Product Revenues of $20.0 Million Reported for the Second Quarter
Conference Call Today at 8:30am Eastern TimeCAMBRIDGE, Mass., Aug. 05, 2020 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today reported financial results and business highlights for the second quarter ended June 30, 2020.Total net product revenues of $20.0 million, compared to $26.2 million in the second quarter of 2019;MACI® net revenue of $15.1 million and Epicel® net revenue of $4.9 million;Gross margin of 57%, compared to gross margin of 66% in the second quarter of 2019;Net loss of $8.3 million, or $0.18 per share, compared to $19.8 million, or $0.45 per share, in the second quarter of 2019, which included the $17.5 million upfront license payment to MediWound Ltd. for North American rights to NexoBrid®;Non-GAAP adjusted EBITDA loss of $3.5 million, compared to positive adjusted EBITDA of $1.8 million in the second quarter of 2019; andAs of June 30, 2020, the company had $80.9 million in cash and investments, compared to $79.0 million as of December 31, 2019, and no debt.Business Highlights and UpdatesTotal net product revenues, which decreased approximately 23% for the quarter, declined approximately 78% in April and 32% in May compared to the same periods in 2019, and increased approximately 29% in June compared to June 2019; MACI implants, which declined approximately 84% in April and 37% in May compared to the same periods in 2019, increased approximately 21% in June compared June 2019;MACI biopsies declined approximately 79% in April and 22% in May compared to the same periods in 2019, and increased approximately 23% in June compared June 2019;Epicel graft volume, which declined 70% in April, increased approximately 20% in the May through June period compared to the same period in 2019;Epicel biopsies increased approximately 6% in the second quarter compared to the second quarter of 2019; andThe company announced the submission of a Biologics License Application to the FDA for NexoBrid for the treatment of severe thermal burns.“In light of the ongoing pandemic, we are very pleased with our second quarter results as we saw a strong recovery as the quarter progressed and COVID-19 restrictions on elective surgeries were lifted across the country,” said Nick Colangelo, President and CEO of Vericel. “Looking ahead, while uncertainties remain, we are confident in the fundamental prospects of our business and for the third quarter we expect MACI revenue growth over the third quarter of 2019, Epicel revenue to increase sequentially over the second quarter of 2020 and return to recent historical levels, and to recognize revenue in connection with the first delivery of NexoBrid under the BARDA procurement contract, which is scheduled to take place later this quarter.”About Vericel Corporation
Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets. The company markets two cell therapy products in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full-thickness burns greater than or equal to 30% of total body surface area. The company also holds an exclusive license for North American rights to NexoBrid®, a registration-stage biological orphan product for debridement of severe thermal burns. For more information, please visit the company’s website at www.vcel.com.GAAP v. Non‑GAAP Measures
Vericel’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. Vericel has provided in this release certain financial information that has not been prepared in accordance with GAAP. Vericel’s management believes that the non-GAAP adjusted EBITDA described in the release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding Vericel’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in Vericel’s industry. However, the non-GAAP financial measures that Vericel uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP.Among the factors that could cause actual results to differ materially from those set forth in the forward-looking statements include, but are not limited to uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic, growth in revenues for MACI and Epicel, the expected target surgeon audience, the estimate of the commercial growth potential of our products and product candidates, availability of funding from the Biomedical Research and Development Authority under its agreement with MediWound Ltd. for use in connection with NexoBrid development activities, potential fluctuations in sales and volumes and our results of operations over the course of the year, competitive developments, timing and conduct of clinical trial and product development activities, timing or likelihood of regulatory approvals, market demand for our products, changes in third party coverage and reimbursement, and our ability to supply or meet customer demand for our products.
With respect to COVID-19, we are currently unable to reasonably estimate the specific extent, or duration, of the impact of the COVID-19 outbreak on our business, financial and operating results. We are also unable to predict how the outbreak will affect the pace with which state and local governments lift restrictions on the performance of elective surgical procedures or whether additional such restrictions may be imposed by states in the future, the availability of physicians and/or their treatment prioritizations or the impact of the outbreak on the overall healthcare infrastructure. In addition, patients who have cancelled or postponed surgeries may not reschedule cases in a timely fashion, or at all. Other disruptions or potential disruptions include restrictions on the ability of Company personnel to travel and access customers for training, promotion and case support, delays in approvals by regulatory bodies, delays in product development efforts, and additional government-imposed quarantines and requirements to “shelter at home” or other incremental mitigation efforts that may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products. The total impact of these disruptions could have a material impact on the Company’s financial condition, cash flows and results of operations.
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, 2019, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2020, Vericel’s Quarterly Report on Form 10-Q for the quarter ended June, 30, 2020, filed with the SEC on August 5, 2020, and in other filings with the SEC. These forward-looking statements reflect our views as of the date hereof and Vericel does not assume and specifically disclaims any obligation 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. Investor Contacts:
Lee Stern
Solebury Trout
[email protected]
+1 (646) 378-2922
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