Tag: Business

Categories
Business Culture Economics Healthcare Lifestyle Regulations & Security Technology

HMG unveils Compass340B as part of extensive rebranding initiative

PARSIPPANY, N.J. — (BUSINESS WIRE) — HMG Consulting Services, LLC. is rebranding to Compass340B, to better reflect what we do: offer a fleet of services and technologies that support 340B stakeholders in achieving their 340B program performance and compliance goals.

 

Compass340B is our customers’ 340B Navigator!

 

“During the formative HMG years, our focus was to build service offerings and tools to ensure they were effective, complementary, and customized to our customers’ needs. As Compass340B, we are keeping with our roots, and looking forward to rolling out our web-based technology that will automate compliance in the second half of 2024,” says Nathan Coney, Vice President Sales of Compass340B.

 

“The improved branding will provide a better understanding of the company’s mission, with enhanced customer experiences, valuable resources, and solutions for the 340B industry. This initiative will also encourage our customers and prospects to stay on top of their 340B program using Compass340B as their guide and our upcoming software to get them there,” Nathan adds.

 

About Compass340B:

HMG Consulting Services, LLC. dba Compass340B was founded in 2015 to support our diverse network in the Healthcare industries by providing solutions specializing in 340B Compliance, External Audits and Business Operations. We are dedicated to providing exceptional solutions to our business partners through three key pillars: Service, Experience, and Relationships.

 

To learn about Compass340B, visit us at www.Compass340B.com

Contacts

Nathan Coney

Vice President, Sales

nconey@compass340b.com

info@compass340b.com
Telephone: 888-819-4447

Categories
Business Culture Economics Lifestyle Local News Regulations & Security Science

Church & Dwight reports fourth quarter and full year 2023 results

2023 Fourth Quarter Results

  • Net Sales growth +6.4%: Domestic +6.4%, Int’l +11.9%, SPD -9.2 %
  • Organic sales +5.3%: Domestic +5.7%, Int’l +9.0%, SPD -9.2%1
  • Gross Margin +260 bps
  • Reported EPS $0.62, Adjusted EPS $0.65, +4.8%1

2023 Full Year Results

  • Net Sales growth +9.2%; Organic Sales +5.3%1
  • Gross Margin +220 bps
  • Reported EPS $3.05, Adjusted EPS $3.17, +6.7%1
  • Cash from operations $1.03 billion

 

 

EWING, N.J. — (BUSINESS WIRE) — Church & Dwight Co., Inc. (NYSE: CHD) today announced full year net sales increased 9.2% to $5,867.9 million, ahead of the Company’s outlook of 9%. Organic sales increased 5.3% due to positive pricing of 4.4% and higher volume of 0.9%.1 Organic sales of consumer products increased 6.2%.

 

Full year EPS was $3.05, an increase of 81.5% compared to 2022 reported EPS. Full year 2023 Adjusted EPS was $3.17, an increase of 6.7% compared to 2022 Adjusted EPS.1 Full year Adjusted EPS exceeded the Company’s outlook of $3.15, driven by higher sales, higher gross margin and a lower tax rate, partially offset by higher SG&A.

 

Q4 net sales were $1,528.0 million, a $92.0 million or 6.4% increase compared to net sales in Q4 2022. This exceeded the Company’s outlook of 5% growth. Organic sales increased 5.3%1, exceeding the Company’s outlook of 4%, driven by 4.0% positive price and product mix and 1.3% higher volume. Reported EPS for Q4 was $0.62. Adjusted EPS in Q4 was $0.65 compared to $0.62 Adjusted EPS in Q4 2022.

 

Matthew Farrell, Chief Executive Officer, commented, “Our full year 2023 results illustrate the strength of our brands, innovative new products, and our focus on execution. We are exiting the year with strong momentum after posting two consecutive quarters of year-over-year volume growth. We expect volume to continue to drive growth into 2024. Our domestic brands grew consumption in 10 of 17 categories in 2023. We grew share on brands representing 60% of our sales. Global online sales accounted for 20% of total consumer sales in 2023, an increase of 26% compared to 2022.

 

“Our recent acquisitions, THERABREATH™ mouthwash and HERO™, the maker of MIGHTY PATCH™ acne care products, both experienced high consumption growth and grew market share throughout 2023. We expect these brands to deliver strong growth in 2024.

 

“Organic revenue growth for the Domestic Division grew 5.7% in 2023 driven by growth across much of the portfolio. Organic revenue growth for the International Division grew 8.5% in 2023, driven by broad-based growth in our country subsidiaries and our Global Markets Group. The International Division will continue to be a growth engine for the Company in 2024. Our Specialty Products Division declined 7.9% in 2023, largely due to declining sales of our MEGALAC dairy supplement within our Animal Nutrition business. We will be exiting this part of the Animal Nutrition business during Q1 2024.

 

“We were especially pleased by the strong gross margin expansion that we saw in 2023 with productivity, pricing, volume, and strong contributions from higher margin acquisitions more than offsetting inflation.

 

“Finally, strong sales and margin expansion along with efficient working capital management were all key drivers of our strong cash flow generation in 2023, achieving over $1 billion in cash from operations for the first time.

 

Fourth Quarter Review

Consumer Domestic net sales were $1,193.0 million, a $72.2 million or 6.4% increase driven by both household and personal care sales growth. Organic sales increased 5.7% due to price and product mix (+4.2%) and volume (+1.5%). This is the second consecutive quarter of volume growth, despite the impact of ceasing sub-optimal laundry promotions. Growth was led by HERO acne treatments, THERABREATH mouthwash, ARM & HAMMER™ Cat Litter, ARM & HAMMER™ baking soda and ARM & HAMMER™ unit dose laundry detergent.

 

Consumer International net sales were $258.8 million, a $27.5 million or 11.9% increase. Foreign currency exchange rates impacted sales favorably by (+2.7%). Organic sales increased 9.0% due to a combination of higher price and product mix (+5.1%) and higher volume (+3.9%). This is the fourth consecutive quarter of volume growth. Q4 organic sales were primarily driven by STERIMAR™, THERABREATH, ARM & HAMMER baking soda and HERO.

 

Specialty Products net sales were $76.2 million, a $7.7 million or a 9.2% decrease. Organic sales decreased 9.2% primarily due to lower volume (9.0%) driven by the dairy business, particularly MEGALAC which continues to be impacted by low-priced imports.

 

Gross margin increased 260 basis points to 44.6% due to improved pricing, volume, productivity, and the impact of the HERO acquisition, partially offset by higher manufacturing costs.

 

Marketing expense was $219.0 million, which was $29.3 million higher than prior year. Marketing expense as a percentage of net sales increased 110 basis points to 14.3%.

 

Selling, general, and administrative expense (SG&A) was $246.2 million, including $7.3 million of charges related to restricted stock that was issued for the HERO acquisition. Adjusted SG&A was $238.9 million or 15.6% of net sales, a 210 basis points increase, primarily due to higher incentive compensation from improved business performance, investment spending for future growth and minor asset write-offs related to our Specialty Products division.

 

Income from Operations was $216.1 million. Adjusted Income from Operations was $223.4 million, an increase of 2.2% inclusive of higher marketing and SG&A.

 

Other Expense was $20.9 million, a decrease of $4.6 million primarily due to higher interest income.

 

The effective tax rate decreased to 21.3% compared to 26.4% in Q4 2022. On an adjusted basis the tax rate was 20.5% compared to a rate of 21.3% in Q4 2022. The reported tax rate of 26.4% in Q4 2022 was unusually high due to the impact of the FLAWLESS™ intangible asset impairment charge.

 

Operating Cash Flow

For the full year 2023, cash from operations was $1,030.6 million, an increase of $145.4 million due to higher cash earnings and improvements in working capital. Capital expenditures for the full year were $223.5 million, a $44.7 million increase from the prior year as we invested in capacity expansion projects.

 

At December 31, 2023, cash on hand was $344.5 million, while total debt was $2.4 billion.

 

4% Dividend Increase and Share Repurchase

Consistent with the Company’s capital allocation strategy, the Company’s Board of Directors declared a 4% increase in the quarterly dividend from $0.2725 to $0.28375 per share, equivalent to an annual dividend of $1.135 per share. This raises the annual dividend payout from $267 million to approximately $276 million. The quarterly dividend will be payable March 1st, 2024, to stockholders of record at the close of business on February 15th, 2024. This is the 28th consecutive year in which the Company has increased the dividend. The Company has paid a consecutive quarterly dividend for 123 years.

 

In Q4, the Company spent $300 million to repurchase 3.3 million shares of common stock. Currently, the Company has approximately 246 million weighted average shares outstanding.

 

Mr. Farrell commented, “Our dividend increase and share repurchases reflect the Company’s desire for stockholders to benefit from our strong cash generation and reflects our confidence in continuing our strong performance. 2024 should be another year of strong cash flow. Our robust cash flow enables us to return cash to our stockholders while maintaining significant financial flexibility to aggressively pursue acquisitions and invest in our business.”

 

2024 New Products

Mr. Farrell commented, “Product innovation continues to be a big driver of our success and we are excited about our new product launches. In 2024, we expect new product launches to drive a significant increase in net sales as we lead with innovation in a number of key categories.”

 

ARM & HAMMER™ Laundry is launching Deep Clean™ Liquid and Deep Clean Unit Dose Laundry Detergent. Arm & Hammer Deep Clean will be our most premium Arm & Hammer laundry detergent, entering the mid-tier of the category using pH Power Technology to penetrate deep into fibers where dirt, odor, and stains linger, delivering a superior clean at a price consumers can afford.

 

ARM & HAMMER™ launched Power Sheets™ Laundry Detergent online in August 2023. This innovative laundry solution is effective, convenient, and eliminates plastic bottle waste. ARM & HAMMER™ is the first major brand to offer a detergent sheet in the U.S. and became the #2 detergent sheet on Amazon within 4 weeks of launch. It was the #1 top seller in the laundry category on Amazon Prime Day. Due to its online success, Power Sheets ™ will be available in select brick & mortar retailers in early 2024.

 

ARM & HAMMER™ Hardball™ Clumping Litter is being expanded nationally in early 2024, after successful in-market testing in 2023. This transformational plant-based substrate is lightweight and creates virtually indestructible clumps for no-mess scooping. We expect this new litter to help ARM & HAMMER capture a greater share of the lightweight litter category.

 

THERABREATH™, the #1 alcohol-free mouthwash brand, is entering the antiseptic segment of the category with the launch of TheraBreath™ Deep Clean Oral Rinse. Antiseptic mouthwashes account for 30% of the category. This product is formulated to kill 99.9% of germs that cause bad breath, plaque & gingivitis without the burn.

 

BATISTE™, the leader in dry shampoo, is meeting consumers’ desire for longer-lasting results with new BATISTE Sweat Activated and BATISTE Touch Activated dry shampoos. These breakthrough products are formulated with advanced technology and release a burst of fragrance whenever you sweat or touch your hair. Both new products deliver up to 24 hours of freshness.

 

HERO™ continues to drive the majority of growth in the acne category as the #1 patch brand in the U.S. In 2024, Hero will continue to launch innovative solutions in patches combined with new launches, such as Dissolve Away Daily Cleansing Balm, that will broaden our offerings of gentle and effective solutions for acne-prone skin.

 

Outlook for 2024

Mr. Farrell stated, “We exited 2023 with strong consumption growth across the majority of our categories. We are confident about 2024 and remain focused on offering high quality products to consumers at the right value.

 

“We are evolving our long-term Evergreen business model in 2024. The last revision was in 2018. Our new annual Evergreen model reflects our expectation of faster topline growth, greater margin expansion, and a higher cadence of growth investment, specifically in ecommerce and international. The revised evergreen model calls for 4% organic net sales growth (previously 3%), 25 to 50 basis points of gross margin expansion (previously 25 bps), marketing as a percentage of sales continues to approximate 11% (no change), and SG&A leverage of 0-25 bps (previously 25 bps) reflecting investments which will help sustain accelerated growth for years to come. We are maintaining our 8% industry leading annual EPS growth target.

 

“In 2024 we expect full year reported and organic sales growth to be approximately 4-5%.1 The organic sales outlook excludes Megalac from both years and the impact from foreign currency. We expect full year reported gross margin to expand approximately 50 to 75 basis points versus 2023. We expect an increase in manufacturing costs primarily due to capacity related investments, third party manufacturing cost increases, and moderate commodity inflation. We expect to more than offset our cost increases through carryover product pricing, mix, higher volume and productivity. We expect marketing as a percentage of sales to be approximately 11% and we expect to leverage SG&A while making investments in our International and ecommerce infrastructure.

 

“Our Adjusted EPS expectation for 2024 is 7-9% growth (mid-point $3.42 Adjusted EPS), inclusive of a 1% EPS drag related to exiting the MEGALAC business. Excluding the MEGALAC impact, Adjusted EPS growth expectation is 8-10%. Our tax rate is expected to increase 170 bps to approximately 23%. The higher tax rate represents a 2% drag to Adjusted EPS. This outlook reflects strong operating fundamentals including organic sales growth, volume growth, margin expansion and operating income growth.

 

“Other expense for 2024 is expected to be approximately $85 million, compared to $90 million in 2023.

 

“Cash flow from operations is expected to be approximately $1.0 billion. We expect 2024 capital expenditures of approximately $180 million as we complete the major capacity investments that were initiated in 2023. We expect capital spending to return to historical levels (2% of sales) in 2025. We will pursue accretive acquisitions that meet our strict criteria, with an emphasis on fast-moving consumable products, similar to our last 3 acquisitions (ZICAM, THERABREATH, and HERO).

 

“In past years, we have highlighted and discussed 14 power brands within our portfolio. In the future, we will focus our communication on seven brands that we expect to be the key drivers of growth. These brands, which today represent 70% of our sales and profits, primarily compete in larger categories and have the potential for global expansion. The seven brands are ARM & HAMMER™, OXICLEAN™, BATISTE™, VITAFUSION™, WATERPIK™, THERABREATH™ and HERO™.

 

“For Q1, we expect reported and organic sales growth of approximately 4%1, gross margin expansion and higher marketing spending (+100 basis points) to support our strong innovation pipeline. As a result of the shift in marketing spend to Q1, we expect Adjusted EPS of $0.85 per share, flat versus last year’s adjusted Q1 EPS.”1

 

1 Organic Sales, Adjusted SG&A, Adjusted Income from Operations, Adjusted Tax Rate and Adjusted EPS are non-GAAP measures. See Non-GAAP reconciliations included at the end of this release.

 

Church & Dwight Co., Inc. (NYSE: CHD) will host a webcast to discuss fourth quarter and year end 2023 results on Feb. 2, 2024, at 12:00 p.m. (ET). The presentation will broadcast online at investor.churchdwight.com/investors/news-events. Click on Church & Dwight Co., Inc. 2024 Analyst Day to register for the webcast.

 

Church & Dwight Co., Inc. (NYSE: CHD) founded in 1846, is the leading U.S. producer of sodium bicarbonate, popularly known as baking soda. The Company manufactures and markets a wide range of personal care, household, and specialty products under recognized brand names such as ARM & HAMMER®, TROJAN®, OXICLEAN®, SPINBRUSH®, FIRST RESPONSE®, NAIR®, ORAJEL®, XTRA®, L’IL CRITTERS® and VITAFUSION®, BATISTE®, WATERPIK®, ZICAM®, THERABREATH® and HERO®. For more information, visit the Company’s website.

 

Church & Dwight has a strong heritage of commitment to people and the planet. In the early 1900’s, we began using recycled paperboard for all packaging of household products. Today, virtually all our paperboard packaging is from certified, sustainable sources. In 1970, the ARM & HAMMER brand introduced the first nationally distributed, phosphate-free detergent. That same year, Church & Dwight was honored to be the sole corporate sponsor of the first annual Earth Day. In 2023, our continued progress earned continued public recognition, including the Newsweek Magazine’s Americas Most Responsible and America’s Greenest Companies lists, the EPA’s Green Power Partnership-Top 100 list, the 2023 Wall Street Journal Management Top 250 List, the 2022/2023 Forbes Magazine: Americas Best Midsize Employer Award and the FTSE4Good Index Series, amongst others.

 

For more information, see the Church & Dwight 2022 Sustainability Report at: https://churchdwight.com/responsibility/

This press release contains forward-looking statements, including, among others, statements relating to net sales and earnings growth; gross margin changes; trade, marketing, and SG&A spending; recessionary conditions; interest rates; inflation; sufficiency of cash flows from operations; earnings per share; cost savings programs; consumer demand and spending; the effects of competition; the effect of product mix; volume growth, including the effects of new product launches into new and existing categories; the impact of acquisitions (including earn-outs); and capital expenditures. Other forward-looking statements in this release may be identified by the use of such terms as “may,” “could,” “expect,” “intend,” “believe,” “plan,” “estimate,” “forecast,” “project,” “anticipate,” “to be,” “to make” or other comparable terms. These statements represent the intentions, plans, expectations and beliefs of the Company, and are based on assumptions that the Company believes are reasonable but may prove to be incorrect. In addition, these statements are subject to risks, uncertainties and other factors, many of which are outside the Company’s control and could cause actual results to differ materially from such forward-looking statements. Factors that could cause such differences include a decline in market growth, retailer distribution and consumer demand (as a result of, among other things, political, economic and marketplace conditions and events), including those relating to the outbreak of contagious diseases; other impacts of the COVID-19 pandemic and its impact on the Company’s operations, customers, suppliers, employees, and other constituents, and market volatility and impact on the economy (including contributions to recessionary conditions), resulting from global, nationwide or local or regional outbreaks or increases in infections, new variants, and the risk that the Company will not be able to successfully execute its response plans with respect to the pandemic or localized outbreaks and the corresponding uncertainty; the impact of new legislation such as the U.S. CARES Act, the EU Medical Device Regulation, new cosmetic and device regulations in Mexico, and the U.S. Modernization of Cosmetic Regulation Act; the impact on the global economy of the Russia/Ukraine war and increased conflict in the Middle East, including the impact of export controls and other economic sanctions; potential recessionary conditions or economic uncertainty; the impact of continued shifts in consumer behavior, including accelerating shifts to on-line shopping; unanticipated increases in raw material and energy prices, including as a result of the Russia/Ukraine war, increased conflict in the Middle East or other inflationary pressures; delays and increased costs in manufacturing and distribution; increases in transportation costs; labor shortages; the impact of price increases for our products; the impact of inflationary conditions; the impact of supply chain and labor disruptions; the impact of severe or inclement weather on raw material and transportation costs; adverse developments affecting the financial condition of major customers and suppliers; competition; changes in marketing and promotional spending; growth or declines in various product categories and the impact of customer actions in response to changes in consumer demand and the economy, including increasing shelf space or on-line share of private label and retailer-branded products or other changes in the retail environment; consumer and competitor reaction to, and customer acceptance of, new product introductions and features; the Company’s ability to maintain product quality and characteristics at a level acceptable to our customers and consumers; disruptions in the banking system and financial markets; the Company’s borrowing capacity and ability to finance its operations and potential acquisitions; higher interest rates; foreign currency exchange rate fluctuations; transition to, and shifting economic policies in the United States; potential changes in export/import and trade laws, regulations and policies of the United States and other countries, including any increased trade restrictions or tariffs; increased or changing regulation regarding the Company’s products and its suppliers in the United States and other countries where it or its suppliers operate; market volatility; issues relating to the Company’s information technology and controls; the impact of natural disasters, including those related to climate change, on the Company and its customers and suppliers, including third party information technology service providers; integrations of acquisitions or divestiture of assets; the outcome of contingencies, including litigation, pending regulatory proceedings and environmental matters; and changes in the regulatory environment in the countries where we do business.

 

For a description of additional factors that could cause actual results to differ materially from the forward-looking statements, please see Item 1A, “Risk Factors” in the Company’s annual report on Form 10-K and quarterly reports on Form 10-Q. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by the U.S. federal securities laws. You are advised, however, to consult any further disclosures the Company makes on related subjects in its filings with the United States Securities and Exchange Commission.

 

This press release also contains non-GAAP financial information. Management uses this information in its internal analysis of results and believes that this information may be informative to investors in gauging the quality of the Company’s financial performance, identifying trends in its results and providing meaningful period-to-period comparisons. The Company has included reconciliations of these non-GAAP financial measures to the most directly comparable financial measure calculated in accordance with GAAP. See the end of this press release for these reconciliations. These non-GAAP financial measures should not be considered in isolation or as a substitute for the comparable GAAP measures. In addition, these non-GAAP financial measures may not be the same as similar measures provided by other companies due to potential differences in methods of calculation and items being excluded. They should be read in connection with the Company’s financial statements presented in accordance with GAAP.

 

 

CHURCH & DWIGHT CO., INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Income (Unaudited)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

December 31,

December 31,

(In millions, except per share data)

2023

2022

2023

2022

Net Sales

$

1,528.0

$

1,436.0

$

5,867.9

$

5,375.6

Cost of sales

846.7

833.5

3,279.4

3,125.6

Gross Profit

681.3

602.5

2,588.5

2,250.0

Marketing expenses

219.0

189.7

641.3

535.2

Selling, general and administrative expenses

246.2

611.2

889.8

1,117.0

Income from Operations

216.1

(198.4

)

1,057.4

597.8

Equity in earnings of affiliates

0.6

2.3

8.7

12.3

Other income (expense), net

(21.5

)

(27.8

)

(98.7

)

(86.8

)

Income before Income Taxes

195.2

(223.9

)

967.4

523.3

Income taxes

41.5

(59.2

)

211.8

109.4

Net Income

$

153.7

$

(164.7

)

$

755.6

$

413.9

Net Income per share – Basic

$

0.63

$

(0.68

)

$

3.09

$

1.70

Net Income per share – Diluted

$

0.62

$

(0.67

)

$

3.05

$

1.68

Dividends per share

$

0.27

$

0.26

$

1.09

$

1.05

Weighted average shares outstanding – Basic

244.6

243.6

244.9

242.9

Weighted average shares outstanding – Diluted

247.0

246.1

247.6

246.3

CHURCH & DWIGHT CO., INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets (Unaudited)

(Dollars in millions)

Dec. 31, 2023

Dec. 31, 2022

Assets

Current Assets

Cash and Cash Equivalents

$

344.5

$

270.3

Accounts Receivable

526.9

422.0

Inventories

613.3

646.6

Other Current Assets

45.0

57.0

Total Current Assets

1,529.7

1,395.9

Property, Plant and Equipment (Net)

927.7

761.1

Equity Investment in Affiliates

12.0

12.7

Trade Names and Other Intangibles

3,302.3

3,431.6

Goodwill

2,431.5

2,426.8

Other Long-Term Assets

366.0

317.5

Total Assets

$

8,569.2

$

8,345.6

Liabilities and Stockholders’ Equity

Short-Term Debt

$

3.9

$

74.0

Current portion of Long-Term debt

199.9

0.0

Other Current Liabilities

1,218.2

1,109.8

Total Current Liabilities

1,422.0

1,183.8

Long-Term Debt

2,202.2

2,599.5

Other Long-Term Liabilities

1,089.6

1,072.4

Stockholders’ Equity

3,855.4

3,489.9

Total Liabilities and Stockholders’ Equity

$

8,569.2

$

8,345.6

Contacts

Rick Dierker

Chief Financial Officer

609-806-1200

Read full story here

Categories
Business Economics Lifestyle Perspectives Regulations & Security

AM Best revises outlooks to negative for Amica Mutual Insurance Company and subsidiaries

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has revised the outlooks to negative from stable and affirmed the Financial Strength Rating (FSR) of A+ (Superior) and the Long-Term Issuer Credit Rating (Long-Term ICR) of “aa-” (Superior) of Amica Mutual Insurance Company (Amica Mutual) and its wholly owned subsidiary, Amica Property and Casualty Insurance Company (together known as Amica Mutual Group).

 

At the same time, AM Best has revised the outlooks to negative from stable and affirmed the FSR of A+ (Superior) and the Long-Term ICR of “aa-” (Superior) of Amica Life Insurance Company (Amica Life), a wholly owned subsidiary of Amica Mutual. All companies are domiciled in Lincoln, RI.

The Credit Ratings (ratings) reflect Amica Mutual Group’s balance sheet strength, which AM Best assesses as strongest, as well as its adequate operating performance, favorable business profile and appropriate enterprise risk management (ERM).

 

The ratings of Amica Life reflect its balance sheet strength, which AM Best assesses as strongest, as well as its adequate operating performance, neutral business profile and appropriate ERM.

 

The negative outlooks for Amica Mutual Group reflect the decline in its balance sheet strength, specifically a deterioration in risk-adjusted capitalization in recent years. Increased loss costs in both the auto and homeowner’s line of business have driven substantial underwriting losses in 2022 and 2023, which has significantly impacted the group’s surplus position and overall liquidity. Nonetheless, the group’s liquidity profile remains supported by Federal Home Loan Bank borrowing capacity, reinsurance and portfolio cash flow. Additionally, Amica Mutual Group’s results rely heavily on net investment income and realized capital gains, which have contributed collectively to positive net earnings in most years. However, this benefit was muted in 2022 and 2023 due to the turbulent investment markets and rapid increases in interest rates, which caused underwriting losses to outpace investment earnings.

 

AM Best notes that Amica has implemented multiple strategic initiatives, which are expected to correct performance gradually. These include substantial rate increases in both the auto and homeowners’ line of business, as well as a renewed focus on profitable geographic areas and reducing dividends. While this is expected to improve the group’s operating performance in the more near term, it is not expected to replenish its loss of surplus within that same time frame. Additionally, the negative outlooks further reflect the potential for continued capital erosion as management’s strategic action plan comes to fruition.

 

The negative outlooks for Amica Life follow that of Amica Mutual and reflect the potential removal of rating enhancement provided by the property/casualty parent. Given the strong parental support that includes continuous capital contributions, ample liquidity access and the sharing of brand names and consumer base, Amica Life benefits from its relationship with its parent.

 

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

 

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

 

Copyright © 2024 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Cristian Sieira
Financial Analyst
+1 908 882 2315
cristian.sieira@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Erik Miller
Director
+1 908 882 2120
erik.miller@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com

Categories
Business Culture Digital - AI & Apps Economics Education Energy Environment Foodies/Tastylicious Government Healthcare International & World Science Technology

Fork & Good hosts first ever tasting of hybrid cultivated meat at Davos

The food startup shared its product with thought leaders and local residents at its first large-scale tasting since the launch of its pilot facility last year

 

 

DAVOS, Sz. — (BUSINESS WIRE) — On Jan. 16, heads of state, industry experts and business leaders gathered for the annual World Economic Forum conference at Davos.

 

At the same time, a smaller, though no less consequential, event took place just 10 minutes away at Sonas Irish Pub. Food startup Fork & Good conducted the city’s first blind tasting of hybrid cultivated meat to gather feedback from an eclectic group of 40 people.

 

Participants each received two small dishes distinguished by blue and yellow stickers. One contained 100% conventional pork and the other a blend of 30% cultivated and 70% conventional pork. (Willing vegetarians also had a chance to enjoy dumplings made with a blend of plant and cultivated pork).

 

“Mixing cultivated meat with conventional meat has many advantages,” said Fork & Good Chief Scientific Officer Gabor Forgacs.

 

“It helps alleviate the rising supply chain and environmental challenges meat producers face. It also allows for the gradual introduction of cultured meat through products consumers are already used to.”

 

Perhaps most importantly, it tastes just like meat — because it is 100% meat. As Fork & Good co-founders expected, participants at the blind tasting found no major difference between the two samples. An informal poll after the tasting showed more than half of the group preferred the 30/70 blend over conventional meat on its own. The group was equally split when asked to guess which dish contained cultivated meat.

 

The tasting was led by Fork & Good CEO Niya Gupta, who said, “We are aiming to serve everyone everywhere with affordable meat so it’s exciting to get input in this open and democratic way. We had everyone, from an American professor to a Swedish nonprofit worker to a Chinese student — even a regular Swiss person walking in off the street looking for a beer. Their feedback has been critical to us as we continue our product development journey.”

 

One of the participants, global data science leader Dr. Richard Kerr, said, “I wasn’t able to tell the difference between the samples, to the point that I thought it was going to be revealed that all the samples were 100% cultured. I love the idea, and will continue to follow [Fork & Good’s] progress with interest.”

 

The lunchtime tasting was a part of UnDavos, an informal entrepreneurship-focused gathering that takes place the same week as the WEF conference. Mark Turrell, founder of UnDavos and CTO of Fresh Solutions AI, invited Fork & Good to present their product at a “meal for the future” event.

 

“It was amazing to physically experience technology being integrated into our food — the food in our mouths,” Turrell said.

 

In addition to the blind tasting, Fork & Good was invited to the main WEF conference as a Technology Pioneer, one of just 100 early-stage startups developing innovative technologies to address global challenges. Gupta participated in back-to-back meetings and roundtables, including a bilateral meeting with one of the world’s largest meat producers who couldn’t tell the difference between conventional meat and Fork & Good’s hybrid cultivated meat.

 

Founded in 2018, Fork & Good launched its pilot facility in Jersey City, New Jersey. The facility is already capable of producing six to ten times more meat per square foot than is currently possible by conventional means. Fork & Good’s cultivated meat is ready for market, pending regulatory approval by the FDA and USDA.

 

ABOUT FORK AND GOOD

From its facility in Jersey City, Fork & Good is on a mission to grow the best of meat for everyone, everywhere. The company takes a novel approach to cultivating meat by growing muscle cells directly in proprietary bioreactors for maximum flavor and nutritional value—while drastically reducing the amount of land and water used in conventional livestock production. The team has 150+ years of combined experience that spans food, agriculture, and science, and is committed to helping build the industry in a safe, transparent way. Learn more at: www.forkandgood.com.

 

Contacts

Emily Bogan, Business Operations Manager

Email: hello@forkandgood.com
Phone: (201) 201-1392

Categories
Business Economics Healthcare Lifestyle Local News Science

Bristol Myers Squibb reports fourth quarter and full-year financial results for 2023

Results Reflect Continued Strength of In-Line and New Products, Pipeline Execution and Business Development Activity, Supporting Growth Momentum into 2024

 

  • Reports Fourth Quarter Revenues of $11.5 Billion; GAAP EPS of $0.87 and Non-GAAP EPS of $1.70
    • In-Line and New Product Portfolio Revenues Increased 9% to $9.8 Billion
  • Reports Full-Year Revenues of $45.0 Billion; GAAP EPS of $3.86 and Non-GAAP EPS of $7.51
    • In-Line and New Product Portfolio Revenues Increased 7% to $37.9 Billion
  • Strengthens Long-Term Growth Profile Through Multiple Transactions, Including Planned Acquisitions of Karuna Therapeutics and RayzeBio and Strategic Collaboration with SystImmune; Completes Purchase of Mirati Therapeutics
  • Advances Research Pipeline Including U.S. Approval of Augtyro and FDA Acceptance of sBLAs for Breyanzi in Follicular Lymphoma and Mantle Cell Lymphoma for Priority Review
  • Provides 2024 Guidance with Revenues Increasing by Low Single-Digits; Non-GAAP EPS Range $7.10 to $7.40, Excludes Impact of Pending Transactions

 

 

PRINCETON, N.J. — (BUSINESS WIRE) — Bristol Myers Squibb (NYSE: BMY) today reports results for the fourth quarter and full year of 2023, which reflect strong pipeline acceleration, continued portfolio diversification, and momentum in our business.

“We saw good performance in the fourth quarter from our in-line and new products and took several actions to strengthen the company and build a foundation for sustainable growth,” said Christopher Boerner, Ph.D., chief executive officer, Bristol Myers Squibb.

 

“In 2024, our focus is on delivering strong commercial execution and accelerating opportunities that enhance our growth profile in the middle of the decade and beyond.”

 

 

Fourth Quarter

Full Year

$ in millions, except per share amounts

2023

2022

Change

Change Excl.

F/X**

2023

2022

Change

Change Excl.

F/X**

Total Revenues

$11,477

$11,406

1%

1%

$45,006

$46,159

(2)%

(2)%

EPS — GAAP*

0.87

0.95

(8)%

N/A

3.86

2.95

31%

N/A

EPS — Non-GAAP*

1.70

1.82

(7)%

N/A

7.51

7.70

(2)%

N/A

Acquired IPRD charge and Licensing Income Net Impact (Decrease)/Increase

(0.20)

(0.01)

N/A

N/A

(0.28)

(0.24)

N/A

N/A

* GAAP and Non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income.

** See “Use of Non-GAAP Financial Information”.

 

 

FOURTH QUARTER RESULTS

All comparisons are made versus the same period in 2022 unless otherwise stated.

  • Bristol Myers Squibb posted fourth quarter revenues of $11.5 billion, an increase of 1% both on a reported and when adjusted for foreign exchange basis, primarily due to higher sales of new product portfolio, as well as Eliquis and Opdivo, partially offset by lower sales of Revlimid.
  • U.S. revenues increased 1% to $8.0 billion primarily due to higher sales of new product portfolio, Eliquis and Opdivo, partially offset by lower sales of Revlimid.
  • International revenues remained relatively flat at $3.5 billion, primarily due to lower sales of Revlimid, offset by higher sales ofnew product portfolio and Opdivo.
  • On a GAAP basis, gross margin decreased from 77.3% to 76.1% and on a non-GAAP basis, gross margin decreased from 77.9% to 76.4% primarily due to product mix and lower hedge settlement gains.
  • On a GAAP and non-GAAP basis, marketing, selling and administrative expenses decreased 9% to $2.1 billion primarily due to timing of spend.
  • On a GAAP and non-GAAP basis, research and development expenses remained relatively flat at $2.5 billion.
  • On a GAAP and non-GAAP basis, Acquired IPRD increased to $600 million from $52 million primarily due to the reacquired mavacamten rights of $445 million in China and certain other Asian territories. On a GAAP and non-GAAP basis, licensing income was $67 million compared to $16 million during the same period a year ago.
  • On a GAAP basis, amortization of acquired intangible assets decreased 3% to $2.3 billion primarily due to the Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
  • On a GAAP basis, income tax benefit was $88 million despite pre-tax earnings of $1.7 billion primarily due to a valuation allowance reversal related to unrealized equity investment losses and foreign currency. In 2022, the income tax benefit was $166 million despite pre-tax earnings of $1.9 billion primarily due to the release of income tax reserves. On a non-GAAP basis, the effective tax rate changed from 10.9% to 14.9%, primarily due to release of income tax reserves in 2022.
  • The company reported on a GAAP basis net earnings attributable to Bristol Myers Squibb of $1.8 billion, or $0.87 per share, compared to $2.0 billion, or $0.95 per share, for the same period a year ago. In addition to the items above, the decrease in GAAP EPS was driven by lower losses in equity investments. The company reported on a non-GAAP basis net earnings attributable to Bristol Myers Squibb of $3.5 billion, or $1.70 per share, compared to $3.9 billion, or $1.82 per share, for the same period a year ago. The EPS results in the fourth quarter of 2023 also include the impact of lower weighted-average common shares outstanding.

 

 

FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS

($ amounts in millions)

Quarter Ended December

31, 2023

% Change from Quarter

Ended December 31,

2022

% Change from

Quarter Ended

December 31,

2022 Ex-F/X**

U.S.(c)

Int’l

WW(d)

U.S.(c)

Int’l

WW(d)

Int’l

WW(d)

In-Line Products

Eliquis

$

1,899

$

975

$

2,874

11%

1%

7%

(3)%

6%

Opdivo

1,411

976

2,387

12%

3%

8%

4%

8%

Orencia

766

219

985

8%

8%

8%

11%

9%

Pomalyst/Imnovid

632

258

890

1%

2%

1%

—%

1%

Yervoy

343

223

566

(1)%

—%

— %

1%

—%

Sprycel

417

109

526

—%

(32)%

(9)%

(31)%

(9)%

Mature and other products (a)

202

278

480

9%

(6)%

—%

(5)%

1%

Total In-Line Products

5,670

3,038

8,708

8%

(1) %

5 %

(1)%

5%

New Product Portfolio

Reblozyl

274

46

320

75%

10%

61%

5%

60%

Opdualag

187

3

190

80%

N/A

83%

N/A

83%

Abecma

56

44

100

(40)%

42%

(20)%

39%

(21)%

Zeposia

101

32

133

74%

52%

68%

43%

66%

Breyanzi

85

16

101

*

23%

84%

23%

84%

Camzyos

84

4

88

*

N/A

*

N/A

*

Sotyktu

56

7

63

*

N/A

*

N/A

*

Onureg

31

16

47

15%

60%

27%

50%

24%

Inrebic

19

10

29

12%

67%

26%

67%

26%

Augtyro

1

—

1

N/A

N/A

N/A

N/A

N/A

Total New Product Portfolio

894

178

1,072

71%

45%

66%

39%

65%

Total In-Line and New Product Portfolio

6,564

3,216

9,780

13%

1%

9%

1%

9%

Recent LOE Products (b)

Revlimid

1,262

188

1,450

(38)%

(21)%

(36)%

(20)%

(36)%

Abraxane

177

70

247

53%

11%

38%

22%

42%

Total Recent LOE Products

1,439

258

1,697

(33)%

(15)%

(30)%

(11)%

(30)%

Total Revenues

$

8,003

$

3,474

$

11,477

1%

—%

1%

—%

1%

*

In excess of +100%

**

See “Use of Non-GAAP Financial Information”.

(a)

Includes over-the-counter (OTC) products, royalty revenue and mature products.

(b)

Recent LOE Products includes products with significant expected decline in revenue from a prior reporting period as a result of a loss of exclusivity.

(c)

Includes Puerto Rico.

(d)

Worldwide (WW) includes U.S. and International (Int’l).

 

 

FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS

In-Line Products

Revenues for in-line products in the fourth quarter were $8.7 billion compared to $8.3 billion in the prior year period. In-line products revenue was largely driven by:

  • Eliquis worldwide revenues increased 7%, or 6% when adjusted for foreign exchange impacts. U.S. revenues were $1.9 billion compared to $1.7 billion in the prior year period, representing an increase of 11% primarily due to higher demand, partially offset by GTN adjustments in 2023. International revenues were $975 million compared to $970 million in the prior year period, representing an increase of 1%, or a decrease of 3% when adjusted for foreign exchange impacts, primarily driven by lower average net selling prices and generic erosion in several European countries.
  • Opdivo worldwide revenues increased 8% both on a reported and when adjusted for foreign exchange basis. U.S. revenues increased 12% to $1.4 billion compared to $1.3 billion in the prior year period primarily due to higher demand. International revenues were $976 million compared to $951 million in the prior year period, representing an increase of 3%, or 4% when adjusted for foreign exchange impacts, primarily due to higher demand as a result of launches for new indications and core indications.

New Product Portfolio

  • New product portfolio worldwide revenues increased to $1.1 billion compared to $645 million in the prior year period, representing a growth of 66%, or 65% when adjusted for foreign exchange impacts, primarily driven by higher demand across the portfolio, including for Reblozyl, Opdualag, Camzyos, Sotyktu, Zeposia and Breyanzi.

Recent LOE Products

  • Revlimid worldwide revenues declined to $1.5 billion compared to $2.3 billion in the prior year period, representing a decline of 36%, both on a reported and when adjusted for foreign exchange basis, primarily due to generic erosion.

PRODUCT AND PIPELINE UPDATE

The company recently achieved several important regulatory and clinical milestones. In November 2023, Augtyro received U.S. regulatory approval in non-small cell lung cancer. The U.S. Food and Drug Administration (FDA) also accepted supplemental Biologics License Applications (sBLAs) for Breyanzi to expand into follicular lymphoma and mantle cell lymphoma.

Oncology

Category

Asset

Milestone

Regulatory

KRAZATI®

(adagrasib)

The European Commission (EC) granted conditional marketing authorization for KRAZATI as a targeted treatment option for adult patients with KRASG12C -mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy.

repotrectinib

The European Medicines Agency (EMA) validated the marketing authorization application for repotrectinib as a treatment for ROS1 tyrosine kinase inhibitor (TKI)-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic NSCLC and TKI naïve- and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on the registrational Phase 1/2 TRIDENT-1 trial and CARE study. Application validation confirms the submission is complete and begins the EMA’s centralized review procedure.

Opdivo®

(nivolumab)

The FDA accepted the sBLA for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.

In addition, the EMA validated the type II variation application for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. Application validation confirms the submission is complete and begins the EMA’s centralized review procedure.

The FDA’s sBLA acceptance and the EMA’s application validation are based on results from the Phase 3 CheckMate -901 trial.

AugtyroTM

(repotrectinib)

The FDA approved Augtyro, a TKI, for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The approval is based on results from the pivotal TRIDENT-1 study.

Clinical &

Research

Subcutaneous

nivolumab

Data from the Phase 3 CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma who have received prior systemic therapy, demonstrated noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to intravenous Opdivo. In addition, subcutaneous nivolumab displayed noninferior objective response rate as assessed by Blinded Independent Central Review (BICR) versus intravenous Opdivo.

Opdivo

Four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo in combination with CABOMETYX® (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) continued to show superior progression-free survival (PFS) and objective response rates in patients treated with Opdivo plus CABOMETYX over sunitinib, regardless of risk classification based on International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) scores. Superior overall survival (OS) was also observed in patients treated with the combination.

Opdivo+Yervoy

Eight-year data from the Phase 3 CheckMate -214 trial evaluating Opdivo plus Yervoy versus sunitinib continued to demonstrate long-term survival results, reducing the risk of death by 28% in patients with previously untreated advanced or metastatic RCC, regardless of IMDC risk group. Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients.

The Phase 3 CheckMate -8HW trial evaluating Opdivo plus Yervoy compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer (MSI-H/dMMR mCRC) met the dual primary endpoint of PFS as assessed by BICR at a pre-specified interim analysis. The study is ongoing to assess the other dual primary endpoint of PFS per BICR in patients receiving Opdivo plus Yervoy compared to Opdivo alone, as well as secondary endpoints, including overall survival.

In addition, data from the Phase 3 CheckMate -8HW trial showed that the combination of Opdivo plus Yervoy reduced the risk of disease progression or death by 79% versus chemotherapy as a first-line treatment for patients with MSI-H/dMMR mCRC compared to chemotherapy. Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy in MSI-H/dMMR mCRC.

OpdualagTM

(nivolumab and

relatlimab)

The Phase 3 RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab for the treatment of microsatellite stable metastatic colorectal cancer patients whose disease has progressed following at least one, but no more than four, prior lines of therapy for metastatic disease will be discontinued due to futility based on a planned analysis conducted by an independent data monitoring committee. It was determined that the trial was unlikely to meet its primary endpoints upon completion. The recommendation to stop the study was not based on safety concerns.

Hematology

Category

Asset

Milestone

Regulatory

Abecma®

(idecabtagene

vicleucel)

The Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended marketing authorization approval of Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the European Union.

Reblozyl®

(luspatercept-

aamt)

Japan’s Ministry of Health, Labour and Welfare (MHLW) granted manufacturing and marketing approval for Reblozyl 25 mg/75 mg injection for subcutaneous use indicated for myelodysplastic syndrome (MDS)-related anemia. The approval is based on the results of the global Phase 3 COMMANDS trial and the Phase 3 MEDALIST study, as well as a Japanese Phase 2 study (Study MDS-003) in red blood cell transfusion-independent low-risk MDS patients.

Breyanzi®

(lisocabtagene

maraleucel)

The FDA accepted sBLAs for Breyanzi to expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor. The FDA granted both applications Priority Review and assigned a PDUFA goal date of May 23, 2024, for Breyanzi in relapsed or refractory FL and May 31, 2024, for Breyanzi in relapsed or refractory MCL.

In addition, Japan’s MHLW has also accepted the company’s supplemental New Drug Application (sNDA) for Breyanzi for the treatment of relapsed or refractory FL.

In relapsed or refractory FL, the applications for Breyanzi in the U.S. and Japan are based on results from the TRANSCEND FL study. In relapsed or refractory MCL, the application for Breyanzi in the U.S. is based on results from the MCL cohort of the TRANSCEND NHL 001 study.

Abecma

Japan’s MHLW granted manufacturing and marketing approval of the sNDA for an additional indication for Abecma for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. The approval is based on the interim analysis from the KarMMa-3 trial.

Breyanzi

The FDA accepted the sBLA for Breyanzi to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor. The FDA granted the application Priority Review and assigned a PDUFA goal date of March 14, 2024.

Clinical &

Research

Abecma

Results from the preplanned final progression-free survival (PFS) analysis of the pivotal Phase 3, open-label, global, randomized controlled KarMMa-3 trial demonstrated a significantly improved PFS maintained with Abecma compared to standard regimens, with a 51% reduction in the risk of disease progression or death.

Breyanzi

First disclosure of primary analysis results from the high-risk, second-line cohort of the Phase 2 TRANSCEND FL trial evaluating Breyanzi in patients with relapsed or refractory FL demonstrated 95.7% complete response for patients with high-risk relapsed or refractory FL treated in a second-line setting.

Reblozyl

Updated results from the primary analysis of the Phase 3 COMMANDS trial, comparing Reblozyl versus epoetin alfa for the treatment of anemia in erythropoiesis stimulating agent (ESA)-naïve patients with lower-risk myelodysplastic syndromes who may require red blood cell transfusions, confirmed positive outcome of the interim analysis with superior efficacy and durability compared to ESAs.

 

 

FULL YEAR FINANCIAL RESULTS

All comparisons are made versus the same period in 2022 unless otherwise stated.

  • Bristol Myers Squibb posted revenues of $45.0 billion, a decrease of 2%, both on a reported and when adjusted for foreign exchange basis, primarily due to lower sales of Revlimid, partially offset by higher sales of our new product portfolio and Opdivo.
  • U.S. revenues decreased 1%to$31.6 billion due to lower sales of Revlimid resulting from generic erosion and, as previously disclosed, an increase in the number of patients receiving free drug product for Revlimid, and to a lesser extent Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products. This was partially offset by an increase in demand for Opdivo, Eliquis and new product portfolio.
  • International revenues decreased 6% to $13.5 billion, or 5% when adjusted for foreign exchange impacts, primarily due to lower sales of Revlimid and Eliquis, partially offset by an increase in demand for Opdivo and new product portfolio.
  • On a GAAP basis, gross margin decreased from 78.0% to 76.2% and on a non-GAAP basis, gross margin decreased from 78.8% to 76.6%, primarily due to product mix and lower hedge settlement gains.
  • On a GAAP and non-GAAP basis, marketing, selling and administrative expenses decreased 1% to $7.8 billion and $7.7 billion, respectively.
  • On a GAAP basis, research and development expenses decreased 2% to $9.3 billion. On a non-GAAP basis, research and development expenses decreased 1% to $9.1 billion.
  • On a GAAP and non-GAAP basis, Acquired IPRD increased 12% to $913 million. On a GAAP and non-GAAP basis, licensing income was $142 million during the year compared to $103 million in 2022.
  • On a GAAP basis, amortization of acquired intangible assets decreased 6% to $9.0 billion. The decrease was primarily due to the Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
  • On a GAAP basis, effective tax rate changed from 17.7% to 4.7% primarily due to the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment and changes in income tax reserves, valuation allowances and IRS guidance regarding deductibility of certain non-U.S. research and development expenses. On a non-GAAP basis, the effective tax rate changed from 15.3% to 14.7%.
  • The company reported on a GAAP basis net earnings attributable to Bristol Myers Squibb of $8.0 billion, or $3.86 per share, compared to $6.3 billion, or $2.95 per share. In addition to the items above, the GAAP EPS was impacted by lower losses on equity investments as well as litigation and other settlement income in 2023. On a non-GAAP basis, net earnings attributable to Bristol Myers Squibb were $15.6 billion, or $7.51 per share, compared to $16.5 billion, or $7.70 per share. In addition to the non-GAAP drivers noted above, the non-GAAP EPS was impacted by higher royalty and investment income, as well as lower weighted-average common shares outstanding.

 

 

FULL YEAR PRODUCT REVENUE HIGHLIGHTS

($ amounts in millions)

Year Ended December 31,

2023

% Change from Year

Ended December 31,

2022

% Change from

Year Ended

December 31,

2022 Ex-F/X**

U.S.(c)

Int’l

WW(d)

U.S.(c)

Int’l

WW(d)

Int’l

WW(d)

In-Line Products

Eliquis

$

8,592

$

3,614

$

12,206

10%

(10)%

4%

(10)%

3%

Opdivo

5,283

3,726

9,009

10%

8%

9%

11%

10%

Orencia

2,754

847

3,601

4%

3%

4%

6%

5%

Pomalyst/Imnovid

2,357

1,084

3,441

(3)%

2%

(2)%

3%

(1)%

Yervoy

1,388

850

2,238

6%

3%

5%

5%

6%

Sprycel

1,446

484

1,930

(3)%

(28)%

(11)%

(25)%

(10)%

Mature and other products (a)

772

1,123

1,895

3%

(13)%

(7)%

(11)%

(6)%

Total In-Line Products

22,592

11,728

34,320

6%

(3)%

3%

(2)%

4%

New Product Portfolio

Reblozyl

811

197

1,008

37%

56%

41%

54%

40%

Opdualag

617

10

627

*

N/A

*

N/A

*

Abecma

358

114

472

21%

25%

22%

24%

21%

Zeposia

324

110

434

83%

51%

74%

47%

72%

Breyanzi

303

61

364

*

97%

100%

*

*

Camzyos

226

5

231

*

N/A

*

N/A

*

Sotyktu

157

13

170

*

N/A

*

N/A

*

Onureg

117

51

168

23%

76%

35%

72%

35%

Inrebic

74

36

110

7%

*

29%

*

29%

Augtyro

1

—

1

N/A

N/A

N/A

N/A

N/A

Total New Product Portfolio

2,988

597

3,585

80%

63%

77%

61%

76%

Total In-Line and New Product Portfolio

25,580

12,325

37,905

12%

(1)%

7%

—%

8%

Recent LOE Products (b)

Revlimid

5,266

831

6,097

(37)%

(49)%

(39)%

(47)%

(39)%

Abraxane

709

295

1,004

22%

28%

24%

39%

27%

Total Recent LOE Products

5,975

1,126

7,101

(33)%

(39)%

(34)%

(36)%

(34)%

Total Revenues

$

31,555

$

13,451

$

45,006

(1)%

(6)%

(2)%

(5)%

(2)%

 

Contacts

For more information, contact:
Media: media@bms.com
Investor Relations: investor.relations@bms.com

Read full story here

Categories
Business Energy Environment Lifestyle Travel & Leisure

Joby to install first electric air taxi charger in greater New York City region

SANTA CRUZ, Calif. — (BUSINESS WIRE) — Joby Aviation, Inc. (NYSE: JOBY), a company developing electric vertical take-off and landing (eVTOL) aircraft for commercial passenger service, on Sunday announced it has signed a definitive agreement with Helo Holdings, Inc. (“HHI”), to install the first air taxi charger in the greater New York City region at the company’s heliport in Kearny, New Jersey, located just a two minute flight from Manhattan.

 

The agreement, which provides Joby with an operational base for its electric air taxi in the NYC region, builds on the partnership already established between Joby and HHI in November 2023, when Kearny served as a temporary home base for Joby’s aircraft. Joby completed several flights at Kearny in preparation for the Company’s exhibition flight in New York City at an event hosted by the New York City Economic Development Corporation and Mayor Eric Adams. The city has committed to electrify the Downtown Manhattan Heliport to enable electric air taxi operations.

 

First opened in 2011, the Kearny heliport is the largest vertical-lift facility on the east coast with 27 parking spots for helicopters and plans to expand to 32. The heliport provides ground services as well as hangar space for maintenance operations to helicopter operators in the NYC region, one of the busiest low-altitude corridors in the world.

 

As part of the agreement, HHI will upgrade its electrical infrastructure to support the installation of Joby’s Global Electric Aviation Charging System (“GEACS”), designed to support the safe and efficient operation of all electric aircraft under development today, including Joby’s quiet, emissions-free air taxi.

 

“We’re pleased to expand our partnership with HHI as we prepare to install our GEACS charging system at Kearny Heliport. Kearny is expected to become the first heliport with an air taxi charger in the tri-state area and enable the launch of our quiet, emissions-free air taxi service in the greater New York City region,” said JoeBen Bevirt, Founder and CEO of Joby.

 

The GEACS charging interface is already in use at Joby’s flight test center in Marina, California and at Edwards Air Force Base. Joby recently announced a definitive agreement with Clay Lacy Aviation to install a charging system at John Wayne Airport (SNA) in Orange County, Calif.

 

Jeff Hyman, Founder and CEO of HHI, commented, “We continue to expand our footprint in Kearny in support of one of the busiest low-altitude corridors in the world, and we’re thrilled to partner with Joby, one of the leading developers of electric air taxis, to bring the next wave of quiet aircraft to residents of the tri-state area.”

 

In 2022, Joby announced a multi-year, multi-city commercial and operational partnership with Delta Air Lines to deliver seamless airport trips for its customers across several locations, including Los Angeles and New York City.

 

Joby’s air taxi is designed to carry a pilot and four passengers at speeds of up to 200 mph, offering high-speed mobility with a fraction of the noise produced by helicopters and no in-flight emissions.

 

About Joby

Joby Aviation, Inc. (NYSE: JOBY) is a California-based transportation company developing an all-electric, vertical take-off and landing air taxi which it intends to operate as part of a fast, quiet, and convenient service in cities around the world. To learn more, visit www.jobyaviation.com.

 

About HHI

Helo Holdings, Inc. has over twelve years of experience in heliport operations in the Northeast Corridor. In 2010, HHI opened the Kearny Heliport, located in Kearny, New Jersey, just two minutes’ flying time from Manhattan. Situated in the busiest helicopter corridor in the world, the facility offers tarmac parking spaces for 28 helicopters, 63,500 square feet of hangar space as well as office space, maintenance services, a pilot-friendly amenities lounge, and a 24,000-gallon fuel facility. HHI has owned, expanded and operated this vibrant heliport since its inception, carrying out day-to-day heliport operations, flight tracking, aviation facilities management, management of helicopter service providers, and aviation property management. Kearny Heliport has been awarded Heliport of the Year in 2013, 2019, 2022 & 2023 by ERHC.

 

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements regarding the development and performance of our aircraft, the growth of our manufacturing capabilities, our regulatory outlook, progress and timing; our business plan, objectives, goals and market opportunity; plans for, and potential benefits of, our strategic partnerships; and the planned locations for our services. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “will”, “should”, “can have”, “likely” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. All forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including: our ability to launch our aerial ridesharing service and the growth of the urban air mobility market generally; our ability to produce aircraft that meet our performance expectations in the volumes and on the timelines that we project, and our ability to launch our service; the competitive environment in which we operate; our future capital needs; our ability to adequately protect and enforce our intellectual property rights; our ability to effectively respond to evolving regulations and standards relating to our aircraft; our reliance on third-party suppliers and service partners; uncertainties related to our estimates of the size of the market for our service and future revenue opportunities; and other important factors discussed in the section titled “Risk Factors” in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 1, 2023, and in future filings and other reports we file with or furnish to the SEC. Any such forward-looking statements represent management’s estimates and beliefs as of the date of this presentation. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Contacts

Joby Aviation

Investors:

investors@jobyaviation.com

Media:

press@jobyaviation.com

Categories
Business Culture Digital - AI & Apps Economics Lifestyle Regulations & Security Technology

Align appoints Vinod Paul as president of Align Managed Services

Vinod Paul to Lead Strategic Direction and Expansion of Align’s Managed Services Portfolio

NEW YORK — (BUSINESS WIRE) — #ITservices — Align, the leading global provider of technology infrastructure solutions and Managed IT Services, announces the appointment of Vinod Paul as President of Align Managed Services, effective immediately.

 

In his new role, Vinod will continue to drive the strategic direction, expansion, and profitability of Align’s managed services portfolio, including cloud solutions, cybersecurity, and tailored products designed for the financial services community. Vinod’s vision and leadership will be instrumental in shaping the company’s growth strategy, while overseeing client services, technology and thought leadership in both the financial services and Managed Services industries.

 

Vinod joined Align in 2017 and has since served as Chief Operating Officer, before being appointed as President. Under his leadership, Align has expanded its global customer base and broadened its managed services offerings in the financial services sector. In 2023, Align was named MSP of the Year by Channel Futures and was ranked 60th in the global MSP 501 list. Other accolades include Best Cloud Services Provider by Hedgeweek, CRN’s Triple Crown Award by Channel Co. and more – click here to view our full list of awards.

 

Vinod has more than 20 years of experience in the Managed Services industry, with a proven track record of delivering innovative and customer-centric solutions. Prior to Align, he held senior leadership roles at several global IT firms, including ECI, IBM Global Services, Lucent Technologies, and Tyco Submarine Systems. In 2022, he received the honor of being included in Channel Futures’ Most Influential MSP leaders of 2022 List. Vinod was also recognized as a 2023 Honoree by Help for Children (HFC). Founded with a mission to make a profound difference in the lives of children in need, HFC is a renowned charitable organization dedicated to the prevention and treatment of child abuse for youth across the globe.

 

“Vinod is a visionary leader who has transformed our managed services business and delivered exceptional results for our customers and the broader financial services industry,” said Jim Dooling, CEO and President of Align Communications.

 

“He has a deep understanding of the market dynamics, customer needs, and technology trends that impact our industry. I am confident he will continue to drive growth and innovation for our managed services division and for Align.”

 

“I am honored and excited to take on this new role and lead our talented and dedicated team of managed services professionals,” said Vinod.

 

“Align is renowned for delivering top-notch and cost-efficient IT solutions and managed services to clients within the financial services sector. I am enthusiastic about actively contributing to our continued success, enhancing value for our customers, partners, and team members alike. Our dedication is to cultivate enduring partnerships with our clients, and I am excited to collaborate with our leaders to ensure an unparalleled client experience as a leading managed services provider.”

 

About Align

Align is a premier global provider of technology infrastructure solutions. For over 36 years, leading firms worldwide have relied on Align to guide them through IT challenges, delivering complete, secure solutions for business change and growth. Align is headquartered in Dallas, Texas and has offices in New York City, London, Chicago, San Francisco, Arizona, New Jersey, Texas and Virginia.

 

To learn more about Align Managed Services, visit our website here: https://www.align.com/managed-services and follow Align on LinkedIn and at @AlignITAdvisor on Twitter.

Contacts

Media
Ashley Holbrook
Director of Marketing, Align

aholbrook@align.com

Categories
Business Healthcare Lifestyle Local News Science

Subcutaneous nivolumab (nivolumab and hyaluronidase) shows noninferiority compared to intravenous Opdivo (nivolumab) in advanced or metastatic clear cell renal cell carcinoma in CheckMate -67T trial

CheckMate -67T is the first Phase 3 trial of the subcutaneous formulation of Opdivo to evaluate and demonstrate noninferior pharmacokinetics, efficacy and safety vs. its intravenous formulation

Subcutaneous nivolumab demonstrated noninferior pharmacokinetics (co-primary endpoints) and objective response rate (key powered secondary endpoint) compared to intravenous Opdivo

Results from the Phase 3 CheckMate -67T trial will be presented in a late-breaking oral presentation at ASCO GU 2024 in the first ever disclosure for subcutaneous formulation of Opdivo

 

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ASCO — Bristol Myers Squibb (NYSE: BMY) today announced the first disclosure of data from the Phase 3 CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy, demonstrating noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo.

 

In addition, subcutaneous nivolumab displayed noninferior objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo. These results will be featured in a late-breaking oral presentation (Abstract #LBA360) at the American Society of Clinical Oncology (ASCO) 2024 Genitourinary Cancers Symposium from January 25-27, 2024.

“The data from CheckMate -67T with the subcutaneous formulation of nivolumab co-formulated with recombinant human hyaluronidase represent a groundbreaking advancement in oncology research for physicians and our patients,” said Saby George, M.D., F.A.C.P., professor of Oncology and Medicine, director of Network Clinical Trials, Department of Medicine, Roswell Park Comprehensive Cancer Center.

 

“Having the option to administer immunotherapy subcutaneously could undoubtedly reduce the treatment burden that patients diagnosed with cancer currently face, as well as help maximize efficiencies within healthcare systems. As it stands, intravenous immunotherapy infusion can take precious time, which we know is an important commodity for patients and the doctors who treat them. That’s why these results indicating noninferiority with subcutaneous nivolumab have the potential to be practice-changing and to improve patients’ treatment experience with one injection that can be given in under five minutes and, in some cases, outside of the infusion center.”

 

In the CheckMate -67T trial investigating subcutaneous nivolumab (n=248) vs. IV Opdivo (n=247) in patients with advanced of metastatic ccRCC:

  • Cavgd28: Noninferiority of subcutaneous nivolumab to IV Opdivo was shown for the time-averaged serum concentration over the first 28 days, with a geometric mean ratio of 2.098 (90% Confidence Interval [CI]: 2.001 – 2.200).
  • Cminss: Noninferiority of subcutaneous nivolumab to IV Opdivo was shown for the minimum serum concentration at steady state, with a geometric mean ratio of 1.774 (90% CI: 1.633 – 1.927).
  • ORR: Noninferiority was also seen in the key powered secondary endpoint of ORR by BICR, with subcutaneous nivolumab demonstrating an ORR of 24.2% vs. 18.2% with IV Opdivo (Relative Risk Ratio [RR] 1.33; 95% CI: 0.94 to 1.87).
  • PFS: Median PFS by BICR with subcutaneous nivolumab was 7.23 months and 5.65 months with IV Opdivo.
  • Safety: The safety profile of subcutaneous nivolumab was consistent with the IV formulation. Incidence of local injection site reactions with subcutaneous nivolumab was 8.1%. Additionally, reactions were low grade and transient. Among patients treated with subcutaneous nivolumab (n=247), grade 3-4 adverse events (AEs) occurred in 35.2% of patients vs. 40.8% of patients treated with IV Opdivo (n=245). Treatment-related AEs occurred in 9.7% vs. 14.7% of patients, serious AEs in 21.1% vs. 22.9% of patients and treatment-related serious AEs in 6.5% of patients for both the subcutaneous and IV formulations.

 

“These results from the CheckMate -67T trial build on our deep scientific expertise in the use of immunotherapy in solid tumor oncology and our commitment to finding ways to help improve quality of life for patients,” said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb.

 

“We are thrilled to present this research for the first time evaluating subcutaneous nivolumab, demonstrating noninferiority compared to intravenous Opdivo and supporting subcutaneous nivolumab as a potential new option to improve healthcare efficiency. Convenience is an important benefit of subcutaneous immunotherapy and we are excited about the potential for this treatment to reduce patient burden and provide greater flexibility to patients and health care providers. We look forward to discussing next steps for subcutaneous nivolumab across multiple tumor types with health authorities.”

 

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -67T clinical trial.

 

About CheckMate -67T

CheckMate -67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo co-formulated with Halozyme’s proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or intravenous Opdivo. The co-primary endpoints of the trial are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. intravenous Opdivo. Objective response rate (ORR) is a key secondary endpoint.

 

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 431,000 new cases and 179,000 deaths worldwide each year. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. Clear cell renal carcinoma (ccRCC) is the most common form of RCC, affecting about 7 out of 10 people with RCC. The five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 14% and five-year disease-free survival (DFS) rates for those with localized disease that can be resected are just over 50%.

 

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.

 

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

 

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

 

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

 

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In September 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

 

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

 

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.

 

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

 

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

 

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune- mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

 

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

 

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

 

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

 

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

 

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

 

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

 

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

 

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%).In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%).

 

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%).

 

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%).

 

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.7% (22/666) of patients, including Grade 3 (4.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

Read full story here

Categories
Business Digital - AI & Apps Economics Energy Environment Lifestyle Science Technology

Leading Independent Proxy Advisory Firm Glass Lewis recommends shareholders vote ONLY on the WHITE proxy card ‘FOR’ all of Ocean Power Technologies Board nominees

Both Leading Independent Proxy Advisory Firms – ISS and Glass Lewis – Now Recommend Voting “FOR ALL” of the Board’s Highly Qualified and Experienced Nominees

 

OPT Continues to Urge All Holders to Vote ONLY on the WHITE Proxy Card Today “FOR” All the Company’s Board Nominees and Other Proposals

 

 

MONROE TWP., N.J. — (BUSINESS WIRE) — Ocean Power Technologies, Inc. (NYSE American: OPTT)

“(OPT” or the “Company),” a leader in innovative and cost-effective low-carbon marine power, data, and service solutions, today announced that Glass, Lewis & Co., LLC (“Glass Lewis”), a leading independent proxy advisory firm, has joined Institutional Shareholder Services Inc.

 

 

“(ISS)” in recommending that the Company’s shareholders vote ONLY on the WHITE proxy card “FOR” all of the OPT Board of Directors’ (the “Board)” highly qualified and experienced director nominees at the upcoming 2023 Annual Meeting of Stockholders “(2023 Annual Meeting),” scheduled to be held on Wednesday, Jan. 31, 2024, via live webcast.

 

In its report recommending support for all of OPT’s director nominees, Glass Lewis notes that:1

  • “[…] the incumbent directors appear to have appropriate qualifications and expertise to oversee the Company and that the board is sufficiently independent.”
  • “[…] we note that the incumbent chairman, Mr. Cryan, has considerable turnaround experience, including at three companies and has served in an executive position at a firm that consults companies facing challenges.”
  • “We observe that the board has also undergone significant refreshment in recent years, five out of six incumbent directors were appointed to the board in 2020 or 2021 and that average tenure of the incumbent directors is four years.”

In addition, Glass Lewis shares the Company’s concerns as to the purpose of Paragon’s interest in OPT:

  • “[…] we do question the nature of Paragon’s interest in the Company and we share the concern raised by the incumbent board that Paragon may have an undisclosed agenda.”

 

As a reminder, shareholders may receive proxy materials from an activist investor, Paragon Technologies, Inc. “(Paragon)” (OTC Pink: PGNT). A vote for any of Paragon’s purported nominees on theblue proxy card will not be counted at the 2023 Annual Meeting. Shareholders are urged not to sign or return any blue proxy card and to discard Paragon’s materials. Please vote only on the WHITE proxy card. If a shareholder previously signed a blue proxy card sent by Paragon, that proxy card can be revoked by voting on a new WHITE proxy card. Only the latest-dated proxy card will count.

 

Shareholders are urged to protect their investment by voting “FOR” all of OPT’s proposals, including voting “FOR ALL” of the OPT Board’s highly qualified and experienced director nominees, by promptly signing, dating, and returning each of the WHITE proxy cards they have received or by voting by telephone or internet. Time is short so shareholders are urged to vote TODAY the WHITE proxy card to ensure that their votes are received in time to be counted at the 2023 Annual Meeting.

 

***

THE OPT BOARD UNANIMOUSLY RECOMMENDS A VOTE “FOR” ALL THE COMPANY’S PROPOSALS, INCLUDING A VOTE “FOR ALL” THE OPT BOARD’S NOMINEES ON THE WHITE PROXY CARD

OPT SHAREHOLDERS ARE REMINDED THAT THEIR VOTE IS VERY IMPORTANT, NO MATTER HOW MANY OR HOW FEW SHARES THEY OWN

TIME IS SHORT SO PLEASE VOTE THE WHITE PROXY CARD TODAY

PLEASE COMPLETE, DATE, SIGN, AND RETURN EVERY WHITE PROXY CARD YOU RECEIVE

DO NOT SIGN OR RETURN ANY BLUE PROXY CARD SENT BY PARAGON

***

 

If shareholders have any questions or require assistance in voting your WHITEproxy card, please contact Morrow Sodali, our proxy solicitation firm, at:

MORROW SODALI

509 Madison Avenue Suite 1206

New York, NY 10022

Shareholders Call Toll Free: (800) 662-5200

Banks, Brokers, Trustees, and Other Nominees Call Collect: (203) 658-9400

Email: OPT@investor.MorrowSodali.com

 

About Ocean Power Technologies

OPT provides intelligent maritime solutions and services that enable safer, cleaner, and more productive ocean operations for the defense and security, oil and gas, science and research, and offshore wind markets. Our PowerBuoy® platforms provide clean and reliable electric power and real-time data communications for remote maritime and subsea applications. We also provide WAM-V® autonomous surface vessels (ASVs) and marine robotics services. The Company’s headquarters is in Monroe Township, New Jersey and has an additional office in Richmond, Calif. To learn more, visit www.OceanPowerTechnologies.com.

 

Forward-Looking Statements

This press release may contain forward-looking statements that are within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any such forward-looking statements in this release are identified by certain words or phrases such as “may”, “will”, “aim”, “will likely result”, “believe”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “plan”, “contemplate”, “seek to”, “future”, “objective”, “goal”, “project”, “should”, “will pursue” and similar expressions or variations of such expressions. These forward-looking statements reflect OPT’s current expectations about its future performance, plans, and objectives. By their nature, forward-looking statements rely on a number of assumptions and estimates that could be inaccurate and involve risks and uncertainties that could cause actual results to materially differ from those anticipated or expressed in any forward-looking statement. These estimates and assumptions reflect our best judgment based on currently known market conditions and other factors. Although we believe such estimates and assumptions to be reasonable, they are inherently uncertain and involve a number of risks and uncertainties that are beyond our control, including, without limitation risks related to our ability to execute on our strategy, drive growth, and create value for our stockholders; our ability to develop, market, and commercialize our products; our ability to monetize our opportunity pipeline; our ability to achieve and, thereafter, sustain profitability; our ability to win government contracts, including in the defense and security sectors; the possibility that we may not be able to obtain the necessary facility and personnel clearances to qualify for certain government contracts, including in the defense and security sectors; our ability to continue the development of our proprietary technologies; our expected continued use of cash from operating activities unless or until we achieve positive cash flow from the commercialization of our products and services; our ability to obtain additional funding, as and if needed; our history of operating losses, which we expect to continue for at least the short term and possibly longer; our ability to control our expenses; our ability to attract and retain qualified personnel, including executive management; our ability to manage and mitigate risks associated with our internal cyber security protocols and protection of the data we collect and distribute; our ability to protect our intellectual property portfolio; the impact of inflation related to the U.S. dollar on our business, operations, customers, suppliers and manufacturers, and personnel; our ability to meet product development, manufacturing and customer delivery deadlines; our ability to identify and penetrate markets for our products, services, and solutions; and the risks related to the actions of Paragon Technologies, Inc. against OPT and the related litigation brought against OPT in the Delaware Court of Chancery, including the amount of related costs incurred by OPT and the disruption caused to OPT’s business activities by these actions.

 

Many of these factors are beyond our ability to control or predict. These factors are not intended to represent a complete list of the general or specific factors that may affect us. Additional factors are described in OPT’s Form 10-K, Form 10-Q, and Form 8-K reports (including all amendments to those reports). Any forward-looking statements speak only as of the date on which such statements are made, and OPT undertakes no obligation or intent to update such forward-looking statements to reflect events or circumstances arising after such date. OPT cautions investors not to place undue reliance on any such forward-looking statements. These cautionary statements qualify all forward-looking statements attributable to us or persons acting on our behalf.

 

Important Additional Information And Where To Find It

OPT has filed with the SEC a revised definitive proxy statement on Schedule 14A on December 4, 2023, including a form of WHITEproxy card, and other relevant documents with respect to its solicitation of proxies for OPT’s 2023 Annual Meeting of Stockholders scheduled to be held on January 31, 2024 (the “2023 Annual Meeting”). INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REVISED DEFINITIVE PROXY STATEMENT (INCLUDING THE SUPPLEMENT THERETO FILED WITH THE SEC ON JANUARY 3, 2024 AND ANY OTHER AMENDMENTS OR SUPPLEMENTS TO OPT’S REVISED DEFINITIVE PROXY STATEMENT) FILED BY OPT AND ANY OTHER RELEVANT DOCUMENTS THAT OPT FILES WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT OPT’S SOLICITATION. Investors and security holders may obtain copies of these documents and other documents filed with the SEC by OPT free of charge through the website maintained by the SEC at www.sec.gov. Copies of the documents filed by OPT are also available free of charge by accessing OPT’s corporate website at www.oceanpowertechnologies.com, by writing to OPT’s Corporate Secretary at Ocean Power Technologies, Inc., 28 Engelhard Drive, Suite B, Monroe Twp., N.J. 08831, or by contacting OPT at (609) 730-0400.

 

Certain Participant Information

OPT, its directors, and executive officers may be deemed to be participants in the solicitation of proxies with respect to a solicitation by OPT in connection with matters to be considered at OPT’s 2023 Annual Meeting. Information about OPT’s executive officers and directors, including information regarding the direct and indirect interests, by security holdings or otherwise, is available in OPT’s revised definitive proxy statement for the 2023 Annual Meeting (including the schedules and appendices thereto), which was filed with the SEC on Dec. 4, 2023. To the extent holdings of OPT securities reported in the revised definitive proxy statement for the 2023 Annual Meeting have changed or subsequently change, such changes have been or will be reflected on Statements of Change in Ownership on Forms 3, 4, or 5 filed with the SEC. These documents are or will be available free of charge at the SEC’s website at www.sec.gov.

___________________________________

1 Permission to quote Glass Lewis was neither sought nor obtained. Emphases added.

Contacts

Investors:

609-730-0400 x401 or

InvestorRelations@oceanpowertech.com

Media:

609-730-0400 x402 or

MediaRelations@oceanpowertech.com
Or

Longacre Square Partners

Joe Germani / Dan Zacchei

jgermani@longacresquare.com / dzacchei@longacresquare.com

Categories
Healthcare Lifestyle Local News News Now! Science

Opdivo (nivolumab) plus Yervoy (ipilimumab) reduced the risk of disease progression or death by 79% versus chemotherapy in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer in CheckMate -8HW trial

First presentation of data from the Phase 3 randomized trial shows statistically significant and clinically meaningful improvement in progression-free survival with Opdivo plus Yervoy compared to chemotherapy as first-line treatment in this patient population

 

Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as first-line treatment in MSI-H/dMMR mCRC

 

Late-breaking data to be featured in oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium and highlighted as part of official Congress press program

 

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ASCO—Bristol Myers Squibb (NYSE: BMY) on Monday announced results from the Phase 3 CheckMate -8HW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice of chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) as a first-line treatment for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

 

The dual immunotherapy combination of Opdivo and Yervoy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR), with a reduction in the risk of disease progression or death by 79% (Hazard Ratio [HR]: 0.21; 95% Confidence Interval [CI]: 0.14-0.32; p<0.0001) compared to chemotherapy in patients with centrally confirmed MSI-H/dMMR mCRC.

These late-breaking data (Abstract #LBA768) will be featured in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium on Saturday, January 20 at 9:15 a.m. Pacific Time and will be highlighted as part of the Congress’ official press program.

 

Improvement in PFS was noted beginning at approximately three months and was sustained throughout. Median PFS was not yet reached in the Opdivo plus Yervoy arm (95% CI: 38.4-NE) vs. 5.9 months in the chemotherapy arm (95% CI: 4.4-7.8). Consistent PFS benefit was observed across all pre-specified subgroups, including patients with KRAS or NRAS mutations, and those with baseline liver, lung, or peritoneal metastases.

 

The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. Grade 3/4 treatment-related adverse events (TRAEs) occurred in 23% of patients in the Opdivo plus Yervoy arm and 48% of patients in the chemotherapy arm. Any grade TRAE-related discontinuation was 17% in the Opdivo plus Yervoy arm and 32% in the chemotherapy arm.

 

“Patients with MSI-H/dMMR metastatic colorectal cancer are less likely to benefit from chemotherapy,” said Thierry Andre, M.D., Head of the Medical Oncology Department, Sorbonne University and Hospital Saint-Antoine, Paris, France. “An impressive improvement in PFS and sustained benefit beginning at three months was observed with nivolumab plus ipilimumab versus chemotherapy in this trial. These results demonstrate the meaningful efficacy of this combination with practice-changing potential for this patient population.”

 

Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as first line treatment in MSI-H/dMMR mCRC.

 

“With research from the full CheckMate clinical development program, BMS has revolutionized the oncology landscape and helped change survival expectations for people with cancer. Today, with these data from CheckMate -8HW, we showed that Opdivo plus Yervoy reduced the risk of disease progression or death by an unprecedented 79%,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. “These results build on the benefit of Opdivo and Yervoy in MSI-H/dMMR metastatic colorectal cancer as previously demonstrated in CheckMate -142 and reinforce our commitment to exploring the potential of these therapies to help more patients in need.”

 

CheckMate -8HW is ongoing to assess the second dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as secondary endpoints, including overall survival (OS).

 

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.

 

About CheckMate -8HW

CheckMate -8HW (NCT04008030) is a Phase 3 randomized, open-label trial evaluating Opdivo plus Yervoy compared to Opdivo alone or investigator’s choice chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

 

Approximately 830 patients were randomized to receive either Opdivo monotherapy (Opdivo 240 mg Q2W for six doses, followed by Opdivo 480 mg Q4W), Opdivo plus Yervoy (Opdivo 240 mg plus Yervoy 1 mg/kg Q3W for four doses, followed by Opdivo 480 mg Q4W), or investigator’s choice of chemotherapy. The dual primary endpoints of the trial are progression-free survival (PFS) per blinded independent central review (BICR) for Opdivo plus Yervoy compared to investigator’s choice of chemotherapy in the first line setting and PFS per BICR for Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy. The trial also includes several secondary safety and efficacy endpoints, including overall survival (OS).

 

The study is ongoing to assess the second dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as secondary endpoints.

 

About MSI-H or dMMR Colorectal Cancer

Colorectal cancer (CRC) is a cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. CRC is the third most commonly diagnosed cancer in the world. In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease; it is the second leading cause of cancer-related deaths among men and women combined.

 

Mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors. Approximately 5-7% of metastatic CRC patients have dMMR or MSI-H tumors; they are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.

 

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research programs uniquely position the company to approach cancer from every angle.

 

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

 

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

 

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

 

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In September 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

 

About Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

 

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

 

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune- mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

Read full story here