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Vericel Reports Fourth-Quarter and Year-End 2016 Financial ResultsRecord Revenues of $16.5 Million Reported for the Fourth Quarter Conference Call Today at 8:00am Eastern Time CAMBRIDGE, Mass., March 10, 2017 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, today reported financial results and business highlights for the fourth quarter and year ended December 31, 2016. Total net revenues for the quarter ended December 31, 2016 were approximately $16.5 million and included approximately $12.7 million of Carticel® (autologous cultured chondrocytes) net revenues and approximately $3.8 million of Epicel® (cultured epidermal autografts) net revenues. Total Carticel and Epicel net revenues in the fourth quarter increased approximately 8% over the same period in 2015. Total net revenues for the year ended December 31, 2016 were approximately $54.4 million, including approximately $38.9 million of Carticel net revenues and approximately $15.5 million of Epicel net revenues. Total Carticel and Epicel net revenues for 2016 increased approximately 8% compared to total Carticel and Epicel net revenues for 2015. Gross profit for the quarter and year ended December 31, 2016 was $8.9 million, or 54% of net revenues, and $26.1 million, or 48% of net revenues, respectively, compared to $8.2 million, or 53% of net product revenues, and $24.7 million, or 48% of net product revenues, for the quarter and year ended December 31, 2015, respectively. Research and development expenses for the quarter and year ended December 31, 2016 were $4.3 million and $15.3 million, respectively, versus $7.4 million and $18.9 million for the same periods in 2015. The decrease in fourth-quarter and full-year research and development expenses is primarily due to higher research, development and regulatory expenses incurred in the fourth quarter of 2015 associated with the MACI® (autologous cultured chondrocytes on porcine collage membrane) Biologics License Application (BLA) and the Humanitarian Device Exemption (HDE) supplement submitted in December 2015 to revise the labeled indications for use of Epicel, offset in part by additional clinical trial expenses associated with the open-label crossover extension portion of the ixCELL-DCM study. Selling, general and administrative expenses for the quarter and year ended December 31, 2016 were $7.9 million and $27.4 million, respectively, compared to $5.7 million and $22.5 million for the same periods in 2015. The increase in selling, general and administrative expenses in 2016 is primarily due to the costs associated with Vericel’s new provider of patient support and reimbursement services for Carticel and MACI and additional facility fees, technology infrastructure, personnel costs and professional services related to preparing for the commercial launch of MACI. Loss from operations for the quarter and year ended December 31, 2016 was $5.9 million and $19.2 million, respectively, compared to $5.0 million and $16.7 million for the same periods in 2015. Material non-cash items impacting the operating loss for the quarter and year ended December 31, 2016 included $0.5 million and $2.5 million, respectively, of stock-based compensation expense and $0.5 million and $1.9 million, respectively, in depreciation and amortization expense. Loss from operations for the quarter and year ended December 31, 2016 also included $2.6 million from the write-off of the commercial use rights primarily related to Carticel. Given the approval of MACI in December 2016 and the planned replacement of Carticel with MACI, it was determined that the Carticel-related intangible asset was fully impaired as of December 31, 2016. Excluding this charge, loss from operations for the quarter and year ended December 31, 2016 would have been $3.3 million and $16.6 million, respectively. Other income (expense) for the quarter and year ended December 31, 2016 was ($0.3) million for both periods, compared to less than $0.1 million and $0.3 million, respectively, for the same periods in 2015. The change for the quarter and year ended December 31, 2016 is primarily due to the interest expense related to the outstanding revolver and credit term loans incurred in 2016. Vericel reported a net loss for the quarter and year ended December 31, 2016 of $6.2 million, or $0.34 per share, and $19.6 million, or $1.18 per share, respectively, compared to a net loss of $4.9 million, or $0.28 per share, and $16.3 million, or $0.97 per share, for the same periods in 2015. Vericel reported an adjusted net loss, a non-GAAP financial measure, for the quarter and year ended December 31, 2016 of $3.5 million, or $0.14 per share, and $16.9 million, or $0.73 per share, respectively, compared to an adjusted net loss of $5.0 million, or $0.20 per share, and $16.7 million, or $0.67 per share, for the same periods in 2015. The adjusted net loss excludes the non-cash loss on impairment of the Carticel-related intangible asset, the non-cash change in the fair value of warrants and the non-cash accumulated dividend on the Series B convertible preferred stock. The adjusted net loss per share includes common shares reserved as treasury shares received in exchange for the Series A non-voting convertible preferred stock in 2015. The Series A non-voting convertible preferred stock was exchanged for common shares in 2016. On March 9, 2017 all outstanding shares of Series B Convertible Preferred Stock were converted into common stock. As of March 10, 2017, the company had 32,723,646 shares of common stock outstanding. As of December 31, 2016, the company had $23.0 million in cash and cash equivalents compared to $14.6 million in cash and cash equivalents at December 31, 2015. Recent Business Highlights
“In 2016 we created the drivers for long-term growth of the company by achieving two important regulatory milestones with the approval of a pediatric indication for Epicel and the approval of MACI,” said Nick Colangelo, president and CEO of Vericel. “These significant approvals, combined with our expanded sales and marketing infrastructure and a strong balance sheet, have positioned the company for strong revenue growth in the years ahead.” Conference Call Information If you are unable to participate in the live call, the webcast will be available at http://investors.vcel.com/events.cfm until March 14, 2018. A replay of the call will also be available until 12:00 pm (EDT) on March 14, 2017 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 61247055. About Vericel Corporation Epicel®, Carticel®, and MACI® are registered trademarks of Vericel Corporation. © 2017 Vericel Corporation. All rights reserved. GAAP v. Non-GAAP Measures This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of our products and growth in revenues, intended product development, clinical activity timing, regulatory progress, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "we believe," "we intend," and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "potential," "could," "may," or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements, estimating the commercial growth potential of our products and product candidates and growth in revenues and improvement in costs, market demand for our products, and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel's Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission ("SEC") on March 14, 2016, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management's current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
RECONCILIATION OF REPORTED NUMERATOR AND DENOMINATOR IN NET LOSS PER SHARE (GAAP) TO ADJUSTED NET LOSS PER SHARE (NON-GAAP MEASURE) – UNAUDITED
CONTACT: Chad Rubin The Trout Group [email protected] (646) 378-2947 or Lee Stern The Trout Group [email protected] (646) 378-2922 |