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Cross River deepens roots in New Jersey with the opening of new headquarters in Fort Lee

A true demonstration of successful private-public collaboration, Company is joined by leaders from the community to cut the ribbon on its new home

Since its founding in New Jersey in 2008, Company has grown to over 520 team members and plans to hire 100 more by year-end

 

FORT LEE, N.J. — (BUSINESS WIRE) — Cross River Bank (“Cross River”), a technology-focused financial services organization and Banking-as-a-Service (“BaaS”) provider based in Fort Lee, today announced the grand opening of its new headquarters at 2115 Linwood Avenue. At a ribbon-cutting ceremony yesterday, Cross River was joined by New Jersey leaders and elected officials, as well as Cross River board members and investors.


“We are immensely proud that in calling New Jersey home, Cross River has recognized the wealth of advantages our state has to offer, including one of the most diverse and educated workforces in the country,” said Governor Phil Murphy. “Cross River and companies like them are exactly the type of innovative firms that will help bring our state once again to the forefront of the innovation economy.”

“There is one address in the fintech industry, and that is Cross River. Our new headquarters is emblematic of our growth here in New Jersey, but more importantly, plants the seed of the future for Cross River,” said Gilles Gade, Founder, CEO and Chairman of Cross River. “We thank Governor Murphy and the NJEDA for their support and we’re thrilled to celebrate this momentous occasion with the entire Cross River family, together with our community partners and neighbors who have been right beside us from the very beginning.”

Cross River merges the forward-thinking offerings of a technology company with the established expertise of a bank, while maintaining a strong focus on regulatory compliance and consumer protection. As a New Jersey state-chartered community bank, Cross River has demonstrated firsthand how the state’s structure and support has played an integral role in propelling economic advancement, innovation and increased investment opportunities. Under the leadership of Governor Phil Murphy and the New Jersey Economic Development Authority (NJEDA) led by Tim Sullivan, Cross River was awarded a Grow NJ Grant to help purchase a new 70,000-square-foot building in Fort Lee. Since announced in 2019, Cross River has already hired more than 400 team members, nearly doubling its workforce in New Jersey.

“Attracting and supporting the growth of innovative companies that create good-paying jobs for New Jersey workers and support the success of other emerging New Jersey businesses is central to Governor Phil Murphy’s plan for a stronger, fairer New Jersey economy,” said New Jersey Economic Development Authority CEO Tim Sullivan. “In addition to creating hundreds of new jobs, Cross River is committed to helping entrepreneurs overcome challenges by improving access to capital and offering educational resources that help to prepare them for future opportunities. The NJEDA congratulates Cross River on opening this new office, and we are excited for their continued growth in New Jersey.”

“Cross River represents the true spirit of the state of New Jersey—innovative, forward-thinking and hyper-community focused,” said Fort Lee Mayor Mark Sokolich. “Fort Lee is incredibly excited to continue to be the home for Cross River, and we look forward to the company’s continued growth and success here.”

Cross River is at the forefront of both banking and technology, powering some of the most successful companies like Affirm, Coinbase, Rocket Loans, Stripe and Upstart. Having opened its doors in Teaneck in June of 2008 with the primary goal of providing access to responsible credit products for businesses and consumers in need, Cross River has flourished in the state as a result of its public-private collaboration and the support of the local legislators and organizations like the NJEDA, Choose New Jersey, the New Jersey-Israel Commission and the New Jersey Bankers Association.

“The talent in New Jersey and the region has been one of the key ingredients to our success and growth as a leading fintech company,” said David Nachbar, Global Head of People at Cross River. “We have the best and the brightest people, the vast majority of whom live close by, right here in New Jersey.”

A pillar of the New Jersey community, Cross River has driven innovation and job creation in the state, with a strong focus on giving back. Cross River’s substantial impact on the advancement of industry standards and accomplishments as an outstanding corporate citizen has been recognized by both national and local organizations including the American Bankers Association, the Independent Community Bankers of America, NJBIZ, TechUnited:NJ and the Teaneck and Fort Lee Chambers of Commerce.

About Cross River

Cross River is a fast-growing financial services organization that merges the forward-thinking offerings of a technology company with the established expertise and traditional services of a bank. Since its founding in 2008, Cross River has developed strategic partnerships with leading technology companies, marketplace lenders and payment providers, while maintaining a strong focus on regulatory compliance and consumer protection. Cross River provides a highly secure, API-based banking platform and comprehensive suite of products encompassing lending, payments, risk management and Banking-as-a-Service (BaaS) offerings to deliver responsible financial solutions that empower businesses and consumers anytime, anywhere. Cross River Bank is a New Jersey state-chartered FDIC insured bank. For more information, please visit Cross River’s website at www.crossriver.com or Twitter @crossriverbank.

Contacts

Media
Cross River

Eden Hoffman

Phone: 201-808-7000 x538

ehoffman@crossriver.com

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Business

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

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 items1,2*

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 below1,2

$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

Read full story here

Categories
Business Entertainment News

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 21st 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:

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.

Follow us on Twitter at twitter.com/sf_newengland

Like us on Facebook at facebook.com/sixflagsne

Follow us on Instagram at instagram.com/SFNewEngland

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

Categories
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

Categories
Business Local News

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

Categories
Business Technology

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

Categories
Business Healthcare

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.

Copyright © 2021 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

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

Categories
Business

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

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.

Copyright © 2021 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

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

Categories
Business Sports & Gaming

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

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Healthcare Local News

Bristol Myers Squibb presents positive data from two pivotal Phase 3 psoriasis studies demonstrating superiority of deucravacitinib compared to placebo and Otezla® (apremilast)

Significantly more patients treated with deucravacitinib achieved PASI 75 and sPGA 0/1 compared to patients treated with placebo and Otezla at Week 16, with an increased benefit versus Otezla at Week 24 and maintained through Week 52

Deucravacitinib was well tolerated with a low rate of discontinuation due to adverse events

Deucravacitinib is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action

Results presented as late-breaking research at the 2021 American Academy of Dermatology Virtual Meeting Experience

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #AADVMX2021—Bristol Myers Squibb (NYSE:BMY) today announced positive results from two pivotal Phase 3 trials evaluating deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. The POETYK PSO-1 and POETYK PSO-2 trials, which evaluated deucravacitinib 6 mg once daily, met both co-primary endpoints versus placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI) 75 response and a static Physician’s Global Assessment score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib. Deucravacitinib was well tolerated with a low rate of discontinuation due to adverse events (AEs).


Deucravacitinib demonstrated superior skin clearance compared with Otezla® (apremilast) for key secondary endpoints in both studies, as measured by PASI 75 and sPGA 0/1 responses at Week 16 and Week 24. Findings include:

PASI 75 Response in POETYK PSO-1 and POETYK PSO-2:

  • At Week 16, 58.7% and 53.6% of patients receiving deucravacitinib achieved PASI 75 response, respectively, versus 12.7% and 9.4% receiving placebo and 35.1% and 40.2% receiving Otezla.
  • At Week 24, 69.0% and 59.3% of patients receiving deucravacitinib achieved PASI 75 response, respectively, versus 38.1% and 37.8% receiving Otezla.
  • Among patients who achieved PASI 75 response at Week 24 with deucravacitinib and continued treatment with deucravacitinib, 82.5% and 81.4%, respectively, maintained PASI 75 response at Week 52.

sPGA 0/1 Response in POETYK PSO-1 and POETYK PSO-2:

  • At Week 16, 53.6% and 50.3% of patients receiving deucravacitinib achieved sPGA 0/1 response, respectively, versus 7.2% and 8.6% receiving placebo and 32.1% and 34.3% receiving Otezla.
  • At Week 24, 58.4% and 50.4% of patients receiving deucravacitinib achieved sPGA 0/1 response, respectively, versus 31.0% and 29.5% receiving Otezla.

“In both pivotal studies, deucravacitinib was superior to Otezla across multiple endpoints, including measures of durability and maintenance of response, suggesting that deucravacitinib has the potential to become a new oral standard of care for patients who require systemic therapy and need a better oral option for their moderate to severe plaque psoriasis,” said April Armstrong, M.D., M.P.H., Associate Dean and Professor of Dermatology at the University of Southern California. “As many patients with moderate to severe plaque psoriasis remain undertreated or even untreated, it is also highly encouraging to see that deucravacitinib improved patient symptoms and outcomes to a greater extent than Otezla.”

Superiority of Deucravacitinib Versus Placebo and Otezla

Deucravacitinib demonstrated a robust efficacy profile, including superiority to placebo for the co-primary endpoints and to Otezla for key secondary endpoints. In addition to PASI 75 and sPGA 0/1 measures, deucravacitinib was superior to Otezla across both studies in multiple other secondary endpoints, demonstrating significant and clinically meaningful efficacy improvements in symptom burden and quality of life measures.

POETYK PSO-1 and POETYK PSO-2 Results at Week 16 and Week 24

Endpoint

POETYK PSO-1 (n=666)

POETYK PSO-2 (n=1,020)

Deucravacitinib

6 mg

(n=332)

Otezla

30 mg

(n=168)

Placebo

(n=166)

Deucravacitinib

6 mg

(n=511)

Otezla

30 mg

(n=254)

Placebo

(n=255)

PASI 75*a

Week 16

58.7%*†

35.1%

12.7%

53.6%*‡

40.2%

9.4%

Week 24

69.0%†

38.1%

–

59.3%†

37.8%

–

sPGA 0/1*b

Week 16

53.6%*†

32.1%

7.2%

50.3%*†

34.3%

8.6%

Week 24

58.4%†

31.0%

–

50.4%†

29.5%

–

(Scalp) ss-PGA 0/1c

Week 16

70.8%*†

39.1%

17.4%

60.3%*†

37.3%

17.3%

Week 24

71.8%†

42.7%

–

59.7%‡

41.6%

–

PSSD-Symptoms CFBd

Week 16

-26.7*†

-17.8

-3.6

-28.3*†

-21.1

-4.7

Week 24

-31.9†

-20.7

–

-29.1†

-21.4

–

DLQI 0/1e

Week 16

40.7%*†

28.6%

10.6%

38.0%*†

23.1%

9.8%

Week 24

47.8%‡

24.2%

–

41.8%†

21.5%

–

*Co-primary endpoints for POETYK PSO-1 and POETYK PSO-2 were PASI 75 and sPGA 0/1 for deucravacitinib vs placebo at Week 16.

a. PASI 75 is defined as at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores. *p<0.0001 vs placebo. †p<0.0001 vs Otezla. ‡p=0.0003 vs Otezla.

b. sPGA 0/1 is defined as a static Physician’s Global Assessment (sPGA) score of clear or almost clear. *p<0.0001 vs placebo. †p<0.0001 vs Otezla.

c. ss-PGA 0/1 is defined as a scalp-specific Physician’s Global Assessment (ss-PGA) score of clear or almost clear in those with ss-PGA of at least 3 (moderate) at baseline. POETYK PSO-1: *p<0.0001 vs placebo. †p<0.0001 vs Otezla. POETYK PSO-2: *p<0.0001 vs placebo. †p<0.0001 vs Otezla. ‡p=0.0002 vs Otezla.

d. Change from baseline (CFB) in Psoriasis Symptoms and Signs Diary (PSSD) captures improvement in symptoms of itch, pain, stinging, burning and skin tightness in patient eDiaries. *p<0.0001 vs placebo. †p<0.0001 vs Otezla.

e. Dermatology Life Quality Index (DLQI) 0/1 scores reflect no effect at all on patient’s life in patients with a baseline DLQI score of ≥2. POETYK PSO-1: *p<0.0001 vs placebo. †p=0.0106 vs Otezla. ‡p<0.0001 vs Otezla. POETYK PSO-2: *p<0.0001 vs placebo. †p<0.0001 vs Otezla.

Safety and Tolerability

Deucravacitinib was well-tolerated and had a similar safety profile in both trials. At Week 16, 2.9% of 419 patients on placebo, 1.8% of 842 patients on deucravacitinib and 1.2% of 422 patients on Otezla experienced serious adverse events (SAEs) across both studies. The most common AEs (≥5%) with deucravacitinib treatment at Week 16 were nasopharyngitis and upper respiratory tract infection with low rates of headache, diarrhea and nausea. At Week 16, 3.8% of patients on placebo, 2.4% of patients on deucravacitinib and 5.2% of patients on Otezla experienced AEs leading to discontinuation. Across POETYK PSO-1 and POETYK PSO-2 over 52 weeks, SAEs when adjusted for exposure (exposure adjusted incidence per 100 patient-years [EAIR]) were 5.7 with placebo, 5.7 with deucravacitinib and 4.0 with Otezla. In the same timeframe across both studies, EAIRs for AEs leading to discontinuation were 9.4 with placebo, 4.4 with deucravacitinib and 11.6 with Otezla. No new safety signals were observed during Weeks 16‒52.

Across both Phase 3 trials, rates of malignancy, major adverse cardiovascular events (MACE), venous thromboembolism (VTE) and serious infections were low and generally consistent across active treatment groups. No clinically meaningful changes were observed in multiple laboratory parameters (including anemia, blood cells, lipids and liver enzymes) over 52 weeks.

“The findings from both studies affirm that deucravacitinib – a first-in-class, oral, selective TYK2 inhibitor with a unique mechanism of action that inhibits the IL-12, IL-23 and Type 1 IFN pathways – may become an oral treatment of choice for people living with psoriasis. We believe deucravacitinib has significant potential across a broad range of immune-mediated diseases, and we are committed to further advancing our expansive clinical program with this agent,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “We are in discussions with health authorities with the goal of bringing this new therapy to appropriate patients as soon as possible. At Bristol Myers Squibb, we are committed to building an immunology portfolio that addresses pressing unmet needs that exist for those impacted by serious dermatologic conditions and other immune-mediated diseases, to ultimately deliver the promise of living a better life.”

These results are available as a late-breaking research presentation (Session S033 – Late-Breaking Research Abstracts) as part of the 2021 American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX). Full results of both studies will be submitted to a medical journal for peer review. In November 2020 and February 2021, respectively, Bristol Myers Squibb announced positive topline results from POETYK PSO-1 and POETYK PSO-2.

Visit www.bms.com/media/medical-meetings/bms-at-aad-vmx.html for more information on Bristol Myers Squibb’s scientific approach and resources on psoriasis and immune-mediated diseases.

Virtual Investor Event

Bristol Myers Squibb will host a virtual Investor Event on Friday, April 23, 2021 at 10:30 a.m. EDT to discuss the POETYK PSO-1 and POETYK PSO-2 data presented at AAD VMX. Company executives will provide an overview of data presented and address questions from investors and analysts.

Investors and the general public are invited to listen to a live webcast of the event at http://investor.bms.com. Materials related to the webcast will be available at the same website prior to the event. An archived edition of the Investor Event will be available later that day.

About Deucravacitinib

Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action. Deucravacitinib is the first and only TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-12, IL-23 and Type 1 interferon (IFN), key cytokines involved in psoriasis pathogenesis. Deucravacitinib achieves a high degree of selectivity by uniquely binding to the regulatory, rather than the active, domain of TYK2, which is structurally distinct from the regulatory domains of Janus kinase (JAK) 1, 2 and 3. At therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2 or JAK3. Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib.

Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. In addition to POETYK PSO-1 and POETYK PSO-2, Bristol Myers Squibb is evaluating deucravacitinib in three other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462); POETYK PSO-4 (NCT03924427); POETYK PSO-LTE (NCT04036435). Deucravacitinib is not approved for any use in any country.

About the Phase 3 POETYK PSO-1 and POETYK PSO-2 Studies

PrOgram to Evaluate the efficacy and safety of deucravacitinib, a selective TYK2 inhibitor (POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) are global Phase 3 studies designed to evaluate the safety and efficacy of deucravacitinib compared to placebo and Otezla® (apremilast) in patients with moderate to severe plaque psoriasis. Both POETYK PSO-1, which enrolled 666 patients, and POETYK PSO-2, which enrolled 1,020 patients, were multi-center, randomized, double-blind trials that evaluated deucravacitinib (6 mg once daily) compared with placebo and Otezla (30 mg twice daily). POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24.

The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 response and those who achieved static Physician’s Global Assessment (sPGA) score of 0 or 1 at Week 16 versus placebo. Key secondary endpoints of the trials included the percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at Week 16 and other measures.

About Psoriasis

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in Europe and approximately 7.5 million people in the United States. Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct round or oval plaques typically covered by silvery-white scales. Despite the availability of effective systemic therapy, many patients with moderate to severe psoriasis remain undertreated or even untreated and are dissatisfied with current treatments. People with psoriasis report an impact on their emotional well-being, straining both personal and professional relationships and causing a reduced quality of life. Psoriasis is associated with multiple comorbidities that may impact patients’ well-being, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease and depression.

About Bristol Myers Squibb

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

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

Otezla® (apremilast) is a registered trademark of Amgen Inc.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that deucravacitinib (BMS-986165) may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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