Market Newsdesk

• Round led by Quark Venture LP and Global Health Sciences (GHS) Fund

• Funds to support advancement of anti-inflammatory therapy, Auxora
  
  ^TM
  
  , currently being evaluated in severe and critical COVID-19 pneumonia and acute pancreatitis with SIRS

• Zafi Avnur, Ph.D., chief scientific officer and partner at Quark Venture, joins Board of Directors
  

LA JOLLA, Calif., March 11, 2021 (GLOBE NEWSWIRE) — CalciMedica Inc. (“CalciMedica” or the “Company”), a clinical-stage biotechnology company targeting calcium release-activated calcium (CRAC) channels for the treatment of severe acute and chronic inflammatory diseases, today announced it has secured a $21 million Series D financing led by Quark Venture LP and GHS Fund (Quark Venture LP and GF Securities) and joined by previous investors, Valence Life Sciences and Sanderling Ventures. In conjunction with the financing, Zafi Avnur, Ph.D., chief scientific officer and partner at Quark Venture, will join the company’s board of directors. Proceeds from the financing will support the clinical development of CalciMedica’s portfolio of CRAC channel inhibitors including Auxora^TM which is being evaluated in an ongoing blinded placebo-controlled clinical trial in severe and critical COVID-19 pneumonia, with over 200 patients randomized to date, and in a Phase 2b trial in acute pancreatitis that will start enrolling patients in the coming weeks. The private financing will be completed in multiple closings.

“We thank GHS Fund and Quark Venture for its financial support and welcome Dr. Avnur to the board of directors,” said Rachel Leheny, Ph.D., chief executive officer of CalciMedica. “Her extensive and diverse experience in life sciences that spans three decades working with advanced clinical compounds will be critical as we continue to asses and advance our pipeline which includes Auxora in severe and critical COVID-19 pneumonia, acute pancreatitis, and other inflammatory indications.”

Karimah Es Sabar, CEO and partner, Quark Venture added, “We are pleased to invest in CalciMedica and provide support for the further development of the company’s promising CRAC channel inhibitors platform. We believe in Auxora’s potential to be a critical component of treatment for COVID-19 and other acute inflammatory indications. Our investment in CalciMedica reflects our strong commitment to enabling innovative companies developing life-saving therapies.”

Prior to joining Quark Venture, Dr. Avnur was the Global Head of Academic Innovation, Roche Partnering 2009 – 2016. She was responsible for creating relationships with the world’s leading academic institutions and world class innovators, gaining Roche early access to innovation. Dr. Avnur was named Distinguished Scientist, the highest scientific appointment at Roche. Prior to her partnering roles, she worked in pharmaceuticals and diagnostics research and development for nearly 20 years and she participated in global committees at Roche that managed the research drug discovery portfolios for both Inflammatory and Viral Diseases. Dr. Avnur has created eleven startup companies.

Auxora is currently under evaluation in a blinded, placebo-controlled clinical trial enrolling up to 400 patients with severe and critical COVID-19 pneumonia. To date over 200 patients have been randomized. Patients are receiving either Auxora or matched lipid nano-emulsion placebo in addition to standard of care, which includes dexamethasone and may include remdesivir. For more information about the clinical trial, visit clinicaltrials.gov.

About CalciMedica, Inc.

CalciMedica is a privately-held, clinical-stage biotechnology company with a platform focused on CRAC channel drug discovery and development for the treatment of severe acute and chronic inflammatory diseases, including acute pancreatitis, chronic pancreatitis, COVID-19 pneumonia and acute respiratory distress syndrome (ARDS). The company has a portfolio of potent and selective small molecule CRAC channel inhibitors, including its lead product Auxora, that prevent CRAC channel overactivation that can cause organ injury in numerous settings, including endothelial apoptosis, pancreatic necrosis, tissue fibrosis and diffuse alveolar damage. Data from both a Phase 2a acute pancreatitis trial and a Phase 2 COVID-19 pneumonia trial suggest that Auxora prevents organ tissue damage and allows for rapid restoration of organ function. CalciMedica is headquartered in San Diego, CA. For more information, please visit the company website at www.calcimedica.com.

CalciMedica Contact:

Rachel Leheny, Ph.D.
Chief Executive Officer
[email protected]
858-952-5500

Media Contact:

Gloria Gasaatura
LifeSci Communications
[email protected]
646-970-4688

SANTA BARBARA, Calif., March 11, 2021 (GLOBE NEWSWIRE) — Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”), a medical aesthetics company uniquely focused on plastic surgeons, today announced its audited financial results for the fourth quarter and full year ended December 31, 2020.

Ron Menezes, President and Chief Executive Officer of Sientra, stated, “We continue to build on our strong fourth quarter results, which were driven primarily by our investment and market outperformance in our core breast products segment. While the augmentation channel remains a key performance driver, we were also able to gain market share in the hospital channel despite pandemic related challenges faced by the reconstruction market. Ahead of further market normalization in 2021, we remain hyper focused on expanding our hospital account base by continuing to capitalize on customer receptivity to the technical differentiation and compelling safety profile of our tissue expander portfolio, grounded by AlloX2^®. We also expect to benefit in 2021 from targeted digital efforts directed towards patients and surgeons, an expanded and more productive sales force, and educational peer to peer initiatives that will add new accounts and drive continued share gains.”

Mr. Menezes continued, “Our 2021 performance will also be driven by our commitment to establish a culture of focus and accountability, with disciplined investment and execution on commercial, product development and manufacturing initiatives designed to drive revenue and operating leverage. Meanwhile, we expect to reach our goal to achieve break-even contribution margin from miraDry in 2021, as we evaluate the strategic alternatives for the business.”

Mr. Menezes concluded, “Given our progress to date on each of these initiatives, we currently expect breast product segment net sales to grow in excess of 30% in the first quarter 2021 compared to the first quarter 2020.”

Fourth Quarter 2020 Financial Results

• Total net sales for the fourth quarter 2020 were $22.6 million, a decrease of 2% compared to total net sales of $23.2 million for the same period in 2019.
• Net sales for the Breast Products segment totaled $17.9 million in the fourth quarter 2020, an increase of 40% compared to $12.8 million for the same period in 2019 and 17% sequential growth over the quarter ending September 30, 2020.
• Net sales for the miraDry segment totaled $4.8 million in the fourth quarter 2020, a 54% decrease compared to $10.4 million for the same period in 2019 and 22% sequential growth over the quarter ending September 30, 2020.
• Gross profit for the fourth quarter 2020 was $11.1 million, or 48.9% of sales, compared to gross profit of $14.2 million, or 61.3% of sales, for the same period in 2019.  
• Operating expenses for the fourth quarter 2020 decreased by 13.1% to $28.2 million from $32.4 million, excluding $1.1 million of restructuring charges related to Sientra’s organizational efficiency initiative, in the same period in 2019.
• Net loss for the fourth quarter 2020 was ($21.2) million, or ($0.42) per share, compared to a net loss of ($20.2) million, or ($0.41) per share, for the same period in 2019.
• On a non-GAAP basis, adjusted EBITDA loss for the fourth quarter 2020 decreased by 24.6% to ($10.5) million from ($14.0) million for the same period in 2019.

Full Year 2020 Financial Results

• Total net sales for the full year 2020 were $71.2 million, a decrease of 14.9% compared to total net sales of $83.7 million for the same period in 2019.
• Net sales for the Breast Products segment totaled $55.0 million in the full year 2020, an increase of 18.6% compared to $46.4 million for the full year 2019.
• Net sales for the miraDry segment totaled $16.2 million in the full year 2020, a 56.5% decrease compared to $37.3 million for the full year 2019.
• Gross profit for the full year 2020 was $38.9 million, or 54.7% of sales, compared to gross profit of $50.7 million, or 60.6% of sales, for the full year 2019.
• Operating expenses for the full year 2020 decreased by 29.2% to $109.2 million from $154.3 million for the full year 2019.
• Net loss for the full year 2020 was ($89.9) million, or ($1.79) per share, compared to a net loss of ($106.8) million, or ($2.63) per share, for the full year 2019.
• On a non-GAAP basis, adjusted EBITDA loss for the full year 2020 decreased by 35.4% to ($47.0) million from ($72.8) million for the full year 2019.
• Net cash and cash equivalents as of December 31, 2020 were $55.0 million, compared to $63.5 million as of September 30, 2020. The cash balance as of December 31, 2020 does not include net proceeds from the closing of the Company’s public offering of common stock on February 11, 2021 of approximately $39.1 million.

Full Year 2021 Financial Outlook

For full year 2021, the Company expects to achieve total net sales of $78 million to $84 million, representing growth of 10% to 18% compared to net sales of $71.2 million in 2020.

• Anticipates Breast Products net sales of $70 to $74 million, representing growth of 27% to 35% over 2020; and
• Anticipates miraDry net sales of $8 to $10 million.

Conference Call

Sientra will hold a conference call today, March 11, 2021 at 4:30 pm ET to discuss third quarter results. The dial-in numbers are 844-464-3933 for domestic callers and 765-507-2612 for international callers. The conference ID is 3371629. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.sientra.com. The webcast will be archived on the website following the completion of the call.  

Use of Non-GAAP Financial Measures

Sientra has supplemented its US GAAP net income (loss) with a non-GAAP measure of Adjusted EBITDA. Management believes that this non-GAAP financial measure provides useful supplemental information to management and investors regarding the performance of the Company, facilitates a more meaningful comparison of results for current periods with previous operating results, and assists management in analyzing future trends, making strategic and business decisions and establishing internal budgets and forecasts. A reconciliation of non-GAAP Adjusted EBITDA to GAAP net income (loss), the most directly comparable GAAP measure, is provided in the schedule below.

There are limitations in using this non-GAAP financial measure because it is not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. This non-GAAP financial measure should not be considered in isolation or as a substitute for GAAP financial measures. Investors and potential investors should consider non-GAAP financial measures only in conjunction with Sientra’s financial statements prepared in accordance with GAAP and the reconciliations of the non-GAAP financial measure provided in the schedule below.

About Sientra

Headquartered in Santa Barbara, California, Sientra is a medical aesthetics company uniquely focused on plastic surgeons. The Company offers a suite of products designed to make a difference in patients’ lives by enhancing their body image, growing their self-esteem, and restoring their confidence. Sientra has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. The Company’s Breast Products Segment includes its Sientra round and shaped breast implants, the first fifth generation breast implants approved by the FDA for sale in the United States, its ground-breaking Allox2® breast tissue expander with patented dual-port and integral drain technology, and BIOCORNEUM® the #1 performing, preferred and recommended scar gel of plastic surgeons(*). The Company’s miraDry Segment, comprised of its miraDry® system, is approved for sale in over 56 international markets and is the only non-surgical, FDA-cleared device indicated for the permanent reduction of underarm sweat and hair and may also reduce odor.

Sientra uses its investor relations website to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Sientra is routinely posted and is accessible on the Company’s investor relations website at www.sientra.com.

^(*)

 Data on file

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are made only as of the date of this release. The words ‘‘believe,’’ ‘‘may,’’ ‘‘might,’’ ‘‘could,’’ ‘‘will,’’ ‘‘aim,’’ ‘‘estimate,’’ ‘‘continue, ‘‘anticipate,’’ ‘‘intend,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘position,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections and other forward-looking statements. Forward-looking statements may include information concerning the impact of the COVID-19 pandemic on the Company and its operations, the Company’s possible or assumed future results of operations, including descriptions of the Company’s revenues, profitability, anticipated growth rates, market outlook, impact of marketing programs and overall business strategy. Such statements are subject to risks and uncertainties, including the scope and duration of the COVID-19 pandemic, the Company’s ability to recapture delayed procedures resulting from the COVID-19 pandemic, the positive reaction from plastic surgeons and their patients to Sientra’s Breast Products, the positive reaction from plastic surgeons and patients to Sientra’s marketing, sales and educational programs, the ability to execute on the Company’s commercial, product development and manufacturing initiatives, the ability of the Company to drive revenue and operating leverage, the ability to meet consumer demand, the growth of the sale of bioTips in its miraDry segment, and the Company’s ability to manage its operating expenses and cash balance. Additional factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Sientra’s public filings with the Securities and Exchange Commission. All statements other than statements of historical fact are forward-looking statements. The words ‘‘believe,’’ ‘‘may,’’ ‘‘might,’’ ‘‘could,’’ ‘‘will,’’ ‘‘aim,’’ ‘‘estimate,’’ ‘‘continue, ‘‘anticipate,’’ ‘‘intend,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘position,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections and other forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, and such estimates, projections and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection or forward-looking statement. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business.

Contact

Investor Relations
805-679-8885

Sientra, Inc.
Consolidated Statements of Operations
(In thousands, except per share and share amounts)
(Unaudited)
		Three Months Ended								Year Ended
		December 31,								December 31,
		2020				2019				2020				2019
Net sales		$	22,644			$	23,210			$	71,241			$	83,699
Cost of goods sold			11,569				8,971				32,302				33,012
Gross profit			11,075				14,239				38,939				50,687
Operating expenses:
Sales and marketing			14,939				19,202				52,553				80,189
Research and development			2,564				4,011				10,311				13,537
General and administrative			10,691				9,233				38,191				46,771
Restructuring			(87	)			1,083				1,762				1,083
Impairment			—				—				6,432				12,674
Total operating expenses			28,107				33,529				109,249				154,254
Loss from operations			(17,032	)			(19,290	)			(70,310	)			(103,567	)
Other income (expense), net:
Interest income			3				323				206				1,406
Interest expense			(2,162	)			(1,292	)			(9,451	)			(4,568	)
Change in fair value of derivative liability			(2,050	)			—				(10,470	)			—
Other income (expense), net			37				46				111				(55	)
Total other income (expense), net			(4,172	)			(923	)			(19,604	)			(3,217	)
Loss before income taxes			(21,204	)			(20,213	)			(89,914	)			(106,784	)
Income tax			33				34				33				34
Net loss		$	(21,237	)		$	(20,247	)		$	(89,947	)		$	(106,818	)
Basic and diluted net loss per share attributable to common stockholders		$	(0.42	)		$	(0.41	)		$	(1.79	)		$	(2.63	)
Weighted average outstanding common shares used for net loss per share attributable to common stockholders:
Basic and diluted			50,462,124				49,506,169				50,233,175				40,654,272

Sientra, Inc.
Condensed Consolidated Balance Sheets
(In thousands)
(Unaudited)
		December 31,				December 31,
		2020				2019
Assets
Current assets:
Cash and cash equivalents		$	54,967			$	87,608
Accounts receivable, net			23,503				27,548
Inventories, net			48,648				39,612
Prepaid expenses and other current assets			2,154				2,489
Total current assets			129,272				157,257
Property and equipment, net			13,106				12,314
Goodwill			9,202				9,202
Other intangible assets, net			9,387				17,390
Other assets			8,011				8,241
Total assets		$	168,978			$	204,404
Liabilities and Stockholders’ Equity
Current liabilities:
Current portion of long-term debt		$	4,670			$	6,508
Accounts payable			6,504				9,352
Accrued and other current liabilities			32,389				32,551
Customer deposits			17,905				13,943
Sales return liability			9,192				8,116
Total current liabilities			70,660				70,470
Long-term debt, net of current portion			60,500				38,248
Derivative liability			26,570				—
Deferred and contingent consideration			2,350				5,177
Warranty reserve and other long-term liabilities			9,455				8,627
Total liabilities			169,535				122,522
Stockholders’ equity:
Total stockholders’ equity			(557	)			81,882
Total liabilities and stockholders’ equity		$	168,978			$	204,404

Sientra, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
		Year Ended December 31,
		2020				2019
Cash flows from operating activities:
Net loss		$	(89,947	)		$	(106,818	)
Adjustments to reconcile net loss to net cash used in operating activities:
Impairment			6,432				12,674
Depreciation and amortization			4,094				3,524
Provision for doubtful accounts			4,423				2,298
Provision for warranties			1,271				929
Provision for inventory			3,601				2,626
Fair value adjustments to derivative liability			10,470				—
Fair value adjustments of other liabilities held at fair value			96				969
Amortization of debt discount and issuance costs			4,347				359
Stock-based compensation expense			8,344				12,478
Payments of contingent consideration liability in excess of acquisition-date fair value			—				(1,968	)
Other non-cash adjustments			375				290
Changes in assets and liabilities:
Accounts receivable			(378	)			(7,320	)
Inventories			(12,808	)			(10,921	)
Prepaid expenses, other current assets and other assets			935				(8,513	)
Accounts payable, accrueds, and other liabilities			(6,420	)			6,694
Customer deposits			3,961				4,008
Sales return liability			1,077				2,068
Legal settlement payable			—				(410	)
Net cash used in operating activities			(60,127	)			(87,033	)
Cash flows from investing activities:
Purchase of property and equipment			(4,037	)			(4,071	)
Business acquisitions, net of cash and restricted cash acquired			—				(17,943	)
Net cash used in investing activities			(4,037	)			(22,014	)
Cash flows from financing activities:
Proceeds from option exercises and employee stock purchase plan			865				1,341
Net proceeds from issuance of common stock			263				107,734
Payments related to tax witholding on vested restricted stock units (RSUs)			(1,791	)			(3,064	)
Gross borrowings under the Term Loan			—				5,000
Repayments under the Term Loan			(25,000	)			—
Gross borrowings under the PPP loan			6,652				—
Gross borrowings under the Revolving Loan			—				22,296
Repayment of the Revolving Loan			(6,508	)			(15,788	)
Net proceeds from issuance of the Convertible Note			60,000				—
Payments of contingent consideration up to acquisition-date fair value			—				(5,766	)
Deferred financing costs			(2,958	)			(1,997	)
Net cash provided by financing activities			31,523				109,756
Net increase (decrease) in cash, cash equivalents and restricted cash			(32,641	)			709
Cash, cash equivalents and restricted cash at:
Beginning of period			87,951				87,242
End of period		$	55,310			$	87,951
Reconciliation of cash, cash equivalents, and restricted cash to the consolidated balance sheets
Cash and cash equivalents		$	54,967			$	87,608
Restricted cash included in other assets			343				343
Total cash, cash equivalents and restricted cash		$	55,310			$	87,951

Sientra, Inc.
Reconciliation of Net Loss to Non-GAAP Adjusted EBITDA
(Unaudited)
		Three Months Ended								Year Ended
		December 31,								December 31,
Dollars, in thousands		2020				2019				2020				2019
Net loss, as reported		$	(21,237	)		$	(20,247	)		$	(89,947	)		$	(106,818	)
Adjustments to net loss:
Interest (income) expense and other, net			2,122				923				9,134				3,217
Provision for income taxes			33				34				33				34
Depreciation and amortization			1,098				986				4,094				3,524
Fair value adjustments to contingent consideration			68				454				135				1,044
Fair value adjustments to derivative liability			2,050				—				10,470				—
Stock-based compensation			2,879				2,797				8,344				12,478
Restructuring			(87	)			1,083				1,762				1,083
One-time severance charges			2,539				—				2,539				—
Impairment			—				—				6,432				12,674
Total adjustments to net loss			10,702				6,277				42,943				34,054
Adjusted EBITDA		$	(10,535	)		$	(13,970	)		$	(47,004	)		$	(72,764	)
		Three Months Ended								Year Ended
		December 31,								December 31,
As a Percentage of Revenue**		2020				2019				2020				2019
Net loss, as reported			(93.8	%)			(87.2	%)			(126.3	%)			(127.6	%)
Adjustments to net loss:
Interest (income) expense and other, net			9.4	%			4.0	%			12.8	%			3.8	%
Provision for income taxes			0.1	%			0.1	%			0.0	%			0.0	%
Depreciation and amortization			4.8	%			4.2	%			5.7	%			4.2	%
Fair value adjustments to contingent consideration			0.3	%			2.0	%			0.2	%			1.2	%
Fair value adjustments to derivative liability			9.1	%			0.0	%			14.7	%			0.0	%
Stock-based compensation			12.7	%			12.1	%			11.7	%			14.9	%
Restructuring			(0.4	%)			4.7	%			2.5	%			1.3	%
One-time severance charges			11.2	%			0.0	%			3.6	%			0.0	%
Impairment			0.0	%			0.0	%			9.0	%			15.1	%
Total adjustments to net loss			47.3	%			27.0	%			60.3	%			40.7	%
Adjusted EBITDA			(46.5	%)			(60.2	%)			(66.0	%)			(86.9	%)
** Adjustments may not add to the total figure due to rounding

FREMONT, Calif., March 11, 2021 (GLOBE NEWSWIRE) — Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and year ended December 31, 2020, as well as business highlights.

“Over this past year, we made important progress in advancing Qtrypta^TM towards the market,” said Steven Lo, president and chief executive officer of Zosano. “We expect to receive the FDA’s feedback on our pharmacokinetic study protocol shortly, and if supportive of our proposal, we are prepared to initiate this study quickly. Our clear priority is to resubmit our NDA as soon as possible so that patients suffering from debilitating migraines have access to Qtrypta, if approved. Separately, last year we also executed feasibility study agreements with Mitsubishi Tanabe Pharma Corporation and two other partners to explore additional potential therapeutic applications of our transdermal microneedle system technology.”

Select Business Highlights

• Completed a Type A meeting with the U.S. Food and Drug Administration (“FDA”) Division of Neurology II (the “Division”) on January 29, 2021 regarding the requirements for resubmission of the Qtrypta (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (“NDA”) following the Complete Response Letter received on October 20, 2020
  • Company plans to conduct an additional pharmacokinetic study that incorporates a patient skin assessment for inclusion in an NDA resubmission package, pending review of the study protocol by the FDA
• Presented a post-hoc retrospective analysis of data from the ZOTRIP trial at the January 2021 Annual Headache Cooperative of the Pacific Winter Conference that suggested that Qtrypta™ conferred therapeutic benefit at 30 minutes consistent with recently published criteria for early onset of action, and that those patients who were pain free at 30 minutes were still pain free at 2 hours
• Entered into three feasibility study agreements including one with Mitsubishi Tanabe Pharma Corporation. Under these agreements, Zosano plans to evaluate the feasibility of formulating each partner’s pharmaceutical agent for administration with its proprietary transdermal microneedle system technology
• Partnered with EVERSANA, a leading provider of commercial services to the life science industry, to commercialize and distribute Qtrypta™, if approved, in the United States

Financial Results for the Fourth Quarter Ended December 31, 2020

Zosano reported a net loss for the fourth quarter of 2020 of $8.1 million, or $0.08 per share on a basic and diluted basis, compared with a net loss of $8.9 million, or $0.46 per share on a basic and diluted basis, for the same quarter in 2019.

Research and development expenses for the fourth quarter of 2020 were $5.4 million, compared with $5.6 million for the same quarter in 2019. The decrease of $0.2 million was due to $0.4 million of lower employee and consulting expenses partially offset by higher depreciation expense.

General and administrative expenses for the fourth quarter of 2020 were $2.6 million, compared with $3.1 million for the same quarter in 2019. The decrease of $0.5 million was primarily due to lower employee related expenses and professional service fees.

As of December 31, 2020, cash and cash equivalents were $35.3 million, compared with $6.3 million as of December 31, 2019.

Financial Results for the Fiscal Year Ended December 31, 2020

Zosano reported a net loss for the full year 2020 of $33.4 million, or $0.49 per share on a basic and diluted basis, compared with a net loss of $37.6 million, or $2.29 per share on a basic and diluted basis, for the full year 2019.

Research and development expenses for the full year 2020 were $21.6 million, compared with $25.4 million in 2019. The decrease of $3.8 million was primarily due to a decrease in pre-clinical and clinical trial costs, related to the completion of the Qtrypta™ long-term safety study, partially offset by an increase in costs associated with the scale up and technology transfer to our commercial manufacturing organizations.

General and administrative expenses for the full year 2020 were $11.2 million, compared with $11.8 million in 2019. The decrease of $0.6 million primarily resulted from lower employee related expenses.

About Zosano Pharma

Zosano Pharma Corporation is a clinical-stage biopharmaceutical company focused on developing products where rapid administration of approved molecules with established safety and efficacy profiles may provide substantial benefit to patients, in markets where patients remain underserved by existing therapies. The company’s transdermal microneedle system technology consists of titanium microneedles coated with drug that are designed to enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is Qtrypta™ (M207), which is a proprietary formulation of zolmitriptan designed to be delivered via its transdermal microneedle system technology, as an acute treatment for migraine. Learn more at www.zosanopharma.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company’s plans to conduct an additional pharmacokinetic study that incorporates a patient skin assessment for inclusion in an NDA resubmission package, the timing with respect to the FDA’s feedback on the pharmacokinetic study protocol, plans for resubmission of the company’s Qtrypta NDA to the FDA, plans to evaluate and explore additional potential therapeutic applications of the company’s transdermal microneedle system technology under feasibility study agreements, the potential benefits of Qtrypta for patients and other future events and expectations described in this press release. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict, and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the company’s ability to obtain additional cash resources to continue operations, the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in the company’s most recent annual report on Form 10-K and quarterly reports on Form 10-Q. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, Zosano cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.

Zosano Contacts:

Christine Matthews
Chief Financial Officer
510-745-1200

Zosano PR:

Sylvia Wheeler or Alexandra Santos
[email protected] or [email protected] 

ZOSANO PHARMA CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

	Three Months Ended December 31,										Year Ended December 31,
	2020					2019					2020					2019
	(unaudited)					(unaudited)
Service revenue	$	224				$	—				$	224				$	—
Operating expenses:
Cost of service revenue	171					—					171					—
Research and development	5,352					5,643					21,622					25,385
General and administrative	2,637					3,103					11,189					11,812
Total operating expenses	8,160					8,746					32,982					37,197
Loss from operations	(7,936		)			(8,746		)			(32,758		)			(37,197		)
Other income (expense):
Interest income	1					4					18					207
Interest expense	(158		)			(166		)			(719		)			(523		)
Other income (expense), net	(5		)			(32		)			90					(76		)
Loss before provision for income taxes	(8,098		)			(8,940		)			(33,369		)			(37,589		)
Provision for income taxes	—					—					—					—
Net loss	$	(8,098	)			$	(8,940	)			$	(33,369	)			$	(37,589	)
Net loss per common share – basic and diluted	$	(0.08	)			$	(0.46	)			$	(0.49	)			$	(2.29	)
Weighted-average shares used in computing net loss per common share – basic and diluted	102,066					19,409					67,907					16,384

ZOSANO PHARMA CORPORATION

CONDENSED BALANCE SHEETS

(in thousands, except par value and share amounts)

	December 31, 2020					December 31, 2019
ASSETS
Current assets:
Cash and cash equivalents	$	35,263				$	6,316
Prepaid expenses and other current assets	453					497
Total current assets	35,716					6,813
Restricted cash	455					455
Property and equipment, net	30,909					24,636
Operating lease right-of-use assets	4,928					5,763
Other long-term assets	3					3
Total assets	$	72,011				$	37,670
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,884				$	4,356
Accrued compensation	2,294					2,015
Build-to-suit obligation, current portion	4,779					4,554
Operating lease liabilities, current portion	1,378					1,140
Paycheck Protection Program loan, current portion	809					—
Other accrued liabilities	3,367					4,172
Total current liabilities	14,511					16,237
Build-to-suit obligation, long-term portion, net of debt issuance costs and discount	4,359					6,095
Operating lease liabilities	4,687					5,931
Paycheck Protection Program loan, long-term portion	812					—
Other liabilities	127					15
Total liabilities	24,496					28,278
Stockholders’ equity:
Preferred stock, $0.0001 par value, 5,000,000 shares authorized; none issued and outstanding as of December 31, 2020 and 2019	—					—
Common stock, $0.0001 par value; 250,000,000 shares authorized as of December 31, 2020 and 2019, respectively; 102,066,218 and 23,503,214 shares issued and outstanding as of December 31, 2020 and 2019, respectively	10					2
Additional paid-in capital	379,695					308,211
Accumulated deficit	(332,190		)			(298,821		)
Total stockholders’ equity	47,515					9,392
Total liabilities and stockholders’ equity	$	72,011				$	37,670

OKLAHOMA CITY, March 11, 2021 (GLOBE NEWSWIRE) — WPX Energy, Inc. (“WPX”), a wholly-owned subsidiary of Devon Energy Corporation (the “Company”), notified The Bank of New York Mellon Trust Company, N.A., as trustee (the “Trustee”) under that certain Indenture, dated as of September 8, 2014, between WPX and the Trustee (as supplemented, the “Indenture”), of its intention to redeem the aggregate principal amounts set forth below with respect to the following notes issued under the Indenture:

• $210,000,000 of the 5.250% Senior Notes due 2027 (the “2027 Notes”);
• $175,000,000 of the 5.875% Senior Notes due 2028 (the “2028 Notes”); and
• $315,000,000 of the 4.500% Senior Notes due 2030 (the “2030 Notes” and, together with the 2027 Notes and the 2028 Notes, the “Notes”).

Such Notes will be redeemed in accordance with the terms set forth in the Indenture regarding the redemption of Notes following a cash equity contribution to, or other equity offering by, WPX. The redemption price will equal (1) 105.250%, 105.875% and 104.500% of the principal amount of the 2027 Notes, the 2028 Notes and 2030 Notes being redeemed, respectively, plus (2) accrued and unpaid interest, if any, up to, but not including, the applicable redemption date. The funds for the redemption will be contributed to WPX by the Company on or prior to the applicable redemption date, which is March 26, 2021 for the 2028 Notes and the 2030 Notes being redeemed and April 10, 2021 for the 2027 Notes being redeemed.

“This debt redemption is another important step in our plan to return value to shareholders,” said Jeff Ritenour, executive vice president and chief financial officer. “With this redemption we will have executed on nearly half of our $1.5 billion board authorized debt repurchase program and we will continue to manage toward our stated leverage target of 1 times net debt-to-EBITDA or less.”

ABOUT DEVON ENERGY

Devon Energy is a leading oil and gas producer in the U.S. with a premier multi-basin portfolio headlined by a world-class acreage position in the Delaware Basin. Devon’s disciplined cash-return business model is designed to achieve strong returns, generate free cash flow and return capital to shareholders, while focusing on safe and sustainable operations. For more information, please visit www.devonenergy.com.

Investor Contacts Scott Coody, 405-552-4735 Chris Carr, 405-228-2496

Media Contact Lisa Adams, 405-228-1732

FORWARD LOOKING STATEMENTS

This press release contains “forward-looking statements” within the meaning of the federal securities laws. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Devon. These risks include, but are not limited to: the risk that we do not complete the debt repurchase program or meet or maintain our leverage target; and the other risks identified in Devon’s 2020 Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission.  Investors are cautioned that any such statements are not guarantees of future performance and that actual results or developments may differ materially and adversely from those projected in the forward-looking statements. The forward-looking statements in this press release are made as of the date hereof, and Devon does not undertake, and expressly disclaim, any duty to update or revise our forward-looking statements based on new information, future events or otherwise.

Full year 2020 net sales of approximately $3.5 million increased 46% over $2.4 million for full year 2019

Further reduced net cash usage to $3.7 million in the fourth quarter 2020 versus $4.1 million in the third quarter 2020

Ended 2020 with cash and cash equivalents of $22.6 million, excluding $6.9 million raised subsequent to the end of the year

Company to host conference call and webcast today, March 11, 2021 at 4:30pm ET

ROCKAWAY, N.J., March 11, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced fourth quarter and full year 2020 financial results and provided an operational update.

Fourth Quarter 2020 and Recent Highlights

	•		Reported full year 2020 net sales of approximately $3.5 million, representing an increase of 46% over $2.4 million for full year 2019; fourth quarter net sales of approximately $928,000, an increase of 38% over the fourth quarter of 2019;
	•		Used net cash of approximately $3.7 million, down from $4.1 million in the third quarter of 2020 and $9.4 million in the fourth quarter of 2019;
	•		Secured unique CMS Level II HCPCS reimbursement code for “Non-invasive vagus nerve stimulator”;
	•		Announced inclusion of gammaCore in new NHS England and NHS Improvement MedTech Funding Mandate Policy 2021/22, and two-year extension of gammaCore listing in the NHS Supply Chain Catalogue;
	•		Announced Scottish Health Technology Group recommendation for use of gammaCore™ in NHS Scotland cluster headache patients;
	•		Executed distribution agreements with Pro Medica Baltic, RSK Medical and Medistar for distribution of gammaCore Sapphire in Eastern Europe, Canada and Australia, respectively;
	•		Obtained 510(k) clearance of gammaCore to expand its indication into preventative and acute treatment of adolescent migraine (ages 12-17);
	•		Announced completion of enrollment in the investigator-initiated SAVIOR-1 clinical trial evaluating gammaCore Sapphire CV in hospitalized COVID-19 patients exhibiting respiratory symptoms;
	•		Announced publication of a peer reviewed paper entitled: “Non-Invasive vagus nerve stimulation to reduce ileus after major colorectal surgery: Early development study” in the journal Colorectal Disease on use of nVNS to reduce post-operative ileus after major colorectal surgery;
	•		Announced selection of gammaCore for NIDA-sponsored study in opioid use disorders;
	•		Announced full enrollment in study of gammaCore for the acute treatment of stroke supported by the Turkish Neurological Society; and
	•		Presented positive topline results from the PREMIUM II study evaluating gammaCore for the prevention of migraine subsequent to early trial termination in March 2020 due to COVID-19.

Dan Goldberger, Chief Executive Officer of electroCore, commented: “We had a highly productive fourth quarter across all facets of our business in spite of the challenges and headwinds of the pandemic. We delivered 38% year-over-year revenue growth in the quarter, we achieved a major U.S. reimbursement milestone in the establishment of a unique Level II HCPCS code for ‘Non-invasive vagus nerve stimulator’, we signed three ex–U.S. distribution agreements, we continued expanding the gammaCore indication for use to include adolescents suffering from migraine, we saw the progression of clinical trials in four additional indications: COVID-19, stroke, post-operative ileus and opioid use disorder, and we realized continued support by NHS England to cover gammaCore therapy through inclusion in the new NHS Improvement MedTech Funding Mandate.

“Notably, we were able to achieve all of this while continuing to manage our cash prudently. Our net cash usage for the fourth quarter of $3.7 million was down from $4.1 million in the third quarter of 2020 and down significantly from $9.4 million in the same period last year. Our cash balance at December 31, 2020 provides substantial runway to execute our plan into 2022.

“Looking ahead, while the course of the pandemic remains difficult to predict, I believe we have taken steps to ensure continued growth of gammaCore in our core revenue generating channels while working to establish and capitalize on new opportunities. I believe gammaCore has broad potential utility across a very diverse range of indications, and along with the entire electroCore team, I remain committed to making this therapy available to every individual who can potentially benefit from it.”

Fourth Quarter and Full Year 2020 Financial Results

For the quarter ended December 31, 2020, electroCore reported net sales of approximately $928,000 compared to $675,000 in the same period of 2019, and at the upper end of guidance provided in the company’s January 11, 2021 business update. For the full year 2020, the company reported net sales of approximately $3.5 million, as compared to net sales of approximately $2.4 million for the full year 2019.

Revenue from the Department of Veterans Affairs (“VA”) and Department of Defense (“DOD”) decreased 21% sequentially to $509,000 in the fourth quarter of 2020 from $646,000 in the third quarter of 2020 and increased 35% as compared to $378,000 in the fourth quarter of 2019. Paid months of therapy shipped to the VA and DOD decreased 22% sequentially to 1,232 in the fourth quarter of 2020 from 1,571 in the third quarter of 2020 and increased 49% as compared to 829 in the fourth quarter of 2019.

Revenue from outside the United States increased sequentially to $311,000 in the fourth quarter of 2020 from $278,000 in the third quarter and increased 6% as compared to $294,000 in the fourth quarter of 2019. Paid months of therapy shipped outside the United States increased 12% sequentially to 1,143 in the fourth quarter of 2020 from 1,020 in the third quarter of 2020 and increased 19% as compared to 961 in the fourth quarter of 2019.

Gross profit for the fourth quarter of 2020 was $109,000 inclusive of an increase of $434,000 in inventory reserves, as compared to $284,000 for the fourth quarter of 2019. Gross margin for the fourth quarter excluding the increase to inventory reserves was 59%, compared to 42% in the fourth quarter of 2019. Gross margin for the full year 2020 was 50% as compared to 52% for the full year of 2019. Excluding the increase to inventory reserves, gross margin for full year 2020 was 63%.

Total operating expenses in the fourth quarter of 2020 were approximately $6.4 million, a reduction of approximately $2.5 million from $8.9 million in the fourth quarter of 2019. Total operating expenses for the full year 2020 were $26.5 million as compared to $47.3 million for the full year 2019.

Research and development expense in the fourth quarter of 2020 was $1.0 million, as compared to $1.6 million for the same period in 2019. Research and development expenses for the full year 2020 were $4.2 million as compared to $9.9 million for the full year 2019.

Selling, general and administrative expense in the fourth quarter of 2020 was $5.4 million, as compared to $7.3 million for the same period in 2019. Selling, general and administrative expense for the full year 2020 was $21.8 million as compared to $35.4 million for the full year 2019.

GAAP net loss in the fourth quarter of 2020 was $6.3 million as compared to a GAAP net loss of $8.5 million in the fourth quarter of 2019. GAAP net loss for the full year 2020 was a loss of $23.5 million as compared to a GAAP net loss of $45.1 million for the full year 2019.

Adjusted EBITDA net loss in the fourth quarter of 2020 was a loss of $4.3 million as compared to a loss of $6.7 million in the fourth quarter of 2019. Adjusted EBITDA net loss for the full year 2020 was a loss of $18.4 million as compared to an adjusted EBITDA net loss of $39.0 million for the full year 2019.

The company defines adjusted EBITDA net loss as GAAP net loss, excluding income tax expense/benefit, depreciation and amortization, stock-compensation expense, write-off of right of use operating lease, increase in inventory reserves, restructuring and other severance related charges, legal fees associated with stockholders’ litigation and total other income/expense. A reconciliation of GAAP net loss to Non-GAAP adjusted EBITDA net loss has been provided in the financial statement tables included in this press release.

Net cash used in the quarter ended December 31, 2020 was approximately $3.7 million, as compared to $4.1 million in the third quarter of 2020, and $9.4 million in the fourth quarter of 2019. Net cash used for the full year 2020 was $20.2 million as compared to net cash used of $44.5 million for the full year 2019.

Cash and cash equivalents and marketable securities at December 31, 2020 totaled approximately $22.6 million, as compared to approximately $24.1 million at December 31, 2019. Subsequent to the end of the fourth quarter, the company raised approximately $6.9 million through the company’s previously announced stock purchase agreement, resulting in a pro forma cash and cash equivalents and marketable securities balance of $29.5 million as of December 31, 2020.

Webcast and Conference Call Information

electroCore’s management team will host a conference call today, March 11, 2021, beginning at 4:30 p.m. ET.

Investors interested in listening to the conference call or webcast may do so by dialing 877-407-4018 for domestic callers or 201-689-8471 for international callers, using conference ID: 13715729, or through the following link: http://public.viavid.com/index.php?id=143276

An archived webcast of the event will be available on the “Investors” section of the company’s website at: www.electrocore.com.

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.

About gammaCore
™

gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients. 

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

•	gammaCore is contraindicated for patients with:
	○	An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
	○	A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
	○	An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location

•	Safety and efficacy of gammaCore have not been evaluated in the following patients:
	○	Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
	○	Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
	○	Pediatric patients (younger than 12 years)
	○	Pregnant women
	○	Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

gammaCore Sapphire™ CV has received Emergency Use Authorization (EUA) from the FDA for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus Nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.

gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.

gammaCore Sapphire CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.

Please refer to gammaCore Sapphire CV (nVNS) Instructions for Use for Use for all of the important warnings and precautions before using or prescribing gammaCore Sapphire CV (nVNS).

Forward-Looking Statement

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans, its expected cash runway, its pipeline or potential markets for its technologies, the timing, outcome and impact of regulatory, clinical and commercial developments including commercialization of, and potential reimbursement for, gammaCore Sapphire CV, the business, operating or financial impact of such studies, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.

Investors:

Hans Vitzthum
LifeSci Advisors
617-430-7578
[email protected]

or

Media Contact:

Summer Diaz
electroCore
816-401-6333
[email protected]

electroCore, Inc.

Consolidated Statements of Operations

(Unaudited)

(In thousands, except per share data)

		Three months ended December 31,								Year ended December 31,
		2020				2019				2020				2019
Net sales		$	928.2			$	675.0			$	3,495.8			$	2,390.3
Cost of goods sold			818.9				391.0				1,737.5				1,157.0
Gross profit			109.3				284.0				1,758.3				1,233.3
Operating expenses:
Research and development			1,018.7				1,623.0				4,201.3				9,902.2
Selling, general and administrative			5,413.8				7,267.0				21,840.9				35,422.3
Restructuring and other severance related charges			—				—				464.6				1,997.3
Total operating expenses			6,432.5				8,890.0				26,506.8				47,321.8
Loss from operations			(6,323.2	)			(8,606.0	)			(24,748.5	)			(46,088.5	)
Other (income)/expense
Interest and other income			(3.8	)			(121.0	)			(84.3	)			(970.6	)
Other expense/(income)			4.4				(4.3	)			17.8				12.3
Total other expense/(income)			0.6				(125.3	)			(66.5	)			(958.3	)
Loss before income taxes			(6,323.8	)			(8,480.7	)			(24,682.0	)			(45,130.2	)
(Provision)/benefit for income taxes			—				(17.7	)			1,170.9				(17.7	)
Net loss			(6,323.8	)			(8,498.4	)			(23,511.1	)			(45,147.9	)
Net loss per share of common stock – Basic and Diluted			(0.14	)			(0.29	)			(0.60	)			(1.54	)
Weighted average number of shares common shares outstanding –    Basic and Diluted			45,398,309				29,561,345				38,998,698				29,379,975

electroCore, Inc.

Consolidated Balance Sheet Information

(Unaudited)

(in thousands)

		As of December 31,
		2020				2019
Cash and cash equivalents		$	4,241.9			$	13,563.8
Marketable securities		$	18,386.2			$	10,495.4
Total assets		$	31,518.2			$	35,461.7
Current liabilities		$	5,890.3			$	9,144.7
Total liabilities		$	7,873.6			$	10,564.6
Total equity		$	23,644.6			$	24,897.1

(Unaudited) Use of Non-GAAP Financial Measure

The company is presenting adjusted EBITDA net loss because it believes this measure is a useful indicator of its operating performance. electroCore management uses this non-GAAP measure principally as a measure of the company’s core operating performance and believes that this measure is useful to investors because it is frequently used by the financial community, investors, and other interested parties to evaluate companies in the company’s industry. The company also believes that this measure is useful to its management and investors as a measure of comparative operating performance from period to period. Additionally, the company believes its use of non-GAAP adjusted EBITDA net loss from operations facilitates management’s internal comparisons to historical operating results by factoring out potential differences caused by charges not related to its regular, ongoing business, including, without limitation, non-cash charges and certain large and unpredictable charges such as restructuring expenses.

The company has presented adjusted EBITDA net loss as a non-GAAP financial measure in this press release. The company defines adjusted EBITDA net loss as its reported GAAP net loss excluding income tax expense/benefit, depreciation and amortization, stock-based compensation, write-off of right of use operating lease, increase in inventory reserves, restructuring and other severance related charges, legal fees associated with stockholders litigation and total other income/expense.
  

		Three months ended								Year ended
		December 31,								December 31,
		2020				2019				2020				2019
						(in thousands)
GAAP net loss		$	(6,323.8	)		$	(8,498.4	)		$	(23,511.1	)		$	(45,147.9	)
Provision/(benefit) for income taxes			—				17.7			$	(1,170.9	)		$	17.7
Depreciation and amortization			110.6				97.3			$	399.2			$	249.6
Stock-based compensation			775.7				1,205.4			$	3,266.3			$	3,895.8
Write-off of right of use operating lease			557.5				—				557.5				—
Increase in inventory reserves			434.0				—				434.0				—
Restructuring and other severance related charges			—				—			$	464.6			$	1,997.3
Legal fees associated with stockholders’ litigation			135.5			$	641.0			$	1,205.3			$	963.0
Total other (income)/expense			0.6			$	(125.3	)		$	(66.5	)		$	(958.3	)
Adjusted EBITDA net loss		$	(4,309.9	)		$	(6,662.3	)		$	(18,421.6	)		$	(38,982.8	)

The company’s use of a non-GAAP measure has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of its results as reported under GAAP. Some of these limitations are: the non-GAAP measure does not reflect interest or tax payments that may represent a reduction in cash available; although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and the non-GAAP measure does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements; the non-GAAP measure does not reflect the potentially dilutive impact of equity-based compensation; and the non-GAAP measure does not reflect changes in, or cash requirements for, working capital needs; other companies, including companies in electroCore’s industry, may calculate adjusted EBITDA net loss differently, which reduces its usefulness as a comparative measure. Because of these and other limitations, you should consider the non-GAAP measure together with other GAAP-based financial performance measures, including various cash flow metrics, net loss, and other GAAP results. A reconciliation of GAAP net loss to non-GAAP adjusted EBITDA net loss has been provided in the preceding financial statements table of this press release.

COSTA MESA, Calif., March 11, 2021 (GLOBE NEWSWIRE) — El Pollo Loco Holdings, Inc. (Nasdaq: LOCO) today announced financial results for the 14-week period ended December 30, 2020

Highlights for the fourth quarter ended December 30, 2020 compared to the fourth quarter ended December 25, 2019 were as follows:

• Total revenue was $110.3 million compared to $107.5 million.
• System-wide comparable restaurant sales decreased 0.2%, including a 3.0% decrease for company-operated restaurants, and a 1.8% increase for franchised restaurants. System-wide comparable restaurant sales declined 2.1% in metropolitan Los Angeles, while increasing 3.3% in other markets.  
• Income from operations was $8.2 million compared to $5.3 million in the prior year period. Restaurant contribution was $15.3 million, or 15.8% of company-operated restaurant revenue, compared to $17.6 million, or 18.6% of company-operated restaurant revenue. Included in income from operations and restaurant contribution margin were approximately $2.9 million in COVID-19 related expenses.
• Net income was $5.5 million, or $0.15 per diluted share, compared to net income of $3.5 million, or $0.10 per diluted share.
• Pro forma net income⁽¹⁾ was $5.7 million, or $0.16 per diluted share, compared to $6.2 million, or $0.18 per diluted share.
• Adjusted EBITDA⁽¹⁾ was $13.6 million, compared to $14.5 million.

  (1) Pro forma net income and adjusted EBITDA are not presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and are defined below under “Key Financial Definitions.” A reconciliation of GAAP net income to pro forma net income and adjusted EBITDA is included in the accompanying financial data. See also “Non-GAAP Financial Measures.”

Bernard Acoca, President and Chief Executive Officer of El Pollo Loco Holdings, Inc., stated, “We posted solid fourth quarter results despite continuing COVID-19-related challenges, especially in our core Los Angeles market. We are particularly pleased with the performance of our non-LA markets that posted comparable sales growth of 3.3%, giving us further confidence that the foundation of our business is strong and the localized challenges we have faced are transitory. Furthermore, we have begun to see a deceleration in COVID-19 cases in California beginning in mid-January, and expect sales trends to improve as businesses reopen and economic activity resumes.”

Acoca continued, “Despite an unusual 2020, we continued to make great progress toward strengthening our brand. During the year, our team was able to successfully complete the execution of our Transformation Agenda, during which we have established a people first culture, strengthened our brand fundamentals, simplified operations and laid the foundation for profitable and responsible growth. Completing this plan during a pandemic of this nature was truly a testament to the resilience and dedication of our restaurant teams and franchise partners, and I am proud to be able to work alongside every one of them.”

Acoca concluded, “As we enter 2021, our company is well positioned for the next phase of growth guided by our new three-year Acceleration Agenda. The strategies within our new agenda will focus on an asset light, franchise driven growth model, continuing to digitize our business to compete more effectively and expanding on what makes us so unique – our L.A. Mex brand identity. We are optimistic about the future of our business and are confident that our go-forward strategies, combined with all we have accomplished to date, will drive sales and profit growth when we return to a more normalized operating environment.”

Fourth Quarter 2020 Financial Results

As discussed previously, in March of 2020 the Company fully drew down its $150.0 million revolving credit facility, adding $34.5 million of cash to its balance sheet. During the fourth quarter, the Company paid down $21.0 million of debt, net of borrowings, and as of December 30, 2020 had $62.8 million of debt outstanding and $13.2 million in cash and equivalents. Subsequent to the end of the fourth quarter, the Company paid down an additional $7.0 million of debt.

Company-operated restaurant revenue in the fourth quarter of 2020 was $96.4 million, compared to $94.8 million in the fourth quarter of 2019. The Company’s fourth quarter of 2020 included 14 weeks, compared to 13 weeks in the fourth quarter of 2019. Revenue attributed to the extra operating week was $4.6 million. In addition to the extra operating week, the increase in company-operated revenue was positively impacted by an increase of $0.9 million of non-comparable restaurant sales on restaurants that had not been open the fifteen months required to be included in comparable restaurant sales and $0.2 million in revenue recognized for the loyalty points program. The increase in company-operated restaurant sales was partially offset by a decrease in company-operated restaurant revenue of $2.7 million due to a 3.0% decrease in company-operated comparable restaurant sales, which the Company believes was primarily related to the impact of the COVID-19 pandemic, a decrease of $0.6 million from the closure of two restaurants and the sale of five company-operated restaurants to franchisees during the fourth quarter of the prior year, and a $0.8 million decrease due to temporary restaurant closures as a result of the COVID-19 pandemic.

Franchise revenue in the fourth quarter of 2020 increased 9.4% to $7.9 million, compared to $7.2 million in the fourth quarter of 2019. This increase was primarily due to a 1.8% increase in franchise comparable restaurant sales, the opening of one new franchise restaurant, revenue generated from five company-operated restaurants sold by the Company to franchisees during the fourth quarter of 2019, as well as $0.7 million for the additional week of franchise revenue recognized in a 14-week quarter. The increase in franchise revenue was partially offset by the closure of eight franchise locations during the same period.

Income from operations in the fourth quarter of 2020 was $8.2 million, compared to $5.3 million in the fourth quarter of 2019. Restaurant contribution was $15.3 million, or 15.8% of company-operated restaurant revenue, compared to $17.6 million, or 18.6% of company-operated restaurant revenue in the fourth quarter of 2019. The decrease in restaurant contribution was largely due to the impact of wage increases in California, sales deleverage, labor costs associated with the COVID-19 pandemic, lapping of a prior year credit card settlement received, commodity inflation and increased delivery fees. The decrease was partially offset by the impact of higher menu prices, labor efficiencies and the sale of lower-performing company-owned restaurants to franchisees during 2019. Restaurant contribution is a non-GAAP measure defined below under “Key Financial Definitions.” A reconciliation of GAAP income from operations to restaurant contribution is included in the accompanying financial data. See also “Non-GAAP Financial Measures.”

General and administrative expenses in the fourth quarter of 2020 were $8.9 million, compared to $10.2 million in the fourth quarter of 2019. The decrease was due primarily to a $0.8 million decrease in legal expenses, a $0.6 million decrease in labor related costs, primarily related to a decrease in management bonus expense, and a $0.2 million decrease in restaurant pre-opening costs. This decrease was partially offset by a $0.2 million increase in stock compensation expenses and a $0.1 million increase in other general and administrative expenses.

Net income for the fourth quarter of 2020 was $5.5 million, or $0.15 per diluted share, compared to net income of $3.5 million, or $0.10 per diluted share, in the fourth quarter of 2019. Pro forma net income was $5.7 million, or $0.16 per diluted share, during the fourth quarter of 2020, compared to $6.2 million, or $0.18 per diluted share, during the fourth quarter of 2019. A reconciliation between GAAP net income and pro forma net income is included in the accompanying financial data. See also “Non-GAAP Financial Measures.”

First Quarter 2021 Update

The COVID-19 pandemic has continued to have a significant impact on our business in the first quarter of 2021. All company-owned and the vast majority of franchise restaurants located in California, which make up 80% of our restaurants, continue to operate with closed dining rooms. System-wide comparable restaurant sales in January and February decreased 3.6% and 1.6%, respectively. As of February 24, 2021, year-to date comparable restaurant sales decreased 2.6% consisting of a 6.8% decline in company-owned restaurants and a 0.5% increase in franchise restaurants. System-wide comparable restaurant sales decreased 5.6% in Los Angeles and surrounding areas and increased 2.7% in other markets. In addition, through February 24, 2021, the company incurred $2.3 million of COVID-19 related expenses, which were primarily due to leaves of absence and overtime pay. These costs have been declining during the first quarter as the number of COVID-19 cases continues to decrease in California.

2021 Outlook

Due to the uncertainty surrounding the COVID-19 pandemic, the company is not yet providing a financial outlook for the year ending December 29, 2021. However, the company is providing the following expectations for 2021:

• The opening of three to five new company-owned restaurants and four to six new franchised restaurants.
• Pro forma income tax rate of 26.5%.

Key Financial Definitions

Comparable restaurant sales reflect the change in year-over-year sales for the comparable company, franchised and total system restaurant base. The comparable restaurant base is defined to include those restaurants open for 15 months or longer and excludes restaurants that were closed during the applicable period. At December 30, 2020, there were 190 restaurants in our comparable company-operated restaurant base and 465 restaurants in our comparable system restaurant base.

Restaurant contribution and restaurant contribution margin are neither required by, nor presented in accordance with GAAP. Restaurant contribution is defined as company-operated restaurant revenue less company restaurant expenses, which are food and paper costs, labor and related expenses, and occupancy and other operating expenses. Restaurant contribution excludes certain costs, such as general and administrative expenses, depreciation and amortization, asset impairment and closed-store reserves, loss on sale of restaurants, recovery of securities lawsuits related legal expenses and other costs that are considered normal operating costs. Accordingly, restaurant contribution is not indicative of overall Company results and does not accrue directly to the benefit of shareholders because of the exclusion of certain corporate-level expenses. Restaurant contribution margin is defined as restaurant contribution as a percentage of net company-operated restaurant revenue. See also “Non-GAAP Financial Measures.”

EBITDA and adjusted EBITDA are neither required by, nor presented in accordance with, GAAP. EBITDA represents net income before interest expense, provision for income taxes, depreciation, and amortization, and adjusted EBITDA represents EBITDA before items that we do not consider representative of our ongoing operating performance, as identified in the GAAP reconciliation in the accompanying financial data. See also “Non-GAAP Financial Measures.”

Pro forma net income is neither required by, nor presented in accordance with, GAAP. Pro forma net income represents net income adjusted for (i) costs (or gains) related to loss (or gains) on disposal of assets or assets held for sale and asset impairment and closed store costs, (ii) amortization expense and other estimate adjustments (whether expense or income) incurred on the Tax Receivable Agreement (“TRA”) completed at the time of our IPO, (iii) legal costs associated with securities class action litigation, (iv) extraordinary legal settlement costs, (v) insurance proceeds received related to securities class action legal expenses, (vi) costs associated with the transition of our CEO and (vii) provision for income taxes at a normalized tax rate of 26.5% for the fourteen and fifty-three weeks ended December 30, 2020 and thirteen and fifty-two weeks ended December 25, 2019, which reflects our estimated long-term effective tax rate, including both federal and state income taxes (excluding the impact of the income tax receivable agreement and valuation allowance) and applied after giving effect to the foregoing adjustments. See the GAAP reconciliation in the accompanying financial data and “Non-GAAP Financial Measures.”

Conference Call

The Company will host a conference call to discuss financial results for the fourth quarter of 2020 today at 4:30 PM Eastern Time. Bernard Acoca, President and Chief Executive Officer and Larry Roberts, Chief Financial Officer will host the call.

The conference call can be accessed live over the phone by dialing 877-407-3982 or for international callers by dialing 201-493-6780. A replay will be available after the call and can be accessed by dialing 844-512-2921 or for international callers by dialing 412-317-6671; the passcode is 13715273. The replay will be available until Thursday, March 25, 2021. The conference call will also be webcast live from the Company’s corporate website at investor.elpolloloco.com under the “Events & Presentations” page. An archive of the webcast will be available at the same location on the corporate website shortly after the call has concluded.

About El Pollo Loco

El Pollo Loco (Nasdaq:LOCO) is the nation’s leading fire-grilled chicken restaurant chain renowned for its masterfully citrus-marinated, fire-grilled chicken and handcrafted entrees using fresh ingredients inspired by Mexican recipes. With more than 475 company-owned and franchised restaurants in Arizona, California, Nevada, Texas, Utah, and Louisiana. El Pollo Loco is expanding its presence in key markets through a combination of company and existing and new franchisee development. Visit us on our website at ElPolloLoco.com.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to risks and uncertainties. All statements other than statements of historical fact included in this press release are forward-looking statements. Forward-looking statements discuss our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business, including in connection with the expected impact of the COVID-19 pandemic. You can identify forward-looking statements because they do not relate strictly to historical or current facts. These statements may include words such as “aim,” “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “outlook,” “potential,” “project,” “projection,” “plan,” “intend,” “seek,” “may,” “could,” “would,” “will,” “should,” “can,” “can have,” “likely,” the negatives thereof and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. They appear in a number of places throughout this press release and include statements regarding our ability to improve growth and profitability as businesses reopen and economic activity resumes from the impacts of COVID-19, as well as our ongoing business intentions, beliefs or current expectations concerning, among other things, our results of operations, financial condition, sales levels, liquidity, prospects, growth, strategies and the industry in which we operate. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those that we expected.

While we believe that our assumptions are reasonable, we caution that it is very difficult to predict the impact of known factors, and it is impossible for us to anticipate all factors that could affect our actual results. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. You should evaluate all forward-looking statements made in this press release in the context of the risks and uncertainties that could cause outcomes to differ materially from our expectations. These factors include, but are not limited to: the impact of the COVID-19 pandemic on our company, our employees, our customers, our partners, our industry and the economy as a whole; our franchisees ability to maintain operations in their individual restaurants; our ability to open new restaurants in existing and new markets and to expand our franchise system, including difficulty in finding sites and in negotiating acceptable leases; our ability to compete successfully and the intense competition in the restaurant industry; the adverse impact of economic conditions on our (i) operating results and financial condition, (ii) ability to comply with the terms and covenants of our debt agreements, and (iii) ability to pay or refinance our existing debt or to obtain additional financing; vulnerability to changes in consumer preferences and economic conditions; political and social factors, including regarding trade, immigration and customer preferences; vulnerability to conditions in the greater Los Angeles area; vulnerability to natural disasters given the geographic concentration and real estate intensive nature of our business; increases in chicken and other input costs; our ability to recognize and respond to and effectively manage the impact of social media and our ability to expand our digital business, deliver orders and catering; delayed or canceled future restaurant openings; restaurant closures, due to financial performance or otherwise; and other risks set forth in our filings with the Securities and Exchange Commission from time to time, including under Item 1A, Risk Factors in our annual report on Form 10-K for the year ended December 25, 2019, and under Item 1A, Risk Factors in our quarterly report on Form 10-Q for the quarters ended March 25, 2020, June 24, 2020 and September 23, 2020 which such filings are available online at www.sec.gov, at www.elpolloloco.com or upon request from El Pollo Loco.

We caution you that the important factors referenced above may not contain all of the factors that are important to you. In addition, we cannot assure you that we will realize the results or developments we expect or anticipate or, even if substantially realized, that they will result in the consequences we anticipate or affect us or our operations in the ways that we expect. The forward-looking statements included in this press release are made only as of the date hereof. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as required by law. If we do update one or more forward-looking statements, no inference should be made that we will make additional updates with respect to those or other forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements.

Non-GAAP Financial Measures

To supplement our consolidated financial statements, which are prepared and presented in accordance with GAAP, we use non-GAAP financial measures which include supplemental measures of operating performance of our restaurants. Our calculations of supplemental measures and other non-GAAP financial measures indicated above may not be comparable to those reported by other companies. These measures have limitations as analytical tools, and are not intended to be considered in isolation or as substitutes for, or superior to, financial measures prepared and presented in accordance with GAAP. We use non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons and to evaluate our restaurants’ financial performance against our competitors’ performance. We believe that they provide useful information about operating results, enhance understanding of past performance and future prospects, and allow for greater transparency with respect to key metrics used by management in its financial and operational decision making. These non-GAAP financial measures may also assist investors in evaluating our business and performance relative to industry peers and provide greater transparency with respect to the Company’s financial condition and results of operation.

Investor Contact:
Fitzhugh Taylor, ICR
[email protected]
714-599-5200

Media Contact:
Hanna Gray, Edible
[email protected]
323-202-1477

EL POLLO LOCO HOLDINGS, INC. UNAUDITED CONSOLIDATED STATEMENTS OF INCOME (in thousands, except share data)
		Fourteen Weeks Ended														Fifty-Three Weeks Ended
		December 30, 2020							December 25, 2019							December 30, 2020							December 25, 2019
		$				%			$				%			$				%			$				%
Revenue:
Company-operated restaurant revenue		$	96,447			87.4			$	94,771			88.1			$	374,064			87.8			$	391,112			88.4
Franchise revenue			7,856			7.1				7,184			6.7				29,418			6.9				28,819			6.5
Franchise advertising fee revenue			6,038			5.5				5,591			5.2				22,605			5.3				22,399			5.1
Total revenue			110,341			100.0				107,546			100.0				426,087			100.0				442,330			100.0
Costs of operations:
Food and paper cost (1)			25,417			26.4				26,714			28.2				98,774			26.4				109,264			27.9
Labor and related expenses (1)			31,247			32.4				28,563			30.1				114,455			30.6				116,703			29.8
Occupancy and other operating expenses (1)			24,555			25.5				21,902			23.1				92,422			24.7				92,005			23.5
Gain on recovery of insurance proceeds, lost profits (1)			—			—				—			—				(2,000	)		(0.5	)			—			—
Company restaurant expenses (1)			81,219			84.3				77,179			81.4				303,651			81.2				317,972			81.3
General and administrative expenses			8,885			8.1				10,154			9.4				35,918			8.4				40,389			9.1
Legal settlements			—			—				—			—				2,566			0.6				—			—
Franchise expenses			7,651			6.9				6,920			6.4				28,761			6.8				27,612			6.2
Depreciation and amortization			4,249			3.9				4,297			4.0				16,878			4.0				17,855			4.0
Loss on disposal of assets			33			0.0				53			0.0				189			0.0				266			0.1
Recovery of securities lawsuits related legal expenses and other insurance claims			—			—				—			—				(123	)		(0.0	)			(10,000	)		(2.3	)
Impairment and closed-store reserves			76			0.1				3,611			3.4				4,691			1.1				4,852			1.1
Loss on disposition of restaurants			—			—				(4	)		(0.0	)			—			—				5,058			1.1
Total expenses			102,113			92.5				102,210			95.0				392,531			92.1				404,004			91.3
Income from operations			8,228			7.5				5,336			5.0				33,556			7.9				38,326			8.7
Interest expense, net of interest income			709			0.6				933			0.9				3,292			0.8				3,687			0.8
Income tax receivable agreement (income) expense			113			0.1				177			0.2				139			0.0				57			0.0
Income before provision for income taxes			7,406			6.7				4,226			3.9				30,125			7.1				34,582			7.8
Provision for income taxes			1,951			1.8				728			0.7				5,651			1.3				9,682			2.2
Net income		$	5,455			4.9			$	3,498			3.3			$	24,474			5.7			$	24,900			5.6
Net income per share:
Basic		$	0.15						$	0.10						$	0.70						$	0.68
Diluted		$	0.15						$	0.10						$	0.68						$	0.67
Weighted average shares used in computing net income per share:
Basic			35,762,655							34,503,722							35,193,325							36,739,209
Diluted			36,290,666							35,242,122							35,796,406							37,441,503

___________________________
(1) Percentages for line items relating to cost of operations and company restaurant expenses are calculated with company-operated restaurant revenue as the denominator. All other percentages use total revenue.

EL POLLO LOCO HOLDINGS, INC. UNAUDITED SELECTED BALANCE SHEETS AND SELECTED OPERATING DATA (dollar amounts in thousands)
		As of
		December 30, 2020				December 25, 2019
Selected Balance Sheet Data:
Cash and cash equivalents		$	13,219			$	8,070
Total assets			605,221				624,752
Total debt			62,800				97,000
Total liabilities			327,643				379,186
Total stockholders’ equity			277,578				245,566

		Fifty-Three Weeks Ended
		December 30, 2020				December 25, 2019
Selected Operating Data:
Company-operated restaurants at end of period			196				195
Franchised restaurants at end of period			283				287
Company-operated:
Comparable restaurant sales (decline) growth			(3.0	)%			1.9	%
Restaurants in the comparable base			190				195

EL POLLO LOCO HOLDINGS, INC. UNAUDITED RECONCILIATION OF NET INCOME TO EBITDA AND ADJUSTED EBITDA (dollar amounts in thousands)
		Fourteen Weeks Ended								Fifty-Three Weeks Ended
		December 30, 2020				December 25, 2019				December 30, 2020				December 25, 2019
Adjusted EBITDA:
Net income, as reported		$	5,455			$	3,498			$	24,474			$	24,900
Provision for income taxes			1,951				728				5,651				9,682
Interest expense, net			709				933				3,292				3,687
Depreciation and amortization			4,249				4,297				16,878				17,855
EBITDA		$	12,364			$	9,456			$	50,295			$	56,124
Stock-based compensation expense (a)			923				677				3,093				2,474
Loss on disposal of assets (b)			33				53				189				266
Recovery of securities lawsuits related legal expense and other insurance claims (c)			—				—				(123	)			(10,000	)
Impairment and closed-store reserves (d)			76				3,611				4,691				4,852
Loss on disposition of restaurants (e)			—				(4	)			—				5,058
Income tax receivable agreement expense (f)			113				177				139				57
Securities class action legal expense (g)			77				372				604				3,181
Legal settlements (h)			—				—				2,566				—
Pre-opening costs (i)			31				173				141				366
Executive transition costs (j)			—				—				—				151
Adjusted EBITDA		$	13,617			$	14,515			$	61,595			$	62,529

__________________________

(a)		Includes non-cash, stock-based compensation.
(b)		Loss on disposal of assets includes the loss on disposal of assets related to retirements and replacement or write-off of leasehold improvements or equipment.
(c)		In fiscal 2020, we received insurance proceeds of $0.1 million related to a property claim. In fiscal 2019, we received insurance proceeds of $10.0 million related to the settlement of the securities class action lawsuit.
(d)		Includes costs related to impairment of long-lived assets and closing restaurants. During fiscal 2020, we recorded non-cash impairment charges of $3.5 million for the year ended December 30, 2020, primarily related to the carrying value of the ROU assets of one restaurant in Texas and the long-lived assets of four restaurants in California. Given the difficulty in projecting results for newer restaurants in newer markets, as well as the impact of the COVID-19 pandemic, we are monitoring the recoverability of the carrying value of the assets of several restaurants on an ongoing basis. For these restaurants, if expected performance is not realized, an impairment charge may be recognized in future periods, and such charge could be material.
		During the quarter and year ended December 25, 2019, we recorded impairment charges of $3.2 million and $3.6 million, respectively, primarily related to the carrying value of the ROU assets of four restaurants sold to franchisees and one restaurant closed during fiscal 2019, and the long-lived assets of one restaurant in California. Additionally, during fiscal 2019, we closed two restaurants in California and two restaurants in Texas and recognized $0.3 million and $1.3 million of closed-store reserve expense for the quarter and year ended 2019, primarily related to the amortization, property taxes and CAM payments for the closed locations.
(e)		During fiscal 2019, we completed the sale of four company-operated restaurants within the San Francisco area to an existing franchisee and seven company-operated restaurants in the Phoenix area to another existing franchisee. These sales resulted in cash proceeds of $4.8 million and a net loss on sale of restaurants of $0.9 million and $5.1 million for the thirteen and thirty-nine weeks ended September 25, 2019, respectively. These restaurants are now included in our franchised restaurant totals.
(f)		On July 30, 2014, we entered into the TRA. This agreement calls for us to pay to our pre-IPO stockholders 85% of the savings in cash that we realize in our taxes as a result of utilizing our net operating losses and other tax attributes attributable to preceding periods. For the quarters and years ended December 30, 2020 and December 25, 2019, income tax receivable agreement expense consisted of the amortization of interest expense and changes in estimates for actual tax returns filed, related to our total expected TRA payments.
(g)		Consists of costs related to the defense of securities lawsuits.
(h)		Includes an expense related to resolution of the longstanding lawsuit involving a contract dispute with one of the Company’s franchisees concerning asserted territory rights, as well as amounts incurred related to the payment of the final settlement amounts for consolidated wage and hour class action lawsuits resolved in prior quarters.
(i)		Pre-opening costs are a component of general and administrative expenses, and consist of costs directly associated with the opening of new restaurants and incurred prior to opening, including management labor costs, staff labor costs during training, food and supplies used during training, marketing costs, and other related pre-opening costs. These are generally incurred over the three to five months prior to opening. Pre-opening costs also include occupancy costs incurred between the date of possession and the opening date for a restaurant.
(j)		Includes costs associated with the transition of our CEO, such as CEO sign-on bonus.

EL POLLO LOCO HOLDINGS, INC. UNAUDITED RECONCILIATION OF NET INCOME TO PRO FORMA NET INCOME (dollar amounts in thousands, except share data)
		Fourteen Weeks Ended								Fifty-Three Weeks Ended
		December 30, 2020				December 25, 2019				December 30, 2020				December 25, 2019
Pro forma net income:
Net income, as reported		$	5,455			$	3,498			$	24,474			$	24,900
Provision for taxes, as reported			1,951				728				5,651				9,682
Income tax receivable agreement expense			113				177				139				57
Loss on disposal of assets			33				53				189				266
Recovery of securities lawsuits related legal expense and other insurance claims			—				—				(123	)			(10,000	)
Loss on disposition of restaurants			—				(4	)			—				5,058
Impairment and closed-store reserves			76				3,611				4,691				4,852
Securities lawsuits related legal expenses			77				372				604				3,181
Legal settlements			—				—				2,566				—
Executive transition costs			—				—				—				151
Provision for income taxes			(2,042	)			(2,235	)			(10,121	)			(10,109	)
Pro forma net income		$	5,663			$	6,200			$	28,070			$	28,038
Pro forma weighted-average share and per share data:
Pro forma net income per share
Basic		$	0.16			$	0.18			$	0.80			$	0.76
Diluted		$	0.16			$	0.18			$	0.78			$	0.75
Weighted-average shares used in computing pro forma net income per share
Basic			35,762,655				34,503,722				35,193,325				36,739,209
Diluted			36,290,666				35,242,122				35,796,406				37,441,503

EL POLLO LOCO HOLDINGS, INC. UNAUDITED RECONCILIATION OF INCOME FROM OPERATIONS TO RESTAURANT CONTRIBUTION (dollar amounts in thousands)
		Fourteen Weeks Ended								Fifty-Three Weeks Ended
		December 30, 2020				December 25, 2019				December 30, 2020				December 25, 2019
Restaurant contribution:
Income from operations		$	8,228			$	5,336			$	33,556			$	38,326
Add (less):
General and administrative expenses			8,885				10,154				35,918				40,389
Legal settlements			—				—				2,566				—
Franchise expenses			7,651				6,920				28,761				27,612
Depreciation and amortization			4,249				4,297				16,878				17,855
Loss on disposal of assets			33				53				189				266
Franchise revenue			(7,856	)			(7,184	)			(29,418	)			(28,819	)
Franchise advertising fee revenue			(6,038	)			(5,591	)			(22,605	)			(22,399	)
Recovery of securities lawsuits related legal expenses and other insurance claims			—				—				(123	)			(10,000	)
Impairment and closed-store reserves			76				3,611				4,691				4,852
Loss on sale of restaurants			—				(4	)			—				5,058
Restaurant contribution		$	15,228			$	17,592			$	70,413			$	73,140
Company-operated restaurant revenue:
Total revenue		$	110,341			$	107,546			$	426,087			$	442,330
Less:
Franchise revenue			(7,856	)			(7,184	)			(29,418	)			(28,819	)
Franchise advertising fee revenue			(6,038	)			(5,591	)			(22,605	)			(22,399	)
Company-operated restaurant revenue		$	96,447			$	94,771			$	374,064			$	391,112
Restaurant contribution margin (%)			15.8		%		18.6		%		18.8		%		18.7		%

Conference call begins at 4:30 p.m. Eastern time today

NEWTOWN, Pa., March 11, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel therapies for patients with cancer, announces financial results for the twelve months ended December 31, 2020 and provides a business update.

Highlights of the fourth quarter of 2020 and recent weeks include:

• ON 123300, Onconova’s proprietary multi-kinase inhibitor, received clearance from the U.S. Food and Drug Administration (FDA) to begin Phase 1 studies
• ON 123300 also received Institutional Review Board (IRB) approval at one U.S. clinical trial site
• The Phase 1 solid tumor study with ON 123300 in China is ongoing and continues to enroll patients
• Raised net proceeds of $35.2 million from two equity offerings; cash and cash equivalents as of February 28, 2021 were approximately $49.5 million
• An independent investigator-initiated study with oral rigosertib in combination with a PD-1 inhibitor in advanced KRAS mutated non-small cell lung cancer is ongoing
• A Special Meeting of Stockholders to consider changes to the capital structure of the Company will reconvene on April 1, 2021

Management Commentary
“The fourth quarter and recent weeks have been active and productive at Onconova as we continue to advance our lead product ON 123300 into the clinic,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “We submitted an Investigational New Drug application to the FDA for a Phase 1 study in advanced cancers including HR+/HER 2- metastatic breast cancer patients resistant to approved second-generation CDK 4/6 inhibitors. In December 2020, we received clearance from the FDA to begin the study, and have since received IRB approval at our first site. We expect the first patient to be enrolled in the second quarter of this year. Two further sites are in the study set-up process.

“This Phase 1 study will assess the safety, tolerability and pharmacokinetics of ON 123300 administered orally at increasing doses starting at 40 mg daily continuously.

“Our partner in China, HanX Pharmaceuticals, continues enrolling a similar patient population in a Phase 1 dose-escalation study with ON 123300 at two sites. The initial dose cohort has been completed and the second dose cohort is enrolling. We are pleased that ON 123300 appears to be well tolerated so far as no dose-limiting toxicities have been seen to date. The HanX study is dosing patients on a 21-day cycle. Collectively, the U.S. and China Phase 1 studies are expected to provide data regarding the safety profile of ON 123300 and potentially provide preliminary efficacy signals in patients with advanced cancer.”

Commenting on ongoing investigator-sponsored studies with oral rigosertib, the company’s RAS pathway inhibitor, Dr. Fruchtman added, “We are currently supporting investigator-initiated studies that are exploring the use of oral rigosertib for cancers driven by mutation of the RAS gene including a Phase 1 study in combination with a PD-1 inhibitor for patients with progressive K-RAS mutated non-small cell lung cancer.  This study is open and continues to enroll patients, with the objectives to identify the recommended Phase 2 dose and to characterize the safety profile of the combination treatment. Results are expected in 2021.

“In addition, an investigator-initiated Phase 1b/2 study with oral rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa is open.  A preclinical study is also evaluating oral rigosertib in clear cell renal carcinoma.  We anticipate additional investigator-initiated studies in RAS-driven cancers in combination with PD-1 inhibitors, including in metastatic melanoma. Other than the cost of supplying oral rigosertib to the investigators, Onconova does not expect to incur significant expense for these studies,” Dr. Fruchtman stated.

Full Year Financial Results

Cash and cash equivalents as of December 31, 2020 were $19.0 million, compared with $22.7 million as of December 31, 2019. Subsequent to the end of the quarter, the Company raised net proceeds of $35.2 million from two equity offerings with institutional investors.   The Company expects that its cash and cash equivalents as of February 28, 2021 will be sufficient to fund ongoing clinical trials and business operations for more than eighteen months.

Research and development expenses were $16.9 million for 2020, compared with $15.5 million for 2019. The increase was primarily related to higher regulatory consulting fees and manufacturing costs related to clinical supply for ON 123300, partially offset by lower expenses for the oral rigosertib combination program and the Phase 3 INSPIRE study in the 2020 period.

General and administrative expenses were $8.3 million for 2020, consistent with 2019. Lower personnel and stock compensation expenses in 2020 due to personnel reductions in the 2019 period were offset by higher pre-commercialization, insurance, and corporate legal and stockholder meeting expenses in the 2020 period.

Net loss for 2020 was $25.2 million, or $0.14 per share on 174.0 million weighted average shares outstanding, compared with a loss of $21.5 million, or $1.49 per share for 2019 on 14.4 million weighted average shares outstanding.

Conference Call and Webcast
Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern time, during which management will discuss financial results for 2020, provide a business update and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 3863774.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel therapies for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is planned to begin a dose-escalation and expansion Phase 1 trial in the U.S. in 2Q21, and a dose-escalation and expansion Phase 1 trial is currently underway in China. Onconova’s product candidate oral rigosertib is currently in a dose-escalation and expansion Phase 1 investigator-initiated study targeting patients with KRAS+ lung adenocarcinoma in combination with nivolumab. In addition, Onconova continues to conduct preclinical work investigating rigosertib in COVID-19. For more information, please visit www.onconova.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the registered direct offering, its patents and clinical development plans including patient enrollment timelines and indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:

Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:

LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
[email protected]

(Tables to follow)

ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands)
	December 31,				December 31,
	2020				2019
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	19,025			$	22,726
Receivables	37				98
Prepaid expenses and other current assets	722				650
Total current assets	19,784				23,474
Property and equipment, net	52				50
Other non-current assets	150				150
Total assets	$	19,986			$	23,674
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	4,833			$	4,271
Accrued expenses and other current liabilities	4,962				3,795
Deferred revenue	226				226
Total current liabilities	10,021				8,292
Warrant liability	321				113
Deferred revenue, non-current	3,469				3,695
Total liabilities	13,811				12,100
Stockholders’ equity:
Preferred stock	–				–
Common stock	1,859				1,112
Additional paid in capital	432,858				413,879
Accumulated other comprehensive income (loss)	14				(18		)
Accumulated deficit	(428,556		)		(403,399		)
Total stockholders’ equity	6,175				11,574
Total liabilities and stockholders’ equity	$	19,986			$	23,674

ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
	Year Ended December 31,
	2020				2019
	(unaudited)
Revenue	$	231			$	2,183
Operating expenses:
General and administrative	8,326				8,345
Research and development	16,898				15,537
Total operating expenses	25,224				23,882
Loss from operations	(24,993		)		(21,699		)
Change in fair value of warrant liability	(208		)		63
Other income, net	48				143
Net loss before income taxes	(25,153		)		(21,493		)
Income tax expense	4				10
Net loss	(25,157		)		(21,503		)
Net loss per share of common stock, basic and diluted	$	(0.14	)		$	(1.49	)
Basic and diluted weighted average shares outstanding	174,035,872				14,384,476