SECURITIES AND EXCHANGE
WASHINGTON, D.C. 20549
Pursuant to Section 13
or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of
Earliest Event Reported): April 2, 2020
(Exact name of registrant
as specified in its charter)
|(State or other jurisdiction of
||(Commission File Number)
||(I.R.S. Employer Identification No.)|
|64 Sidney Street
|(Address of principal executive offices)
number, including area code: (800) 556-0311
Former name or former address,
if changed since last report
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
|¨||Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)
|¨||Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
|¨||Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
|¨||Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class
||Name of each exchange on which registered|
|Common Stock, no par value
Indicate by a check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§240.12b-2 of this chapter). Emerging
Growth Company ¨
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. Results
of Operations and Financial Condition.
On April 2,
2020, Vericel Corporation issued a press release providing an update on its response to the COVID-19 pandemic, preliminary
unaudited first quarter revenue growth and the Company’s cash and investments balance. The press release also announced the
Company’s withdrawal of financial guidance for 2020. A copy of the press release is furnished
as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained
in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Exchange Act or
the Securities Act of 1933, as amended (the “Securities Act”), except as shall be expressly set forth by specific reference
in such filing.
Item 7.01. Regulation FD Disclosure.
The information included in the press release
referred to under Item 2.02 above is also incorporated herein. The information contained in this Item 7.01 and in the accompanying
Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Exchange Act, or incorporated by reference in any filing
under the Exchange Act or the Securities Act, except as shall be expressly set forth by specific reference in such filing.
Item 8.01. Other Events.
The spread of SARS-CoV-2,
which causes coronavirus disease 2019, or COVID-19, creates a number of risks and uncertainties to the Company’s business,
which could have a material adverse effect on its current and future business, operations and financial results. As a result, the
Company is supplementing the risk factors previously included in Item 1A of its Annual Report on Form 10-K, filed with the Securities
and Exchange Commission on February 25, 2020, to add the following new risk factor under the section entitled “Risk Factors
— Risks Related to our Business.”
A pandemic, epidemic or outbreak
of an infectious disease, such as COVID-19, or coronavirus, may materially and adversely impact our business, our operations and
our financial results.
The recent outbreak of COVID-19, which
surfaced in Wuhan, China, in December 2019, has since been declared a pandemic and has spread to multiple global regions, including
the United States and Europe. To date, multiple state and national governments – including those in Massachusetts and
Michigan, where our operations are located – have issued orders requiring businesses that do not conduct essential services
to temporarily close their physical workplaces to employees and customers. Vericel is currently deemed an essential business and,
as a result, is exempt from these state orders, in their current form. In March 2020, we put in place a number of protective measures
in response to the COVID-19 outbreak. These measures include the canceling of all commercial international travel, requesting that
employees limit non-essential personal travel, enhancing our facilities’ janitorial and sanitary procedures, encouraging
employees to work from home to the extent their job function enables them to do so, limiting third-party access to our facilities,
encouraging the use of virtual employee meetings, and providing guidance to our field-based commercial teams concerning their communications
and contact with customers and healthcare professionals. We are reviewing these measures on a daily basis as the situation evolves,
and we are likely to take additional actions as we learn more and as instruction is provided by national, state and local governmental
agencies. Both these existing measures and any future actions we take may result in continued disruption to our business.
The continued outbreak of COVID-19, or
another infectious disease, may lead to the implementation of additional responses, including additional travel restrictions, government-imposed
quarantines and other public health safety measures, which may result in further disruptions to our business and operations. For
example, further executive orders, travel restrictions, and limitations on gatherings could continue to impact our sales force’s
ability to promote our products with healthcare professionals. In addition, healthcare facilities and hospitals may continue to
limit the access of non-patients, including our sales professionals, as we have seen in connection with COVID-19, which could negatively
impact our access to healthcare professionals. Further, in response to COVID-19, many hospitals and surgical centers have cancelled
or postponed elective medical procedures and may continue to do so. As a result of COVID-19, or another infectious disease outbreak,
our customers may continue to postpone or cancel previously scheduled surgeries and may also decline to schedule surgeries utilizing
our products, which would negatively impact our operations and financial results. Additionally, our customers may not reschedule
such postponed or cancelled surgeries on a timely basis, or at all.
The spread of COVID-19 or similar infectious
diseases in the United States may also lead to further government-imposed quarantines and restrictions, which may result in the
closure of our administrative offices, with our employees working outside of our offices for an extended period of time. These
actions may result in the disruption of our manufacturing operations, which are currently accomplished within our administrative
offices. Additionally, such quarantines and restrictions may adversely affect our ability to conduct certain product enhancement
and business development activities. Further, continued delays and disruptions related to COVID-19 or another outbreak either
within the United States or in an area outside the United States, but within the Company’s supply chain, may impact the
Company’s ability to produce our products to meet customer demand, which would negatively impact our operations and financial
oversight and actions regarding our products may be disrupted or delayed in regions impacted by COVID-19, including the United
States and Europe, which may impact review and approval timelines for products in development and/or changes to existing products
that need regulatory review and approval.
Although it is premature to draw any conclusions
at this time, given the reduction of elective surgical procedures as a result of COVID-19, the Company anticipates a decreased
rate of patient enrollment to its PEAK (A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral
Defects of the Knee) Study, which is currently being conducted at ten (10) sites throughout the United States. COVID-19 or a similar
infectious disease may further and negatively impact our clinical trial operations in the United States and in other countries
by limiting our ability to recruit and retain patients, principal investigators and site staff who, as healthcare providers, may
have heightened exposure to COVID-19 or a similar infectious disease if an outbreak occurs in their geography. Additionally, patients
who are already recruited into our clinical trials may be unable or unwilling to attend follow-up visits within the timelines specified
in our trial protocols, potentially impacting our ability to meet our clinical trial endpoints. An outbreak may also affect employees
of third-party contract research organizations located in affected geographies that we rely upon to carry out our clinical trials.
We cannot presently predict the scope and
severity of potential business shutdowns or disruptions, but if we or any of the third parties with whom we engage were to experience
shutdowns or other business disruptions, our ability to conduct our business in the manner and on the timelines presently planned
could be materially and negatively impacted.
The extent to which the current pandemic,
or a future pandemic, impacts our business and operations will depend on future developments, such as the ultimate geographic spread
of the disease, the duration of the outbreak, travel restrictions and governmental actions to contain the outbreak or treat its
impact, which are highly uncertain and cannot be predicted with confidence.
Please also refer to the complete
Item 1A of the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2020
for additional risks and uncertainties facing the Company that may have a material adverse effect on the Company’s business,
operations and financial results.
Item 9.01. Financial Statements and Exhibits.
||Press Release of Vericel Corporation, dated April 2, 2020|
+ Furnished herewith
+ Furnished herewith.
Pursuant to the requirements of
the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: April 2, 2020
||/s/ Sean C. Flynn|
||Name: Sean C. Flynn|
Vice President, General Counsel and Secretary