MYOMO INC
For the period ended Dec 31, 2023. Filed Mar 8, 2024.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2023 · Filed Mar 8, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Consolidated Financial Statements
Note 1 — Description of Business
Myomo Inc. (“Myomo” or the Company”) is a wearable medical robotics company that develops, designs, and produces myoelectric orthotics for people with neuromuscular disorders. The MyoPro ® myoelectric upper limb orthosis product is registered with the Food and Drug Administration as a Class II medical device. The Company provides the device to patients and bills their insurance companies directly, sometimes utilizing the clinical services of orthotics and prosthetics (“O&P”) providers for which they are paid a fee. The Company sells the product to O&P providers around the world and the Veterans Health Administration (“VA”). The Company was incorporated in the State of Delaware on September 1, 2004 and is headquartered in Boston, Massachusetts.
Pursuant to an amended and restated certificate of incorporation, the Company is authorized to issue up to 75,000,000 shares of stock, consisting of 65,000,000 shares of common stock, par value $0.0001, and 10,000,000 shares of undesignated Preferred Stock, par value of $0.0001.
Liquidity
The Company incurred net losses of approximately $8,147,600 and $10,721,000 during the years ended December 31, 2023 and 2022, respectively, and has an accumulated deficit of approximately $96,930,800 and $88,783,200 at December 31, 2023 and 2022, respectively. Cash used in operating activities was approximately $6,172,800 and $10,233,500 for the years ended December 31, 2023 and 2022, respectively. The Company's historical losses and cash used in operations are indicators of substantial doubt regarding the Company's ability to continue as a going concern.
The Company has historically funded its operations through financing activities, including raising equity and debt capital. On January 19, 2024, the Company completed a registered direct equity offering, pursuant to which it sold 1,354,218 shares of common stock and 224,730 pre-funded warrants at $3.80 per share, or $3.7999 per pre-funded warrant, generating net proceeds after fees and expenses of approximately $5.4 million. (See Note 12 - Subsequent Events for further discussion.) On August 29, 2023, The Company completed a public equity offering, selling 5,413,334 shares of common stock and 1,920,000 pre-funded warrants at $0.60 per share, or at $0.5999 per pre-funded warrant, generating proceeds after fees and expenses of approximately $3.9 million. In January 2023, the Company completed a public equity offering pursuant to which it sold 13,169,074 shares of common stock and 6,830,926 pre-funded warrants at $0.325 per share, or $0.3249 per pre-funded warrant, generating proceeds after fees and expenses of approximately $5.7 million. (See Note 7 - Common Stock for further discussion.) During the fourth quarter of 2022, the Company sold 692,914 shares of common stock under a Common Stock Purchase Agreement (the “Purchase Agreement”) with Keystone Capital Partners, LLC (“Keystone”), generating net proceeds after fees and expenses of approximately $0.4 million. (See Note 7 - Common Stock for further discussion.) These financing activities have enabled the Company to sustain its operations.
Management's operating plans are primarily focused on increasing its clinical, reimbursement and manufacturing capacity in order to serve a higher volume of Medicare Part B patients in 2024. The Company believes that based on the final fees published by the Centers for Medicare and Medicaid Services (“CMS”) on February 29, 2024 for the Company’s products (See Note 12 - Subsequent Events for further discussion), if the Company is able to hire at least 50 to 60 additional employees during the first half of 2024 as planned to increase its clinical, reimbursement and manufacturing capacity, and its supply chain is able to meet its volume requirements without disruption, the Company believes it can achieve cash flow breakeven on a quarterly basis by the fourth quarter of 2024. In addition, the Company believes that it has access to capital resources through possible public or private equity offerings, exercises of outstanding warrants, debt financings, or other means. Debt financing may contain other terms that are not favorable to the Company or its stockholders. Based on the Company's latitude as to the timing and amount of certain expenses, its current cash position and the net proceeds received from the equity offering completed in January 2024, the Company believes that the substantial doubt is mitigated as of the issuance date of these financial statements.
Based upon its expected cash flows and the funds raised in the January 2024 equity offering, the Company believes that its available cash will fund its operations for at least the next twelve months from the issuance date of these financial statements. There can be no assurance that the Company will be successful in implementing its operating plans.
Note 2 — Summary of Significant Accounting Policies
Basis of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary Myomo Europe GmbH. All significant intercompany balances and transactions are eliminated.
Comprehensive Loss
Comprehensive loss includes all changes in equity during a period, except those resulting from investments by stockholders and distributions to stockholders, if any. The Company's comprehensive loss includes changes in foreign currency translation adjustments and unrealized gains and losses on short term investments. There was a reclassification which management does not consider to be material out of accumulated other comprehensive income (loss) to other (income) expense related to realized gains or losses on short-term investments in the year ending December 31, 2023. There were no reclassifications in the year ending December 31, 2022.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America require management to make estimates and assumptions that affect certain reported amounts and disclosures. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Actual results could differ from those estimates. The Company’s estimates include deferred income tax valuation allowances, valuation of stock-based compensation, warranty obligations and reserves for slow-moving inventory.
Cash, Cash Equivalents and Short-Term Investments
The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Cash and cash equivalents consist principally of deposit accounts and money market accounts at December 31, 2023 and 2022.
The Company considers all investments with an original maturity of greater than three months to be short-term investments. Short-term investments primarily consists of commercial paper and U.S. Treasury Bills and are carried on the consolidated balance sheets at fair value. Short-term investments as of December 31,2023 consists of U.S. Treasury Bills, which are classified as held-maturity, and Certificates of Deposit totaling approximately $1,994,700 as of December 31, 2023, there wereno Short-term investments as of December 31, 2022. The Company determines the appropriate balance sheet classification of its investments at the time of purchases and evaluates the classification at the date of purchase. Unrealized gains and losses on short-term investments are recorded to accumulated other comprehensive income on the consolidated balance sheets and other gain (loss) on the consolidated statements of comprehensive loss. Once unrealized gains and losses become realized, they are reclassified from other comprehensive gains and losses to cost of goods sold.
Accounts Receivable and Allowance for Credit Losses
The Company reports accounts receivable at invoiced amounts less an allowance for doubtful accounts. The Company evaluates its accounts receivable on a continuous basis, and if necessary, establishes an allowance for doubtful accounts based on a number of factors, including current credit conditions and customer payment history. The Company does not require collateral or accrue interest on accounts receivable and credit terms are generally 30 days. At December 31, 2023 and 2022, the Company recorded an allowance for credit losses accounts which was immaterial to the financial statements.
Inventories
Inventories are recorded at the lower of average cost or net realizable value. Average cost approximates valuation on a first-in, first-out basis. The Company reduces the carrying value of inventory for those items that are potentially excess, obsolete or slow-moving based on changes in customer demand, technology developments or other economic factors. In addition, the carrying value of units used by patients on a trial basis only includes the value of motor units that can be re-used. Orthotic components on trial units are expensed to cost of goods sold once consumed.
Equipment
Equipment is stated at historical cost, net of accumulated depreciation and is depreciated using the straight-line method over the estimated useful lives of the related assets, generally three years. Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or the estimated useful life. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are charged to operations as incurred, and expenditures, which extend the economic life, are capitalized. When assets are retired, or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and any gain or loss on disposal is recognized.
Demonstration units are sometimes provided by the Company to its indirect sales channel for marketing and patient evaluation purposes. These units are manufactured by the Company and are expensed in the consolidated statements of operations to selling, general and administrative expense. During the years ended December 31, 2023 and 2022, the Company charged to operations approximately $37,200 and $19,700, respectively, for these units. Demonstration units provided to its own sales force are capitalized as equipment on the Company’s consolidated balance sheet.
Test units are provided to research and development staff to use in their development process and to end users who are given free units to act as testers so that research and development staff can evaluate and understand their use by patients. A primary objective of these units is to determine when and under what conditions they fail, at which time they are analyzed for cause of failure and then scrapped. These units are expensed in the statements of operations as part of research and development expense. During the year ended December 31, 2023 and 2022 the Company charged to operations approximately $36,700 and $11,200, respectively, for these units.
Impairment of Long-Lived Assets
The Company assesses the recoverability of its long-lived assets, including equipment when there are indications that the assets might be impaired. When evaluating assets for potential impairment, the Company compares the carrying value of the asset to its estimated undiscounted future cash flows. If an asset’s carrying value exceeds such estimated undiscounted cash flows, the Company records an impairment charge for the difference. Based on its assessments, the Company didnot record any impairment charges for the years ended December 31, 2023 and 2022.
Leases
The Company accounts for leases under Accounting Standards Topic 842 (“ASC 842”). The Company assesses whether a contract is or contains a lease at inception of the contract and leases, recognizes right-of-use assets and corresponding lease liabilities at the lease commencement date, except for short-term leases, which are under one year, and leases of low value. For these leases, the Company recognizes the lease payments as an operating expense on a straight-line basis over the term of the lease.
Joint Venture
On March 28, 2022, the Company invested cash consideration of $199,000 for a 19.9%ownership stake in Jiangxi Myomo Medical Assistive Appliance Co., Ltd. (the “JV Company”), a company headquartered in China that is majority-owned by Beijing Ryzur Medical Investment Co., Ltd. (“Ryzur Medical”). In addition, we and the JV Company have entered into a ten-year agreement to license our intellectual property, including recently issued patentsin China and Hong Kong, and purchase MyoPro Control System units from us. The JV Company will manufacture and sell the Company’s current and future products in greater China, including Hong Kong, Macau and Taiwan, and has begun limited operations. The Company accounts for its investment in the JV Company under the equity method because the Company exerts significant influence over its management. The investment is included in total assets on the consolidated balance sheet. As a result of recording its share of losses in the JV Company, the investment was written off as of December 31, 2023. The Company records its share of the JV Company’s earnings in its consolidated statement of operations in other expense (income). The Company will continue to record its share of losses going forward to the extent there are other assets on the consolidated balance sheet from the JV Company. The Company recorded a loss on equity investment of approximately $169,500 and$66,500 for the years ended December 31, 2023 and 2022, respectively.
Revenue Recognition
The Company accounts for revenue under ASC 606, “Revenue from Contracts with Customers” and all the related amendments (Topic 606). Revenues under Topic 606 are required to be recognized either at a “point in time” or “over time,” depending on the facts and circumstances of the arrangement and are evaluated using a five-step model. Generally, the Company recognizes revenue at a point in time.
The Company recognizes revenue after applying the following five steps:
Identification of the contract, or contracts, with a customer,
Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract
Determination of the transaction price, including the constraint on variable consideration
Allocation of the transaction price to the performance obligations in the contract; and
Recognition of revenue when, or as, performance obligations are satisfied.
Revenue is recognized when control of these services is transferred to its customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services.
Product Revenue
The Company derives the majority of its revenue from direct billing. The Company also derives revenue from the sale of its products to clinical consulting services of orthotics and prosthetics or "O&P" providers in the United States and internationally and the VA. Under direct billing, the Company recognizes revenue when all of the following criteria are met:
(i)
The product has been delivered to the patient, including completion of initial instruction on its use.
(ii)
Collection is deemed probable and it has been determined that a significant reversal of the revenue to be recognized is not deemed probable when the uncertainty associated with the variable consideration is resolved; and
(iii)
The amount to be collected is estimable using the “expected value” estimation techniques, or the “most likely amount” as defined in ASC 606.
For revenue derived from certain insurance companies where the Company has demonstrated sufficient payment history, the Company recognizes revenue when it receives a pre-authorization from the insurance company and control passes to the patient upon delivery of the device in an amount that reflects the consideration the Company expect to receive in exchange for the device. During 2023 and 2022, the Company made such a determination for certain insurers. These insurers represented approximately 66% and 44% of direct billing channel revenue in 2023 and 2022, respectively.
Depending on the timing of product deliveries to customers, which is when cost of revenue must be recorded, and when the Company meets the criteria to record revenue, there may be fluctuations in gross margin on an ongoing basis. During the years ended December 31, 2023 and 2022, the Company recognized revenue of approximately $1,554,800 and $2,044,000, respectively, from O&P providers or other third-party payers for which costs related to the completion of the Company’s performance obligations were recorded in a prior period.
For revenues derived from O&P providers, the VA, and distributors, the Company recognizes revenue when control passes to the customer in an amount that reflects the consideration the Company expects to receive in exchange for those services, which may be recognized upon shipment or upon delivery, depending on the terms of the arrangement, provided that persuasive evidence of an arrangement exists, there are no uncertainties regarding customer acceptance and collectability is deemed probable.
The Company has elected to record taxes collected from customers on a net basis and does not include tax amounts in revenue or cost of revenue.
License Revenue
If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when the license is transferred to the customer, the customer is able to use and benefit from the license, and collectability is deemed probable.
On January 21, 2021, the Company entered into a Technology License Agreement (the “Agreement”) with the JV Company. Under the Agreement, the Company is entitled to receive an upfront license fee of $2.7 million, of which $1.7 million and $1.0 million has been paid and recognized as licensee revenue during the years ended December 31, 2023 and 2022, respectively, and is paid in full. In addition, the Company is entitled to receive a guaranteed minimum payment for purchase of MyoPro Control Units for a period of ten years from the effective date of the Agreement. The Company will recognize revenue on these amounts upon invoicing to the JV Company so long as collectability is deemed to be assured.
Contract Balances
The timing of revenue recognition may differ from the timing of payment by customers. The Company records a receivable when revenue is recognized prior to payment and there is an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, the Company records deferred revenue until the performance obligations are satisfied. The Company had approximately $8,500 and $21,200 of deferred revenue as of December 31, 2023 and 2022, respectively.
Disaggregated Revenue from Contracts with Customers
The following table presents revenue by major source:
| 2023 | 2022 | |
|---|---|---|
| Clinical/medical providers | $5,128,864 | $3,841,424 |
| Direct-to-patient | 12,347,374 | 10,713,805 |
| License revenue | 1,764,920 | 1,000,000 |
| Total revenue from contracts with customers | $19,241,158 | $15,555,229 |
Geographic Data
The Company generated 73% of its revenue from the United States,16% from Germany,10% from China and 1% from other international locations for the year ended December 31, 2023. The Company generated 81% of its revenue from the United States,12% from Germany,6% from China and 1% from other international locations for the year ended December 31, 2022.
Cost of Revenue
In conjunction with the adoption of ASC 606, there are certain cases in which the Company will expense costs when incurred as required by ASC 340-40-25, such as when the Company ships the MyoPro device to O&P providers, or provides the device directly to patients, pending reimbursement from certain third-party payers, which triggers revenue recognition. For the years ended December 31, 2023 and December 31, 2022, the Company recorded cost of goods sold of approximately $65,200 and $441,600, respectively, without corresponding revenue. The cost of clinical services by O&P providers for which they are paid a fee in conjunction with devices being sold directly to patients and billing their insurance companies directly are expensed as incurred as required by ASC 340-40-25, as a cost of obtaining a contract. These costs are recorded as sales and marketing expense, with the remaining costs associated with the patient being expensed to cost of revenue.
Shipping and Handling Costs
Shipping and handling costs paid by customers are netted against the related shipping costs we incur. The net cost is recorded in cost of revenues. Historically, such costs have not been material.
Income Taxes
The Company accounts for income taxes under Accounting Standards Codification ASC 740, “Income Taxes” (“ASC 740”). Under ASC 740, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to impact taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.
ASC 740 requires that the tax effects of changes in tax laws or rates be recognized in the financial statements in the period in which the law is enacted.
ASC 740 also clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.
Tax benefits claimed or expected to be claimed on a tax return are recorded in the Company’s financial statements. A tax benefit from an uncertain tax position is only recognized if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position are measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate resolution.
The Company files income tax returns in federal, state and foreign jurisdictions and is no longer subject to examinations by tax authorities for years prior to 2020. Currently, there are no income tax audits in process.
Stock-Based Compensation
The Company accounts for stock awards to employees by measuring the cost of services received in exchange for the award of equity instruments based upon the fair value of the award on the date of grant. The fair value of that award is then ratably recognized as expense over the period during which the recipient is required to provide services in exchange for that award.
Foreign Currency Translation
The functional currency of the Company’s foreign subsidiary, Myomo Europe GmbH, is the Euro. Foreign exchange translation gains and losses from the Euro to U.S. dollars are included in other comprehensive gain. The Company recorded gains of approximately $41,200 and $103,900 during the years ended December 31, 2023 and 2022, respectively, which are included in accumulated other comprehensive income in the consolidated balance sheets. Transactional foreign exchange gains and losses from a foreign currency to the functional currency are included in selling, general and administrative expenses in the consolidated statement of operations. Such amounts were immaterial for the years ended December 31, 2023 and 2022. The balance sheet is translated using the spot date on the day of reporting and the income statement is translated monthly using the average rate for the month.
Net Loss per Share
Basic loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding, plus potentially dilutive common shares. Restricted stock units, stock options and warrants are excluded from the diluted net loss per share calculation when their impact is antidilutive. The Company reported a net loss for the years ended December 31, 2023 and 2022, respectively, and as a result, all potentially dilutive common shares are considered antidilutive for these periods.
Potentially common shares issuable at December 31, 2023 and 2022 consist of:
| 2023 | 2022 | |
|---|---|---|
| Options | 24,529 | 29,605 |
| Warrants | 668,250 | 680,363 |
| Restricted stock units | 1,501,659 | 454,447 |
| Total | 2,194,438 | 1,164,415 |
Due to their nominal exercise price of $0.0001 per share, a total of 8,271,519 outstanding pre-funded warrants as of December 31, 2023 are considered common stock equivalents and are included in weighted average shares outstanding in the accompanying consolidated statements of operations as of the closing dates of the Company's public equity offerings in January 2023 and August 2023, respectively.
Advertising
The Company charges the costs of advertising to operating expenses as incurred. Advertising expense amounted to approximately $3,216,100 and $4,069,300 in 2023 and 2022, respectively.
Research and Development Costs
The Company expenses research and development costs as incurred. Research and development costs primarily consist of salaries and benefits, facility and overhead costs, and outsourced research activities.
Recent Accounting Standards
In October 2023, the FASB issued ASU 2023-06, , “Disclosure Improvements, Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative”, that adds 14 of the 27 identified disclosure or presentation requirements to the Codification, each amendment in the ASU will only become effective if the SEC removes the related disclosure or presentation from its existing regulations by June 30, 2027. The Company currently complies with these disclosure requirements as applicable under Regulation S-X or Regulation S-K and will adopt these new standards depending on timing of when they become effective, which is not expected to have a material impact on its financial position and results of operations.
In September 2022, the FASB issued ASU 2022-04, “Liabilities - Supplier Finance Programs (Subtopic 405-50): Disclosure of Supplier Finance Program Obligations”, that requires entities that use supplier finance programs in connection with the purchase of goods and services to disclose the key terms of the programs and information about obligations outstanding at the end of the reporting period, including a rollforward of those obligations. The guidance does not affect the recognition, measurement or financial statement presentation of supplier finance program obligations. The new standard’s requirements to disclose the key terms of the programs and information about obligations outstanding are effective for fiscal years, including interim periods, beginning after December 15, 2022, except for the requirement to disclose a rollforward of obligations outstanding will be effective for fiscal years beginning after December 15, 2023. Early adoption is permitted. The Company does not believe that this new standard will have a material impact on its financial position and results of operations.
In December 2023, the FASB issued ASU 2023-09, “Accounting standards update, Income Taxes (Topic 740: Improvements to Income Tax Disclosures”. ASU 2023-09 focuses on income tax disclosures around effective tax rates and cash income taxes paid. This amendment in the ASU will become effective for public companies as of December, 15 2024 and effective to all other companies one year later. The Company will adopt these new standards when they become effective, which is not expected to have a material impact on its financial position and results of operations.
Subsequent Events
The Company evaluates whether there have been subsequent events through the date the financial statements were issued and determines whether subsequent events exist that would require recognition in the financial statements or disclosure in the notes of the financial statements.
Note 3 — Inventories
Inventories consist of the following at December 31:
| 2023 | 2022 | |
|---|---|---|
| Finished goods | $321,484 | $512,028 |
| Work in Process | 6,589 | 18,971 |
| Rental units | - | 51,694 |
| Parts and subassemblies | 1,475,434 | 903,581 |
| 1,803,507 | 1,486,274 | |
| Less: Reserve for rental and trial units | - | (86,409) |
| Inventories, net | $1,803,507 | $1,399,865 |
Note 4 — Equipment, net
Equipment consists of the following at December 31:
| 2023 | 2022 | |
|---|---|---|
| Computer equipment | $318,559 | $249,621 |
| Sales demonstration units | 278,710 | 210,624 |
| R&D tools and molds | 52,644 | 52,644 |
| Leasehold improvements | 254,043 | 254,043 |
| Furniture and fixtures | 60,837 | 60,836 |
| 964,793 | 827,768 | |
| Less: accumulated depreciation | (788,999) | (633,485) |
| Equipment, net | $175,794 | $194,283 |
Depreciation expense was approximately $164,300 and $192,800 for the years ended December 31, 2023 and 2022, respectively.
Note 5 — Fair Value of Financial Instruments
The Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820 “Fair Value Measurements” (“ASC 820”), which defines fair value, establishes a framework for measuring fair value, and establishes disclosures about fair value measurements.
ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:
Level 1 — Quoted prices available in active markets for identical assets or liabilities.
Level 2 — Observable inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs.
The carrying amounts of the Company’s financial instruments such as cash and cash equivalents, accounts receivable and accounts payable, approximate fair value due to the short-term nature of these instruments. Cash equivalents consists of a money market fund that limits its investments to only short-term U.S. Treasury securities and repurchase agreements related to these securities.
The Company considers all investments with an original maturity of greater than three months to be short-term investments. Short-term investments primarily consists of commercial paper and U.S. Treasury Bills and are carried on the consolidated balance sheets at fair value. Short-term investments as of December 31,2023 consists of U.S. Treasury Bills, which are classified as held-maturity, and Certificates of Deposit totaling approximately $1,994,700 as of December 31, 2023, there wereno Short-term investments as of December 31, 2022. The Company determines the appropriate balance sheet classification of its investments at the time of purchases and evaluates the classification at the date of purchase. Unrealized gains and losses on short-term investments are recorded to accumulated other comprehensive income on the consolidated balance sheets and other gain (loss) on the consolidated statements of comprehensive loss. Once unrealized gains and losses become realized, they are reclassified from other comprehensive gains and losses to cost of goods sold.
Cash equivalents and short-term investments, which are measured at fair value, were as follows At December 31, 2023:
| In ActiveMarkets forIdenticalAssets orLiabilities(Level 1) | SignificantOtherObservableInputs(Level 2) | SignificantUnobservableInputs(Level 3) | December 31,2023Total | |
|---|---|---|---|---|
| Money market funds | $4,893,387 | — | — | $4,893,387 |
| Commercial paper | — | $746,762 | — | $746,762 |
| Short-term investments | — | $1,994,662 | — | $1,994,662 |
Cash equivalents, which are measured at fair value, were as follows at December 31, 2022:
| In ActiveMarkets forIdenticalAssets orLiabilities(Level 1) | SignificantOtherObservableInputs(Level 2) | SignificantUnobservableInputs(Level 3) | December 31,2022Total | |
|---|---|---|---|---|
| Cash equivalents | $4,350,657 | — | — | $4,350,657 |
Note 6 – Accounts Payable and other Accrued Expenses
Accounts Payable and Other Accrued Expenses consists of the following at December 31:
| 2023 | 2022 | |
|---|---|---|
| Trade payables | $1,073,405 | $569,681 |
| Accrued compensation and benefits | 1,964,487 | 959,228 |
| Accrued professional services | 52,202 | 124,548 |
| Warranty reserve | 231,108 | 234,647 |
| Customer deposits | 1,114,979 | 753,232 |
| Other | 449,763 | 538,026 |
| $4,885,944 | $3,179,362 |
Note 7 — Common Stock
On August 2, 2022, (“the “Agreement Date””) the Company entered into a Purchase Agreement (“Agreement”) with Keystone, establishing an equity line facility under which the Company, at its sole discretion, can direct Keystone to purchase the Company's common stock from time to time through delivery of a purchase notice. The purchase price was at the lesser of prevailing market prices of the Company’s common stock as defined in the Agreement, at a 10% discount. The Company could sell shares of common stock to Keystone up to the Maximum Amount, provided that the Company has agreed to issue no more than 1,399,334 shares of common stock at a discount, representing 19.99% of the Company's outstanding shares on the Agreement Date, of which 50,000 shares were issued to Keystone as a commitment fee after closing of the transaction. During the fourth quarter of 2022, the Company sold 692,914 shares to Keystone at a weighted average sales price of $0.683 per share, generating proceeds after fees and expenses of approximately $376,900. In conjunction with the public equity offering in August 2023, the Company terminated the Agreement.
In addition to the commitment fee, on the Agreement Date the Company paid Keystone $20,000 for its expenses incurred in conjunction with the transaction. The commitment fee was recorded to common stock and Keystone’s expenses reimbursed by the Company were recorded to additional paid-in capital as of December 31, 2022.
The Company entered into an ATM Facility with Alliance Global Partners on August 2, 2022. Under the ATM Facility, the Company may sell up to an aggregate of $15 million of the Company’s common stock from time to time and shall pay to AGP cash commissions of 3.0% of the gross proceeds of sales of common stock under the ATM Facility. There wereno sales under the ATM Facility during the years ended December 31, 2023 and December 31, 2022. In conjunction with public equity offering in August 2023, the Company reduced the amount available to sell under the ATM Facility to $1,000. This amount remains available for sale at December 31, 2023.
On January 17, 2023, the Company completed a public equity offering, selling 13,169,074 shares of common stock and 6,830,926 pre-funded warrants at $0.325 per share or at $0.3249 per warrant, generating proceeds after fees and expenses of approximately $5.7 million. Each pre-funded warrant is exercisable for one share of the Company’s common stock at a nominal exercise price of $0.0001 per share.
On August 29, 2023, the Company completed a public equity offering, selling 5,413,334 shares of common stock and 1,920,000 pre-funded warrants at $0.60 per share, or at $0.5999 per warrant, generating proceeds after fees and expenses of approximately $3.9 million. Each pre-funded warrant is exercisable for one share of the Company’s common stock at a nominal exercise price of $0.0001 per share.
No shares of common stock were issued through the exercise of stock options during the years ended December 31, 2023 and 2022.
During the years ended December 31, 2023 and 2022, the Company issued 339,335 and 137,302 shares of common stock, respectively, upon the vesting of restricted stock units.
Note 8 — Stock Award Plans and Stock-Based Compensation
Equity Incentive Plan
On June 19, 2018, the Company’s Shareholders and Board of Directors (the “Board of Directors”) approved the Myomo, Inc. 2018 Stock Options and Incentive Plan (the “2018 Plan”). On January 1 of each year, the number of shares of common stock reserved and available for issuance under the 2018 Plan will cumulatively increase by 4% of the number shares of common stock outstanding on the immediately preceding December 31 or such lesser number of shares of common stock determined by management in consultation with members of the Board of Directors, including the compensation committee of the Board of Directors.
On January 1, 2023 and 2022, the number of shares reserved and available for issuance under the 2018 Plan increased by 310,024 and 274,789 shares, respectively. At December 31, 2023, there were 119,123 shares available for future grant under the 2018 Plan.
Under the terms of the 2018 Plan, incentive stock options (“ISOs”) may be granted to officers and employees and non-qualified stock options and awards may be granted to directors, consultants, officers and employees of the Company. The exercise price of ISOs cannot be less than the fair market value of the Company’s Common Stock on the date of grant. The options vest over a period determined by the Board of Directors, ranging from immediate tofour years, and expire not more thanten years from the date of grant.
Stock Option Awards
Stock option activity under the Stock Option Plans during the years ended December 31, 2023 and 2022 is as follows:
| Shares | WeightedAverageExercise Price | WeightedAverageRemainingLife (years) | IntrinsicValue | |
|---|---|---|---|---|
| Balance at January 1, 2022 | 31,447 | $40.5800 | 7.51 | $23,194 |
| Granted | 1,700 | 8.0000 | ||
| Forfeited or cancelled | (3,293) | 28.4000 | ||
| Exercised | (249) | 9.1900 | ||
| Balance at December 31, 2022 | 29,605 | 40.5000 | 6.52 | $587 |
| Granted | - | - | ||
| Forfeited or cancelled | (3,139) | 17.5800 | ||
| Expired | (1,937) | 69.6100 | ||
| Balance at December 31, 2023 | 24,529 | $41.1300 | 5.53 | $7,468 |
| Options exercisable at December 31, 2022 | 20,229 | $54.9600 | 5.67 | $587 |
| Options exercisable at December 31, 2023 | 19,733 | $49.0300 | 5.05 | $6,850 |
The Company uses the Black-Scholes option pricing model to estimate the grant date fair value of its stock options. There wasno income tax benefit recognized in the financial statements for share-based compensation arrangements for the years ended December 31, 2023 and 2022. There were no stock options granted during the year ended December 31, 2023. The weighted-average grant date fair value was $6.92 per share for the year ended December 31, 2022. The following weighted average assumptions underlying the calculation of grant date fair value are as follows:
| Volatility | 117.18% |
|---|---|
| Risk-free interest rate | 1.68% |
| Weighted-average expected option term (in years) | 6.25 |
| Dividend yield | 0% |
The stock price volatility for the Company’s options was determined using the Company’s historical volatility since its initial public offering in June 2017. The risk-free interest rate was derived from U.S. Treasury rates existing on the date of grant for the applicable expected option term. The expected term represents the period of time that options are expected to be outstanding. Because the Company has only very limited historical exercise behavior, it determines the expected life assumption using the simplified method, which is an average of the contractual term of the option and its ordinary vesting period. The expected dividend yield assumption is based on the fact that the Company has never paid, nor has any intention to pay, cash dividends.
Restricted Stock Units
Restricted stock unit “RSU” activity for the years ended December 31, 2023 and 2022 is summarized below:
| Number of Shares | Weighted averagegrant date fairvalue | Weighted averageremaining contractuallife (in years) | |
|---|---|---|---|
| Outstanding as of January 1, 2022 | 292,558 | $9.64 | 2.27 |
| Awarded | 340,923 | 2.13 | |
| Vested | (137,332) | 2.47 | |
| Canceled | (41,702) | 5.10 | |
| Outstanding as of December 31, 2022 | 454,447 | 5.06 | 1.44 |
| Awarded | 1,450,445 | 0.57 | |
| Vested | (339,409) | 2.37 | |
| Canceled | (63,824) | 4.51 | |
| Outstanding as of December 31, 2023 | 1,501,659 | $1.53 | 1.22 |
In 2023 and 2022, the Company granted an aggregate of 1,450,445 and 340,923 RSUs to employees, respectively, of which 608,000 and 203,510 RSUs were granted to executive officers, respectively, which vest over a period oftwo years andthree years, respectively. In 2023, the Company granted 239,952 RSUs to independent members of the board of directors, which vest in four equal quarterly installments. No RSUs were granted to independent members of the board of directors in 2022.
The Company determined the fair value of these grants based on the closing price of the Company’s common stock on the respective grant dates. The compensation expense is being amortized over the respective vesting periods.
Awards of RSUs may be net share settled upon vesting to cover the required employee statutory withholding taxes and the remaining amount is converted into shares based upon their share-value on the date the award vests. These payments of employee withholding taxes, if made, are presented in the statements of cash flows as a financing activity.
Share-Based Compensation Expense
The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees and time-based and performance-based restricted stock units to employees and directors, and restricted stock units to employees in the consolidated statements of operations as follows:
| 2023 | 2022 | |
|---|---|---|
| Cost of goods sold | $91,604 | $75,778 |
| Research and development | (4,488) | 127,198 |
| Selling, general and administrative | 1,028,486 | 987,518 |
| Total | $1,115,602 | $1,190,494 |
As of December 31, 2023, there was approximately $25,800 ofunrecognized compensation cost related to unvested stock options which is expected to be recognized over a weighted-average period of 1.5 years.
As of December 31, 2023, there was approximately $867,200 of unrecognized compensation cost related to unvested restricted stock unit awards which is expected to be recognized over a weighted-average period of 1.2 years.
Note 9 — Warrants
The following table presents the Company’s common stock warrant activity for the years ended December 31, 2023 and 2022:
| Warrants | Weighted AverageExercise Price | |||
|---|---|---|---|---|
| Outstanding | Exercisable | Outstanding | Exercisable | |
| Balance, Jan 1, 2022 | 693,643 | 693,643 | 8.76 | 8.76 |
| Expired | (12,614) | (12,614) | 29.30 | 29.30 |
| Exercised | (666) | (666) | — | — |
| Balance, Dec 31, 2022 | 680,363 | 680,363 | 8.30 | 8.30 |
| Issued | 8,750,926 | 8,750,926 | ||
| Expired | (12,113) | (12,113) | 0.53 | 0.53 |
| Exercised | (479,407) | (479,407) | — | — |
| Balance, Dec 31, 2023 | 8,939,769 | 8,939,769 | $0.56 | $0.56 |
Due to their nominal exercise price of $0.0001 per share, a total of 8,271,519 outstanding pre-funded warrants as of December 31, 2023 are considered common stock equivalents and are included in weighted average shares outstanding in the accompanying consolidated statements of operations as of the closing dates of the Companys public equity offerings in January 2023 and August 2023, respectively. A total of 479,407 pre-funded warrants were exercised during the year ended December 31, 2023. The pre-funded warrants have no maturity date. The weighted average remaining contractual life of warrants outstanding and exercisable, excluding pre-funded warrants at December 31, 2023 was 1.1 years.
Note 10 — Commitments and Contingencies
Litigation
The Company may be involved in legal proceedings, claims and assessments arising from the ordinary course of business. Such matters are subject to many uncertainties, and outcomes are not predictable with assurance. During 2022, a former employee that was terminated in 2021 brought an age discrimination claim against the Company. During the fourth quarter of 2023, the Company settled the claim with its former employee. The Company deems it probable that its insurance company will pay its share of the claim. As a result of this assumed gain contingency, the Company reduced its accrual to an amount that is not expected to be covered by insurance, and recorded a liability of approximately $55,000 for severance and legal expenses as of December 31, 2023. There is no other material litigation against the Company at this time.
Operating Leases
The Company has a non-cancelable sublease agreement for its corporate headquarters in Boston, Massachusetts which expired in August 2023. In conjunction with entering into a non-cancelable lease agreement for its manufacturing space in Boston in January 2022, the Company agreed to enter into a lease for its corporate headquarters space, effective September 1, 2023. Both leases in Boston as well as a lease for office space in Fort Worth, TX, expire in 2025. The Fort Worth, TX lease has the option to terminate early, which became available at the Company’s discretion in 2023, which is did not take. Termination options were not included in the lease term for the Company’s existing operating leases. Certain arrangements have discounted rent periods or escalating rent payment provisions. Leases with an initial term of twelve months or less are not recorded on the condensed consolidated balance sheets. We recognize rent expense on a straight-line basis over the lease term.
As of December 31, 2023, operating lease assets were approximately $663,600 and operating lease liabilities were approximately $601,300. The maturity of the Company’s operating lease liabilities as of December 31, 2023, were as follows:
| 2024 | 578,198 |
| 2025 | 102,842 |
| 2026 | — |
| Thereafter | — |
| Total future minimum lease payments | 681,040 |
| Less imputed interest | 79,737 |
| Total operating lease liabilities | $601,303 |
| Included in the consolidated balance sheet: | |
|---|---|
| Current operating lease liabilities | $486,143 |
| Non-current operating lease liabilities | 115,160 |
| Total operating lease liabilities | $601,303 |
For the twelve months ended December 31, 2023, the total lease cost comprised of the following amounts:
| Years ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Operating lease expense | 454,040 | 493,203 |
| Short-term lease expense | 3,989 | 3,250 |
| Total lease expense | $458,029 | $496,453 |
The Company paid cash of approximately $550,600 and $557,500 for its operating leases for the years ended December 31, 2023 and 2022, respectively.
The following summarizes additional information related to operating leases:
| 2023 | 2022 | |
|---|---|---|
| Weighted-average remaining lease term | 1.2 | 1.8 |
| Weighted-average discount rate | 23.3% | 20% |
If the rate implicit in the lease is not readily determinable, the Company uses its incremental borrowing rate as the discount rate. The Company uses its best judgment when determining the incremental borrowing rate, which is the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term to the lease payments in a similar currency.
Licensing Agreement
During 2006, the Company entered into an exclusive licensing agreement (the “MIT License”) with Massachusetts Institute of Technology (“MIT”) for access to certain patent rights that require the payment of royalties, which vary based on the level of the Company’s net sales and whether the customer is located in the United.States, or in an international location. As part of the agreement, the Company was required to pay to MIT a nonrefundable annual license maintenance fee which could have been credited to any royalty amounts due in that same year. The royalty charge for the years ended December 31, 2023 and 2022 was approximately $244,900 and $264,200, respectively, and is included as a component of cost of revenue. The MIT license expired in November 2023.
Warranty Liability
The Company accrues an estimate of their exposure to warranty claims based on historical warranty costs incurred and the number units under warranty to estimate future warranty costs to be insured. Most of the Company’s current product sales include athree-year warranty. The Company assesses the adequacy of their recorded warranty liability annually and adjusts the amount as necessary.
Changes in warranty liability were as follows:
| 2023 | 2022 | |
|---|---|---|
| Accrued warranty liability, beginning of year | $234,647 | $176,281 |
| Accrual provided for warranties issued during the period | 71,797 | 117,986 |
| Adjustments to prior accruals | — | — |
| Actual warranty expenditures | (75,337) | (59,620) |
| Accrued warranty liability, end of year | $231,108 | $234,647 |
Credit Risk
Financial instruments that potentially expose the Company to a concentration of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. The Company attempts to maintain its operating cash within federally insured limits. Its cash equivalents, including money market funds, are invested in instruments that are off the balance sheets of its operating banks. Its short term investments are held in high quality instruments with large companies and U.S. Treasury Bills. Its cash equivalents and short-term investments, to the extent that there are balances in excess of federally insured limits, are with major financial institutions that management believes are financially sound and have minimum credit risk. The Company has not experienced any losses in such accounts and believes credit risks related to its cash, cash equivalents and short-term investments are limited based upon the creditworthiness of the financial institutions holding these funds.
Supplier Finance Program Obligations
The Company finances its Directors and Officers Insurance policy which requires the Company to make a down payment, followed by equal payments over a defined term. During the twelve months ended December 31, 2023, the Company completed its payment obligation associated with its 2022-2023 policy and entered into a new policy covering the twelve-month period ending June 2024. Under this new financing arrangement, the Company made a down payment during the three months ended June 30, 2023 and is making nine equal monthly payments of approximately $29,000, starting in July 2023. No assets are pledged as security under this arrangement.
Major Customers
For the year ended December 31, 2023 and 2022, there wereno customers which accounted for more than 10% of revenues. For the year ended December 31, 2023 a U.S. insurance payer repres ented 38% of product revenues. For the year ended December 31, 2022, a U.S insurance payer represented 32% of product revenues.
For the year ended December 31, 2023 and 2022, one insurer and its affiliates accounted for approximately 71%and 62% of accounts receivable, respectively.
For the year ended December 31, 2023 and 2022, approximately 57% and 60% of the Companys product revenues were derived from patients with Medicare Advantage insurance plans, respectively.
Note 11 — Income Taxes
Income (loss) before provision for income taxes was as follows:
| 2023 | 2022 | |
|---|---|---|
| United States | $(8,716,749) | $(10,831,796) |
| Foreign | $725,186 | $180,711 |
| Loss before income taxes | $(7,991,563) | $(10,651,085) |
The income tax provision (benefit) for the years ended December 31, 2023 and 2022 consists of the following:
| 2023 | 2022 | |
|---|---|---|
| U.S. federal | ||
| Current | $— | $— |
| Deferred | 2,762,774 | (2,791,239) |
| State and local | ||
| Current | — | — |
| Deferred | 3,278,803 | (615,573) |
| Foreign | ||
| Current | 156,002 | 69,937 |
| Deferred | — | — |
| 6,197,579 | (3,336,876) | |
| Change in valuation allowance | (6,041,578) | 3,406,813 |
| Income tax provision | $156,002 | $69,937 |
The reconciliation between the U.S statutory federal income tax rate and the Companys effective rate for the years ended December 31, 2023 and 2022 is as follows:
| 2023 | 2022 | |
|---|---|---|
| U.S. federal statutory rate | 21.00% | 21.00% |
| State income taxes, net of federal benefit | (38.19)% | 5.60% |
| State rate change and other | (2.16)% | (0.06)% |
| NOLs' to expire unutilized due to 382 limitation | (51.74)% | |
| Foreign tax rate differential | (0.82)% | (0.15)% |
| Other permanent items | (5.63)% | (0.28)% |
| Prior year taxes | (0.02)% | 5.91% |
| Change in valuation allowance | 75.60% | (32.67)% |
| Effective rate | (1.95)% | (0.66)% |
The significant components of the Company’s deferred tax assets are as follows:
| 2023 | 2022 | |
|---|---|---|
| Net operating loss carryover | $11,744,294 | $18,052,725 |
| Tax credits | 130,722 | 423,036 |
| Research and Experimental cost capitalization | 1,027,243 | 657,076 |
| Stock-based compensation | 890,334 | 900,144 |
| Other | 610,069 | 411,258 |
| Total deferred tax asset | 14,402,661 | 20,444,240 |
| Less: valuation allowance | (14,402,661) | (20,444,240) |
| Deferred tax asset, net of valuation allowance | $— | $— |
There wereno deferred tax liabilities at December 31, 2023 or 2022.
As of December 31, 2023 and 2022, the Company had approximately $77,360,000 and $72,726,000 of Federal NOLs and $61,239,000 and$67,302,000 of state NOLs, respectively, available to offset future taxable income. The Federal NOLs incurred prior to 2018 of approximately $26,425,0000, if not utilized, begin expiring in the year 2028. The Federal NOLs incurred after 2017 of approximately $50,935,000 have an indefinite carryforward period. The state NOL's if not utilized begin toexpire in 2024 through 2044.
Additionally, the Company has U.S. federal and state research and development tax credits of $437,000 and $167,000, respectively, which will begin to expire in the year 2027 and 2036, respectively.
NOL carryforwards may face limitations caused by changes in ownership under Section 382 of the Internal Revenue Code. During 2023, the Company experienced an ownership change within the meaning of Section 382 of the Internal Revenue Code of 1986. The ownership change has and will continue to subject the Company’s pre-ownership change net operating loss carryforwards to an annual limitation, which will significantly restrict its ability to use them to offset taxable income in periods following the ownership change. The annual use limitation equals the aggregate value of the Company’s stock at the time of the ownership change multiplied by a specified tax-exempt interest rate. As a result of these ownership changes, the Company is limited to an approximately $64,000 annual limitation on its ability to utilize pre-change NOLs during the carryforward period and has determined that approximately $20,000,000 and $48,000,000 of the Company’s pre-change Federal and State NOLs, respectively, will expire unutilized. Accordingly, the deferred tax asset and valuation allowance have been adjusted by approximately $4,200,000 and $3,900,000 to reflect the Federal and State NOL's, respectively that will expire unutilized.
ASC 740 , “Income Taxes” requires that a valuation allowance be established when it is “more likely than not” that all, or a portion of, deferred tax assets will not be realized. A review of all available positive and negative evidence needs to be considered, including the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies. After consideration of all the information available, management believes that uncertainty exists with respect to future realization of its deferred tax assets and has, therefore, established a full valuation allowance as of December 31, 2023 and December 31, 2022. For the years ended December 31, 2023 and December 31, 2022, the change in valuation allowance was a decrease of ($6,042,000) and an increase of $3,407,000, respectively.
The Company recognizes interest and penalties relating to unrecognized tax benefits on the income tax expense line in the statement of operations. There areno tax penalties and interest on the statement of operations as of December 31, 2023 and December 31, 2022. The Company operates in multiple tax jurisdictions and, in the normal course of business, its tax returns are subject to examination by various taxing authorities. Such examinations may result in future assessments by these taxing authorities. The Company is subject to examination by U.S. tax authorities beginning with the year ended December 31, 2020. To the extent the Company has tax attribute carryforwards the tax years in which the attribute was generated may still be adjusted upon examination by the Internal Revenue Service, or state of foreign tax authorities to the extent utilized in a future period.
There wereno accrued interest and penalties at December 31, 2023 and December 31, 2022.
Note 12 — Subsequent Events
On January 19, 2024, the Company completed a registered direct equity offering, selling 1,354,218 shares of common stock and 224,730 pre-funded warrants at $3.80 per share, or at $3.7999 per pre-funded warrant, generating proceeds after fees and expenses of approximately $5.4 million. Each pre-funded warrant is exercisable for one share of the Company’s common stock at a nominal exercise price of $0.0001 per share.
On February 29, 2024, CMS published final fees for the Company's billing codes for the MyoPro. The final average payment determinations for the MyoPro Motion W (L8701) of approximately $33,500 and for the MyoPro Motion G (L8702) of approximately $65,900, become effective April 1, 2024.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.