8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 8, 2020

Myomo, Inc.

(Exact Name of Company as Specified in Charter)

Delaware	001-38109	47-0944526
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
One Broadway, 14th Floor Cambridge, MA		02142
(Address of Principal Executive Offices)		(Zip Code)

Company’s telephone number, including area code: (617) 996-9058

Not applicable

(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	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value per share	MYO	NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 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 7.01. Regulation FD Disclosure.

On April 8, 2020, Myomo, Inc. (the “Company”) issued a press release titled “Myomo Reports Accelerating Growth in MyoPro Pipeline and Record Backlog in the First Quarter of 2020, Provides Update on the Business Impact of COVID-19.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”) or otherwise subject to the liability of that section, nor shall such information be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.

Item 8.01. Other Events.

The Company is supplementing the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2019 with the addition of the following risk factor under the subsection “Risks Associated with Our Business.”

The outbreak of the novel strain of coronavirus, SARS-CoV-2, which causes COVID-19, could adversely impact our business.

The outbreak of the novel coronavirus, SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19), has evolved into a global pandemic. The coronavirus has spread to many regions of the world, including the United States and Europe. As a result of the coronavirus pandemic, we have experienced and may continue to experience disruptions that could materially impact our business. The extent to which the coronavirus impacts our business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning the coronavirus and the actions taken to contain the coronavirus or treat its impact, among others.

As a result of the COVID-19 pandemic, various aspects of our business operations have been, and could continue to be, disrupted. For example, because we provide a custom-fabricated device to each patient, the in-person contact required as part of the fabrication and delivery process is being impacted and likely will continue to be impacted by COVID-19-related public health restrictions on travel and personal interaction. Similarly, the impairment in the ability for patient consultation and fittings is expected to delay for several months our launch of MyoPal, our product for pediatric patients. In addition, we may also experience difficulties in seeking and obtaining reimbursement for our devices from third party and government payers. While we currently believe we have sufficient inventory in our supply chain and currently expect to have sufficient fabrication capacity available to manufacture and deliver devices to patients when public health restrictions are eased, there can be no assurance that we will be able to do so. If we, or any third parties in our supply chain for materials which are used in either the manufacture of our products, are adversely impacted by restrictions resulting from the coronavirus outbreak, our supply chain may be disrupted and our ability to manufacture and ship our products may be limited. In addition, as a result of shelter-in-place orders or other mandated travel restrictions, our on-site staff conducting sales and marketing and engineering activities may not be able to access our office or laboratory space, and these restrictions may adversely impact our contract manufacturing partners as well. Further, these core activities may be significantly limited or curtailed, possibly for an extended period of time.

In response to the pandemic, we have implemented a work from home policy, with substantially all of our employees continuing their work outside of our offices. The increase in working remotely could increase our cyber security risk, create data accessibility concerns, and make us more susceptible to communication disruptions, any of which could adversely impact our business operations or delay necessary interactions with local and federal regulators and manufacturing sites.

In addition, the trading prices for our common stock and other companies in the life sciences industry have been highly volatile as a result of the COVID-19 pandemic. As a result, if we needed to raise additional capital, we may face difficulties raising capital through equity or debt financings, or such financing transactions may be on unfavorable terms. While the potential economic impact brought by and the duration of the pandemic may be difficult to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial markets, which may reduce our ability to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained adverse market event resulting from the spread of COVID-19 could materially and adversely affect our business and the value of our common stock.

The ultimate impact of the current pandemic, or any other health epidemic, is highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, our commercialization, sales and marketing, research, manufacturing and regulatory activities, healthcare systems or the global economy as a whole. However, these effects could have a material adverse impact on our operations, and we will continue to monitor the situation closely.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits:

The following exhibits shall be deemed to be furnished, and not filed:

Exhibit No.	Description
99.1	Press release issued by Myomo, Inc. on April 8, 2020, furnished herewith.

SIGNATURES

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.

	MYOMO, INC.
Date: April 8, 2020	By:	/s/ David A. Henry
		David A. Henry
		Chief Financial Officer

EX-99.1

Exhibit 99.1

Myomo Reports Accelerating Growth in MyoPro Pipeline and Record Backlog in

the First Quarter of 2020, Provides Update on the Business Impact of COVID-19

CAMBRIDGE, Mass. (April 8, 2020) – Myomo, Inc. (NYSE American: MYO) (“Myomo” or the “Company”), a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper-limb paralysis, today reported its pipeline of MyoPro candidates continued to grow during the first quarter of 2020, with more than 700 candidates awaiting insurance reimbursement authorization as of March 31, 2020. This compares with 594 candidates as of December 31, 2019. In addition, the backlog of authorized units increased from 53 at the beginning of 2020 to 80 units as of March 31, 2020.

Paul R. Gudonis, CEO of Myomo, stated, “Our direct-to-patient online marketing activities continued to reach a growing number of paralyzed individuals or their family members during the first quarter, and we were pleased to add a record of more than 300 new candidates into our pipeline, compared with 193 new candidates in the fourth quarter of 2019. With our emphasis on the Direct Billing channel, over 90% of these new candidates will be served directly by Myomo, up from 81% of new candidates the previous quarter. Our emphasis on direct billing has resulted in both revenue growth and margin improvement over the past year.”

Despite the record number of MyoPro new candidates and the backlog of authorized units, the Company expects to encounter delays in generating revenue due to the global COVID-19 pandemic. Because Myomo provides a custom-fabricated device to each patient, the in-person contact required as part of the fabrication and delivery process is being impacted and likely will continue to be impacted by COVID-19-related public health restrictions on travel and personal interaction. In addition, concern over in-person interactions with pediatric patients under these conditions is expected to delay for several months the timing of the Company’s national launch of its MyoPal product, which was targeted for later this year.

“With COVID-19 affecting our U.S. and European markets, our primary concern is for the health of our employees and the patients seeking a MyoPro,” added Mr. Gudonis. “As a result, revenues for the second quarter and possibly the third quarter of 2020 are expected to be negatively impacted.”

Until there is clarity on the relaxation of public health measures related to the pandemic, the Company suspends its guidance for significant revenue growth this year.

“We believe that Myomo is well-positioned to continue building the patient pipeline and authorization backlog through direct-to-patient online advertising, while conducting patient evaluations via telehealth video conferencing. Importantly, we have sufficient inventory in our

supply chain and expect to have the requisite fabrication capacity available to manufacture and deliver devices to patients quickly when public heath restrictions are eased. Our intention is to sustain our front-end marketing and patient evaluation efforts, and maintaining our support staff is integral to these efforts. However, we intend to reduce as many non-payroll expenses and defer other spending as much as possible to mitigate our monthly cash burn over the next several months,” Mr. Gudonis concluded.

Myomo ended the first quarter with approximately $13.7 million in cash and cash equivalents, including approximately $13.5 million in net proceeds from a follow-on equity offering in February 2020 and the use of $2.0 million to repay 50% of the outstanding balance of its term loan and pay a success fee to the lender. Excluding these items, preliminary cash burn for the first quarter was approximately $2.4 million.

About Myomo

Myomo, Inc. is a wearable medical robotics company that offers improved arm and hand function for those suffering from neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to support the arm and restore function to the weakened or paralyzed arms of patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury. It is currently the only marketed device that, sensing a patient’s own EMG signals through non-invasive sensors on the arm, can restore an individual’s ability to perform activities of daily living, including feeding themselves, carrying objects and doing household tasks. Many are able to return to work, live independently and reduce their cost of care. Myomo is headquartered in Cambridge, Massachusetts, with sales and clinical professionals across the U.S and representatives internationally. For more information, please visit www.myomo.com.

Forward Looking Statements

This press release contains forward-looking statements regarding the Company’s future business expectations, including the expectations around growing the patient pipeline and authorization backlog in the near term, first quarter 2020 revenue expectations, a continued negative impact from the COVID-19 virus and resulting public health measures on revenues in the second and third quarters of 2020, the state of our supply chain and fabrication capacity, the intention to quickly ramp device fabrication and deliveries once public health measures are eased and our intention to not reduce headcount at this time and to reduce non-payroll expenses in order to mitigate cash burn, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors.

These factors include, among other things:

• our sales and commercialization efforts;

• our ability to achieve reimbursement from third-party payers for our products;

• our dependence upon external sources for the financing of our operations, to the extent that we do not achieve or maintain cash flow breakeven;

• our ability to effectively execute our business plan and scale up our operations;

• our expectations as to our development programs; and

• general market, economic, environmental and social factors, including the ongoing COVID-19 pandemic, that may affect the evaluation, fitting, delivery and sale of our products to patients.

More information about these and other factors that potentially could affect our financial results is included in Myomo’s filings with the Securities and Exchange Commission, including those contained in the risk factors section of the Company’s annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. Although the forward-looking statements in this release of financial information are based on our beliefs, assumptions and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements or outcomes. No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. The Company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.

Contacts:

For Myomo:

ir@myomo.com

Investor Relations:

Kim Sutton Golodetz

LHA Investor Relations

kgolodetz@lhai.com

212-838-3777

Public Relations:

Katie McCann

Matter Communications

myomo@matternow.com

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