 pandemic.

Non-GAAP R&D expenses were $2.4 billion in the first quarter of 2021, a 13% increase compared to the first quarter of 2020. The increase primarily reflects higher expenses related to clinical development, including investment in COVID-19 development programs, as well as increased investment in discovery research and early drug development, partially offset by lower licensing costs.

Non-GAAP other (income) expense, net, was $141 million of expense in the first quarter of 2021 compared to $169 million of expense in the first quarter of 2020.

The non-GAAP effective income tax rate was 14.1% for the first quarter of 2021.

Non-GAAP EPS was $1.40 for the first quarter of 2021 compared with $1.51 for the first quarter of 2020.

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.

$ in millions, except EPS amounts	First Quarter
	2021	2020
EPS
GAAP EPS	$1.25	$1.26
Difference	0.15	0.25
Non-GAAP EPS that excludes items listed below²	$1.40	$1.51

Net Income
GAAP net income¹	$3,179	$3,219
Difference	377	632
Non-GAAP net income that excludes items listed below^1,2	$3,556	$3,851

Decrease (Increase) in Net Income Due to Excluded Items:
Acquisition- and divestiture-related costs³	$725	$714
Restructuring costs	335	168
(Income) loss from investments in equity securities	(561)	(87)
Charge for the discontinuation of COVID-19 development programs	188	–
Net decrease (increase) in income before taxes	687	795
Income tax (benefit) expense⁴	(310)	(163)
Decrease (increase) in net income	$377	$632

Financial Outlook

The guidance provided below is based on the assumption that the Organon business will be part of Merck for all of 2021; however, the Company expects that the Organon spinoff will occur on June 2, 2021.

Contacts

Media Contact:

Patrick Ryan

(973) 275-7075

Investor Contacts:

Peter Dannenbaum

(908) 740-1037

Raychel Kruper

(908) 740-2107

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Tags Business, New Jersey

Business Entertainment News

Six Flags announces reopening of Six Flags New England, Hurricane Harbor Los Angeles, and Hurricane Harbor Concord

Post author By Michelle Dryden
Post date April 29, 2021
No Comments on Six Flags announces reopening of Six Flags New England, Hurricane Harbor Los Angeles, and Hurricane Harbor Concord

Theme Park Will Open to the Public May 14

ARLINGTON, Texas — (BUSINESS WIRE) — #HurricaneHarborConcord—Six Flags Entertainment Corporation, the world’s largest regional theme park company and the largest operator of waterparks in North America, today announced that Six Flags New England has received state clearance to reopen with rides and attractions. The park, located in Agawam, Massachusetts, will open for its 21^st season to Members and Season Pass holders on May 14, and to the general public on May 15, 2021. Additionally, the company’s two California waterparks, Hurricane Harbor Los Angeles and Hurricane Harbor Concord, will open to the public May 15 and May 22, respectively. The parks will operate at reduced attendance levels, in accordance with state reopening guidelines for theme parks and waterparks, utilizing a reservation system. The parks will implement the extensive safety measures already in use at Six Flags parks throughout the system. Six Flags New England’s Dinosaurs: A Walk Thru Experience will be available through May 23 with paid park admission.

“With today’s announcement, 26 of our 27 parks will be welcoming guests this season,” said Senior Vice President of Park Operations, Bonnie Weber. “The safety of our guests and team members continues to be our highest priority, and we look forward to announcing an opening date for our theme park in Canada in the near future,” continued Weber.

Six Flags New England Park President Pete Carmichael added, “This is a great day for our team. They are ready to get back to work and do what they love, and we are thrilled to reopen our park with all of the great roller coasters, rides, and attractions that Six Flags New England is famous for,” continued Carmichael.

Open Six Flags Parks

The following Six Flags parks have already opened, or will be opening soon, with a full lineup of rides and attractions. Those parks include:

Six Flags Over Texas – open year-round;
Six Flags Fiesta Texas – open year-round;
Hurricane Harbor Oaxtepec – opened February 27;
Six Flags Over Georgia – opened March 6;
Six Flags America – opened March 6;
Frontier City – opened March 13;
Hurricane Harbor Phoenix – opened March 13;
Six Flags Mexico – opened March 18;
Six Flags St. Louis – opened March 20;
Six Flags Great Escape Lodge & Indoor Waterpark – opened March 26;
Six Flags Great Adventure – opened March 27;
Six Flags Magic Mountain – opened April 1;
Six Flags Discovery Kingdom – opened April 1;
Six Flags Great America – opened April 24;
The Great Escape – opening May 1;
Hurricane Harbor Splashtown – opening May 1;
Hurricane Harbor Arlington – opening May 1;
Six Flags White Water – opening May 8;
Six Flags New England – opening May 14;
Hurricane Harbor New Jersey – opening May 15;
Hurricane Harbor OKC – opening May 15;
Hurricane Harbor Los Angeles – opening May 15;
Six Flags Darien Lake – opening May 21;
Hurricane Harbor Concord – opening May 22;
Hurricane Harbor Chicago – opening May 29; and
Hurricane Harbor Rockford – opening May 29.

Park reopening dates are subject to change based on local, state, and federal guidelines related to COVID-19.

Six Flags’ safety plan, developed in consultation with infectious disease experts and utilized throughout the Six Flags network of parks, provides for execution at the highest levels of hygiene and social distancing protocols. The park will adjust these procedures as needed to ensure continued compliance with state recommendations.

Park Reservations System to Control Capacity

Six Flags has established attendance caps for each park that are in accordance with current state guidelines to allow for proper social distancing. All Members, Season Pass holders and guests with a single-day or group ticket will need to make a reservation at www.sixflags.com/reserve. Guests who buy single-day tickets will be able to reserve during the purchase process.

Health and safety protocols include:

Masks will be required to be worn by team members and all guests over the age of two;
Contactless IR thermal imaging will be used to screen temperatures of guests and team members prior to entry;
Advanced security screening technology will allow for touchless bag checks;
Easy-to-identify distance markers have been added in all park entry, restroom, retail locations, and ride and dining queue lines to encourage social distancing;
Modified menus and soon-to-be launched mobile food ordering will help facilitate touchless transactions;
Self-service buffets and salad bars will be reconfigured to eliminate guest contact with food;
Increased sanitization and disinfecting of high touch points including all public seating, tabletops, counters, handrails, doors, deck chairs, life jackets, tubes, rafts, and trash cans will occur frequently;
Restroom staff will be available to disinfect each stall and sink area on a frequent basis;
Multiple alcohol-based hand-sanitizer stations will be located throughout the park;
Safety messaging and reminders will be communicated on Six Flags’ website, newsletters, and in-park announcements; and
Frontline team members will go through extensive COVID-19 training.

Virtual Hiring Fairs

As one of the largest seasonal employers in the country, Six Flags is hosting National Hiring Week now through May 2. The company is hiring for a number of rewarding positions in food service, ride operations, lifeguarding, retail, warehousing, janitorial, maintenance, and security. Applicants may apply online at www.sixflags.com/jobs for a virtual and contact-free process, where they can be interviewed one day, and start earning the next. Additionally, for the first time and for a limited time, new employees will receive a Gold Plus membership for themselves and up to three family members.

About Six Flags Entertainment Corporation

Six Flags Entertainment Corporation is the world’s largest regional theme park company and the largest operator of waterparks in North America, with 27 parks across the United States, Mexico and Canada. For nearly 60 years, Six Flags has entertained hundreds of millions of guests with world-class coasters, themed rides, thrilling waterparks and unique attractions. Six Flags is committed to creating an inclusive environment that fully embraces the diversity of our team members and guests. For more information, visit www.sixflags.com.

About Six Flags New England

Six Flags New England, the Thrill Capital of New England, is home to over 100 rides, shows, attractions and New England’s largest FREE waterpark, Hurricane Harbor. With over 200 acres, Six Flags New England boasts 13 roller coasters, a 500,000 gallon wave pool and world-class shopping and dining for all ages. With a reason to visit every season, Six Flags New England is the premier destination for family fun and is located in western Massachusetts.

Like us on Facebook at facebook.com/sixflagsne

About Six Flags Hurricane Harbor Los Angeles

Six Flags Hurricane Harbor, a 22-acre waterpark located next door to Six Flags Magic Mountain, features over 1.5 million gallons of water in a tropically themed paradise. Enjoy two of the tallest full-enclosed speed slides in Southern California, a relaxing 1,300-foot river cruise, a wave pool, an interactive lagoon, and a splashy kid’s play area. The park operates seasonally May-September.

About Six Flags Hurricane Harbor Concord

Six Flags Hurricane Harbor Concord, Northern California’s Most Thrilling Waterpark, features more than 22 rides and attractions like Break Point Plunge and Splashwater Island. Hurricane Harbor Concord is the premier destination for fun in the sun for the entire family.

Contacts

Sandra Daniels

972.595.5178

sdaniels@sftp.com

Tags Business, New Jersey

Business Healthcare

Teva to present new analyses of AUSTEDO® (deutetrabenazine) tablets and assessment of schizophrenia clinical outcomes at upcoming 2021 American Psychiatric Association annual meeting

Four posters examine the long-term efficacy, safety, and tolerability of AUSTEDO in patients with tardive dyskinesia and a review of clinical outcome measures in schizophrenia

TEL AVIV, Israel & PARSIPPANY, N.J. — (BUSINESS WIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced four new posters examining long-term analyses of AUSTEDO^®(deutetrabenazine) tablets and clinical outcome measures in schizophrenia will be presented at the upcoming 2021 American Psychiatric Association (APA) Annual Meeting taking place May 1-3, 2021.

“These analyses support our ongoing efforts to improve the lives of people with neurological and psychiatric disorders, and we remain committed to driving progress for patients and the physicians who manage their care,” said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. “We look forward to participating in meaningful scientific exchange at APA around the body of evidence supporting the long-term use of AUSTEDO as a treatment option for tardive dyskinesia, and to foster a deeper understanding of the challenges and unmet needs in the mental health space.”

Teva will highlight long-term efficacy, safety, and tolerability data from the pivotal ARM-TD and AIM-TD clinical trials, as well as a three-year open-label extension study for AUSTEDO in the treatment of tardive dyskinesia (TD). These analyses examined the improvements in quality of life (QoL) and patient-centered outcomes with AUSTEDO by assessing QoL via modified craniocervical dystonia questionnaire (mCDQ-24) scores and patient-centered outcomes via abnormal involuntary movement scale (AIMS) scores through week 106 in a three-year open-label extension study. Exposure-adjusted incidence rates (EAIRs) were used to assess the frequency of adverse events (AEs) through week 145 of the study.

Additionally, Teva will present a comprehensive overview of the clinical outcome measures used in schizophrenia over the past 10 years.

Posters will be available online at the start of the meeting on May 1, 2021 and can be accessed via the APA meeting website at: www.psychiatry.org/annualmeeting.

The full set of Teva-sponsored data to be presented includes:

AUSTEDO^®

De novo:

Poster 4849: Long-Term Deutetrabenazine Treatment Is Associated with Sustained Improvements in Quality of Life in Patients with Tardive Dyskinesia
Poster 4390: Improvements in Patient-Centered Outcome Measures with Long-Term Deutetrabenazine Treatment among patients with Tardive Dyskinesia
Poster 4807: Long-Term Safety of Deutetrabenazine in Patients with Tardive Dyskinesia: Results from the Completed, 3-year Open-Label Extension Study

Schizophrenia

De novo:

Poster 4744: Clinical Outcome Assessment Instruments in Schizophrenia: A Scoping Review

AUSTEDO^® Indications and Usage

AUSTEDO^® is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults.

Important Safety Information About AUSTEDO^®

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO^®can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO^® is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO^® is contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO^® is also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine (Xenazine^®) or valbenazine (Ingrezza^®).

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO^® may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO^® in their patients by assessing the effect on chorea and possible adverse effects.

QTc Prolongation: AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO is administered within the recommended dosage range. AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO^®; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO^® may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO^® dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO^®may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO^® dose should be reduced; some patients may require discontinuation of therapy.

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO^®. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO^® and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO^®.

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.

Common Adverse Reactions: The most common adverse reactions for AUSTEDO^® (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO^® (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia.

Please see accompanying full Prescribing Information, including Boxed Warning.

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 and specialty 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 specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding AUSTEDO, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

the commercial success of AUSTEDO;
our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to develop and commercialize biopharmaceutical products; competition for our specialty products, including AUSTEDO, AJOVY^® and COPAXONE^®; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; and the effectiveness of our patents and other measures to protect our intellectual property rights;
our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
our business and operations in general, including: uncertainty regarding the magnitude, duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; and environmental risks;
other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;

and other factors discussed in this press release and in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Contacts

IR Contacts

United States
Kevin C. Mannix

(215) 591-8912

Israel

Yael Ashman

972 (3) 914-8262

PR Contacts

United States
Doris Yiu

(973) 265-3752

Israel
Yonatan Beker

972 (54) 888 5898

Tags Business, New Jersey

Business Local News

NRG Energy, Inc. to report First Quarter 2021 financial results on May 6, 2021

Post author By Michelle Dryden
Post date April 27, 2021
No Comments on NRG Energy, Inc. to report First Quarter 2021 financial results on May 6, 2021

PRINCETON, N.J. — (BUSINESS WIRE) — NRG Energy, Inc. (NYSE:NRG) plans to report its First Quarter 2021 financial results on Thursday, May 6, 2021. Management will present the results during a conference call and webcast at 9:00 a.m. Eastern.

A live webcast of the conference call, including presentation materials, can be accessed through NRG’s website at http://www.nrg.com and clicking on “Presentations & Webcasts” in the “Investors” section found at the top of the home page. The webcast will be archived on the site for those unable to listen in real time.

About NRG Energy

At NRG, we’re bringing the power of energy to people and organizations by putting customers at the center of everything we do. We generate electricity and provide energy solutions and natural gas to approximately 6 million customers through our diverse portfolio of retail brands. A Fortune 500 company, operating in the United States and Canada, NRG delivers innovative solutions while advocating for competitive energy markets and customer choice, working towards a sustainable energy future. More information is available at www.nrg.com. Connect with NRG on Facebook, LinkedIn and follow us on Twitter @nrgenergy.

Contacts

Investors:

Kevin L. Cole, CFA

609.524.4526

investor.relations@nrg.com

Media:

Candice Adams

609.524.5428

candice.adams@nrg.com

Tags Business, New Jersey

Business Technology

Spectranetix announces CMOSS TSM solution for U.S. Army Capability Set 23

Post author By Michelle Dryden
Post date April 27, 2021
No Comments on Spectranetix announces CMOSS TSM solution for U.S. Army Capability Set 23

SUNNYVALE, Calif. — (BUSINESS WIRE) — #C4ISRNET–Spectranetix, Inc., a Pacific Defense company, is proud to announce that its industry-first integration of TrellisWare Technologies’ TSM™ software into a communications solution aligned with the U.S. Army’s C5ISR Modular Open Suite of Standards (CMOSS) and The Open Group’s Sensor Open Systems Architecture™ (SOSA) technical standard has recently completed a successful Phase 2 test under U.S. Army TEM4 CS23 effort.

Spectranetix delivered a prototype ComScan^® multi-mission EW/SIGINT/COMMS/PNT system providing tactical communications network capability in line with U.S. Army’s Capability Set 23 (CS23) objective of modernizing tactical network capacity, resiliency, and convergence.

“Spectranetix is at the forefront of the development and driving the adoption of U.S. Army CMOSS and The Open Group SOSA™ aligned capabilities by our customers,” said Bret Banfield, VP GM of Spectranetix. “This successful TEM4 CMOSS TSM demonstration furthers the Army’s objective of having a multi-mission converged capability on mounted vehicles.”

More information about the importance of industry partners like Spectranetix to the U.S. Army’s Capability Set 23 (CS23) design goals can be found here:

https://www.army.mil/article/244873/industry_partner_events_accelerate_armys_prototype_to_fielding_cycle

The ComScan^® system delivered under this program is CMOSS and SOSA™ aligned and is populated with the Precision Navigation and Timing (PNT) plug-in card and SX-610 Mobile Ad-hoc Networking (MANET) CMOSS Radio Card to enable tactical communications via the TrellisWare^® TSM™ MANET waveform. The TSM™ waveform provides transport of voice, data, and position information over a wide range of frequencies in the UHF/L/S bands without requiring additional infrastructure. TrellisWare’s TSM™ waveform will be fielded as the advanced networking waveform for the ITN Capability Set 21 covering the Handheld, Manpack, and Small Form Factor (HMS) Program of Record (PoR) platforms.

The Phase 2 test was conducted at U.S. Army Support Activity, Fort Dix where the CMOSS ComScan^® system was integrated into the Stryker platform and demonstrated full interoperability with existing hand-held Army Leader radios utilizing TSM-6 waveform. The Phase 1 test was conducted at the U.S. Army’s Open Innovation Lab, APG. Additional demonstrations will be performed at the Army’s NetModX (CGA, Fort Dix, New Jersey; May-June 2021) and PNTAX (White Sands Missile Range, New Mexico; October-November 2021) events.

“This program highlights Spectranetix commitment to bring CMOSS based Tactical Communication capabilities to market and serve the needs of tactical radio and network communications systems in one converged system that is both adaptable and scalable to mission and platform needs,” said Ranjeet Jhutti, Sr. Technical Program Manager (TacCom) at Spectranetix.

About Spectranetix, Inc.

Spectranetix, based in Silicon Valley and Seattle, builds state-of-the-art CMOSS/SOSA™-aligned systems and wireless technologies for defense primes, military groups, government agencies, and commercial industries. Spectranetix’s core competencies are building CMOSS/SOSA™-aligned hardware/software/toolkits, radio frequency communications, electronic warfare technologies, system design, networking, and hardware/software integration. Information about Spectranetix is available at www.spectranetix.com.

Spectranetix is part of the Pacific Defense family of companies. Headquartered in El Segundo, California, Pacific Defense takes an organic, commercial-minded approach to military-use electromagnetic spectrum technologies and solutions. Pacific Defense supports the DoD’s disciplined movement to modular open standards and mirrors the way military services address EMS warfare. For more information visit www.pacific-defense.com.

About TrellisWare Technologies, Inc.

TrellisWare Technologies, Inc. is a worldwide leader in highly advanced algorithms, waveforms, and communications systems that range from small form factor radio products to fully integrated solutions. Our TSM™ waveform is incorporated into a wide range of systems, including TrellisWare radios and trusted industry partner radios, as well as multiple government and commercial solutions. TrellisWare is delivering the next generation of communications for military and commercial markets When Nothing Else Works™. For more information on TrellisWare’s products and solutions, please visit www.trellisware.com.

Contacts

Spectranetix Media Contact
Kent Mader

kent.mader@spectranetix.com

TrellisWare Media Contact
Tina Bachman

TBachman@trellisware.com

Tags Business, New Jersey

Business Healthcare

AM Best assigns credit ratings to Hospitals insurance Company, Inc.

Post author By Michelle Dryden
Post date April 26, 2021
No Comments on AM Best assigns credit ratings to Hospitals insurance Company, Inc.

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has assigned a Financial Strength Rating of A- (Excellent) and a Long-Term Issuer Credit Rating of “a-” to Hospitals Insurance Company, Inc. (HIC) (New York, NY). The outlook assigned to the Credit Ratings (ratings) is stable.

The ratings reflect HIC’s balance sheet strength, which AM Best assesses as strongest, as well as its adequate operating performance, limited business profile and appropriate enterprise risk management.

The balance sheet strength assessment reflects the company’s risk-adjusted capitalization at the strongest level, as measured by Best’s Capital Adequacy Ratio (BCAR), which benefits from modest underwriting leverage, prudent reserving practices and a conservative investment portfolio. The company has a history of organic surplus growth and good quality of capital with no debt or surplus notes. HIC reported pre-tax operating income in each of the prior five years. Five-year average operating ratios and return metrics are better than the medical professional liability (MPL) peer group composite. AM Best expects these metrics to be more in line with or slightly outperform the peer group composite in the future.

HIC specializes in providing MPL insurance to hospitals and physicians affiliated with its insured hospitals in New York. Along with its sister company, Healthcare Risk Advisors (HRA), the combined entities offer an integrated approach to claims handling, risk management and data analytics that can provide a broad set of risk finance and risk transfer solutions to clients. While HIC has elevated product and geographic concentration risks as a single-state, primarily monoline insurer, this is mitigated partially by management’s significant depth of experience in the New York hospital professional liability market.

The Doctors Company, An Interinsurance Exchange (TDC), the second largest MPL insurer in the United States, acquired HIC in 2019. The company served the major N.Y. hospital systems—Mount Sinai, Montefiore and Maimonides—before its acquisition, and continues to do so post-acquisition. HIC recently opened its distribution model to accept other hospitals and physician groups in New York. While growth is projected to be moderate over the next few years, the planned expansion does carry a degree of execution risk. AM Best considers the group’s risk-management capabilities appropriate for the group’s risk profile. HIC has largely adopted the ERM practices of its parent, TDC.

The stable outlooks reflect the expectation that HIC will maintain a balance sheet assessment at the strongest level over the intermediate term with adequate operating results contributing to surplus growth needed to support the company’s expanding book of business following the opening of the HRA/HIC program to hospitals and physician groups in New York.

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 media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

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.

Contacts

Jieqiu Fan
Senior Financial Analyst
+1 908 439 2200, ext. 5372
jieqiu.fan@ambest.com

Sharon Marks
Associate Director
+1 908 439 2200, ext. 5477
sharon.marks@ambest.com

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

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

Tags Business, New Jersey

Business

AM Best revises outlooks to negative for members of GeoVera Insurance Group

Post author By Michelle Dryden
Post date April 25, 2021
No Comments on AM Best revises outlooks to negative for members of GeoVera Insurance Group

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has revised the outlooks to negative from stable and affirmed the Financial Strength Rating (FSR) of A (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICR) of “a” of the members of GeoVera Insurance Group (GeoVera) (headquartered in Fairfield, CA), which operate under an intercompany reinsurance agreement. (See below for a listing of the companies.)

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

The negative outlooks follow several years of outsized catastrophe losses, which has weakened GeoVera’s operating performance relative to similarly assessed companies. The increased catastrophe activity includes almost 30 points in recent annual combined ratios on average. The company budgets a sound catastrophe load annually, but recent related activity has generated losses exceeding budget. In addition, high acquisition costs incrementally increased the expense ratio as part of expansion initiatives introduced in 2015. Although the reinsurance program has been effective in protecting GeoVera from large losses, the company has been impacted by increasingly frequent catastrophe and near catastrophe-level activity, resulting in volatile operating results.

AM Best expects prospective operating performance to improve as a result of management’s strategy to reshape the company’s portfolio and increase pricing on residential wind business while expanding the use of endorsements limiting exposure to weather-driven losses. Under the leadership of its new CEO, GeoVera is executing its strategy to exit admitted wind and non-core markets and diversify its book of business, with renewed growth in the residential earthquake book and assumption of a portion of commercial wind exposure underwritten by AmRisc LLC, a managing general agent that specializes in underwriting commercial catastrophe exposed property. A reduction of the homeowners’ book is expected to help lower the overall expense ratio, which is higher than its peers. Management expects the strategy to return the company to historically strong operating results.

Negative rating action may result if operating results fall short of management’s expectations for its revised underwriting strategy, or if volatility from catastrophe activity results in outsized losses that do not resemble similarly rated entities, or from a significant deterioration in capital strength. Positive rating action may result from consistent operating performance that compares favorably with the group’s composite of personal property companies and similarly rated entities.

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

Coastal Select Insurance Company
GeoVera Insurance Company
GeoVera Reinsurance, Ltd.
GeoVera Specialty Insurance Company

Contacts

Dan Teclaw
Associate Director
+1 908 439 2200, ext. 5394
dan.teclaw@ambest.com

Susan Molineux
Director
+1 908 439 2200, ext. 5829
susan.molineux@ambest.com

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

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

Tags Business, New Jersey

Business Sports & Gaming

BetRivers Lounge opens at PPG Paints Arena

Post author By Michelle Dryden
Post date April 25, 2021
No Comments on BetRivers Lounge opens at PPG Paints Arena

Rivers Casino Pittsburgh and BetRivers.com are the “Official Casino” and “Official Sportsbook” of the Pittsburgh Penguins

PITTSBURGH — (BUSINESS WIRE) — For Pittsburgh hockey fans and sports enthusiasts alike, there’s a new branded, hi-tech addition to PPG Paints Arena. The all-new BetRivers Lounge at PPG Paints Arena will officially open on Saturday, April 24, for the 12:30 p.m. Penguins game vs. the New Jersey Devils. The lounge is located on the FedEx level, third floor, section 119.

Last fall, Rivers Casino Pittsburgh and Rush Street Interactive’s BetRivers.com announced an exclusive deal with the Pittsburgh Penguins to build a sportsbook-style lounge at PPG Paints Arena. The new space features two rows of ticketed bowl seats, a lounge area with club chairs, a generous bar top, hi-def video screens, and streaming odds boards. The BetRivers Lounge at PPG Paints Arena is designed to elevate the game-day experience by integrating BetRivers, the market-leading retail sportsbook and popular online casino, into the arena.

Rivers Casino Pittsburgh and BetRivers.com are the “Official Casino” and the “Official Sportsbook” of the Pittsburgh Penguins.

Guests 21 or older who have BetRivers.com accounts can watch and wager on Penguins games and other sporting events from BetRivers Lounge, anywhere in PPG Paints Arena, at Rivers Casino Pittsburgh, and elsewhere throughout the Commonwealth. All wagering is via personal mobile devices using the BetRivers Pennsylvania app. In addition, while in attendance, in-game betting allows fans to continue to stay engaged throughout the game.

The sportsbook-style lounge at PPG Paints Arena matches the look and feel of the popular in-casino sportsbook at Rivers Casino on the North Shore, and it’s created by the same designer, DMAC Architecture of Chicago.

“The BetRivers Lounge is yet another investment delivered under our Rivers partnership to enhance fan experiences inside PPG Paints Arena,” said David Morehouse, president and CEO of the Penguins. “The lounge will provide a safe and exciting space for fans to enjoy an innovative and multimedia experience while attending Pens games and other live sporting events year-round.”

“Rivers Casino Pittsburgh is particularly proud of our longstanding relationship with the Penguins, and we’re delighted that the BetRivers Lounge is now open,” said Bill Keena, general manager of Rivers Casino Pittsburgh. “The architectural renderings have come to life perfectly, and the views of the ice are terrific.”

“The BetRivers Lounge symbolizes our strong partnership with the Penguins, five-time Stanley Cup champions, and our commitment to Pittsburgh sports generally,” said Mattias Stetz, chief operating officer of Rush Street Interactive, the operator of BetRivers.com. “The new lounge enhances the experience of watching live and wagering in real-time. We are proud to be the exclusive sportsbook of this winning franchise.”

Rush Street Interactive was the first online gaming company to launch online sports wagering in Pennsylvania. It also operates online sportsbooks in Illinois, New Jersey, Indiana, Virginia, Iowa, Michigan, and Colorado.

ABOUT RSI

RSI is a trusted online gaming and sports entertainment company focused on regulated markets in the United States and Latin America. Through its brands, BetRivers.com and PlaySugarHouse.com, RSI was an early entrant in many regulated jurisdictions and is currently live with real-money mobile, online and/or retail operations in ten U.S. states: Pennsylvania, Illinois, New Jersey, New York, Michigan, Indiana, Virginia, Colorado, Iowa and West Virginia. RSI is also active internationally, offering its online casino and sportsbook in the regulated gaming market of Colombia on RushBet.co. RSI offers, through its proprietary online gaming platform, some of the most popular online casino games and sports betting options in the United States. Founded in 2012 in Chicago by gaming industry veterans, RSI was named the 2020 Global Gaming Awards Digital Operator of the Year and the 2020 EGR North America Awards Casino Operator of the Year and Customer Service Operator of the Year. RSI is committed to industry-leading responsible gaming practices and seeks to provide its customers with the resources and services they need to play responsibly. For more information, visit www.rushstreetinteractive.com.

ABOUT RIVERS CASINO PITTSBURGH

Located along the Ohio River’s North Shore, Rivers Casino Pittsburgh features an action-packed gaming floor which includes slots, table games, hybrid gaming seats, poker room, and BetRivers Sportsbook for live sports betting and viewing. The casino offers four distinctive restaurants—Martorano’s Prime, FLIPT, Mian, and Wheelhouse Bar & Grill—a multipurpose Event Center, a riverfront Ballroom and free self-parking. Rivers Casino Pittsburgh is owned and operated by Rush Street Gaming and its affiliates. For the latest information, including new hours of operation, visit RiversCasino.com/Pittsburgh.

Contacts

Pittsburgh Penguins

Jennifer Bullano Ridgley

jbullano@pittsburghpenguins.com
412-255-1777

BetRivers/Rush Street Interactive

Lisa Johnson

lisa@lisajohnsoncommunications.com
609-788-8548

Rivers Casino Pittsburgh

Jack Horner

jack@hornercom.com
412-600-2295

Tags Business, New Jersey

Business Technology

AeroFarms expands global headquarters to support growth and innovation

Post author By Michelle Dryden
Post date April 23, 2021
No Comments on AeroFarms expands global headquarters to support growth and innovation

Indoor vertical farming leader continues commitment to Newark as it expands presence within the community

Co-Founder & CEO David Rosenberg recognized as ROI-NJ Top Technology Influencer

NEWARK, N.J. — (BUSINESS WIRE) — $SV #Agriculture–AeroFarms, a certified B Corporation and leader in indoor vertical farming, today announced that the Company has received its certificate of occupancy for expansion of its global headquarters in Newark, New Jersey. To support its corporate expansion, AeroFarms recently completed the build out of an additional 25,000 square-feet at its headquarters for new office space and more expansive R&D and Innovation Centers of Excellence.

In 2015, AeroFarms partnered closely with the City of Newark and the New Jersey Economic Development Authority (NJEDA), to relocate its headquarters to Newark from the Finger Lakes region of New York with the goal of creating more than 75 year-round jobs in the local community. Today, AeroFarms employs in Newark more than 150 team members, and the Company is delivering on its vision of not only serving the broader New York metro area, but also serving as the global epicenter for large scale commercial indoor vertical farming and the latest in breakthrough proprietary technologies addressing some of the world’s most pressing agricultural challenges.

AeroFarms has been leading the way for innovation and technology breakthroughs since its inception and will continue to build on this legacy through continued R&D and infrastructure to maintain its leadership position as the Company scales. Earlier this week, AeroFarms Co-Founder and CEO David Rosenberg was recognized as a Top Technology Influencer by New Jersey media outlet ROI-NJ, further demonstrating the Company’s leadership in technology and innovation.

“New Jersey and Newark have been the perfect home for AeroFarms to recruit the best talent for horticulture, engineering, data science, operations, and food safety enabling us to reimagine agriculture in the Garden State,” said Rosenberg. “We are scaling farms around the world, partnering closely with major multi-national retailers, and our newly expanded global headquarters will be a showcase for our transformative work and innovation that will further drive our mission to grow the best plants possible for the betterment of humanity.”

AeroFarms has a long history of community involvement, including partnering with Ironbound Community Corporation and NJ Reentry Program, which offers career opportunities to those previously incarcerated. In addition, AeroFarms has made an impact with its Community Farms, working with partners such as Newark-based Philips Academy Charter School and their EcoSpaces program. The Company also partnered with the City of Jersey City and the World Economic Forum’s Healthy Cities and Communities initiative for the first ever municipal indoor vertical farming program, consisting of ten vertical farms throughout Jersey City located in senior centers, schools, public housing complexes, and municipal buildings. The ten sites will grow 19,000 pounds of vegetables annually, using targeted aeroponics water mist and minimal electricity, and the food will be provided to the community for no cost.

About AeroFarms

Since 2004, AeroFarms has been leading the way for indoor vertical farming and championing transformational innovation for agriculture. On a mission to grow the best plants possible for the betterment of humanity, AeroFarms is a Certified B Corporation Company with global headquarters in Newark, New Jersey, United States. Named one of the World’s Most Innovative Companies by Fast Company two years in a row and one of TIME’s Best Inventions, AeroFarms patented, award-winning indoor vertical farming technology provides the perfect conditions for healthy plants to thrive, taking agriculture to a new level of precision, food safety, and productivity while using up to 95% less water and no pesticides versus traditional field farming. AeroFarms enables local production to safely grow all year round for its commercial retail brand that offers peak flavor always®. In addition, through its proprietary growing technology platform, AeroFarms has developed multi-year strategic partnerships ranging from government to major Fortune 500 companies to help uniquely solve agriculture supply chain needs. For additional information, visit: https://aerofarms.com/.

On March 26, 2021, AeroFarms announced a definitive business combination agreement with Spring Valley Acquisition Corp. (Nasdaq: SV). Upon the closing of the business combination, AeroFarms will become publicly traded on Nasdaq under the new ticker symbol “ARFM”. Additional information about the transaction can be viewed here: https://aerofarms.com/investors/

No Offer or Solicitation

This press release does not constitute an offer to sell or a solicitation of an offer to buy, or the solicitation of any vote or approval in any jurisdiction in connection with a proposed potential business combination among Spring Valley and AeroFarms or any related transactions, nor shall there be any sale, issuance or transfer of securities in any jurisdiction where, or to any person to whom, such offer, solicitation or sale may be unlawful. Any offering of securities or solicitation of votes regarding the proposed transaction will be made only by means of a proxy statement/prospectus that complies with applicable rules and regulations promulgated under the Securities Act of 1933, as amended (the “Securities Act”), and Securities Exchange Act of 1934, as amended, or pursuant to an exemption from the Securities Act or in a transaction not subject to the registration requirements of the Securities Act.

Forward Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. All statements, other than statements of present or historical fact included in this presentation, regarding Spring Valley’s proposed acquisition of AeroFarms, Spring Valley’s ability to consummate the transaction, the benefits of the transaction and the combined company’s future financial performance, as well as the combined company’s strategy, future operations, estimated financial position, estimated revenues and losses, projected costs, prospects, plans and objectives of management are forward-looking statements. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the respective management of AeroFarms and Spring Valley and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of AeroFarms and Spring Valley. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; the inability of the parties to successfully or timely consummate the proposed transaction, including the risk that any regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the proposed transaction or that the approval of the stockholders of Spring Valley or AeroFarms is not obtained; failure to realize the anticipated benefits of the proposed transaction; risks relating to the uncertainty of the projected financial information with respect to AeroFarms; risks related to the expansion of AeroFarms’ business and the timing of expected business milestones; the effects of competition on AeroFarms’ business; the ability of Spring Valley or AeroFarms to issue equity or equity-linked securities or obtain debt financing in connection with the proposed transaction or in the future, and those factors discussed in Spring Valley’s final prospectus dated November 25, 2020 under the heading “Risk Factors,” and other documents Spring Valley has filed, or will file, with the SEC. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that neither Spring Valley nor AeroFarms presently know, or that Spring Valley nor AeroFarms currently believe are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Spring Valley’s and AeroFarms’ expectations, plans, or forecasts of future events and views as of the date of this press release. Spring Valley and AeroFarms anticipate that subsequent events and developments will cause Spring Valley’s and AeroFarms’ assessments to change. However, while Spring Valley and AeroFarms may elect to update these forward-looking statements at some point in the future, Spring Valley and AeroFarms specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing Spring Valley’s and AeroFarms’ assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts

AeroFarms Contacts

Investor Relations:

Jeff Sonnek

ICR

Jeff.Sonnek@icrinc.com
1-646-277-1263

Media Relations:

Marc Oshima
AeroFarms

MarcOshima@AeroFarms.com
1-917-673-4602

Tags Business, New Jersey

Business

AM Best places credit ratings of Hallmark Financial Services, Inc. and its subsidiaries under review with developing implications

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has placed under review with developing implications the Long-Term Issuer Credit Rating (Long-Term ICR) of “bbb-” and the Long-Term Issue Credit Rating (Long-Term IR) of Hallmark Financial Services, Inc. (Hallmark Financial) [NASDAQ:HALL]. Concurrently, AM Best has placed under review with developing implications the Financial Strength Rating (FSR) of A- (Excellent) and the Long-Term ICRs of “a-” of the members of Hallmark Insurance Group (Hallmark Group). The companies’ operations are headquartered in Dallas, TX. (See below for a detailed listing of the companies and Credit Ratings [ratings].)

These ratings have been placed under review with developing implications following the announcement by Hallmark Financial that it intends to pursue an initial public offering (IPO) of its specialty commercial business. Hallmark Financial plans to offer a non-controlling ownership stake in the core business of its specialty commercial business segment, as a separate company named Hallmark Specialty Group, Inc. (Hallmark Specialty). The number of shares and price range for Hallmark Specialty has yet to be determined; however, the offered shares are expected to represent an economic ownership stake of approximately 50% as Hallmark Financial intends to retain a majority of the combined vote power of Hallmark Specialty. The IPO process is expected to be completed during the third quarter of 2021.

The under review status reflects the uncertainty surrounding the amount and utilization of capital that will be generated from the IPO process. In addition, the IPO is dependent upon a number of factors and uncertainties heightening execution risk inherent with this transaction. Should the IPO be unsuccessful in raising sufficient funds, Hallmark Group’s risk-adjusted capital may fall below AM Best’s expectations. However, the benefits of the proposed transaction would allow Hallmark Financial and Hallmark Specialty to focus on respective seasoned books of business and profitability to achieve strategic priorities. The ratings will remain under review until AM Best has assessed the ultimate organizational structure of the group and its risk-adjusted capital position, following completion of the IPO.

The FSR of A- (Excellent) and the Long-Term ICRs of “a-” have been placed under review with developing implications for the following members of Hallmark Insurance Group:

American Hallmark Insurance Company of Texas
Hallmark Insurance Company
Hallmark Specialty Insurance Company
Hallmark County Mutual Insurance Company
Hallmark National Insurance Company

The following Long-Term IR has been placed under review with developing implications:

Hallmark Financial Services, Inc.—

“bbb-” on $50 million 6.25% senior unsecured notes, due 2029

The following indicative Long-Term IRs for securities available under the shelf registration have been placed under review with developing implications:

Hallmark Financial Services, Inc.—

“bbb-” on senior unsecured debt
“bb+” on subordinated debt
“bb” on preferred stock

Contacts

Daniel Mangano
Senior Financial Analyst
+1 908 439 2200, ext. 5547
daniel.mangano@ambest.com

Jacqalene Lentz, CPA
Director
+1 908 439 2200, ext. 5762
jacqalene.lentz@ambest.com

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

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

Tags Business, New Jersey