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CRMD SHAREHOLDER ALERT: Investors with substantial losses have opportunity to lead the CorMedix Inc. class action lawsuit

SAN DIEGO — (BUSINESS WIRE) — #CRMDstock—Robbins Geller Rudman & Dowd LLP announces that purchasers of CorMedix Inc. (NASDAQ: CRMD) securities between July 8, 2020 and May 13, 2021, inclusive (“Class Period”) have until September 20, 2021 to seek appointment as lead plaintiff in the CorMedix class action lawsuit. The CorMedix class action lawsuit charges CorMedix and certain of its top executives with violations of the Securities Exchange Act of 1934. The CorMedix class action lawsuit (Patrick v. CorMedix Inc., No. 21-cv-14020) was commenced on July 22, 2021 in the District of New Jersey and is assigned to Judge Julien Xavier Neals.

If you wish to serve as lead plaintiff of the CorMedix class action lawsuit, please provide your information by clicking here. You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at jsanchez@rgrdlaw.com. Lead plaintiff motions for the CorMedix class action lawsuit must be filed with the court no later than September 20, 2021.

 

CASE ALLEGATIONS: The CorMedix class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) deficiencies existed with respect to CorMedix’s lead product candidate DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; (ii) in light of the foregoing deficiencies, the U.S. Food and Drug Administration (“FDA”) was unlikely to approve the DefenCath New Drug Application (“NDA”) for catheter-related bloodstream infections (“CRBSIs”) in its present form; (iii) defendants had downplayed the true scope of the deficiencies with DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; and (iv) as a result, CorMedix’s public statements were materially false and misleading at all relevant times.

 

On March 1, 2021, CorMedix issued a press release “announc[ing] that the [FDA] cannot approve the [NDA] for DefenCath . . . in its present form.” CorMedix informed investors that the “FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility”; that the “FDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns”; that, “[w]hen we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution”; and that “[a]dditionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.” On this News CorMedix’s stock price fell nearly 40%.

 

Then, on April 14, 2021, CorMedix announced that it would have to take additional steps to meet the FDA’s requirements for DefenCath’s manufacturing process, including “[a]ddressing [the] FDA’s concerns regarding the qualification of the filling operation [that] may necessitate adjustments in the process and generation of additional data on operating parameters for manufacture of DefenCath.” On this News CorMedix’s stock price fell more than 15%.

 

Finally, on May 13, 2021, CorMedix announced that “[b]ased on our analyses, we have concluded that additional process qualification will be needed with subsequent validation to address the deficiencies identified by [the] FDA.” After an analyst pressed for clearer information on DefenCath’s manufacturing deficiencies on a conference call held that same day, CorMedix’s Executive Vice President and General Counsel, defendant Phoebe Mounts, disclosed among other things that “there are times when there may be unexpected results obtained”; that the FDA “expect[s] us to generate sufficient data to demonstrate that [the filling] process is a controlled process and is consistent with the agency’s requirements for good manufacturing practice”; that “sterility is a very important part of that process,” as well as “the accuracy in making sure the right volume of DefenCath is loaded into the vials”; that “we’re talking about thousands of vials during the manufacturing run”; that CorMedix must “generat[e] a lot of data to make sure that . . . all the equipment has been qualified for the intended use and every step in the manufacturing process has been qualified”; that “th[e] process needs to be very robust, [and] needs to be reproducible”; and that “the burden is on the manufacturer to demonstrate that the facility can do that process reducibly and generate the required product for commercial distribution.” On this News CorMedix’s stock price fell an additional 20%, further damaging investors.

 

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased CorMedix securities during the Class Period to seek appointment as lead plaintiff in the CorMedix class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the CorMedix class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the CorMedix class action lawsuit. An investor’s ability to share in any potential future recovery of the CorMedix class action lawsuit is not dependent upon serving as lead plaintiff.

 

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: With 200 lawyers in 9 offices nationwide, Robbins Geller Rudman & Dowd LLP is the largest U.S. law firm representing investors in securities class actions. Robbins Geller attorneys have obtained many of the largest shareholder recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig. The 2020 ISS Securities Class Action Services Top 50 Report ranked Robbins Geller first for recovering $1.6 billion for investors last year, more than double the amount recovered by any other securities plaintiffs’ firm. Please visit https://www.rgrdlaw.com/firm.html for more information.

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Services may be performed by attorneys in any of our offices.

Contacts

Robbins Geller Rudman & Dowd LLP

655 W. Broadway, San Diego, CA 92101

J.C. Sanchez, 800-449-4900

jsanchez@rgrdlaw.com

Categories
Business Local News

Church & Dwight reports Q2 2021 results

2021 Second Quarter Results

  • Net Sales +6.4%: Domestic +3.1%, Int’l +21.0%, SPD +11.8%
  • Organic sales +4.5%: Domestic +2.8%, Int’l +10.4%, SPD +11.8%
  • EPS +16.0%; Adjusted -1.3%

 2021 Full Year Outlook

  • Net Sales growth now ~5%; Organic Sales growth now ~4%
  • Adjusted EPS now at lower end of 6-8% range¹
  • Cash from operations approx. $950 million (previous $1 billion)

 

 

EWING, N.J. — (BUSINESS WIRE) — Church & Dwight Co., Inc. (NYSE: CHD) today announced second quarter net sales grew 6.4% to $1,271.1 million. The Company continues to experience strong consumer demand for many of its products. Organic sales grew 4.5% driven by volume, exceeding the Company’s outlook of 4% growth.2

Second quarter 2021 EPS increased 16.0% to $0.87 per share. Adjusted EPS, which excludes a positive acquisition related earn-out adjustment, decreased 1.3% to $0.76, exceeding the Company’s adjusted outlook of $0.69.²

Matthew Farrell, Chief Executive Officer, commented, “Our brands once again drove strong consumption in Q2. Organic sales growth of 4.5% is on top of 8.4% organic growth in Q2 2020. In the U.S., we grew consumption in 13 of the 16 categories in which we compete. Our brands experienced double-digit consumption growth in 9 of those 16 categories, including gummy vitamins, cat litter, dry shampoo, and water flossers. Our personal care categories are benefitting from increased consumer mobility. Consumption is far outpacing shipments as supply chain disruptions continue and fill levels are below normal. Our International business, despite many countries still experiencing lockdowns, delivered broad-based organic sales growth of 10.4%. Global online sales grew 7.2% (on top of 77% growth in Q2 2020) and as a percentage of total sales has expanded to 14.2% in Q2.”

“I’d like to recognize all Church & Dwight employees around the world for their continued dedication to helping us successfully navigate the difficult environment, especially our Supply Chain and R&D teams as the Company continues to face complexities of raw material and labor shortages at our suppliers and third party manufacturers.”

“In the second quarter, we experienced shortages of many key raw materials. Labor shortages at suppliers and third party manufacturers and transportation challenges have resulted in supply issues. Shortages of available trucks and drivers for raw and packaging materials such as chemicals have also impacted supply. Due to a lower case fill rate, we pulled back on Q2 marketing for affected products, especially household products. We expect the supply issues to begin to abate in Q4 as we continue our efforts to improve. Significant inflation of material and component costs is impacting our gross margin outlook. We expect higher input costs and transportation costs to remain elevated for the rest of the year.”

“Our previously announced pricing actions took effect on June 28, which included a high single digit increase in laundry. In July, we announced additional price increases in cat litter, laundry performance additives, baking soda, water flossers, and showerheads. These actions are in response to rising costs in the commodity, labor and transportation markets. Our cumulative price increases cover approximately 50% of our global portfolio of brands.”

Second Quarter Review

Consumer Domestic net sales were $959.7 million, a $28.6 million or 3.1% increase driven by household and personal care sales growth and acquisitions. Organic sales increased 2.8% due to higher volume (+2.5%) and positive price and product mix (+0.3%). Growth was led by WATERPIK® oral care products, ARM & HAMMER® clumping cat litter, BATISTE® dry shampoo, NAIR® hair removal products and TROJAN® condoms.

Consumer International net sales were $226.8 million, a $39.3 million or a 21.0% increase, primarily driven by Global Markets Group organic growth and the impact of currency. Despite continued lockdowns, organic sales increased 10.4% due to higher volume (+12.5%), partially offset by price and product mix (-2.1%). Organic sales were driven primarily by WATERPIK and ARM & HAMMER liquid laundry detergent in the Global Markets Group, WATERPIK, BATISTE and STERIMAR® nasal spray in Europe and GRAVOL® nausea relief products and ARM & HAMMER litter in Canada.

Specialty Products net sales were $84.6 million, an $8.9 million or an 11.8% increase driven by demand for dairy products. Organic sales increased 11.8% due to higher pricing (+5.5%) and higher volume (+6.3%). Milk prices have remained stable in the U.S. dairy market.

Gross margin decreased 340 basis points to 43.4% due to the impact of higher distribution costs as well as higher manufacturing costs primarily related to commodities and higher tariffs, partially offset by productivity and favorable volume and price.

Marketing expense was $117.0 million, a decrease of $5.3 million or 4.3%. Marketing expense as a percentage of net sales decreased 100 basis points to 9.2%. Marketing spending was temporarily lowered in order to reduce demand until customer fill rates could recover.

Selling, general, and administrative expense (SG&A) was $136.5 million or 10.7% of net sales on a reported basis. Adjusted SG&A as a percentage of net sales was 13.7% a decrease of 140 basis points due to lower litigation costs and lower incentive compensation.²

Income from Operations was $298.7 million or 23.5% of net sales. Adjusted Income from Operations was $260.7 million or 20.5% of net sales.²

Other Expense of $11.4 million declined primarily due to lower interest expense resulting from lower interest rates.

The effective tax rate was 24.0% compared to 19.6% in 2020, an increase of 440 basis points (EPS -$0.04) primarily related to lower stock option exercises. The full year tax rate is now expected to be 23% compared to our previous expectation of 22%.

Operating Cash Flow

For the first six months of 2021, cash from operating activities decreased 42.5% to $344.3 million, a $254.3 million decrease from the prior year, as higher cash earnings were offset by an increase in working capital. The increase in working capital is primarily related to lower accounts payable and accrued expense balances as well as the deferral of U.S. Federal income tax payments from the second to the third quarter in the prior year. We expect to generate $950 million of cash from operations for the full year.

Capital expenditures for the first six months were $43.3 million, a $12.4 million increase from the prior year to support production capacity related to increased demand. Full year capex is expected to be $140 million (previously $180 million) primarily due to timing of projects.

At June 30, 2021, cash on hand was $149.8 million, while total debt was $1,946.9 million.

2021 New Products

Mr. Farrell commented, “Innovation has been a hallmark of Church & Dwight’s success. We will continue to invest in new products and R&D to drive long-term revenue and earnings growth and to meet consumer needs. We are very excited about our new product launches.”

“In the household products portfolio, we have introduced OXICLEAN Laundry and Home Sanitizer. It is the first and only sanitizing product that consumers add directly to the washing machine with their regular detergent, that boosts stain fighting and eliminates 99.9% of bacteria and viruses. The product is also designed for cleaning throughout the house on a variety of surfaces for a germ-free clean.”

“In the personal care portfolio, WATERPIK launched WATERPIK IONTM, a water flosser which is 30% smaller and contains a lithium ion battery that lasts up to four weeks with a single charge and is specifically designed for smaller bathroom spaces with limited counter space and electric outlets. To capitalize on its earlier success, WATERPIK SONIC-FUSION®, the world’s first flossing toothbrush, was upgraded to SONIC-FUSION 2.0, with two brush head sizes and two brush speeds. FLAWLESS is capitalizing on the at-home beauty and self-care trends with a facial cleanser system, a shower wand for a full body spa-like experience, and salon at-home manicure and pedicure solutions. VITAFUSION launched POWER ZINC™, Elderberry gummies in both adult and kids’ variants, and Super Immune Support to capitalize on increased consumer interest in immunity.”

Outlook for 2021

Mr. Farrell stated, “We continue to expect 2021 to be another strong year. Our categories are growing and our brands are performing well. As we continue to experience supply chain disruptions, we now expect full year 2021 reported sales growth to be approximately 5% and organic sales growth to be approximately 4%. This is remarkable on top of 9.6% organic growth in 2020.”

“We now expect to be at the lower end of our range of adjusted EPS growth of 6-8%, reflecting continued strong business performance on top of our 2020 results. We now expect an incremental $125 million in full year input costs (previously $90 million) which have been partially offset by announced price increases, a reduction in coupons and promotions, and lower SG&A. In the near-term, incremental inflation combined with a higher tax rate exceed the partial year benefit of our pricing actions. The full benefit of these pricing actions will be realized in 2022.”

Mr. Farrell continued, “We now expect full year gross margin down 75 basis points (previously we expected flat gross margins) and adjusted operating profit margin expansion of 70 basis points (previous outlook of 80 basis points), which exceeds our Evergreen model of +50 basis points.¹ Consistent with our long term view, our marketing support levels are unchanged from our previous outlook of approximately 11.5%. We now expect full year adjusted SG&A to be down 85 basis points largely due to lower incentive compensation and lower travel. The 2021 effective tax rate is expected to be approximately 23% (previously 22%). Finally, our expectation for cash flow from operations is now approximately $950 million (previously $1 billion).”

“In line with our long term strategy, we continue to pursue accretive acquisitions that meet our strict criteria.”

“While consumption is strong, for Q3, we expect reported sales growth of approximately 3.0% and organic sales growth of approximately 1.5% as we are temporarily constrained by supply. We expect Q3 net sales to be comparable to Q2 net sales. Gross margin expansion reflects the impact of price increases. Adjusted EPS is expected to be $0.70 per share, flat from last year’s adjusted Q3 EPS.”1

¹ This press release does not provide a forward-looking reconciliation of adjusted EPS to reported EPS, adjusted operating margin to reported operating margin, and adjusted SG&A to reported SG&A, the most directly comparable GAAP financial measures, expected for the third quarter or full year of 2021, because we are unable to provide such a reconciliation without unreasonable effort. We have excluded the changes in the Company’s potential earn-out liability from our acquisition of the FLAWLESS business from our expected adjusted EPS and adjusted operating margin for these periods. We are required to review the fair value of the earn-out liability quarterly based on changes in sales forecasts, discount rates, volatility assumptions, and other inputs. Our inability to provide a reconciliation to GAAP EPS, operating margin, and SG&A for future periods is due to the uncertainty and inherent difficulty of predicting what these changes will be on a quarter-by-quarter basis or on an annual basis. For the same reasons, we are unable to address the probable significance of the unavailable information, which could be material to our future results.

² See non-GAAP reporting reconciliations included at the end of this release.

Church & Dwight Co., Inc. (NYSE: CHD) will host a conference call to discuss second quarter 2021 results on July 30, 2021 at 10:00 a.m. (ET). To participate, dial 877-322-9846 within the U.S. and Canada, or 631-291-4539 internationally, using access code 8464778. A replay will be available at 855-859-2056 using the same access code through the close of business on August 6, 2021. You also can participate via webcast by visiting the Investor Relations section of the Company’s website at www.churchdwight.com.

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®, FLAWLESS®, and ZICAM®. These thirteen key brands represent approximately 80% of the Company’s products sales. 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 2020, our continued progress earned public recognition, including the 2020 Newsweek’s Most Sustainable Companies list, the EPA’s Green Power Partnership Top 100 list, the 2020 Forbes Magazine: Americas Best-in-State Employer Award and the FTSE4Good Index Series.

For more information, see the Church & Dwight 2020 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; the impact of the COVID-19 pandemic and the Company’s response; gross margin changes; trade, marketing, and SG&A spending; 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 causing recessionary conditions), resulting from 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 regulatory changes or policies associated with the COVID-19 pandemic, including continuing or renewed shutdowns of retail and other businesses in various jurisdictions; the impact of the CARES Act and other governmental actions; the impact of continued shifts in consumer behavior, including accelerating shifts to online shopping; unanticipated increases in raw material and energy prices; delays and increased costs in manufacturing or distribution; increases in transportation costs; the impact of price increases for our products; the impact of supply chain disruptions; the impact of inclement weather on raw material and transportation costs; adverse developments affecting the financial condition of major customers and suppliers; 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 of private label products; 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; foreign currency exchange rate fluctuations; implications of the United Kingdom’s withdrawal from the European Union; 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, including the actual and potential effect of tariffs on Chinese goods imposed by the United States; issues relating to the Company’s information technology and controls; the impact of natural disasters on the Company and its customers and suppliers, including third party information technology service providers; the integration of acquisitions or divestiture of assets; the outcome of contingencies, including litigation, pending regulatory proceedings and environmental matters; and changes in the regulatory environment.

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 10Q. 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

Six Months Ended

(In millions, except per share data)

June 30, 2021

June 30, 2020

June 30, 2021

June 30, 2020

Net Sales

$

1,271.1

$

1,194.3

$

2,510.0

$

2,359.5

Cost of sales

718.9

634.7

1,406.9

1,267.9

Gross Profit

552.2

559.6

1,103.1

1,091.6

Marketing expenses

117.0

122.3

215.7

218.7

Selling, general and administrative expenses

136.5

186.6

286.1

307.6

Income from Operations

298.7

250.7

601.3

565.3

Equity in earnings of affiliates

2.8

2.0

5.4

3.6

Other income (expense), net

(14.2

)

(16.7

)

(28.4

)

(33.5

)

Income before Income Taxes

287.3

236.0

578.3

535.4

Income taxes

69.0

46.3

139.3

115.9

Net Income

$

218.3

$

189.7

$

439.0

$

419.5

Net Income per share – Basic

$

0.89

$

0.77

$

1.79

$

1.71

Net Income per share – Diluted

$

0.87

$

0.75

$

1.76

$

1.67

Dividends per share

$

0.25

$

0.24

$

0.50

$

0.48

Weighted average shares outstanding – Basic

245.2

246.2

245.2

245.9

Weighted average shares outstanding – Diluted

250.0

251.3

249.9

251.2

CHURCH & DWIGHT CO., INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets (Unaudited)

(Dollars in millions)

June 30, 2021

December 31, 2020

Assets

Current Assets

Cash and Cash Equivalents

$

149.8

$

183.1

Accounts Receivable

386.2

398.8

Inventories

555.8

495.4

Other Current Assets

36.9

35.1

Total Current Assets

1,128.7

1,112.4

Property, Plant and Equipment (Net)

613.0

612.8

Equity Investment in Affiliates

9.9

9.1

Trade Names and Other Intangibles

3,049.2

3,110.2

Goodwill

2,229.8

2,229.6

Other Long-Term Assets

337.9

340.4

Total Assets

$

7,368.5

$

7,414.5

Liabilities and Stockholders’ Equity

Short-Term Debt

$

233.1

$

351.4

Current portion of Long-Term debt

200.0

–

Other Current Liabilities

943.0

1,037.2

Total Current Liabilities

1,376.1

1,388.6

Long-Term Debt

1,513.8

1,812.5

Other Long-Term Liabilities

1,101.4

1,193.0

Stockholders’ Equity

3,377.2

3,020.4

Total Liabilities and Stockholders’ Equity

$

7,368.5

$

7,414.5

CHURCH & DWIGHT CO., INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flow (Unaudited)

Six Months Ended

(Dollars in millions)

June 30, 2021

June 30, 2020

Net Income

$

439.0

$

419.5

Depreciation and amortization

110.3

92.4

Change in fair value of business acquisition liabilities

(57.0

)

(20.7

)

Deferred income taxes

20.9

11.4

Non-cash compensation

16.8

15.8

Gain on sale of assets

–

(3.0

)

Other

2.9

0.7

Subtotal

532.9

516.1

Changes in assets and liabilities:

Accounts receivable

12.5

5.9

Inventories

(60.3

)

(42.7

)

Other current assets

2.6

(2.1

)

Accounts payable and accrued expenses

(134.5

)

35.8

Income taxes payable

0.1

87.1

Other

(9.0

)

(1.5

)

Net cash from operating activities

344.3

598.6

Capital expenditures

(43.3

)

(30.9

)

Proceeds from sale of assets

–

7.0

Other

(4.3

)

(2.5

)

Net cash (used in) investing activities

(47.6

)

(26.4

)

Net change in long-term debt

(100.0

)

–

Net change in short-term debt

(118.4

)

(186.2

)

Payment of cash dividends

(123.8

)

(118.1

)

Proceeds from stock option exercises

12.5

44.9

Payment of business acquisition liabilities

–

(14.5

)

Deferred financing and other

(0.1

)

(0.1

)

Net cash (used in) financing activities

(329.8

)

(274.0

)

F/X impact on cash

(0.2

)

(2.2

)

Net change in cash and cash equivalents

$

(33.3

)

$

296.0

2021 and 2020 Product Line Net Sales

Three Months Ended

Percent

6/30/2021

6/30/2020

Change

Household Products

$

523.0

$

544.7

-4.0

%

Personal Care Products

436.7

386.4

13.0

%

Consumer Domestic

$

959.7

$

931.1

3.1

%

Consumer International

226.8

187.5

21.0

%

Total Consumer Net Sales

$

1,186.5

$

1,118.6

6.1

%

Specialty Products Division

84.6

75.7

11.8

%

Total Net Sales

$

1,271.1

$

1,194.3

6.4

%

Six Months Ended

Percent

6/30/2021

6/30/2020

Change

Household Products

$

1,018.2

$

1,039.0

-2.0

%

Personal Care Products

883.9

783.1

12.9

%

Consumer Domestic

$

1,902.1

$

1,822.1

4.4

%

Consumer International

443.2

386.1

14.8

%

Total Consumer Net Sales

$

2,345.3

$

2,208.2

6.2

%

Specialty Products Division

164.7

151.3

8.9

%

Total Net Sales

$

2,510.0

$

2,359.5

6.4

%

Contacts

Rick Dierker

Chief Financial Officer

609-806-1200

Read full story here

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Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as Adjuvant treatment for esophageal or gastroesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy

Approval is based on Phase 3 results from the CheckMate -577 trial

Opdivo is now the first and only adjuvant therapy approved in this setting in the European Union

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #CheckMate—Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT). The EC’s decision is based on results from the Phase 3 CheckMate -577 trial, which demonstrated that treatment with Opdivo following neoadjuvant CRT and complete surgical resection doubled the primary endpoint of disease-free survival (DFS) compared to placebo in the all-randomized population. The safety profile of Opdivo was consistent with previously reported studies.

Results from CheckMate -577 were presented at the European Society for Medical Oncology (ESMO) Virtual Congress in September 2020 and at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2021.

“We have demonstrated that the use of immunotherapy in earlier stages of cancer has the potential to prevent recurrence for certain patients,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “BMS was the first company to bring checkpoint inhibitors into the adjuvant setting for the treatment of patients with melanoma, and we are pleased to be the first to bring adjuvant therapy to patients in the EU with esophageal or gastroesophageal junction cancers who continue to face a high unmet need.”

The EC decision allows for the use of Opdivo for the adjuvant treatment of adult patients with esophageal or GEJ cancer who have residual pathologic disease following prior neoadjuvant CRT in the 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway. Opdivo also received approval from the U.S. Food and Drug Administration (FDA) in May 2021 for the adjuvant treatment of completely resected esophageal or GEJ cancer with residual pathologic disease in patients who have received CRT.

CheckMate -577 Efficacy and Safety Results

Results from the CheckMate -577 include:

  • DFS: Median DFS was 22.4 months in patients receiving Opdivo (95% Confidence Interval [CI]: 16.6 to 34.0) compared to 11.0 months in patients receiving placebo (95% CI: 8.3 to 14.3). Opdivo reduced the risk of disease recurrence or death by 31% compared to placebo (Hazard Ratio [HR] 0.69; 96.4% CI: 0.56 to 0.86; p=0.0003).
  • Safety: The incidence of any treatment-related adverse events (TRAEs), including any grade and Grade 3-4, was 71% and 13% among patients treated with Opdivo compared to 46% and 6% among patients receiving placebo. Serious TRAEs of any grade and Grade 3-4 occurred in less than 10% of patients treated with Opdivo (any grade in 8%, Grade 3-4 in 6%) compared to 3% and 1% of patients receiving placebo, with a low rate of any grade treatment-related discontinuations in both arms (9% for Opdivo vs. 3% in placebo).

About CheckMate -577

CheckMate -577 is a Phase 3 randomized, multi-center, double-blind study evaluating Opdivo as an adjuvant therapy in patients with resected esophageal or gastroesophageal junction (GEJ) cancer who have received neoadjuvant chemoradiotherapy (CRT) and have not achieved a pathological complete response. The primary endpoint of the trial is disease-free survival (DFS) and the secondary endpoint is overall survival (OS). Following neoadjuvant CRT and complete tumor surgical resection (also known as trimodality therapy), a total of 794 patients were randomized to receive placebo (n=262) or Opdivo (n=532) 240 mg by intravenous infusion every two weeks for 16 weeks followed by placebo or Opdivo 480 mg every four weeks until disease recurrence, unacceptable toxicity or withdrawal of consent, with a maximum of one-year total treatment duration. Follow-up for OS is ongoing.

About Esophageal Cancer

Esophageal cancer is the eighth most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region with the highest rate of esophageal adenocarcinoma occurring in North America (65%) and Europe (~40%).

About Gastric Cancer

Gastric cancer, also known as stomach cancer, is the fifth most common cancer and the third leading cause of cancer death worldwide, with over 1,000,000 new cases and approximately 770,000 deaths in 2020. There are several cancers that can be classified as gastric cancer, including certain types of cancers that form in the GEJ, the area of the digestive tract where the esophagus and stomach connect. While GEJ cancer has a lower prevalence than distal gastric cancer, it continues to rise.

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 scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at 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. Because 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 October 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.

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

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 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 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 patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of 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 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 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. This indication is approved under accelerated approval based on tumor 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), 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 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 adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO® (nivolumab) is indicated for the treatment of 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 patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of 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 (4.5%) and Grade 2 (2.2%).

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%) and Grade 2 (4.5%).

In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypothyroidism occurred in 20% (91/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypothyroidism occurred in 18% (122/666) of patients, including Grade 3 (0.6%) and Grade 2 (11%).

In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, diabetes occurred in 2.7% (15/666) of patients, including Grade 4 (0.6%), Grade 3 (0.3%), and Grade 2 (0.9%).

Immune-Mediated Nephritis with Renal Dysfunction

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated nephritis with renal dysfunction occurred in 4.1% (27/666) of patients, including Grade 4 (0.6%), Grade 3 (1.1%), and Grade 2 (2.2%).

Immune-Mediated Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/ exfoliative rashes.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

Contacts

Bristol Myers Squibb

Media Inquiries:
Media@BMS.com

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Nina Goworek

908-673-9711

nina.goworek@bms.com

Read full story here

Categories
Technology

Alpha Wire relaunches ThermoThin hook-up wire

The newest version of ThermoThin offers an ultrathin construction without sacrificing performance

 

ELIZABETH, N.J. — (BUSINESS WIRE) — Alpha Wire, a global leader in wire, cable and tubing solutions, has updated its popular ThermoThin hook-up wire line. Designed to withstand extreme temperatures and featuring an exceptionally small and lightweight construction, ThermoThin offers an ideal solution for demanding applications where space is at a premium.

“Our customers are experiencing significant space constraints as their devices are getting smaller and smaller,” said Julian Del Campo, Product Marketing Manager at Alpha Wire. “ThermoThin is a great option in these situations because of its rugged performance and its compact design.”

These ultrathin wires offer customers the following benefits:

  • Withstands extreme temperatures from -150˚C to +300˚C
  • Space-saving design with a diameter that is up to 35% smaller than PTFE alternatives
  • Environmental resistance to hazards including the sun, water, and chemicals to ensure consistent performance

For more information on ThermoThin, please visit http://www.alphawire.com/Products/Wire/Hook-Up-Wire/ThermoThin.

About Alpha Wire:

For over 95 years, Alpha Wire has developed wire, cable and tubing solutions designed to offer superior performance and reliability across demanding markets including industrial automation, semiconductor fabrication, medical devices, and many more. Founded in 1922, the company is headquartered in Elizabeth, New Jersey and has operations across the globe. For more information, visit us at alphawire.com.

Contacts

Samantha Flannery

Tel: (724) 288-5234

Email: Samantha.Flannery@belden.com

Categories
Business

New report from the Visual Lease Data Institute reveals urgent action needed for private companies to comply with lease accounting standard ASC 842

While 100% of surveyed companies agree on the business value of complying with the lease accounting standard, most are underconfident and unprepared for the looming deadline

 

WOODBRIDGE, N.J. — (BUSINESS WIRE) — Visual Lease, the #1 lease optimization software provider, today unveiled the results of an in-depth study of 500 senior finance and accounting professionals analyzing where companies are in their efforts toward achieving compliance with ASC 842. The report reveals that despite 100% of respondents acknowledging the many benefits that lease accounting can bring, 75% are not yet compliant. This report marks the first release under The Visual Lease Data Institute, a collection of market-leading data, trends and insights on lease accounting, management and optimization created and curated by Visual Lease.


The 2021 Lease Accounting Market Analysis: The Road to Readiness for ASC 842 explores the journey, opportunities and barriers that companies face in their efforts to comply with the new accounting standard published by the Financial Accounting Standards Board (FASB), which requires them to track and fully disclose all qualifying leased assets, including commercial real estate and equipment leases. The report was informed by a proprietary survey of 500 senior finance and accounting professionals at private organizations with more than 1,000 employees. It excludes public sector organizations and governmental entities, which have to comply with a similar lease accounting standard.

 

Key highlights of the report include:

  • Real Business Opportunity – All surveyed senior finance and accounting professionals recognize that complying with ASC 842 will offer their companies substantial benefits, including more transparent valuation of the organization (54%), cost savings (54%), easier preparation for audits (53%) and the ability to make strategic lease decisions (50%).
  • Need for Urgent Action – Despite the significant business opportunity that comes with lease accounting compliance, of the 75% of surveyed companies who are not yet fully compliant, nearly half (46%) are less than halfway through or have not yet begun the process. Moreover, a shocking one in five respondents admit that achieving full compliance has been a low business priority.
  • Pandemic Delays – Many private companies may now be playing catch-up from the impact of Covid-19, with more than two in five respondents (43%) noting that their organization’s process has been delayed due to the global pandemic.
  • Race Against the Clock – With the December 2021 deadline for private companies less than five months away, two in five respondents (40%) are only somewhat, not very, or not at all confident about their organization being ready to reach full compliance with ASC 842. One reason why? More than two in five (42%) surveyed admit that the ASC 842 compliance process has taken more time than expected, which puts those who have not started the process at serious risk. This is particularly concerning considering the average anticipated staff hours to gather all the necessary lease information to fully adopt ASC 842 is 1,334 hours, equivalent to more than 33 weeks of full-time labor for a highly skilled worker.
  • Companies Can’t Do It Alone – More than one in three (36%) of senior finance and accounting professionals surveyed note that they don’t have the right people, technology and tools in place. High among the things they consider to be essential in the process are implementing new (48%) or upgrading existing (51%) lease management and accounting software.
  • Not a One-and-Done Disclosure – Reaching ASC 842 compliance in time for the standard’s effective date is only part of the battle. Ninety-nine percent of respondents expect to face ongoing challenges maintaining compliance after the 2021 deadline. Among the most anticipated challenges include accurately tracking and managing future modifications to leases, adopting new technologies to optimize the process and continuing to train and educate staff.

 

“We understand just how complex lease accounting is,” said Marc Betesh, founder and CEO of Visual Lease. “For 35 years, we’ve seen firsthand how tight lease portfolio management can amount to millions of dollars in savings and improve business performance. With the deadline for private companies to comply with ASC 842 rapidly approaching, we knew it was the right time to gather our insight, experience and expertise to provide you with the first report under The Visual Lease Data Institute. Our goal is simple – to arm you with the information you need to feel confident about your organization’s lease accounting compliance journey.”

 

For full study results and helpful guidance towards ASC 842 compliance, download The 2021 Lease Accounting Market Analysis: The Road to Readiness for ASC 842.

 

About Visual Lease

Visual Lease is the #1 lease optimization software provider for managing, analyzing, streamlining and reporting on lease portfolios. Developed by industry-leading lease professionals and CPAs, it combines GAAP, IFRS and GASB-compliant lease accounting controls with easy, flexible and automated lease management processes. More than 700 of the world’s largest publicly traded, privately-owned and public sector organizations rely on Visual Lease to control their lease portfolios, integrate with their existing business systems and maintain regulatory compliance. Committed to ongoing innovation and unparalleled customer service, Visual Lease helps organizations transform their lease compliance requirements into financial opportunities. For more information, visit visuallease.com.

 

About The Visual Lease Data Institute

The Visual Lease Data Institute is a collection of market-leading data, trends and insights on lease accounting, management and optimization created and curated by Visual Lease, provider of the #1 lease optimization software. The Institute was founded on 35 years’ experience managing lease data and financials and was created to arm organizations with the knowledge required to achieve and maintain lease accounting compliance and leverage their leases as strategic business assets.

Contacts

Erica Bonavitacola

Visual Lease

T+1 732 860 4838

ebonavitacola@visuallease.com

Katie Vroom

Gregory FCA

T+1 212 398 9680

kvroom@gregoryfca.com

Categories
Business

Skechers’ animal rights movement surpasses $7 million in donations

The Company’s BOBS from Skechers Philanthropic Collection Has Helped Save and Support Over 1.3 Million Shelter Dogs and Cats in the United States and Canada

 

LOS ANGELES — (BUSINESS WIRE) — Skechers, The Comfort Technology Company™, is celebrating its newest milestone for its philanthropic BOBS division: the Company’s total donations have now surpassed $7 million for animals in need throughout the United States and Canada. Through its partnership with Petco Love, a national nonprofit working to lead and inspire change for animals, and sales of its extensive BOBS footwear, apparel and accessory offering, Skechers’ funds have helped save and support over 1.3 million shelter pets across North America.


The brand has continued to drive public awareness for animal welfare this summer with National Foster A Pet month in June—hosting pet adoption events at Skechers retail stores with Petco Love’s animal welfare partners. Community members welcomed home dogs and cats from lifesaving organizations in Dallas, Texas; Harahan, Louisiana; Hialeah, Florida; Marlton, New Jersey and Moreno Valley, California. Consumers across America were also able to support Petco Love and more than 4,000 of its animal welfare partners at local Skechers stores, by rounding up their purchases at checkout—a campaign that raised over $87,000 for dogs and cats independent of Skechers’ total donations.

 

“As a brand with a vast network of stores, we love finding new ways to inspire consumers and mobilize our stores for good—and these adoption and round-up events have resonated with the public and help bring our BOBS message to life,” said Michael Greenberg, president of Skechers. “We’ve given more than $3.4 million to Petco Love since we launched our partnership in 2019—a movement that’s already transformed thousands of pets’ and persons’ lives in America and is now building momentum across Canada.”

 

“Our partnership with BOBS from Skechers helps further our mission to end preventable euthanasia and make communities and pet families closer, stronger and healthier,” said Susanne Kogut, president of Petco Love. “Shelter pets were there for us throughout the pandemic providing unconditional love and joy. Fostering, adopting, volunteering, and donating are ways we can be there for them and make a difference.”

 

Initially a philanthropic collection of slip-on styles that donated new shoes to children in need, the BOBS from Skechers movement has grown to include a popular offering of footwear, apparel and accessories dedicated to helping shelter animals. For every BOBS item purchased in the United States and Canada, a donation is made to Petco Love to help support shelter pets and its lifesaving animal welfare organization network.* Skechers has helped save over 955,000 dogs, cats and other animals through pet adoptions, and contributed to the care of over 395,000 additional animals at nurseries, sanctuaries and medical care facilities.

 

The BOBS from Skechers collection is available at Skechers.com, Skechers and Petco stores, and select department and specialty locations in the United States. To learn more, follow BOBS from Skechers on Facebook, Twitter and Instagram, or visit BOBSfromSkechers.com. For more on Petco Love, visit petcolove.org or follow at Facebook, Instagram, and Twitter.

 

*Skechers U.S.A., Inc., 228 Manhattan Beach Blvd., Manhattan Beach, CA 90266, 310-318-3100. Petco Love, 654 Richland Hills Drive, San Antonio, TX 78245, 858-453-7845. During the promotion, BOBS from Skechers will donate twenty-five cents USD per item of specially marked BOBS from Skechers footwear, apparel and accessories sold in the U.S. to Petco Love, a 501c3 nonprofit organization that helps save the lives of dogs, cats and other pets in America’s shelters. The promotion runs from January 1, 2019 through December 31, 2022.

 

Skechers USA Canada Inc., 5055 Satellite Drive, Unit Number 6, Mississauga, ON L4W 5K7 Canada, 877-644-4414. Petco Love, 654 Richland Hills Drive, San Antonio, TX 78245, 858-453-7845. During the promotion, BOBS from Skechers will donate twenty-five cents CAD per item of specially marked BOBS from Skechers footwear, apparel and accessories sold in Canada to Petco Love, a nonprofit organization that helps save the lives of dogs, cats and other pets in Canada’s shelters. The promotion runs from January 1, 2020 through December 31, 2022.

 

Skechers USA Canada Inc., 5055 Satellite Drive, Unit Number 6, Mississauga, ON L4W 5K7 Canada, 877-644-4414. Petco Love, 654 Richland Hills Drive, San Antonio, TX 78245, 858-453-7845. Pendant la promotion, 25 cents seront versées avec chaque vente de chaussure, vêtement et accessoire portant la marque BOBS de Skechers au Canada à Petco Love, une organisation sans but lucratif dédiée à sauver la vie des chiens, chats et autres animaux en refuges au Canada. La promotion est valide du 1 janvier 2020 et se termine le 31 décembre 2022.

 

About SKECHERS USA, Inc.

Skechers (NYSE:SKX), The Comfort Technology Company based in Southern California, designs, develops and markets a diverse range of lifestyle and performance footwear, apparel and accessories for men, women and children. The Company’s collections are available in the United States and over 170 countries and territories via department and specialty stores, and direct to consumers through 4,057 Company and third-party-owned retail stores and e-commerce websites. The Company manages its international business through a network of global distributors, joint venture partners in Asia, Israel and Mexico, and wholly-owned subsidiaries in Canada, Japan, India, Europe and Latin America. For more information, please visit about.skechers.com and follow us on Facebook, Instagram, Twitter, and TikTok.

 

About BOBS from Skechers

BOBS from Skechers’ charitable collection of shoes, apparel and accessories have improved animals’ lives: over the past five years, Skechers has contributed more than $7 million to help more than 1.3 million shelter pets, including saving more than 955,000 rescued pets in the United States and Canada. It all started in 2011, when Skechers launched a movement to support children impacted by natural disasters and poverty – a cause that has helped the Company donate more than 16 million new pairs of shoes to kids in more than 60 countries worldwide. To learn more about BOBS from Skechers’ commitment to making a difference, visit BOBSfromSkechers.com and follow the brand on Facebook, Instagram and Twitter.

 

About Petco Love (Formerly Petco Foundation)

Petco Love is a nonprofit changing lives by making communities and pet families closer, stronger, and healthier. Since our founding in 1999 as the Petco Foundation, we’ve empowered animal welfare organizations by investing $300 million in adoption and other lifesaving efforts. We’ve helped find loving homes for more than 6.5 million pets in partnership with Petco and organizations nationwide. Today, our love for pets drives us to lead with innovation, creating tools animal lovers need to reunite lost pets, and lead with passion, inspiring and mobilizing communities and our more than 4,000 animal welfare partners to drive lifesaving change alongside us. Is love calling you? Join us. Visit petcolove.org or follow at Facebook, Instagram, Twitter and LinkedIn to be part of the lifesaving work we’re leading every day.

 

This announcement contains forward-looking statements that are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements may include, without limitation, Skechers’ future domestic and international growth, financial results and operations including expected net sales and earnings, its development of new products, future demand for its products, its planned domestic and international expansion, opening of new stores and additional expenditures, and advertising and marketing initiatives. Forward-looking statements can be identified by the use of forward-looking language such as “believe,” “anticipate,” “expect,” “estimate,” “intend,” “plan,” “project,” “will be,” “will continue,” “will result,” “could,” “may,” “might,” or any variations of such words with similar meanings. Any such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in forward-looking statements. Factors that might cause or contribute to such differences include the disruption of business and operations due to the COVID-19 pandemic; international economic, political and market conditions including the challenging consumer retail markets in the United States; sustaining, managing and forecasting costs and proper inventory levels; losing any significant customers; decreased demand by industry retailers and cancellation of order commitments due to the lack of popularity of particular designs and/or categories of products; maintaining brand image and intense competition among sellers of footwear for consumers, especially in the highly competitive performance footwear market; anticipating, identifying, interpreting or forecasting changes in fashion trends, consumer demand for the products and the various market factors described above; sales levels during the spring, back-to-school and holiday selling seasons; and other factors referenced or incorporated by reference in Skechers’ annual report on Form 10-K for the year ended December 31, 2020 and its quarterly report on Form 10-Q for the three months ended March 31, 2021. More specifically, the COVID-19 pandemic has had and is currently having a significant impact on Skechers’ business, financial conditions, cash flow and results of operations. Forward-looking statements with respect to the COVID-19 pandemic include, without limitation, Skechers’ plans in response to this pandemic. At this time, there is significant uncertainty about the COVID-19 pandemic, including without limitation, (i) the duration and extent of the impact of the pandemic, (ii) governmental responses to the pandemic, including how such responses could impact Skechers’ business and operations, as well as the operations of its factories and other business partners, (iii) the effectiveness of Skechers’ actions taken in response to these risks, and (iv) Skechers’ ability to effectively and timely adjust its plans in response to the rapidly changing retail and economic environment. Taking these and other risk factors associated with the COVID-19 pandemic into consideration, the dynamic nature of these circumstances means that what is stated in this press release could change at any time, and as a result, actual results could differ materially from those contemplated by such forward-looking statements. The risks included here are not exhaustive. Skechers operates in a very competitive and rapidly changing environment. New risks emerge from time to time and we cannot predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, you should not place undue reliance on forward-looking statements as a prediction of actual results. Moreover, reported results should not be considered an indication of future performance.

Contacts

Caitlin Faford

Rogers & Cowan/PMK

caitlin.faford@rogersandcowanpmk.com

Jennifer Clay

Skechers USA

jennc@skechers.com

Razan Monzer

Skechers Canada

razan.monzer@skechers.com

Lisa Lane

Petco Love

media@petcolove.org

Categories
Business

Citizens Financial Group, Inc. announces agreement to acquire Investors Bancorp, Inc.

Solidifies Citizens’ banking franchise serving communities in the greater New York City and Philadelphia metropolitan areas and across New Jersey

Adds approximately $27 billion in total assets, $20 billion in deposits*, and an attractive commercial and consumer customer base

 

PROVIDENCE, R.I. & SHORT HILLS, N.J. — (BUSINESS WIRE) — Citizens Financial Group, Inc. (NYSE: CFG or “Citizens”) and Investors Bancorp, Inc. (NASDAQ: ISBC) (“Investors”) announced today that they have entered into a definitive agreement and plan of merger under which Citizens will acquire all of the outstanding shares of Investors for a combination of stock and cash.

The acquisition of Investors enhances Citizens’ banking franchise, adding an attractive middle market/small business and consumer customer base while building its physical presence in the northeast with the addition of 154 branches* located in the greater New York City and Philadelphia metropolitan areas and across New Jersey. The acquisition complements Citizens’ recently announced acquisition of HSBC East Coast branches and national online deposits which is expected to close in first quarter 2022. The combined Citizens franchise will operate across some of the most attractive retail and commercial banking markets in the United States characterized by large and dense population centers, areas of high-income households and centers of robust business activity.

 

“The acquisition of Investors, following on the heels of the acquisition of HSBC’s East Coast branches, further strengthens our formidable franchise in the northeast, together adding roughly one million customers and boosting our near and long-term growth potential,” said Bruce Van Saun, chairman and chief executive officer of Citizens. “We are confident in our ability to successfully integrate these acquisitions, and to over time deliver the same attractive offerings to customers and strong financial performance in the New York City metro region and New Jersey as we do in other major metro areas we serve.”

 

“Joining Citizens, with its broad capabilities, scale and commitment to excellence in customer service opens exciting opportunities for our combined company,” said Kevin Cummings, chairman and chief executive officer of Investors. “Citizens shares Investors’ deep commitment to serving customers, supporting colleagues and giving back to local communities. Our local-market expertise and personal touch will align well with Citizens’ approach and together we will drive long-term value for all our stakeholders.”

 

Highlights of the proposed transaction to acquire Investors:

Creates long-term shareholder value

  • Immediately accretive to EPS; given substantial synergies, expected to add approximately 6.4% to 2023 fully-diluted EPS. Combined with HSBC, transactions add 8.8% to 2023 fully-diluted EPS
  • Expected to deliver a strong internal rate of return of over 20% and an estimated return on invested capital of approximately 13%
  • Accelerates achievement of long-term financial goals; expected to improve return on tangible common equity by approximately 120 basis points and efficiency ratio by approximately 270 basis points
  • Expected to be CET1 neutral at closing
  • Modest tangible book value per share dilution of approximately 2.6% expected at close with an approximately 2.5-year earn-back

 

Identified cost savings and other synergies

  • Identified approximately $130 million of fully-phased in annual cost savings, after provision for adding investments in brand marketing and technology capabilities; this is approximately 30% of Investors’ estimated 2021 cost base
  • Total estimated pre-tax integration costs of approximately $400 million
  • Meaningful revenue upside expected but not included in transaction estimates

 

Advances Citizens’ strategy with solid presence in important markets

  • Expands upon our recently announced HSBC acquisition, building Citizens’ brand presence in the important greater New York City and Philadelphia metropolitan and New Jersey markets and combined, adding about one million customers
  • Citizens combined with Investors and HSBC reaches top-10 NYC Metro deposit ranking
  • Fills branch gap, connecting New England to the Mid-Atlantic market and adding to our leadership position in the Philadelphia MSA; adds 154 branches, including approximately 130 in the New York City MSA
  • Provides branch base and brand reach to expand commercial lending and fee opportunities in the region; adds attractive middle market/ small business customer base
  • Opportunity to drive household growth and share while accelerating lending and wealth growth in consumer

 

Under the terms of the agreement and plan of merger, Investors shareholders will receive 0.297 of a share of CFG common stock and $1.46 in cash for each share of Investors they own. Following completion of the transaction, former Investors shareholders will collectively own approximately 14% of the combined company. The implied total transaction value based on closing prices on July 27, 2021 is approximately $3.5 billion.

 

Key members of Investors’ management team are expected to join Citizens, ensuring business and client continuity. Upon closing of the transaction, Kevin Cummings, Investors’ Chairman and Chief Executive Officer, and Michele N. Siekerka, who are current members of the board of directors of Investors, are expected to join Citizens’ board of directors.

 

The agreement and plan of merger has been unanimously approved by the boards of directors of each company and the transaction is expected to close in first or second quarter 2022, subject to approval by the shareholders of Investors, receipt of required regulatory approvals and other customary closing conditions.

 

Morgan Stanley & Co. LLC acted as financial advisor to Citizens in connection with the transaction and Sullivan & Cromwell, LLP served as legal advisor. Keefe, Bruyette & Woods, A Stifel Company, served as lead financial advisor; Piper Sandler & Co. and Lazard also served as financial advisors, and Luse Gorman, PC served as legal advisor to Investors.

 

Additional Information

CFG management will host a live conference call this morning with details as follows:

Time:

8:00 am (ET)

Dial-in:

Individuals may call in by dialing 844-291-5495, conference ID 1199032

Webcast/Presentation:

The live webcast will be available at http://investor.citizensbank.com under Events & Presentations.

Replay Information:

A replay of the conference call will be available beginning at 11:00 am ET on July 28 through August 28, 2021. Please dial 866-207-1041 and enter access code 6041235. The webcast replay will be available at http://investor.citizensbank.com under Events & Presentations.

A presentation providing additional information on the transaction is available at https://investor.citizensbank.com/about-us/investor-relations/events-and-presentations/2021.aspx.

 

Cautionary Statement About Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the financial condition, results of operations, business plans and future performance of Citizens and Investors. Words such as “anticipates,” “believes,” “estimates,” “expects,” “forecasts,” “intends,” “plans,” “projects,” “targets,” “designed,” “could,” “may,” “should,” “will” or other similar words and expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Citizens’ and Investors’ current expectations and assumptions regarding Citizens’ and Investors’ businesses, the economy, and other future conditions.

 

Because forward-looking statements relate to future results and occurrences, they are subject to inherent risks, uncertainties, changes in circumstances and other factors that are difficult to predict. Many possible events or factors could affect Citizens’ and/or Investors’ future financial results and performance and could cause the actual results, performance or achievements of Citizens and/or Investors to differ materially from any anticipated results expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, (1) the risk that the cost savings, any revenue synergies and other anticipated benefits of the proposed transaction may not be realized or may take longer than anticipated to be realized, including as a result of the impact of, or problems arising from, the integration of the two companies or as a result of the condition of the economy and competitive factors in areas where Citizens and Investors do business, (2) disruption to the parties’ businesses as a result of the announcement and pendency of the proposed transaction and diversion of management’s attention from ongoing business operations and opportunities, (3) the occurrence of any event, change or other circumstances that could give rise to the right of one or both of the parties to terminate the definitive merger agreement between Citizens and Investors, (4) the risk that the integration of Citizens’ and Investors’ operations will be materially delayed or will be more costly or difficult than expected or that Citizens and Investors are otherwise unable to successfully integrate their businesses, (5) the failure to obtain the necessary approvals of the stockholders of Investors, (6) the outcome of any legal proceedings that may be instituted against Citizens and/or Investors, (7) the failure to obtain required governmental approvals or a delay in obtaining such approvals (and the risk that such approvals may result in the imposition of conditions that could adversely affect the combined company or the expected benefits of the proposed transaction), (8) reputational risk and potential adverse reactions of Citizens’ and/or Investors’ customers, suppliers, employees or other business partners, including those resulting from the announcement or completion of the proposed transaction, (9) the failure of any of the closing conditions in the definitive merger agreement to be satisfied on a timely basis or at all, (10) delays in closing the proposed merger, (11) the possibility that the proposed merger may be more expensive to complete than anticipated, including as a result of unexpected factors or events, (12) the dilution caused by Citizens’ issuance of additional shares of its capital stock in connection with the proposed transaction, (13) general competitive, economic, political and market conditions, (14) other factors that may affect future results of Investors and/or Citizens including changes in asset quality and credit risk, the inability to sustain revenue and earnings growth, changes in interest rates and capital markets, inflation, customer borrowing, repayment, investment and deposit practices, the impact, extent and timing of technological changes, capital management activities, and other actions of the Federal Reserve Board and legislative and regulatory actions and reforms, and (15) the impact of the ongoing global COVID-19 pandemic on Citizens’ and/or Investors’ businesses, the ability to complete the proposed transaction and/or any of the other foregoing risks.

 

Except to the extent required by applicable law or regulation, each of Citizens and Investors disclaims any obligation to update such factors or to publicly announce the results of any revisions to any of the forward-looking statements included in this communication to reflect future events or developments. Further information regarding Citizens, Investors and factors which could affect the forward-looking statements contained herein can be found in Citizens’ Annual Report on Form 10-K for the fiscal year ended December 31, 2020, its Quarterly Reports on Form 10-Q for the periods ended March 31, 2021 and September 30, 2020, and its other filings with the Securities and Exchange Commission (the “SEC”), and in Investors’ Annual Report on Form 10-K for the fiscal year ended December 31, 2020, its subsequent Quarterly Reports on Form 10-Q, and its other filings with the SEC.

 

Additional Information and Where to Find It

In connection with the proposed transaction, Citizens will file a registration statement on Form S-4 with the SEC. The registration statement will include a proxy statement of Investors that will be sent to Investors’ stockholders seeking certain approvals related to the proposed transaction, and a prospectus of Citizens.

The information contained in this communication does not constitute an offer to sell or a solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

 

INVESTORS AND SECURITY HOLDERS OF INVESTORS AND CITIZENS AND THEIR RESPECTIVE AFFILIATES ARE URGED TO READ, WHEN AVAILABLE, THE REGISTRATION STATEMENT ON FORM S-4, THE PROXY STATEMENT AND PROSPECTUS TO BE INCLUDED WITHIN THE REGISTRATION STATEMENT ON FORM S-4 AND ANY OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT INVESTORS, CITIZENS AND THE PROPOSED TRANSACTION.

 

Investors and security holders will be able to obtain a free copy of the registration statement, including the proxy statement and prospectus contained therein, as well as other relevant documents filed with the SEC containing information about Investors and Citizens, without charge, at the SEC’s website (http://www.sec.gov). Copies of documents filed with the SEC by Citizens will be made available free of charge in the “SEC Filings” section of will’s website, https://investor.citizensbank.com/about-us/investor-relations/financial-information/sec-filings.aspx. Copies of documents filed with the SEC by Investors will be made available free of charge in the “Investor Relations” section of Investors’ website, https://www.myinvestorsbank.com/Investor-Relations, under the heading “SEC Filings.”

 

Participants in Solicitation

Investors and certain of its directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction under the rules of the SEC. Citizens and its directors and officers are not a participant in such solicitation of proxies. Information regarding Investors’ directors and executive officers is available in its proxy statement, which was filed with the SEC on April 15, 2021, and certain other documents filed by Investors with the SEC. Other information regarding the participants in the solicitation of proxies in respect of the proposed transaction and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement to be filed by Investors, the prospectus to be filed by Citizens and other relevant materials to be filed with the SEC. Free copies of these documents, when available, may be obtained as described in the preceding paragraph.

 

About Citizens Financial Group, Inc.

Citizens Financial Group, Inc. is one of the nation’s oldest and largest financial institutions, with $185.1 billion in assets as of June 30, 2021. Headquartered in Providence, Rhode Island, Citizens offers a broad range of retail and commercial banking products and services to individuals, small businesses, middle-market companies, large corporations and institutions. Citizens helps its customers reach their potential by listening to them and by understanding their needs in order to offer tailored advice, ideas and solutions. In Consumer Banking, Citizens provides an integrated experience that includes mobile and online banking, a 24/7 customer contact center and the convenience of approximately 3,000 ATMs and approximately 1,000 branches in 11 states in the New England, Mid-Atlantic and Midwest regions. Consumer Banking products and services include a full range of banking, lending, savings, wealth management and small business offerings. In Commercial Banking, Citizens offers a broad complement of financial products and solutions, including lending and leasing, deposit and treasury management services, foreign exchange, interest rate and commodity risk management solutions, as well as loan syndication, corporate finance, merger and acquisition, and debt and equity capital markets capabilities. More information is available at www.citizensbank.com or visit us on Twitter, LinkedIn or Facebook.

 

About Investors Bancorp, Inc.

Investors Bancorp, Inc. is the holding company for Investors Bank, which is headquartered in Short Hills, New Jersey and operates 154 branches* located throughout New Jersey and New York.

Contacts

Citizens Media: Peter Lucht — 781.655.2289

Citizens Investor Relations: Kristin Silberberg — 203.900.6854

Investors Media: Dorian Hansen — 973.924.5100

Categories
Business

Exelon and Chicago’s Museum of Science and Industry partner on Green Lab Grants to advance Stem education in under-resourced communities

Schools, education nonprofits in five states and DC can apply for $1 million in grants to modernize or create state-of-the-art science labs, encouraging STEM careers

 

CHICAGO — (BUSINESS WIRE) — The Exelon Foundation and Exelon Corp., the nation’s largest generator of carbon-free energy, today launched the Green Lab Grants program, which will provide grants of up to $50,000 each for public and private schools as well as nonprofit organizations that operate out-of-school programs serving Title I-eligible students, to invest in hands-on educational spaces where students can prepare for careers in science, technology, math and/or engineering (STEM). The grants, which will total $1 million annually, will be administered by the Museum of Science and Industry, Chicago, and will target organizations in communities where Exelon operates including Illinois, Delaware, Maryland, New Jersey, Pennsylvania and Washington, D.C..

“It is critical that we engage, educate and inspire the next generation of STEM leaders and provide them the tools and resources they need to prepare for future professional careers,” said Chris Crane, Exelon president and CEO. “By partnering with the museum, we can promote youth problem-solving and creativity using new technologies, better equipping students to address some of the most pressing issues we face today, including climate change.”

“The Museum of Science and Industry, Chicago, is thrilled to partner with Exelon in this effort to increase access to learning opportunities and cutting-edge tools for students in under-resourced communities,” said Rabiah Mayas, MSI’s Davee Vice President of Education. “We’re committed to supporting our next generation of innovators and problem solvers to tackle critical issues like the climate crisis.”

In addition to STEM grants, the Exelon STEM Innovation Leadership Academy is a prime feature of Exelon’s commitment to encourage young women in STEM and develop tomorrow’s workforce. Sponsored by the Exelon Foundation, this free, week-long experience for teen girls ages 16-19 from diverse and low-income communities is held each summer in the Washington, D.C. metro region, Chicago and Philadelphia. To date, nearly 600 students have completed the Academy. Exelon also launched the STEM Leadership Academy Scholarship program this year, which is designed to be a supportive and clear pathway from student engagement in the Academy to entry into the energy workforce, ideally as an Exelon employee. Valued at approximately $1 million, the scholarship is available to alumnae of the Academy program and will cover all costs associated with college, including tuition, room and board and all other expenses that aren’t covered by other confirmed scholarships, family contributions and work-study grants.

Applications for the Green Lab grants are now open. The deadline to submit an application is October 1, 2021.

For more information about how Exelon invests in its communities through workforce development, education and corporate relations programs, click here.

About Exelon

Exelon Corporation (Nasdaq: EXC) is a Fortune 100 energy company with the largest number of electricity and natural gas customers in the U.S. Exelon does business in 48 states, the District of Columbia and Canada and had 2020 revenue of $33 billion Exelon serves approximately 10 million customers in Delaware, the District of Columbia, Illinois, Maryland, New Jersey and Pennsylvania through its Atlantic City Electric, BGE, ComEd, Delmarva Power, PECO and Pepco subsidiaries. Exelon is one of the largest competitive U.S. power generators, with more than 31,000 megawatts of nuclear, gas, wind, solar and hydroelectric generating capacity comprising one of the nation’s cleanest and lowest-cost power generation fleets. The company’s Constellation business unit provides energy products and services to approximately 2 million residential, public sector and business customers, including three fourths of the Fortune 100. Follow Exelon on Twitter @Exelon.

About the Exelon Foundation

The Exelon Foundation is an independent, nonprofit organization funded solely by Exelon Corporation through shareholder dollars. The mission of the Foundation is to encourage respect for the environment, support innovative STEM education programs and strengthen the social and economic fabric of the community by providing a match to Exelon employee contributions.

Contacts

Liz Keating

Corporate Communications

312-394-4111

elizabeth.keating@exeloncorp.com

Categories
Business

AM Best places credit ratings of Nagico Holdings Limited’s main operating subsidiaries under review with positive implications

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has placed under review with positive implications the Financial Strength Rating of B++ (Good) and the Long-Term Issuer Credit Rating of “bbb+” (Good) of the two operating subsidiaries of Nagico Holdings Limited – National General Insurance Corporation (NAGICO) N.V. (St. Maarten) and Nagico Insurance Company Limited (Anguilla) (collectively referred to as Nagico).

This Credit Rating (rating) action follows Nagico’s announcement on July 27, 2021 that the group has entered into a definitive agreement whereby Peak Reinsurance Company Limited (Peak Re) will acquire the remaining 50% of Nagico’s outstanding shares. Peak Re currently owns 50% of Nagico.

The positive implications status reflects AM Best’s expectation that Nagico will benefit from the financial strength of Peak Re as it integrates into the group. The transaction is targeted to close prior to the end of 2021.

The ratings will remain under review until the transaction closes, all customary regulatory approvals are received and AM Best evaluates Nagico’s role in the Peak Re organization.

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

Contacts

Ricardo Longchallon
Senior Financial Analyst
+1 908 439 2200, ext. 5676
ricardo.longchallon@ambest.com

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

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

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

Categories
Sports & Gaming

Gannett and Tipico announce strategic sports betting agreement

Multi-year deal powered by Tipico’s proprietary technology and gaming data, and USA TODAY NETWORK’s scale and fanbase

 

MCLEAN, Va. — (BUSINESS WIRE) — Gannett Co., Inc (“Gannett”, “we”, “us”, “our” or “the Company”) (NYSE:GCI), today announced an exclusive agreement with Tipico USA Technology, Inc. (“Tipico”), a U.S.-based subsidiary of European based Tipico Group of Companies, the leading sports betting provider in Germany, utilizing their Tipico Sportsbook brand. This strategic alliance leverages the power and breadth of the USA TODAY NETWORK consisting of more than 250 daily local sites including The Indy Star and Detroit Free Press, and its USA TODAY Sports Media Group, including in-depth USA TODAY Sports coverage across the country with over 200 additional sports sites in the portfolio, such as For The Win, Golfweek, and MMA Junkie.

“Our highly engaged audience of more than 46 million sports fans crave analysis, betting insights, odds and unique features which we will provide with our Tipico alliance,” said Michael Reed, Gannett Chairman and Chief Executive Officer. “Tipico adds incredible expertise from their European operations and next generation product capabilities, which offer our sports enthusiasts and local consumers a way to become even more invested in the games and sports they care about.”

 

Transaction Highlights

  • Tipico to become the exclusive sports betting and iGaming provider for Gannett, with integration of odds, props, free to play games and betting trends across the USA TODAY NETWORK.
  • The five-year agreement includes $90 million in media spend by Tipico together with performance incentives payable to Gannett for customer referrals.
  • Subject to certain conditions being met over the five-year term of the agreement, Gannett will have the right to acquire up to 4,990 common shares in Tipico’s US business, representing a minority interest. The exercise of such right will be subject to applicable laws including applicable gaming regulations.
  • Gannett will provide Tipico exclusive access to premium marketing assets at a pre-negotiated value based upon the expected aggregate sum of the cash consideration, performance incentives, and right to acquire common shares.
  • These assets will focus on integrating year-round custom content across the USA TODAY NETWORK, including video series, columns, blog posts, newsletters, contests, social media and events, beginning with the 2021 NFL season.
  • Additionally, Tipico will co-brand all NFL Wire Team sites and For The Win, including a re-launch of the Bets subsection to “Bet For The Win, powered by Tipico Sportsbook” and providing co-branded digital odds pages throughout the USA TODAY NETWORK, in print and digital.

 

“We are thrilled to gain exclusive access to Gannet’s portfolio of iconic brands and premium digital properties,” said Adrian Vella, Tipico U.S. Chief Executive Officer. “Integrating their leading media properties with Tipico Sportsbook marks an important moment as we begin our acceleration in the U.S. Gannett’s best-in-class editorial operations and massive local footprint, partnered with Tipico’s game changing technology, including end-to-end proprietary sports betting and iGaming products, will offer U.S. fans a slam dunk combination.”

 

Gannett is uniquely positioned to reach sports enthusiasts through its footprint in over 250 communities across the U.S., and with more than 500 respected sports journalists covering both professional and college sports and writing for dedicated NFL, NBA, and college football fan sites such as HoopsHype, Broncos Wire, Rockets Wire and Buckeyes Wire. The Company also plans to invest in talent across product and editorial divisions to develop new, innovative experiences and content for its sports readers. The Company plans to also leverage its live events and promotions division, USA TODAY NETWORK Ventures, to help drive awareness and activations during popular sports seasons.

 

“This historic agreement with Gannett, one of the most trusted names in global News media and sports, will immediately bring additional credibility and trust to Tipico Sportsbook’s U.S. operations,” said Stephen Krombolz, Tipico Vice President of U.S. Business Development and Strategy. “These assets will serve as a key component of our North American marketing strategy, driving awareness of the Tipico brand and our products among Gannett’s millions of readers, viewers and listeners – ultimately delivering fantastic acquisition and retention opportunities as we prepare to scale rapidly in the U.S.”

 

Product integrations are expected to begin in August to complement the start of the NFL season. USA TODAY Sports Media Group audiences across digital platforms will experience new integrations powered by Tipico Sportsbook’s betting odds on digital sites. For residents in Colorado and New Jersey, where Tipico operations will be live this fall, readers will experience a seamless integration to Tipico’s Sportsbook. Visitors to any other USA TODAY Sports Media Group sites will find a listing of sports betting odds and sports betting content, as well as iGaming, free to play games and sweepstakes. In addition, readers of USA TODAY and many local print newspapers within the USA TODAY NETWORK will find Tipico betting odds within the Sports section.

 

ABOUT GANNETT

Gannett Co., Inc. (NYSE: GCI) is a subscription-led and digitally focused media and marketing solutions company committed to empowering communities to thrive. With an unmatched reach at the national and local level, Gannett touches the lives of millions with our Pulitzer Prize-winning content, consumer experiences and benefits, and advertiser products and services. Our current portfolio of media assets includes USA TODAY, local media organizations in 46 states in the U.S., and Newsquest, a wholly owned subsidiary operating in the United Kingdom with more than 120 local news media brands. Gannett also owns the digital marketing services companies ReachLocal, Inc., UpCurve, Inc., and WordStream, Inc., which are marketed under the LOCALiQ brand, and runs the largest media-owned events business in the U.S., USA TODAY NETWORK Ventures. To connect with us, visit www.gannett.com.

 

About Tipico U.S.

Tipico is a U.S. sportsbook originally founded in Europe in 2004. As the leading sports betting provider in Germany and one of the top sports betting companies worldwide, Tipico offers digital and mobile betting entertainment across 30 different sports and invests heavily in the development of technologies that make the sports betting experience better and safer, placing the highest value on player protection. Tipico Group Ltd. employs over 1,800 people worldwide and another 4,200 people working in the Tipico associated franchise network. Launched in the United States in 2020, Tipico is a fast-rising player in the space, with established U.S. operations and business headquarters in Hoboken, New Jersey. For more information, please visit www.tipico.com/us, or www.tipico-group.com.

 

Cautionary Statement Regarding Forward-Looking Statements

Certain items in this press release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the strategic alliance and sports betting agreement, and our future plans and expectations. These statements are based on management’s current expectations and beliefs and are subject to a number of risks and uncertainties. These and other risks and uncertainties could cause actual results to differ materially from those described in the forward-looking statements, many of which are beyond our control. The Company can give no assurance its expectations will be attained. Accordingly, you should not place undue reliance on any forward-looking statements contained in

this press release. For a discussion of some of the risks and important factors that could cause actual results to differ from such forward-looking statements, see the risks and other factors detailed from time to time in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the Securities and Exchange Commission. Furthermore, new risks and uncertainties emerge from time to time, and it is not possible for the Company to predict or assess the impact of every factor that may cause its actual results to differ from those contained in any forward-looking statements. Such forward-looking statements speak only as of the date of this press release. The Company expressly disclaims any obligation to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or change in events, conditions or circumstances on which any statement is based.

Contacts

Gannett Investor Relations Contact
Trisha Gosser

SVP, Finance & Investor Relations

703-854-3000

investors@gannett.com

Gannett Media Contact
Lark-Marie Anton

Senior Vice President, Communications

(646) 906-4087

lark@gannett.com

Tipico Media Contact
Keith Gormley

VP, US Marketing

Keith.gormley@tipico.com