Newsdesk, Author at Market Newsdesk

November 11, 2020 4:08 pm

Cyclacel Pharmaceuticals Reports Third Quarter 2020 Financial Results

– Conference Call Scheduled November 11, 2020 at 4:30 p.m. ET –

BERKELEY HEIGHTS, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) — Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; “Cyclacel” or the “Company”), a biopharmaceutical company developing innovative medicines based on cancer cell biology, today reported its financial results for the third quarter 2020 and certain business highlights.

The Company’s net loss applicable to common shareholders for the three months ended September 30, 2020 was $2.3 million. As of September 30, 2020, cash and cash equivalents totaled $23.1 million. Based on current spending, the Company estimates it has sufficient resources to fund planned operations, including research and development, through the end of 2022.

“We continue to execute on our clinical development plan for fadraciclib and CYC140 in both liquid and solid cancers,” said Spiro Rombotis, President and Chief Executive Officer. “The recent ENA presentation highlighted fadraciclib’s oral bioavailability and deepening confirmed response as a single agent. Recent publications elaborated the mechanistic rationale for fadraciclib highlighting dual inhibition of CDK2 and CDK9 cancer pathways. We are encouraged by evidence of antileukemic activity in our studies of fadraciclib in combination with venetoclax in hematological malignancies, including CLL. Dr. Mark Kirschbaum, our newly appointed CMO, is reviewing our programs and streamlining our clinical work flows to progress our clinical strategy and improve efficiency. We are looking forward to reporting data from ongoing studies and outlining our clinical development plans for fadraciclib and CYC140 to drive shareholder value.”

Key Corporate Highlights

Appointed Mark Kirschbaum, M.D. as Senior Vice President and Chief Medical Officer. Dr. Kirschbaum is a highly experienced hematologist/oncologist with over 30 years of experience in molecular medicine, new drug development, clinical trial design and patient care. He has management experience in academic research, clinical practice and pharmaceutical industry settings. As CMO, he is responsible for advancing Cyclacel’s pipeline and is leading clinical strategy, patient safety and medical affairs.
Fadraciclib
Oral
Presentation
at the Plenary Session of the 32
^nd
EORTC-NCI-AACR (ENA)
Symposium 2020

• In part 2 of a Phase 1, dose escalation study, fadraciclib was administered intravenously as monotherapy to 24 heavily pretreated patients with various advanced solid tumors.

• Out of 11 patients treated at the fourth dose level one achieved confirmed partial response (PR) and two stable disease (SD).

• The PR was observed after a month and a half on fadraciclib in a patient with MCL1-amplified endometrial cancer who had failed seven lines of prior therapy. The patient remains on treatment after 16 months with 92% reduction in target tumor lesions.

• SD was observed in a patient with cyclin E amplified ovarian cancer who achieved 29% shrinkage in target tumor lesions after four months and a patient with fallopian tube adenocarcinoma with undetermined protein level.

• In three patients treated in part 3 with oral fadraciclib high oral bioavailability and overlapping pharmacokinetics were observed compared to the intravenously administered, identical schedule in part 2.

CYC065-02 Phase 1 fadraciclib i.v. and venetoclax p.o.
in CLL
– five patients with R/R CLL have been treated in four dose levels up to 150 mg/m² of fadraciclib in combination with venetoclax. Fadraciclib is administered after completion of venetoclax ramp. Antileukemic activity was observed in three patients who achieved MRD negativity on the combination, one in bone marrow and two in bone marrow and peripheral blood. The latter two patients have also demonstrated continued shrinkage of lymph nodes on the combination. In one patient all target lesions and in the other 2 out of 4 lesions have shrunk below 1.5 cm. Both are waiting for confirmation of response. Preclinical data support a dual targeting strategy of both BCL2 and MCL1 in CLL.
CYC065-0
3
Phase 1
fadraciclib
i.v.
and
venetoclax p.o
.
in
AML/MDS
– fourteen heavily pretreated patients with relapsed/refractory (R/R) AML were treated in five dose levels up to 200 mg/m² of fadraciclib in combination with venetoclax. Antileukemic activity has been observed in four out of twelve patients available for assessment. Preclinical data in AML suggest that targeting both MCL1 and BCL2 may be more beneficial than inhibiting either protein alone.
CYC140-01 Phase 1 CYC140 i.v. – We have enrolled 7 patients in our first-in-human, dose escalation study evaluating CYC140 in patients with advanced leukemias. CYC140 is a small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers. In parallel with hematological malignancies, we are planning studies of CYC140 in solid tumors.
CYC682-11
Phase 1
part 2 sapacitabine p.o.
and venetoclax p.o.
– twelve patients have been enrolled in a dose escalation study in our DNA Damage Response (DDR) program evaluating an oral combination of sapacitabine and venetoclax in patients with R/R AML/MDS. Two patients, previously treated with combination therapies including hypomethylating agents, have achieved 5 and 6 cycles of treatment respectively. Sapacitabine is a nucleoside analogue that is active in AML and MDS R/R to prior therapy such as cytarabine or hypomethylating agents. Preclinical data demonstrated synergy of sapacitabine with a BCL2 inhibitor, which may offer an effective, oral treatment regimen for patients who have failed front-line therapy.
Appointed
Karin L. Walker to the Board of Directors. Ms. Walker brings over 30 years of extensive finance experience in biopharmaceuticals, including in public biotechnology companies, and technology companies. Ms. Walker currently serves as the Chief Accounting Officer of Prothena Corporation plc, a late-stage clinical company with expertise in protein dysregulation and a pipeline of novel investigational therapeutics focused on neurodegenerative and rare peripheral amyloid diseases, and has held this position since 2013.

More information on our clinical trials can be found here.

Key Business Objectives

Treat first patient with orally-administered fadraciclib in Phase 1/2 advanced solid tumors study;
Report initial data from fadraciclib-venetoclax Phase 1 study in R/R AML/MDS & CLL;
Report safety and PK data from Phase 1 study of fadraciclib oral formulation;
Report initial data from CYC140 Phase 1 first-in-human study in R/R leukemias; and
Report initial data from sapacitabine-venetoclax Phase 1 study in R/R AML/MDS;

Financial Highlights

As of September 30, 2020, cash and cash equivalents totaled $23.1 million, compared to $11.9 million as of December 31, 2019. The increase of $11.2 million was primarily due to net proceeds of $18.3 million from an equity financing in April 2020, offset by net cash used in operating activities of $6.8 million. There were no revenues for each of the three months ended September 30, 2020 and 2019.

Research and development expenses were $1.1 million for each of the three months ended September 30, 2020 and 2019. Research and development expenses relating to transcriptional regulation increased by approximately $0.1 million for the three months ended September 30, 2020 as we continue to progress the clinical evaluation of fadraciclib.

General and administrative expenses for the three months ended September 30, 2020 were $1.5 million, compared to $1.3 million for the same period of the previous year. The increase of $0.2 million for the three months ended September 30, 2020 is due to increased professional costs.

Total other income, net, for the three months ended September 30, 2020 was $35,000, compared to $174,000 for the same period of the previous year. The decrease of approximately $140,000 for the three months ended September 30, 2020 is primarily related to reductions in foreign exchange gains and interest income.

United Kingdom research & development tax credits were $0.3 million for each of the three months ended September 30, 2020 and 2019.

Net loss for the three months ended September 30, 2020 was $2.3 million compared to $1.9 million for the same period in 2019.

The Company estimates that cash resources of $23.1 million as of September 30, 2020 will fund currently planned programs through the end of 2022.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 4884678.

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and DNA damage response biology. The transcriptional regulation program is evaluating fadraciclib as a single agent in solid tumors and in combination with venetoclax in patients with relapsed or refractory AML/MDS and CLL. The anti-mitotic program is evaluating CYC140, a PLK1 inhibitor, in advanced leukemias/MDS patients. The DNA damage response program is evaluating an oral combination of sapacitabine and venetoclax in patients with relapsed or refractory AML/MDS. An investigator-sponsored trial (IST) is evaluating an oral combination of sapacitabine and olaparib in patients with BRCA mutant breast cancer. Cyclacel’s strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. For additional information, please visit www.cyclacel.com.

Forward-looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel’s product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.


Contacts

Company:	Paul McBarron, (908) 517-7330, [email protected]

Investor Relations:	Russo Partners LLC, Eric Ando, (646) 218-4604, [email protected]

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF
OPERATIONS (LOSS)

(In $000s, except share and per share amounts)

			Three Months Ended
			September 30,
				2019			2020

Revenues:
Total revenues				–			–
Operating expenses:
	Research and development			1,063			1,075
	General and administrative			1,285			1,497
Total operating expenses				2,348			2,572
Operating loss				(2,348	)		(2,572	)
Other income (expense):
	Foreign exchange gains (losses)			79			(25	)
	Interest income			42			4
	Other income, net			53			56
		Total other income (expense), net		174			35
Loss before taxes				(2,174	)		(2,537	)
Income tax benefit				273			281
Net loss				(1,901	)		(2,256	)
Dividend on convertible exchangeable preferred shares				(50	)		(50	)
Net loss applicable to common shareholders			$	(1,951	)	$	(2,306	)
Basic and diluted earnings per common share:
Net loss per share – basic and diluted			$	(2.27	)	$	(0.47	)
Weighted average common shares outstanding				859,998			4,863,984

CYCLACEL PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEET

(In $000s, except share, per share, and liquidation preference amounts)

	December 31,		September 30,
	2019		2020

ASSETS
Current assets:
Cash and cash equivalents	$	11,885	$	23,130
Prepaid expenses and other current assets		2,132		2,804
Total current assets		14,017		25,934

Property and equipment, net		27		64
Right-of-use lease asset		1,264		1,215
Total assets	$	15,308	$	27,213
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	890	$	455
Accrued and other current liabilities		1,530		1,257
Total current liabilities		2,420		1,712
Lease liability		1,191		1,063
Total liabilities		3,611		2,775

Stockholders’ equity		11,697		24,438
Total liabilities and stockholders’ equity	$	15,308	$	27,213

SOURCE: Cyclacel Pharmaceuticals, Inc.

November 11, 2020 4:08 pm

SpartanNash Announces Third Quarter Fiscal 2020 Financial Results

SpartanNash Announces Third Quarter Fiscal 2020 Financial Results

Reports Third Quarter Retail Comparable Store Sales of 10.6%

Generates EPS of $0.56; Adjusted EPS Increased 133% to $0.70

Adjusted EBITDA increased 37.2% to $57.0 million

Updates Fiscal Year 2020 Outlook

GRAND RAPIDS, Mich.–(BUSINESS WIRE)–
SpartanNash Company (the “Company”) (Nasdaq: SPTN) today reported financial results for its 12-week third quarter ended October 3, 2020.

Third Quarter Fiscal 2020 Highlights

Net sales growth of 3.1% to $2.06 billion from $2.00 billion in the prior year quarter, representing the eighteenth consecutive quarter of growth.
Retail comparable store sales of 10.6% were positive for the fifth consecutive quarter.
EPS of $0.56 per share, compared to a loss of $(0.01) per share in the prior year quarter; adjusted EPS of $0.70 per share, an increase of 133% over $0.30 per share in the prior year quarter.
Adjusted EBITDA increase of 37.2%, to $57.0 million from $41.6 million in the prior year quarter.
Subsequent to the end of the third quarter, the Company extended its commercial agreement with Amazon. In connection with this agreement, the Company issued stock warrants to a subsidiary of Amazon, subject to certain vesting conditions.

“In the past nine weeks since taking the CEO position I’ve visited a great number of our distribution centers and retail stores. The passion demonstrated by our associates is nothing short of inspirational,” said Tony Sarsam, President and Chief Executive Officer. “I am energized and excited about the profitable growth opportunities that lie ahead for our business. As I immerse further into our business, I will continue to assess our long-term strategy, focus on motivating our associates and recognizing their accomplishments, identifying opportunities to make investments to improve the efficiency and effectiveness of our supply chain, and evaluating how to best position SpartanNash to deliver shareholder value for years to come.”

Consolidated net sales for the third quarter increased $61.0 million, or 3.1%, to $2.06 billion from $2.00 billion in the prior year quarter. The increase in net sales was generated through higher sales attributable to increased consumer demand related to COVID-19 in the Company’s Retail and Food Distribution segments, as well as continued growth with existing Food Distribution customers, partially offset by the continued impact of domestic base access and commissary shopping restrictions associated with COVID-19 in the Military segment.

Gross profit for the third quarter was $324.8 million, or 15.8% of net sales, compared to $290.4 million, or 14.5% of net sales, in the prior year quarter. The improvement in the gross profit rate was driven by improvements in margin rates at all three segments, as well as an increase in the proportion of Retail and Food Distribution segment sales, which generate higher margin rates than the Military segment.

Reported operating expenses for the third quarter were $295.8 million, or 14.4% of net sales, compared to $274.6 million, or 13.7% of net sales, in the prior year quarter. The increase in expenses as a rate of sales compared to the prior year quarter was due to increased incentive compensation related to improved Company performance, a higher mix of Retail segment sales which have higher operating expense rates, higher supply chain expenses in the Food Distribution segment, and a $5.2 million increase in restructuring and asset impairment charges, partially offset by increased leverage of retail store labor expenses and other fixed costs due to the higher sales volume in the quarter.

The Company reported operating earnings of $29.0 million compared to $15.8 million in the prior year quarter. The increase was attributable to increased sales volume, as well as the changes in rates of margin and operating expenses previously mentioned, partially offset by higher impairment charges. Adjusted operating earnings⁽¹⁾ were $35.8 million compared to $20.3 million in the prior year quarter and are adjusted for the items detailed in Table 3.

Interest expense decreased $3.9 million from the prior year quarter due to multiple rate cuts implemented by the Federal Reserve during 2019 and in early 2020, as well as the Company’s pay down of the debt balance made possible by higher earnings and lower required investments in working capital. Postretirement benefit expense was favorable $10.1 million from cycling charges related to the termination of the Company’s pension plan in the prior year quarter.

The Company reported earnings from continuing operations of $20.0 million, or $0.56 per diluted share, compared to a loss from continuing operations of $0.3 million, or $0.01 per diluted share, in the prior year quarter. The improvement reflects the operating earnings and non-operating expense changes noted above. Adjusted earnings from continuing operations⁽²⁾ for the third quarter were $25.1 million, or $0.70 per diluted share. Adjusted earnings from continuing operations for the prior year quarter were $10.9 million, or $0.30 per diluted share. A reconciliation of reported earnings from continuing operations to adjusted earnings from continuing operations is included at Table 4.

Adjusted EBITDA⁽³⁾ increased $15.4 million, or 37.2%, to $57.0 million compared to $41.6 million in the prior year quarter due to factors mentioned above.

Please see the financial tables at the end of this press release for a reconciliation of each non-GAAP financial measure to the most directly comparable measure, prepared and presented in accordance with GAAP.

Segment Financial Results

Food Distribution

Net sales for Food Distribution increased $73.2 million, or 7.8%, to $1.01 billion from $0.94 billion in the prior year quarter. The increase was due to sales growth with existing customers, as well as incremental volume associated with increased consumer demand related to COVID-19, partially offset by the impact of the Company’s decision to exit its Fresh Production operations.

Reported operating earnings for Food Distribution were $9.2 million compared to $11.7 million in the prior year quarter. During the quarter, the Company made the decision to abandon a tradename within this segment to better align with the Company’s overall transportation operations and to provide a more integrated solution to its customers, resulting in a $7.0 million impairment of the associated indefinite-lived tradename asset. The decrease in reported operating earnings for Food Distribution was due to this asset impairment charge, as well as an increase in supply chain and corporate administrative expenses, partially offset by increased earnings due to the higher sales volume. Third quarter adjusted operating earnings⁽¹⁾ were $15.7 million compared to $15.5 million in the prior year quarter. Adjusted operating earnings exclude asset impairment and restructuring charges in both years and losses associated with the Fresh Kitchen operations in the prior year quarter.

Retail

Net sales for Retail increased $35.1 million, or 6.2%, to $596.7 million from $561.6 million in the prior year quarter primarily due to increased consumer demand related to COVID-19, as discussed above. Comparable store sales of 10.6% were partially offset by the impact of lower fuel sales, as well as store closures. During the quarter, the Company experienced more than 175% growth in its eCommerce business.

Reported operating earnings for Retail were $22.3 million compared to $6.7 million in the prior year quarter. The increase in reported operating earnings was due to the increase in sales volume, improvements in margin rates, including inventory shrink, and improved leverage of store labor. These favorable variances were partially offset by higher incentive compensation due to the improved segment performance. Adjusted operating earnings⁽¹⁾ were $22.6 million compared to $7.3 million in the prior year quarter and exclude merger/acquisition and integration expenses in the current year and restructuring charges in the prior year quarter.

Military Distribution

Net sales for Military Distribution decreased $47.2 million, or 9.5%, to $452.0 million from $499.2 million in the prior year quarter. Growth in private label and export sales were more than offset by the impact of domestic base access and commissary shopping restrictions associated with COVID-19, which have led to significant declines in Defense Commissary Agency sales as a whole.

The reported operating loss for Military Distribution was $2.5 million compared to $2.6 million in the prior year quarter. The change was driven by improved margin rates, partially offset by higher corporate administrative expenses, the impact of lower sales volumes and, to a lesser extent, increases in the rate of warehousing expenses. Adjusted operating loss⁽¹⁾ was $2.5 million for the quarter in both years.

Balance Sheet and Cash Flow

Cash flows provided by operating activities for the year-to-date period of fiscal 2020 were $223.8 million compared to $140.0 million in the prior year, driven by increased profitability and reductions in working capital. In 2020, the Company has generated $178.0 million in free cash flow⁽⁴⁾ year-to-date, compared to $93.1 million in the prior year. The Company reduced net long-term debt⁽⁵⁾ by $145.0 million year-to-date in fiscal 2020. The reduction in net long-term debt, combined with increased profitability, resulted in an improvement in the Company’s net long-term debt to adjusted EBITDA ratio over this period of time from 3.7x to 2.3x, calculated on a trailing thirteen periods basis.

Capital expenditures and IT capital⁽⁶⁾ totaled $53.5 million in the year-to-date period compared to $46.9 million in the prior year.

Through the third quarter of fiscal 2020, the Company has declared $20.8 million in quarterly cash dividends equal to $0.1925 per common share. The Company also repurchased 860,752 shares for a total of $10.0 million in the first quarter of fiscal 2020, at an average price of $11.62 per share.

Outlook

For the 53-week fiscal year ending January 2, 2021, the Company is updating its annual outlook from what was previously provided on August 12, 2020 to reflect actual financial results, its expectations for the remainder of the fiscal year, and the forecasted impact of stock warrants, which were granted early in the fourth quarter.

For fiscal year 2020, the Company now anticipates adjusted earnings per share from continuing operations⁽⁷⁾ of approximately $2.42 to $2.50 compared to its prior projection of $2.40 to $2.60. The Company’s updated guidance reflects the continued benefits of sales trends associated with COVID-19 and the related increase in consumer demand, offset by estimated non-cash stock warrant expense of $6.0 million to $7.0 million, or $0.13 to $0.15 per diluted share. Reported earnings per share from continuing operations are expected to range from $2.09 to $2.17 compared to its prior projection of $2.13 to $2.41.

The Company now expects fiscal 2020 adjusted EBITDA to range from $237.0 million to $242.0 million compared to its prior guidance of $232.0 million to $242.0 million.

The Company’s updated guidance now reflects capital expenditures and IT capital in the range of $80.0 million to $85.0 million for the fiscal year. Depreciation and amortization have been updated to a range of $88.0 million to $90.0 million. Interest expense is now expected to range from $18.0 million to $18.5 million. The Company’s updated guidance now reflects an adjusted effective tax rate of 23.5% to 24.0% and a reported effective tax rate of 13.0% to 13.5%.

Conference Call

A telephone conference call to discuss the Company’s third quarter 2020 financial results is scheduled for Thursday, November 12, 2020 at 8:00 a.m. ET. A live webcast of this conference call will be available on the Company’s website, www.spartannash.com/webcasts. Simply click on “For Investors” and follow the links to the live webcast. The webcast will remain available for replay on the Company’s website for approximately ten days.

About SpartanNash

SpartanNash (Nasdaq: SPTN) is a Fortune 400 company whose core businesses include distributing grocery products to a diverse group of independent and chain retailers, its corporate-owned retail stores and U.S. military commissaries and exchanges; as well as operating a premier fresh produce distribution network. SpartanNash serves customer locations in all 50 states and the District of Columbia, Europe, Cuba, Puerto Rico, Honduras, Bahrain, Djibouti and Egypt. SpartanNash currently operates 156 supermarkets, primarily under the banners of Family Fare, Martin’s Super Markets, D&W Fresh Market, VG’s Grocery and Dan’s Supermarket. Through its MDV military division, SpartanNash is a leading distributor of grocery products to U.S. military commissaries.

Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These include statements preceded by, followed by or that otherwise include the words “outlook,” “believe,” “anticipates,” “continue,” “expects,” “guidance,” “trend,” “on track,” “encouraged” or “plan” or similar expressions. The statements in the “Outlook” section of this press release are inherently forward looking. Forward-looking statements relating to expectations about future results or events are based upon information available to SpartanNash as of today’s date, and are not guarantees of the future performance of the Company, and actual results may vary materially from the results and expectations discussed. Additional risks and uncertainties include, but are not limited to, disruption associated with the COVID-19 pandemic and the Company’s ability to compete in the highly competitive grocery distribution, retail grocery, and military distribution industries. Additional information concerning these and other risks is contained in SpartanNash’s most recently filed Annual Report on Form 10-K, recent Current Reports on Form 8-K and other SEC filings. All subsequent written and oral forward-looking statements concerning SpartanNash, or other matters and attributable to SpartanNash or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. SpartanNash does not undertake any obligation to publicly update any of these forward-looking statements to reflect events or circumstances that may arise after the date hereof.

⁽¹⁾ A reconciliation of operating earnings to adjusted operating earnings, a non-GAAP financial measure, is provided in Table 3 below.

⁽²⁾ A reconciliation of earnings from continuing operations to adjusted earnings from continuing operations, a non-GAAP financial measure, is provided in Table 4 below.

⁽³⁾ A reconciliation of net earnings to Adjusted EBITDA, a non-GAAP financial measure, is provided in Table 2 below.

⁽⁴⁾ A reconciliation of net cash provided by operating activities to free cash flow, a non-GAAP financial measure, is provided in Table 6 below.

⁽⁵⁾ A reconciliation of long-term debt and finance lease obligations to net long-term debt, a non-GAAP financial measure, is provided in Table 5 below.

⁽⁶⁾ A reconciliation of purchases of property and equipment to capital expenditures and IT capital, a non-GAAP financial measure, is provided in Table 7 below.
⁽⁷⁾ A reconciliation of projected earnings per share from continuing operations to adjusted earnings per share from continuing operations, a non-GAAP financial measure, is provided in Table 8 below.

SPARTANNASH COMPANY AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

	12 Weeks Ended						40 Weeks Ended
	October 3,			October 5,			October 3,			October 5,
(In thousands, except per share amounts)	2020			2019			2020			2019
Net sales	$	2,060,816		$	1,999,808		$	7,101,373		$	6,538,112
Cost of sales		1,735,994			1,709,447			6,014,610			5,581,015
Gross profit		324,822			290,361			1,086,763			957,097

Operating expenses
Selling, general and administrative		289,039			273,286			981,066			900,160
Merger/acquisition and integration		242			—			242			1,364
Restructuring charges and asset impairment		6,543			1,296			20,455			10,215
Total operating expenses		295,824			274,582			1,001,763			911,739

Operating earnings		28,998			15,779			85,000			45,358

Other expenses and (income)
Interest expense		3,522			7,375			14,810			27,952
Loss on debt extinguishment		—			329			—			329
Postretirement benefit expense (income)		101			10,221			(597	)		19,677
Other, net		(141	)		(180	)		(547	)		(1,071	)
Total other expenses, net		3,482			17,745			13,666			46,887

Earnings (loss) before income taxes and discontinued operations		25,516			(1,966	)		71,334			(1,529	)
Income tax expense (benefit)		5,564			(1,656	)		7,513			(1,973	)
Earnings (loss) from continuing operations		19,952			(310	)		63,821			444

Loss from discontinued operations, net of taxes		—			(27	)		—			(126	)
Net earnings (loss)	$	19,952		$	(337	)	$	63,821		$	318

Basic earnings (loss) per share:
Earnings (loss) from continuing operations	$	0.56		$	(0.01	)	$	1.78		$	0.01
Loss from discontinued operations		—			—			—			—
Net earnings (loss)	$	0.56		$	(0.01	)	$	1.78		$	0.01

Diluted earnings (loss) per share:
Earnings (loss) from continuing operations	$	0.56		$	(0.01	)	$	1.78		$	0.01
Loss from discontinued operations		—			—			—			—
Net earnings (loss)	$	0.56		$	(0.01	)	$	1.78		$	0.01


Weighted average shares outstanding:
Basic		35,730			36,340			35,900			36,248
Diluted		35,732			36,340			35,900			36,248

SPARTANNASH COMPANY AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

	October 3,			December 28,
(In thousands)	2020			2019
Assets
Current assets
Cash and cash equivalents	$	26,903		$	24,172
Accounts and notes receivable, net		387,114			345,320
Inventories, net		586,351			537,212
Prepaid expenses and other current assets		73,192			58,775
Property and equipment held for sale		21,942			31,203
Total current assets		1,095,502			996,682

Property and equipment, net		562,326			615,816
Goodwill		181,035			181,035
Intangible assets, net		119,039			130,434
Operating lease assets		269,025			268,982
Other assets, net		94,632			82,660

Total assets	$	2,321,559		$	2,275,609

Liabilities and Shareholders’ Equity
Current liabilities
Accounts payable	$	501,099		$	405,370
Accrued payroll and benefits		91,001			59,680
Other accrued expenses		53,439			51,295
Current portion of operating lease liabilities		43,705			42,440
Current portion of long-term debt and finance lease liabilities		5,338			6,349
Total current liabilities		694,582			565,134

Long-term liabilities
Deferred income taxes		52,952			43,111
Operating lease liabilities		261,621			267,350
Other long-term liabilities		48,033			30,272
Long-term debt and finance lease liabilities		540,920			682,204
Total long-term liabilities		903,526			1,022,937

Commitments and contingencies

Shareholders’ equity
Common stock, voting, no par value; 100,000 shares authorized; 35,871 and 36,351 shares outstanding		484,612			490,233
Preferred stock, no par value, 10,000 shares authorized; no shares outstanding		—			—
Accumulated other comprehensive loss		(1,479	)		(1,600	)
Retained earnings		240,318			198,905
Total shareholders’ equity		723,451			687,538

Total liabilities and shareholders’ equity	$	2,321,559		$	2,275,609

SPARTANNASH COMPANY AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

	40 Weeks Ended
(In thousands)	October 3, 2020			October 5, 2019
Cash flow activities
Net cash provided by operating activities	$	223,832		$	140,034
Net cash used in investing activities		(35,536	)		(117,645	)
Net cash used in financing activities		(185,565	)		(17,385	)
Net cash used in discontinued operations		—			(153	)
Net increase in cash and cash equivalents		2,731			4,851
Cash and cash equivalents at beginning of the period		24,172			18,585
Cash and cash equivalents at end of the period	$	26,903		$	23,436

SPARTANNASH COMPANY AND SUBSIDIARIES SUPPLEMENTAL FINANCIAL DATA Table 1: Net Sales and Operating Earnings (Loss) by Segment (Unaudited)

	12 Weeks Ended										40 Weeks Ended
(In thousands)	October 3, 2020					October 5, 2019					October 3, 2020					October 5, 2019
Food Distribution Segment:
Net sales	$	1,012,204		49.1	%	$	939,047		47.0	%	$	3,471,561		48.9	%	$	3,043,668		46.6	%
Operating earnings		9,191					11,699					34,990					36,564
Retail Segment:
Net sales		596,659		29.0	%		561,605		28.1	%		2,010,483		28.3	%		1,833,347		28.0	%
Operating earnings		22,318					6,726					59,416					14,600
Military Segment:
Net sales		451,953		21.9	%		499,156		24.9	%		1,619,329		22.8	%		1,661,097		25.4	%
Operating loss		(2,511	)				(2,646	)				(9,406	)				(5,806	)
Total:
Net sales	$	2,060,816		100.0	%	$	1,999,808		100.0	%	$	7,101,373		100.0	%	$	6,538,112		100.0	%
Operating earnings		28,998					15,779					85,000					45,358

Non-GAAP Financial Measures

In addition to reporting financial results in accordance with GAAP, the Company also provides information regarding Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (“adjusted EBITDA”), adjusted operating earnings, adjusted earnings from continuing operations, total net long-term debt, free cash flow and projected adjusted earnings per diluted share from continuing operations. These are non-GAAP financial measures, as defined below, and are used by management to allocate resources, assess performance against its peers and evaluate overall performance. The Company believes these measures provide useful information for both management and its investors. The Company believes these non-GAAP measures are useful to investors because they provide additional understanding of the trends and special circumstances that affect its business. These measures provide useful supplemental information that helps investors to establish a basis for expected performance and the ability to evaluate actual results against that expectation. The measures, when considered in connection with GAAP results, can be used to assess the overall performance of the Company as well as assess the Company’s performance against its peers. These measures are also used as a basis for certain compensation programs sponsored by the Company. In addition, securities analysts, fund managers and other shareholders and stakeholders that communicate with the Company request its financial results in these adjusted formats.

Current year adjusted operating earnings, adjusted earnings from continuing operations, and adjusted EBITDA exclude “Fresh Cut operating losses” subsequent to the decision to exit these operations during the first quarter, severance associated with cost reduction initiatives, and fees paid to a third-party advisory firm associated with Project One Team, the Company’s initiative to drive growth while increasing efficiency and reducing costs. Pension termination income related to a refund from the annuity provider associated with the final reconciliation of participant data is excluded from adjusted earnings from continuing operations. These items are considered “non-operational” or “non-core” in nature. Prior year adjusted operating earnings, adjusted earnings from continuing operations, and adjusted EBITDA exclude “Fresh Kitchen operating losses” subsequent to the decision to exit these operations at the beginning of the third quarter, costs associated with organizational realignment, which include significant changes to the Company’s management team, and fees paid to a third-party advisory firm associated with Project One Team, the Company’s initiative to drive growth while increasing efficiency and reducing costs. Pension termination costs, primarily related to non-operating settlement expense associated with the distribution of pension assets, are excluded from adjusted earnings from continuing operations, and to a lesser extent adjusted operating earnings.

Table 2: Reconciliation of Net Earnings to Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (Adjusted EBITDA) (A Non-GAAP Financial Measure) (Unaudited)

	12 Weeks Ended						40 Weeks Ended
(In thousands)	October 3, 2020			October 5, 2019			October 3, 2020			October 5, 2019
Net earnings (loss)	$	19,952		$	(337	)	$	63,821		$	318
Loss from discontinued operations, net of tax		—			27			—			126
Income tax expense (benefit)		5,564			(1,656	)		7,513			(1,973	)
Other expenses, net		3,482			17,745			13,666			46,887
Operating earnings		28,998			15,779			85,000			45,358
Adjustments:
LIFO expense		387			1,268			3,158			3,761
Depreciation and amortization		20,858			20,351			68,611			67,513
Merger/acquisition and integration		242			—			242			1,364
Restructuring, asset impairment and other charges		6,543			1,296			20,455			10,215
Fresh Cut operating losses		—			—			2,262			—
Fresh Kitchen operating losses		—			2,204			—			2,204
Stock-based compensation		1,033			638			5,181			6,735
Non-cash rent		(1,188	)		(1,082	)		(3,981	)		(4,542	)
Costs associated with Project One Team		—			—			493			5,428
Organizational realignment costs		—			935			—			1,812
Severance associated with cost reduction initiatives		40			—			5,121			—
Loss on disposal of assets		35			—			3,462			—
Other non-cash charges		94			187			193			710
Adjusted EBITDA	$	57,042		$	41,576		$	190,197		$	140,558

Table 2: Reconciliation of Net Earnings to Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization, continued (Adjusted EBITDA) (A Non-GAAP Financial Measure) (Unaudited)

	12 Weeks Ended						40 Weeks Ended
(In thousands)	October 3, 2020			October 5, 2019			October 3, 2020			October 5, 2019
Food Distribution:
Operating earnings	$	9,191		$	11,699		$	34,990		$	36,564
Adjustments:
LIFO expense		295			639			1,684			1,869
Depreciation and amortization		7,413			7,390			24,561			25,368
Merger/acquisition and integration		—			—			—			(130	)
Restructuring, asset impairment and other charges		6,538			1,043			19,222			10,724
Fresh Cut operating losses		—			—			2,262			—
Fresh Kitchen operating losses		—			2,204			—			2,204
Stock-based compensation		522			302			2,524			3,319
Non-cash rent		31			147			125			353
Costs associated with Project One Team		—			—			265			2,877
Organizational realignment costs		—			495			—			960
Severance associated with cost reduction initiatives		—			—			3,143			—
(Gain) loss on disposal of assets		(6	)		—			1,613			—
Other non-cash charges		52			14			103			391
Adjusted EBITDA	$	24,036		$	23,933		$	90,492		$	84,499
Retail:
Operating earnings	$	22,318		$	6,726		$	59,416		$	14,600
Adjustments:
LIFO (gain) expense		(15	)		257			586			858
Depreciation and amortization		10,489			10,197			34,570			33,048
Merger/acquisition and integration		242			—			242			1,494
Restructuring charges (gains) and asset impairment		5			253			1,233			(509	)
Stock-based compensation		364			222			1,756			2,325
Non-cash rent		(1,134	)		(1,149	)		(3,818	)		(4,612	)
Costs associated with Project One Team		—			—			164			1,845
Organizational realignment costs		—			318			—			616
Severance associated with cost reduction initiatives		9			—			1,441			—
Loss on disposal of assets		34			—			1,905			—
Other non-cash charges		30			243			64			410
Adjusted EBITDA	$	32,342		$	17,067		$	97,559		$	50,075
Military:
Operating loss	$	(2,511	)	$	(2,646	)	$	(9,406	)	$	(5,806	)
Adjustments:
LIFO expense		107			372			888			1,034
Depreciation and amortization		2,956			2,764			9,480			9,097
Stock-based compensation		147			114			901			1,091
Non-cash rent		(85	)		(80	)		(288	)		(283	)
Costs associated with Project One Team		—			—			64			706
Organizational realignment costs		—			122			—			236
Severance associated with cost reduction initiatives		31			—			537			—
Loss (gain) on disposal of assets		7			—			(56	)		—
Other non-cash charges (gains)		12			(70	)		26			(91	)
Adjusted EBITDA	$	664		$	576		$	2,146		$	5,984

Notes: Adjusted EBITDA is a non-GAAP operating financial measure that the Company defines as net earnings plus interest, discontinued operations, depreciation and amortization, and other non-cash items including deferred (stock) compensation, the LIFO provision, as well as adjustments for items that do not reflect the ongoing operating activities of the Company and costs associated with the closing of operational locations.

Adjusted EBITDA and adjusted EBITDA by segment are not measures of performance under accounting principles generally accepted in the United States of America and should not be considered as a substitute for net earnings, cash flows from operating activities and other income or cash flow statement data. The Company’s definitions of adjusted EBITDA and adjusted EBITDA by segment may not be identical to similarly titled measures reported by other companies.

Table 3: Reconciliation of Operating Earnings to Adjusted Operating Earnings (A Non-GAAP Financial Measure) (Unaudited)

	12 Weeks Ended						40 Weeks Ended
(In thousands)	October 3, 2020			October 5, 2019			October 3, 2020			October 5, 2019
Operating earnings	$	28,998		$	15,779		$	85,000		$	45,358
Adjustments:
Merger/acquisition and integration		242			—			242			1,364
Restructuring, asset impairment and other		6,543			1,296			20,455			10,215
Fresh Cut operating losses		—			—			2,262			—
Fresh Kitchen operating losses		—			2,204			—			2,204
Costs associated with Project One Team		—			—			493			5,428
Organizational realignment costs		—			935			—			1,812
Expenses associated with tax planning		(15	)		—			82			—
Pension termination		—			28			—			48
Severance associated with cost reduction initiatives		40			43			5,121			484
Adjusted operating earnings	$	35,808		$	20,285		$	113,655		$	66,913
Reconciliation of operating earnings (loss) to adjusted operating earnings (loss) by segment:
Food Distribution:
Operating earnings	$	9,191		$	11,699		$	34,990		$	36,564
Adjustments:
Merger/acquisition and integration		—			—			—			(130	)
Restructuring, asset impairment and other		6,538			1,043			19,222			10,724
Fresh Cut operating losses		—			—			2,262			—
Fresh Kitchen operating losses		—			2,204			—			2,204
Costs associated with Project One Team		—			—			265			2,877
Organizational realignment costs		—			495			—			960
Expenses associated with tax planning		(8	)		—			44			—
Pension termination		—			15			—			26
Severance associated with cost reduction initiatives		—			31			3,143			392
Adjusted operating earnings	$	15,721		$	15,487		$	59,926		$	53,617
Retail:
Operating earnings	$	22,318		$	6,726		$	59,416		$	14,600
Adjustments:
Merger/acquisition and integration		242			—			242			1,494
Restructuring charges (gains) and asset impairment		5			253			1,233			(509	)
Costs associated with Project One Team		—			—			164			1,845
Organizational realignment costs		—			318			—			616
Expenses associated with tax planning		(5	)		—			27			—
Pension termination		—			10			—			17
Severance associated with cost reduction initiatives		9			12			1,441			83
Adjusted operating earnings	$	22,569		$	7,319		$	62,523		$	18,146
Military:
Operating loss	$	(2,511	)	$	(2,646	)	$	(9,406	)	$	(5,806	)
Adjustments:
Costs associated with Project One Team		—			—			64			706
Organizational realignment costs		—			122			—			236
Expenses associated with tax planning		(2	)		—			11			—
Pension termination		—			3			—			5
Severance associated with cost reduction initiatives		31			—			537			9
Adjusted operating loss	$	(2,482	)	$	(2,521	)	$	(8,794	)	$	(4,850	)

Notes: Adjusted operating earnings is a non-GAAP operating financial measure that the Company defines as operating earnings plus or minus adjustments for items that do not reflect the ongoing operating activities of the Company and costs associated with the closing of operational locations.

Adjusted operating earnings is not a measure of performance under accounting principles generally accepted in the United States of America and should not be considered as a substitute for operating earnings, cash flows from operating activities and other income or cash flow statement data. The Company’s definition of adjusted operating earnings may not be identical to similarly titled measures reported by other companies.

Table 4: Reconciliation of Earnings (loss) from Continuing Operations to Adjusted Earnings from Continuing Operations (A Non-GAAP Financial Measure) (Unaudited)

	12 Weeks Ended
	October 3, 2020						October 5, 2019
				per diluted						per diluted
(In thousands, except per share amounts)	Earnings			share			Earnings			share
Earnings (loss) from continuing operations	$	19,952		$	0.56		$	(310	)	$	(0.01	)
Adjustments:
Merger/acquisition and integration		242						—
Restructuring, asset impairment and other		6,543						1,296
Fresh Kitchen operating losses		—						2,204
Organizational realignment costs		—						935
Loss on debt extinguishment		—						329
Severance associated with cost reduction initiatives		40						43
Expenses associated with tax planning		(15	)					—
Pension termination		—						10,159
Total adjustments		6,810						14,966
Income tax effect on adjustments (a)		(1,830	)					(3,751	)
Impact of CARES Act (b)		212						—
Total adjustments, net of taxes		5,192			0.14	*		11,215			0.31
Adjusted earnings from continuing operations	$	25,144		$	0.70		$	10,905		$	0.30

	40 Weeks Ended
	October 3, 2020						October 5, 2019
				per diluted						per diluted
(In thousands, except per share amounts)	Earnings			share			Earnings			share
Earnings from continuing operations	$	63,821		$	1.78		$	444		$	0.01
Adjustments:
Merger/acquisition and integration		242						1,364
Restructuring, asset impairment and other		20,455						10,215
Fresh Cut operating losses		2,262						—
Fresh Kitchen operating losses		—						2,204
Costs associated with Project One Team		493						5,428
Organizational realignment costs		—						1,812
Loss on debt extinguishment		—						329
Severance associated with cost reduction initiatives		5,121						484
Expenses associated with tax planning		82						—
Pension termination		(1,004	)					19,510
Total adjustments		27,651						41,346
Income tax effect on adjustments (a)		(6,827	)					(10,166	)
Impact of CARES Act (b)		(9,298	)					—
Total adjustments, net of taxes		11,526			0.32			31,180			0.86
Adjusted earnings from continuing operations	$	75,347		$	2.10		$	31,624		$	0.87
* Includes rounding

(a)		The income tax effect on adjustments is computed by applying the applicable tax rate to the adjustments.
(b)		Represents tax impacts attributable to the Coronavirus Aid, Relief and Economic Security (“CARES”) Act, primarily related to additional deductions and the utilization of net operating loss carrybacks.

Notes: Adjusted earnings from continuing operations is a non-GAAP operating financial measure that the Company defines as earnings from continuing operations plus or minus adjustments for items that do not reflect the ongoing operating activities of the Company and costs associated with the closing of operational locations.

Adjusted earnings from continuing operations is not a measure of performance under accounting principles generally accepted in the United States of America and should not be considered as a substitute for net earnings, cash flows from operating activities and other income or cash flow statement data. The Company’s definition of adjusted earnings from continuing operations may not be identical to similarly titled measures reported by other companies.

Table 5: Reconciliation of Long-Term Debt and Finance Lease Obligations to Net Long-Term Debt (A Non-GAAP Financial Measure) (Unaudited)

	October 3,			December 28,
(In thousands)	2020			2019
Current portion of long-term debt and finance lease liabilities	$	5,338		$	6,349
Long-term debt and finance lease liabilities		540,920			682,204
Total debt		546,258			688,553
Cash and cash equivalents		(26,903	)		(24,172	)
Net long-term debt	$	519,355		$	664,381

Notes: Net long-term debt is a non-GAAP financial measure that is defined as long-term debt and finance lease obligations plus current maturities of long-term debt and finance lease obligations less cash and cash equivalents. The Company believes both management and its investors find the information useful because it reflects the amount of long-term debt obligations that are not covered by available cash and temporary investments. Net long-term debt is not a substitute for GAAP financial measures and may differ from similarly titled measures of other companies.

Table 6: Reconciliation of Net Cash Provided by Operating Activities to Free Cash Flow (A Non-GAAP Financial Measure) (Unaudited)

	40 Weeks Ended
(In thousands)	October 3, 2020		October 5, 2019
Net cash provided by operating activities	$	223,832	$	140,034
Less:
Purchases of property and equipment		45,880		46,905
Free cash flow	$	177,952	$	93,129

Notes: Free cash flow is a non-GAAP financial measure calculated by subtracting capital expenditures from cash flows provided by operating activities, the most directly comparable GAAP measure. The Company believes it is a useful indicator of liquidity that provides information to both management and investors about the amount of cash generated from operations that, after capital expenditures, can be used for strategic business objectives, including the repayment of long-term debt. Free cash flow is not a substitute for GAAP financial measures and may differ from similarly titled measures of other companies.

Table 7: Reconciliation of Purchases of Property and Equipment to Capital Expenditures and IT Capital (A Non-GAAP Financial Measure) (Unaudited)

	40 Weeks Ended
(In thousands)	October 3, 2020		October 5, 2019
Purchases of property and equipment	$	45,880	$	46,905
Plus:
Cloud computing spend		7,658		—
Capital expenditures and IT capital	$	53,538	$	46,905

Notes: Capital expenditures and IT capital is a non-GAAP financial measure calculated by adding spending related to the development of cloud computing applications spend to capital expenditures, the most directly comparable GAAP measure. Cloud computing spend only includes costs incurred during the application development phase and does not include ongoing costs of hosting or maintenance associated with these applications, which are expensed as incurred. The Company believes it is a useful indicator of the Company’s investment in its facilities and systems as it transitions to more cloud-based IT systems. Capital expenditures and IT capital is not a substitute for GAAP financial measures and may differ from similarly titled measures of other companies.

Table 8: Reconciliation of Projected Earnings per Diluted Share from Continuing Operations to Projected Adjusted Earnings per Diluted Share from Continuing Operations (A Non-GAAP Financial Measure) (Unaudited)

	53 Weeks Ending January 2, 2021
	Low			High
Earnings from continuing operations	$	2.09		$	2.17
Adjustments, net of taxes:
Merger/acquisition and integration expenses		0.01			0.01
Costs associated with Project One Team		0.01			0.01
Pension termination		(0.02	)		(0.02	)
Restructuring and asset impairment		0.43			0.43
Severance associated with cost reduction initiatives		0.11			0.11
Fresh Cut operating losses		0.05			0.05
Impact of CARES Act		(0.26	)		(0.26	)
Adjusted earnings from continuing operations	$	2.42		$	2.50

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005748/en/

Investors:

Mark Shamber

Chief Financial Officer and Executive Vice President

(616) 878-8023

Chris Mandeville

ICR

(203) 682-8304

Jeff Sonnek

ICR

(646) 277-1263

Media:

Meredith Gremel

Vice President Corporate Affairs and Communications

(616) 878-2830

KEYWORDS: United States North America Michigan

INDUSTRY KEYWORDS: Retail Supermarket Food/Beverage

MEDIA:

November 11, 2020 4:08 pm

TELA Bio Announces Third Quarter 2020 Financial Results

MALVERN, Pa., Nov. 11, 2020 (GLOBE NEWSWIRE) — TELA Bio, Inc. (“TELA”) (Nasdaq: TELA), a commercial-stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction, today reported financial results for the third quarter ended September 30, 2020.

Recent Highlights

Reported revenue of $5.3 million for the third quarter of 2020, increasing 34% over the third quarter of 2019
Presented additional data from the BRAVO post-market study, further demonstrating a low incidence of surgical site infections and occurrences and an initial two-year hernia recurrence rate of zero
Strategically added to commercial sales team and continued to educate surgeons through TELA LIVE virtual programs

“I am pleased with our strong third quarter results and proud of our team in continuing to execute and deliver to our customers and patients despite the ongoing challenges associated with the current pandemic,” said Antony Koblish, co-founder, President and Chief Executive Officer of TELA Bio. “While we are encouraged by the healthy rebound we saw in hernia procedures in the third quarter, there continues to be uncertainty in light of the increased number of daily COVID-19 cases in certain regions of the country. However, we remain cautiously optimistic and prepared as a team to meet the challenges of these dynamic times and adapt our commercial plan to ensure that we can continue to support our customers and advance our mission of improving patient care and outcomes.”

Third Quarter 2020 Financial Results

Revenue was $5.3 million for the third quarter of 2020, an increase of 34% compared to the prior year period. Despite strong quarterly revenue, revenue growth in the third quarter was impacted by lower than expected procedural volumes as a result of hospitals and patients deferring elective procedures and other factors related to the COVID-19 pandemic.

Gross profit was $3.3 million for the third quarter of 2020, or 62% of revenue, compared to $2.6 million, or 66% of revenue, in the same period in 2019. The decrease in gross margin was due to the increase in the charge for excess and obsolete inventory adjustments as a percentage of revenue.

Operating expenses were $10.2 million in the third quarter of 2020, compared to $6.5 million in the same period in 2019. The increase was due to the expansion of our commercialization activities, increased outside development expenses and increased costs associated with operating as a public company, which were partially offset by lower travel and consulting expenses resulting from the cost containment actions taken in response to the COVID-19 pandemic.

Loss from operations was $6.9 million in the third quarter of 2020, compared to a loss from operations of $3.9 million in the same period in 2019.

Net loss was $7.7 million in the third quarter of 2020, compared to a net loss of $4.7 million in the same period in 2019.

Total cash and cash equivalents at September 30, 2020 were $81.5 million.

Financial Outlook

There is considerable uncertainty and lack of visibility regarding the Company’s near-term revenue growth prospects and product development plans due to the rapidly evolving environment resulting from the COVID-19 pandemic. The COVID-19 pandemic is a highly fluid situation, and it is not currently possible for the Company to reasonably estimate the impact that it may have on financial and operating results. Accordingly, TELA Bio will not be providing 2020 financial guidance.

Conference Call and Webcast Details

The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Wednesday, November 11, 2020, at 4:30 PM ET.

To participate in the call, please dial (855) 548-1219 (domestic) or (409) 217-8881 (international) and provide conference ID 1670209. The live webcast will be available on the Events & Presentations page of the Investors section of TELA’s website.

About TELA Bio, Inc.

TELA Bio, Inc. is a commercial-stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction. TELA’s products are designed to improve on shortcomings of existing biologics and minimize long-term exposure to permanent synthetic material. TELA’s portfolio is supported by quality, data-driven science and extensive pre-clinical research that has consistently demonstrated advantages over other commercially available products.

Caution Regarding Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of TELA’s management. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: the impact to our business of the ongoing COVID-19 pandemic, including but not limited to any impact on our ability to market our products, demand for our products due to deferral of procedures using our products or disruption in our supply chain, our ability to achieve or sustain profitability, our ability to gain market acceptance for our products and to accurately forecast and meet customer demand, our ability to compete successfully, our ability to enhance our product offerings, development and manufacturing problems, capacity constraints or delays in production of our products, maintenance of coverage and adequate reimbursement for procedures using our products, product defects or failures. These and other risks and uncertainties are described more fully in the “Risk Factors” section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and TELA assumes no obligation to updates to our forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.

TELA Bio Contact

Stuart Henderson
Vice President, Corporate Development and Investor Relations
TELA Bio, Inc.
484-320-2930

Investor Contact
Greg Chodaczek
347-620-7010
[email protected]

TELA Bio, Inc.

Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)


	September 30,			December 31,
	2020			2019
Assets
Current assets:
Cash and cash equivalents	$	81,467		$	45,302
Short-term investments		—			9,285
Accounts receivable, net		2,640			2,836
Inventory		4,042			4,603
Prepaid expenses and other assets		867			2,308
Total current assets		89,016			64,334
Property and equipment, net		652			677
Intangible assets, net		2,683			2,911
Total assets	$	92,351		$	67,922

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	976		$	3,171
Accrued expenses and other current liabilities		4,369			3,542
Total current liabilities		5,345			6,713
Long‑term debt with related party		30,673			30,243
Other long‑term liabilities		—			4
Total liabilities		36,018			36,960

Stockholders’ equity:
Preferred stock; $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding		—			—
Common stock; $0.001 par value: 200,000,000 shares authorized; 14,432,472 and 11,406,976 shares issued and 14,432,220 and 11,406,221 shares outstanding at September 30, 2020 and December 31, 2019, respectively		14			11
Additional paid-in capital		245,199			198,829
Accumulated other comprehensive loss		(17	)		(19	)
Accumulated deficit		(188,863	)		(167,859	)
Total stockholders’ equity		56,333			30,962
Total liabilities and stockholders’ equity	$	92,351		$	67,922

TELA Bio, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)


	Three months ended						Nine months ended
	September 30,						September 30,
	2020			2019			2020			2019
Revenue	$	5,313		$	3,973		$	12,546		$	10,582
Cost of revenue (excluding amortization of intangible assets)		1,950			1,293			4,746			4,045
Amortization of intangible assets		76			76			228			228
Gross profit		3,287			2,604			7,572			6,309
Operating expenses:
Sales and marketing		6,342			4,736			15,734			12,678
General and administrative		2,607			1,208			7,274			3,737
Research and development		1,201			516			3,092			3,230
Total operating expenses		10,150			6,460			26,100			19,645
Loss from operations		(6,863	)		(3,856	)		(18,528	)		(13,336	)
Other (expense) income:
Interest expense		(898	)		(899	)		(2,661	)		(2,725	)
Change in fair value of preferred stock warrant liability		—			34			—			(4	)
Other income		58			55			185			172
Total other (expense) income		(840	)		(810	)		(2,476	)		(2,557	)
Net loss		(7,703	)		(4,666	)		(21,004	)		(15,893	)
Accretion of redeemable convertible preferred stock to redemption value		—			(2,058	)		—			(6,843	)
Net loss attributable to common stockholders	$	(7,703	)	$	(6,724	)	$	(21,004	)	$	(22,736	)
Net loss per common share, basic and diluted	$	(0.53	)	$	(22.58	)	$	(1.69	)	$	(76.62	)
Weighted average common shares outstanding, basic and diluted		14,421,990			297,750			12,431,257			296,743
Comprehensive loss:
Net loss	$	(7,703	)	$	(4,666	)	$	(21,004	)	$	(15,893	)
Foreign currency translation adjustment		(29	)		1			2			(2	)
Comprehensive loss	$	(7,732	)	$	(4,665	)	$	(21,002	)	$	(15,895	)

November 11, 2020 4:08 pm

ECN Capital Reports US$0.10 in Adjusted Net Income per Common Share in Q3-2020

Solid Q3 Results

TORONTO, Nov. 11, 2020 (GLOBE NEWSWIRE) — ECN Capital Corp. (TSX: ECN) (“ECN Capital” or the “Company”) today reported financial results for the three-month period ended September 30, 2020.

For the three-month period ended September 30, 2020, ECN Capital reported Adjusted netincomeapplicable to common shareholders from continuing operations of $23.3 million or $0.10 per share (basic) versus $17.0 million or $0.07 per share (basic) for the previous three-month period ended June 30, 2020 and $18.2 million or $0.08 per share (basic) for the same period last year.

“ECN’s strong Q3 earnings of $0.10, reflects ongoing strength in each of our businesses, which was apparent before Covid-19 and has continued in its face.”, said Steven Hudson, CEO of ECN Capital Corp. “We are reiterating guidance for 2020 at $0.31-$0.33, which is 15-22% above 2019 and given our performance confidently reiterating our guidance for 2021 at $0.44 – $0.53. I am very pleased with the resiliency of each of our businesses and look forward updating everyone at our Investor Day on February 4, 2021”

Originations for the three-month period ended September 30, 2020 were $842 million versus $676 million in the previous three-month period and $639 million for the same period last year.

Total Earning Assets
Manage
d
and Advis
ory as at September 30, 2020 were $32.2 billion, versus $33.3 billion as at June 30, 2020 and $32.6 billion at September 30, 2019.

Adjusted
EBITDA for the three-month period ended September 30, 2020 was $38.9 million versus $31.3 million for the previous three-month period and $34.0 million for the same period last year.

Operating Expenses for the three-month period ended September 30, 2020 were $30.6 million versus $29.9 million reported for the previous three-month period and $29.3 million for the same period last year.

Net Income
(loss)
attributable to common shareholders for the three-month period ended September 30, 2020 was $5.6 million versus ($1.8) million for the previous three-month period and $2.4 million for the same period last year.

Dividends Declared

The Company’s Board of Directors has authorized and declared a quarterly dividend of $0.025 per outstanding common share to be paid on December 31, 2020 to shareholders of record at the close of business on December 15, 2020. These dividends are designated to be eligible dividends for purposes of section 89(1) of the Income Tax Act (Canada).

The Company’s Board of Directors declared the following dividends on ECN Capital’s preferred shares:

A quarterly dividend of $0.40625 per outstanding Cumulative 5-Year Rate Reset Preferred Share, Series A (TSX: ECN.PR.A) payable on December 31, 2020 to shareholders of record on the close of business on December 15, 2020. These dividends are designated to be eligible dividends for purposes of section 89(1) of the Income Tax Act (Canada).
A quarterly dividend of $0.390625 per outstanding Cumulative 5-Year Rate Reset Preferred Share, Series C (TSX: ECN.PR.C) payable on December 31, 2020 to shareholders of record on the close of business on December 15, 2020. These dividends are designated to be eligible dividends for purposes of section 89(1) of the Income Tax Act (Canada).

Webcast

The Company will host its analyst briefing to discuss these results commencing at 5:30 PM (ET) on Wednesday, November 11, 2020. The call can be accessed as follows:

Webcast	http://services.choruscall.ca/links/ecncapitalcorp20201111.html

Toll-free dial in	North America 1-800-319-8560 International 1-604-638-5345 Passcode 47234#

Presentation slides	http://ecncapitalcorp.com/investors/presentations

The webcast will be available until December 11, 2020. A recording of the conference call may also be accessed until February 11, 2021 by dialing 1-800-319-6413 and entering the passcode 5576#.

Non-IFRS Measures

The Company’s interim unaudited consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and the accounting policies we adopted in accordance with IFRS.

The Company believes that certain Non-IFRS Measures can be useful to investors because they provide a means by which investors can evaluate the Company’s underlying key drivers and operating performance of the business, exclusive of certain adjustments and activities that investors may consider to be unrelated to the underlying economic performance of the business of a given period. Throughout this Press Release, management used a number of terms and ratios which do not have a standardized meaning under IFRS and are unlikely to be comparable to similar measures presented by other organizations. A full description of these measures can be found in the Management Discussion & Analysis that accompanies the financial statements for the three and nine-month periods ended September 30, 2020.

ECN Capital’s Management Discussion and Analysis as at and for the three and nine-month periods ended September 30, 2020 has been filed on SEDAR (www.sedar.com) and is available under the investor section of the Company’s website (www.ecncapitalcorp.com).

About ECN Capital Corp.

With managed and advised assets of US$32 billion, ECN Capital Corp. (TSX: ECN) is a leading provider of business services to North American based banks, credit unions, life insurance companies, pension funds and investment funds (collectively our “Partners”). ECN Capital originates, manages and advises on credit assets on behalf of its Partners, specifically unsecured loan portfolios, secured loan portfolios and credit card portfolios. Our Partners are seeking high quality assets to match with their deposits or other liabilities. These services are offered through three operating businesses: Service Finance, Triad Financial Services and The Kessler Group.

Contact

John Wimsatt
647-649-4634
[email protected]

Forward-looking Statements

This release includes forward-looking statements regarding ECN Capital and its business. Such statements are based on the current expectations and views of future events of ECN Capital’s management. In some cases the forward-looking statements can be identified by words or phrases such as “may”, “will”, “expect”, “plan”, “anticipate”, “intend”, “potential”, “estimate”, “believe” or the negative of these terms, or other similar expressions intended to identify forward-looking statements. Forward-looking statements in this press release include those relating to
the future financial and operating performance of ECN Capital, the strategic advantages, business plans and future opportunities of ECN Capital and the ability of ECN Capital to access adequate funding sources, identify and execute on acquisition opportunities and transition t
o an asset management business.
The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting ECN Capital, including risks regarding the equipment finance industry, economic factors, and many other factors bey
ond the control of ECN Capital.
No forward-looking statement can be guaranteed. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information.
A discussion of the material risks and assumptions associated with this outlook can be fou
nd in ECN Capital’s
September
30
,
20
20
MD&A and
201
9
AIF Di
sclosure Document dated March
26
,
20
20
which
ha
ve
been filed on SEDAR and can be accessed at
www.sedar.com
.
Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and ECN Capital does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

November 11, 2020 4:08 pm

OpGen Reports Third Quarter 2020 Financial Results and Provides Business Update

OpGen takes strategic steps to expand the Unyvero platform and product pipeline, to focus on the pending Acuitas AMR Gene Panel (isolates) FDA clearance and expects to invest significantly in bioinformatics
OpGen subsidiary Ares Genetics received notification of exercise of option to negotiate for a potential future license by its IVD Partner
OpGen
has
discontinue
d
Acuitas AMR Gene Panel (urine) clinical trial and
will
discontinue FISH product line globally by mid-2021
Total Revenue for Q3 2020 was approximately $1.
1
million dollars
Maintained strong balance sheet with $10.
5
million cash as of September 30, 2020

Conference call to be held at 4:30 p.m. Eastern Time today

GAITHERSBURG, Md., Nov. 11, 2020 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, reported today its financial and operating results for the three and nine months ended September 30, 2020 and provided a business update. Total OpGen revenue for the third quarter of 2020 was approximately $1.1 million, up from $0.6 million in the third quarter of 2019. The financial results for the three months ended September 30, 2020 reflect the consummation of our business combination with Curetis GmbH on April 1, 2020. OpGen’s cash as of September 30, 2020 was approximately $10.5 million. The company has access to an additional $6.4 million under its expanded ATM program and has 594,000 warrants outstanding at an average exercise price of $2.16. In addition, the Company continues to have access to an additional €5.0 million tranche of non-dilutive debt financing for COVID-19 related R&D programs from the European Investment Bank.

As previously reported, OpGen announced details regarding a strategic reprioritization of its product portfolio, platform pipeline and priorities going forward. This reprioritization was based on feedback from extensive market research, a customer survey of 150 stakeholders in the decision making on new diagnostic platforms, and key-opinion-leader interviews conducted by an independent market research firm over the past two quarters. Following a review of this research, OpGen and its board decided to consolidate the company’s product portfolio on its proprietary Unyvero platform and unique bioinformatics capabilities. As a result of this change in priority, the company anticipates the following key impacts:

Product portfolio going forward is centered around rapid, molecular diagnostic platform offerings and increased focus on value added bioinformatics solutions, including Ares Genetics’ next generation sequencing-based and artificial intelligence powered AMR and AST prediction capabilities.
Following the successful completion of the three phases of the partnered R&D program as announced in the during our second quarter 2020 earnings call, Ares Genetics has recently received formal notification from its undisclosed global leading IVD corporation partner that they have exercised their option to exclusively negotiate with Ares Genetics the scope and terms of a potential exclusive license or other arrangement with Ares to Ares Genetics’ technology in the field of human clinical diagnostics in the coming months.
Platform consolidation to realize significant operational synergies and cost savings over time as fewer products and platforms would need to be maintained from a regulatory, quality management and logistics and service standpoint.
Unyvero platform and product portfolio to be expanded beyond lower respiratory tract infections such as pneumonia (LRT / LRT BAL) to include complicated urinary tract infections (cUTI) and invasive joint infections (IJI) in the U.S. with clinical trials for future FDA submission and clearance anticipated to start in 2021. Similar products in both clinical indication areas using the same sample types have already been successfully developed and CE-IVD marked and are commercially available in Europe and other markets.
Recent notification from the FDA has indicated that the agency plans to continue prioritizing emergency use authorization (EUA) requests for diagnostic products intended to address the COVID-19 pandemic for at least the remainder of the year, which will impact the statutory review periods for ongoing submissions. During this time, the FDA plans to provide monthly updates regarding the ongoing impact of such prioritization of EUAs on our Acuitas AMR Gene Panel for Isolates submission. Despite such impact, OpGen has remained in open and ongoing dialogue with the FDA regarding the status of the Acuitas AMR Gene Panel for Isolates submission since our October 2020 formal response to the FDA’s Additional Information (AI) requests. If the Acuitas AMR Gene Panel for Isolates is cleared by the FDA, OpGen anticipates swift commercial launch in the U.S. in the following months.
Legacy FISH products business including Quick FISH^® and PNA FISH^® to be discontinued by mid-2021 in Europe, the U.S. and rest of world with last production lots to be manufactured in early 2021. All customers in the U.S. and distributors in Europe have been informed of the discontinuation and OpGen expects last stocking orders to come in by year-end with several orders already received.
Acuitas AMR Gene Panel (urine) clinical trial has been discontinued and all clinical trial sites have been notified as focus shifts to Unyvero platform for complicated UTI indication as well as additional future applications.

Oliver Schacht, President and CEO of OpGen commented, “Reprioritization efforts including the consolidation of our product portfolio highlights our focus on rapid, molecular diagnostic offerings and bioinformatics as we look to 2021 and beyond. Additionally, the discontinuation of the Acuitas AMR Gene Panel (urine) clinical trial and the Legacy FISH products business will result in significant operational synergies and cost savings for OpGen. We believe this shift will create meaningful, long term shareholder value for our investors, partners and healthcare provides alike as we continue to establish ourselves as industry leaders in molecular diagnostics and bioinformatics space.”

Third
Quarter
and
Nine Month
2020
F
inancial Results

Total revenue for the third quarter of 2020 was approximately $1.1 million, up from $0.6 million in the third quarter of 2019. Total revenue for the nine months ended September 30, 2020 was $2.9 million, compared with $2.7 million for the nine months ended September 30, 2019;
Operating expenses for the third quarter of 2020 were $7.2 million, compared with $4.1 million in the third quarter of 2019. Operating expenses for the nine months ended September 30, 2020 were $19.6 million, compared with $12.4 million for the nine months ended September 30, 2019;
The net loss for the third quarter of 2020 was $7.7 million or $0.40 per share, compared with $3.5 million or $3.95 per share in the third quarter of 2019. The net loss for the nine months ended September 30, 2020 was $19.1 million or $1.36 per share, compared with a net loss of $9.9 million or $13.32 per share for the nine months ended September 30, 2019; and
Cash and cash equivalents were $10.5 million as of September 30, 2020.

The company also announced accomplishment of the following key milestones in the third quarter of 2020 and year to date:

OpGen’s subsidiary Curetis GmbH obtained CE mark certification in the European Union for its own SARS-CoV-2 Kit with PULB for the detection of SARS-CoV-2, the virus that causes COVID-19.
OpGen announced that subsidiary Ares Genetics GmbH won the Austrian national digitization award and was also nominated for the 40^th Austrian Innovation Award for its artificial intelligence powered, next-generation sequencing based molecular antibiotic susceptibility test marketed under the brand name ARESupa – Universal Pathogenome Assay.
OpGen’s subsidiary Curetis GmbH was awarded EUR 350 thousand in non-dilutive grant funding in a collaboration project with InfectoGnostics campus at Jena University Hospital.
OpGen announced the award of a German Federal Government grant to its subsidiary, Curetis GmbH, and collaborators Carpegen GmbH and the Clinic for Small Animal Internal Medicine of the LMU Ludwig-Maximilians University to collaborate on a project focused on travel related and enteric diseases in small animals.
OpGen’s subsidiary Ares Genetics GmbH in collaboration with researchers from the Johns Hopkins University School of Medicine, announced the publishing of a peer-reviewed study on modifiable risk factors for the emergence of ceftolozane-tazobactam resistance in P. aeruginosa in the journal Clinical Infectious Diseases.
OpGen announced the release of a new peer-reviewed publication that demonstrates the clinical utility of the Unyvero LRT panel and its potential impact on antibiotic use in hospitalized patients with suspected pneumonia compared to treatment directed based on microbiological culture results.
OpGen successfully completed its study collaboration with Karolinska Institutet on bacterial co-infections in COVID-19 pneumonia patients and data on the Unyvero HPN Panel was presented by the Karolinska investigators at ECCVID 2020.
OpGen significantly improved its working capital position in the third quarter of 2020 through the sale of approximately 1.8 million shares of common stock under the company’s ATM program and the exercise of warrants from the October 2019 financing for gross proceeds of $4.3 million during the third quarter. During the nine months ended September 30, 2020, the Company sold approximately 11.4 million shares of common stock under the company’s ATM program and upon exercise of warrants from the October 2019 offering for gross proceeds of $24.4 million.
The German Federal Ministry for Economic Affairs and Energy (BMWi) concluded its investigation of the OpGen business combination with Curetis with regards to its impact on the public order and security of the Federal Republic of Germany as well as national healthcare interests in the light of the current COVID-19 pandemic. No further action is expected from the Federal government on this matter.

Mr. Schacht commented, “I am pleased with our third quarter financial results and am encouraged by the exciting business updates that were issued this quarter including the CE mark certification for our SARS-CoV-2 Kit, notable awards and grants, peer-reviewed publications and the submission of our formal response letter to the FDA, which upon continued positive interactions with the FDA, makes us believe there should be a near-term clearance decision once the COVID-19 related FDA delays allow the agency to respond. In addition to the business and pipeline progress achieved this quarter, we are excited to provide further details about our reprioritization strategy aimed at creating both near-term and long-term growth potential for the company. As we wrap up 2020 OpGen is in a strong position to achieve pipeline and growth targets in the years ahead and I look forward to the company’s continued successes.”

Conference Call Information

OpGen’s management will host a conference call today, November 11 at 4:30 p.m. ET to discuss the third quarter financial results and other business activities, as well as answer questions. Dial-in information is below:

Dial-in Information

U.S. Dial-in Number: +1 (877) 705 6003
International Dial-in Number: +1 (201) 493 6725
Webcast: http://public.viavid.com/index.php?id=142176
Conference ID: 13712431

Following the conclusion of the conference call, a replay will be available through November 25, 2020. The live, listen-only webcast of the conference call may also be accessed by visiting the Investors section of the Company’s website at www.opgen.com. A replay of the webcast will be available following the conclusion of the call and will be archived on the Company’s website for 90 days. Replay access information is below:

Replay Information

U.S. Dial-in Number: +1 (844) 512 2921
International Dial-in Number: +1 (412) 317 6671
Replay PIN: 13712431

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas^® Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.

For more information, please visit www.opgen.com.

Forward-Looking Statements

This press release includes statements regarding OpGen’s third quarter 2020 results, the company’s strategic portfolio and product pipeline priorities, the ongoing integration of OpGen with its acquired subsidiaries, Curetis GmbH and Ares Genetics GmbH, and the impact of COVID-19 on the company and general market conditions. These statements and other statements regarding OpGen’s future plans and goals constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the realization of expected benefits of our business combination transaction with Curetis GmbH, the success of our commercialization efforts, the impact of COVID-19 on the Company’s operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen’s business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

OpGen:

Oliver Schacht
President and CEO
[email protected]

OpGen Press Contact:

Matthew Bretzius
FischTank Marketing and PR
[email protected]

OpGen Investor Contact:

Megan Paul
Edison Group
[email protected]

OpGen, Inc.
Consolidated Balance Sheets
(unaudited)

	September 30, 2020			December 31, 2019
Assets
Current assets
Cash and cash equivalents	$	10,488,072		$	2,708,223
Accounts receivable, net		423,432			567,811
Inventory, net		2,975,060			473,030
Note receivable		—			2,521,479
Prepaid expenses and other current assets		1,072,364			396,760
Total current assets		14,958,928			6,667,303
Property and equipment, net		3,370,847			130,759
Finance lease right-of-use assets, net		571,329			958,590
Operating lease right-of-use assets		1,373,418			1,043,537
Goodwill		8,057,894			600,814
Intangible assets, net		16,071,680			817,550
Other noncurrent assets		300,744			203,271
Total assets	$	44,704,840		$	10,421,824
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable	$	1,240,351		$	1,056,035
Accrued compensation and benefits		2,003,002			855,994
Accrued liabilities		2,664,581			1,046,661
Deferred revenue		51,622			9,808
Short-term notes payable		1,156,517			373,599
Short-term finance lease liabilities		348,000			579,030
Short-term operating lease liabilities		1,142,435			1,017,414
Total current liabilities		8,606,508			4,938,541
Note payable		18,159,433			329,456
Deriviative liabilities		74,239			—
Long-term finance lease liabilities		76,701			313,263
Long-term operating lease liabilities		554,295			547,225
Other long term liabilites		154,716			–
Total liabilities		27,625,892			6,128,485
Commitments
Stockholders’ equity
Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued and outstanding at September 30, 2020 and December 31, 2019, respectively		—			—
Common stock, $0.01 par value; 50,000,000 shares authorized; 19,799,348 and 5,582,280 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively		197,993			55,823
Additional paid-in capital		208,892,463			178,779,814
Accumulated deficit		(193,625,510	)		(174,524,983	)
Accumulated other comprehensive income/(loss)		1,614,002			(17,315	)
Total stockholders’ equity		17,078,948			4,293,339
Total liabilities and stockholders’ equity	$	44,704,840		$	10,421,824

OpGen, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Revenue
Product sales	$	601,562		$	573,035		$	1,569,799		$	1,597,505
Laboratory services		112,892			185			138,884		$	5,435
Collaboration revenue		342,311			75,000			1,153,400			1,075,000
Total revenue		1,056,765			648,220			2,862,083			2,677,940
Operating expenses
Cost of products sold		1,350,296			262,373			2,340,766			681,568
Cost of services		159,794			196,184			550,115			592,647
Research and development		2,433,553			1,139,369			6,630,134			4,069,335
General and administrative		2,356,413			1,560,706			6,549,432			4,901,136
Sales and marketing		932,671			376,955			2,258,980			1,142,755
Transaction costs		—			538,061			470,322			538,061
Impairment of intangible assets		—			—			750,596			—
Impairment of right-of-use asset		—			—			—			520,759
Total operating expenses		7,232,727			4,073,648			19,550,345			12,446,261
Operating loss		(6,175,962	)		(3,425,428	)		(16,688,262	)		(9,768,321	)
Other (expense) income
Interest and other income/(expense)		19,965			1,043			101,644			(8,213	)
Interest expense		(1,183,927	)		(49,099	)		(2,267,085	)		(142,672	)
Foreign currency transaction losses		(501,168	)		(8,954	)		(794,832	)		(9,426	)
Change in fair value of derivative financial instruments		165,497			—			548,008			67
Total other expense		(1,499,633	)		(57,010	)		(2,412,265	)		(160,244	)
Loss before income taxes		(7,675,595	)		(3,482,438	)		(19,100,527	)		(9,928,565	)
Provision for income taxes		—			—			—			—
Net loss	$	(7,675,595	)	$	(3,482,438	)	$	(19,100,527	)	$	(9,928,565	)

Net loss per common share – basic and diluted	$	(0.40	)	$	(3.95	)	$	(1.36	)	$	(13.32	)
Weighted average shares outstanding – basic and diluted		19,116,864			882,280			14,016,896			745,471
Net loss	$	(7,675,595	)	$	(3,482,438	)	$	(19,100,527	)	$	(9,928,565	)
Other comprehensive income – foreign currency translation		1,266,901			7,298			1,631,317			5,174
Comprehensive loss	$	(6,408,694	)	$	(3,475,140	)	$	(17,469,210	)	$	(9,923,391	)

November 11, 2020 4:08 pm

QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test That Can Accurately Analyze Over 30 Samples Per Hour

QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test That Can Accurately Analyze Over 30 Samples Per Hour

QIAreach™ SARS-CoV-2 Antigen Test, developed in partnership with Ellume, is an important step towards decentralized mass screening by processing samples in 2–15 minutes

Digital results for dozens of samples per hour and the ability to process antibody tests in parallel, setting new standards in scalability and flexibility

Test submitted to FDA for Emergency Use Authorization for US, CE-IVD marking for European Union and other markets expected by year’s end

HILDEN, Germany & GERMANTOWN, Md.–(BUSINESS WIRE)–
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) has started commercialization of a portable digital test in the United States that can be used by laboratories to detect SARS-CoV-2 antigens in people with active infections in 2-15 minutes. A point of care (POC) claim will be added and EUA amended later this year.

The QIAreach™ SARS-CoV-2 Antigen Test, developed in partnership with the Australian digital diagnostics company Ellume, sets new standards in scalability, validation and flexibility by processing more than 30 swab samples per hour, providing digital test results that do not require subjective interpretation, and allowing antibody tests to run simultaneously with antigen tests. This flexibility will be particularly valuable when vaccines are introduced.

QIAGEN has begun marketing and distributing QIAreach™ SARS-CoV-2 Antigen Test in the United States after applying for FDA emergency use authorization (EUA) for symptomatic patients. CE-IVD registration for European Union and other markets is expected as early as by the end of the year.

“As existing approaches often lack scalability and accuracy, antigen testing is playing an increasingly important role in national testing strategies as a complementary tool to PCR, the gold-standard for detecting active COVID-19 infections,” said Thierry Bernard, Chief Executive Officer of QIAGEN. “QIAreach SARS-CoV Antigen is a fast, digital and easy to use test that makes use of sensitive nanoparticle technology from Ellume. In as little as two minutes it allows objective reading of test results that provide clear qualitative interpretation. And it addresses the growing need for higher throughput testing for SARS-CoV-2 antigen by processing up to eight tests per hub simultaneously.”

Please find the full press release here

###

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005760/en/

QIAGEN

Investor Relations

e-mail: [email protected]

John Gilardi

+49 2103 29 11711

Phoebe Loh

+49 2103 29 11457

Public Relations

e-mail: [email protected]

Thomas Theuringer

+49 2103 29 11826

Robert Reitze

+49 2103 29 11676

KEYWORDS: Maryland Switzerland United States Austria North America Europe Germany

INDUSTRY KEYWORDS: Medical Devices Health Infectious Diseases Research Science Biotechnology

MEDIA:

November 11, 2020 4:08 pm

Resonant to Present at the Virtual Fall Investor Summit

GOLETA, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) — Resonant Inc. (NASDAQ: RESN), a leader in transforming the way radio frequency, or RF, front-ends are being designed and delivered for mobile handset and wireless devices, today announced that management will present at the Virtual Fall Investor Summit, hosted by Investor Summit Group and taking place November 16-18, 2020.

George B. Holmes, Chairman and Chief Executive Officer of Resonant, is scheduled to participate in one-on-one meetings throughout the event and will host a virtual presentation as follows:

Virtual Fall Investor Summit

Date: Monday, November 16, 2020
Time: 3:30 p.m. Eastern time (12:30 p.m. Pacific time)
Webcast: https://www.webcaster4.com/Webcast/Page/2038/38523

A live audio webcast and archive of the summit presentation will be available using the webcast link above. For more information on the Investor Summit Group Virtual Fall Summit or to schedule a one-on-one meeting, please contact the Company’s investor relations contact or your Investor Summit Group representative.

About Resonant Inc.

Resonant (NASDAQ: RESN) is transforming the market for RF front-ends (RFFE) by disrupting the RFFE supply chain through the delivery of solutions that leverage our Infinite Synthesized Network (ISN) software tools platform, capitalize on the breadth of our IP portfolio, and are delivered through our services offerings. In a market that is critically constrained by limited designers, tools and capacity, Resonant addresses these critical problems by providing customers with ever increasing design efficiency, reduced time to market and lower unit costs. Customers leverage Resonant’s disruptive capabilities to design cutting edge filters and modules, while capitalizing on the added stability of a diverse supply chain through Resonant’s fabless ecosystem-the first of its kind. Working with Resonant, customers enhance the connectivity of current mobile devices, while preparing for the demands of emerging 5G applications.

To learn more about Resonant, view the series of videos published on its website that explain Resonant’s technologies and market positioning:

For more information, please visit www.resonant.com.

Resonant uses its website (https://www.resonant.com) and LinkedIn page (https://www.linkedin.com/company/resonant-inc-/) as channels of distribution of information about its products, its planned financial and other announcements, its attendance at upcoming investor and industry conferences, and other matters. Such information may be deemed material information, and Resonant may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor the company’s website and its social media accounts in addition to following the company’s press releases, SEC filings, public conference calls, and webcasts.

About Resonant’s ISN
^®
Technology

Resonant can create designs for difficult bands, modules and other complex RF Front End requirements that we believe have the potential to be manufactured for half the cost and developed in half the time of traditional approaches. ISN is a suite of proprietary mathematical methods, software design tools and network synthesis techniques that enable us to explore a much larger set of possible design solutions that regularly incorporate our proprietary technology. We then quickly deliver design simulations to our customers, which they manufacture or have manufactured by one of our foundry partners. These improved solutions still use Surface Acoustic Wave (SAW) or Temperature Compensated Surface Acoustic Wave (TC-SAW) manufacturing methods and perform as well as those using higher cost manufacturing methods such as Bulk Acoustic Wave (BAW). Resonant’s method delivers excellent predictability, enabling achievement of the desired product performance in roughly half as many turns through the fab. In addition, because Resonant’s models are fundamental, integration with its foundry and fab customers is seamless because its models speak the “fab language” of basic material properties and dimensions.

Investor Relations Contact:

Greg Falesnik or Brooks Hamilton
MZ Group – MZ North America
(949) 546-6326
[email protected]

November 11, 2020 4:08 pm

Yelp to Participate in the RBC Capital Markets Global Technology, Internet, Media and Telecommunications Conference

SAN FRANCISCO–(BUSINESS WIRE)–
Yelp Inc. (NYSE: YELP), the company that connects people with great local businesses, today announced that management will present at the RBC Capital Markets Global Technology, Internet, Media and Telecommunications Conference on Wednesday, November 18, 2020 at 1:00 p.m. Pacific Time.

The live and archived webcasts of the presentation will be available on the company’s investor relations website at www.yelp-ir.com.

About Yelp

Yelp Inc. (www.yelp.com) connects people with great local businesses. With unmatched local business information, photos, and review content, Yelp provides a one-stop local platform for consumers to discover, connect, and transact with local businesses of all sizes by making it easy to request a quote, join a waitlist, and make a reservation, appointment, or purchase. Yelp was founded in San Francisco in July 2004.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005662/en/

Yelp Inc.

Kate Krieger

Investor Relations

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Social Media Restaurant/Bar Marketing Data Management Communications Technology Mobile/Wireless Retail

MEDIA:

Logo

November 11, 2020 4:08 pm

Alector to Present at the Stifel 2020 Virtual Healthcare Conference

SOUTH SAN FRANCISCO, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) — Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that Sabah Oney, Ph.D., chief business officer of Alector, will participate in a fireside chat at the Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18, 2020, at 4:40 p.m. ET.

A live webcast of the fireside chat will be available on the “Events & Presentations” page within the Investors section of the Alector website at http://investors.alector.com. A replay will be available on the Alector website for 30 days following the event.

About Alector
Alector is a clinical stage biotechnology company pioneering immuno-neurology, a novel therapeutic approach for the treatment of neurodegenerative diseases. The Company is developing a broad portfolio of innate immune system programs, designed to functionally repair genetic mutations that cause dysfunction of the brain’s immune system and enable the rejuvenated immune cells to counteract emerging brain pathologies. Immuno-neurology targets immune dysfunction as a root cause of multiple pathologies that are drivers of degenerative brain disorders. The Company’s immuno-neurology product candidates are supported by biomarkers and target genetically defined patient populations in frontotemporal dementia and Alzheimer’s disease. This scientific approach is also the basis for the Company’s immuno-oncology programs. Alector is headquartered in South San Francisco, California. For additional information, please visit www.alector.com.

Contacts
Media:
Erica Jefferson
Vice President, Communications and Public Affairs
Alector, Inc.
301-928-4650
[email protected]

1AB
Dan Budwick
973-271-6085
[email protected]

Investors:
Alector, Inc.
[email protected]

November 11, 2020 4:08 pm

Pulse Biosciences to Participate in Upcoming Investor Conferences

Pulse Biosciences to Participate in Upcoming Investor Conferences

HAYWARD, Calif.–(BUSINESS WIRE)–
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced plans to participate in three upcoming virtual investor conferences.

Management is scheduled to present at the Stifel Healthcare Conference on Tuesday, November 17, 2020 at 4:00pm ET.

Management is scheduled to present at the Stephens Annual Investment Conference on Thursday, November 19, 2020 at 4:00pm ET.

Management is also scheduled to participate in the Piper Sandler Healthcare Conference hosting one-on-one meetings Tuesday, December 1, 2020. A presentation webcast will be available in advance of the event on Monday, November 23, 2020 at 10:00am ET.

Interested parties may access a live and recorded webcast from all conferences on the “Investors” section of the Company’s website at www.pulsebiosciences.com.

About Pulse Biosciences®

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. If cleared, the CellFX® System will be the first commercial product to harness the distinctive advantages of the Company’s proprietary Nano-Pulse Stimulation™ (NPS™) technology, such as the ability to non-thermally clear cells while sparing non-cellular tissue, to treat a variety of applications for which an optimal solution remains unfulfilled. Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy. Subject to regulatory approval, the initial commercial use of the CellFX System is expected to address a range of dermatologic conditions that share high demand among patients and practitioners for improved dermatologic outcomes. Designed as a multi-application platform, the CellFX System is intended to offer customer value with a utilization-based revenue model across a spectrum of clinical applications. To learn more please visit www.pulsebiosciences.com.

Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation technology are for investigational use only.

Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005645/en/

Investors:

Pulse Biosciences

Sandra Gardiner, EVP and CFO

510.241.1077

[email protected]

or

Gilmartin Group

Philip Trip Taylor

415.937.5406

[email protected]

Media:

Tosk Communications

Nadine D. Tosk

504.453.8344

[email protected] or

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Medical Devices Health

MEDIA: