On February 24, 2022 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the fourth quarter and year ended December 31, 2021, and provided full-year 2022 financial guidance (Press release, Vericel, FEB 24, 2022, View Source [SID1234608994]).

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Fourth Quarter 2021 Financial Highlights

Total net revenue of $47.6 million, compared to $45.2 million in the fourth quarter of 2020
MACI net revenue of $37.3 million, Epicel net revenue of $9.7 million, and NexoBrid revenue of $0.5 million related to the U.S. Biomedical Advanced Research and Development Authority (BARDA) procurement for emergency response preparedness
Gross margin of 72%, compared to 74% in the fourth quarter of 2020
Net income of $4.5 million, or $0.09 per share, compared to $12.2 million, or $0.25 per share, in the fourth quarter of 2020
Non-GAAP adjusted EBITDA of $12.8 million, compared to $16.0 million in the fourth quarter of 2020
Operating cash flow of $10.6 million
Full Year 2021 Financial Highlights

Total net revenue of $156.2 million, compared to $124.2 million in 2020
MACI net revenue of $111.6 million, Epicel net revenue of $41.5 million, and NexoBrid revenue of $3.1 million related to BARDA procurement for emergency response preparedness
Gross margin of 68%, compared to gross margin of 68% in 2020
Net loss of $7.5 million, or $0.16 per share, compared to net income of $2.9 million, or $0.06 per share, in 2020
Non-GAAP adjusted EBITDA of $29.5 million, compared to $18.6 million in 2020
Operating cash flow of $29.0 million
As of December 31, 2021, the Company had approximately $129 million in cash and investments, compared to $100 million as of December 31, 2020, and no debt
Business Highlights and Updates

Total net revenue growth of 26% for 2021, in line with the Company’s compounded annual revenue growth rate since the launch of MACI in 2017
Full-year net revenue growth of 18% for MACI, achieving record quarterly revenue in the fourth quarter
Full-year net revenue growth of 51% for Epicel and the fifth straight quarter with revenue over $9.5 million
Achieved 20% growth in surgeons taking MACI biopsies and 30% growth in MACI biopsies for the year, with a record quarterly high in the number of biopsies and the number of surgeons taking biopsies in the fourth quarter
Achieved over 30% growth in Epicel biopsies and burn centers treating patients with Epicel compared to 2020
Announced plans for a new state-of-the-art cell therapy manufacturing facility and corporate headquarters to support long-term growth
"We delivered another strong year of revenue growth and generated record adjusted EBITDA and operating cash flow to end the year in a very strong financial position," said Nick Colangelo, President and CEO of Vericel. "The Company continues to execute very well across all areas of the business, generating record revenue and biopsies for MACI in the fourth quarter and driving over 50% growth in Epicel revenue for the year. Looking forward, given the significant market opportunities and the continued progress across both of our franchises, we believe that we are well-positioned for continued strong revenue and profitability growth in 2022 and the years ahead."

2022 Financial Guidance

Total net revenue for 2022 expected to be in the range of $178 to $189 million
MACI revenue expected to be in the range of $132 to $141 million
Epicel revenue expected to be in the range of $45.5 to $47.5 million
Gross margin expected to be approximately 70%
Adjusted EBITDA margin expected to be approximately 21%
Fourth Quarter 2021 Results
Total net revenue for the quarter ended December 31, 2021 increased 5% to $47.6 million, compared to $45.2 million in the fourth quarter of 2020. Total net product revenue for the quarter included $37.3 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $9.7 million of Epicel (cultured epidermal autografts) net revenue, compared to $34.7 million of MACI net revenue and $9.6 million of Epicel net revenue, respectively, in the fourth quarter of 2020. Total net revenue for the quarter also included $0.5 million of revenue related to the procurement of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) by BARDA for emergency response preparedness, compared to $1.0 million in the fourth quarter of 2020.

Gross profit for the quarter ended December 31, 2021 was $34.0 million, or 72% of net revenue, compared to $33.6 million, or 74% of net revenue, for the fourth quarter of 2020.

Total operating expenses for the quarter ended December 31, 2021 were $29.9 million, compared to $21.4 million for the same period in 2020. The increase in operating expenses was primarily due to an increase in stock-based compensation expense driven by share price appreciation.

Net income for the quarter ended December 31, 2021 was $4.5 million, or $0.09 per share, compared to net income of $12.2 million, or $0.25 per share, for the fourth quarter of 2020.

Non-GAAP adjusted EBITDA for the quarter ended December 31, 2021 was $12.8 million, or 27% of net revenue, compared to $16.0 million, or 35% of net revenue, for the fourth quarter of 2020. A table reconciling non-GAAP measures is included in this press release for reference.

Full-Year 2021 Results
Total net revenue for the year ended December 31, 2021 increased 26% to $156.2 million, compared to $124.2 million in 2020. Total net product revenue for the year included $111.6 million of MACI net revenue and $41.5 million of Epicel net revenue, compared to $94.4 million of MACI net revenue and $27.5 million of Epicel net revenue, respectively, in 2020. Total net revenue in 2021 also included $3.1 million of revenue related to the procurement of NexoBrid by BARDA for emergency response preparedness, compared to $2.2 million of revenue in 2020.

Gross profit for the year ended December 31, 2021 was $106.0 million, or 68% of net revenue, compared to $84.2 million, or 68% of net revenue, in 2020.

Total operating expenses for the year ended December 31, 2021 were $113.9 million, compared to $81.9 million in 2020. The increase in operating expenses was primarily due to an increase in stock-based compensation expense driven by share price appreciation and lower spend in 2020 due to COVID-19-related factors.

Net loss for the year ended December 31, 2021 was $7.5 million, or $0.16 per share, compared to net income of $2.9 million, or $0.06 per share, in 2020.

Non-GAAP adjusted EBITDA for the year ended December 31, 2021 was $29.5 million, or 19% of net revenue, compared to $18.6 million, or 15% of net revenue, in 2020. A table reconciling non-GAAP measures is included in this press release for reference.

As of December 31, 2021, the Company had approximately $129 million in cash and investments, compared to approximately $100 million as of December 31, 2020, and no debt.

Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Time and can be accessed through the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software, if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s fourth quarter 2021 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.

If you are unable to participate in the live call, the webcast will be available at View Source until February 24, 2023. A replay of the call will also be available until 11:30am (EDT) on February 28, 2022 by calling (855) 859-2056, or from outside the U.S. by calling (404) 537-3406. The conference ID is 5795764.