SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35280 VERICEL CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Michigan 94 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED: September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35280 VERICEL CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identif ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED: June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35280 VERICEL CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identificati ...

| --- | --- | |-------|---------------------------------------------------------------------------------------------------------| | | | | | Advanced Therapies for the Sports Medicine and Severe Burn Care Markets CORPORATE PRESENTATION MAY 2021 | Safe Harbor | --- | --- | --- ...

VERICEL Q1 2021 RESULTS MAY 5, 2021 Safe Harbor | --- | --- | --- ...

Financial Performance - Vericel's net revenue for Q1 2021 was $34.6 million, a 29.5% increase from $26.7 million in Q1 2020, driven by strong volume growth for MACI and Epicel[99]. - MACI generated $23.8 million in revenue for Q1 2021, up from $20.3 million in Q1 2020, reflecting a 7.4% increase[101]. - Epicel revenue increased to $9.8 million in Q1 2021 from $6.4 million in Q1 2020, representing a 53.1% growth[94]. - The net loss for Q1 2021 was $3.3 million, an improvement from a net loss of $4.7 million in Q1 2020[97]. - Gross profit for the three months ended March 31, 2021, was $22.985 million, an increase from $16.756 million in the same period in 2020, resulting in a gross profit margin of 66% compared to 63%[102][103]. Operating Expenses - Total operating expenses for Q1 2021 were $26.3 million, compared to $21.8 million in Q1 2020, indicating a 20.5% increase[98]. - Research and development costs decreased to $3.630 million for the three months ended March 31, 2021, from $3.763 million in the same period in 2020, with significant expenses allocated to MACI and Epicel[104]. - Selling, general and administrative costs rose to $22.660 million for the three months ended March 31, 2021, up from $18.069 million in the same period in 2020, primarily due to increased stock-based compensation and sales force expenses[105]. - Non-cash stock-based compensation expense increased to $7.019 million for the three months ended March 31, 2021, from $3.768 million in the same period in 2020, driven by rising stock prices[108]. Cash Flow and Investments - Cash provided by operating activities was $10.086 million for the three months ended March 31, 2021, compared to $4.686 million in the same period in 2020, reflecting improved cash collections[111]. - As of March 31, 2021, total cash and cash equivalents were $58.2 million, with short-term investments of $25.4 million and long-term investments of $26.0 million[111]. - The company generated $12.186 million from investing activities during the three months ended March 31, 2021, compared to $13.742 million in the same period in 2020[111]. - The company believes its current cash and investments will support operations for at least 12 months, although ongoing COVID-19 impacts may affect this outlook[115]. - A 1% unfavorable change in interest rates could result in a decrease of approximately $0.4 million in the fair value of the investment portfolio as of March 31, 2021[120]. Regulatory and Market Conditions - The FDA accepted the BLA for NexoBrid on September 16, 2020, with a PDUFA target date of June 29, 2021, for potential approval[90]. - The company maintains a significant safety stock of key raw materials and does not expect current supply chain interruptions to impact manufacturing operations[86]. - MACI procedures were significantly impacted by COVID-19 restrictions in early 2020, but the effects had largely dissipated by Q1 2021[82]. - Epicel procedure volumes were less affected by the pandemic, although some slowdown was observed in Q2 2020[83]. Other Income - Total other income decreased to $159,000 for the three months ended March 31, 2021, compared to $371,000 in the same period in 2020, mainly due to lower returns on investments[106].

Product Overview - Vericel Corporation markets two FDA-approved autologous cell therapy products: MACI for knee cartilage defects and Epicel for severe burns [18]. - The company’s MACI product is the only FDA-approved autologous chondrocyte implant (ACI) product on the market in the United States [113]. - The company’s Epicel product is the only FDA-approved option for patients with total body surface area (TBSA) burns greater than 30% [114]. - NexoBrid recorded revenue of $2.2 million associated with its delivery to BARDA during the year ended December 31, 2020 [50]. - The Annual Distribution Number (ADN) for Epicel was determined to be 360,400, significantly larger than the volume of grafts sold in 2019 [45]. Revenue and Growth Strategies - MACI revenue growth strategy includes increasing the number of surgeons implanting MACI and the average number of implants per surgeon [20]. - Epicel revenue is expected to grow by expanding the number of burn centers consistently using the product [20]. - In the year ended December 31, 2020, MACI net revenues totaled $94.4 million, impacted by the COVID-19 pandemic which disrupted normal business seasonality [40]. - Epicel net revenues for the year ended December 31, 2020, amounted to $27.5 million, with over 100 patients treated annually in the U.S. [46]. - Approximately 750,000 patients undergo cartilage repair procedures annually in the U.S., with 125,000 considered clinically appropriate for MACI [37]. Impact of COVID-19 - The COVID-19 pandemic led to a significant increase in cancellations of scheduled MACI procedures, with over 95% of U.S. surgical capacity affected by restrictions [22]. - The pandemic has heightened risks related to clinical trial operations, including potential delays in patient visits and study monitoring [127]. - The company reported a net income of $2.9 million for the year ended December 31, 2020, marking its first net income in history, following a net loss of $9.7 million in 2019 [141]. - The unpredictability of the pandemic may lead to further restrictions impacting elective surgical procedures and overall business operations [127]. - The company has largely restricted on-site staff to essential personnel, encouraging remote work for the majority of employees [130]. Regulatory Environment - The FDA requires extensive nonclinical and clinical studies to demonstrate safety, purity, and potency for biological products, which can be costly and time-consuming [67]. - The BLA submission process incurs significant costs, potentially totaling several million dollars, including application user fees and annual prescription drug product program user fees [76]. - The FDA has established an accelerated approval pathway for regenerative advanced therapies, allowing for priority review or accelerated approval based on surrogate or intermediate endpoints [85]. - The FDA requires manufacturers to report adverse effects and maintain rigorous quality control post-approval [92]. - The company is subject to complex laws and regulations pertaining to healthcare fraud and abuse, including the federal Anti-Kickback Statute and the False Claims Act [105]. Manufacturing and Supply Chain - The company maintains a significant safety stock of key raw materials and does not expect current supply chain interruptions to impact manufacturing operations [25]. - Manufacturing operations are limited to a single facility in Cambridge, Massachusetts, posing risks if disruptions occur [180]. - Compliance with FDA regulations is essential, and failures by third-party manufacturers could delay product availability [187]. - The complexity of manufacturing cell therapy products leads to significant costs and challenges compared to traditional pharmaceuticals [190]. - The company has identified several areas for potential improvement in the manufacturing processes of MACI and Epicel [52]. Competition and Market Dynamics - The company faces intense competition from major multinational medical device and pharmaceutical companies, as well as smaller biotechnology firms [111]. - The company’s reimbursement status for newly approved therapeutics remains uncertain, impacting potential returns on investment [110]. - The success of NexoBrid is contingent on market acceptance, competition, and the size of the target markets [177]. - The company relies on specialty pharmacy distributors for reimbursement of its products, assuming credit and collection risks associated with third-party payers [150]. - The company faces intense competition from larger companies, which may require substantial new research and development activities [164]. Financial Position and Future Outlook - As of December 31, 2020, the company had an accumulated deficit of approximately $375.8 million and $100.1 million in cash, cash equivalents, and investments, positioning it to sustain operations for at least 12 months [141]. - The company’s ability to achieve profitability will depend on increasing sales of current products and successfully commercializing new products, amidst ongoing research and development expenses [142]. - The company has incurred losses since its inception in 1989, and while it believes it can achieve profitability without raising additional capital, significant operating losses may continue in the coming years [144]. - The company’s stock price has been highly volatile due to the COVID-19 pandemic, impacting its ability to raise capital through common stock sales [134]. - The company’s products are based on novel technologies, which present inherent risks and challenges in product development, regulatory compliance, and market acceptance [145].

or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED: September 30, 2020 Commission File Number 001-35280 VERICEL CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identif ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED: June 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35280 VERICEL CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identificati ...

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED: March 31, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35280 VERICEL CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Michi ...