VERICEL
Q3 2020 RESULTS
NOVEMBER 5, 2020
Safe Harbor
Vericel cautions you that all statements other than statements of historical fact included in this presentation that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Our actual results may differ materially from those expressed or implied by the forward-looking statements in this presentation. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.
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 our expectations regarding future revenues, growth in revenues, market penetration for MACI® and Epicel®, growth in profit, gross margins and operating margins, the ability to achieve or sustain profitability, contributions to adjusted EBITDA, the expected target surgeon audience, potential
fluctuations in sales and volumes and our results of operations over the course of the year, timing and conduct of clinical trial and product development activities, timing or likelihood of regulatory approvals, the estimate of the commercial growth potential of our products and product candidates, availability of funding from the U.S. Biomedical Research and Development Authority under its agreement with MediWound Ltd. for use in connection with NexoBrid® development activities, competitive developments, changes in third party coverage and reimbursement, our ability to supply or meet customer demand for our products, and the wide- ranging impacts of the COVID-19 pandemic on our business or the economy generally.
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 whether the outbreak will cause state and local governments to impose future restrictions on the performance of elective surgical procedures or the pace with which such restrictions may be lifted should they be imposed, the willingness or ability of patients to seek treatment, the availability of physicians and/or their treatment prioritizations or the impact of the outbreak on the overall healthcare infrastructure. 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 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. With respect to FDA's review of the pending NexoBrid Biologics License Application, the COVID-19 pandemic may impact the FDA's response times to regulatory submissions, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of NexoBrid. 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 September, 30, 2020, filed with the SEC on November 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.
Vericel Q3 2020 Financial Results - November 5, 2020 | 2 |
Third-Quarter 2020 Financial and Business Highlights
Financial Highlights
Record third quarter MACI revenue and total revenues, and the second highest quarterly Epicel revenue in history
Gross margin of 70% for the quarter
Record third quarter net income of $3.6 million Non-GAAP adjusted EBITDA of $6.7 million Operating cash flow of $4.6 million
Business Highlights
Achieved double-digit growth in MACI implants and biopsies, including a record monthly high for biopsies in September
Announced the first delivery of NexoBrid to BARDA for emergency response preparedness
Announced that the FDA accepted for review the NexoBrid Biologics License Application for the treatment of severe thermal burns, with a PDUFA goal date of June 29, 2021
Vericel Q3 2020 Financial Results - November 5, 2020 | 3 |
Third-Quarter 2020 Revenue Details
NexoBrid
(BARDA)
Epicel
MACI
$Millions
$35
$30
$25
$20
$15
$10 $5
$0
Total Revenues
$30.5 | $32.3 | |||
$1.2 | ||||
$6.7 | ||||
$9.9 | ||||
$22.5 | ||||
$6.0 | ||||
$14.3 | ||||
$4.4 | $20.6 | $24.4 | ||
$16.4 | ||||
$9.9 | ||||
Q3 2017 | Q3 2018 | Q3 2019 | Q3 2020 |
Record third quarter MACI revenue and total revenues
Second highest quarterly Epicel revenue in history
First NexoBrid revenue related to BARDA procurement
Vericel Q3 2020 Financial Results - November 5, 2020 | 4 |
Continued Momentum in MACI Implant and Biopsy Volumes in the Third Quarter
% of Prior Year
2020 MACI Implant | 2020 MACI Biopsy | % of US Surgical | |
Volume vs. 2019 | Volume vs. 2019 | Capacity Online (estimate) |
120%
100%
80%
60%
40%
20%
0%
Q1 | Q2 | Q3 |
Double digit growth in implants and biopsies vs. Q3 2019
Record monthly high for biopsies in September
Vericel Q3 2020 Financial Results - November 5, 2020 | 5 |
MACI Well-Positioned to Continue Strong Performance
Strong revenue growth prior to COVID-19 crisis and rapid recovery as elective surgery restrictions lifted
Reflects strong underlying demand for MACI in the marketplace based on unique patient benefits
MACI patients are typically young, active and otherwise healthy
Large, symptomatic focal cartilage defects that impact quality of life and will not heal with passage of time
MACI procedures performed on an outpatient basis more than 95% of the time
~50/50 historical split between hospital outpatient surgery centers and ambulatory surgery centers
Orthopedic practices are a significant source of revenue for hospitals and surgery centers
Many orthopedic surgeons are expected to increase surgery volume in 2H 2020
Staying connected with surgeons and patients
Surgeons connecting with patients via telemedicine, supported by virtual sales calls with MACI digital content
Case management team continues to work with offices and patients to move cases through the pipeline and schedule or reschedule cases
Vericel Q3 2020 Financial Results - November 5, 2020 | 6 |
Third-Quarter 2020 Financial Results
Three Months Ended | Nine Months Ended | |||||||
September 30, | September 30, | |||||||
Unaudited, amounts in thousands except per share amounts | 2020 | 2019 | 2020 | 2019 | ||||
Net Sales | $ | 32,258 | $ | 30,499 | $ | 78,950 | $ | 78,460 |
Gross Profit | 22,471 | 21,175 | 50,581 | 51,474 | ||||
Gross Margin | 70% | 69% | 64% | 66% | ||||
Research and Development | 2,913 | 3,096 | 9,902 | 27,174 | ||||
Selling, General and Administrative | 16,041 | 14,982 | 50,596 | 44,761 | ||||
Total Operating Expenses | 18,954 | 18,078 | 60,498 | 71,935 | ||||
Operating Income (Loss) | 3,517 | 3,097 | (9,917) | (20,461) | ||||
Other Income (Expense) | 101 | 373 | 561 | 1,295 | ||||
Net Income (Loss) | $ | 3,618 | $ | 3,470 | $ | (9,356) | $ | (19,166) |
Net Income (Loss) Per Share (Diluted) | $ | 0.08 | $ | 0.07 | $ | (0.21) | $ | (0.44) |
Weighted average number of common shares outstanding | 47,314 | 46,667 | 45,112 | 43,979 | ||||
Q3 2020 Operating Cash Flow of $4.6 million
Ended Q3 2020 with $85.5 million in cash and investments, and no debt
Vericel Q3 2020 Financial Results - November 5, 2020 | 7 |
Expected Fourth Quarter and Full-Year 2020 Results Demonstrate Strong Execution and Underlying Product Demand*
Expecting full-year product revenue growth for 2020 and second NexoBrid shipment to BARDA in the fourth quarter
Full-year revenue expectations would result in positive net income and operating cash flow for 2020
Key drivers of MACI growth have recovered and are positioned to accelerate into 2021
*Expectations assume that widespread restrictions on elective surgeries are not reinstated in the U.S. | 8 |
Vericel Q3 2020 Financial Results - November 5, 2020 |
VERICEL Q3 2020 FINANCIAL RESULTS
APPENDIX
9
Reconciliation of Third Quarter Reported GAAP Net Income (Loss) to Adjusted EBITDA (Non-GAAP Measure) - Unaudited
Three Months | ||
Ended September 30, | ||
Quarterly Adjusted EBITDA | 2020 | 2019 |
Net Income (GAAP) | $3,618 | $3,470 |
Stock compensation expense | 2,675 | 3,285 |
Depreciation and amortization | 570 | 475 |
Net interest expense (income) | (119) | (383) |
Adjusted EBITDA (Non-GAAP) (unaudited) | $6,744 | $6,847 |
Nine Months | ||
Ended September 30, | ||
Year-to-Date Adjusted EBITDA | 2020 | 2019 |
Net Loss (GAAP) | ($9,356) | ($19,166) |
Non-recurring license agreement purchase | -0- | 17,500 |
Stock compensation expense | 10,819 | 10,095 |
Depreciation and amortization | 1,649 | 1,174 |
Net interest expense (income) | (569) | (1,287) |
Adjusted EBITDA (Non-GAAP) (unaudited) | $2,543 | $8,316 |
Vericel Q3 2020 Financial Results - November 5, 2020 | 10 |
Vericel Capitalization Table
Capitalization (as of September 30, 2020) | Shares |
Common Stock | 45,315,098 |
Options Outstanding | 5,691,570 |
Unvested Restricted Stock Units | 272,750 |
Fully Diluted Shares Outstanding | 51,279,418 |
Vericel Q3 2020 Financial Results - November 5, 2020 | 11 |
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Vericel Corporation published this content on 05 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 November 2020 18:46:03 UTC