Tag: Business

AM Best affirms credit ratings of Highmark Inc. and most subsidiaries; upgrades credit ratings of Highmark Casualty Insurance Company

OLDWICK, N.J.–(BUSINESS WIRE)–AM Best has affirmed the Financial Strength Rating (FSR) of A (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICR) of “a” of Highmark Inc. (Highmark) (Camp Hill, PA) and its life/health (L/H) subsidiaries, collectively known as Highmark Inc. Group. Concurrently, AM Best has affirmed the FSRs of A (Excellent) and the Long-Term ICRs of “a” of Highmark’s dental subsidiaries, which operate under the United Concordia brand name. Additionally, AM Best has upgraded the FSR to A (Excellent) from A- (Excellent) and the Long-Term ICR to “a” from “a-” of Highmark Casualty Insurance Company (Highmark Casualty) (Pittsburgh, PA). Lastly, AM Best has affirmed the Long-Term Issue Credit Ratings (Long-Term IR) of “a-” on Highmark’s existing senior unsecured notes. The outlook of these Credit Ratings (ratings) is stable. (See below for a detailed listing of the companies and the Long-Term IRs).

The ratings of Highmark Inc. Group reflect its balance sheet strength, which AM Best categorizes as strongest, as well as its adequate operating performance, neutral business profile and appropriate enterprise risk management (ERM).

Highmark continues to maintain the strongest level of risk-adjusted capital based on contributions from its favorable operating results over the past three years. Highmark’s operating results are driven by good underwriting results in its commercial and Medicare Advantage business segments, as well as stable earnings from its medical stop loss business written mainly by HM Life Insurance Company and favorable investment income. Overall operating results over the past several years were enhanced by the proceeds from the sale of its subsidiaries, Davis Vision in 2017 and Visionworks in 2019. Premium development has been challenging for the group due to competitive and economic pressure in its primary markets. Highmark is one of the largest Blue Cross Blue Shield plans in the nation, offering health products and services in service areas across three states. Highmark has good business diversification through its medical stop loss business, national dental operations and technology platform services. Highmark also is part of an integrated delivery system with its affiliate, Allegheny Health Network, in its Pennsylvania service area, offering coordinated and high-quality cost-effective care and health insurance products. Highmark also has a well-developed and comprehensive ERM program, which is incorporated into business operations and strategic planning.

The ratings of United Concordia reflect its balance sheet strength, which AM Best categorizes as very strong, as well as its adequate operating performance, neutral business profile and appropriate ERM.

United Concordia’s risk-adjusted capitalization has declined modestly over the past two years, as the dividends to its parent have exceeded net earnings due to the planned return of certain excess capital to its parent. Nevertheless, risk-adjusted capital presently remains at the very strong level. AM Best will continue to monitor the capitalization of the dental entities, with the expectation that they will be supported by the parent organization as needed. Finally, premium growth and operating earnings have been especially strong, driven in part by the company’s government contracts including the Federal Employees Dental and Visions Insurance Program and TRICARE Dental Plan. United Concordia has a large membership base, with almost 9 million individuals and a large national dental network with over 127,000 dentists.

The ratings of Highmark Casualty reflect its balance sheet strength, which AM Best categorizes as strongest, as well as its adequate operating performance, limited business profile and appropriate ERM.

The rating upgrades of Highmark Casualty reflect rating enhancement received based on its strategic

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importance and dependence on its affiliate, HM Life Insurance Company, from which it derives the majority of its premiums through a quota share arrangement for medical stop loss business.

The FSR of A (Excellent) and the Long-Term ICRs of “a” have been affirmed, with stable outlooks for Highmark Inc. and its following L/H subsidiaries:

HM Health Insurance Company
HM Life Insurance Company
HM Life Insurance Company of New York
Highmark Choice Company
Highmark West Virginia Inc.

The FSR of A (Excellent) and the Long-Term ICRs of “a” have been affirmed, with stable outlooks for the following dental subsidiaries of Highmark Inc.:

United Concordia Companies, Inc.
United Concordia Insurance Company
United Concordia Insurance Company of New York
United Concordia Dental Plans of California, Inc.
United Concordia Dental Plans of Pennsylvania, Inc.
United Concordia Dental Plans, Inc.

The FSR has been upgraded to A (Excellent) from A- (Excellent) and the Long-Term ICR to “a” from “a-”, with a stable outlook for Highmark Casualty Insurance Company, an insurance subsidiary of Highmark Inc.:

The following Long-Term IRs have been affirmed, with stable outlooks:

Highmark Inc.—

–“a-” on $350 million 4.75% senior unsecured notes, due 2021

–“a-” on $250 million 6.125% senior unsecured notes, due 2041

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

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

Contacts

Bridget Maehr

Associate Director

+1 908 439 2200, ext. 5321

bridget.maehr@ambest.com

Christopher Sharkey

Manager, Public Relations

+1 908 439 2200, ext. 5159

christopher.sharkey@ambest.com

Joseph Zazzera, MBA

Director

+1 908 439 2200, ext. 5797

joseph.zazzera@ambest.com

Jim Peavy

Director, Public Relations

+1 908 439 2200, ext. 5644

james.peavy@ambest.com

Tags AM Best, Business, Credit Ratings, Financial. Strength Rating, FSR, Highmark Inc., ICRs, Life Insurance, Long-Term ICR, Risk Management, Risk ManagementAM Best

Business

Movado Group, Inc. announces second quarter results

Post author By Michelle Dryden
Post date August 27, 2020
No Comments on Movado Group, Inc. announces second quarter results

~ Second Quarter Net Sales of $88.5 million ~

~ Second Quarter Loss Per Share of ($0.28), or ($0.07) Excluding Restructuring Plan and Other Items ~

~ Ends Second Quarter with Cash of $170 million ~

~ Announces Licensing Partnership with Calvin Klein ~

PARAMUS, N.J.–(BUSINESS WIRE)–Movado Group, Inc. (NYSE: MOV) today announced second quarter and six-month results for the period ended July 31, 2020.

Efraim Grinberg, Chairman and Chief Executive Officer, stated, “We remain focused on ensuring the safety and health of our employees, customers and the communities where we operate. In a quarter that was significantly impacted globally by the COVID-19 pandemic, I am proud of our team’s ability to build on our multi-year investments in our digital center of excellence and adapt to support our ongoing mission to put consumers first, allowing them to connect with our great brands, designs and platforms wherever and whenever they choose to shop. These efforts allowed us to capture strong online demand where our Movado brand generated a 130% increase in our own and third party ecommerce sales. In North America, we reopened our outlet stores in June and were encouraged by the improved sequential performance in July, despite reduced stores hours. We are also seeing encouraging demand in our domestic department store channel. In China, we had a 16% increase in sales for the quarter with trends continuing to accelerate and we had positive top line growth in France and Germany, despite our customers being closed for nearly half of the quarter.”

Mr. Grinberg continued, “The aggressive actions we took at the height of the pandemic have positioned us well to continue to navigate the current environment. We have implemented initiatives that are expected to generate $90 million in cost savings in this fiscal year and have strengthened our financial health as evidenced by our cash balance of $170 million after repaying $37 million on our revolver at quarter end. As we look to the remainder of the year, we continue to expect improving sales trends in the second half relative to the first half with improved profitability and we will continue to be disciplined and agile in managing the business given the continued uncertainty. The actions we have taken, combined with our strong liquidity, enable us to leverage our powerful portfolio of brands which will be further strengthened by the exciting new licensing partnership announced today to design and develop Calvin Klein timepieces and jewelry. As a result, we have confidence that we will emerge from this extraordinary period a stronger company that is even better positioned to deliver long-term shareholder value.”

Non-GAAP Items (See attached table for GAAP and Non-GAAP measures)

Second quarter fiscal 2021 results of operations included the following items:

Operating expenses include a $0.7 million pre-tax charge, or $0.5 million after tax, representing $0.02 per diluted share, associated with the amortization of acquired intangible assets related to the acquisition of Olivia Burton;
$0.3 million pre-tax charge, or $0.2 million after tax, representing $0.01 per diluted share, associated with the amortization of acquired intangible assets and deferred compensation related to the acquisition of MVMT;
$7.4 million pre-tax charge, or $5.0 million after tax, representing $0.22 per diluted share, related to corporate initiatives primarily in response to the COVID-19 pandemic; and
Other non-operating income includes a $1.3 million pre-tax gain, or $0.8 million after tax, representing $0.04 per diluted share, associated with the sale of a non-operating asset in Switzerland.

Second quarter Fiscal 2020 results of operations included the following items:

Operating expenses include a $0.7 million pre-tax charge, or $0.6 million after tax, representing $0.02 per diluted share, associated with the amortization of acquired intangible assets related to Olivia Burton;
$1.1 million pre-tax charge, or $0.9 million after tax, representing $0.04 per diluted share, associated with the amortization of acquired intangible assets and deferred compensation related to the acquisition of MVMT;
$0.3 million pre-tax gain, or $0.2 million after tax, representing $0.01 per diluted share, associated with the change in estimate of the remaining accrual for the fiscal 2018 cost saving initiatives; and
Other non-operating income includes a $13.6 million pre-tax benefit, or $10.4 million after tax, representing $0.44 per diluted share, associated with the remeasurement of the contingent consideration liability associated with the MVMT acquisition.

Second Quarter Fiscal 2021 (See attached table for GAAP and Non-GAAP measures)

Net sales decreased 43.9% to $88.5 million compared to $157.8 million in the second quarter of fiscal 2020 primarily due to the impact of the COVID-19 pandemic. Net sales on a constant dollar basis also decreased 43.9%.
Gross profit was $45.4 million, or 51.2% of sales, compared to $85.3 million, or 54.1% of sales, in the second quarter last year. The decrease in gross margin percentage was primarily the result of unfavorable changes in channel and product mix, decreased leverage on fixed costs due to decreased sales, and U.S. special tariff headwinds.
Operating expenses were $54.3 million compared to $76.6 million in the prior year period. For the second quarter of fiscal 2021, adjusted operating expenses were $45.9 million, which excludes the operating expense charges mentioned above in the Non-GAAP Items section. For the second quarter of fiscal 2020, adjusted operating expenses were $75.1 million, which excludes the operating expense charges mentioned above in the Non-GAAP Items section. The decrease in adjusted operating expenses was primarily due to the Company’s initiative to minimize all non-essential operating expenses such as certain marketing, selling and payroll related expenses.
Operating loss was $8.9 million compared to operating income of $8.8 million in the second quarter of fiscal 2020. Adjusted operating loss for the second quarter of fiscal 2021 was $0.6 million, which excludes the fiscal 2021 charges listed above in the Non-GAAP Items section, compared to adjusted operating income for the second quarter of fiscal 2020 of $10.3 million, which excludes the fiscal 2020 charges listed above in the Non-GAAP Items section.
The Company recorded a tax benefit of $1.6 million compared to a tax provision of $4.7 million in the second quarter of fiscal 2020. The Company recorded an adjusted tax provision in the second quarter of fiscal 2021 of $0.6 million compared to an adjusted tax provision of $1.8 million for the second quarter of fiscal 2020.
Net loss was $6.6 million, or $0.28 per diluted share, compared to net income of $17.5 million, or $0.75 per diluted share, in the second quarter of fiscal 2020 . Adjusted net loss for the fiscal 2021 period was $1.7 million, or $0.07 per diluted share, which excludes the second quarter fiscal 2021 net charges listed above in the Non-GAAP Items section after the associated tax effects. This compares to adjusted net income in the second quarter of fiscal 2020 of $8.3 million, or $0.36 per diluted share, which excludes the second quarter fiscal 2020 net charges listed above in the Non-GAAP Items section after the associated tax effects.

First Half Fiscal 2021 (See attached table for GAAP and Non-GAAP measures)

Net sales were $158.2 million compared to $304.4 million in the first six months of fiscal 2020, a decrease of 48.0% primarily due to the COVID-19 pandemic. Net sales on a constant dollar basis decreased 47.8%.
Gross profit was $77.2 million, or 48.8% of sales, compared to $164.2 million, or 54.0% of sales in the same period last year. Adjusted gross profit for the first six months of fiscal 2021, which excludes $3.5 million in corporate initiative charges related to the impact to the business of the COVID-19 pandemic, was $80.8 million, or 51.0% of net sales. Adjusted gross profit for the first six months of fiscal 2020, which excludes $0.1 million in adjustments associated with the amortization of acquisition accounting adjustments related to the MVMT acquisition, was $164.4 million, or 54.0% of net sales. The decrease in adjusted gross margin percentage was primarily the result of decreased leverage on fixed costs due to decreased sales, unfavorable changes in channel and product mix, unfavorable foreign currency exchange rates and U.S. special tariff headwinds.
Operating expenses were $268.3 million as compared to $150.5 million in the first six months of last fiscal year. For the first six months of fiscal 2021, adjusted operating expenses were $99.0 million, which excludes $155.9 million in adjustments related to the impairment of goodwill and certain intangible assets, $11.1 million in corporate initiative charges related to the impact to the business from the COVID-19 pandemic, $1.4 million of expenses associated with the amortization of acquired intangible assets related to Olivia Burton and $1.0 million in adjustments associated with the amortization of acquired intangible assets and deferred compensation related to the MVMT acquisition. For the first six months of fiscal 2020, adjusted operating expenses were $146.9 million, which excludes $1.4 million of expenses associated with the amortization of acquired intangible assets related to Olivia Burton and $2.5 million in adjustments associated with the amortization of acquired intangible assets, accounting adjustments and deferred compensation related to the MVMT acquisition, partially offset by $0.3 million in adjustments associated with the change in estimate of the remaining accrual for the fiscal 2018 cost saving initiatives. The decrease in adjusted operating expenses was primarily due to the Company’s initiative to minimize all non-essential operating expenses such as certain marketing, selling and payroll related expenses.
Operating loss was $191.1 million compared to operating income of $13.8 million in the first six months of fiscal 2020. Adjusted operating loss for the first six months of fiscal 2021 was $18.2 million, which excludes the fiscal 2021 charges listed in the immediately preceding bullet, compared to adjusted operating income of $17.4 million in the first six months of fiscal 2020 which excludes the fiscal 2020 net charges listed in the immediately preceding bullet.
The Company recorded a tax benefit in the first six months of fiscal 2021 of $33.9 million as compared to a tax provision of $5.6 million in the first six months of last year. Based upon adjusted pre-tax income, the adjusted tax benefit was $4.3 million in the first half of fiscal 2021 compared to an adjusted tax provision of $3.1 million in the first half of fiscal 2020.
Net loss was $156.6 million, or $6.75 per diluted share, compared to net income of $21.4 million, or $0.92 per diluted share, in the first six months of fiscal 2020. Adjusted net loss for the first half of fiscal 2021 was $14.7 million, or $0.63 per diluted shares, which excludes $131.1 million, net of $24.9 million of tax, in adjustments related to the impairment of goodwill and certain intangible assets, $10.0 million, net of $4.6 million of tax, in corporate initiative charges related to the impact to the business from the COVID-19 pandemic, $1.1 million, net of $0.3 million of tax, of expenses associated with the amortization of acquired intangible assets related to Olivia Burton and $0.6 million, net of $0.4 million of tax, in adjustments associated with the amortization of acquired intangible assets and deferred compensation related to the MVMT acquisition, and $0.8 million, net of $0.5 million of tax, associated with a gain on the sale of a non-operating asset in Switzerland. This compares to adjusted net income for the first half of fiscal 2020 of $13.9 million, or $0.60 per diluted share, which excludes $1.1 million, net of $0.3 million of tax, of expenses associated with the amortization of acquired intangible assets related to Olivia Burton; $2.0 million, net of $0.6 million of tax, of expenses related to the amortization of acquired intangible assets, accounting adjustments and deferred compensation related to MVMT; $10.4 million, net of $3.3 million of tax, of gains associated with the remeasurement of the contingent consideration liability associated with the MVMT acquisition; and $0.2 million, net of $0.1 million of tax, of gains associated with the change in estimate of the remaining accrual for the fiscal 2018 cost saving initiatives.

Fiscal 2021 Outlook

Given the dynamic nature of the COVID-19 crisis and lack of visibility, the potential financial impact to the business cannot be reasonably estimated. The Company is not providing fiscal 2021 guidance.

Conference Call

The Company’s management will host a conference call and audio webcast to discuss its results today, August 27, 2020 at 9:00 a.m. Eastern Time. The conference call may be accessed by dialing (877) 407-0784. Additionally, a live webcast of the call can be accessed at www.movadogroup.com. The webcast will be archived on the Company’s website approximately one hour after the conclusion of the call. Additionally, a telephonic re-play of the call will be available at 12:00 p.m. ET on August 27, 2020 until 11:59 p.m. ET on September 10, 2020 and can be accessed by dialing (844) 512-2921 and entering replay pin number 13708469.

Movado Group, Inc. designs, sources, and distributes MOVADO®, MVMT®, OLIVIA BURTON®, EBEL®, CONCORD®, COACH®, TOMMY HILFIGER®, HUGO BOSS®, LACOSTE®, SCUDERIA FERRARI®, REBECCA MINKOFF® and URI MINKOFF® watches worldwide, and operates Movado company stores in the United States and Canada.

In this release, the Company presents certain financial measures that are not calculated according to generally accepted accounting principles in the United States (“GAAP”). Specifically, the Company is presenting adjusted gross profit, adjusted gross margin, adjusted operating expenses and adjusted operating income, which are gross profit, gross margin, operating expenses and operating income, respectively, under GAAP, adjusted to eliminate the amortization of acquisition accounting adjustments related to the Olivia Burton and MVMT acquisitions, corporate initiatives and the impairment of goodwill and certain intangible assets. The Company is also presenting adjusted tax provision, which is the tax provision under GAAP, adjusted to eliminate the impact of charges for the Olivia Burton and MVMT acquisitions, corporate initiatives, the impairment of goodwill and certain intangible assets and the gain on sale of a non-operating asset. The Company believes these adjusted measures are useful because they give investors information about the Company’s financial performance without the effect of certain items that the Company believes are not characteristic of its usual operations. The Company is also presenting adjusted net income, adjusted earnings per share and adjusted effective tax rate, which are net income, earnings per share and effective tax rate, respectively, under GAAP, adjusted to eliminate the after-tax impact of amortization of acquisition accounting adjustments related to the Olivia Burton and MVMT acquisitions, corporate initiatives, the impairment of goodwill and certain intangibles and the gain on sale of a non-operating asset. The Company believes that adjusted net income, adjusted earnings per share and adjusted effective tax rate are useful measures of performance because they give investors information about the Company’s financial performance without the effect of certain items that the Company believes are not characteristic of its usual operations. Additionally, the Company is presenting constant currency information to provide a framework to assess how its business performed excluding the effects of foreign currency exchange rate fluctuations in the current period. Comparisons of financial results on a constant dollar basis are calculated by translating each foreign currency at the same US dollar exchange rate as in effect for the prior-year period for both periods being compared. The Company believes this information is useful to investors to facilitate comparisons of operating results. These non-GAAP financial measures are designed to complement the GAAP financial information presented in this release. The non-GAAP financial measures presented should not be considered in isolation from or as a substitute for the comparable GAAP financial measures, and the methods of their calculation may differ substantially from similarly titled measures used by other companies.

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The Company has tried, whenever possible, to identify these forward-looking statements using words such as “expects,” “anticipates,” “believes,” “targets,” “goals,” “projects,” “intends,” “plans,” “seeks,” “estimates,” “may,” “will,” “should” and variations of such words and similar expressions. Similarly, statements in this press release that describe the Company’s business strategy, outlook, objectives, plans, intentions or goals are also forward-looking statements. Accordingly, such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements and levels of future dividends to differ materially from those expressed in, or implied by, these statements. These risks and uncertainties may include, but are not limited to general economic and business conditions which may impact disposable income of consumers in the United States and the other significant markets (including Europe) where the Company’s products are sold, uncertainty regarding such economic and business conditions, trends in consumer debt levels and bad debt write-offs, general uncertainty related to possible terrorist attacks, natural disasters, pandemics, including the effect of the COVID-19 pandemic and other diseases on travel and traffic in our retail stores and the stores of our wholesale customers, supply disruptions and delivery delays from our Chinese and other suppliers as a result of the COVID-19 pandemic, adverse impact on the Company’s wholesale customers and customer traffic in the Company’s stores as a result of increased uncertainty and economic disruption caused by the COVID-19 pandemic, the stability of the European Union (including the impact of the United Kingdom’s process to exit from the European Union), the stability of the United Kingdom after its exit from the European Union, and defaults on or downgrades of sovereign debt and the impact of any of those events on consumer spending, changes in consumer preferences and popularity of particular designs, new product development and introduction, decrease in mall traffic and increase in e-commerce, the ability of the Company to successfully implement its business strategies, competitive products and pricing, the impact of “smart” watches and other wearable tech products on the traditional watch market, seasonality, availability of alternative sources of supply in the case of the loss of any significant supplier or any supplier’s inability to fulfill the Company’s orders, the loss of or curtailed sales to significant customers, the Company’s dependence on key employees and officers, the ability to successfully integrate the operations of acquired businesses without disruption to other business activities, the possible impairment of acquired intangible assets including goodwill if the carrying value of any reporting unit were to exceed its fair value, volatility in reported earnings resulting from changes in the estimated fair value of contingent acquisition consideration, the continuation of the company’s major warehouse and distribution centers, the continuation of licensing arrangements with third parties, losses possible from pending or future litigation, the ability to secure and protect trademarks, patents and other intellectual property rights, the ability to lease new stores on suitable terms in desired markets and to complete construction on a timely basis, the ability of the Company to successfully manage its expenses on a continuing basis, information systems failure or breaches of network security, the continued availability to the Company of financing and credit on favorable terms, business disruptions, and general risks associated with doing business outside the United States including, without limitation, import duties, tariffs (including retaliatory tariffs), quotas, political and economic stability, changes to existing laws or regulations, and success of hedging strategies with respect to currency exchange rate fluctuations, and the other factors discussed in the Company’s Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. These statements reflect the Company’s current beliefs and are based upon information currently available to it. Be advised that developments subsequent to this press release are likely to cause these statements to become outdated with the passage of time. The Company assumes no duty to update its forward looking statements and this release shall not be construed to indicate the assumption by the Company of any duty to update its outlook in the future.

(Tables to follow)


MOVADO GROUP, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)


	Three Months Ended						Six Months Ended
	July 31,						July 31,

		2020			2019			2020			2019

Net sales	$	88,538		$	157,816		$	158,204		$	304,365

Cost of sales		43,182			72,477			80,955			140,153

Gross profit		45,356			85,339			77,249			164,212

Operating expenses		54,272			76,563			112,409			150,462
Impairment of goodwill and intangible assets		–			–			155,919			–
Total operating expenses		54,272			76,563			268,328			150,462

Operating (loss)/income		(8,916	)		8,776			(191,079	)		13,750

Non-operating (expense)/income:
Gain on sale of a non-operating asset		1,317			–			1,317			–
Change in contingent consideration		–			13,627			–			13,627
Interest expense		(590	)		(225	)		(861	)		(449	)
Interest income		8			24			23			45

(Loss)/Income before income taxes		(8,181	)		22,202			(190,600	)		26,973

(Benefit)/Provision for income taxes		(1,559	)		4,741			(33,889	)		5,588

Net (loss)/income		(6,622	)		17,461			(156,711	)		21,385

Less: Net loss attributable to noncontrolling interests		(7	)		(44	)		(103	)		(45	)

Net (loss)/income attributable to Movado Group, Inc.	$	(6,615	)	$	17,505		$	(156,608	)	$	21,430

Diluted Income Per Share Information
Net (loss)/income attributable to Movado Group, Inc.	$	(0.28	)	$	0.75		$	(6.75	)	$	0.92

Weighted diluted average shares outstanding		23,240			23,292			23,191			23,370


MOVADO GROUP, INC.
GAAP AND NON-GAAP MEASURES
(In thousands, except for percentage data)
(Unaudited)


	As Reported
	Three Months Ended
	July 31,				% Change

	2020		2019

Total net sales, as reported	$	88,538	$	157,816	-43.9	%

Total net sales, constant dollar basis	$	88,461	$	157,816	-43.9	%



	As Reported
	Six Months Ended
	July 31,				% Change

	2020		2019

Total net sales, as reported	$	158,204	$	304,365	-48.0	%

Total net sales, constant dollar basis	$	158,813	$	304,365	-47.8	%

MOVADO GROUP, INC.
GAAP AND NON-GAAP MEASURES
(In thousands, except per share data)
(Unaudited)

	Net Sales		Gross Profit		Operating (Loss)/Income			Pre-tax (Loss)/Income			(Benefit)/Provision for Income Taxes			Net (Loss)/Income Attributable to Movado Group, Inc.			Diluted EPS
Three Months Ended July 31, 2020
As Reported (GAAP)	$	88,538	$	45,356	$	(8,916	)	$	(8,181	)	$	(1,559	)	$	(6,615	)	$	(0.28	)
Olivia Burton Costs (1)		–		–		671			671			139			532		$	0.02
MVMT Costs (2)		–		–		284			284			108			176		$	0.01
Gain On Sale of a Non-Operating Asset (3)		–		–		–			(1,317	)		(474	)		(843	)	$	(0.04	)
Corporate Initiatives (4)		–		–		7,368			7,368			2,353			5,015		$	0.22
Adjusted Results (Non-GAAP)	$	88,538	$	45,356	$	(593	)	$	(1,175	)	$	567		$	(1,735	)	$	(0.07	)


Three Months Ended July 31, 2019
As Reported (GAAP)	$	157,816	$	85,339	$	8,776		$	22,202		$	4,741		$	17,505		$	0.75
Olivia Burton Costs (1)		–		–		690			690			131			559			0.02
MVMT Costs (2)		–		–		1,125			1,125			270			855			0.04
Change In Contingent Consideration (5)		–		–		–			(13,627	)		(3,270	)		(10,357	)		(0.44	)
Cost Savings Initiatives (6)		–		–		(320	)		(320	)		(77	)		(243	)		(0.01	)
Adjusted Results (Non-GAAP)	$	157,816	$	85,339	$	10,271		$	10,070		$	1,795		$	8,319		$	0.36


	Net Sales		Gross Profit		Operating (Loss)/Income			Pre-tax (Loss)/Income			(Benefit)/Provision for Income Taxes			Net (Loss)/Income Attributable to Movado Group, Inc.			Diluted EPS
Six Months Ended July 31, 2020
As Reported (GAAP)	$	158,204	$	77,249	$	(191,079	)	$	(190,600	)	$	(33,889	)	$	(156,608	)	$	(6.75	)
Olivia Burton Costs (1)		–		–		1,356			1,356			258			1,098		$	0.05
MVMT Costs (2)		–		–		981			981			373			608		$	0.03
Goodwill and Intangible Asset Impairment (7)		–		–		155,919			155,919			24,867			131,052		$	5.65
Gain On Sale of a Non-Operating Asset (3)		–		–		–			(1,317	)		(474	)		(843	)	$	(0.04	)
Corporate Initiatives (4)		–		3,508		14,608			14,608			4,592			10,016		$	0.43
Adjusted Results (Non-GAAP)	$	158,204	$	80,757	$	(18,215	)	$	(19,053	)	$	(4,273	)	$	(14,677	)	$	(0.63	)


Six Months Ended July 31, 2019
As Reported (GAAP)	$	304,365	$	164,212	$	13,750		$	26,973		$	5,588		$	21,430		$	0.92
Olivia Burton Costs (1)		–		–		1,402			1,402			266			1,136			0.05
MVMT Costs (2)		–		140		2,598			2,598			624			1,974			0.08
Change In Contingent Consideration (5)		–		–		–			(13,627	)		(3,270	)		(10,357	)		(0.44	)
Cost Savings Initiatives (6)		–		–		(320	)		(320	)		(77	)		(243	)		(0.01	)
Adjusted Results (Non-GAAP)	$	304,365	$	164,352	$	17,430		$	17,026		$	3,131		$	13,940		$	0.60

Contacts

ICR, Inc.

Rachel Schacter/Allison Malkin

203-682-8200

Read full story here

Tags #Pandemic, #Results, Business, Communties, COVID-19, Digital, Investment, Movado Group Inc., Quarter, Taxes, Taxes#Pandemic

Healthcare

Dr. Reddy’s Laboratories announces the launch of Penicillamine Capsules USP, 250 mg in the U.S. market

Post author By Michelle Dryden
Post date August 27, 2020
No Comments on Dr. Reddy’s Laboratories announces the launch of Penicillamine Capsules USP, 250 mg in the U.S. market

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Penicillamine Capsules USP, 250 mg, a therapeutic equivalent generic version of Cuprimine® (penicillamine) Capsules, 250 mg, approved by the U.S. Food and Drug Administration (USFDA).

The Cuprimine® brand and generic market had U.S. sales of approximately $80 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health*.

Dr. Reddy’s Penicillamine Capsules, USP is available as 250 mg capsules in a bottle count sizes of 100.

Please click here for prescribing information including boxed warning.

Warnings

Physicians planning to use penicillamine should thoroughly familiarize themselves with its toxicity, special dosage considerations, and therapeutic benefits. Penicillamine should never be used casually. Each patient should remain constantly under the close supervision of the physician. Patients should be warned to report promptly any symptoms suggesting toxicity.

Cuprimine® is a trademark of Bausch Health Companies Inc.

*IQVIA Retail and Non-Retail MAT June 2020

RDY-0820-305

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the “Risk Factors” and “Forward-Looking Statements” sections of our Annual Report on Form 20-F for the year ended March 31, 2020. The company assumes no obligation to update any information contained herein.”

Contacts

INVESTOR RELATIONS
AMIT AGARWAL

amita@drreddys.com
(PH: +91-40-49002135)

MEDIA RELATIONS
APARNA TEKURI

aparnatekuri@drreddys.com
(PH: +91-40-49002446)

Tags #USFDA, Business, Cuprimine, Dr. Reddy's Laboratories, Generic, Healthcare, Markets, Penicillamine Capsules USP, Physicians, Therapeutic, Therapeutic#USFDA

Business

MetLife Investment Management originates $6.2 billion in private placement debt for 1H 2020

Post author By Michelle Dryden
Post date August 26, 2020
No Comments on MetLife Investment Management originates $6.2 billion in private placement debt for 1H 2020

Private placement debt portfolio grows to $91.2 billion¹

WHIPPANY, N.J.–(BUSINESS WIRE)–MetLife Investment Management (MIM), the institutional asset management business of MetLife, Inc. (NYSE: MET), today announced it originated $6.2 billion in private placement debt for the first half of 2020, across nearly 100 transactions. This included $1.7 billion of investments originated on behalf of institutional clients.

“Despite COVID-driven economic uncertainty and associated volatility in the fixed income markets, we remained active throughout the first six months of 2020, serving as a key capital partner to our issuers,” said John Wills, global head of private placements at MIM.

MIM’s private placement debt origination for the first half of 2020 comprised $4.5 billion in corporate private placement debt transactions and $1.7 billion in infrastructure private placement debt transactions. This origination activity, which added 29 new credits, helped grow MIM’s total private placement debt portfolio to $91.2 billion as of June 30, 2020.

MIM’s corporate private placement activity was diversified across industry sectors, including general industrial, healthcare, professional services, retail and utilities. MIM was selective in its infrastructure private placement opportunities and participated in transactions that provided strong structural protections and relative value across the following sectors: electric transmission, renewable power, social housing and infrastructure, and stadiums. Investments included nearly $550 million in six transactions across the renewable power and social housing and infrastructure sectors.

“I am proud of our team’s efforts to support our borrowers and institutional investor clients,” added Wills. “The breadth, depth and experience of our deal sourcing and credit management capabilities served our clients across the corporate, insurance and pension communities well during these extremely difficult times. We expect that MIM will continue to be a leading private placement provider in corporate and infrastructure debt, benefiting from our size, sector expertise and global footprint.”

About MetLife Investment Management

MetLife Investment Management, the institutional asset management business of MetLife, Inc. (NYSE: MET), is a global public fixed income, private capital and real estate investment manager providing tailored investment solutions to institutional investors worldwide. MetLife Investment Management provides public and private pension plans, insurance companies, endowments, funds and other institutional clients with a range of bespoke investment and financing solutions that seek to meet a range of long-term investment objectives and risk-adjusted returns over time. MetLife Investment Management has over 150 years of investment experience and as of June 30, 2020, had $629.1 billion² in total assets under management. For more information, visit https://investments.metlife.com.

About MetLife

MetLife, Inc. (NYSE: MET), through its subsidiaries and affiliates (“MetLife”), is one of the world’s leading financial services companies, providing insurance, annuities, employee benefits and asset management to help its individual and institutional customers navigate their changing world. Founded in 1868, MetLife has operations in more than 40 markets globally and holds leading positions in the United States, Japan, Latin America, Asia, Europe and the Middle East. For more information, visit www.metlife.com.

Forward-Looking Statements

The forward-looking statements in this news release, such as “expect,” “will,” and “continue” are based on assumptions and expectations that involve risks and uncertainties, including the “Risk Factors” MetLife, Inc. describes in its U.S. Securities and Exchange Commission filings. MetLife’s future results could differ, and it has no obligation to correct or update any of these statements.

______________________________

¹ As of June 30, 2020. At estimated fair value. Includes corporate and infrastructure private placement debt contained in MetLife’s general account, separate accounts and non-proprietary assets of unaffiliated/third party clients.

² Total assets under management is comprised of all MetLife general account and separate account assets and unaffiliated/third party assets, at estimated fair value, managed by MIM.

Contacts

James Murphy

(973) 355-4673

Tags #1H, #Debt, #MIM, Asset, Business, COVID, Investment, Management, Markets, MetLife, MetLife#1H

Business

CS Energy achieves 1 gigawatt installed of solar projects

Post author By Michelle Dryden
Post date August 26, 2020
No Comments on CS Energy achieves 1 gigawatt installed of solar projects

National EPC energy firm, majority owned by funds managed by Ares Management Corporation, achieved significant milestone in August 2020

EDISON, N.J.–(BUSINESS WIRE)–CS Energy, LLC, a leading integrated energy firm that designs and builds optimized projects in the solar, storage and emerging energy industries, announced today that it has reached a major milestone: completing the installation of 1 gigawatt of solar energy projects.

The 1 GW achievement puts CS Energy in a distinguished category. According to Solar Power World’s Top Solar Contractors* rankings, fewer than 10 EPCs have installed 1 GW of solar as of 2020, but with CS Energy’s consistent 20 percent annual growth rate, the milestone was reached quickly. The company closed 2018 with 650 MW of completed solar projects and ended 2019 with 820 MW. In 2020, CS Energy reached 1,000 MW, despite industry contractions resulting from the COVID-19 pandemic.

“This is an incredible milestone, and one only possible because of the hard work and dedication of our team,” shared Matthew Skidmore, CEO of CS Energy. “I am so proud of our talented workforce, which has completed CS Energy projects to the highest standards of quality and safety across the country. We’re excited to put our deep experience to work for our clients as we begin installing the next gigawatt.”

CS Energy has completed nearly 200 solar projects across 16 states, in a mix of utility-scale solar projects and energy storage projects. Much of the 1 GW has been completed in the last three years as the firm manages increasingly larger projects, such as a recent 29 MW solar project in New Jersey. The growth coincides with funds managed by the Infrastructure and Power strategy of Ares Management Corporation taking majority ownership of the company in 2018.

“We made a strategic investment in CS Energy knowing the firm had the capabilities to expand its impact on renewable energy projects across the country,” shared Keith Derman, Partner and Co-Head of Ares Infrastructure and Power. “We are thrilled that CS Energy has been able to achieve such a substantial milestone and consider it a testament to the company’s legacy of experience and reliability.”

The 1 GW accomplishment comes as CS Energy garners additional recognition from the solar industry. CS Energy was named the nation’s number-one commercial solar installer in 2019 by global research firm Wood Mackenzie. With more than 10 percent of the U.S. market share, CS Energy installed as much as the second- and third-ranked companies combined. In 2020, CS Energy once again made Solar Power World magazine’s annual list of Top Solar Contractors, ranking in the Top 10 for national EPCs, and as the #1 solar contractor in both New York and New Jersey.

Additionally, the company utilizes its expertise to lead a variety of solar industry subsectors. CS Energy is considered an expert in landfill solar installations, having installed more than 160 MW on top of closed capped landfills. CS Energy is also on the forefront of Solar + Storage projects: the company has installed more than 135 MWh of energy storage projects and is ranked as the #2 Solar + Storage installer in the nation by Solar Power World.

Starting with just 12 employees in 2004, the company has grown to a highly skilled team of more than 160 people. CS Energy began in the solar industry as part of The Conti Group, a construction and engineering firm that has been operating for more than 115 years. Building on the organic success in the solar industry, the group branched out into Conti Solar, a wholly owned subsidiary of The Conti Group, in 2017. Conti Solar was majority acquired by funds managed by the Infrastructure and Power strategy of Ares Management Corporation in 2018 the company rebranded as CS Energy.

“CS Energy is thriving from the roots planted at The Conti Group—roots in skilled construction, quality customer service, and an educated leadership group. It’s been a pleasure to see CS Energy deliver on our shared vision of creating a nation-leading integrated energy company,” said Kurt Conti, Chairman of the Board of The Conti Group.

* https://www.solarpowerworldonline.com/2020-top-solar-contractors/

About CS Energy

CS Energy is an industry-leading engineering, procurement and construction (EPC) energy firm that designs and builds optimized projects in solar, energy storage, and emerging energy industries. CS Energy’s attention to detail, flawless execution and highly talented workforce has enabled the company to successfully design and install over 1 GW of solar projects across the United States. CS Energy leverages strong relationships with solar developers, IPPs, utilities, off-takers, suppliers, and landowners to help our customers streamline the project development process, lower project costs, and create value for all stakeholders. Majority-owned by Ares Infrastructure and Power, CS Energy has an experienced and committed management team and the financial resources required to continue expanding its solar and energy storage business as a trusted and long-term partner.

About Ares Management Corporation

Ares Management Corporation (NYSE: ARES) is a leading global alternative investment manager operating integrated businesses across Credit, Private Equity and Real Estate. Ares Management’s investment groups collaborate to deliver innovative investment solutions and consistent and attractive investment returns for fund investors throughout market cycles. Ares Management’s global platform had approximately $165 billion of assets under management as of June 30, 2020 with more than 1,300 employees operating across North America, Europe, Asia and Australia, pro forma for the acquisition of SSG Capital Holdings Limited which closed on July 1, 2020.

About Ares Infrastructure and Power

Ares Infrastructure and Power (“AIP”) strategy seeks to provide flexible capital for cash-generating assets across the climate infrastructure, natural gas generation, and energy transportation sectors. AIP leverages a broadly skilled and cohesive team of more than 25 investment professionals with deep domain experience and has deployed nearly $9 billion of capital in more than 200 different infrastructure and power assets and companies.

About The Conti Group

The Conti Group is a privately held group of companies spanning the construction, engineering, renewable energy, real estate, technology and biotech markets whose mission is to create positive impact and great value for customers, partners, employees, and society.

Contacts

CS Energy Media:
Dianaliz Santiago-Borcan

732.520.5143

dborcan@csenergy.com

Tags #Milestone, #Pandemic, #Projects, #Solar, #Storage, Business, Contractors, COVID-19, CS Energy, Gigawatt, Gigawatt#Milestone

Business

Statement in response to news of the indictment of Teva USA

Post author By Michelle Dryden
Post date August 26, 2020
No Comments on Statement in response to news of the indictment of Teva USA

TEL AVIV & PARSIPPANY, N.J.–(BUSINESS WIRE)–Today Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) is responding to news reports detailing that a federal grand jury in Philadelphia, Pennsylvania has returned a criminal indictment charging Teva USA with three counts of antitrust violations under the Sherman Act.

Teva is deeply disappointed that the government has chosen to proceed with this prosecution. The Company has been investigating this matter for over four years and has concluded that Teva did not participate in price fixing. Based on our internal review, Teva firmly rejects the allegations and will vigorously defend the Company in court. Teva has fully cooperated throughout the course of the Department of Justice (DOJ) investigation and has attempted to reach a resolution in the best interest of the Company, its stakeholders and the patients the company serves. The DOJ has shown an unwillingness to consider alternatives that would not deeply impact Teva and the stakeholders who depend on the Company, including the patients who benefit from our medicines.

As we defend this matter, Teva will maintain focus on its critical role in the U.S. healthcare system, ensuring access to affordable medicines, including helping millions of patients who suffer multiple chronic conditions. One out of every 10 of the 3.69 billion generic prescriptions written in the United States each year is filled with a Teva product.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at http://www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

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

our ability to successfully defend against the DOJ criminal charges;
the potential impact the DOJ criminal charges, and a potential criminal conviction, may have on our business and operations in general, including our ability to defend and reach a favorable resolution of the civil, private and other litigations related to this matter, the effects on our current indebtedness and our ability to incur additional indebtedness, engage in additional transactions, make new investments, and our ability to continue to do business with governmental bodies in the United States;
our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
our business and operations in general, including: uncertainty regarding the magnitude, duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; adequacy of and our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; effectiveness of our restructuring plan announced in December 2017; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time including due to modified government operations due to the COVID-19 pandemic and effects on product and patent approvals; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;

and other factors discussed in our Quarterly Reports on Form 10-Q for the first and second quarters of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Contacts

IR Contacts
United States
Kevin C. Mannix (215) 591-8912

Israel
Yael Ashman 972 (3) 926-7516

PR Contacts
United States
Kelley Dougherty (973) 832-2810

Israel
Yonatan Beker 972 (54) 888 5898

Tags #DOJ, #Federal, #Indictment, #News, #Stakeholder, #Teva USA, Business, medicines, Pharmaceutical, products, products#DOJ

Business

Mercury Insurance offers contactless home inspections to policyholders in New York and New Jersey through Flyreel

Post author By Michelle Dryden
Post date August 25, 2020
No Comments on Mercury Insurance offers contactless home inspections to policyholders in New York and New Jersey through Flyreel

Mercury’s home inspection app minimizes health risks by eliminating the need for outsiders to make an in-person home visit

LOS ANGELES–(BUSINESS WIRE)–Today, Mercury Insurance announced that the company is offering New York and New Jersey homeowners policyholders DIY inspection services using an advanced Artificial Intelligence (AI) assistant. Created by Flyreel, the app guides homeowners through a self-inspection of their property and gives them the option for a contactless experience, helping policyholders maintain their physical distance from those outside of the household during the COVID-19 pandemic. The AI assistant is available to download as a mobile app from the Apple App Store and Google Play.

“We do so much with smartphones now that giving our insureds the ability to use photos and video to capture and verify the characteristics of their property made so much sense,” said Holly Sacks, Mercury Insurance portfolio underwriter. “The AI in our app is top-class, making it super simple to complete a self-inspection. The step-by-step instructions are easy to follow and fun to use!”

New Mercury homeowner policyholders will be emailed a link to download the app and activate it. Then, they can complete the self-inspection at their leisure with no appointment needed. The virtual inspection is conducted with state-of-the-art AI, high fidelity video and a conversation feature to streamline the experience while capturing everything Mercury needs to accurately underwrite a policy. It also helps catalog belongings and building materials in the event the customer needs to file a claim. On average, the self-inspection process takes less than 30 minutes.

Flyreel, Mercury’s home inspection app technology partner, is the pioneer in developing advanced AI to help insurance providers protect policyholders and their property using AI-assisted, self-service inspections.

“We’re grateful for the opportunity to support Mercury Insurance as they push the envelope of innovation, deploying the best of today’s technology to better serve their customers,” said Cole Winans, CEO of Flyreel. “Their relentless commitment to protecting homeowners while delivering an industry-leading customer experience makes us proud to be their partner.”

Visit https://www.mercuryinsurance.com/insurance/homeowners/ to learn more about Mercury’s products and services.

About Mercury Insurance

Mercury Insurance (MCY) is a multiple-line insurance organization predominantly offering personal automobile, homeowners and business insurance through a network of independent agents in Arizona, California, Florida, Georgia, Illinois, Nevada, New Jersey, New York, Oklahoma, Texas and Virginia. Since 1962, Mercury has specialized in offering quality insurance at affordable prices. For more information, visit www.mercuryinsurance.com or Facebook and follow the company on Twitter.

About Flyreel

Flyreel provides Total Property Understanding^TM for underwriting, loss control and claims. Flyreel’s advanced AI assistant guides users through fully configurable workflows. As users scan their property with their smartphone camera, Flyreel’s proprietary computer vision technology automatically documents critical property data like hazards, risks, features, materials and more. Flyreel’s AI Assistant can “react and respond” to data collected by the policyholder, adapting and customizing conversational workflows based on the unique attributes that it “sees” in near real-time. To learn more about Flyreel, visit https://www.flyreel.co/.

Contacts

PCG – Kyle Reuter (424) 903-3657

kreuter@pacificcommunicationsgroup.com

Flyreel, Inc. – Alyson Austin (949) 403-0484

alyson@gaffneyaustin.com

Tags #Policyholders, Apple App, Business, COVID-19 Pandemic, Customers, Flyreel, Google Play, Homeowners, Mercury Insurance, Technology, Technology#Policyholders

Healthcare

Merck’s KEYTRUDA® (pembrolizumab) receives two new approvals in Japan

Post author By Michelle Dryden
Post date August 24, 2020
No Comments on Merck’s KEYTRUDA® (pembrolizumab) receives two new approvals in Japan

KEYTRUDA Now Approved for Patients With PD-L1-Positive Esophageal Squamous Cell Carcinoma Who Have Progressed After Chemotherapy and for a Six-Week Dosing Schedule Across All Adult Indications

Six-Week Dosing Schedule for KEYTRUDA Now Approved in Japan, US and Europe

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). KEYTRUDA monotherapy is now approved for the treatment of patients whose tumors are PD-L1-positive, and have radically unresectable, advanced or recurrent esophageal squamous cell carcinoma (ESCC) who have progressed after chemotherapy. Additionally, KEYTRUDA was approved for use at an additional recommended dosage of 400 mg every six weeks (Q6W) administered as an intravenous infusion over 30 minutes across all adult indications, including KEYTRUDA monotherapy and combination therapy. This new dosage option will be available in addition to the current dose of 200 mg every three weeks (Q3W). With these approvals, KEYTRUDA has 13 indications across seven tumor types plus MSI-H tumors in Japan.

“We remain committed to improving outcomes for as many patients with cancer as possible, including those with esophageal squamous cell carcinoma, which is a leading cause of cancer-related death in Japan,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “With today’s approvals, specific patients with esophageal cancer can receive a much-needed new treatment option, and adult patients receiving KEYTRUDA will now have the option of a dosing schedule that reduces how often they are at the clinic for treatment.”

The approval for KEYTRUDA for the treatment of certain patients with ESCC is based on results from the global Phase 3 KEYNOTE-181 trial, in which an improvement in overall survival (OS) was observed for KEYTRUDA monotherapy compared with chemotherapy (paclitaxel, docetaxel or irinotecan) in patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10) (HR=0.64 [95% CI, 0.46-0.90]). The median OS was 10.3 months (95% CI, 7.0-13.5) for KEYTRUDA compared with 6.7 months (95% CI, 4.8-8.6) for chemotherapy.

The approval of KEYTRUDA for a Q6W dosing regimen is based on pharmacokinetic modeling and exposure-response analyses. The pharmacokinetic modeling data was supported by an interim analysis of pharmacokinetic, efficacy and safety data from KEYNOTE-555 from a cohort of patients (Cohort B) treated with KEYTRUDA 400 mg Q6W.

“In Japan, more than 90% of esophageal cancers are squamous cell carcinomas. Patients with advanced disease face a poor prognosis and are in critical need of new treatment options,” said Jannie Oosthuizen, president, MSD Japan. “These approvals reinforce our commitment to innovative research that will continue to help more patients with cancer in Japan.”

About Esophageal Cancer in Japan

Esophageal cancer, a type of cancer that is particularly difficult to treat, begins in the inner layer (mucosa) of the esophagus and grows outward. There are two main types of esophageal cancer: squamous cell carcinoma and adenocarcinoma. In Japan, more than 90% of all esophageal cancers are squamous cell carcinomas. Globally, esophageal cancer is the seventh most commonly diagnosed cancer, and it is estimated there were more than 572,000 new esophageal cancer cases and nearly 509,000 deaths resulting from the disease in 2018.

About KEYTRUDA^® (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA^® (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) ≥10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. 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.

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

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA 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 tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Adult Indications: Additional Dosing Regimen of 400 mg Every 6 Weeks

KEYTRUDA is indicated for use at an additional recommended dosage of 400 mg every 6 weeks for all approved adult indications. This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor–blocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality.

Contacts

Media:

Pamela Eisele

(267) 305-3558

Ayn Wisler

(908) 740-5590

Investors:

Peter Dannenbaum

(908) 740-1037

Courtney Ronaldo

(908) 740-6132

Read full story here

Tags #Canada, #Japan, #Therapy, Business, Healthcare, Keytruda, Merck, Oncology, Pembrolizumab, Tumors, Tumors#Canada

Business

AM Best affirms credit ratings of American Federated Insurance Company and American Federated Life Insurance Company

Post author By Michelle Dryden
Post date August 22, 2020
No Comments on AM Best affirms credit ratings of American Federated Insurance Company and American Federated Life Insurance Company

OLDWICK, N.J.–(BUSINESS WIRE)–AM Best has affirmed the Financial Strength Rating of B (Fair) and the Long-Term Issuer Credit Ratings of “bb” of American Federated Insurance Company (AFIC) and American Federated Life Insurance Company (AFLIC). The outlook of these Credit Ratings (ratings) is stable. Both companies are known collectively as American Federated Insurance Companies and are domiciled in Flowood, MS.

The ratings of AFIC reflect its balance sheet strength, which AM Best categorizes as very strong, as well as its strong operating performance, limited business profile and marginal enterprise risk management (ERM). The ratings also reflect drag from the parent holding company, First Tower Finance Company LLC (First Tower Finance).

The ratings of AFLIC reflect its balance sheet strength, which AM Best categorizes as very strong, as well as its adequate operating performance, limited business profile and marginal ERM. The ratings also reflect drag from the parent holding company, First Tower Finance.

The American Federated Insurance Companies are indirect, wholly owned subsidiaries of First Tower Finance, a multiline specialty finance company. Prospect Capital Corporation [NASDAQ: PSEC], a publicly traded closed-end investment company, indirectly owns an 80.1% majority interest in First Tower Finance and its subsidiaries.

AFIC provides credit insurance coverage on collateralized personal loans originated by the consumer finance subsidiaries of First Tower Finance, and involuntary unemployment insurance.

AFLIC provides credit life and credit accident and health insurance coverages for individuals that have personal loans originated by the consumer finance subsidiaries of First Tower Finance. Given the products offered by the two companies, AM Best will continue to monitor the potential effects of COVID-19 and the macroeconomic environment on the business profiles and operations of AFIC and AFLIC.

The drag to the ratings of AFIC and AFLIC reflects the considerable financial leverage with a deficit in members’ equity at First Tower Finance, stemming from a 2014 transaction involving the return of First Tower Finance’s capital to its members.

Contacts

Jeffrey Stary

Financial Analyst
+1 908 439 2200, ext. 5689
jeffrey.stary@ambest.com

Raymond Thompson, CPCU, ARe, ARM
Director
+1 908 439 2200, ext. 5621
raymond.thompson@ambest.com

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

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

Tags #AFIC, #AFLIC, #Stable, AM Best, American Federated Insurance Company, American Federated Life Insurance Company, Business, Collateral, Credit Ratings, Finance, Finance#AFIC

Sports & Gaming

FanDuel expands fantasy sports offerings with the addition of Best Ball and Daily Snake Drafts

Post author By Michelle Dryden
Post date August 21, 2020
No Comments on FanDuel expands fantasy sports offerings with the addition of Best Ball and Daily Snake Drafts

NEW YORK–(BUSINESS WIRE)–#FanDuelBestBall–Today, FanDuel announced the expansion of its industry-leading fantasy sports products with the launch of Best Ball and Daily Snake Drafts ahead of the football season.

Best Ball contests are the simplest way to play fantasy football, bringing the popular season-long fantasy game on to FanDuel’s fantasy platform. The Pro Football Best Ball slates are small, single-entry contests with a shared player pool. Users draft a 20 player fantasy team before or during the football season, then keep that team for the remainder of the season. Unlike other FanDuel contests, there is no salary cap and one player per team. There are also no trades or waiver claims like other season long fantasy football products. Every week, FanDuel automatically combines the scores of your best players at each position (9 players in total) to generate your score for that week. There are only 2-12 users in each contest, and the user with the highest cumulative score at the end of the season wins. As of today, Best Ball contests are available on FanDuel.com or via the FanDuel DFS app, and you can choose from a variety of contest sizes and entry fees starting at $1.

“Best Ball games are perfect for sports fans looking to play fantasy for the first time, or who love the season-long fantasy format,” said John Griffin, General Manager Fantasy, FanDuel Group. “These contests are a hybrid of season-long and daily fantasy, and users can draft a team once and never have to set their lineups again or watch waiver wires, which is incredibly appealing to fans of all levels.”

To celebrate the launch of Best Ball, FanDuel will debut a new commercial featuring former NFL Head Football Coach, Jeff Fisher. The new spot from BBH NY, highlights the fact that FanDuel’s new fantasy sports addition is simple and easy to play. In the hilarious spot, Coach Fisher helps a fan with his Best Ball picks, while multitasking in the kitchen. Only 15 wins shy of being in the top-10 winningest coaches of all time, Coach Fisher is not only a world class talent evaluator, he also cooks a mean paella.

FanDuel will also offer daily Snake Draft contests for select NBA, NHL, golf and MLB games. Snake Draft contests for the football season will be available in early September. Daily Snake Drafts are single-entry, easy-to-enter, small contests with a shared player pool, letting you draft a team for each game day or week. Unlike other FanDuel contests, there’s no salary cap. In addition, the player pool is shared so players can only be drafted by one user. Everyone in the contest picks players one after another in real-time, with 30 seconds to pick, until your rosters for that week are full.

About FanDuel Group

FanDuel Group is an innovative sports-tech entertainment company that is changing the way consumers engage with their favorite sports, teams, and leagues. The premier gaming destination in the United States, FanDuel Group consists of a portfolio of leading brands across gaming, sports betting, daily fantasy sports, advance-deposit wagering, and TV/media, including FanDuel, Betfair US, and TVG. FanDuel Group has a presence across 45 states and 8.5 million customers. The company is based in New York with offices in California, New Jersey, Florida, Oregon, and Scotland. FanDuel Group is a subsidiary of Flutter Entertainment plc, a leading international sports betting and gaming operator and a constituent of the FTSE 100 index of the London Stock Exchange.

Contacts

FanDuel

Emily Bass

press@fanduel.com

Tags #FanDuelBestBall, Business, Contests, Daily Snake Drafts, Fanduel, Fantasy, Football, industry, Players, Score, Season, Sports, Sports#FanDuelBestBall