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Taysha Gene Therapies Receives Rare Pediatric Disease and Orphan Drug Designations for TSHA-103 for the Treatment of Epilepsy Caused by SLC6A1 Haploinsufficiency

Designations provide validation of encouraging preclinical data generated to date

TSHA-103 joins portfolio of rare pediatric disease and orphan drug designated product candidates including TSHA-101 for GM2 gangliosidosis, TSHA-102 for Rett syndrome, TSHA-104 for SURF1-associated Leigh syndrome and TSHA-118 for CLN1

DALLAS–(BUSINESS WIRE)–
Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today announced that it has received both rare pediatric disease and orphan drug designations from the U.S. Food and Drug Administration (FDA) for TSHA-103, an AAV-9-based gene therapy in development for SLC6A1-related epilepsy.

“We are pleased by the FDA’s acknowledgement of the imperative need to develop therapies for such a severe and life-threatening condition,” said RA Session II, President, Founder and CEO of Taysha. “We are encouraged by the early evidence of our gene therapy approach to potentially treat this devastating disease. These designations in now five programs underscore the critical nature of our work and add momentum for these programs. We remain committed to advancing our pipeline of innovative and potentially transformative product candidates as we aim to eradicate monogenic CNS disease.”

SLC6A1 epilepsy is an autosomal dominant genetic disorder characterized by the loss of function of one copy of the SLC6A1 gene, with clinical manifestations of seizures, epilepsy, language impairment and intellectual disability.

“Haploinsufficiency in the SLC6A1 gene has been identified as a cause of genetic epilepsy, yet there remains a lack of approved disease-modifying therapies,” said Steven Gray, Ph.D., Chief Scientific Advisor at Taysha and Associate Professor in the Department of Pediatrics at UT Southwestern. “The designations highlight the innovation of TSHA-103 and the importance of developing a treatment for patients living with this devastating disease.”

“As a mother of a child affected by SLC6A1, Taysha’s dedication to developing a treatment for this community is greatly applauded,” said Amber Freed, Founder of SLC6A1 Connect. “We are delighted that the FDA recognizes the unmet medical need and the role that TSHA-103 may play.”

The FDA grants rare pediatric disease designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the United States. The Rare Pediatric Disease Priority Review Voucher Program is intended to address the challenges that drug companies face when developing treatments for these unique patient populations. Under this program, companies are eligible to receive a priority review voucher following approval of a product with rare pediatric disease designation if the marketing application submitted for the product satisfies certain conditions, including approval prior to December 11, 2022 unless changed by legislation. If issued, a sponsor may redeem a priority review voucher for priority review of a subsequent marketing application for a different product candidate, or the priority review voucher could be sold or transferred to another sponsor.

Orphan drug designation is granted by the FDA Office of Orphan Products Development to investigational treatments that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the United States. The program was developed to encourage the development of medicines for rare diseases, and benefits include tax credits and application fee waivers designed to offset some development costs as well as eligibility for market exclusivity for seven years post approval.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our team’s proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platform—an engine for potential new cures—with a goal of dramatically improving patients’ lives. More information is available at www.tayshagtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates, including TSHA-103, to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential benefits of rare pediatric disease designation and orphan drug designation to our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which is available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201203005269/en/

Company Contact:

Kimberly Lee, D.O.

SVP, Corporate Communications and Investor Relations

Taysha Gene Therapies

[email protected]

Media Contact:

Carolyn Hawley

Canale Communications

[email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Children FDA Baby/Maternity Genetics Other Health Biotechnology General Health Pharmaceutical Consumer Health

MEDIA:

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Donaldson Company Reports First Quarter 2021 Earnings

Total first quarter 2021 sales of replacement parts significantly outperformed new equipment

Operating margin grew 0.5 percentage points from prior year, driven by gross margin

Sales trends improving, with year-over-year growth anticipated in the second half of fiscal 2021

Fiscal 2021 operating margin expected to be up from the prior year, due to higher gross margin

MINNEAPOLIS–(BUSINESS WIRE)–
Donaldson Company, Inc. (NYSE: DCI) today reported first quarter 2021 net earnings of $61.9 million, compared with $65.0 million in 2020. First quarter 2021 earnings per share (EPS)¹ declined 4.4 percent to $0.48 from $0.51 in 2020.

“We are pleased with our first quarter results, which reflect the durability of our business model combined with our ability to gain market share, increase gross margin and manage expenses during an uneven macro-economic environment,” said Tod Carpenter, chairman, president and chief executive officer. “As expected, our sizable base of replacement parts sales mitigated the impact from the pandemic-related cautiousness pressuring our first-fit and new equipment businesses, and newly established customer relationships in China contributed to strong growth in that country.

“For the balance of fiscal 2021, we anticipate overall sales trends will improve, including year-over-year growth in the second half of the year. Our Advance and Accelerate portfolio² continues to outperform the company average, and we plan to drive further investments into those businesses. While we expect the economic environment will remain uncertain, we also feel confident in our plans to grow our profit margin. We expect higher gross margin from further progress on our optimization initiatives, which leverage our recently completed capacity expansion projects. At the same time, we will maintain disciplined control of our discretionary expenses while pursuing continuous improvement opportunities, which we have done throughout our 105-year history. I believe we have a strong foundation for executing our strategic priorities, and I want to thank our valued customers and suppliers for their continued engagement, as well as our global team for their commitment to advancing filtration for a cleaner world.”

1		All earnings per share figures refer to diluted earnings per share.
2		Advance and Accelerate includes Industrial Air Filtration replacement parts, Engine Aftermarket, Venting Solutions, Process Filtration, Semiconductor and Industrial Hydraulics.

Operating Results

First quarter 2021 sales declined 5.4 percent to $636.6 million from $672.7 million in 2020. Currency translation had a favorable impact of approximately 1.0 percent on total sales, reflecting benefits in the Engine Products (“Engine”) and Industrial Products (“Industrial”) segments of approximately 0.7 percent and 2.0 percent, respectively.

		Three Months Ended
		October 31, 2020
		Reported % Change			Constant Currency % Change
Engine Products segment
Off-Road		(5.6	)%		(7.4	)%
On-Road		(21.4	)		(21.9	)
Aftermarket		(0.7	)		(1.2	)
Aerospace and Defense		(26.5	)		(27.5	)
Total Engine Products segment		(5.0	)		(5.7	)
Industrial Products segment
Industrial Filtration Solutions		(9.0	)		(11.3	)
Gas Turbine Systems		11.0			9.9
Special Applications		(4.4	)		(5.5	)
Total Industrial Products segment		(6.1	)		(8.1	)
Total Company		(5.4	)%		(6.4	)%

First quarter 2021 Engine sales declined 5.0 percent, reflecting uneven conditions across markets and geographies. The Aerospace and Defense sales decline was due primarily to commercial aerospace, reflecting industry-wide pressure from the COVID-19 pandemic. The sales decline in the remaining Engine businesses was due primarily to conditions in the Americas where pandemic-related uncertainty contributed to lower levels of equipment production and utilization. Sales in the Asia-Pacific region increased from the prior year, led by China where market share gains and improving economic conditions drove strong sales growth in Donaldson’s On-Road and Off-Road first-fit businesses, and within both Aftermarket channels.

First quarter 2021 Industrial sales declined 6.1 percent, driven primarily by performance of Industrial Filtration Solutions. In most geographies, the COVID-19 pandemic’s impact on industrial production and customers’ willingness to make capital investments is driving lower demand for dust collection products. Conditions are more favorable in China, where sales of dust collection products increased as benefits from market share gains were complemented by recovery from the COVID-19 pandemic. Sales of Process Filtration products to the food and beverage industry are steadier, as lower sales of new equipment were partially offset by higher sales of replacement parts. Gas Turbine Systems benefited from strong replacement parts sales in every major region. Within Special Applications, lower sales of disk drive filters and membrane products were partially offset by strong growth in sales of Integrated Venting Solutions.

First quarter 2021 operating income as a rate of sales increased to 13.7 percent from 13.2 percent in 2020, despite a negative impact of approximately 0.5 percentage points from higher depreciation and amortization expense related to Donaldson’s capacity expansion projects.

First quarter 2021 gross margin increased to 35.0 percent from 34.4 percent in 2020, reflecting lower raw material costs, due in part to the Company’s procurement initiatives, and a favorable mix of sales. These benefits were partially offset by a loss of leverage on lower sales, including an impact from higher depreciation expense related to the Company’s capacity expansion projects. Donaldson reduced its first quarter 2021 operating expense by 5.0 percent from 2020. As a rate of sales, operating expense was 21.3 percent, compared with 21.2 percent in the prior year, reflecting a loss of leverage on lower sales that was almost entirely offset by disciplined expense management and lower expenses following the COVID-19 pandemic.

First quarter 2021 interest expense declined to $3.5 million from $4.7 million in 2020, reflecting interest rate favorability and a lower debt level. Other expense was $1.5 million in first quarter 2021, compared with income of $2.6 million in 2020. The year-over-year change was driven primarily by charges related to Donaldson’s support of its communities and local efforts to combat the pandemic, including a donation of face masks, combined with a pension-related impact. Donaldson’s first quarter 2021 effective income tax rate was 24.7 percent, compared with 24.9 percent in 2020. Donaldson paid first quarter 2021 dividends of $26.6 million and repurchased approximately 0.3 percent of its outstanding shares for $15.6 million.

Fiscal 2021 Expectations

Due to continued uncertainty related to the COVID-19 pandemic, Donaldson is not issuing detailed guidance for full-year 2021 at this time; however, the Company has identified several factors that are expected to impact its full-year 2021 results, including:

• Second quarter sales are expected to be up sequentially from first quarter, with a year-over-year change between a 4 percent decline and a 1 percent increase;
• Sales in the second half of fiscal 2021 are expected to increase as improving economic conditions are complemented by stronger sales in the Advance and Accelerate portfolio;
• Gross margin is expected to increase as year-over-year sales trends improve and benefits from the Company’s optimization initiatives ramp up, while incremental benefits from raw material costs and a favorable mix of sales are expected to be lower;
• The Company plans to keep full-year 2021 operating expense as a rate of sales roughly flat with 2020, with higher incentive compensation and continued investments in strategic priorities largely offset by improving leverage and disciplined expense controls;
• The full-year 2021 effective income tax rate is now expected to be 24 to 26 percent;
• Capital expenditures are still planned meaningfully below fiscal 2020 as projects related to capacity expansion, manufacturing and supply chain optimization projects and Donaldson’s new R&D facility are completed;
• Donaldson expects to repurchase at least 1 percent of its outstanding shares, consistent with its commitment to offset annual dilution from stock-based compensation; and
• Free cash flow conversion is still expected above 100 percent, reflecting strong first quarter conversion and anticipated increases in working capital later in the fiscal year.

Miscellaneous

The Company will webcast its first quarter 2021 earnings conference call today at 9:00 a.m. CST. To listen to the webcast, visit the “Events & Presentations” section of Donaldson’s Investor Relations website (IR.Donaldson.com), and click on the “listen to webcast” option. The webcast replay will be available at approximately 12:00 p.m. CST today.

Statements in this release regarding future events and expectations, such as forecasts, plans, trends and projections relating to the Company’s business and financial performance, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and are identified by words or phrases such as “will likely result,” “are expected to,” “will continue,” “will allow,” “estimate,” “project,” “believe,” “expect,” “anticipate,” “forecast,” “plan,” and similar expressions. These forward-looking statements speak only as of the date such statements are made and are subject to risks and uncertainties that could cause the Company’s results to differ materially from these statements. These factors include, but are not limited to, pandemics and unexpected events, including the Coronavirus (COVID-19) pandemic; economic and industrial conditions worldwide; the Company’s ability to maintain competitive advantages; threats from disruptive innovation; highly competitive markets with pricing pressure; the Company’s ability to protect and enforce its intellectual property; the difficulties in operating globally; customer concentration in certain cyclical industries; significant demand fluctuations; unavailable raw materials or material cost inflation; inability of operations to meet customer demand; difficulties with information technology systems and security; foreign currency fluctuations; governmental laws and regulations; litigation; changes in tax laws and tax rates; regulations and results of examinations; the Company’s ability to attract and retain qualified personnel; changes in capital and credit markets; execution of the Company’s acquisition, divestiture and other strategic transactions strategy; the possibility of intangible asset impairment; the Company’s ability to manage productivity improvements; unexpected events and business disruptions; the Company’s ability to maintain an effective system of internal control over financial reporting; the United Kingdom’s decision to end its membership in the European Union and other factors included in Part I, Item 1A, “Risk Factors” of the Company’s Annual Report on Form 10-K for the fiscal year ended July 31, 2020. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law. The results presented herein are preliminary, unaudited and subject to revision until the Company files its results with the United States Securities and Exchange Commission on Form 10-Q.

About Donaldson Company

Founded in 1915, Donaldson (NYSE: DCI) is a global leader in technology-led filtration products and solutions, serving a broad range of industries and advanced markets. Our diverse, skilled employees at over 140 locations on six continents partner with customers—from small business owners to the world’s biggest OE brands—to solve complex filtration challenges. Discover how Donaldson is Advancing Filtration for a Cleaner World at www.Donaldson.com.

CONDENSED CONSOLIDATED STATEMENTS OF EARNINGS
(In millions, except per share amounts)
(Unaudited)
		Three Months Ended
		October 31,
		2020			2019				Change
Net sales		$	636.6		$	672.7			(5.4	)%
Cost of sales			413.9			441.4			(6.2	)
Gross profit			222.7			231.3			(3.7	)
Operating expenses			135.5			142.6			(5.0	)
Operating income			87.2			88.7			(1.6	)
Interest expense			3.5			4.7			(24.8	)
Other expense (income), net			1.5			(2.6	)		(154.7	)
Earnings before income taxes			82.2			86.6			(5.0	)
Income taxes			20.3			21.6			(5.8	)
Net earnings		$	61.9		$	65.0			(4.8	)%
Weighted average shares – basic			126.8			126.9			(0.1	)%
Weighted average shares – diluted			128.0			128.6			(0.4	)%
Net earnings per share – basic		$	0.49		$	0.51			(4.7	)%
Net earnings per share – diluted		$	0.48		$	0.51			(4.4	)%
Dividends paid per share		$	0.21		$	0.21			—	%
Note: Amounts may not foot due to rounding.

CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions)
(Unaudited)
		October 31,			July 31,
		2020			2020
Assets
Current assets:
Cash and cash equivalents		$	270.0		$	236.6
Accounts receivable, net			465.1			455.3
Inventories, net			329.5			322.7
Prepaid expenses and other current assets			79.0			82.1
Total current assets			1,143.6			1,096.7
Property, plant and equipment, net			617.1			631.6
Goodwill			315.0			316.8
Other long-term assets			193.7			199.5
Total assets		$	2,269.4		$	2,244.6
Liabilities and shareholders’ equity
Current liabilities:
Short-term borrowings		$	1.0		$	3.8
Current maturities of long-term debt			5.7			5.7
Trade accounts payable			209.4			187.7
Current income taxes			27.5			17.6
Other current liabilities			175.8			192.0
Total current liabilities			419.4			406.8
Long-term debt			576.3			617.4
Other long-term liabilities			210.2			216.6
Total liabilities			1,205.9			1,240.8
Redeemable non-controlling interest			10.9			10.9
Total shareholders’ equity			1,052.6			992.9
Total liabilities & shareholders’ equity		$	2,269.4		$	2,244.6

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited)
		Three Months Ended
		October 31,
		2020				2019
Operating Activities
Net earnings		$	61.9			$	65.0
Adjustments to reconcile net earnings to net cash provided by operating activities:
Depreciation and amortization			23.3				21.2
Deferred income taxes			(2.9	)			3.1
Stock-based compensation expense			6.3				6.6
Other, net			7.3				7.1
Changes in operating assets and liabilities			33.0				(16.9	)
Net cash provided by operating activities			128.9				86.1
Investing Activities
Net expenditures on property, plant and equipment			(18.8	)			(37.1	)
Net cash used in investing activities			(18.8	)			(37.1	)
Financing Activities
Proceeds from long-term debt			—				122.9
Repayments of long-term debt			(40.0	)			(111.1	)
Change in short-term borrowings			(2.8	)			58.2
Purchase of treasury stock			(15.6	)			(65.0	)
Dividends paid			(26.6	)			(26.6	)
Tax withholding for stock compensation transactions			(2.2	)			(4.1	)
Exercise of stock options			8.3				11.0
Net cash used in financing activities			(78.9	)			(14.7	)
Effect of exchange rate changes on cash			2.2				(2.1	)
Increase in cash and cash equivalents			33.4				32.2
Cash and cash equivalents, beginning of period			236.6				177.8
Cash and cash equivalents, end of period		$	270.0			$	210.0

CONSOLIDATED RATE ANALYSIS
(Unaudited)
		Three Months Ended
		October 31,
		2020			2019
Gross margin		35.0	%		34.4	%
Operating expenses rate		21.3	%		21.2	%
Operating income rate (operating margin)		13.7	%		13.2	%
Other expense (income), net rate		0.2	%		(0.4	)%
Depreciation and amortization rate		3.7	%		3.2	%
EBITDA rate		17.1	%		16.7	%
Effective tax rate		24.7	%		24.9	%
Cash conversion ratio		177.7	%		75.4	%
Note: Rate analysis metrics are computed by dividing the applicable amount by net sales, and cash conversion ratio reflects free cash flow divided by net earnings. See the Reconciliation of Non-GAAP Financial Measures schedule for additional information. Amounts may not foot due to rounding.

SEGMENT DETAIL
(In millions)
(Unaudited)
		Three Months Ended October 31,
		2020				2019				Change
NET SALES
Engine Products segment
Off-Road		$	64.8			$	68.6			(5.6	)%
On-Road			32.0				40.7			(21.4	)
Aftermarket			317.0				319.4			(0.7	)
Aerospace and Defense			22.4				30.5			(26.5	)
Total Engine Products segment			436.2				459.2			(5.0	)
Industrial Products segment
Industrial Filtration Solutions			135.6				149.0			(9.0	)
Gas Turbine Systems			23.0				20.7			11.0
Special Applications			41.8				43.8			(4.4	)
Total Industrial Products segment			200.4				213.5			(6.1	)
Total Company		$	636.6			$	672.7			(5.4	)%
EARNINGS BEFORE INCOME TAXES
Engine Products segment		$	60.4			$	62.4			(3.2	)%
Industrial Products segment			27.5				29.5			(6.8	)
Corporate and Unallocated			(5.7	)			(5.3	)		(7.5	)
Total Company		$	82.2			$	86.6			(5.0	)%
EARNINGS BEFORE INCOME TAXES %
Engine Products segment			13.9		%		13.6		%	0.3
Industrial Products segment			13.7		%		13.8		%	(0.1	)
Note: Percentage is calculated by dividing earnings before income taxes by sales. Amounts may not foot due to rounding.

SEGMENT SALES PERCENT CHANGE FROM PRIOR PERIODS BY GEOGRAPHY, AS REPORTED
(Unaudited)
		Three Months Ended October 31, 2020
Engine Products segment		TOTAL			US/CA			EMEA			APAC			LATAM
Off-Road		(5.6	)%		(14.1	)%		(16.4	)%		28.1	%		0.2	%
On-Road		(21.4	)		(28.0	)		(5.0	)		(7.7	)		(38.1	)
Aftermarket		(0.7	)		(9.0	)		7.3			12.0			(3.9	)
Aerospace and Defense		(26.5	)		(11.8	)		(52.3	)		(26.8	)
Total Engine Products segment		(5.0	)		(12.3	)		(3.6	)		12.7			(4.1	)
Industrial Products segment
Industrial Filtration Solutions		(9.0	)		(18.5	)		(2.2	)		0.8			(22.0	)
Gas Turbine Systems		11.0			19.5			(10.0	)		93.1			(21.0	)
Special Applications		(4.4	)		(3.9	)		(4.9	)		(4.0	)		(84.8	)
Total Industrial Products segment		(6.1	)		(13.1	)		(3.4	)		1.3			(23.0	)
Total Company		(5.4	)%		(12.5	)%		(3.5	)%		7.9	%		(6.5	)%

SEGMENT SALES PERCENT CHANGE FROM PRIOR PERIODS BY GEOGRAPHY, CONSTANT CURRENCY
(Unaudited)
		Three Months Ended October 31, 2020
Engine Products segment		TOTAL			US/CA			EMEA			APAC			LATAM
Off-Road		(7.4	)%		(14.1	)%		(21.4	)%		25.8	%		19.5	%
On-Road		(21.9	)		(28.0	)		(8.3	)		(9.2	)		(28.2	)
Aftermarket		(1.2	)		(9.0	)		3.3			9.3			2.8
Aerospace and Defense		(27.5	)		(11.8	)		(55.1	)		(28.3	)
Total Engine Products segment		(5.7	)		(12.3	)		(7.7	)		10.3			3.0
Industrial Products segment
Industrial Filtration Solutions		(11.3	)		(18.5	)		(7.5	)		(1.6	)		(17.5	)
Gas Turbine Systems		9.9			19.5			(11.4	)		87.6			(19.2	)
Special Applications		(5.5	)		(3.9	)		(10.3	)		(4.1	)		(84.8	)
Total Industrial Products segment		(8.1	)		(13.1	)		(8.3	)		0.1			(18.9	)
Total Company		(6.4	)%		(12.5	)%		(7.9	)%		6.0	%		0.2	%
Note: The constant currency presentation, which is a non-GAAP measure, excludes the impact of fluctuations in foreign currency exchange rates. The Company believes providing constant currency information provides valuable supplemental information regarding its results of operations. The Company calculates constant currency percentages by converting its current period local currency financial results using the prior period exchanges rates and compared these adjusted amounts to its prior period reported results. Amounts may not foot due to rounding.

RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(In millions, except per share amounts)
(Unaudited)
		Three Months Ended
		October 31,
		2020				2019
Net cash provided by operating activities		$	128.9			$	86.1
Net capital expenditures			(18.8	)			(37.1	)
Free cash flow		$	110.1			$	49.0
Net earnings		$	61.9			$	65.0
Income taxes			20.3				21.6
Interest expense			3.5				4.7
Depreciation and amortization			23.3				21.2
EBITDA		$	109.0			$	112.5
Note: Although free cash flow and EBITDA are not measures of financial performance under GAAP, the Company believes they are useful in understanding its financial results. Free cash flow is a commonly used measure of a company’s ability to generate cash in excess of its operating needs. EBITDA is a commonly used measure of operating earnings less non-cash expenses. The Company evaluates its results of operations both on an as reported and a constant currency basis. A shortcoming of these financial measures is that they do not reflect the Company’s actual results under GAAP. Management does not intend these items to be considered in isolation or as a substitute for the related GAAP measures. Amounts may not foot due to rounding.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20201203005257/en/

Charley Brady (952) 887-3753

 

KEYWORDS: Minnesota United States North America

INDUSTRY KEYWORDS: Automotive Manufacturing Aftermarket Aerospace Automotive Manufacturing Other Automotive General Automotive Other Manufacturing Performance & Special Interest Off-Road Trucks & SUVs Engineering

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Lantheus Holdings, Inc. Announces Agreement to Sell Its Puerto Rico Radiopharmacy and PET Manufacturing Facility and Enter into Long-Term Supply Agreement

Transaction Extends Relationship with Strategic Partner

NORTH BILLERICA, Mass.–(BUSINESS WIRE)–
Lantheus Holdings, Inc. (NASDAQ: LNTH) (the Company), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced its entry into a stock purchase agreement to sell its Puerto Rico radiopharmacy and positron emission tomography (PET) manufacturing facility (PMF) to PharmaLogic Holdings Corp. (PharmaLogic). As part of the transaction, Lantheus and PharmaLogic will also enter into a long-term supply agreement under which Lantheus will continue to supply PharmaLogic with Lantheus’ products and PharmaLogic will commit to purchase certain products. The transaction is subject to customary closing conditions and is expected to close early in the first quarter of 2021.

The transaction includes both the Lantheus radiopharmacy and PMF businesses located in San Juan, Puerto Rico. The radiopharmacy prepares individual, patient-ready doses of radiopharmaceuticals, and the PMF manufactures the drug product for individual, patient-ready doses of fluorodeoxygluocose (FDG). The long-term supply agreement provides that Lantheus’ nuclear medicine products currently sold through the radiopharmacy will continue to be available in Puerto Rico.

“This transaction extends our strategic relationship with PharmaLogic, the fundamental business of which is dedicated to nuclear medicine and radiopharmaceutical production, simplifies our distribution model in Puerto Rico, and allows us to use the proceeds from the transaction to invest in our core businesses and product pipeline,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. “We look forward to working closely with PharmaLogic to close the transaction and execute a smooth transition for customers, patients, suppliers and employees.”

“This transaction will further expand PharmaLogic’s geographical presence in North America,” said Steve Chilinski, Chief Executive Officer of PharmaLogic. “We are proud to be a customer-centric company committed to providing leading innovations and solutions to North American practitioners, and we are thrilled to partner with Lantheus to continue to provide their robust nuclear medicine portfolio to customers and patients in Puerto Rico.”

The purchase price for the transaction is $18 million in cash, subject to working capital and other customary adjustments. Proceeds from this transaction are intended to be used in the Company’s core businesses and product pipeline.

About Lantheus Holdings, Inc.

Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY^® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite^® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA^® for the treatment of certain rare neuroendocrine tumors; and RELISTOR^® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit www.lantheus.com.

About PharmaLogic

PharmaLogic Holdings Corp is a leading radiopharmacy group with over 40 facilities across North America. In addition to managing PET cyclotron facilities and SPECT nuclear pharmacies distributing diagnostic agents and therapeutics to hospitals and clinics, PharmaLogic provides mobile PET imaging services, as well as supporting the translation of new radiopharmaceuticals from early stage clinical trials through commercialization. For more information, visit www.radiopharmacy.com.

Safe Harbor for Forward-Looking and Cautionary Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “expect,” “intend,” “will” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) conditions to the closing of the sale agreement may not be satisfied; (ii) the transaction may involve unexpected costs, liabilities or delays; (iii) the ability to secure, and the time and process of securing, regulatory approvals and other interactions with regulatory authorities for the transaction; (iv) the anticipated benefits of the transaction and use of proceeds from the transaction may not be fully realized or may take longer to realize than expected; (v) the impact of the COVID-19 pandemic on our business, financial condition and prospects; and (vi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

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Mark Kinarney

Senior Director, Investor Relations

978-671-8842

[email protected]

Melissa Downs

Director, Corporate Communications

646-975-2533

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: General Health Science Health Research

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PureTech Initiates Phase 2 trial of LYT-100 (Deupirfenidone) in Long COVID Respiratory Complications and Related Sequelae

COVID-19 survivors may be at risk for persistent complications, a condition referred to as Long COVID or Long Haul COVID

LYT-100, an anti-fibrotic and anti-inflammatory agent, holds potential for treating inflammation and fibrosis implicated in a range of respiratory conditions, including those associated with COVID-19

BOSTON–(BUSINESS WIRE)–PureTech Health plc (LSE: PRTC, Nasdaq: PRTC) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced the initiation of its global, Phase 2 trial of LYT-100 (deupirfenidone) in Long COVID respiratory complications and related sequelae. LYT-100 is PureTech’s wholly-owned product candidate that is being advanced for the potential treatment of conditions involving inflammation and fibrosis and disorders of lymphatic flow. The initiation follows the completion of a Phase 1 multiple ascending dose and food effect study for LYT-100, which demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201203005177/en/

Fibrosis and inflammation are common mechanisms across several lung diseases, and there is increasing data that respiratory complications of SARS-CoV-2 (COVID-19), including shortness of breath, begin during the acute phase of illness and may persist as lung fibrosis develops. Similar respiratory complications caused by Severe Acute Respiratory Syndrome (SARS) lasted for years in many survivors. According to a research letter published in the Journal of the American Medical Association (JAMA), more than 40 percent of COVID-19 survivors assessed in an Italian study still reported shortness of breath an average of 60 days following symptom onset.¹ These data suggest that a significant percentage of COVID-19 survivors may be at risk for respiratory complications and other sequelae, which is a condition that is now colloquially referred to as “Long COVID.”

“COVID-19 is a global public health crisis with severe and long-lasting effects. Patients around the world have reported persistent suffering, including serious respiratory complications that can last for months after the acute infection resolves, and – even with vaccines – there is great a need for treatment options for Long COVID,” said Toby Maher, M.D., Ph.D., professor of clinical medicine and director of interstitial lung disease at Keck School of Medicine of the University of Southern California and the principal investigator on PureTech’s Long COVID Phase 2 trial. “The anti-fibrotic and anti-inflammatory properties of LYT-100 hold potential for treating a range of respiratory conditions, including the long-lasting health burden associated with post-acute COVID-19. I am encouraged by the data generated with LYT-100 to date, and I am excited to be involved in this trial addressing a critically important public health need in the current COVID-19 pandemic.”

LYT-100 is a deuterated, oral small molecule designed to overcome the challenges associated with pirfenidone, an approved and marketed anti-inflammatory and anti-fibrotic drug. Pirfenidone is currently approved for the treatment of idiopathic pulmonary fibrosis (IPF), but it is associated with significant tolerability issues and dose-limiting toxicities. LYT-100, a new chemical entity, retains the pharmacology of pirfenidone but has a differentiated PK profile, which is designed to enable improved tolerability, less frequent dosing and potentially increased efficacy.

PureTech’s global, randomized, double-blind, placebo-controlled Phase 2 trial is designed to evaluate the efficacy, safety and tolerability of LYT-100 in adults with post-acute COVID-19 respiratory complications. The primary endpoint of the trial will be the six-minute walk test distance. Secondary endpoints, including pharmacokinetics, inflammatory biomarkers, imaging and patient-reported outcomes including dyspnea and the 36-Item Short Form Health Survey, will also be evaluated. The study has initiated in both the United States and Europe, and results are expected in the second half of 2021.

About LYT-100

LYT-100 is PureTech’s most advanced wholly-owned product candidate. A deuterated form of pirfenidone, an approved anti-inflammatory and anti-fibrotic drug, LYT-100 is being advanced for the potential treatment of conditions involving inflammation and fibrosis and disorders of lymphatic flow, including lung dysfunction conditions (e.g., IPF, unclassifiable interstitial lung diseases (uILDs), Long COVID respiratory complications and related sequelae) and lymphedema. PureTech completed a Phase 1 multiple ascending dose and food effect trial evaluating LYT-100 in healthy volunteers and found it to be well-tolerated at all doses tested. PureTech has initiated a Phase 2 trial evaluating LYT-100 as a potential treatment for Long COVID respiratory complications and related sequelae. PureTech also intends to initiate a Phase 2a proof-of-concept study evaluating LYT-100 in patients with breast cancer-related, upper limb secondary lymphedema in Q4 2020. PureTech is also advancing LYT-100 for the treatment of IPF and is planning registration-enabling studies.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTech’s Founded Entities, is comprised of 24 products and product candidates, including two that have received FDA clearance and European marketing authorization. All of the underlying programs and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Company’s unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that are or may be forward-looking statements, including statements that relate to the company’s future prospects, developments, and strategies. The forward looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, our expectations regarding the potential therapeutic benefits of LYT-100, the expected timing of results from our Phase 2 trial of LYT-100, our plans and timing for a Phase 2a proof-of-concept study evaluating LYT-100 in patients with breast cancer-related, upper limb secondary lymphedema and those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

_____________________________

¹ Carfì, A., Bernabei, R., & Landi, F. (2020). Persistent Symptoms in Patients After Acute COVID-19. Jama, 324(6), 603. doi:10.1001/jama.2020.12603

View source version on businesswire.com: https://www.businesswire.com/news/home/20201203005177/en/

Investors

Allison Mead Talbot

+1 617 651 3156

[email protected]

EU media

Ben Atwell, Rob Winder

+44 (0) 20 3727 1000

[email protected]

U.S. media

Adam Silverstein

+1 917 697 9313

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Research FDA Clinical Trials Biotechnology General Health Pharmaceutical Health Science Oncology Other Science

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COVID-19 survivors may be at risk for persistent complications, a condition referred to as Long COVID or Long Haul COVID. Fibrosis and inflammation are common mechanisms across several lung diseases, and there is increasing data that respiratory complications of COVID-19, including shortness of breath, begin during the acute phase of illness and may persist as lung fibrosis develops. PureTech’s wholly-owned product candidate, LYT-100 (deupirfenidone), is an anti-fibrotic and anti-inflammatory agent that holds potential for treating inflammation and fibrosis implicated in a range of respiratory conditions, including those associated with COVID-19. The Company today announced the initiation of its global, Phase 2 trial of LYT-100 in Long COVID respiratory complications and related sequelae. (Graphic: Business Wire)

Old Dominion Freight Line Provides Update for Fourth-Quarter 2020

THOMASVILLE, N.C.–(BUSINESS WIRE)–
Old Dominion Freight Line, Inc. (Nasdaq: ODFL) today reported certain less-than-truckload (“LTL”) operating metrics for November 2020. Revenue per day increased 6.3% as compared to November 2019 due to a 5.2% increase in LTL tons per day and an increase in LTL revenue per hundredweight. The change in LTL tons per day was attributable to a 2.6% increase in LTL weight per shipment and a 2.5% increase in LTL shipments per day. For the quarter-to-date period, LTL revenue per hundredweight and LTL revenue per hundredweight excluding fuel surcharges increased 0.5% and 3.8%, respectively, as compared to the same period last year.

Greg C. Gantt, President and Chief Executive Officer of Old Dominion, commented, “Old Dominion’s revenue results for November include increases in both our volumes and yield. The increase in tonnage reflects the additional demand for our industry-leading service as well as further improvement in the domestic economy. Although there continues to be risk to the economy associated with the pandemic, we are increasing the capacity of our team to prepare for anticipated growth.”

Forward-looking statements in this news release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We caution the reader that such forward-looking statements involve risks and uncertainties that could cause actual events and results to be materially different from those expressed or implied herein, including, but not limited to, the following, many of which will continue to be amplified by the current COVID-19 pandemic: (1) the competitive environment with respect to industry capacity and pricing, including the use of fuel surcharges, which could negatively impact our total overall pricing strategy and our ability to cover our operating expenses; (2) our ability to collect fuel surcharges and the effectiveness of those fuel surcharges in mitigating the impact of fluctuating prices for diesel fuel and other petroleum-based products; (3) the negative impact of any unionization, or the passage of legislation or regulations that could facilitate unionization, of our employees; (4) the challenges associated with executing our growth strategy, including our ability to successfully consummate and integrate any acquisitions; (5) changes in our goals and strategies, which are subject to revision at any time at our discretion; (6) various economic factors such as recessions, downturns in the economy, global uncertainty and instability, changes in international trade policies, changes in U.S. social, political, and regulatory conditions or a disruption of financial markets, which may decrease demand for our services or increase our costs; (7) public health issues, such as the current COVID-19 pandemic, that may negatively affect the economy; (8) changes in relationships with our significant customers; (9) the impact of changes in tax laws, rates, guidance and interpretations, including those related to certain provisions of the Tax Cuts and Jobs Act; (10) increases in driver and maintenance technician compensation or difficulties attracting and retaining qualified drivers and maintenance technicians to meet freight demand; (11) our exposure to claims related to cargo loss and damage, property damage, personal injury, workers’ compensation, group health and group dental, including increased premiums, adverse loss development, increased self-insured retention or deductible levels and claims in excess of insured coverage levels; (12) cost increases associated with employee benefits, including costs associated with employee healthcare plans; (13) the availability and cost of capital for our significant ongoing cash requirements; (14) the availability and cost of new equipment and replacement parts, including regulatory changes and supply constraints that could impact the cost of these assets; (15) decreases in demand for, and the value of, used equipment; (16) the availability and cost of diesel fuel; (17) the costs and potential liabilities related to compliance with, or violations of, existing or future governmental laws and regulations, including environmental laws, engine emissions standards, hours-of-service for our drivers, driver fitness requirements and new safety standards for drivers and equipment; (18) the costs and potential liabilities related to various legal proceedings and claims that have arisen in the ordinary course of our business, some of which include collective and/or class action allegations; (19) the costs and potential liabilities related to governmental proceedings, inquiries, notices or investigations; (20) the costs and potential liabilities related to our international business relationships; (21) the costs and potential adverse impact of compliance with, or violations of, current and future rules issued by the Department of Transportation, the Federal Motor Carrier Safety Administration (the “FMCSA”) and other regulatory agencies; (22) the costs and potential adverse impact of compliance associated with FMCSA’s electronic logging device (“ELD”) regulations and guidance, including the operation of our fleet and safety management systems on the ELD hardware and software platform; (23) seasonal trends in the LTL industry, including harsh weather conditions and disasters; (24) our ability to retain our key employees and continue to effectively execute our succession plan; (25) the concentration of our stock ownership with the Congdon family; (26) the costs and potential adverse impact associated with future changes in accounting standards or practices; (27) potential costs and liabilities associated with cyber incidents and other risks with respect to our systems and networks or those of our third-party service providers, including system failure, security breach, disruption by malware or ransomware or other damage; (28) failure to comply with data privacy, security or other laws and regulations; (29) failure to keep pace with developments in technology, any disruption to our technology infrastructure, or failures of essential services upon which our technology platforms rely, which could cause us to incur costs or result in a loss of business; (30) the costs and potential adverse impact associated with transitional challenges in upgrading or enhancing our technology systems; (31) legal, regulatory or market responses to climate change concerns; (32) damage to our reputation through unfavorable perceptions or publicity, including those related to environmental, social and governance issues, cybersecurity and data privacy concerns; (33) failure to adapt to new technologies implemented by our competitors in the LTL and transportation industry; (34) the costs and potential adverse impact of compliance with anti-terrorism measures on our business; (35) dilution to existing shareholders caused by any issuance of additional equity; (36) the impact of a quarterly cash dividend or the failure to declare future cash dividends; (37) fluctuations in the amount and frequency of our stock repurchases; (38) recent and future volatility in the market value of our common stock; (39) the impact of certain provisions in our articles of incorporation, bylaws, and Virginia law that could discourage, delay or prevent a change in control of us or a change in our management; and (40) other risks and uncertainties described in our most recent Annual Report on Form 10-K and other filings with the SEC. Our forward-looking statements are based upon our beliefs and assumptions using information available at the time the statements are made. We caution the reader not to place undue reliance on our forward-looking statements as (i) these statements are neither a prediction nor a guarantee of future events or circumstances and (ii) the assumptions, beliefs, expectations and projections about future events may differ materially from actual results. We undertake no obligation to publicly update any forward-looking statement to reflect developments occurring after the statement is made, except as otherwise required by law.

Old Dominion Freight Line, Inc. is a leading, less-than-truckload (“LTL”), union-free motor carrier providing regional, inter-regional and national LTL services through a single integrated organization. Our service offerings, which include expedited transportation, are provided through an expansive network of service centers located throughout the continental United States. Through strategic alliances, the Company also provides LTL services throughout North America. In addition to its core LTL services, the Company offers a range of value-added services including container drayage, truckload brokerage and supply chain consulting.

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Adam N. Satterfield

Senior Vice President, Finance and

Chief Financial Officer

(336) 822-5721

KEYWORDS: United States North America North Carolina

INDUSTRY KEYWORDS: Trucking Rail Transport Logistics/Supply Chain Management

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Can-Fite to Present at Benzinga Global Small Cap Conference on December 8, 2020

PETACH TIKVA, Israel–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that the Company’s CEO Dr. Pnina Fishman will present at Benzinga’s inaugural Global SmallCap Conference on Tuesday, December 8, 2020 at 3:00 pm ET on Track 2. Investors interested in viewing Can-Fite’s presentation may register with free access here for the two-day conference which takes place virtually from December 8-9, 2020.

About Benzinga

Benzinga is a leading financial media company dedicated to making information easier to consume. Benzinga’s news desk is constantly breaking stories and moving billions of dollars of market capitalization through its real-time news tool, Benzinga Pro. Benzinga’s original content is syndicated to 70 partner websites including Yahoo! Finance MSN, CNNMoney, Fox Business and MarketWatch.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, inflammatory disease and COVID-19. The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite’s liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and successfully achieved its primary endpoint in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the COVID-19 pandemic; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201203005068/en/

Can-Fite BioPharma

Motti Farbstein

[email protected]

+972-3-9241114

KEYWORDS: New York United States North America Israel Middle East

INDUSTRY KEYWORDS: Professional Services Oncology Health Finance Pharmaceutical Biotechnology

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REX American Resources Reports Fiscal 2020 Third Quarter EPS of $1.44

DAYTON, Ohio–(BUSINESS WIRE)–
REX American Resources Corporation (NYSE: REX) (“REX” or “the Company”) today reported financial results for its fiscal 2020 third quarter (“Q3 ‘20”) ended October 31, 2020. REX management will host a conference call and webcast today at 11:00 a.m. ET.

Conference Call:			212/231-2912
Webcast / Replay URL:			www.rexamerican.com/Corp/Page4.aspx
			The webcast will be available for replay for 30 days.

REX American Resources’ Q3 ‘20 results principally reflect its interests in six ethanol production facilities and its refined coal operation. The One Earth Energy, LLC (“One Earth”) and NuGen Energy, LLC (“NuGen”) ethanol production facilities are consolidated, as is the refined coal entity, while those of its four other ethanol plants are reported as equity in income of unconsolidated ethanol affiliates. The Company reports results for its two business segments as ethanol and by-products, and refined coal.

REX’s Q3 ‘20 net sales and revenue rose 43.4% to $124.3 million, compared with $86.7 million in Q3 ‘19. The year-over-year net sales and revenue increase was primarily due to higher ethanol production levels, which led to a 56.7% increase in ethanol gallons sold and more than offset a small year-over-year decline in the average selling price per gallon of ethanol. Primarily reflecting these factors and an improved crush spread, Q3 ‘20 gross profit for the Company’s ethanol and by-products segment rose to $18.9 million, from $0.03 million in Q3 ‘19. As a result, the ethanol and by-products segment generated a profit before income taxes of $17.0 million in Q3 ‘20, compared to a loss of $2.8 million in Q3 ‘19. The Company’s refined coal operation incurred a $1.3 million gross loss and a $1.3 million loss before income taxes in Q3 ‘20, compared to a $1.8 million gross loss and a loss before income taxes of $1.6 million in Q3 ‘19. REX reported a Q3 ‘20 profit before income taxes and non-controlling interests of $15.1 million, compared with a loss before income taxes and non-controlling interests of $4.9 million in the comparable year ago period. While the refined coal operation negatively impacted gross profit and income before income taxes, it contributed a tax benefit of $1.0 million and $2.2 million for Q3 ‘20 and Q3 ‘19, respectively.

Net income attributable to REX shareholders in Q3 ‘20 was $8.8 million, compared to a net loss of $2.1 million in Q3 ‘19. Q3 ‘20 basic and diluted net income per share attributable to REX common shareholders was $1.44, compared to a net loss per share of $0.32 in Q3 ‘19. Per share results in Q3 ‘20 and Q3 ‘19 are based on 6,143,000 and 6,319,000 diluted weighted average shares outstanding, respectively.

Segment Income Statement Data:

		Three Months Ended						Nine Months Ended
($ in thousands)		October 31,						October 31,
		2020			2019			2020			2019
Net sales and revenue:
Ethanol & By-Products (1)		$	124,217		$	86,603		$	246,694		$	296,826
Refined coal(2) (3)			34			68			134			288
Total net sales and revenue		$	124,251		$	86,671		$	246,828		$	297,114
Gross profit (loss):
Ethanol & By-Products (1)		$	18,929		$	28		$	11,259		$	12,312
Refined coal (2)			(1,250)			(1,786)			(4,241)			(6,420)
Total gross profit (loss)		$	17,679		$	(1,758)		$	7,018		$	5,892
Income (loss) before income taxes:
Ethanol & By-Products (1)		$	17,007		$	(2,822)		$	1,397		$	3,491
Refined coal (2)			(1,270)			(1,648)			(4,235)			(6,351)
Corporate and other			(626)			(434)			(1,873)			(1,146)
Total income (loss) before income taxes		$	15,111		$	(4,904)		$	(4,711)		$	(4,006)
(Provision) benefit for income taxes:
Ethanol & By-Products		$	(5,071)		$	945		$	(17)		$	(160)
Refined coal			985			2,181			4,863			9,282
Corporate and other			34			105			461			279
Total (provision) benefit for income taxes		$	(4,052)		$	3,231		$	5,307		$	9,401
Segment profit (loss):
Ethanol & By-Products		$	9,660		$	(2,330)		$	49		$	684
Refined coal			(227)			607			821			3,209
Corporate and other			(592)			(329)			(1,412)			(868)
Net income (loss) attributable to REX common shareholders		$	8,841		$	(2,052)		$	(542)		$	3,025

(1)		Includes results attributable to non-controlling interests of approximately 25% for One Earth and approximately 1% for NuGen.
(2)		Includes results attributable to non-controlling interests of approximately 5%.
(3)		Refined coal sales are reported net of the cost of coal.

REX American Resources’ Chief Executive Officer, Zafar Rizvi, commented, “The strength of our third quarter results highlight the resiliency and adaptability of our teams and the efficiency of our plants as our two consolidated plants returned to production during the second quarter.

“Reflecting our solid balance sheet and long-term commitment to enhance shareholder value, during the quarter we repurchased 198,173 REX shares and in fiscal 2020 to date, we have returned over $19 million to shareholders through the repurchase of 316,349 shares. We ended the fiscal 2020 third quarter in a strong financial and liquidity position with cash and cash equivalents and short-term investments in excess of $202 million and working capital of $226 million and no bank debt.”

Balance Sheet

At October 31, 2020, REX had cash, cash equivalents and short-term investments of $202.3 million, $42.4 million of which was at the parent company, and $159.9 million of which was at its consolidated production facilities. This compares with cash, cash equivalents and short-term investments at January 31, 2020, of $205.7 million, $62.3 million of which was at the parent company, and $143.4 million of which was at its consolidated ethanol production facilities.

During the fiscal third quarter ended October 31, 2020 the Company repurchased 198,173 shares of its common stock at a cost $13.3 million, and subsequent to the end of the third quarter the Company purchased an additional 9,500 shares. As a result, the Company can repurchase approximately 33,512 additional shares under its current repurchase authorization. Reflecting all purchases to date, REX presently has approximately 5,992,002 shares of common stock outstanding.

The following table summarizes select data related to REX’s

consolidated alternative energy interests:

		Three Months Ended						Nine Months Ended
		October 31,						October 31,
		2020			2019			2020			2019
Average selling price per gallon of ethanol		$	1.31		$	1.39		$	1.28		$	1.34
Average selling price per ton of dried distillers grains		$	129.38		$	134.57		$	136.49		$	137.48
Average selling price per pound of non-food grade corn oil		$	0.24		$	0.26		$	0.25		$	0.25
Average selling price per ton of modified distillers grains		$	56.68		$	56.56		$	52.44		$	59.67
Average cost per bushel of grain		$	3.28		$	4.15		$	3.57		$	3.79
Average cost of natural gas (per MmBtu)		$	2.09		$	2.51		$	2.87		$	2.98

Supplemental data related to REX’s alternative energy interests:

REX American Resources Corporation Ethanol Ownership Interests/Effective Annual Gallons Shipped as of October 31, 2020 (gallons in millions)
Entity	Trailing Twelve Months Gallons Shipped	Current REX Ownership Interest	REX’s Current Effective Ownership of Trailing Twelve Month Gallons Shipped
One Earth Energy, LLC Gibson City, IL	119.5	75.3%	90.0
NuGen Energy, LLC Marion, SD	95.9	99.5%	95.4
Big River Resources West Burlington, LLC West Burlington, IA	103.1	10.3%	10.6
Big River Resources Galva, LLC Galva, IL	113.7	10.3%	11.7
Big River United Energy, LLC Dyersville, IA	117.9	5.7%	6.7
Big River Resources Boyceville, LLC Boyceville, WI	55.2	10.3%	5.7
Total	605.3	n/a	220.1

Third Quarter Conference Call

REX will host a conference call at 11:00 a.m. ET today. Senior management will discuss the quarterly financial results and host a question and answer session. The dial in number for the audio conference call is 212/231-2912 (domestic and international callers).

Participants can also listen to a live webcast of the call on the Company’s website, www.rexamerican.com/Corp/Page4.aspx. A webcast replay will be available for 30 days following the live event at www.rexamerican.com/Corp/Page4.aspx.

About REX American Resources Corporation

REX American Resources has interests in six ethanol production facilities, which in aggregate shipped approximately 605 million gallons of ethanol over the twelve-month period ended October 31, 2020. REX’s effective ownership of the trailing twelve-month gallons shipped (for the twelve months ended October 31, 2020) by the ethanol production facilities in which it has ownership interests was approximately 220 million gallons. In addition, the Company acquired a refined coal operation in August 2017. Further information about REX is available at www.rexamerican.com.

This news announcement contains or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements can be identified by use of forward-looking terminology such as “may,” “expect,” “believe,” “estimate,” “anticipate” or “continue” or the negative thereof or other variations thereon or comparable terminology. Readers are cautioned that there are risks and uncertainties that could cause actual events or results to differ materially from those referred to in such forward-looking statements. These risks and uncertainties include the risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission and include among other things: the effect of pandemics such as COVID-19 on the Company’s business operations, including impacts on supplies, demand, personnel and other factors, the impact of legislative and regulatory changes, the price volatility and availability of corn, distillers grains, ethanol, non-food grade corn oil, gasoline and natural gas, ethanol and refined coal plants operating efficiently and according to forecasts and projections, changes in the international, national or regional economies, weather, results of income tax audits, changes in income tax laws or regulations, the impact of U.S. foreign trade policy, changes in foreign currency exchange rates and the effects of terrorism or acts of war. The Company does not intend to update publicly any forward-looking statements except as required by law.

– statements of operations follow –

REX AMERICAN RESOURCES CORPORATION AND SUBSIDIARIES
Consolidated Statements of Operations
(in thousands, except per share amounts)
Unaudited
		Three Months Ended						Nine Months Ended
		October 31,						October 31,
		2020			2019			2020			2019
Net sales and revenue		$	124,251		$	86,671		$	246,828		$	297,114
Cost of sales			106,572			88,429			239,810			291,222
Gross profit (loss)			17,679			(1,758)			7,018			5,892
Selling, general and administrative expenses			(4,257)			(4,133)			(13,300)			(13,629)
Equity in income (loss) of unconsolidated ethanol affiliates			1,152			(15)			168			350
Interest and other income, net			537			1,002			1,403			3,381
Income (loss) before income taxes and non-controlling interests			15,111			(4,904)			(4,711)			(4,006)
(Provision) benefit for income taxes			(4,052)			3,231			5,307			9,401
Net income (loss) including non-controlling interests			11,059			(1,673)			596			5,395
Net income attributable to non-controlling interests			(2,218)			(379)			(1,138)			(2,370)
Net income (loss) attributable to REX common shareholders		$	8,841		$	(2,052)		$	(542)		$	3,025
Weighted average shares outstanding – basic and diluted			6,143			6,319			6,221			6,318
Basic and diluted net income (loss) per share attributable to REX common shareholders		$	1.44		($	0.32)		($	0.09)		$	0.48

– balance sheets follow –

REX AMERICAN RESOURCES CORPORATION AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands)
Unaudited
		October 31,			January 31,
ASSETS		2020			2020
CURRENT ASSETS:
Cash and cash equivalents		$	173,075		$	179,658
Short-term investments			29,216			26,073
Restricted cash			884			1,113
Accounts receivable			12,496			12,969
Inventory			21,616			35,634
Refundable income taxes			5,947			6,029
Prepaid expenses and other			9,771			9,659
Total current assets			253,005			271,135
Property and equipment-net			154,401			163,327
Operating lease right-of-use assets			14,054			16,173
Deferred taxes			22,297			17,061
Other assets			1,278			342
Equity method investment			30,126			32,464
TOTAL ASSETS		$	475,161		$	500,502
LIABILITIES AND EQUITY
CURRENT LIABILITIES:
Accounts payable – trade		$	15,588		$	18,900
Current operating lease liabilities			5,105			4,935
Accrued expenses and other current liabilities			6,049			7,764
Total current liabilities			26,742			31,599
LONG TERM LIABILITIES:
Deferred taxes			4,138			4,334
Long-term operating lease liabilities			8,548			10,688
Other long-term liabilities			282			275
Total long-term liabilities			12,968			15,297
COMMITMENTS AND CONTINGENCIES
EQUITY:
REX shareholders’ equity:
Common stock, 45,000 shares authorized, 29,853 shares issued at par			299			299
Paid in capital			149,077			148,789
Retained earnings			586,443			586,985
Treasury stock, 23,852 and 23,561 shares, respectively			(353,910)			(335,066)
Total REX shareholders’ equity			381,909			401,007
Non-controlling interests			53,542			52,599
Total equity			435,451			453,606
TOTAL LIABILITIES AND EQUITY		$	475,161		$	500,502

– statements of cash flows follow –

REX AMERICAN RESOURCES CORPORATION AND SUBSIDIARIES
Consolidated Statements of Cash Flows
(in thousands)
Unaudited
		Nine Months Ended
		October 31,
		2020			2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income		$	596		$	5,395
Adjustments to reconcile net income to net cash
provided by (used in) operating activities:
Depreciation			15,697			17,682
Amortization of operating lease right-of-use assets			3,982			4,648
Income from equity method investments			(168)			(350)
Dividends received from equity method investments			2,506			1,003
Interest income from investments			(200)			(25)
Deferred income tax			(5,431)			(9,828)
Stock based compensation expense			122			215
Gain on disposal of property and equipment			(58)			–
Changes in assets and liabilities:
Accounts receivable			473			(5,013)
Inventory			14,018			(12,561)
Refundable income taxes			82			473
Prepaid expenses and other assets			(517)			(583)
Accounts payable-trade			(4,302)			5,618
Other liabilities			(5,301)			(9,010)
Net cash provided by (used in) operating activities			21,499			(2,336)
CASH FLOWS FROM INVESTING ACTIVITIES:
Capital expenditures			(6,610)			(2,643)
Purchases of short-term investments			(68,225)			–
Sales of short-term investments			65,282			15,000
Other			(474)			369
Net cash (used in) provided by investing activities			(10,027)			12,726
CASH FLOWS FROM FINANCING ACTIVITIES:
Treasury stock acquired			(18,089)			–
Payments to noncontrolling interests holders			(283)			(2,598)
Capital contributions from minority investor			88			258
Net cash used in financing activities			(18,284)			(2,340)
NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS
AND RESTRICTED CASH			(6,812)			8,050
CASH, CASH EQUIVALENTS AND RESTRICTED CASH-Beginning of period			180,771			188,812
CASH, CASH EQUIVALENTS AND RESTRICTED CASH-End of period		$	173,959		$	196,862
Non cash investing activities – Accrued capital expenditures		$	198		$	272
Non cash financing activities – Stock awards accrued		$	–		$	99
Non cash financing activities – Stock awards issued		$	240		$	487
Initial operating lease right-of-use assets and liabilities recorded
upon adoption of ASC 842		$	–		$	20,918
Operating lease right-of-use assets acquired and liabilities assumed
upon lease execution		$	1,863		$	432

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20201203005167/en/

Douglas Bruggeman

Chief Financial Officer

(937) 276-3931

Joseph Jaffoni, Norberto Aja

JCIR

(212) 835-8500

[email protected]

KEYWORDS: Ohio United States North America

INDUSTRY KEYWORDS: Oil/Gas Coal Alternative Energy Energy Utilities

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OLB Sees Strong Opportunities in the Hospitality Sector for Its DoubleBeam Payments Platform

Cloud-Based Platform Facilitates Online and Mobile Services That Help Cafeterias and Food Service Operators Overcome COVID Restrictions

NEW YORK–(BUSINESS WIRE)–The OLB Group, Inc. (NASDAQ: OLB), a provider of cloud-based omnicommerce and payment acceptance solutions for small- and mid-sized merchants, announced that its DoubleBeam cloud-based payment services platform has been optimized to enable hospitality providers to expand business opportunities and deliver safe customer service options in COVID-restricted environments.

DoubleBeam is a fully integrated component of OLB’s omnicommerce portfolio, delivering comprehensive marketing, ordering, payment, and fulfillment processes through intuitive software and hardware. Utilized by operators of every size, DoubleBeam leverages the cloud to provide frictionless customer service and simple integration with back office processes and kitchen operations.

“We’ve been working hard throughout the pandemic to ensure that DoubleBeam customers can easily transition from a traditional premise-centric business model to a cloud-based infrastructure that facilitates safe business practices, including online ordering and fulfillment, contactless payment, and flexible delivery options,” said Ronny Yakov, chief executive officer for OLB. “By processing millions of transactions each month, DoubleBeam is proving its value as a secure and reliable solution that helps hospitality providers and other businesses flourish in the most challenging situations. We expect this trend to continue as more organizations seek efficient options to maintain operations.”

DoubleBeam hardware and software can often be set up in less than 15 minutes. The platform’s features include seamless order entry and processing with a direct link to kitchen printing systems, templates for menu management, a website builder, marketing and loyalty programs, and a free mobile app. DoubleBeam online and mobile apps also allow customers to pay for orders before entering the establishment, store favorite orders and payment sources, and provides a pathway for advertising and loyalty promotions.

DoubleBeam, and the entire OLB omnicommerce solution set, offer merchants a broad array of seamless integrations with inventory, warehouse, and supply chain management, accounting, employee scheduling and time tracking, and other business platforms.

Merchants interested in implementing DoubleBeam services can set up an account at https://doublebeam.com/get-started/. Resellers interested in adding DoubleBeam to their portfolio should visit https://doublebeam.com/new-reseller.

For more information about The OLB Group, please visit www.olb.com and www.olb.com/investors-data.

Investor Database for Future Press Releases and Industry Updates

Interested investors and shareholders are invited to be added to the corporate email database for corporate press releases and industry updates by sending an email to [email protected].

Safe Harbor Statement

All statements from The OLB Group, Inc. in this news release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements concerning the impact of COVID-19 on our operations and financial condition our ability to implement our proprietary merchant boarding and CRM system and to roll out our Omni Commerce applications to our current merchants and the integration of our secure payment gateway with our crowdfunding platform. While the Company’s management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of our control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include statements regarding the expected revenue and income for operations to be generated by The OLB Group, Inc. For other factors that may cause our actual results to differ from those that are expected, see the information under the caption “Risk Factors” in the Company’s most recent Form 10-K and 10-Q filings, and amendments thereto, as well as other public filings with the SEC since such date. The Company operates in a rapidly changing and competitive environment, and new risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statement.

About The OLB Group, Inc.

The OLB Group, Inc. is a payment facilitator and commerce service provider that delivers cloud-based merchant services for web-based and brick-and-mortar organizations. OLB provides a seamless, end-to-end digital commerce solution that includes site creation, hosting, transaction processing and payment gateway, order fulfillment, customer service, outbound marketing, sales reporting, and fundraising. With services from private label shopping sites designed to maintain the unique look or feel of the merchant website, to order fulfillment and customer service, OLB remains invisible to the user and promotes the merchant’s brand with market-leading technology and solutions. For more information about solutions, services, or to find a reseller, please visit www.olb.com. Investor information is available at www.olb.com/investors-data.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201203005032/en/

Glenn Goldberg

Parallel Communications, Inc.

[email protected]

(5160 705-6116

The OLB Group – Investor Relations

Rick Lutz

[email protected]

(212) 278-0900 EXT: 333

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Technology Retail Other Travel Destinations Travel Finance Supply Chain Management Small Business Banking Online Retail Professional Services Other Retail Vacation Software

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