Tag: Financial

Catalent, Inc. reports second quarter fiscal 2021 results

Post author By Michelle Dryden
Post date February 2, 2021
No Comments on Catalent, Inc. reports second quarter fiscal 2021 results

Q2’21 net revenue of $910.8 million increased 26% as-reported, or 24% in constant currency, compared to Q2’20. Organic, constant currency net revenue grew 17%, compared to Q2’20.
Q2’21 net earnings of $88.4 million increased 94%, or 88% in constant currency, compared to Q2’20.
Q2’21 Adjusted EBITDA of $223.5 million increased 31% as-reported, or 28% in constant currency, compared to Q2’20.
Q2’21 Biologics segment net revenue of $403.9 million increased more than 75%, compared to Q2’20.
Increasing guidance to reflect projected net revenue growth of 23-28% and Adjusted EBITDA growth of 26-33%, compared to projected net revenue growth in previous guidance of 16-22% and Adjusted EBITDA growth of 17-26%.

SOMERSET, N.J. — (BUSINESS WIRE) — Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced financial results for the second quarter of fiscal 2021, which ended December 31, 2020.

“Our second quarter results reflect robust organic growth in our Biologics segment, and our increased guidance reflects our expectation of continued strong results for these offerings for the remainder of our fiscal year. Additional capacity in our drug product and drug substance offerings will come on line in the second half of our fiscal year to help fight the pandemic and serve other critical patient needs,” said John Chiminski, Chair and Chief Executive Officer of Catalent, Inc.

Second Quarter 2021 Consolidated Results

Net revenue of $910.8 million increased 26% as reported, or 24% in constant currency, from the $721.4 million reported for the second quarter a year ago. Overall organic revenue growth (i.e., excluding the effect of acquisitions) was 17%.

Net earnings were $88.4 million. Accounting for the net earnings attributable to holders of Catalent’s Series A convertible preferred stock, net earnings attributable to common shareholders were $76.6 million, or $0.46 per basic share, compared to net earnings attributable to common shareholders of $34.3 million, or $0.23 per basic share, in the second quarter a year ago.

EBITDA from operations, as referenced in the GAAP to non-GAAP reconciliation provided later in this release, was $205.9 million, an increase of $50.6 million from $155.3 million in the second quarter a year ago. Second quarter fiscal 2021 Adjusted EBITDA (see the GAAP to non-GAAP reconciliation provided later in this release) was $223.5 million, or 24.5% of net revenue, compared to $171.0 million, or 23.7% of net revenue, in the second quarter a year ago. This represents an increase of 30.7% as reported, and an increase of 27.8% on a constant-currency basis.

Adjusted Net Income (see the GAAP to non-GAAP reconciliation) was $114.4 million, or $0.63 per diluted share, compared to Adjusted Net Income of $72.0 million, or $0.45 per diluted share, in the second quarter a year ago.

Second Quarter 2021 Segment Review

Biologics

Net revenue from the Biologics segment was $403.9 million for the second quarter of fiscal 2021, an increase of 79% as reported and 76% in constant currency, compared to the second quarter a year ago. Segment EBITDA (see the GAAP to non-GAAP reconciliation provided later in this release) in the second quarter of fiscal 2021 was $135.5 million, an increase of 115% as reported and 109% in constant currency compared to the second quarter a year ago. Segment EBITDA margin was 33.5% in the second quarter of fiscal 2021 compared to 28.0% in the second quarter of the prior year.

Excluding the effect of acquisitions, net revenue increased 65% and segment EBITDA increased 104% compared to the three months ended December 31, 2019.

The Biologics segment represented 44% of Catalent’s total net revenue in the second quarter of fiscal 2021.

Softgel and Oral Technologies

Net revenue from the Softgel and Oral Technologies segment was $246.6 million for the second quarter of fiscal 2021, a decrease of 8% as reported or 10% in constant currency, compared to the second quarter a year ago. Segment EBITDA was $45.6 million in the second quarter of fiscal 2021, a decrease of 29% as reported, or 31% in constant currency, compared to the second quarter a year ago. Segment EBITDA margin was 18.5% in the second quarter of fiscal 2021 compared to 24.1% in the second quarter of the prior year.

The Softgel and Oral Technologies segment represented 27% of Catalent’s total net revenue in the second quarter of fiscal 2021.

Oral and Specialty Delivery

Net revenue from the Oral and Specialty Delivery segment was $169.9 million for the second quarter of fiscal 2021, an increase of 19% as reported and 17% in constant currency, over the second quarter a year ago. Segment EBITDA in the second quarter of fiscal 2021 was $44.2 million, an increase of 34% as reported, or 31% in constant currency, compared to the second quarter a year ago. Segment EBITDA margin was 26.0% in the second quarter of fiscal 2021 compared to 23.1% in the second quarter of the prior year.

Excluding the effect of acquisitions, net revenue increased 2% and segment EBITDA increased 9% compared to the three months ended December 31, 2019.

The Oral and Specialty Delivery segment represented 19% of Catalent’s total net revenue in the second quarter of fiscal 2021.

Clinical Supply Services

Net revenue from the Clinical Supply Services segment was $93.5 million for the second quarter of fiscal 2021, an increase of 6% as reported and 4% in constant currency, compared to the second quarter a year ago. Segment EBITDA in the second quarter of fiscal 2021 was $25.3 million, an increase of 5% as reported, or 2% in constant currency, compared to the second quarter a year ago. Segment EBITDA margin was 27.1% in the second quarter of fiscal 2021 compared to 27.3% in the second quarter of the prior year.

The Clinical Supply Services segment represented 10% of Catalent’s total net revenue in the second quarter of fiscal 2021.

Balance Sheet and Liquidity

As of December 31, 2020, Catalent had $3.1 billion in total debt, and $2.2 billion in total debt net of cash and short-term investments, compared to $2.1 billion in total net debt as of September 30, 2020. The current debt structure does not include any significant maturity until 2026.

Catalent’s net leverage ratio (see the GAAP to non-GAAP reconciliation provided later in this release) as of December 31, 2020 was 2.6x, compared to 2.6x at September 30, 2020 and 4.2x at December 31, 2019.

Fiscal Year 2021 Outlook

Catalent is raising its previously issued guidance to reflect second quarter performance and to account for higher net underlying demand, including increased demand related to COVID-19 treatments and vaccines, partially offset by lower demand in some offerings attributable to the effects of the pandemic.

The revised guidance assumes no major unforeseen change to either the current status of the COVID-19 pandemic generally or its effect on Catalent’s operations and business. The revised guidance does not assume the receipt of any vaccine or treatment order from any of our customers beyond what either has been received to date or is deemed required under executed take-or-pay arrangements. The revised guidance ranges are wider than the ranges we have forecasted in the previous few fiscal years due to the continuing uncertainty in both revenues and costs across our businesses engendered by the COVID-19 pandemic. The revised guidance projects:

Net revenue for fiscal 2021 in the range of $3.80 billion to $3.95 billion, compared to the previous range of $3.58 billion to $3.78 billion;
Adjusted EBITDA for fiscal 2021 in the range of $950 million to $1,000 million, compared to the previous range of $880 million to $950 million;
Adjusted Net Income for fiscal 2021 in the range of $475 million to $525 million, compared to the previous range of $410 million to $470 million; and
A fully diluted share count in the range of 180 million to 182 million shares on a weighted-average basis, which includes the outstanding Series A Convertible Preferred Stock as-if converted, compared to the previous range of 178 million to 180 million shares.

Earnings Webcast

The Company’s management will host a webcast to discuss the results at 8:15 a.m. ET today. Catalent invites all interested parties to listen to the webcast, which will be accessible through Catalent’s website at http://investor.catalent.com. A supplemental slide presentation will also be available in the “Investors” section of Catalent’s website prior to the start of the webcast. The webcast replay, along with the supplemental slides, will be available for 90 days in the “Investors” section of Catalent’s website at www.catalent.com.

About Catalent, Inc.

Catalent, Inc. (NYSE: CTLT), an S&P 500^® company, is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs more than 14,000 people, including approximately 2,500 scientists, at more than 45 facilities across four continents and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, please visit www.catalent.com.

Non-GAAP Financial Measures

Use of EBITDA from operations, Adjusted EBITDA, Adjusted Net Income and Segment EBITDA

Management measures operating performance based on consolidated earnings from operations before interest expense, expense (benefit) for income taxes, and depreciation and amortization, adjusted for the income or loss attributable to non-controlling interests (“EBITDA from operations”). EBITDA from operations is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP, and is subject to important limitations.

Catalent believes that the presentation of EBITDA from operations enhances an investor’s understanding of its financial performance. Catalent believes this measure is a useful financial metric to assess its operating performance across periods by excluding certain items that it believes are not representative of its core business and uses this measure for business planning purposes.

In addition, given the significant investments that Catalent has made in the past in property, plant and equipment, depreciation and amortization expenses represent a meaningful portion of its cost structure. Catalent believes that EBITDA from operations will provide investors with a useful tool for assessing the comparability between periods of its ability to generate cash from operations sufficient to pay taxes, to service debt and to undertake capital expenditures because it eliminates depreciation and amortization expense. Catalent presents EBITDA from operations in order to provide supplemental information that it considers relevant for the readers of its consolidated financial statements, and such information is not meant to replace or supersede U.S. GAAP measures. Catalent’s definition of EBITDA from operations may not be the same as similarly titled measures used by other companies.

Catalent evaluates the performance of its segments based on segment earnings before non-controlling interest, other (income) expense, impairments, restructuring costs, interest expense, income tax expense (benefit), and depreciation and amortization (“segment EBITDA”). Moreover, under Catalent’s credit agreement, its ability to engage in certain activities, such as incurring certain additional indebtedness, making certain investments and paying certain dividends, is tied to ratios based on Adjusted EBITDA, which is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP, and is subject to important limitations. Adjusted EBITDA is the covenant compliance measure used in the credit agreement governing debt incurrence and restricted payments. Because not all companies use identical calculations, Catalent’s presentation of Adjusted EBITDA may not be comparable to other similarly titled measures of other companies.

Management also measures operating performance based on Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per share. Adjusted Net Income (Loss) is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP and is subject to important limitations. Catalent believes that the presentation of Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per share enhances an investor’s understanding of its financial performance. Catalent believes these measures are a useful financial metric to assess its operating performance across periods by excluding certain items that it believes are not representative of its core business and Catalent uses these measures for business planning purposes. Catalent defines Adjusted Net Income (Loss) as net earnings (loss) adjusted for amortization attributable to purchase accounting and adjustments for other cash and non-cash items included in the table below, partially offset by its estimate of the tax effects of such cash and non-cash items. Catalent believes that Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per share provides investors with a useful tool for assessing the comparability between periods of its ability to generate cash from operations available to its stockholders. Catalent’s definition of Adjusted Net Income (Loss) may not be the same as similarly titled measures used by other companies.

The most directly comparable U.S. GAAP measure to EBITDA from operations, Adjusted EBITDA and Adjusted Net Income (Loss) is net earnings (loss). Included in this release is a reconciliation of net earnings (loss) to EBITDA from operations, Adjusted EBITDA and Adjusted Net Income.

Catalent does not provide a reconciliation of forward-looking non-GAAP financial measures to their comparable U.S. GAAP financial measures because it could not do so without unreasonable effort due to the unavailability of the information needed to calculate reconciling items and due to the variability, complexity and limited visibility of the adjusting items that would be excluded from the non-GAAP financial measures in future periods. When planning, forecasting, and analyzing future periods, Catalent does so primarily on a non-GAAP basis without preparing a U.S. GAAP analysis as that would require estimates for various cash and non-cash reconciling items that would be difficult to predict with reasonable accuracy. For example, equity compensation expense would be difficult to estimate because it depends on Catalent’s future hiring and retention needs, as well as the future fair market value of its common stock, all of which are difficult to predict and subject to constant change. It is equally difficult to anticipate the need for or magnitude of a presently unforeseen one-time restructuring expense or the values of end-of-period foreign currency exchange rates. As a result, Catalent does not believe that a U.S. GAAP reconciliation would provide meaningful supplemental information about its outlook.

Use of Constant Currency

As changes in exchange rates are an important factor in understanding period-to-period comparisons, Catalent believes the presentation of results on a constant-currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant-currency information compares results between periods as if exchange rates had remained constant period over period. Catalent uses results on a constant-currency basis as one measure to evaluate its performance. Catalent calculates constant currency by calculating current-year results using prior-year foreign currency exchange rates. Catalent generally refers to such amounts calculated on a constant-currency basis as excluding the impact of foreign exchange or being on a constant-currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with U.S. GAAP. Results on a constant-currency basis, as Catalent presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with U.S. GAAP.

Forward-Looking Statements

This release contains both historical and forward-looking statements. All statements other than statements of historical fact, are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “foresee,” “likely,” “may,” “will,” “would,” or other words or phrases with similar meanings. Similarly, statements that describe Catalent’s objectives, plans, or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent’s expectations and projections. Some of the factors that could cause actual results to differ include, but are not limited to, the following: the current or future effects of the COVID-19 pandemic on Catalent’s and its clients’ businesses; participation in a highly competitive market and increased competition that may adversely affect Catalent’s business; demand for its offerings, which depends in part on its customers’ research and development and the clinical and market success of their products; product and other liability risks that could adversely affect Catalent’s results of operations, financial condition, liquidity and cash flows; failure to comply with existing and future regulatory requirements; failure to provide quality offerings to customers could have an adverse effect on Catalent’s business and subject it to regulatory actions and costly litigation; problems providing the highly exacting and complex services or support required; global economic, political and regulatory risks to Catalent’s operations; inability to enhance existing or introduce new technology or service offerings in a timely manner; inadequate patents, copyrights, trademarks and other forms of intellectual property protections; fluctuations in the costs, availability, and suitability of the components of the products Catalent manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials; changes in market access or healthcare reimbursement in the United States or internationally; fluctuations in the exchange rate of the U.S. dollar against other currencies, including as a result of the U.K.’s exit from the European Union; adverse tax legislative or regulatory initiatives or challenges or adjustments to Catalent’s tax positions; loss of key personnel; risks generally associated with information systems; inability to complete any future acquisitions or other transactions that may complement or expand its business or divest of non-strategic businesses or assets and difficulties in successfully integrating acquired businesses and realizing anticipated benefits of such acquisitions; risks associated with timely and successfully completing, and correctly anticipating the future demand predicted for, capital expansion projects at existing facilities, offerings and customers’ products that may infringe on the intellectual property rights of third parties; environmental, health and safety laws and regulations, which could increase costs and restrict operations; labor and employment laws and regulations or labor difficulties, which could increase costs or result in operational disruptions; additional cash contributions required to fund Catalent’s existing pension plans; substantial leverage that may limit its ability to raise additional capital to fund operations and react to changes in the economy or in the industry; and exposure to interest-rate risk to the extent of its variable-rate debt preventing it from meeting its obligations under its indebtedness. For a more detailed discussion of these and other factors, see the information under the caption “Risk Factors” in Catalent’s Annual Report on Form 10-K for the fiscal year ended June 30, 2020, filed August 31, 2020. All forward-looking statements speak only as of the date of this release or as of the date they are made, and Catalent does not undertake to update any forward-looking statement as a result of new information or future events or developments except to the extent required by law.

More products. Better treatments. Reliably supplied.™

Catalent, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited; dollars and shares in millions, except per share data)

	Three Months Ended December 31,				FX Impact		Constant Currency Increase/(Decrease)
	2020		2019				Change $		Change %
Net revenue	$	910.8	$	721.4	$	17.9	$	171.5	24	%
Cost of sales	612.6		489.2		10.9		112.5		23	%
Gross margin	298.2		232.2		7.0		59.0		25	%
Selling, general, and administrative expenses	165.5		141.0		1.4		23.1		16	%
Impairment charges and (gain) loss on sale of assets	0.6		1.7		—		(1.1)		(65)	%
Restructuring and other	5.5		0.5		0.1		4.9		980	%
Operating earnings	126.6		89.0		5.5		32.1		36	%
Interest expense, net	25.9		34.9		0.2		(9.2)		(26)	%
Other (income) expense, net	(8.3)		(4.4)		1.8		(5.7)		130	%
Earnings before income taxes	109.0		58.5		3.5		47.0		80	%
Income tax expense	20.6		13.0		0.7		6.9		53	%
Net earnings	$	88.4	$	45.5	$	2.8	$	40.1	88	%
Less: Net earnings attributable to preferred shareholders	(11.8)		(11.2)		—		—		—	%
Net earnings attributable to common shareholders	$	76.6	$	34.3	$	—	$	—	—	%

Weighted average shares outstanding – basic	167.1		146.1
Weighted average diluted shares outstanding – diluted	169.3		147.7

Earnings per share:
Basic
Net earnings	$	0.46	$	0.23
Diluted
Net earnings	$	0.45	$	0.23


Catalent, Inc. and Subsidiaries
Selected Segment Financial Data
(Unaudited; dollars in millions)

	Three Months Ended December 31,				FX Impact		Constant Currency Increase/(Decrease)
	2020		2019				Change $		Change %
Biologics
Net revenue	$	403.9	$	225.2	$	7.9	$	170.8	76	%
Segment EBITDA	135.5		63.0		3.9		68.6		109	%
Softgel and Oral Technologies
Net revenue	246.6		267.9		5.2		(26.5)		(10)	%
Segment EBITDA	45.6		64.5		1.0		(19.9)		(31)	%
Oral and Specialty Delivery
Net revenue	169.9		143.2		2.7		24.0		17	%
Segment EBITDA	44.2		33.1		0.9		10.2		31	%
Clinical Supply Services
Net revenue	93.5		87.9		2.0		3.6		4	%
Segment EBITDA	25.3		24.0		0.9		0.4		2	%
Inter-segment revenue elimination	(3.1)		(2.8)		0.1		(0.4)		(14)	%
Unallocated costs	(44.7)		(29.3)		(2.1)		(13.3)		(45)	%
Combined totals
Net revenue	$	910.8	$	721.4	$	17.9	$	171.5	24	%

EBITDA from operations	$	205.9	$	155.3	$	4.6	$	46.0	30	%

Contacts

Investor Contact:

Catalent, Inc.

Paul Surdez

732-537-6325

investors@catalent.com

Read full story here

Tags #Results, Catalent, Financial, Fiscal, Report, Technologies, Technology, Technology#Results

Technology

NICE Actimize honored for AI and advanced analytics innovation in Holistic Trade Surveillance by Regulation Asia

Post author By Michelle Dryden
Post date January 27, 2021
No Comments on NICE Actimize honored for AI and advanced analytics innovation in Holistic Trade Surveillance by Regulation Asia

NICE Actimize receives Regulation Asia’s Excellence Award for innovation in artificial intelligence and analytics to spot market abuse, conduct risk and suspicious communications

HOBOKEN, N.J. — (BUSINESS WIRE) — NICE Actimize, a NICE (Nasdaq: NICE) business, announced today that its Holistic Trade and Communications Surveillance solutions suite was recognized by the “Regulation Asia Awards for Excellence 2020” for the second consecutive year with the “Best Solution in Market & Trading Surveillance” award. The Regulation Asia awards program recognizes excellence by firms that work to ensure the highest compliance standards are upheld in the financial industry, and which have shaped the regulatory landscape in Asia Pacific.

Regulation Asia’s “Best Solution” category recognizes solutions designed with specific regulatory requirements in mind, assessed on multiple criteria, including the ease and speed of implementation, flexibility, robustness, scalability, transparency, technical support, cost, and return on investment for end clients, the judges noted. According to Regulation Asia, NICE Actimize was specifically cited as the ‘Winner’ for its use of artificial intelligence and analytics to spot market abuse, conduct risk and suspicious communications early on, thereby preventing reputational, financial and regulatory risk.

Among NICE Actimize’s solutions underscored by this award win is SURVEIL-X, the industry’s first AI-powered, cloud-native, true holistic trade-related surveillance suite. SURVEIL-X accurately and efficiently detects virtually all forms of risky behavior to ensure compliance with key global regulations while protecting financial services organizations from previously undetectable risks that could result in fines and reputational damage.

“Today’s regulations continue to create constant change for financial services organizations, elevating the importance of effective compliance monitoring and trade-related surveillance technology,” said Bradley Maclean, Co-founder, Regulation Asia. “For the second consecutive year, our panel of industry experts have recognized the innovations NICE Actimize offers through its holistic trade and communications surveillance solutions, as well as its use of advanced technologies to enhance its portfolio of financial crime compliance solutions. This award also acknowledges NICE Actimize’s work over the past year to keep up with rapidly changing regulatory requirements.”

“We continue our commitment to the Asia Pacific region and thank Regulation Asia’s expert panel of judges for once again recognizing our innovation in trade and communications surveillance,” said Chris Wooten, EVP, NICE. “NICE Actimize’s end-to-end surveillance suite is a clear leader when it comes to solving today’s increasingly complex challenges. We continue to infuse SURVEIL-X with machine learning and other advanced technologies to support our clients as they meet growing regulatory demands and the need to increase operational efficiency.”

To view a video discussing NICE Actimize’s win in its category, please click here.

For further information on the Regulation Asia Awards, please click here.

About the Regulation Asia Awards for Excellence

The Regulation Asia Awards for Excellence recognizes technology companies, legal and consulting firms, and exchanges that have shaped the regulatory landscape in Asia Pacific, as well as outstanding technology projects both in mature and emerging markets by large tech firms and innovative startups that help meet the requirements of a specific regulatory change infrastructure.

About Regulation Asia

Regulation Asia is the leading source for actionable regulatory intelligence for Asia Pacific markets. Since 2013, our audience and subscription base have grown to include regulatory bodies, exchanges, banks, asset managers and service providers, allowing us to play a key role in the regulatory agenda. Visit www.regulationasia.com or connect via LinkedIn or Twitter.

About NICE Actimize

NICE Actimize is the largest and broadest provider of financial crime, risk and compliance solutions for regional and global financial institutions, as well as government regulators. Consistently ranked as number one in the space, NICE Actimize experts apply innovative technology to protect institutions and safeguard consumers’ and investors’ assets by identifying financial crime, preventing fraud and providing regulatory compliance. The company provides real-time, cross-channel fraud prevention, anti-money laundering detection, and trading surveillance solutions that address such concerns as payment fraud, cybercrime, sanctions monitoring, market abuse, customer due diligence and insider trading. Find us at www.niceactimize.com, @NICE_Actimize or Nasdaq: NICE.

About NICE

NICE (Nasdaq: NICE) is the world’s leading provider of both cloud and on-premises enterprise software solutions that empower organizations to make smarter decisions based on advanced analytics of structured and unstructured data. NICE helps organizations of all sizes deliver better customer service, ensure compliance, combat fraud and safeguard citizens. Over 25,000 organizations in more than 150 countries, including over 85 of the Fortune 100 companies, are using NICE solutions. www.nice.com.

Trademark Note: Actimize, the Actimize logo, NICE and the NICE logo are trademarks or registered trademarks of NICE Ltd. and/or its subsidiaries. All other marks are trademarks of their respective owners. For a full list of NICE’s marks, please see: http://www.nice.com/nice-trademarks.

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, including the statements by Mr. Wooten, are based on the current beliefs, expectations and assumptions of the management of NICE Ltd. (the “Company”). In some cases, such forward-looking statements can be identified by terms such as “believe,” “expect,” “seek,” “may,” “will,” “intend,” “should,” “project,” “anticipate,” “plan,” “estimate,” or similar words. Forward-looking statements are subject to a number of risks and uncertainties that could cause the actual results or performance of the Company to differ materially from those described herein, including but not limited to the impact of changes in economic and business conditions, including as a result of the COVID-19 pandemic; competition; successful execution of the Company’s growth strategy; success and growth of the Company’s cloud Software-as-a-Service business; changes in technology and market requirements; decline in demand for the Company’s products; inability to timely develop and introduce new technologies, products and applications; difficulties or delays in absorbing and integrating acquired operations, products, technologies and personnel; loss of market share; an inability to maintain certain marketing and distribution arrangements; the Company’s dependency on third-party cloud computing platform providers, hosting facilities and service partners;, cyber security attacks or other security breaches against the Company; the effect of newly enacted or modified laws, regulation or standards on the Company and our products and various other factors and uncertainties discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”). For a more detailed description of the risk factors and uncertainties affecting the company, refer to the Company’s reports filed from time to time with the SEC, including the Company’s Annual Report on Form 20-F. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company undertakes no obligation to update or revise them, except as required by law.

Contacts

Press:
Cindy Morgan-Olson +1 551 256 5202, cindy.morgan-olson@niceactimize.com, ET

Investors
Marty Cohen, +1 551 256 5354, ir@nice.com, ET

Yisca Erez +972 9 775 3798, ir@nice.com, CET

Tags #Risk, Analytics, Asia, Communications, Financial, NICE Actimize, Software, Surveillance, Technology, Technology#Risk

Healthcare

Catalent, Inc. reports first quarter fiscal 2021 results

Post author By Michelle Dryden
Post date November 3, 2020
No Comments on Catalent, Inc. reports first quarter fiscal 2021 results

Q1’21 net revenue of $845.7 million increased 27% as-reported, or 26% in constant currency, compared to Q1’20. On an organic basis, constant currency net revenue in Q1’21 grew 20% compared to Q1’20.
Q1’21 Adjusted EBITDA of $174.4 million increased 37% as-reported, or 35% in constant currency, compared to Q1’20.
Q1’21 Biologics segment net revenue of $377.1 million doubled compared to Q1’20.
Net debt leverage of 2.6x as of September 30; more than $1 billion in cash and cash equivalents on-hand at September 30.
Increased guidance reflects revenue growth of 16-22% and adjusted EBITDA growth of 17-26%, compared to previous guidance of revenue growth of 12-16% and adjusted EBITDA growth of 12-19%.

SOMERSET, N.J.–(BUSINESS WIRE)–Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced financial results for the first quarter of fiscal 2021, which ended September 30, 2020.

“Catalent’s strong start to fiscal 2021 was driven by robust growth in our Biologics segment, which doubled its revenue year-over-year and represented 44% of Catalent’s total revenue in the first quarter. Ongoing elevated demand across our drug product, drug substance and cell and gene therapy offerings, as well as new demand related to potential COVID-19 vaccines and treatments, were partially offset by headwinds in our Softgel and Oral Technologies and Oral and Specialty Delivery segments,” said John Chimi in nski, Chair and Chief Executive Officer of Catalent, Inc. He added, “We have accelerated our growth-related capital expenditures to meet the near-term needs of customers and patients, and to position Catalent for long-term value creation.”

First Quarter 2021 Consolidated Results

First quarter 2021 net revenue of $845.7 million increased 27% as reported, or 26% in constant currency, from the $664.7 million reported for the first quarter a year ago. Overall organic growth was 20%.

First quarter 2021 net earnings were $82.4 million. Accounting for the net earnings attributable to preferred shareholders on Catalent’s Series A convertible preferred stock, net earnings attributable to common shareholders were $68.8 million, or $0.42 per basic share, compared to a net loss attributable to common shareholders of $8.0 million, or a loss of $0.05 per basic share, in the first quarter a year ago.

First quarter 2021 EBITDA from operations, as referenced in the GAAP to non-GAAP reconciliation provided later in this release, was $161.8 million, an increase of $71.7 million from $90.1 million in the first quarter a year ago. First quarter 2021 Adjusted EBITDA (see the GAAP to non-GAAP reconciliation provided later in this release) was $174.4 million, or 20.6% of net revenue, compared to $127.1 million, or 19.1% of net revenue, in the first quarter a year ago. This represents an increase of 37.2% as reported, and an increase of 35.5% on a constant-currency basis.

First quarter 2021 Adjusted Net Income (see the GAAP to non-GAAP reconciliation) was $78.1 million, or $0.43 per diluted share, compared to Adjusted Net Income of $40.5 million, or $0.26 per diluted share, in the first quarter a year ago.

First Quarter 2021 Segment Review

Biologics

Net revenue from the Biologics segment was $377.1 million for the first quarter of fiscal 2021, an increase of 100% as reported and 98% in constant currency, compared to the first quarter a year ago. Segment EBITDA in the first quarter of fiscal 2021 was $106.5 million, an increase of 197% as reported and 194% in constant currency compared to the first quarter a year ago. Segment EBITDA margin was 28.2% in the first quarter of fiscal 2021 compared to 19.0% in the first quarter of the prior year.

Excluding the effect of acquisitions, net revenue increased 83% and segment EBITDA increased 179% compared to the three months ended September 30, 2019.

The Biologics segment represented 44% of Catalent’s total net revenue in the first quarter of fiscal 2021.

Softgel and Oral Technologies

Net revenue from the Softgel and Oral Technologies segment was $221.1 million for the first quarter of fiscal 2021, a decrease of 16% as reported or 17% in constant currency, compared to the first quarter a year ago. Segment EBITDA was $37.8 million in the first quarter of fiscal 2021, a decrease of 18% as reported, or 20% in constant currency, compared to the first quarter a year ago. Segment EBITDA margin was 17.1% in the first quarter of fiscal 2021 compared to 17.6% in the first quarter of the prior year.

After excluding the impact of the October 2019 divestiture of the segment’s consumer health manufacturing site in Australia, net revenue decreased 12% and segment EBITDA decreased 21% compared to the three months ended September 30, 2019.

The Softgel and Oral Technologies segment represented 26% of Catalent’s total net revenue in the first quarter of fiscal 2021.

Oral and Specialty Delivery

Net revenue from the Oral and Specialty Delivery segment was $158.3 million for the first quarter of fiscal 2021, an increase of 19% as reported and 17% in constant currency, over the first quarter a year ago. Segment EBITDA in the first quarter of fiscal 2021 was $21.4 million, a decrease of 23% as reported, or 26% in constant currency, compared to the first quarter a year ago. Segment EBITDA margin was 13.5% in the first quarter of fiscal 2021 compared to 20.9% in the first quarter of the prior year.

Excluding the effect of acquisitions, net revenue decreased 1% and segment EBITDA decreased 61% compared to the three months ended September 30, 2019.

The Oral and Specialty Delivery segment represented 19% of Catalent’s total net revenue in the first quarter of fiscal 2021.

Clinical Supply Services

Net revenue from the Clinical Supply Services segment was $92.7 million for the first quarter of fiscal 2021, an increase of 10% as reported and 8% in constant currency, compared to the first quarter a year ago. Segment EBITDA in the first quarter of fiscal 2021 was $25.0 million, an increase of 16% as reported, or 13% in constant currency, compared to the first quarter a year ago. Segment EBITDA margin was 27.0% in the first quarter of fiscal 2021 compared to 25.5% in the first quarter of the prior year.

The Clinical Supply Services segment represented 11% of Catalent’s total net revenue in the first quarter of fiscal 2021.

Backlog for the Clinical Supply Services segment, defined as estimated future service revenues from work not yet completed under signed contracts, was $428 million as of September 30, 2020, compared to backlog of $425 million as of June 30, 2020 and $374 million as of September 30, 2019. The segment recorded net new business wins of $99 million during the first quarter of fiscal 2021, an increase of 6.4% compared to the net new business wins recorded in the first quarter of the prior year.

Balance Sheet and Liquidity

As of September 30, 2020, Catalent had $3.1 billion in total debt, and $2.1 billion in total debt net of cash and short-term investments, compared to $2.1 billion in total net debt as of June 30, 2020 . The current debt structure does not include any significant maturity until 2026.

Catalent’s net leverage ratio as of September 30, 2020 was 2.6x, compared to 2.8x at June 30, 2020 and 4.3x at September 30, 2019.

Fiscal Year 2021 Outlook

Catalent is raising its previously issued guidance to reflect first quarter performance and to account for higher net underlying demand, including increased demand related to COVID-19 treatments and vaccines, partially offset by lower demand attributed to the effects of the pandemic in some offerings.

The revised guidance continues to assume no major change to either the current status of the COVID-19 pandemic generally or its effect on Catalent’s operations and business. Also, as with the earlier guidance, the revised guidance does not assume the receipt by any of our customers of any marketing approval, on an emergency basis or otherwise, for their COVID-19 vaccine candidates (but does include the projected revenue from take-or-pay arrangements in executed contracts). The guidance ranges set forth below are broader than in recent years due to the increased uncertainty introduced by the COVID-19 pandemic. The revised guidance projects:

Net revenue in the range of $3.58 billion to $3.78 billion, compared to the previous range of $3.45 billion to $3.60 billion;
Adjusted EBITDA in the range of $880 million to $950 million, compared to the previous range of $840 million to $890 million;
Adjusted Net Income in the range of $410 million to $470 million, compared to the previous range of $390 million to $435 million; and
A fully diluted share count in the range of 178 million to 180 million shares on a weighted-average basis, counting the Series A convertible preferred shares as-if converted, unchanged from previous guidance.

Earnings Webcast

About Catalent, Inc.

Catalent, Inc. (NYSE: CTLT), an S&P 500^® company, is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs more than 14,000 people, including approximately 2,400 scientists, at more than 40 facilities across four continents and in fiscal 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, please visit www.catalent.com.

Non-GAAP Financial Measures

Use of EBITDA from operations, Adjusted EBITDA, Adjusted Net Income and Segment EBITDA

Management measures operating performance based on consolidated earnings from operations before interest expense, expense/(benefit) for income taxes, and depreciation and amortization, adjusted for the income or loss attributable to non-controlling interests (“EBITDA from operations”). EBITDA from operations is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP, and is subject to important limitations.

Catalent evaluates the performance of its segments based on segment earnings before non-controlling interest, other (income)/expense, impairments, restructuring costs, interest expense, income tax expense/(benefit), and depreciation and amortization (“segment EBITDA”). Moreover, under Catalent’s credit agreement, its ability to engage in certain activities, such as incurring certain additional indebtedness, making certain investments and paying certain dividends, is tied to ratios based on Adjusted EBITDA, which is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP, and is subject to important limitations. Adjusted EBITDA is the covenant compliance measure used in the credit agreement governing debt incurrence and restricted payments. Because not all companies use identical calculations, Catalent’s presentation of Adjusted EBITDA may not be comparable to other similarly titled measures of other companies.

Management also measures operating performance based on Adjusted Net Income/(Loss) and Adjusted Net Income/(Loss) per share. Adjusted Net Income/(Loss) is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP and is subject to important limitations. Catalent believes that the presentation of Adjusted Net Income/(Loss) and Adjusted Net Income/(Loss) per share enhances an investor’s understanding of its financial performance. Catalent believes these measures are a useful financial metric to assess its operating performance across periods by excluding certain items that it believes are not representative of its core business and Catalent uses these measures for business planning purposes. Catalent defines Adjusted Net Income/(Loss) as net earnings/(loss) adjusted for amortization attributable to purchase accounting and adjustments for other cash and non-cash items included in the table below, partially offset by its estimate of the tax effects of such cash and non-cash items. Catalent believes that Adjusted Net Income/(Loss) and Adjusted Net Income/(Loss) per share provides investors with a useful tool for assessing the comparability between periods of its ability to generate cash from operations available to its stockholders. Catalent’s definition of Adjusted Net Income/(Loss) may not be the same as similarly titled measures used by other companies.

The most directly comparable U.S. GAAP measure to EBITDA from operations is operating earnings/(loss). The most directly comparable U.S. GAAP measure to Adjusted EBITDA and Adjusted Net Income/(Loss) is net earnings/(loss). Included in this release is a reconciliation of operating earnings/(loss) to EBITDA from operations and a reconciliation of net earnings/(loss) to Adjusted EBITDA and Adjusted Net Income.

Use of Constant Currency

Forward-Looking Statements

More products. Better treatments. Reliably supplied.™

Catalent, Inc. and Subsidiaries Consolidated Statements of Operations (Unaudited; dollars and shares in millions, except per share data)
	Three Months Ended September 30,				FX Impact		Constant Currency Increase/(Decrease)
	2020		2019				Change $		Change %
Net revenue	$	845.7	$	664.7	$	9.7	$	171.3	26	%
Cost of sales	596.8		487.0		5.8		104.0		21	%
Gross margin	248.9		177.7		3.9		67.3		38	%
Selling, general, and administrative expenses	164.7		142.8		0.9		21.0		15	%
Impairment charges and (gain)/loss on sale of assets	1.8		(0.2)		—		2.0		(1,000)	%
Restructuring and other	0.9		0.7		0.1		0.1		14	%
Operating earnings	81.5		34.4		2.9		44.2		128	%
Interest expense, net	25.3		36.3		0.2		(11.2)		(31)	%
Other (income)/expense, net	(11.2)		4.9		1.5		(17.6)		(359)	%
Earnings/(loss) before income taxes	67.4		(6.8)		1.2		73.0		(1,074)	%
Income tax expense	(15.0)		(6.9)		(0.1)		(8.0)		116	%
Net earnings	$	82.4	$	0.1	$	1.3	$	81.0	81,000	%
Less: Net earnings attributable to preferred shareholders	(13.6)		(8.1)		—		—		—	%
Net earnings/(loss) attributable to common shareholders	$	68.8	$	(8.0)	$	—	$	—	—	%

Weighted average shares outstanding	164.1		145.7
Weighted average diluted shares outstanding	166.5		145.7

Earnings/(loss) per share:
Basic
Net earnings/(loss)	$	0.42	$	(0.05)
Diluted
Net earnings/(loss)	$	0.41	$	(0.05)

Contacts

Investor Contact:

Catalent, Inc.

Paul Surdez

732-537-6325

investors@catalent.com

Read full story here

Tags #Results, Catalent Inc., Financial, First Quarter, Revenue, Technologies, Technologies#Results

Business

Elmer Bancorp, Inc. announces third quarter 2020 financial results

Post author By Michelle Dryden
Post date October 31, 2020
No Comments on Elmer Bancorp, Inc. announces third quarter 2020 financial results

ELMER, N.J.–(BUSINESS WIRE)–ELMER BANCORP, INC. (“Elmer Bancorp” or the “Company”) (OTC Pink: ELMA), the parent company of The First National Bank of Elmer (the “Bank”), announces its operating results for the three and nine months ended September 30, 2020.

For the three months ended September 30, 2020, Elmer Bancorp reported net income of $183,000, or $0.16 per common share compared to $556,000, or $0.49 per common share for the quarter ended September 30, 2019. For the nine months ended September 30, 2020 net income totaled $1.147 million, or $1.00 per common share compared to $1.486 million, or $1.30 per common share for the nine months ended September 30, 2019.

Net income for both the three and nine-month periods ended September 30, 2020 was significantly impacted by increases in the provision for loan losses. For the three months ended September 30, 2020, provisions for loan losses totaled $335,000 compared to $23,000 for the three months ended September 30, 2019, an increase of $312,000. For the nine-month period ended September 30, 2020, provisions for loan losses totaled $571,000 compared to $198,000 for the nine months ended September 30, 2019, an increase of $373,000. These increases in the loan loss provision were necessary due to the uncertainties in the economy and the ability of businesses to recover from the effects of the coronavirus pandemic. Management continues to remain cautious in the current operating environment by increasing the loan loss provisions and adding to the allowance for losses. As a result, at September 30, 2020, the allowance for loan losses was 1.52% of total core loans (excluding Paycheck Protection Program loans (PPP)) compared to 1.39% of total loans at December 31, 2019.

Net interest income for the three months ended September 30, 2020 totaled $2.716 million, compared to $2.776 million for the three months ended September 30, 2019. For the nine months ended September 30, 2020, net interest income totaled $8.311 million compared to $8.365 million for the nine-month period of 2019. An increase in interest income on loans resulting from core loan growth year-over-year and interest income related to the addition of $32.0 million in SBA PPP loans was more than offset by a reduction in interest income on investments, primarily interest on overnight investments resulting from the significant drop in interest rates in 2020.

Non-interest income for the three months ended September 30, 2020 was $50,000 lower than the same three-month period last year and $62,000 lower than the nine-month period last year. Significant declines in service charges on deposit accounts, primarily overdraft fees and losses on the sale of other real estate were partially offset by an increase in the cash surrender value of Bank Owned Life Insurance (“BOLI”) as the Company increased it’s investment in BOLI year-over-year. In addition, fee income on the placement of mortgages increased year-over-year. Non-interest expenses were higher for both the three and nine months ended September 30, 2020 versus the prior year periods by $112,000 and $19,000, respectively. Higher employment costs, legal and professional services and data processing expenses were partially offset by lower occupancy costs (building maintenance and repairs and snow removal costs) and lower write-downs on other real estate.

Elmer Bancorp’s total assets at September 30, 2020 totaled $326.6 million compared to $285.4 million at September 30, 2019. Total core assets (excluding PPP related assets) totaled $294.9 million, an increase of $9.5 million over September 30, 2019 and $9.1 million higher than December 31, 2019. Loans totaled $289.1 million at September 30, 2020. Total core loans (excluding PPP loans) at September 30, 2020 were $257.4 million, $21.0 million higher than September 30, 2019 and $14.1 million higher than December 31, 2019. The growth in loans was attributable to increases in commercial real estate loans, construction loans and residential mortgage loans.

Deposits saw a significant increase primarily resulting from the PPP loan program and other government stimulus programs. At September 30, 2020, total deposits were $296.8 million, an increase of $39.6 million over the December 31, 2019 total of $257.2 million. Increases in non-interest-bearing demand deposits, money market accounts and savings deposits contributed to the increase in deposit levels.

Stockholders’ equity at September 30, 2020 totaled $28.1 million compared to $26.8 million at December 31, 2019. Book value per share at September 30, 2020 was $24.46 per common share compared to $23.32 at December 31, 2019 and $23.24 at September 30, 2019. The Company and the Bank met all capital requirements at September 30, 2020.

Brian W. Jones, President and Chief Executive Officer, stated, “As we come to the close of another quarter in 2020, we continue to navigate through these economically troubled times by providing continued support for our loyal customer base whether it be through forbearance agreements, assisting in the process of applying for, or the forgiveness of, SBA PPP loans, or by providing new extensions of credit. While our earnings performance for the third quarter and the year-to-date 2020 was significantly impacted by increased loan loss provisions and the lower interest rate environment, we remain a strong institution. We are pleased that we have been able to maintain positive growth trends in both our core loan portfolio and deposit base. In addition, the Board of Directors declared a $0.16 per common share dividend on October 1, 2020, payable on November 2, 2020 to stockholders of record as of the close of business on October 16, 2020. Yet, as the coronavirus pandemic continues, there remains much uncertainty in the months ahead regarding future economic conditions and the overall effect the pandemic will have on the capital of many financial institutions. As we continue to remain cautious, we anticipate future increases in the provision for loan losses to bolster our allowance for possible loan losses related to the COVID-19 pandemic. The continued support of our loyal customer base, stockholders and employees is very much appreciated and we wish you all good health.”

The First National Bank of Elmer, a nationally chartered bank headquartered in Elmer, New Jersey, has a long history of serving the community since its beginnings in 1903. We are a community bank focused on providing deposit and loan products to retail customers and to small and mid-sized businesses from our six full-service branch offices located in Cumberland, Gloucester and Salem Counties, New Jersey, including our main office located at 10 South Main Street in Elmer, New Jersey. Deposits at The First National Bank of Elmer are insured up to the legally maximum amount by the Federal Deposit Insurance Corporation (FDIC).

For more information about Elmer Bank and its products and services, please visit our website at www.elmerbank.com or call toll free 1-877-358-8141.

Forward-Looking Statements

This press release and other statements made from time to time by the Company’s management contain express and implied statements relating to our future financial condition, results of operations, credit quality, corporate objectives, and other financial and business matters, which are considered forward-looking statements. These forward-looking statements are necessarily speculative and speak only as of the date made, and are subject to numerous assumptions, risks and uncertainties, all of which may change over time. Actual results could differ materially from those expected or implied by such forward-looking statements. Risks and uncertainties which could cause our actual results to differ materially and adversely from such forward-looking statements include economic conditions affecting the financial industry: changes in interest rates and shape of the yield curve, credit risk associated with our lending activities, risks relating to our market area, significant real estate collateral and the real estate market, operating, legal and regulatory risk, fiscal and monetary policy, economic, political and competitive forces affecting our business, our ability to identify and address cyber-security risks, and management’s analysis of these risks and factors being incorrect, and/or the strategies developed to address them being unsuccessful. Any statements made that are not historical facts should be considered forward-looking statements. You should not place undue reliance on any forward-looking statements. We undertake no obligation to update forward-looking statements or to make any public announcement when we consider forward-looking statements to no longer be accurate because of new information of future events, except as may be required by applicable law or regulation.

ELMER BANCORP, INC. AND SUBSIDIARIES
SELECTED FINANCIAL DATA
(unaudited)

	Nine Months Ended				Three Months Ended
	9/30/2020		9/30/2019		9/30/2020		6/30/2020		9/30/2019
Statement of Income Data:	(dollars in thousands, except per share data)

Interest income	$	9,019	$	9,193	$	2,941	$	3,075	$	3,030
Interest expense		708		804		225		232		254
Net interest income		8,311		8,389		2,716		2,843		2,776
Provision for loan losses		571		198		335		143		23
Net interest income after provision for loan losses		7,740		8,191		2,381		2,700		2,753
Non-interest income		686		724		220		220		270
Non-interest expense		6,878		6,860		2,368		2,250		2,257
Income before income tax expense		1,548		2,055		233		670		766
Income tax expense		401		569		50		178		210
Net income	$	1,147	$	1,486	$	183	$	492	$	556

Earnings per share:
Basic	$	1.00	$	1.30	$	0.16	$	0.43	$	0.49
Diluted	$	1.00	$	1.30	$	0.16	$	0.43	$	0.49
Weighted average shares outstanding (y-t-d)		1,148,271		1,147,230		1,148,271		1,148,066		1,147,230


Statement of Condition Data (Period End):	9/30/2020		9/30/2019		12/31/2019		6/30/2020
Total investments	$	9,145	$	12,577	$	12,215	$	9,950
Total gross loans	$	289,147	$	236,386	$	243,309	$	283,869
Allowance for loan losses	$	3,922	$	3,432	$	3,391	$	3,589
Total assets	$	326,600	$	285,382	$	285,843	$	326,859
Total deposits	$	296,828	$	257,105	$	257,192	$	296,767
Total stockholders’ equity	$	28,092	$	26,664	$	26,762	$	27,902
Book value per share	$	24.46	$	23.24	$	23.32	$	24.29

Contacts

Matthew A. Swift

Senior Vice President

Chief Financial Officer and

Chief Operating Officer

1-856-358-7000

Tags #PPP, #Results, Elmer Bancorp Inc., Financial, Loans, Paycheck Protection Program, The First National Bank, Third Quarter 2020, Third Quarter 2020#PPP

Business

AdvanSix announces third quarter 2020 financial results

Post author By Michelle Dryden
Post date October 30, 2020
No Comments on AdvanSix announces third quarter 2020 financial results

Strong volume growth, cash flow generation, cost management and capital discipline

Sales of $282 million, down (9%) versus prior year – Volume up 5%, Pass-through pricing (13%)

EPS Loss of ($0.02) – includes $20 million pre-tax income impact of planned plant turnaround

Cash Flow from Operations of $36 million, up $2 million versus prior year

PARSIPPANY, N.J.–(BUSINESS WIRE)–AdvanSix (NYSE: ASIX) today announced its financial results for the third quarter ending September 30, 2020. Overall, the Company generated higher cash flow in the third quarter while mitigating the ongoing impacts of COVID-19 and executing its planned plant turnaround.

Third Quarter 2020 Results

Sales down approximately 9% versus prior year, as 5% higher volume was more than offset by 13% lower raw material pass-through pricing and 1% unfavorable impact of market-based pricing
Net Loss of ($0.7) million, a decrease of $8.6 million versus the prior year
EBITDA of $15.8 million, a decrease of $9.1 million versus the prior year
3Q20 planned plant turnaround successfully completed – approximately $20 million unfavorable pre-tax income impact (compared to approximately $5 million unfavorable impact in 3Q19)
Cash Flow from Operations of $35.5 million, an increase of $2.4 million versus the prior year
Capital Expenditures of $16.0 million, $19.2 million favorable versus the prior year
Free Cash Flow of $19.6 million, an increase of $21.6 million versus the prior year
As of 3Q20, approximately $17 million of cash on hand with approximately $111 million of additional capacity available under the revolving credit facility

“Our diverse product portfolio and global low-cost position continue to serve us well as we navigate through the current environment,” said Erin Kane, president and CEO of AdvanSix. “We have seen nylon volume returning to pre-COVID levels and we continue to optimize our mix across end uses, applications and geographies through the recovery. The performance of the remainder of our portfolio, including ammonium sulfate, acetone and other high-value intermediates, remains resilient complementing ongoing benefits from our focused cost management and high-return capital investments. We generated higher cash flow in the quarter, as anticipated, supported by efficient working capital performance and reduced capital expenditures.”

Summary third quarter 2020 financial results for the Company are included below:

($ in Thousands, Except Earnings Per Share)	3Q 2020	3Q 2019
Sales	$281,910	$310,633
Net Income (Loss)	(692)	7,921
Diluted Earnings (Loss) Per Share	($0.02)	$0.28
EBITDA ⁽¹⁾	15,806	24,949
EBITDA Margin % ⁽¹⁾	5.6%	8.0%
Cash Flow from Operations	35,533	33,173
Free Cash Flow ⁽¹⁾⁽²⁾	19,572	(2,012)
⁽¹⁾See “Non-GAAP Measures” included in this press release for non-GAAP reconciliations ⁽²⁾Net cash provided by operating activities less capital expenditures

Sales of $281.9 million decreased approximately 9% versus the prior year. Raw material pass-through pricing was unfavorable by 13% following a net cost decrease in benzene and propylene (inputs to cumene which is a key feedstock to our products). Market-based pricing was unfavorable by 1% compared to the prior year reflecting challenging end market conditions in our nylon and caprolactam product lines and lower sales prices in ammonium sulfate, partially offset by improved industry dynamics in chemical intermediates, particularly acetone. Sales volume in the quarter increased 5% driven by increases in nylon and higher domestic granular ammonium sulfate sales.

Sales by product line represented the following approximate percentage of our total sales:

	3Q 2020	3Q 2019
Nylon	26%	25%
Caprolactam	18%	26%
Ammonium Sulfate Fertilizers	22%	20%
Chemical Intermediates	34%	29%

EBITDA of $15.8 million in the quarter decreased $9.1 million versus the prior year primarily due to the unfavorable impact of planned plant turnarounds, unfavorable sales mix and lower market-based pricing, partially offset by productivity and disciplined cost management, and the favorable impact of lower raw material costs including natural gas and sulfur.

Earnings per share decreased $0.30 versus the prior year to a loss of ($0.02) in the quarter driven by the factors discussed above.

Cash flow from operations of $35.5 million in the quarter increased $2.4 million versus the prior year primarily due to the favorable impact of changes in working capital, partially offset by lower net income. Capital expenditures of $16.0 million in the quarter decreased $19.2 million versus the prior year following the completion of several high-return growth and cost savings investments.

COVID-19 Response Summary

As previously discussed, the U.S. Department of Homeland Security designated our industry as “essential critical infrastructure” during the response to COVID-19 for both public health and safety as well as community well-being. During the third quarter, we continued to execute our business continuity and mitigation plans with a focus on health and safety including, among other actions, on-site medical personnel to actively monitor employees and contractors, thermal screening, social distancing measures, telecommuting, upgraded personal protective equipment, face coverings at all facilities, and exposure management protocols.

Outlook

Targeting strong caprolactam plant utilization and optimizing nylon mix across end uses, applications and geographies
Expect stable ammonium sulfate fertilizer environment to continue through 2020/2021 planting season
Expect favorable acetone industry supply and demand balance to continue
Continued disciplined cost management – expect $20 to $25 million full year 2020 cost reduction
Capital Expenditures expected to be approximately $85 million in 2020 (down approximately $65 million versus 2019); Expect Capital Expenditures to be $80 to $90 million in 2021
Expect a reduction in net debt and leverage levels in 4Q20 with robust cash generation supported by working capital improvements and cash tax benefits associated with the CARES Act
Expect pre-tax income impact of planned plant turnarounds to be $25 to $30 million in 2021 (versus approximately $32 million in 2020)

“During this dynamic time, we continue to strengthen our ability to deliver long-term shareholder return. We are focused on executing for the remainder of 2020 and driving best possible outcomes for the business. Looking ahead to 2021, our priorities are focused on continued operational excellence and improving through-cycle profitability, enhancing our portfolio resiliency through differentiated product growth and mix optimization, and being strong and disciplined stewards of capital,” added Kane.

Conference Call Information

AdvanSix will discuss its results during its investor conference call today starting at 9:00 a.m. ET. To participate on the conference call, dial (844) 855-9494 (domestic) or (412) 858-4602 (international) approximately 10 minutes before the 9:00 a.m. ET start, and tell the operator that you are dialing in for AdvanSix’s third quarter 2020 earnings call. The live webcast of the investor call as well as related presentation materials can be accessed at http://investors.advansix.com. Investors can hear a replay of the conference call from 12 noon ET on October 30 until 12 noon ET on November 6 by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international). The access code is 10148290.

About AdvanSix

AdvanSix is a leading manufacturer of Nylon 6, a polymer resin which is a synthetic material used by our customers to produce fibers, filaments, engineered plastics and films that, in turn, are used in such end-products as carpets, automotive and electronic components, sports apparel, food packaging and other industrial applications. As a result of our backward integration and the configuration of our manufacturing facilities, we also sell caprolactam, ammonium sulfate fertilizer, acetone and other intermediate chemicals, all of which are produced within unit operations across our integrated manufacturing value chain. More information on AdvanSix can be found at http://www.advansix.com.

Forward Looking Statements

This release contains certain statements that may be deemed “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, that address activities, events or developments that our management intends, expects, projects, believes or anticipates will or may occur in the future are forward-looking statements. Forward-looking statements may be identified by words such as “expect,” “anticipate,” “estimate,” “outlook,” “project,” “strategy,” “intend,” “plan,” “target,” “goal,” “may,” “will,” “should” and “believe” and other variations or similar terminology and expressions. Although we believe forward-looking statements are based upon reasonable assumptions, such statements involve known and unknown risks, uncertainties and other factors, many of which are beyond our control and difficult to predict, which may cause the actual results or performance of the Company to be materially different from any future results or performance expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: general economic and financial conditions in the U.S. and globally, including the impact of the coronavirus (COVID-19) pandemic and any resurgences; the scope and duration of the pandemic and pace of recovery; the timing of the development and distribution of an effective vaccine or treatment for COVID-19; governmental, business and individuals’ actions in response to the pandemic, including our business continuity and cash optimization plans that have been, and may in the future be, implemented; the impact of social and economic restrictions and other containment measures taken to combat virus transmission; the effect on our customers’ demand for our products and our suppliers’ ability to manufacture and deliver our raw materials, including implications of reduced refinery utilization in the U.S.; our ability to sell and provide our goods and services, including as a result of travel and other COVID-19-related restrictions; the ability of our customers to pay for our products; and any closures of our and our customers’ offices and facilities; risks associated with increased phishing, compromised business emails and other cybersecurity attacks and disruptions to our technology infrastructure; risks associated with employees working remotely or operating with a reduced workforce; risks associated with our indebtedness including compliance with financial and restrictive covenants, and our ability to access capital on reasonable terms, at a reasonable cost or at all due to economic conditions resulting from COVID-19 or otherwise; the impact of scheduled turnarounds and significant unplanned downtime and interruptions of production or logistics operations as a result of mechanical issues or other unanticipated events such as fires, severe weather conditions, natural disasters and pandemics including the COVID-19 pandemic; price fluctuations, cost increases and supply of raw materials; our operations and growth projects requiring substantial capital; growth rates and cyclicality of the industries we serve including global changes in supply and demand; failure to develop and commercialize new products or technologies; loss of significant customer relationships; adverse trade and tax policies; extensive environmental, health and safety laws that apply to our operations; hazards associated with chemical manufacturing, storage and transportation; litigation associated with chemical manufacturing and our business operations generally; inability to acquire and integrate businesses, assets, products or technologies; protection of our intellectual property and proprietary information; prolonged work stoppages as a result of labor difficulties or otherwise; cybersecurity, data privacy incidents and disruptions to our technology infrastructure; failure to maintain effective internal controls; disruptions in transportation and logistics; our inability to achieve some or all of the anticipated benefits of our spin-off including uncertainty regarding qualification for expected tax treatment; fluctuations in our stock price; and changes in laws or regulations applicable to our business. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Such forward-looking statements are not guarantees of future performance, and actual results, developments and business decisions may differ from those envisaged by such forward-looking statements. We identify the principal risks and uncertainties that affect our performance in our filings with the Securities and Exchange Commission (SEC), including the risk factors in Part 1, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, as updated in subsequent reports filed with the SEC.

Non-GAAP Financial Measures

This press release includes certain non-GAAP financial measures intended to supplement, not to act as substitutes for, comparable GAAP measures. Reconciliations of non-GAAP financial measures to GAAP financial measures are provided in this press release. Investors are urged to consider carefully the comparable GAAP measures and the reconciliations to those measures provided. Non-GAAP measures in this press release may be calculated in a way that is not comparable to similarly-titled measures reported by other companies.

AdvanSix Inc. Condensed Consolidated Balance Sheets (Unaudited) (Dollars in thousands, except share and per share amounts)
	September 30, 2020		December 31, 2019
ASSETS
Current assets:
Cash and cash equivalents	$	16,686	$	7,050
Accounts and other receivables – net	97,101		104,613
Inventories – net	173,873		171,710
Taxes receivable	13,807		2,047
Other current assets	7,096		5,117
Total current assets	308,563		290,537

Property, plant and equipment – net	765,125		755,881
Operating lease right-of-use assets	110,360		135,985
Goodwill	15,005		15,005
Other assets	36,079		38,561
Total assets	$	1,235,132	$	1,235,969

LIABILITIES
Current liabilities:
Accounts payable	$	179,652	$	205,911
Accrued liabilities	35,610		28,114
Operating lease liabilities – short-term	31,724		38,005
Deferred income and customer advances	6,176		19,696
Total current liabilities	253,162		291,726

Deferred income taxes	121,445		110,071
Operating lease liabilities – long-term	79,085		98,347
Line of credit – long-term	313,000		297,000
Postretirement benefit obligations	36,783		32,410
Other liabilities	10,623		5,537
Total liabilities	814,098		835,091

STOCKHOLDERS’ EQUITY
Common stock, par value $0.01; 200,000,000 shares authorized; 31,622,910 shares issued and 28,030,271 outstanding at September 30, 2020; 31,423,898 shares issued and 27,914,777 outstanding at December 31, 2019	316		314
Preferred stock, par value $0.01; 50,000,000 shares authorized and 0 shares issued and outstanding at September 30, 2020 and December 31, 2019	—		—
Treasury stock at par (3,592,639 shares at September 30, 2020; 3,509,121 shares at December 31, 2019)	(36)		(35)
Additional paid-in capital	183,356		180,884
Retained earnings	248,479		229,166
Accumulated other comprehensive loss	(11,081)		(9,451)
Total stockholders’ equity	421,034		400,878
Total liabilities and stockholders’ equity	$	1,235,132	$	1,235,969

AdvanSix Inc. Condensed Consolidated Statements of Operations (Unaudited) (Dollars in thousands, except share and per share amounts)

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Sales	$	281,910	$	310,633	$	817,644	$	970,743

Costs, expenses and other:
Costs of goods sold	265,758		280,123		736,504		850,131
Selling, general and administrative expenses	16,177		19,261		50,827		58,683
Interest expense, net	1,981		1,293		5,827		3,727
Other non-operating expense (income), net	(334)		522		216		1,144
Total costs, expenses and other	283,582		301,199		793,374		913,685

Income (loss) before taxes	(1,672)		9,434		24,270		57,058
Income tax expense (benefit)	(980)		1,513		4,957		13,617
Net income (loss)	$	(692)	$	7,921	$	19,313	$	43,441

Earnings (loss) per common share
Basic	$	(0.02)	$	0.29	$	0.69	$	1.54
Diluted	$	(0.02)	$	0.28	$	0.69	$	1.49

Weighted average common shares outstanding
Basic	28,079,937		27,608,985		28,037,651		28,192,760
Diluted	28,079,937		28,581,451		28,092,712		29,164,024

AdvanSix Inc. Condensed Consolidated Statements of Cash Flows (Unaudited) (Dollars in thousands)
	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Cash flows from operating activities:
Net income (loss)	$	(692)	$	7,921	$	19,313	$	43,441
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization	15,497		14,222		45,061		42,094
Loss on disposal of assets	95		3,066		143		4,967
Deferred income taxes	1,389		(960)		11,895		9,149
Stock based compensation	603		2,001		3,503		7,575
Accretion of deferred financing fees	141		106		412		320
Restructuring charges	—		—		—		12,623
Changes in assets and liabilities:
Accounts and other receivables	(22,385)		16,399		7,445		51,170
Inventories	9,851		(24,245)		(2,163)		(26,739)
Taxes receivable	(3,634)		1,994		(11,760)		(34)
Accounts payable	31,285		17,742		(9,939)		(12,844)
Accrued liabilities	1,840		(2,699)		7,776		(4,470)
Deferred income and customer advances	913		(1,236)		(13,520)		(20,608)
Other assets and liabilities	630		(1,138)		5,920		(6,108)
Net cash provided by operating activities	35,533		33,173		64,086		100,536

Cash flows from investing activities:
Expenditures for property, plant and equipment	(15,961)		(35,185)		(67,563)		(106,386)
Other investing activities	(373)		(918)		(898)		(2,203)
Net cash used for investing activities	(16,334)		(36,103)		(68,461)		(108,589)

Cash flows from financing activities:
Borrowings from line of credit	49,000		106,500		268,500		316,750
Payments of line of credit	(124,000)		(95,500)		(252,500)		(250,750)
Payment of line of credit facility fees	—		—		(425)		—
Principal payments of finance leases	(176)		(2,279)		(534)		(4,656)
Purchase of treasury stock	—		(12,800)		(1,032)		(53,067)
Issuance of common stock	—		—		2		16
Net cash provided by (used for) financing activities	(75,176)		(4,079)		14,011		8,293

Net change in cash and cash equivalents	(55,977)		(7,009)		9,636		240
Cash and cash equivalents at beginning of period	72,663		17,057		7,050		9,808
Cash and cash equivalents at the end of period	$	16,686	$	10,048	$	16,686	$	10,048

Supplemental non-cash investing activities:
Capital expenditures included in accounts payable					$	5,802	$	27,344

AdvanSix Inc. Non-GAAP Measures (Dollars in thousands) Reconciliation of Net Cash Provided by Operating Activities to Free Cash Flow
	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Net cash provided by operating activities	$	35,533	$	33,173	$	64,086	$	100,536
Expenditures for property, plant and equipment	(15,961)		(35,185)		(67,563)		(106,386)
Free cash flow ⁽¹⁾	$	19,572	$	(2,012)	$	(3,477)	$	(5,850)

⁽¹⁾ Free cash flow is a non-GAAP measure defined as Net cash provided by operating activities less Expenditures for property, plant and equipment

The Company believes that this metric is useful to investors and management as a measure to evaluate our ability to generate cash flow from business operations and the impact that this cash flow has on our liquidity.

Reconciliation of Net Income to EBITDA
	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Net income (loss)	$	(692)	$	7,921	$	19,313	$	43,441
Interest expense, net	1,981		1,293		5,827		3,727
Income tax expense (benefit)	(980)		1,513		4,957		13,617
Depreciation and amortization	15,497		14,222		45,061		42,094
EBITDA ⁽²⁾	$	15,806	$	24,949	$	75,158	$	102,879
One-time Pottsville restructuring charges ⁽³⁾	—		—		—		12,623
EBITDA excluding one-time Pottsville restructuring charges	$	15,806	$	24,949	$	75,158	$	115,502

Sales	$	281,910	$	310,633	$	817,644	$	970,743

EBITDA margin ⁽⁴⁾	5.6%		8.0%		9.2%		10.6%

EBITDA margin excluding one-time Pottsville restructuring charges	5.6%		8.0%		9.2%		11.9%

⁽²⁾ EBITDA is a non-GAAP measure defined as Net Income before Interest, Income Taxes, Depreciation and Amortization
⁽³⁾ Prior year one-time Pottsville restructuring charges reflect the closure of the Company’s Pottsville, Pennsylvania films plant
⁽⁴⁾ EBITDA margin is defined as EBITDA divided by Sales

The Company believes the non-GAAP financial measures presented in this release provide meaningful supplemental information as they are used by the Company’s management to evaluate the Company’s operating performance, enhance a reader’s understanding of the financial performance of the Company, and facilitate a better comparison among fiscal periods and performance relative to its competitors, as these non-GAAP measures exclude items that are not considered core to the Company’s operations.

AdvanSix Inc. Appendix (Pre-tax income impact, Dollars in millions) Planned Plant Turnaround Schedule⁽⁵⁾

	1Q	2Q	3Q	4Q	FY
2017	—	~$10	~$4	~$20	~$34
2018	~$2	~$10	~$30	—	~$42
2019	—	~$5	~$5	~$25	~$35
2020E	~$2	~$7	~$20	~$3	~$32
2021E	—	$11-$13	—	$14-$17	$25-$30

⁽⁵⁾ Primarily reflects the impact of fixed cost absorption, maintenance expense, and the purchase of feedstocks which are normally manufactured by the Company.

Contacts

Media
Debra Lewis

(973) 526-1767

debra.lewis@advansix.com

Investors
Adam Kressel

(973) 526-1700

adam.kressel@advansix.com

Tags #AdvanSix, #Results, Fiber, Financial, Material, Synthetic, Third Quarter, Third Quarter#AdvanSix

Healthcare

Merck announces third-quarter 2020 financial results

Post author By Michelle Dryden
Post date October 27, 2020
No Comments on Merck announces third-quarter 2020 financial results

Third-Quarter 2020 Worldwide Sales Were $12.6 Billion, an Increase of 1%; Excluding the Impact from Foreign Exchange, Sales Grew 2%
- KEYTRUDA Sales Grew 21% to $3.7 Billion
- Animal Health Sales Grew 9% to $1.2 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 12%

Third-Quarter 2020 GAAP EPS Was $1.16; Third-Quarter Non-GAAP EPS Was $1.74
Advanced and Expanded Broad Pipeline
- Announced Additional Positive Phase 3 Results for Investigational Pneumococcal Conjugate Vaccine (V114) in Adults
- Presented Phase 3 Data for Investigational Gefapixant in Development for Chronic Cough; Early Data for MK-4830 in Oncology and MK-8507 for HIV
- Expanded Pipeline with Seagen Collaborations in Oncology

Company Advances Research Programs and Clinical Trials for COVID-19-Related Vaccine and Orally Available Antiviral Research Candidates

Company Narrows and Raises 2020 Full-Year Revenue Range to be Between $47.6 Billion and $48.6 Billion, Including a Negative Impact from Foreign Exchange of Approximately 1.5%

Company Narrows and Lowers 2020 Full-Year GAAP EPS Range to be Between $4.55 and $4.65; Narrows and Raises 2020 Full-Year Non-GAAP EPS Range to be Between $5.91 and $6.01, Including a Negative Impact from Foreign Exchange of Approximately 2.5%

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2020.

“We continue to execute on our strategic priorities and remain confident we will achieve solid full-year revenue growth despite the impact of the ongoing COVID-19 pandemic. Demand for our products remains robust, and production, supply and distribution of our medicines, vaccines and animal health products are moving forward with minimal disruption,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “I am confident in our ability to advance our promising pipeline and clinical trials despite the challenging environment, and I believe that our leadership and track record of solid commercial execution will continue to drive long-term growth.”

Financial Summary

	$ in millions, except EPS amounts	Third Quarter
	$ in millions, except EPS amounts	2020	2019	Change	Change Ex- Exchange
	Sales	$12,551	$12,397	1%	2%
	GAAP net income¹	2,941	1,901	55%	59%
	Non-GAAP net income that excludes certain items^1,2*	4,427	3,873	14%	17%
	GAAP EPS	1.16	0.74	57%	62%
	Non-GAAP EPS that excludes certain items²*	1.74	1.51	16%	18%
*Refer to table on page 11.

GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) was $1.16 for the third quarter of 2020. Non-GAAP EPS of $1.74 for the third quarter of 2020 excludes acquisition- and divestiture-related costs, restructuring costs, pretax charges of $1.1 billion related to certain license and collaboration agreements, and certain other items. Year-to-date results can be found in the attached tables.

COVID-19 Research Highlights

Building on the company’s experience with antivirals and vaccines, Merck advanced its multiple scientific programs in an effort to help combat SARS-CoV-2, specifically,

Molnupiravir (formerly known as MK-4482) — an orally available antiviral candidate in development for the treatment of COVID-19 in collaboration with Ridgeback Bio with the initiation of two large pivotal Phase 2/3 trials: a trial anticipated to enroll approximately 1,450 non-hospitalized adult COVID-19 patients (outpatient) and another planned to enroll approximately 1,300 hospitalized adult COVID-19 patients;
V591 — a SARS-CoV-2 vaccine candidate that uses a measles virus vector platform has entered Phase 1 development; and
V590 — a SARS-CoV-2 vaccine candidate in development in collaboration with the International AIDS Vaccine Initiative (IAVI) that uses a recombinant vesicular stomatitis virus (rVSV) platform, the same platform used for Merck’s approved Ebola Zaire virus vaccine, will enter Phase 1 development shortly.

Oncology Pipeline Highlights

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

Merck announced the following regulatory milestones for KEYTRUDA:
- Approval in the United States by the Food and Drug Administration (FDA) of an expanded indication as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) based on the Phase 3 KEYNOTE-204 trial and an updated pediatric indication for the treatment of pediatric patients with refractory cHL or cHL that has relapsed after two or more lines of therapy, both of which were previously approved under the FDA’s accelerated approval process; and
- Two approvals in Japan: (1) as monotherapy 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 based on the KEYNOTE-181 trial; and (2) 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.
Merck presented results from the pivotal Phase 3 KEYNOTE-590 trial for the first-line treatment of patients with locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. In the study, KEYTRUDA in combination with platinum-based chemotherapy (cisplatin plus 5-fluorouracil [5-FU]) significantly improved overall survival (OS) and progression-free survival (PFS) versus chemotherapy regardless of histology or PD-L1 expression status.
Merck presented five-year survival results from the pivotal Phase 3 KEYNOTE-024 trial at the ESMO Virtual Congress 2020, which demonstrated a sustained, long-term survival benefit and durable responses with KEYTRUDA versus chemotherapy as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] ≥50%) with no EGFR or ALK genomic tumor aberrations. Results from KEYNOTE-024 represent the longest follow-up survival data for an immunotherapy in a randomized Phase 3 study for the first-line treatment of metastatic NSCLC.
Merck presented long-term findings from the EORTC1325/KEYNOTE-054 trial evaluating KEYTRUDA as adjuvant therapy in resected, high-risk stage III melanoma at the ESMO Virtual Congress 2020.
Merck presented three-year survival data from the KEYNOTE-021 (Cohort G) study that evaluated KEYTRUDA in combination with chemotherapy in patients with advanced nonsquamous NSCLC regardless of PD‑L1 expression with no EGFR or ALK genomic tumor aberrations at the IASLC 2020 North America Conference on Lung Cancer (NACLC). Updated follow-up data from a Phase 1/2 study of quavonlimab (MK-1308), a novel investigational anti-CTLA-4 antibody, in combination with KEYTRUDA in patients with advanced NSCLC also was presented; a Phase 3 study of quavonlimab coformulated with KEYTRUDA in first-line advanced NSCLC is planned.
Merck and AstraZeneca announced the adoption of two positive opinions by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Lynparza:
- As a first-line maintenance treatment with bevacizumab for homologous recombination deficient (HRD)-positive advanced ovarian cancer who are in complete or partial response following completion of first-line platinum-based chemotherapy in combination with bevacizumab based on the Phase 3 PAOLA-1 trial, and
- As monotherapy for the treatment of BRCA1/2 metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed following a prior therapy that included a new hormonal agent based on the Phase 3 PROfound trial. Final results from this study were recently presented at the ESMO Virtual Congress 2020.
Merck and AstraZeneca presented positive five-year follow-up data from the Phase 3 SOLO-1 trial, which demonstrated a long-term PFS benefit of Lynparza versus placebo as a first-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated (BRCAm) ovarian cancer who were in complete or partial response to platinum-based chemotherapy.
Merck and Eisai presented first-time data from two studies evaluating KEYTRUDA plus Lenvima at the ESMO Virtual Congress 2020: data from the Phase 2 LEAP-004 study for the second-line treatment of patients with unresectable or advanced melanoma who progressed on anti-PD-1/PD-L1 therapy and from the Phase 2 LEAP-005 study in previously-treated patients with six tumor types, including biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma multiforme, ovarian cancer and triple-negative breast cancer.
Merck also presented new data for three investigational medicines from its oncology pipeline at the ESMO Virtual Congress 2020:
- New Phase 1 data for the company’s anti-TIGIT therapy vibostolimab (MK-7684) as monotherapy and in combination with KEYTRUDA in patients with metastatic NSCLC,
- First-time Phase 1 results for the novel anti-immunoglobulin-like transcript 4 (ILT4) therapy MK-4830 in patients with advanced solid tumors, and
- New Phase 2 data evaluating the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482 in von Hippel-Lindau (VHL) patients with non-renal cell carcinoma (RCC) tumors and updated data in VHL patients with clear cell RCC.

Other Pipeline Highlights

Merck announced that two Phase 3 adult studies [the pivotal PNEU-AGE trial (V114-019) as well as the PNEU-TRUE trial (V114-020)] and separately two other Phase 3 adult studies [the PNEU-PATH (V114-016) and PNEU-DAY (V114-017) trials], evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, each met their primary immunogenicity objectives. These findings, and additional Phase 3 data from the clinical program, will form the basis of global regulatory licensure applications beginning with the FDA before the end of the year.
Merck presented results from two pivotal Phase 3 trials (COUGH-1 and COUGH-2) evaluating gefapixant, an investigational, orally administered selective P2X3 receptor antagonist, in which gefapixant 45 mg twice daily demonstrated a statistically significant reduction in 24-hour cough frequency compared to placebo at Week 12 and 24 in adult patients with refractory or unexplained chronic cough. The gefapixant 15 mg twice daily treatment arms did not meet the primary efficacy endpoint in either Phase 3 study. The results were presented at the Virtual European Respiratory Society (ERS) International Congress 2020.
Merck presented Week 96 data from the Phase 2b trial that showed islatravir, the company’s investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI), in combination with doravirine (PIFELTRO), maintained viral suppression in treatment-naïve adults with HIV-1 infection. Also presented at the virtual 2020 International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2020 Virtual) were results from Phase 1/1b studies for MK-8507, the company’s investigational once-weekly, oral non-nucleoside reverse transcriptase inhibitor (NNRTI), that support further investigation for once-weekly oral administration as part of combination antiretroviral therapy.
The FDA has granted V181, the company’s investigational dengue vaccine in Phase 1 development, Fast Track designation.

Business Developments

Merck and Seagen Inc. (formerly known as Seattle Genetics, Inc.) announced two strategic oncology collaborations, in which Merck will make $810 million of upfront payments in the aggregate as well as acquire a $1 billion equity stake in Seagen common stock:
- Companies to co-develop and co-commercialize Seagen’s ladiratuzumab vedotin, an investigational antibody-drug conjugate targeting LIV-1, globally; and
- Companies enter into exclusive license and co-development agreement to accelerate global reach of Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor for the treatment of HER-2 positive cancers. Merck was granted an exclusive license to commercialize Tukysa in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe.
Merck and Hanmi Pharmaceutical announced that the companies have entered into an exclusive licensing agreement for the development, manufacture and commercialization of efinopegdutide (formerly HM12525A), Hanmi’s investigational once-weekly glucagon-like peptide-1 (GLP-1)/glucagon receptor dual agonist, for the treatment of nonalcoholic steatohepatitis (NASH);
Merck announced the completion of its acquisition of IdentiGEN, a leader in DNA-based animal traceability solutions for livestock and aquaculture; and
Merck announced the completion of its acquisition of the worldwide rights to VECOXAN (diclazuril), an oral suspension for the prevention of coccidiosis in calves and lambs.

Organon & Co.

Merck continued to make progress on the Organon & Co. (Organon) spinoff, including additional leadership appointments, and expects the transaction to be completed in the second quarter of 2021.

Third-Quarter Financial Impact of COVID-19

In the third quarter, the estimated negative impact of the COVID-19 pandemic to Merck’s pharmaceutical revenue was approximately $475 million, bringing the company’s year-to-date negative impact on revenue to approximately $2.1 billion. Lower back-to-school demand negatively impacted vaccine sales, in particular GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in the U.S. In addition, access to health care providers remains reduced, although improved from the second quarter. The negative impact to Animal Health sales in the third quarter was immaterial.

Operating expenses were positively impacted in the third quarter by approximately $115 million, primarily driven by lower promotional and selling costs as well as lower research and development (R&D) expenses, net of investments in COVID-19-related antiviral and vaccine research programs.

Third-Quarter Revenue Performance

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

$ in millions	Third Quarter
	2020	2019	Change	Change Ex- Exchange
Total Sales	$12,551	$12,397	1%	2%
Pharmaceutical	11,320	11,095	2%	2%
KEYTRUDA	3,715	3,070	21%	21%
JANUVIA / JANUMET	1,327	1,311	1%	2%
GARDASIL / GARDASIL 9	1,187	1,320	-10%	-10%
PROQUAD, M-M-R II and VARIVAX	576	623	-8%	-7%
PNEUMOVAX 23	375	237	58%	58%
BRIDION	320	284	13%	13%
ROTATEQ	210	180	16%	17%
SIMPONI	209	203	3%	0%
ISENTRESS / ISENTRESS HD	205	250	-18%	-18%
Lynparza*	196	123	59%	58%
IMPLANON / NEXPLANON	189	199	-5%	-4%
Lenvima*	142	109	30%	29%
Animal Health	1,220	1,122	9%	12%
Livestock	758	726	5%	8%
Companion Animals	462	396	17%	18%
Other Revenues**	11	180	-94%	-33%

*Alliance revenue for these products represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.

**Other revenues are comprised primarily of third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.

Pharmaceutical Revenue

Third-quarter pharmaceutical sales increased by $225 million, or 2%, to $11.3 billion. The increase was driven primarily by growth in oncology and certain hospital acute care products, partially offset by the negative impact of the COVID-19 pandemic and the ongoing impacts of the loss of market exclusivity for several products.

Growth in oncology was largely driven by higher sales of KEYTRUDA, which grew 21% to $3.7 billion in the quarter. In the U.S., sales of KEYTRUDA grew 24% to $2.2 billion. Global sales growth of KEYTRUDA reflects continued strong momentum from the NSCLC indications as well as continued uptake in other indications, including adjuvant melanoma, RCC, bladder, head and neck squamous cell carcinoma (HNSCC) and microsatellite instability-high (MSI-H) cancers as well as uptake following the recent launch of the Q6W dosing regimen in the U.S., partially offset by the negative impacts of the COVID-19 pandemic and pricing in Japan. Also contributing to growth in oncology was higher alliance revenue related to Lynparza and Lenvima reflecting continued uptake in approved indications in the U.S., Europe and China.

Performance in hospital acute care reflects higher demand globally for BRIDION (sugammadex), a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults undergoing surgery and the ongoing launch of PREVYMIS (letermovir), a medicine for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

In addition, sales of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCI) increased slightly in the quarter reflecting strong demand from certain international markets, partially offset by continued pricing pressure in the U.S.

Vaccine sales performance reflects higher sales of PNEUMOVAX 23 (pneumococcal vaccine polyvalent), a vaccine to help prevent pneumococcal disease, primarily driven by higher volumes in the U.S., Europe and Japan attributable in part to increased demand for pneumococcal vaccination during the COVID-19 pandemic.

Vaccine sales were negatively affected by declines in sales of GARDASIL [Human Papillomavirus Quadrivalent (Types 6,11,16 and 18) Vaccine, Recombinant]/GARDASIL 9, vaccines to prevent certain cancers and other diseases caused by HPV, largely due to lower demand in the U.S. and Hong Kong, SAR, PRC attributable to the COVID-19 pandemic, partially offset by higher volumes in China and in Europe.

Combined sales of pediatric vaccines VARIVAX (Varicella Virus Vaccine Live), a vaccine to help prevent chickenpox; PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), a combination vaccine to help protect against measles, mumps, rubella and varicella; and M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live), a vaccine to help prevent measles, mumps and rubella, declined in the third quarter, primarily due to lower demand in the U.S. related to the COVID-19 pandemic.

Pharmaceutical sales in the quarter were negatively affected by the ongoing impacts from the loss of market exclusivity, including for NUVARING (etonogestrel/ethinyl estradiol vaginal ring), NOXAFIL (posaconazole) and EMEND (aprepitant)/EMEND (fosaprepitant dimeglumine) for Injection.

Animal Health Revenue

Animal Health sales totaled $1.2 billion in the third quarter of 2020, an increase of 9% compared with the third quarter of 2019; excluding the unfavorable effect from foreign exchange, Animal Health sales grew 12%. Growth in companion animal products was driven largely by higher demand in companion animal vaccines and higher demand for the BRAVECTO (fluralaner) line of products for parasitic control. Performance in livestock products reflects higher demand globally for ruminant, poultry and swine products.

Third-Quarter Expense, EPS and Related Information

The tables below present selected expense information.

$ in millions Third-Quarter 2020	GAAP	Acquisition- and Divestiture- Related Costs³	Restructuring Costs	Certain Other Items	Non-GAAP²
Cost of sales	$3,481	$285	$38	$−	$3,158
Selling, general and administrative	2,450	207	15	−	2,228
Research and development	3,390	16	19	1,082	2,273
Restructuring costs	114	−	114	−	−
Other (income) expense, net	(312)	−	−	(1)	(311)
Third-Quarter 2019
Cost of sales	$3,990	$941	$62	$−	$2,987
Selling, general and administrative	2,589	22	1	−	2,566
Research and development	3,204	6	1	982	2,215
Restructuring costs	232	−	232	−	−
Other (income) expense, net	35	6	–	−	29

GAAP Expense, EPS and Related Information

Gross margin was 72.3% for the third quarter of 2020 compared to 67.8% for the third quarter of 2019. The increase reflects lower acquisition- and divestiture-related costs and the favorable effect of product mix, partially offset by the unfavorable effects of pricing pressure, inventory write-offs, higher amortization of intangible assets related to collaborations and foreign exchange.

Selling, general and administrative expenses were $2.5 billion in the third quarter of 2020, a decrease of 5% compared to the third quarter of 2019. The decrease primarily reflects lower administrative and selling costs, including less travel and meeting expenses, due in part to the COVID-19 pandemic, partially offset by higher acquisition- and divestiture-related costs, primarily reflecting costs related to the company’s planned spinoff of Organon.

Research and development expenses were $3.4 billion in the third quarter of 2020, an increase of 6% compared with the third quarter of 2019. The increase was primarily driven by higher upfront payments related to collaborations and license agreements, higher expenses related to clinical development and increased investment in discovery research and early drug development, partially offset by lower charges for the acquisitions of businesses, as well as lower laboratory, travel and meeting expenses due to the COVID-19 pandemic.

Other (income) expense, net, was $312 million of income in the third quarter of 2020 compared to $35 million of expense in the third quarter of 2019, primarily due to higher income from investments in equity securities, net, which was $360 million in 2020 compared with $16 million in 2019, largely from the recognition of unrealized gains on securities.

The effective income tax rate was 14.1% for the third quarter of 2020 compared to 18.7% in the third quarter of 2019. The effective income tax rate in 2019 reflects the unfavorable impact of a charge for the acquisition of Peloton Therapeutics, Inc. (Peloton) for which no tax benefit was recognized.

GAAP EPS was $1.16 for the third quarter of 2020 compared with $0.74 for the third quarter of 2019.

Non-GAAP Expense, EPS and Related Information

Non-GAAP gross margin was 74.8% for the third quarter of 2020 compared to 75.9% for the third quarter of 2019. The decrease in non-GAAP gross margin reflects the unfavorable effects of pricing pressure, inventory write-offs, higher amortization of intangible assets related to collaborations and foreign exchange, partially offset by the favorable effect of product mix.

Non-GAAP selling, general and administrative expenses were $2.2 billion in the third quarter of 2020, a decrease of 13% compared to the third quarter of 2019. The decrease primarily reflects lower administrative and selling costs, including less travel and meeting expenses, due in part to the COVID-19 pandemic.

Non-GAAP R&D expenses were $2.3 billion in the third quarter of 2020, a 3% increase compared to the third quarter of 2019. The increase was primarily driven by higher expenses related to clinical development and increased investment in discovery research and early drug development, partially offset by lower laboratory, travel and meeting expenses due to the COVID-19 pandemic.

Contacts

Media:

Pamela Eisele

(267) 305-3558

Patrick Ryan

(201) 452-2409

Investors:

Peter Dannenbaum

(908) 740-1037

Michael DeCarbo

(908) 740-1807

Read full story here

Tags #MRK, #MSD, Financial, Merck, NYSE, Revenue, Third Quarter 2020, Third Quarter 2020#MRK

Business

NRG Energy, Inc. to report Third Quarter 2020 financial results November 5, 2020

Post author By Michelle Dryden
Post date October 17, 2020
No Comments on NRG Energy, Inc. to report Third Quarter 2020 financial results November 5, 2020

PRINCETON, N.J.–(BUSINESS WIRE)–$NRG #earnings–NRG Energy, Inc. (NYSE:NRG) plans to report Third Quarter 2020 financial results on Thursday, November 5, 2020. Management will present the results during a conference call and webcast at 9:00 a.m. Eastern.

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

About NRG Energy

At NRG, we’re bringing the power of energy to people and organizations by putting customers at the center of everything we do. We generate electricity and provide energy solutions and natural gas to more than 3.7 million residential, small business, and commercial and industrial customers through our diverse portfolio of retail brands. A Fortune 500 company, operating in the United States and Canada, NRG delivers innovative solutions while advocating for competitive energy markets and customer choice, and by working towards a sustainable energy future. More information is available at www.nrg.com. Connect with NRG on Facebook, LinkedIn and follow us on Twitter @nrgenergy, @nrginsight.

Contacts

Investors:
Kevin L. Cole, CFA

609.524.4526

investor.relations@nrg.com

Media:
Candice Adams

609.524.5428

candice.adams@nrg.com

Tags #Results, #Webcasts, Financial, Fortune 500, Management, Natural Gas, NRG Energy Inc., Third Quarter 2020, Third Quarter 2020#Results

Business

NICE Actimize announces ENGAGE LIVE, the largest virtual financial crime risk management customer event of the year, focused on the power of always on AI

Over 1000 attendees from leading Global financial services organizations will attend the conference featuring 35+ sessions dedicated to financial crime solutions and services

HOBOKEN, N.J.–(BUSINESS WIRE)–#Engage–Navigating today’s “Always On” environment with zero compromise requires powerful innovation and smart, strategic decisioning. With this in mind, NICE Actimize, a NICE (NASDAQ: NICE) business today announced ENGAGE LIVE, the financial crime industry’s largest virtual customer event of the year. To be held on October 14-15, 2020, this free event will provide unprecedented insights to guide business decisions at the world’s leading financial institutions. Global financial services organizations will attend the event, featuring more than 35 sessions and six tracks dedicated to financial crime solutions and services.

Focused on the “Always On” environment reflected within the rapidly-changing financial crime industry, the event highlights innovation fueled by Digital Acceleration, Cloud Transformation, Always on AI and Actionable Data. Spotlighted at the interactive Solutions Showcase, event attendees can view the latest technologies in action from NICE Actimize and its X-Sight Marketplace partners. The Showcase will also feature strategic partners, including Infosys, a global leader in next-generation digital services and consulting. Online “Pods” will be staffed for live chat and networking opportunities.

Featuring content to suit every role and interest across anti-money laundering, enterprise fraud, financial markets compliance, and case management, this global event offers a wealth of informative sessions, including visionary keynotes from Craig Costigan, NICE Actimize CEO; Chad Hetherington, NICE Actimize VP, Global Head of Product; and Yossi Levin, NICE Actimize VP, Global Head of Engineering.

Danica Patrick, Robert Herjavec Headline Celebrity Keynotes

On October 14, Danica Patrick, former world-renowned racing driver, will also deliver a keynote to kick off the event. As a professional racecar driver, Patrick broke barriers and set records with her impressive on-track performance. Attendees will have the exclusive opportunity to hear her story and unique perspective on how to stay ahead with speed and agility.

And entrepreneur and leading Shark featured on ABC’s Shark Tank, Robert Herjavec, will join ENGAGE LIVE on October 15. Born in Eastern Europe, and escaping Communism with his parents from the former Yugoslavia, Herjavec rose to launch his own computer company from his basement. In 2003, he founded the Herjavec Group, and it quickly became one of America’s fastest growing technology companies. His motivational business advice has received millions of impressions through TV, print, radio and digital media.

Additional guest speakers include Frank McKenna, Chief Fraud Strategist of Point Predictive, and author of the well-known industry blog “FrankonFraud.” McKenna is an advocate for fraud managers and data scientists, who has dedicated his career to fighting fraud across the world. He has worked with over 200 banks, lenders, and finance companies, to solve fraud issues that impact customers.

“Organizations that accelerate digital transformation will become tomorrow’s leaders,” said Craig Costigan, NICE Actimize CEO who will deliver the opening keynote. “Balancing risk and customer experience is an imperative to transitioning successfully. To help our customers perfect that balancing act, we’ve introduced several innovations fuelled by the Power of our ‘Always On’ AI strategy which is built on the solid foundation of our cloud platforms, Xceed and X-Sight, which provide ease and flexibility for organizations of all sizes.”

To register for ENGAGE LIVE, go to our registration link by clicking here.

To view the complete ENGAGE LIVE Agenda, please click here.

Additional NICE Actimize ENGAGE LIVE resources:

On Twitter — Follow @NICE_Actimize and the event hashtag #ENGAGE2020LIVE.
On LinkedIn — Look for company updates at www.linkedin.com/company/actimize.

About NICE Actimize

NICE Actimize is the largest and broadest provider of financial crime, risk and compliance solutions for regional and global financial institutions, as well as government regulators. Consistently ranked as number one in the space, NICE Actimize experts apply innovative technology to protect institutions and safeguard consumers and investors assets by identifying financial crime, preventing fraud and providing regulatory compliance. The company provides real-time, cross-channel fraud prevention, anti-money laundering detection, and trading surveillance solutions that address such concerns as payment fraud, cybercrime, sanctions monitoring, market abuse, customer due diligence and insider trading. Find us at www.niceactimize.com, @NICE_Actimize or Nasdaq: NICE.

About NICE

Trademark Note: NICE and the NICE logo are trademarks or registered trademarks of NICE Ltd. All other marks are trademarks of their respective owners. For a full list of NICE’s marks, please see: www.nice.com/nice-trademarks.

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, including the statements by Mr. Costigan, are based on the current beliefs, expectations and assumptions of the management of NICE Ltd. (the “Company”). In some cases, such forward-looking statements can be identified by terms such as “believe,” “expect,” “seek,” “may,” “will,” “intend,” “should,” “project,” “anticipate,” “plan,” “estimate,” or similar words. Forward-looking statements are subject to a number of risks and uncertainties that could cause the actual results or performance of the Company to differ materially from those described herein, including but not limited to the impact of changes in economic and business conditions, including as a result of the COVID-19 pandemic; competition; successful execution of the Company’s growth strategy; success and growth of the Company’s cloud Software-as-a-Service business; changes in technology and market requirements; decline in demand for the Company’s products; inability to timely develop and introduce new technologies, products and applications; difficulties or delays in absorbing and integrating acquired operations, products, technologies and personnel; loss of market share; an inability to maintain certain marketing and distribution arrangements; the Company’s dependency on third-party cloud computing platform providers, hosting facilities and service partners;, cyber security attacks or other security breaches against the Company; the effect of newly enacted or modified laws, regulation or standards on the Company and our products and various other factors and uncertainties discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”). For a more detailed description of the risk factors and uncertainties affecting the company, refer to the Company’s reports filed from time to time with the SEC, including the Company’s Annual Report on Form 20-F. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company undertakes no obligation to update or revise them, except as required by law.

Contacts

Corporate Media Contact:

Cindy Morgan-Olson, +1-646-408-5896, ET, NICE Actimize, cindy.morgan-olson@niceactimize.com

Investors:

Marty Cohen, +1 551 256 5354, ET, ir@nice.com
Yisca Erez, +972-9-775-3798, CET, ir@nice.com

, , {item content}, October 5, 2020

Tags #Crime, #Engage, #Infosys, #Risk, #Virtual, Cloud, ENGAGE LIVE, Financial, NICE, NICE Actimize, NICE Actimize#Crime

Business

AdvanSix to release third quarter financial results and hold investor conference call on October 30

Post author By Michelle Dryden
Post date September 30, 2020
No Comments on AdvanSix to release third quarter financial results and hold investor conference call on October 30

PARSIPPANY, N.J.–(BUSINESS WIRE)–AdvanSix (NYSE: ASIX) will issue its third quarter 2020 financial results before the opening of the New York Stock Exchange on Friday, October 30. The company will also hold a conference call with investors at 9:00 a.m. ET that day.

Conference Call Details

To participate on the conference call, dial (844) 855-9494 (domestic) or (412) 858-4602 (international) approximately 10 minutes before the 9:00 a.m. ET start, and tell the operator that you are dialing in for AdvanSix’s third quarter 2020 earnings call. A replay of the conference call will be available from 12 noon ET on October 30 until 12 noon ET on November 6. You can listen to the replay by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international). The access code is 10148290.

Presentation Materials / Webcast Details

A real-time audio webcast of the presentation can be accessed at http://investors.advansix.com. Related materials will be posted prior to the presentation at that site, and a replay of the webcast will be available on the AdvanSix investor website for 90 days following the presentation.

About AdvanSix

Contacts

Media
Debra Lewis

(973) 526-1767

debra.lewis@advansix.com

Investors
Adam Kressel

(973) 526-1700

adam.kressel@advansix.com

, , {item content}, September 30, 2020

Tags #AdvanSix, #Results, Conference Call, Financial, Third Quarter, Third Quarter#AdvanSix

Healthcare

Legend Biotech reports second quarter 2020 financial results

Post author By Michelle Dryden
Post date August 29, 2020
No Comments on Legend Biotech reports second quarter 2020 financial results

SOMERSET, N.J.–(BUSINESS WIRE)–Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today reported financial results for the quarter ended June 30, 2020.

“Legend Biotech continues to execute on our corporate strategy, advancing the development of our lead product candidate, ciltacabtagene autoleucel (cilta-cel), in collaboration with Janssen Biotech, Inc. as well as our other pipeline programs,” said Frank Zhang, Ph.D., Chief Executive Officer and Chairman of the Board of Legend Biotech. “We look forward to presenting data from the CARTITUDE-1 study at a major medical conference in the second half of 2020.”

Second Quarter 2020 & Recent Highlights

Collaborative Research and License Agreement with Noile-Immune Biotech. On April 27, 2020, Legend Biotech entered into a collaborative research and license agreement with Noile-Immune Biotech Inc. pursuant to which Legend Biotech obtained a license to develop and commercialize next-generation CAR-T and/or TCR-T cell therapies incorporating Noile-Immune’s PRIME (proliferation-inducing and migration-enhancing) technology for up to two targets for all indications.
Updated Results from Janssen sponsored Phase 1b/2 CARTITUDE-1 study. On May 13, 2020, Legend Biotech announced positive follow up data (median of 11.5 months) from the Phase 1b portion of the CARTITUDE-1 study evaluating cilta-cel¹ (JNJ-4528) in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM).
Appointment of Three New Directors. In May 2020, Dr. Corazon (Corsee) Dating Sanders, Dr. Darren Ji, and Mr. Philip Yau joined Legend Biotech’s Board of Directors.
Successful Initial Public Offering. On June 9, 2020, Legend Biotech successfully completed its initial public offering for total gross proceeds of approximately $487.3 million.
Appointment of Dr. Frank Zhang as CEO. On August 1, 2020, the Board of Directors of Legend Biotech appointed Dr. Frank Zhang to serve as Chief Executive Officer, succeeding Dr. Yuan Xu upon her resignation.
First Breakthrough Therapy Designation from China CDE. On August 5, 2020, Legend Biotech announced that the China Center for Drug Evaluation (“CDE”), National Medical Products Administration recommended Breakthrough Therapy Designation (“BTD”) for cilta-cel for the treatment of adults with relapsed/refractory multiple myeloma. The designation was granted on August 13, 2020, making cilta-cel the first investigational product to obtain BTD in China.

Key Upcoming Milestones

Legend Biotech, in collaboration with Janssen Biotech, Inc., anticipates the presentation of data from the CARTITUDE-1 study at a major medical conference in the second half of 2020.
Janssen Biotech, Inc., Legend Biotech’s collaboration partner, expects to initiate the BLA filing for cilta-cel to the U.S. FDA by the end of 2020 and also expects that a marketing authorization application will be submitted to the European Medicines Agency (“EMA”) in early 2021.
Legend Biotech expects to use the data from CARTIFAN-1 in support of a regulatory submission for approval in China in 2021.
Legend Biotech intends to submit an IND application for LB1901 in relapsed or refractory T cell Lymphoma (“TCL”) in the second half of 2020.

The extent to which the COVID-19 may impact our business and clinical trials is highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak and social distancing regulations, travel restrictions, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

Financial Results for the Quarter Ended June 30, 2020

Cash and Cash Equivalents:

As of June 30, 2020, Legend Biotech had approximately $562.4 million of cash and cash equivalents and approximately $75.6 million in time deposits.

Revenue

Revenue for the three months ended June 30, 2020 was $11.6 million compared to $10.1 million for the three months ended June 30, 2019. This increase of $1.5 million was primarily due to additional milestone payments from Janssen Biotech, Inc. that were achieved in late 2019, which resulted in additional consideration being allocated to steering committee service for the three month ended June 30, 2020. Revenue for the three months ended June 30, 2020 and June 30, 2019 consisted of recognition of upfront and milestone payments allocated to steering committee service pursuant to the license and collaboration agreement with Janssen Biotech, Inc. Legend Biotech has not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended June 30, 2020 were $53.6 million compared to $32.6 million for the three months ended June 30, 2019. This increase of $21.0 million was primarily due to a higher number of clinical trials, a higher number of patients enrolled in those trials and a higher number of research and development product candidates in the three months ended June 30, 2020.

Administrative Expenses

Administrative expenses for the three months ended June 30, 2020 were $4.5 million compared to $1.6 million for the three months ended June 30, 2019. This increase of $2.9 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to aid continued research and development activities.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended June 30, 2020 were $9.6 million compared to $5.0 million for the three months ended June 30, 2019. This increase of $4.6 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel.

Other Income and Gains

Other income and gains for the three months ended June 30, 2020 was $1.3 million compared to $1.2 million for the three months ended June 30, 2019.

Fair Value Loss of Convertible Redeemable Preferred Shares

For the three months ended June 30, 2020, Legend Biotech reported a one-time non-cash charge of $80.0 million caused by changes of fair value of Series A convertible redeemable preferred shares (Series A Preferred Shares). Upon listing on the Nasdaq Global Market, all outstanding Series A Preferred Shares were converted into ordinary shares of Legend Biotech and all accrued but unpaid dividends were settled in the form of ordinary shares of Legend Biotech.

Loss for the Period

For the three months ended June 30, 2020, net loss was $134.9 million, or $0.63 per share, compared to a net loss of $28.8 million, or $0.14 per share, for the three months ended June 30, 2019.

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 700 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture best-in-class cell therapies for patients in need.

We are engaged in a strategic collaboration with Janssen Biotech, Inc. to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; the anticipated timing of, and ability to progress, clinical trials; the ability to make, and the timing of, regulatory submissions in the United States, Europe and Asia, including the BLA filing for cilta-cel to the U.S. FDA, the submission of a marketing authorization application for cilta-cel to the EMA, and the submission of an IND LB1901 in relapsed or refractory TCL; the ability to generate, analyze and present data from clinical trials; patient enrollment; and the potential benefits of our product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the “Risk Factors” section of the prospectus filed with the Securities and Exchange Commission on June 8, 2020. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

LEGEND BIOTECH CORPORATION

UNAUDITED INTERIM CONDENSED

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2020 AND 2019

	Three months ended June 30		Six months ended June 30
(in thousands, US$, except share and per share data)	2020 (unaudited)	2019 (unaudited)	2020 (unaudited)	2019 (unaudited)
(in thousands, US$, except share and per share data)	2020 (unaudited)	2019 (unaudited)	2020 (unaudited)	2019 (unaudited)
REVENUE	11,600	10,087	23,146	20,140
Other income and gains	1,265	1,221	3,796	4,073
Research and development expenses	(53,567)	(32,640)	(101,570)	(53,929)
Administrative expenses	(4,508)	(1,607)	(7,938)	(2,712)
Selling and distribution expenses	(9,557)	(5,030)	(16,102)	(7,786)
Other expenses	(37)	(478)	(82)	(625)
Fair value loss of convertible redeemable preferred shares	(79,984)	—	(79,984)	—
Finance costs	(88)	(19)	(4,079)	(57)


LOSS BEFORE TAX	(134,876)	(28,466)	(182,813)	(40,896)
Income tax (expense)/credit	—	(336)	3,709	(336)
LOSS FOR THE PERIOD	(134,876)	(28,802)	(179,104)	(41,232)
Attributable to:
Equity holders of the parent	(134,876)	(28,802)	(179,104)	(41,232)
LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT
Ordinary shares—basic	(0.63)	(0.14)	(0.86)	(0.21)
Ordinary shares—diluted	(0.63)	(0.14)	(0.86)	(0.21)
Ordinary shares used in loss per share computation:
Ordinary shares—basic	215,551,887	200,000,000	207,775,944	200,000,000
Ordinary shares—diluted	215,551,887	200,000,000	207,775,944	200,000,000

LEGEND BIOTECH CORPORATION

UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION AS AT JUNE 30, 2020 AND DECEMBER 31, 2019

	June 30, 2020 (Unaudited)	December 31, 2019
(in thousands, US$)
NON-CURRENT ASSETS
Property, plant and equipment	88,589	70,079
Advance payments for property, plant and equipment	2,121	665
Right-of-use assets	7,786	9,348
Intangible assets	978	519
Total non-current assets	99,474	80,611
CURRENT ASSETS
Inventories	1,668	1,157
Trade receivables	—	29,991
Prepayments, other receivables and other assets	33,517	16,777
Pledged short-term deposits	256	256
Time deposits	75,559	75,559
Cash and cash equivalents	562,391	83,364
Total current assets	673,391	207,104
Total assets	772,865	287,715
CURRENT LIABILITIES
Trade and notes payables	6,976	9,586
Other payables and accruals	60,429	70,854
Lease liabilities	1,314	1,027
Contract liabilities	46,312	46,294
Total current liabilities	115,031	127,761
NON-CURRENT LIABILITIES
Contract liabilities	254,714	277,765
Lease liabilities	2,119	5,058
Total non-current liabilities	256,833	282,823
Total liabilities	371,864	410,584
EQUITY
Share capital	26	20
Reserves/(deficits)	400,975	(122,889)
Total ordinary shareholders’ equity/(deficit)	401,001	(122,869)
Total equity/(deficit)	401,001	(122,869)
Total liabilities and equity	772,865	287,715

LEGEND BIOTECH CORPORATION

UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2020 AND 2019

	Three months ended June 30		Six months ended June 30
(in thousands, US$)	2020 (Unaudited)	2019 (Unaudited)	2020 (Unaudited)	2019 (Unaudited)
LOSS BEFORE TAX	(134,876)	(28,466)	(182,813)	(40,896)
CASH FLOWS USED IN OPERATING ACTIVITIES	(56,885)	(38,766)	(102,681)	(43,025)
CASH FLOWS USED IN INVESTING ACTIVITIES	(9,212)	(36,031)	(26,711)	(150,909)
CASH FLOWS FROM/(USED IN) FINANCING ACTIVITIES	459,803	(7,177)	608,558	21,500
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS	393,706	(81,974)	479,166	(172,434)
Effect of foreign exchange rate changes, net	(112)	(16)	(139)	(11)
Cash and cash equivalents at beginning of the period	168,797	119,711	83,364	210,166
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD.	562,391	37,721	562,391	37,721
ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS
Cash and bank balances	638,206	149,032	638,206	149,032
Less: Pledged short-term deposits	256	250	256	250
Time deposits	75,559	111,061	75,559	111,061
Cash and cash equivalents as stated in the statement of financial position	562,391	37,721	562,391	37,721
Cash and cash equivalents as stated in the statement of cash flows	562,391	37,721	562,391	37,721

¹tacabtagene autoleucel (cilta-cel) refers to both JNJ-4528 (the identifier for the investigational product being studied outside of China) and LCAR-B38M CAR-T cell (the identifier for the investigational product being studied in China), both of which identify the same CAR-T cell therapy.

Contacts

Media and Investor Relations:

Jessie Yeung, Head of Corporate Finance and Investor

Relations, Legend Biotech jessie.yeung@legendbiotech.com or

investor@legendbiotech.com

Tags #Results, Biopharmaceutical, Clinical, Financial, Global, Healthcare, Legend Biotech, Oncology, Second Quarter, Therapies, Therapies#Results