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[10-Q] Myomo Inc. Quarterly Earnings Report

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(Neutral)
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(Neutral)
Form Type
10-Q
Rhea-AI Filing Summary

Myomo, Inc. (MYO) reported strong top-line growth for the period ended June 30, 2025 with revenue of $9.65 million in the quarter, up 28% year-over-year, and $19.48 million for the six months, up 73% versus prior year. Higher sales were driven by more units and higher average selling prices following CMS reimbursement updates. Gross profit rose in absolute terms but gross margin narrowed to 62.7% in Q2 from 70.8% a year ago due to higher material and manufacturing overhead costs tied to a new headquarters and facility.

The company reported a quarterly net loss of $4.63 million (loss per share $0.11) and a six-month net loss of $8.10 million as operating expenses increased substantially: R&D +99% and selling, clinical & marketing +88% for the quarter. Cash, cash equivalents and short-term investments totaled about $15.48 million at June 30, 2025, and management states this funding is expected to cover operations for at least 12 months. The company drew $2.5 million on its revolving line and $1.5 million on its term loan during the quarter and disclosed a material weakness in IT general controls that is being remediated.

Myomo, Inc. (MYO) ha registrato una solida crescita dei ricavi per il periodo chiuso al 30 giugno 2025, con entrate di $9.65 milioni nel trimestre, in aumento del 28% su base annua, e $19.48 milioni nei sei mesi, +73% rispetto all’anno precedente. L’incremento delle vendite è stato trainato da un maggior numero di unità vendute e da un prezzo medio di vendita più elevato a seguito degli aggiornamenti dei rimborsi del CMS. Il profitto lordo è cresciuto in valore assoluto, ma il margine lordo si è ridotto al 62.7% nel 2° trimestre rispetto al 70.8% dell’anno scorso, a causa di costi più elevati per materiali e oneri di produzione legati alla nuova sede e struttura.

La società ha riportato una perdita netta trimestrale di $4.63 milioni (perdita per azione $0.11) e una perdita netta sui sei mesi di $8.10 milioni, mentre le spese operative sono aumentate significativamente: R&S +99% e vendite, attività cliniche & marketing +88% nel trimestre. Liquidità, equivalenti di cassa e investimenti a breve termine ammontavano a circa $15.48 milioni al 30 giugno 2025; la direzione ritiene che questi fondi copriranno le operazioni per almeno 12 mesi. Durante il trimestre la società ha utilizzato $2.5 milioni sulla linea di credito revolving e $1.5 milioni sul prestito a termine e ha comunicato una carenza significativa nei controlli IT generali che è in fase di risoluzione.

Myomo, Inc. (MYO) informó un fuerte crecimiento de ingresos para el periodo terminado el 30 de junio de 2025, con ingresos de $9.65 millones en el trimestre, un aumento del 28% interanual, y $19.48 millones en los seis meses, +73% respecto al año anterior. El mayor volumen de ventas se debió a más unidades vendidas y a un precio medio de venta más alto tras las actualizaciones de reembolso del CMS. El beneficio bruto aumentó en términos absolutos, pero el margen bruto se redujo al 62.7% en el 2T desde 70.8% hace un año, debido a mayores costes de materiales y gastos generales de fabricación vinculados a la nueva sede y planta.

La compañía registró una pérdida neta trimestral de $4.63 millones (pérdida por acción $0.11) y una pérdida neta en seis meses de $8.10 millones, mientras que los gastos operativos crecieron sustancialmente: I+D +99% y ventas, clínico & marketing +88% en el trimestre. Efectivo, equivalentes de efectivo e inversiones a corto plazo sumaban aproximadamente $15.48 millones al 30 de junio de 2025; la dirección afirma que estos fondos deberían cubrir las operaciones al menos 12 meses. Durante el trimestre la empresa utilizó $2.5 millones de su línea revolvente y $1.5 millones de su préstamo a plazo y reveló una debilidad material en los controles generales de TI que se está corrigiendo.

Myomo, Inc. (MYO)ëŠ� 2025ë…� 6ì›� 30ì� 종료 기간ì—� 대í•� 견조í•� 매출 성장ì� 보고했습니다. 분기 ë§¤ì¶œì€ $9.65 million으로 ì „ë…„ ë™ê¸° 대ë¹� 28% ì¦ê°€í–ˆê³ , ìƒë°˜ê¸� ë§¤ì¶œì€ $19.48 million으로 ì „ë…„ 대ë¹� 73% 늘었습니ë‹�. 매출 ì¦ê°€ëŠ� CMS 환급 ë³€ê²½ì— ë”°ë¥¸ íŒë§¤ 단위 ì¦ê°€ì™€ í‰ê·  íŒë§¤ê°€ ìƒìйì—� 기ì¸í•©ë‹ˆë‹�. ì´ì´ìµì€ 금액 기준으로 ì¦ê°€í–ˆìœ¼ë‚�, 새로ìš� 본사 ë°� 시설ê³� ê´€ë ¨ëœ ìžìž¬ë¹� ë°� 제조간접ë¹� ìƒìŠ¹ìœ¼ë¡œ ì¸í•´ 2분기 ì´ë§ˆì§„ì€ ì „ë…„ 70.8%ì—서 62.7%ë¡� 축소ë˜ì—ˆìŠµë‹ˆë‹�.

회사ëŠ� 분기 순ì†ì‹� $4.63 million(주당 ì†ì‹¤ $0.11)ê³� ìƒë°˜ê¸� 순ì†ì‹� $8.10 millionì� 보고했으ë©�, 연구개발ë¹� +99% ë°� ì˜ì—…·임ìƒÂ·ë§ˆì¼€íŒ� 비용 +88% ë“� ìš´ì˜ë¹„ê°€ í¬ê²Œ ì¦ê°€í–ˆìŠµë‹ˆë‹¤. 2025ë…� 6ì›� 30ì� 기준 현금·현금성ìžì‚°Â·ë‹¨ê¸°íˆ¬ìžëŠ” ì•� $15.48 millionì´ì—ˆê³�, ê²½ì˜ì§„ì€ ì� ìžê¸ˆì� 향후 최소 12개월ê°� ìš´ì˜ì� ì§€ì›í•  것으ë¡� ë³´ê³  있습니다. 분기 ì¤� 회사ëŠ� 회전 신용한ë„ì—서 $2.5 million, 기한부 대출ì—ì„� $1.5 millionì� ì¸ì¶œí–ˆìœ¼ë©�, 개선 ì¤‘ì¸ IT ì¼ë°˜ 통제ì� 중대í•� 결함(material weakness)ì� 공시했습니다.

Myomo, Inc. (MYO) a enregistré une forte croissance du chiffre d’affaires pour la période close le 30 juin 2025, avec des revenus de $9.65 millions au trimestre, en hausse de 28% sur un an, et $19.48 millions sur six mois, +73% par rapport à l’année précédente. Cette hausse provient d’un plus grand nombre d’unités vendues et d’un prix moyen de vente plus élevé après les mises à jour des remboursements du CMS. Le bénéfice brut a augmenté en valeur absolue, mais la marge brute s’est contractée à 62.7% au T2 contre 70.8% un an plus tôt, en raison de coûts plus élevés des matériaux et des charges de fabrication liés à un nouveau siège et une nouvelle installation.

La société a déclaré une perte nette trimestrielle de $4.63 millions (perte par action $0.11) et une perte nette sur six mois de $8.10 millions, les charges d’exploitation ayant augmenté fortement : R&D +99% et ventes, clinique & marketing +88% au trimestre. La trésorerie, les équivalents de trésorerie et les placements à court terme s’élevaient à environ $15.48 millions au 30 juin 2025 ; la direction indique que ces fonds devraient couvrir les opérations pendant au moins 12 mois. Au cours du trimestre, la société a tiré $2.5 millions sur sa ligne renouvelable et $1.5 millions sur son prêt à terme et a divulgué une faiblesse importante dans les contrôles généraux informatiques qui est en cours de correction.

Myomo, Inc. (MYO) verzeichnete für den Zeitraum bis zum 30. Juni 2025 ein starkes Umsatzwachstum: $9.65 Millionen im Quartal, ein Anstieg von 28% gegenüber dem Vorjahr, und $19.48 Millionen in den sechs Monaten, +73% im Jahresvergleich. Das Umsatzplus wurde durch mehr ausgelieferte Einheiten und höhere durchschnittliche Verkaufspreise nach Aktualisierungen der CMS-Erstattungen getrieben. Der Bruttogewinn stieg absolut, doch die Bruttomarge schrumpfte auf 62.7% im Q2 gegenüber 70.8% vor einem Jahr, bedingt durch erhöhte Material- und Fertigungsgemeinkosten im Zusammenhang mit neuer Zentrale und Anlage.

Das Unternehmen meldete einen Quartalsverlust von $4.63 Millionen (Verlust je Aktie $0.11) und einen Halbjahresverlust von $8.10 Millionen, da die Betriebsaufwendungen stark zunahmen: F&E +99% und Vertrieb, klinisch & Marketing +88% im Quartal. Zahlungsmittel, Zahlungsmitteläquivalente und kurzfristige Anlagen beliefen sich am 30. Juni 2025 auf rund $15.48 Millionen; das Management geht davon aus, dass diese Mittel die Geschäftstätigkeit für mindestens 12 Monate decken werden. Im Quartal zog das Unternehmen $2.5 Millionen von seiner revolvierenden Kreditlinie und $1.5 Millionen von seinem Terminkredit in Anspruch und gab eine wesentliche Schwäche der IT-General Controls bekannt, die behoben wird.

Positive
  • Revenue growth: Quarterly revenue rose to $9.65M (up 28%) and six-month revenue to $19.48M (up 73%)
  • Improved reimbursement environment: CMS final payment determinations and updated fees (approx. $34.3k and $67.5k) support higher average selling prices
  • Liquidity events: December 2024 equity offering generated ~ $15.8M net proceeds and company accessed $4.0M of debt in H1 2025
  • Product update: Introduced the MyoPro 2X in the U.S. on April 30, 2025
Negative
  • Widening losses and cash burn: Net loss of $4.63M in Q2 and $8.10M for six months; operating cash use of $11.54M in six months
  • Sharp expense increases: R&D up ~99% and selling, clinical & marketing up ~88% in the quarter versus prior year, pressuring near-term profitability
  • Gross margin compression: Quarterly gross margin declined to 62.7% from 70.8% year-over-year due to higher material and manufacturing overhead
  • Concentration and receivable risk: High exposure to CMS (56% of quarterly revenues; ~67% of accounts receivable at June 30, 2025)
  • Material weakness in internal controls: Identified deficiencies in IT general controls that remain under remediation

Insights

Revenue growth is notable but heavy spending widened losses; liquidity is adequate near-term.

Myomo's revenue acceleration is meaningful: a 28% quarterly increase and 73% year-to-date rise show demand traction, partly reflecting CMS reimbursement rate changes and direct-billing scale-up. However, operating expense expansion—driven by advertising, clinical headcount and R&D—pushed the six-month net loss to $8.1 million and produced negative operating cash flow of $11.5 million. Cash and short-term investments of ~$15.5 million plus recent borrowings provide a near-term runway, but continued cash burn makes execution on revenue growth and margin improvement critical. Monitor cash conversion, gross margin recovery, and effectiveness of increased clinical capacity investments.

Material weakness in IT controls is a governance red flag despite remediation steps.

The company disclosed a material weakness related to information technology general controls, including privileged access and user provisioning deficiencies. Management has implemented compensating controls and is testing remediation, but until controls operate effectively over time, there is a heightened risk of misstatements or unauthorized transactions. Given the company’s increasing reliance on financings and debt covenants, strong, tested internal controls are essential to maintain investor confidence and lender relationships.

Myomo, Inc. (MYO) ha registrato una solida crescita dei ricavi per il periodo chiuso al 30 giugno 2025, con entrate di $9.65 milioni nel trimestre, in aumento del 28% su base annua, e $19.48 milioni nei sei mesi, +73% rispetto all’anno precedente. L’incremento delle vendite è stato trainato da un maggior numero di unità vendute e da un prezzo medio di vendita più elevato a seguito degli aggiornamenti dei rimborsi del CMS. Il profitto lordo è cresciuto in valore assoluto, ma il margine lordo si è ridotto al 62.7% nel 2° trimestre rispetto al 70.8% dell’anno scorso, a causa di costi più elevati per materiali e oneri di produzione legati alla nuova sede e struttura.

La società ha riportato una perdita netta trimestrale di $4.63 milioni (perdita per azione $0.11) e una perdita netta sui sei mesi di $8.10 milioni, mentre le spese operative sono aumentate significativamente: R&S +99% e vendite, attività cliniche & marketing +88% nel trimestre. Liquidità, equivalenti di cassa e investimenti a breve termine ammontavano a circa $15.48 milioni al 30 giugno 2025; la direzione ritiene che questi fondi copriranno le operazioni per almeno 12 mesi. Durante il trimestre la società ha utilizzato $2.5 milioni sulla linea di credito revolving e $1.5 milioni sul prestito a termine e ha comunicato una carenza significativa nei controlli IT generali che è in fase di risoluzione.

Myomo, Inc. (MYO) informó un fuerte crecimiento de ingresos para el periodo terminado el 30 de junio de 2025, con ingresos de $9.65 millones en el trimestre, un aumento del 28% interanual, y $19.48 millones en los seis meses, +73% respecto al año anterior. El mayor volumen de ventas se debió a más unidades vendidas y a un precio medio de venta más alto tras las actualizaciones de reembolso del CMS. El beneficio bruto aumentó en términos absolutos, pero el margen bruto se redujo al 62.7% en el 2T desde 70.8% hace un año, debido a mayores costes de materiales y gastos generales de fabricación vinculados a la nueva sede y planta.

La compañía registró una pérdida neta trimestral de $4.63 millones (pérdida por acción $0.11) y una pérdida neta en seis meses de $8.10 millones, mientras que los gastos operativos crecieron sustancialmente: I+D +99% y ventas, clínico & marketing +88% en el trimestre. Efectivo, equivalentes de efectivo e inversiones a corto plazo sumaban aproximadamente $15.48 millones al 30 de junio de 2025; la dirección afirma que estos fondos deberían cubrir las operaciones al menos 12 meses. Durante el trimestre la empresa utilizó $2.5 millones de su línea revolvente y $1.5 millones de su préstamo a plazo y reveló una debilidad material en los controles generales de TI que se está corrigiendo.

Myomo, Inc. (MYO)ëŠ� 2025ë…� 6ì›� 30ì� 종료 기간ì—� 대í•� 견조í•� 매출 성장ì� 보고했습니다. 분기 ë§¤ì¶œì€ $9.65 million으로 ì „ë…„ ë™ê¸° 대ë¹� 28% ì¦ê°€í–ˆê³ , ìƒë°˜ê¸� ë§¤ì¶œì€ $19.48 million으로 ì „ë…„ 대ë¹� 73% 늘었습니ë‹�. 매출 ì¦ê°€ëŠ� CMS 환급 ë³€ê²½ì— ë”°ë¥¸ íŒë§¤ 단위 ì¦ê°€ì™€ í‰ê·  íŒë§¤ê°€ ìƒìйì—� 기ì¸í•©ë‹ˆë‹�. ì´ì´ìµì€ 금액 기준으로 ì¦ê°€í–ˆìœ¼ë‚�, 새로ìš� 본사 ë°� 시설ê³� ê´€ë ¨ëœ ìžìž¬ë¹� ë°� 제조간접ë¹� ìƒìŠ¹ìœ¼ë¡œ ì¸í•´ 2분기 ì´ë§ˆì§„ì€ ì „ë…„ 70.8%ì—서 62.7%ë¡� 축소ë˜ì—ˆìŠµë‹ˆë‹�.

회사ëŠ� 분기 순ì†ì‹� $4.63 million(주당 ì†ì‹¤ $0.11)ê³� ìƒë°˜ê¸� 순ì†ì‹� $8.10 millionì� 보고했으ë©�, 연구개발ë¹� +99% ë°� ì˜ì—…·임ìƒÂ·ë§ˆì¼€íŒ� 비용 +88% ë“� ìš´ì˜ë¹„ê°€ í¬ê²Œ ì¦ê°€í–ˆìŠµë‹ˆë‹¤. 2025ë…� 6ì›� 30ì� 기준 현금·현금성ìžì‚°Â·ë‹¨ê¸°íˆ¬ìžëŠ” ì•� $15.48 millionì´ì—ˆê³�, ê²½ì˜ì§„ì€ ì� ìžê¸ˆì� 향후 최소 12개월ê°� ìš´ì˜ì� ì§€ì›í•  것으ë¡� ë³´ê³  있습니다. 분기 ì¤� 회사ëŠ� 회전 신용한ë„ì—서 $2.5 million, 기한부 대출ì—ì„� $1.5 millionì� ì¸ì¶œí–ˆìœ¼ë©�, 개선 ì¤‘ì¸ IT ì¼ë°˜ 통제ì� 중대í•� 결함(material weakness)ì� 공시했습니다.

Myomo, Inc. (MYO) a enregistré une forte croissance du chiffre d’affaires pour la période close le 30 juin 2025, avec des revenus de $9.65 millions au trimestre, en hausse de 28% sur un an, et $19.48 millions sur six mois, +73% par rapport à l’année précédente. Cette hausse provient d’un plus grand nombre d’unités vendues et d’un prix moyen de vente plus élevé après les mises à jour des remboursements du CMS. Le bénéfice brut a augmenté en valeur absolue, mais la marge brute s’est contractée à 62.7% au T2 contre 70.8% un an plus tôt, en raison de coûts plus élevés des matériaux et des charges de fabrication liés à un nouveau siège et une nouvelle installation.

La société a déclaré une perte nette trimestrielle de $4.63 millions (perte par action $0.11) et une perte nette sur six mois de $8.10 millions, les charges d’exploitation ayant augmenté fortement : R&D +99% et ventes, clinique & marketing +88% au trimestre. La trésorerie, les équivalents de trésorerie et les placements à court terme s’élevaient à environ $15.48 millions au 30 juin 2025 ; la direction indique que ces fonds devraient couvrir les opérations pendant au moins 12 mois. Au cours du trimestre, la société a tiré $2.5 millions sur sa ligne renouvelable et $1.5 millions sur son prêt à terme et a divulgué une faiblesse importante dans les contrôles généraux informatiques qui est en cours de correction.

Myomo, Inc. (MYO) verzeichnete für den Zeitraum bis zum 30. Juni 2025 ein starkes Umsatzwachstum: $9.65 Millionen im Quartal, ein Anstieg von 28% gegenüber dem Vorjahr, und $19.48 Millionen in den sechs Monaten, +73% im Jahresvergleich. Das Umsatzplus wurde durch mehr ausgelieferte Einheiten und höhere durchschnittliche Verkaufspreise nach Aktualisierungen der CMS-Erstattungen getrieben. Der Bruttogewinn stieg absolut, doch die Bruttomarge schrumpfte auf 62.7% im Q2 gegenüber 70.8% vor einem Jahr, bedingt durch erhöhte Material- und Fertigungsgemeinkosten im Zusammenhang mit neuer Zentrale und Anlage.

Das Unternehmen meldete einen Quartalsverlust von $4.63 Millionen (Verlust je Aktie $0.11) und einen Halbjahresverlust von $8.10 Millionen, da die Betriebsaufwendungen stark zunahmen: F&E +99% und Vertrieb, klinisch & Marketing +88% im Quartal. Zahlungsmittel, Zahlungsmitteläquivalente und kurzfristige Anlagen beliefen sich am 30. Juni 2025 auf rund $15.48 Millionen; das Management geht davon aus, dass diese Mittel die Geschäftstätigkeit für mindestens 12 Monate decken werden. Im Quartal zog das Unternehmen $2.5 Millionen von seiner revolvierenden Kreditlinie und $1.5 Millionen von seinem Terminkredit in Anspruch und gab eine wesentliche Schwäche der IT-General Controls bekannt, die behoben wird.

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4

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2025

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to .

Commission File Number 001-38109

 

MYOMO, INC.

(Exact name of Registrant as Specified in its Charter)

 

 

Delaware

47-0944526

(State or Other Jurisdiction of

(I.R.S. Employer

Incorporation or Organization)

 

Identification No.)

 

 

45 Blue Sky Drive, Suite 101, Burlington, Massachusetts

01803

(Address of principal executive offices)

(Zip Code)

(617) 996-9058

Registrant’s Telephone Number, Including Area Code

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes: ☒ No: ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No

At August 4, 2025, the registrant has 37,801,070 shares of common stock, par value $0.0001 per share, outstanding.

 

 

 

 


CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q includes forward-looking statements. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar matters that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will” and “would” or the negatives of these terms or other comparable terminology.

You should not place undue reliance on forward looking statements. The cautionary statements set forth in this Quarterly Report on Form 10-Q, including in “Risk Factors” and those contained in our Annual Report on Form 10-K filed with the United States Securities and Exchange Commission on March 10, 2025 and elsewhere, identify important factors which you should consider in evaluating our forward-looking statements. These factors include, among other things:

our ability to achieve or obtain sufficient reimbursement from third-party payers for our products;
our dependence upon external sources for the financing of our operations;
our ability to scale the business to return to positive cash flow from operations;
our revenue concentration with Medicare and with a particular insurance payer as a result of focusing our efforts on patients with insurers who have previously reimbursed for the MyoPro;
our ability to continue normal operations and patient interactions without supply chain disruption in order to deliver and fit our custom-fabricated devices;
our marketing and commercialization efforts;
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 obtain and maintain our strategic collaborations and to realize the intended results of such collaborations;
our ability to effectively execute our business plan and scale up our operations;
our ability to remediate the material weakness in our internal control over financial reporting;
our expectations as to our product development programs, including improving our existing products and developing new products;
our ability to maintain and grow our reputation and to achieve and maintain the market acceptance of our products;
our expectations as to our clinical research program and clinical results;
our ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual property rights of others;
our ability to gain and maintain regulatory approvals;
our ability to compete and succeed in a highly competitive and evolving industry; and
general market, economic, environmental and social factors that may affect the evaluation, fitting, delivery and sale of our products to patients; and
other risks and uncertainties, including those listed under the captain “Risk Factors” in this Quarterly Report on Form 10-Q.

Although the forward-looking statements in this Quarterly Report on Form 10-Q and those contained in our Annual Report on Form 10-K for the year ended December 31, 2024, 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. We undertake no obligation, other than as may be required by law, to re-issue this Quarterly Report on Form 10-Q, or otherwise make public statements updating our forward-looking statements.

 


TABLE of CONTENTS

PART I. FINANCIAL INFORMATION

 

 

 

 

 

Item 1. Financial Statements (interim periods unaudited)

 

1

 

 

 

Condensed Consolidated Balance Sheets at June 30, 2025 and December 31, 2024 (audited)

1

 

 

Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2025 and 2024

2

 

 

 

 

 

 

Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2025 and 2024

 

 

3

 

 

 

Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2025 and 2024

4

 

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024

5

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

6

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

17

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

22

 

 

Item 4. Controls and Procedures

23

 

 

PART II. OTHER INFORMATION

 

 

 

 

 

Item 1. Legal Proceedings

25

 

 

Item 1A. Risk Factors

25

 

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds from Registered Securities

27

 

 

Item 5 Other Information

 

 

27

 

 

 

 

Item 6. Exhibits

28

 

 

Signatures

 

 

29

 

 

 


 

Part 1. FINANCIAL INFORMATION

Item 1. Financial statements

MYOMO, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

 

June 30,

 

 

December 31,

 

 

 

2025

 

 

2024

 

 

 

(unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

14,240,432

 

 

$

24,372,373

 

Short-term investments

 

 

1,241,515

 

 

 

492,990

 

Accounts receivable, net

 

 

7,054,545

 

 

 

3,825,291

 

Inventories

 

 

4,125,597

 

 

 

3,165,965

 

Prepaid expenses and other current assets

 

 

1,381,721

 

 

 

933,377

 

Total Current Assets

 

 

28,043,810

 

 

 

32,789,996

 

Restricted Cash

 

 

375,000

 

 

 

375,000

 

Operating lease assets with right of use, net

 

 

7,058,063

 

 

 

7,584,663

 

Equipment, net

 

 

2,908,804

 

 

 

1,330,008

 

Other assets

 

 

286,670

 

 

 

164,412

 

Total Assets

 

$

38,672,347

 

 

$

42,244,079

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

Accounts payable and accrued expenses

 

 

8,313,862

 

 

 

9,021,817

 

Current operating lease liability

 

 

460,351

 

 

 

748,021

 

Income taxes payable

 

 

204,110

 

 

 

318,885

 

Deferred revenue

 

 

108,780

 

 

 

83,115

 

Current portion long-term debt

 

 

166,667

 

 

 

 

Revolving credit line

 

 

2,500,000

 

 

 

 

Total Current Liabilities

 

 

11,753,770

 

 

 

10,171,838

 

Non-current operating lease liability

 

 

7,970,116

 

 

 

7,358,184

 

Long-term debt

 

 

1,333,333

 

 

 

 

Total Liabilities

 

 

21,057,219

 

 

 

17,530,022

 

Commitments and Contingencies

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding

 

 

 

 

 

 

Common stock par value $0.0001 per share, 65,000,000 shares authorized;
37,780,310 and 34,378,297 shares issued as of June 30, 2025
   and December 31, 2024, respectively; and
37,780,283 and 34,378,270
   shares outstanding at June 30, 205 and December 31, 2024, respectively

 

 

3,778

 

 

 

3,439

 

Additional paid-in capital

 

 

128,781,048

 

 

 

127,846,026

 

Accumulated other comprehensive income (loss)

 

 

48,334

 

 

 

(14,406

)

Accumulated deficit

 

 

(111,211,568

)

 

 

(103,114,538

)

Treasury stock, 27 shares at cost

 

 

(6,464

)

 

 

(6,464

)

Total Stockholders’ Equity

 

 

17,615,128

 

 

 

24,714,057

 

Total Liabilities and Stockholders’ Equity

 

$

38,672,347

 

 

$

42,244,079

 

 

The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.

1


 

MYOMO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

 

 

 

For the Three Months ended

 

 

For the Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Revenue

 

$

9,652,234

 

 

$

7,520,767

 

 

$

19,484,048

 

 

$

11,275,156

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

3,600,061

 

 

 

2,195,255

 

 

 

6,822,246

 

 

 

3,650,601

 

Gross profit

 

 

6,052,173

 

 

 

5,325,512

 

 

 

12,661,802

 

 

 

7,624,555

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

2,001,331

 

 

 

1,007,224

 

 

 

3,791,355

 

 

 

1,963,438

 

Selling, clinical and marketing

 

 

5,233,885

 

 

 

2,777,135

 

 

 

9,629,689

 

 

 

5,138,980

 

General and administrative

 

 

3,407,277

 

 

 

2,656,217

 

 

 

7,351,332

 

 

 

5,525,968

 

 

 

 

10,642,493

 

 

 

6,440,576

 

 

 

20,772,376

 

 

 

12,628,386

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(4,590,320

)

 

 

(1,115,064

)

 

 

(8,110,574

)

 

 

(5,003,831

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other (income), net

 

 

 

 

 

 

 

 

 

 

 

 

Interest (income), net

 

 

(106,549

)

 

 

(107,242

)

 

 

(298,540

)

 

 

(242,535

)

 

 

 

(106,549

)

 

 

(107,242

)

 

 

(298,540

)

 

 

(242,535

)

Loss before income taxes

 

 

(4,483,771

)

 

 

(1,007,822

)

 

 

(7,812,034

)

 

 

(4,761,296

)

Income tax expense

 

 

148,201

 

 

 

113,785

 

 

 

284,996

 

 

 

195,943

 

Net loss

 

$

(4,631,972

)

 

$

(1,121,607

)

 

$

(8,097,030

)

 

$

(4,957,239

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

41,582,737

 

 

 

37,368,488

 

 

 

41,518,959

 

 

 

37,060,543

 

Net loss per share attributable to common stockholders

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.11

)

 

$

(0.03

)

 

$

(0.20

)

 

$

(0.13

)

The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.

2


 

MYOMO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited)

 

 

 

For the Three Months Ended

 

 

For the Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Net loss

 

$

(4,631,972

)

 

$

(1,121,607

)

 

$

(8,097,030

)

 

$

(4,957,239

)

Other comprehensive income (loss), net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

164,878

 

 

 

(8,623

)

 

 

62,739

 

 

 

55,219

 

Other comprehensive income (loss)

 

 

164,878

 

 

 

(8,623

)

 

 

62,739

 

 

 

55,219

 

Comprehensive loss

 

$

(4,467,094

)

 

$

(1,130,230

)

 

$

(8,034,291

)

 

$

(4,902,020

)

 

The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.

 

3


 

MYOMO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (unaudited)

 

 

For the Three and Six Months Ended June 30, 2025 and 2024

 

Common stock

Additional
Paid-in

Accumulated Comprehensive

Accumulated

Treasury Stock

Total
Stockholders’

 

Shares

Amount

Capital

Income (Loss)

Deficit

Shares

Amount

Equity

Balance, December 31, 2024

34,378,297

$3,439

$127,846,026

$(14,406)

$(103,114,538)

27

$(6,464)

$24,714,057

Common stock issued upon vesting of restricted stock units

59,031

7

(7)

Common stock issued upon vesting of incentive stock options

708

Stock-based compensation

540,204

540,204

Other comprehensive income/(loss)

(102,139)

(102,139)

Net loss

(3,465,058)

(3,465,058)

Balance, March 31, 2025

34,438,036

$3,446

$128,386,223

$(116,545)

$(106,579,596)

27

$(6,464)

$21,687,064

Common stock issued upon vesting of restricted stock units

644,149

64

(64)

Stock-based compensation

 

 

394,889

394,889

Common stock issued upon vesting of incentive stock options

20

 

 

 

 

 

 

 

Exercise of pre-funded warrants

2,698,105

268

268

Other comprehensive income/(loss)

164,879

164,879

Net loss

 

(4,631,972)

(4,631,972)

Balance, June 30, 2025

37,780,310

$3,778

$128,781,048

$48,334

$(111,211,568)

27

$(6,464)

$17,615,128

 

 

 

 

 

 

 

 

 

Balance, December 31, 2023

27,135,061

$2,715

$105,840,239

$83,669

$(96,930,809)

27

$(6,464)

$8,989,350

Proceeds from sale of common stock in registered direct offering, net of offering costs of $547,257

1,354,218

135

4,598,636

4,598,771

Proceeds from sale of 224,730 pre-funded warrants in registered direct offering, net of offering costs of $90,814

763,138

763,138

Common stock issued upon vesting of restricted stock units

300,544

31

(31)

Stock-based compensation

320,288

320,288

Other comprehensive income/(loss)

63,842

63,842

Net loss

(3,835,632)

(3,835,632)

Balance, March 31, 2024

28,789,823

$2,881

$111,522,270

$147,511

$(100,766,441)

27

$(6,464)

$10,899,757

Common stock issued upon vesting of restricted stock units

636,801

63

(63)

Stock-based compensation

(91,893)

(91,893)

Exercise of pre-funded warrants

774,730

77

77

Other comprehensive income/(loss)

(8,623)

(8,623)

Net loss

(1,121,607)

(1,121,607)

Balance, June 30, 2024

30,201,354

$3,021

$111,430,314

$138,888

$(101,888,048)

27

$(6,464)

$9,677,711

 

 

 

The accompanying notes are an integral part of the consolidated unaudited financial statements.

4


 

MYOMO, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)

 

For the Six Months Ended June 30,

 

2025

 

 

2024

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

 

Net loss

 

$

(8,097,030

)

 

$

(4,957,239

)

Adjustments to reconcile net loss to net cash used in operations:

 

 

 

 

 

 

Depreciation

 

 

349,240

 

 

 

65,663

 

Stock-based compensation

 

 

935,093

 

 

 

228,395

 

Accretion of discount on short-term investments

 

 

(23,383

)

 

 

(108,999

)

Credit losses

 

 

51,643

 

 

 

5,257

 

Amortization of deferred offering costs

 

 

60,045

 

 

 

 

Amortization of right-of-use assets

 

 

526,600

 

 

 

124,057

 

Other non-cash charges

 

 

(91,984

)

 

 

44,631

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(2,975,272

)

 

 

(102,234

)

Inventories

 

 

(1,204,740

)

 

 

(816,055

)

Prepaid expenses and other current assets

 

 

(615,940

)

 

 

(363,375

)

Other assets

 

 

(130,801

)

 

 

(214,937

)

Accounts payable and accrued expenses

 

 

(531,182

)

 

 

990,973

 

Income taxes payable

 

 

(144,392

)

 

 

176,235

 

Operating lease liabilities

 

 

140,536

 

 

 

(237,365

)

Deferred revenue

 

 

25,666

 

 

 

3,505

 

Tenant improvement allowance

 

 

183,726

 

 

 

 

Net cash used in operating activities

 

 

(11,542,175

)

 

 

(5,161,488

)

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

Purchases of short-term investments

 

 

(1,225,410

)

 

 

(5,482,757

)

Maturities of short-term investments

 

 

500,000

 

 

 

4,450,000

 

Purchases of equipment

 

 

(1,928,036

)

 

 

(179,173

)

Net cash used in investing activities

 

 

(2,653,446

)

 

 

(1,211,930

)

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

Net proceeds from common stock offering

 

 

 

 

 

4,598,771

 

Deferred debt origination costs

 

 

(36,506

)

 

 

 

Proceeds from sale of pre-funded warrants, net of offering costs

 

 

 

 

 

763,138

 

Net Proceeds from issuance of debt

 

 

4,000,000

 

 

 

 

Net cash provided by financing activities

 

 

3,963,494

 

 

 

5,361,909

 

 

 

 

 

 

 

Effect of foreign exchange rate changes on cash

 

 

100,186

 

 

 

(13,697

)

 

 

 

 

 

 

Net (decrease) increase in cash and cash equivalents

 

 

(10,131,941

)

 

 

(1,025,206

)

 

 

 

 

 

 

Cash and cash equivalents, beginning of period

 

 

24,747,373

 

 

 

6,871,306

 

 

 

 

 

 

 

Cash and cash equivalents, end of period

 

$

14,615,432

 

 

$

5,846,100

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING
   AND FINANCING ACTIVITIES

 

 

 

 

 

 

Unrealized gain from mark to market on short-term investments

 

$

268

 

 

$

2,809

 

 

The accompanying notes are an integral part of the condensed consolidated unaudited financial statements.

5


 

MYOMO, INC.

NOTES TO CONDENSED CONSOLIDATED UNAUDITED 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 U.S. Food and Drug Administration as a Class II medical device. The Company sells its products directly to patients, to Orthotics and Prosthetics ("O&P") providers around the world, the Veterans Health Administration, and distributors in Europe and Australia. The Company was incorporated in the State of Delaware on September 1, 2004 and is headquartered in Burlington, Massachusetts.

Note 2 — Liquidity

 

The Company had cash, cash equivalents and short-term investments of approximately $15,482,000 as of June 30, 2025. The Company incurred net losses of approximately $8,097,000 and 4,957,200 during the six months ended June 30, 2025 and 2024, respectively, and has an accumulated deficit of approximately $111,211,600 and $103,114,500 at June 30, 2025 and December 31, 2024, respectively. Cash used in operating activities was approximately $11,542,200 and $5,161,500 for the six months ended June 30, 2025 and 2024, respectively.

 

The Company has historically funded its operations through financing activities, including issuing equity and debt. On December 6, 2024, the Company completed a public offering, selling 3,450,000 shares of common stock at $5.00 per share, generating net proceeds after taxes and fees of approximately $15.8 million. 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 to purchase common stock 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 7 - Common Stock and Warrants for further discussion. On July 11, 2024, the Company entered into a Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (“Silicon Valley Bank”), which provides the Company the ability to borrow up to $4.0 million against eligible accounts receivable. In February 2025, the Company entered into an amendment to the Loan and Security Agreement, which among other changes, provides for a $3.0 million term loan facility which is available to be drawn at any time before February 28, 2026. On June 30, 2025, the Company drew $2.5 million on its line of credit and $1.5 million under its term loan facility (See Note 8 - Debt for further discussion.) Financing activities, such as the December 2024 public offering, have enabled the Company to sustain its operations.

 

Based upon its current cash, cash equivalents, short-term investments, as well as the future expected cash flows, the Company believes that its available current cash, cash equivalents, and short-term investments will fund its operations for at least the next twelve months from the issuance date of these financial statements.

 

Note 3 — Summary of Significant Accounting Policies

Interim Financial Statements

The accompanying unaudited condensed consolidated financial statements and notes are representations of the Company’s management, who are responsible for their integrity and objectivity. These statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") for interim financial information pursuant to Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for annual financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) that are considered necessary for a fair presentation of the condensed consolidated financial statements of the Company as of June 30, 2025 and for the three and six months ended June 30, 2025 and 2024. The results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the operating results for the fiscal year ending December 31, 2025, or any other period. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2024 and 2023 and for the years then ended, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

Basis of Consolidation

The condensed 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 Income (Loss)

Comprehensive loss includes all changes in equity during a period, except those resulting from investments by stockholders and distributions to stockholders. The Company's comprehensive loss includes changes in foreign currency translation adjustments and unrealized gains and losses on short term investments. There were reclassifications out of accumulated other comprehensive income (loss) to other (income) expense

6


 

related to realized gains or losses on short-term investments in the three and six months ended June 30, 2025 and 2024, respectively, which are not considered material..

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 these estimates. The Company’s significant estimates include deferred 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 June 30, 2025 and December 31, 2024.

The Company considers all investments with an original maturity of greater than three months but less than one year to be short-term investments. Short-term investments as of June 30, 2025 and December 31, 2024 consist of U.S. Treasury Bills and U.S. Government Agency Bills, which are classified as held-to-maturity, totaling approximately $1,241,500 and $493,000 as of June 30, 2025, and December 31, 2024, respectively. The Company determines the appropriate balance sheet classification of its investments at the time of purchases and evaluates the classification at each balance sheet date. All of the Company's U.S. Treasury Bills mature within the subsequent twelve months from the date of purchase.

The Company's cash balances as of June 30, 2025 and December 31, 2024 consist of the following:

 

 

 

June 30,
2025

 

 

December 31,
2024

 

Cash, cash equivalents, and restricted cash

 

 

 

 

 

 

Cash

 

 

1,541,887

 

 

 

662,999

 

Money market funds

 

 

12,698,545

 

 

 

23,334,374

 

Restricted Cash

 

 

375,000

 

 

 

375,000

 

 

 

$

14,615,432

 

 

$

24,372,373

 

Short-term investments

 

 

 

 

 

 

US government agency debt securities

 

$

497,605

 

 

$

492,990

 

Treasury bills

 

 

743,910

 

 

 

 

 

 

$

1,241,515

 

 

$

492,990

 

Accounts Receivable and Allowance for Credit Losses

The Company reports accounts receivable at invoiced amounts less an allowance for credit losses accounts. The Company evaluates its accounts receivable on a continuous basis and, if necessary, establishes an allowance for credit losses 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 June 30, 2025, and December 31, 2024, the Company recorded an allowance for credit losses accounts of approximately $107,900 and $56,300, respectively.

Revenue Recognition

 

The Company accounts for revenue under ASC 606, “Revenue from Contracts with Customers” and all of 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:

1)
Identification of the contract, or contracts, with a customer,
2)
Identification of the performance obligations in the contract, including whether they are distinct within the context of the contract,
3)
Determination of the transaction price, including the constraint on variable consideration,
4)
Allocation of the transaction price to the performance obligations in the contract, and
5)
Recognition of revenue when, or as, performance obligations are satisfied.

7


 

Revenue is recognized when control of these services is transferred to our customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services.

Product Revenue

Increasingly, the Company derives its revenue from direct billing. The Company also derives revenue from the sale of its products to O&P providers in the United States and internationally and the Veterans Administration (“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. As an example, the Company will record revenue if it is notified that insurance intends to pay and a payment amount is provided, 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 patients under Medicare Part B, the Company recognizes revenue once it has obtained sufficient medical documentation to demonstrate medical necessity and when control of the device passes to the patient. Patients with Medicare Part B represented 72% and 61% of direct billing revenues for the three months ended June 30, 2025 and 2024, respectively, and 74% and 49% of direct billing revenues for the six months ended June 30, 2025 and 2024, respectively. For revenue derived from certain commercial insurance companies where the Company has demonstrated sufficient payment history or has obtained payer contracts, 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 expects to receive in exchange for the device. These insurers represented 15% and 27% of direct billing channel revenue during the three months ended June 30, 2025 and 2024, respectively. These insurers represented 15% and 35% of direct billing channel revenue during the six months ended June 30, 2025 and June 30, 2024, respectively. In cases where the Company is the direct provider and it does not have sufficient collection history with the payer, the Company recognizes revenue when payment is received, as then all of the revenue recognition criteria have been met.

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. During the three months ended June 30, 2025 and 2024, the Company recognized revenue of approximately $721,300 and $1,865,800, respectively, and during the six months ended June 30, 2025 and 2024, the Company recognized revenue of approximately $1,557,400 and $1,745,000, respectively, from third-party payers for which costs related to the completion of the Company’s performance obligations were not recorded in the current period.

 

For revenues derived from O&P providers and the VA, 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. Revenues 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.

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 $108,800 and $83,100 of deferred revenue as of June 30, 2025 and December 31, 2024, respectively..

 

Disaggregated Revenue from Contracts with Customers

The following table presents revenue by major source:

 

8


 

 

 

For the Three Months
Ended June 30,

 

 

For the Six Months
Ended June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Direct to patient

 

$

7,420,904

 

 

$

5,829,407

 

 

$

15,228,681

 

 

$

8,059,833

 

Clinical/Medical providers

 

 

2,231,330

 

 

 

1,691,360

 

 

$

4,255,367

 

 

$

3,215,323

 

Total revenue from contracts with customers

 

$

9,652,234

 

 

$

7,520,767

 

 

$

19,484,048

 

 

$

11,275,156

 

 

Geographic Data

The Company generated 85% of its total revenue from the United States and 15% from Germany for the three months ended June 30, 2025,and 86% of its total revenue from the United States and 14% from Germany, for the three months ended June 30, 2024.

 

During the six months ended June 30, 2025, the Company generated 86% of its total revenues from the United States and 14% from Germany. During the six months ended June 30, 2024, the Company generated 82% of its total revenues from the United States, 17% from Germany and 1% from other international locations.

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. In certain cases, the Company ships the MyoPro, and provides the device directly to patients, pending reimbursement from third party payers, after which revenue is recognized. For the three and six months ended June 30, 2025, the Company recorded cost of goods sold of approximately $60,200 and $92,600, respectively, without corresponding revenue. For the three and six months ended June 30, 2024, the Company recorded cost of goods sold of $121,800 and $144,600, respectively, without corresponding revenue. Direct billing fees paid to O&P providers for services they provide in conjunction with patient evaluations are expensed as incurred as required by ASC 340-40-25. These costs are recorded as sales and marketing expense. Internal costs incurred and fees paid to O&P providers to measure, fit and deliver the device to patients are expensed to cost of revenue.

Advertising

The Company charges the costs of advertising to operating expenses as incurred. Advertising expense amounted to approximately $2,229,900 and $849,600 for the three months ended June 30, 2025 and 2024, respectively, and approximately $3,839,600 and $1,636,900 during the six months ended June 30, 2025 and 2024, respectively.

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 (loss) gain. The Company recorded a gain of approximately $164,900 and a loss of approximately $9,200 during the three months ended June 30, 2025 and 2024, respectively, and gains of approximately $62,700 and $52,400 during the six months ended June 30, 2025 and 2024, respectively, which are included in accumulated other comprehensive income in the condensed consolidated balance sheet. Transaction and translation foreign exchange gains and losses from a foreign currency to the functional currency are included in cost of goods sold in the consolidated statements of operations. Such amounts were immaterial for the three months ended June 30, 2025 and 2024. The balance sheet is translated using the spot rate on the day of reporting and the statement of operations is translated monthly using the average rate for the month.

 

Net Loss per Share

Basic net 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, 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 three months ended June 30, 2025 and 2024, and as a result, all potentially dilutive common shares are considered antidilutive for these periods.

Potential dilutive common shares issuable consist of the following at:

 

 

 

June 30,

 

 

 

2025

 

 

2024

 

Stock options

 

 

22,117

 

 

 

23,629

 

Restricted stock units

 

 

1,734,038

 

 

 

1,275,862

 

Other warrants

 

 

-

 

 

 

668,250

 

Total

 

 

1,756,155

 

 

 

1,967,741

 

 

9


 

 

Due to their nominal exercise price of $0.0001 per share, a total of 4,363,414 and 7,721,516 outstanding pre-funded warrants as of June 30, 2024 and 2025, respectively are considered common stock equivalents and are included in weighted average shares outstanding in the accompanying condensed consolidated statements of operations as of the closing dates of the Company's public equity offerings in January 2023, August 2023, and January 2024, respectively.

 

Recently Adopted 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 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 as of December 15, 2025. 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.

 

Note 4 — Inventories

Inventories consist of the following at:

 

 

 

June 30,
2025

 

 

December 31,
2024

 

Finished goods

 

$

1,334,290

 

 

$

1,289,368

 

Work in process

 

 

121,836

 

 

 

60,731

 

Parts and subassemblies

 

 

2,669,471

 

 

 

1,815,866

 

Inventories, net

 

$

4,125,597

 

 

$

3,165,965

 

 

 

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 Measurement” (“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 consist of money market funds that limit their investments to only short-term U.S. Treasury Securities and repurchase agreements related to these securities. Short-term investments primarily consists of commercial paper and U.S. Treasury Bills and are carried on the condensed consolidated balance sheets at amortized cost which approximates fair value.

10


 

Cash equivalents and short-term investments measured at fair value on a recurring basis at June 30, 2025 were as follows:

 

 

 

In Active
Markets for
Identical Assets
or Liabilities
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

 

Total

 

Cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

 

12,698,545

 

 

$

 

 

$

 

 

$

12,698,545

 

 

 

$

12,698,545

 

 

$

 

 

$

 

 

$

12,698,545

 

Short-term investments

 

 

 

 

 

 

 

 

 

 

 

 

US government agency debt securities

 

 

 

 

 

497,605

 

 

 

 

 

 

497,605

 

US Treasury

 

 

 

 

 

743,910

 

 

 

 

 

 

743,910

 

 

 

$

 

 

$

1,241,515

 

 

$

 

 

$

1,241,515

 

 

Cash equivalents and short-term investments measured at fair value on a recurring basis at December 31, 2024 were as follows:

 

 

 

In Active
Markets for
Identical Assets
or Liabilities
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

 

Total

 

Money market funds

 

$

23,334,374

 

 

 

 

 

 

 

 

$

23,334,374

 

Short-term investments

 

 

 

 

$

492,990

 

 

 

 

 

$

492,990

 

 

 

Note 6 - Accounts Payable and Other Accrued Expenses

Accounts Payable and Other Accrued Expenses consists of the following at:

 

 

 

June 30,
2025

 

 

December 31,
2024

 

Trade payables

 

$

2,514,945

 

 

$

1,169,901

 

Accrued compensation and benefits

 

 

2,970,257

 

 

 

5,009,385

 

Accrued professional services

 

 

51,253

 

 

 

54,257

 

Warranty reserve

 

 

144,322

 

 

 

129,615

 

Customer deposits

 

 

2,020,985

 

 

 

2,194,804

 

Accrued insurance

 

 

380,712

 

 

 

128,556

 

Other

 

 

231,388

 

 

 

335,299

 

 

 

$

8,313,862

 

 

$

9,021,817

 

 

Note 7 — Common Stock and Warrants

On December 6, 2024, the Company completed a public equity offering, selling 3,450,000 shares of common stock at $5.00 per share, generating net proceeds after fees and expenses of approximately $15.8 million.

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.

As of June 30, 2025, 4,363,414 pre-funded warrants remain exercisable. 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.

.

During the three months ended June 30, 2025 and 2024, 2,698,105 and 774,730 pre-funded warrants were exercised, respectively.

11


 

During the six months ended June 30, 2025, 668,250 investor warrants issued in the Company's public offering in February 2020 expired unexercised.

728 shares of common stock were issued through the exercise of stock options during the six months ended June 30, 2025. There were no shares of common stock issued upon the exercise of stock options during the six months ended June 30, 2024.

During the three months ended June 30, 2025 and 2024, 644,149 and 636,801 restricted stock units vested, respectively.

 

Note 8 —Debt

Line of Credit

On July 11, 2024 (the “Effective Date”), the Company, entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank.

The Loan Agreement provides for a revolving line of credit whereby the Company may borrow up to $4,000,000 (the “Revolving Line”), which Revolving Line may be increased to $5,500,000 available until July 10, 2026, at Silicon Valley Bank’s sole discretion upon the occurrence of certain events. Amounts advanced by Silicon Valley Bank are based on 80% of “eligible accounts”, which includes all receivables in the United States, reduced by aged amounts and customers and insurance payers with concentrations in excess of defined limits, among other deductions. The outstanding principal amount of any advance shall accrue interest at a floating rate per annum equal to the greater of (i) 8.50% and (ii) the “prime rate” as published in The Wall Street Journal for the relevant period plus one-half percent (0.50%). The Revolving Line is secured on a first priority basis by all of Company’s assets other than intellectual property and certain customary exceptions. Any newly formed or acquired subsidiary of the Company or any guarantor under the Loan Agreement, will either join the Loan Agreement as a co-borrower or become a guarantor under the Loan Agreement, as determined by Silicon Valley Bank in its sole discretion. The Company is using the Revolving Line for working capital and general business purposes.

The Revolving Line terminates, and any outstanding principal amount of all advances made thereunder, and any accrued and unpaid interest thereon, become immediately due and payable on the two year anniversary of the Effective Date. The Company must also pay Silicon Valley Bank (i) a commitment fee of $20,000, (ii) an “Anniversary Fee” of 0.50% of the Revolving Line and (iii) an “Unused Revolving Line Facility Fee” of 0.50% per annum of the average unused portion of the Revolving Line. In addition, upon termination of the Loan Agreement or the Revolving Line prior to the two year anniversary of the Effective Date, the Company must pay a termination fee of 1.00% of the Revolving Line, subject to certain exceptions.

 

Term Loan Facility

 

On February 18, 2025, the Company entered into a First Amendment (the “Amendment”) to the Loan Agreement. The Amendment provides for, among other things, a new term loan facility (the “Term Loan”) to the Company of up to $3,000,000, available to the Company until February 28, 2026. Advances under the Term Loan (collectively, the “Term Loan Advances”) will be payable in 36 equal monthly installments of principal plus interest, commencing on March 1, 2026, and to the extent not paid, all remaining obligations will become due and payable on February 1, 2029. Term Loan Advances shall accrue interest at a floating rate per annum equal to the greater of (a) 5.0% or (b) the “prime rate,” as published from time to time in the money rates section of the Wall Street Journal, minus 1.0%. At the Company’s option, the Company may prepay all outstanding borrowings under the Term Loan, plus accrued and unpaid interest thereon, subject to a prepayment premium ranging from 1.0% to 3.0%, depending on the year of prepayment. The Term Loan also provides for an end of term charge equal to 2.50% of the aggregate principal amount of any loans prepaid or repaid, as applicable.

The Amendment also makes certain changes to the Company’s revolving line of credit under the Loan Agreement, including (i) increasing the defined limit for concentration of Medicare receivables that may be included as “eligible accounts” under the Loan Agreement, and (ii) increasing the permitted aggregate maximum balance that may be maintained in the Company’s German subsidiary.

Borrowings under both facilities are subject to compliance with various covenants. The Company is in compliance with these covenants as of June 30, 2025.

The Company recorded approximately $199,500 in debt origination costs during the year ended December 31, 2024 in conjunction with entering into the Loan Agreement, which includes the commitment fee and the Anniversary Fee. The Company capitalized the debt origination costs and is amortizing them into interest expense using the interest rate method, which approximates straight-line amortization over the term of the Loan Agreement. As of June 30, 2025, the balance of debt origination costs was approximately $134,400, which is included in other long-term assets on the condensed consolidated balance sheet. The Company amortized approximately $31,000 and $62,000 of debt origination costs to interest expense during the three and six months ended June 30, 2025, respectively.

During the three months ended June 30, 2025 the Company borrowed $2,500,000 under the Revolving Line and $1,500,000 under the Term Loan facility.

12


 

 

 

Note 9 — Stock Award Plans and Stock-Based Compensation

 

As of June 30, 2025, there were 636,974 shares available for issuance under the Myomo, Inc. 2018 Stock Option 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, 2025, 1,375,130 shares were added to the share reserve under the 2018 Plan.

 

 

Recipients of awards of restricted stock units typically sell shares in the open market to cover their individual tax liabilities and remit the proceeds to the Company, which offsets withholding taxes paid by the Company. In certain circumstances, stock awards 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. In such instances, these payments of employee withholding taxes are presented in the statements of cash flows as a financing activity. There were no stock awards that were net share settled during the three and six months ended June 30, 2025.

Share-Based Compensation Expense

The Company accounts for stock awards to employees and non-employees 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.

The Company attributes the value of stock-based compensation to operations on the straight-line method such that the expense associated with awards is evenly recognized over the vesting period.

The Company recognized stock-based compensation expense related to the issuance of stock option awards and restricted stock units to employees, non-employees and directors in the statements of operations as follows:

 

 

 

For the Three Months Ended

 

 

For the Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Cost of goods sold

 

$

28,005

 

 

$

(10,591

)

 

$

69,723

 

 

$

12,796

 

Research and development

 

 

43,942

 

 

 

8,719

 

 

 

122,097

 

 

 

32,964

 

Selling, clinical and marketing

 

 

101,657

 

 

 

7,190

 

 

 

193,149

 

 

 

53,251

 

General and administrative

 

 

221,285

 

 

 

(97,211

)

 

 

550,124

 

 

 

129,384

 

Total

 

$

394,889

 

 

$

(91,893

)

 

$

935,093

 

 

$

228,395

 

 

As of June 30, 2025, there was approximately $1,000 of unrecognized compensation cost related to unvested stock options that is expected to be recognized over a weighted-average period of 0.43 years.

As of June 30, 2025, there was approximately $4,972,300 of unrecognized compensation expense related to unvested restricted stock units that is expected to be recognized over a weighted-average period of 2.65 years.

Note 9 — Commitments and Contingencies

Litigation

 

The Company may be involved from time to time 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. There are no material claims, assessments, or litigation against the Company as of June 30, 2025.

Operating Leases

 

The Company had a lease agreement for its corporate headquarters in Boston, Massachusetts, which expired in January 2025 and has a lease agreement for office space in Fort Worth, TX. which expires in December 2025. In August 2024, the Company entered into a lease agreement for a new corporate headquarters and manufacturing facility in Burlington, Massachusetts. The Company began relocating operations in December 2024 and completed the move in January 2025. The term of the lease is 88 months following the rent commencement date, which

13


 

was May 11, 2025. The Company has the option to extend the new lease for an additional five years, subject to certain conditions being satisfied. Under the new lease, the Company provided a security deposit to the landlord in the form of a letter of credit for $375,000. The Company has collateralized the letter of credit with cash in a separate bank account, which is accounted for as long-term restricted cash on the condensed consolidated balance sheet. Termination options are either not included, or have expired, for the Company’s other 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 consolidated balance sheets. We recognize rent expense on a straight-line basis over the lease term.

 

As of June 30, 2025, operating lease assets were approximately $7,058,100. The amount and the maturity of the Company’s operating lease liabilities as of June 30, 2025, are as follows:

 

 

 

 

 

 

 

 

 

June 30, 2025

 

2025

 

 

 

 

 

 

 

 

607,230

 

2026

 

 

 

 

 

 

 

 

1,197,919

 

2027

 

 

 

 

 

 

 

 

1,525,416

 

2028

 

 

 

 

 

 

 

 

1,592,125

 

Thereafter

 

 

 

 

 

 

 

 

6,523,473

 

Total future minimum lease payments

 

 

 

 

 

 

 

 

11,446,163

 

Less imputed interest

 

 

 

 

 

 

 

 

3,015,696

 

Total operating lease liabilities

 

 

 

 

 

 

 

$

8,430,467

 

Included in the condensed consolidated balance sheet:

 

 

 

 

 

 

 

 

 

Current operating lease liabilities

 

 

 

 

 

 

 

$

460,351

 

Non-current operating lease liabilities

 

 

 

 

 

 

 

 

7,970,116

 

Total operating lease liabilities

 

 

 

 

 

 

 

$

8,430,467

 

 

For the three and six months ended June 30, 2025 and 2024, the total lease cost is comprised of the following amounts:

 

 

 

For the Three Months
Ended June 30,

 

 

For the Six Months
Ended June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Operating lease expense

 

 

347,811

 

 

 

87,835

 

 

 

749,620

 

 

 

175,671

 

Short-term lease expense

 

 

537

 

 

 

1,608

 

 

 

2,259

 

 

 

3,268

 

Total lease expense

 

$

348,348

 

 

$

89,443

 

 

$

751,879

 

 

$

178,939

 

 

The following summarizes additional information related to operating leases:

 

 

 

 

 

 

 

June 30, 2025

 

 

December 31, 2024

 

Weighted-average remaining lease term (in years)

 

 

 

 

 

 

7.22

 

 

 

7.80

 

Weighted-average discount rate

 

 

 

 

 

 

8.6

%

 

 

8.6

%

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 year ended December 31, 2023, the Company entered into a policy covering the twelve-month period ending June 2024. Under this financing arrangement, the Company made nine equal monthly payments of approximately $27,000, starting in July 2023. During the six months ended June 30, 2024, the Company completed its payment obligation associated with its 2023-2024 policy and entered into a new policy covering the twelve-month period ending in June 2025. Under this financing arrangement, the Company made a down payment of approximately $39,000 during the three months ended June 30, 2024, and made nine equal monthly payments of approximately $39,000, starting in July 2024. During the three months ended June 30, 2025, the Company entered into a new financing arrangement for its 2025-2026 policy covering the twelve month period ending in June 2026. The Company made a down payment of $68,400 and will make 10 equal monthly payments of approximately $40,300, starting in July 2025. Changes in the Company's supplier finance obligations were as follows:

 

 

14


 

 

 

 

 

For the Six Months Ended June 30,

 

2025

 

 

2024

 

Balance January 1

 

$

181,256

 

 

$

142,217

 

Increase

 

 

 

 

 

 

Expensed

 

 

(98,508

)

 

 

(80,109

)

Balance March 31,

 

$

82,748

 

 

$

62,108

 

Increase

 

 

456,000

 

 

 

349,909

 

Expensed

 

 

(85,160

)

 

 

(78,593

)

Balance June 30,

 

$

453,588

 

 

$

333,424

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

No assets are pledged as security under this arrangement.

 

Note 11 — Segment Reporting and Major Customers

 

Segment Reporting

ACS 280, “Segment Reporting” establishes standards for reporting information about operating segments on a basis consistent with the Company’s internal organization structure as well as information about products, business segments, and major customers in financial statements. The Company conducts its business in one operating segment, and sells products in one family, which are versions of the MyoPro. While the Company has several sales channels and operates in different geographies, the Chief Executive Officer, who is the Company's chief operating decision-maker, and is responsible for allocating resources and assessing the performance of the Company, manages the Company's business on a consolidated basis, focusing on revenue, gross margin, certain operating expenses, loss from operations, other expenses (income), Income Tax, and Net loss. The Chief Executive Officer reviews the consolidated balance sheet with relation to consolidated Assets. The Chief Executive Officer does not review any additional or more disaggregated level.

 

 

 

For the Three Months Ended

For The Six Months Ended

 

 

 

June 30,

June 30,

 

For the six months ended June 30,

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

9,652,234

 

 

$

7,520,767

 

 

$

19,484,048

 

 

$

11,275,156

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

3,600,061

 

 

 

2,195,255

 

 

 

6,822,246

 

 

 

3,650,601

 

Gross profit

 

 

6,052,173

 

 

 

5,325,512

 

 

 

12,661,802

 

 

 

7,624,555

 

Gross margin

 

 

62.7

%

 

 

70.8

%

 

 

65.0

%

 

 

67.6

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Payroll and benefits expense

 

 

7,663,736

 

 

 

4,803,648

 

 

 

14,441,271

 

 

 

9,202,430

 

Advertising

 

 

2,229,940

 

 

 

849,610

 

 

 

3,839,629

 

 

 

1,636,859

 

All other segment operating expenses

 

 

2,536,971

 

 

 

1,685,364

 

 

 

5,816,202

 

 

 

3,424,137

 

Payroll and benefits expense in cost of revenue

 

 

(1,788,154

)

 

 

(898,046

)

 

 

(3,324,726

)

 

 

(1,635,040

)

 

 

 

10,642,493

 

 

 

6,440,576

 

 

 

20,772,376

 

 

 

12,628,386

 

Loss from operations

 

$

(4,590,320

)

 

$

(1,115,064

)

 

$

(8,110,574

)

 

$

(5,003,831

)

Other expense (income)

 

 

(106,549

)

 

 

(107,242

)

 

 

(298,540

)

 

 

(242,535

)

Income Tax Expense

 

 

148,201

 

 

 

113,785

 

 

 

284,996

 

 

 

195,943

 

Net Loss

 

$

(4,631,972

)

 

$

(1,121,607

)

 

$

(8,097,030

)

 

$

(4,957,239

)

 

Major Customers

For the three and six months ended June 30, 2025 and 2024, there were no customers which accounted for more than 10% of revenues. For the three months ended June 30, 2025 and 2024, the Centers for Medicare and Medicaid Services ("CMS") represented 56% and 47% of revenues, respectively. For the six months ended June 30, 2025 and 2024, CMS represented 58% and 35% of revenues, respectively. For the three and six months ended June 30, 2024, a U.S. insurance payer represented 20% and 24% of revenues, respectively.

15


 

 

At June 30, 2025, CMS and a U.S. commercial insurer and its affiliates accounted for approximately 67% and 9% of accounts receivable, respectively. At December 31, 2024, CMS and a U.S. commercial insurer and its affiliates accounted for approximately 36% and 19% of accounts receivable, respectively.

 

For the three and six months ended June 30, 2025, approximately 20% and 19% of the Company's revenues, respectively, were derived from patients with Medicare Advantage insurance plans. For the three and six months ended June 30, 2024, approximately 26% and 30% of the Company's revenues were derived from patients with Medicare Advantage insurance plans, respectively.

 

Note 12 — Subsequent Events

The Company evaluated subsequent events through the date the financial statements were issued, and determined that there have been no subsequent events that would require recognition in the financial statements or disclosure in the notes to the unaudited condensed consolidated financial statements.

 

16


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion should be read in conjunction with our condensed consolidated financial statements and the related notes contained elsewhere in this Quarterly Report on Form 10-Q and in our other Securities and Exchange Commission filings. The following discussion may contain predictions, estimates, and other forward-looking statements that involve a number of risks and uncertainties, including those discussed under “Risk Factors”, “Cautionary Statement Regarding Forward-Looking Statements” and elsewhere in this Quarterly Report on Form 10-Q and those described under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2024. These risks could cause our actual results to differ materially from any future performance suggested below.

Overview

We are a wearable medical robotics company, specializing in myoelectric braces, or orthotics, for people with neuromuscular disorders. We develop and market the MyoPro product line, which is a myoelectric-controlled upper limb brace, or orthosis. The orthosis is a rigid brace used for the purpose of supporting a patient’s weak or deformed arm to enable and improve functional activities of daily living (“ADLs”), in the home and community. It is custom constructed by a trained professional during a custom fabrication process for each individual user to meet their specific needs. Our products are designed to help regain function in individuals with neuromuscular conditions due to brachial plexus injury, stroke, traumatic brain injury, spinal cord injury and other neurological disorders.

 

We utilize digital ads on various platforms as well as television ads to reach patients who are potential candidates for our product. Once the prospective patient contacts us or is referred to us, either our trained clinical staff or a trained Orthotics and Prosthetics (“O&P”) provider will evaluate the patient for their suitability as a candidate. Initial evaluations by our trained clinical staff are often conducted using telehealth techniques, followed by an in-person clinical evaluation of the candidate. Prior to obtaining authorizations from commercial insurance companies, the patient’s medical records are collected and reviewed to make sure the device is appropriate for their condition and a prescription is always obtained from a physician. Once these documents are obtained, a pre-authorization request is submitted to the patient’s insurer. If we receive a pre-authorization, we proceed to measure the patient’s arm. If the patient is covered by Medicare Part B, no pre-authorization is required and we can move directly to taking measurements of the patient's arm. This is done either in person, or in some cases using a digital measurement kit supplied to the patient. We then use those measurements to 3D print orthotic parts, which are used to fabricate the MyoPro, and then deliver it to the patient. Since we are directly providing the device to the patient and then billing insurance ourselves, we refer to this process as direct billing. We also call on O&P practices in the United States, Europe and Australia that provide our products to their patients as well as generate indirect sales. The MyoPro product line has been approved by the Veterans Administration (“VA”) for impaired veterans, and over 130 VA facilities have ordered devices for their patients.

 

Our myoelectric orthoses have been clinically shown in peer reviewed published research studies to help regain the ability to complete functional tasks by supporting the affected joint and enabling individuals to self-initiate and control movement of their partially paralyzed limbs by using their own muscle signals. Our technology was originally developed at MIT in collaboration with medical experts affiliated with Harvard Medical School. Myomo was incorporated in 2004.

Other historical milestones include:

In 2012, we introduced the MyoPro. The primary business focus shifted from developing devices that were designed for rehabilitation therapy and sold to hospitals to providing an assistive device through O&P providers to patients who are otherwise impaired for use at home, work, and in the community that facilitates ADLs.
During 2015, we extended our basic MyoPro for the elbow with the introduction of the MyoPro Motion W, a multi-articulated non-powered wrist and the MyoPro Motion G, which includes a powered grasp. The MyoPro Motion W allows the user to use their sound arm to adjust the device and then, for instance, open a refrigerator door, carry a shopping bag, hold a cell phone, or stabilize themselves to avoid a fall and potential injury. The MyoPro Motion G model allows users with severely weakened or clenched hands, such as seen in certain stroke survivors, to open and close their hands and perform a large number of ADLs.
On June 9, 2017, we completed our initial public offering (“IPO”) and a private offering concurrent with the IPO, generating net proceeds of $6.9 million in the aggregate.
On July 31, 2017, we met the criteria to apply the CE Mark for the MyoPro. This has enabled us to sell the MyoPro to individuals in the European Union (the “EU”).
In November 2018, we announced that the Centers for Medicare and Medicaid Services, (“CMS”), had published two new codes (L8701, L8702) pursuant to our application for Healthcare Common Procedure Coding System (“HCPCS”) codes which become effective in early 2019.
In 2019, we transitioned our business to become a direct provider of the MyoPro to patients and bill insurance companies directly.
In July 2021, we became accredited as a Medicare provider.
In January 2022, we introduced MyoPro 2+ and began in-house fabrication of the device.

17


 

On November 1, 2023, CMS issued a final rule that resulted in a change in the benefit category associated with the products billed under the HCPCS codes for our products from durable medical equipment rental to a brace, which would permit reimbursement of MyoPro sales on a lump sum basis. The rule became effective on January 1, 2024
On February 29. 2024, CMS published final payment determinations for the HCPCS codes describing our products which are L8701, for the MyoPro Motion W, and L8702, for the MyoPro Motion G, which became effective on April 1, 2024. These fees were subsequently updated to approximately $34,300 for the Motion W and approximately $67,500 for the Motion G, effective January 1, 2025. These fees are subject to annual inflationary adjustments.
On April 30, 2025, we introduced an enhanced version of our flagship product, now known as the MyoPro 2X in the United States.

 

Equity Offerings

On December 6, 2024, we completed a public offering, selling 3,450,000 shares of common stock at $5.00 per share, generating net proceeds after fees and expenses of approximately $15.8 million. Net proceeds from the offering are expected to be used to grow revenues in our direct billing channel through additional advertising spending and the addition of clinical, reimbursement and manufacturing headcount to support expected increasing demand, to increase R&D spending in order to accelerate the completion of sustaining and new product development activities, to fund systems and headcount to support growth in the O&P channel, to fund associated working capital requirements and general corporate purposes. On January 19, 2024 we 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 $3.7999 per pre-funded warrant, generating net proceeds after fees and expenses of approximately $5.4 million. Each pre-funded warrant in the above offering entitles the holder to one share of common stock upon exercise at a nominal exercise price of $0.0001 per share. See section titled “Liquidity” for further discussion.

 

 

Results of Operations

 

We have been growing revenues while incurring net losses and negative cash flows from operations since inception and anticipate this to continue for all of 2025. Our plan for 2025 is to invest in increasing demand and adding capacity to support our direct billing channel, while making investments to increase revenues in the U.S. O&P channel.

The following table sets forth our revenue, cost of revenue, gross profit and gross margin for each of the periods presented.

 

 

For the Three Months
Ended June 30,

Period-to-Period
Change

For the Six Months
Ended June 30,

Period-to-Period
Change

 

2025

2024

$

%

2025

2024

$

%

Revenue

$9,652,234

$7,520,767

$2,131,467

28%

$19,484,048

$11,275,156

$8,208,892

73%

Cost of revenue

3,600,061

2,195,255

1,404,806

64%

6,822,246

3,650,601

3,171,645

87%

Gross profit

$6,052,173

$5,325,512

$726,661

14%

$12,661,802

$7,624,555

$5,037,247

66%

Gross margin %

62.7%

70.8%

 

-8.1%

65.0%

67.6%

 

-2.7%

 

Revenues

We derive revenue primarily from providing devices directly to patients and billing insurance companies or Medicare directly. We also sell our products to O&P providers in the U.S, Europe and Australia, to the VA, and to rehabilitation hospitals. Though we increasingly provide devices directly to patients, we sometimes utilize the clinical services of O&P providers for which they are paid a fee.

Revenue increased by approximately $2.1 million and $8.2 million, or 28% and 73%, for the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024. Higher revenues in the three and six months ended June 30, 2025 were due to a higher number of revenue units and a higher average sales price, as revenues in the three and six months ended June 30, 2024 were recognized based on reimbursement amounts prior to the effective date of the fees published by CMS. Revenues generated through the direct bill channel were approximately $7.4 million and $15.2 million, or 77% and 78% in the three and six months ended June 30, 2025, respectively, compared to approximately $3.3 million and $8.1 million or 55% and 71%, of revenues in the three and six months ended June 30, 2024, respectively.

Cost of Revenue and Gross Margin

18


 

Cost of revenue consists of direct costs for the manufacturing, printing of orthotic parts, fabrication and fitting of our products, changes in inventory and warranty reserves, and overhead costs allocated to cost of revenue.

Gross margin was 62.7% and 65.0% for the three and six months ended June 30, 2025 respectively, compared to 70.8% and 67.6% for the three and six months ended June 30, 2024, respectively. The decreases in gross margin were primarily due to higher material costs and increased manufacturing overhead spending, including payroll and lease cost for our new headquarters and manufacturing facility, offset by a higher average selling price.

Operating Expenses

The following table sets forth our operating expenses for each of the periods presented.

 

 

 

For the Three Months
Ended June 30,

 

Period-to-Period
Change

 

For the Six Months
Ended June 30,

Period-to-Period
Change

 

 

2025

 

2024

 

$

 

%

 

2025

 

2024

$

 

%

Research and development

 

$2,001,331

 

$1,007,224

 

$994,107

 

99%

 

$3,791,355

 

$1,963,438

$1,827,917

 

93%

Selling, clinical and marketing

 

5,233,885

 

2,777,135

 

2,456,750

 

88%

 

9,629,689

 

5,138,980

4,490,709

 

87%

General and administrative

 

3,407,277

 

2,656,217

 

751,060

 

28%

 

7,351,332

 

5,525,968

1,825,364

 

33%

Total operating expenses

 

$10,642,493

 

$6,440,576

 

$4,201,917

 

65%

 

$20,772,376

 

$12,628,386

$8,143,990

 

64%

 

Research and development

Research and development (“R&D”) expenses consist of costs for our R&D personnel, including salaries, benefits, bonuses and stock-based compensation, product development costs, clinical studies, and the cost of certain third-party contractors and travel expense. R&D costs are expensed as they are incurred. We intend to invest in enhancing our existing products in 2025 and expect R&D costs to increase on an annual basis.

R&D expenses increased by approximately $1.0 million and $1.8 million, or 99% and 93%, during the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024. The increases were primarily due to higher costs for payroll and outside engineering services as we are adding headcount in order to accelerate our sustaining engineering and product development efforts.

Selling, clinical and marketing

Selling, clinical, and marketing (“SC&M”) expenses consist of costs for our field clinical staff, clinical training organization, and marketing personnel, including salaries, benefits, bonuses, stock-based compensation and other variable compensation, costs of advertising, marketing and promotional events, corporate communications, product marketing and travel expenses. Variable compensation for personnel engaged in sales and marketing activities is generally earned and recorded as expense in the period in which the measurable work is performed. We expect SC&M expenses to increase in 2025 as we increase our advertising spending and clinical capacity to grow revenues in our direct billing channel.

SC&M expenses increased by approximately $2.5 million and $4.5 million or 88% and 87%, during the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024. The increases were primarily due to higher payroll costs due to increased headcount in our clinical functions to support higher expected sales volume in 2025, and increases in advertising expense in an effort to overcome challenges in lead generation during the first quarter of 2025 and to position us for revenue growth in the second half of the year and beyond.

General and administrative

General and administrative (“G&A”) expenses consist primarily of costs for administrative, reimbursement, and finance personnel, including salaries, benefits, bonuses and stock-based compensation, professional fees associated with legal matters, consulting expenses, costs for pursuing insurance reimbursements for our products and costs required to comply with the regulatory requirements of the SEC, as well as costs associated with accounting systems, insurance premiums and other corporate expenses. We expect that G&A expenses will increase in 2025 as a result of increasing our reimbursement capacity in order to grow revenue in the direct billing channel.

G&A increased by approximately $751,000 and $1.8 million, or 28% and 33%, during the three and six months ended June 30, 2025, respectively, as compared to the same periods in 2024. The increases were primarily due to increased payroll costs due to increased headcount in our reimbursement functions as part of our plan to increase our reimbursement capacity in 2025 in order to serve Medicare Part B patients, as well as higher expense related to stock-based compensation.

19


 

Other (income), net

The following table sets forth our other income, net for each of the periods presented:

 

 

 

For the Three Months
Ended June 30,

 

 

Period-to-Period
Change

 

 

For the Six Months
Ended June 30,

 

 

Period-to-Period
Change

 

 

 

2025

 

 

2024

 

 

$

 

 

%

 

 

2025

 

 

2024

 

 

$

 

 

%

 

Interest income, net

 

 

(106,549

)

 

 

(107,242

)

 

 

693

 

 

 

(1

)%

 

 

(298,540

)

 

 

(242,535

)

 

 

(56,005

)

 

 

23

%

Total other income, net

 

$

(106,549

)

 

$

(107,242

)

 

$

693

 

 

 

(1

)%

 

$

(298,540

)

 

$

(242,535

)

 

$

(56,005

)

 

 

23

%

 

Other (income), net was approximately $106,500 and $298,500 for the three and six months ended June 30, 2025, respectively, compared to approximately $107,200 and $242,500 for the same periods in 2024, respectively. Other (income), net for the three months ended June 30, 2025 was flat compared to the same period a year ago. The increase in other (income), net for the six months ended June 30, 2025 was due primarily to higher interest income as a result of a higher average investment balance compared to the prior year period.

Income tax expense

 

Income tax expense recorded during the three and six months ended June 30, 2025 and 2024 represents the provision for income taxes for our wholly-owned subsidiary, Myomo Europe GmbH. Income tax expense increased in the three and six months ended June 30, 2025 as a result of higher taxable income compared to the same periods in 2024.

Adjusted EBITDA

We believe that the presentation of Adjusted EBITDA, a non-GAAP financial measure, provides investors with additional information about our financial results. Adjusted EBITDA is an important supplemental measure used by our board of directors and management to evaluate our operating performance from period-to-period on a consistent basis and as a measure for planning and forecasting overall expectations and for evaluating actual results against such expectations.

We define Adjusted EBITDA as earnings before interest, taxes, depreciation and amortization adjusted for, stock-based compensation and other unusual items.

Adjusted EBITDA is not in accordance with, or an alternative to, measures prepared in accordance with U.S. GAAP. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles. As a non-GAAP measure, Adjusted EBITDA has limitations in that it does not reflect all of the amounts associated with our results of operations as determined in accordance with U.S. GAAP. In particular:

 

Adjusted EBITDA does not reflect the amounts we paid in taxes or other components of our tax provision;
Adjusted EBITDA does not include interest income;
Adjusted EBITDA does not include depreciation expense from fixed assets;
Adjusted EBITDA does not include the impact of stock-based compensation;

Because of these limitations, you should consider Adjusted EBITDA alongside other financial performance measures including net income (loss) and our financial results presented in accordance with U.S. GAAP.

The following table provides a reconciliation of net loss to Adjusted EBITDA for each of the periods indicated:

 

 

 

For the Three Months
Ended June 30,

 

 

For the Six Months
Ended June 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

GAAP net loss

 

$

(4,631,972

)

 

$

(1,121,607

)

 

$

(8,097,030

)

 

$

(4,957,239

)

Adjustments to reconcile to Adjusted EBITDA:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

(106,549

)

 

 

(107,242

)

 

 

(298,540

)

 

 

(242,535

)

Depreciation expense

 

 

190,798

 

 

 

35,979

 

 

 

349,240

 

 

 

65,663

 

Stock-based compensation

 

 

394,889

 

 

 

(91,893

)

 

 

935,093

 

 

 

228,395

 

Income tax expense

 

 

148,201

 

 

 

113,785

 

 

 

284,996

 

 

 

195,943

 

Adjusted EBITDA

 

$

(4,004,633

)

 

$

(1,170,978

)

 

$

(6,826,241

)

 

$

(4,709,773

)

 

20


 

 

Liquidity and Capital Resources

Liquidity

We measure our liquidity in a number of ways, including the following:

 

 

 

June 30,
2025

 

 

December 31,
2024

 

Cash and cash equivalents

 

$

14,240,432

 

 

$

24,372,373

 

Short-term investments

 

 

1,241,515

 

 

 

492,990

 

Total

 

 

15,481,947

 

 

 

24,865,363

 

Working capital

 

$

16,290,040

 

 

$

22,618,158

 

 

As of June 30, 2025, we had working capital of approximately $16.2 million and stockholders’ equity of approximately $17.6 million. We used approximately $11.5 million in cash for operating activities during the six months ended June 30, 2025. Cash used in operations was impacted during the three months ended June 30, 2025 by a payment hold placed on us by one of the Durable Medical Equipment Medicare Administrative Contractors, known as the DME MACs, in order to process our address change to our new headquarters facility in Burlington, MA. This payment hold increased accounts receivable during the second quarter of 2025 by approximately $1.5 million. As of the issuance date of these financial statements, we have been paid for these held claims. Considering our current cash, cash equivalents, and short-term investment balances and our operating plans discussed below, we believe there is sufficient cash, cash equivalents, and short-term investments to fund our operations and capital expenditures for the next 12 months from the date of this report.

 

We have historically funded our operations through financing activities, including raising equity and debt capital. In December 2024, we completed a public equity offering, pursuant to which we sold 3,450,000 shares of common stock at $5.00 per share, generating net proceeds after fees and expenses of approximately $15.8 million. In January 2024, we completed a registered direct equity offering, pursuant to which we 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. In July 2024, we entered into a Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company, which provides us the ability to borrow up to $4.0 million against eligible accounts receivable. We amended the Loan and Security Agreement in February 2025 to provide for, among other changes, a $3.0 million term loan facility, which is available to be drawn at any time until February 28, 2026. During the three months ended June 30, 2025, we borrowed $2.5 million under the line of credit and $1.5 million under the term loan facility. Our ability to borrow under these facilities is subject to various covenants. We are in compliance with these covenants as of June 30, 2025.

Our business is dependent upon reimbursement of our products by insurance companies and government-controlled health care plans such as Medicare and Medicaid in the United States and by statutory health insurance plans in Germany, which could prevent our revenues from growing to the level necessary to return to cash flow breakeven and remain that way on a sustaining basis. We believe that we have access to capital resources, if necessary, through potential public or private equity offerings, debt financings, or other means. If we are unable to obtain adequate funds on reasonable terms, we may be required to significantly curtail or discontinue operations or obtain funds by entering into financing agreements on unattractive terms. We may also explore strategic alternatives for the purpose of maximizing stockholder value. There can be no assurance we will be successful in implementing our plans to sustain our operations and continue to conduct our business.

Cash Flows

 

 

 

Six Months Ended June 30,

 

 

 

2025

 

 

2024

 

Net cash used in operating activities

 

$

(11,542,175

)

 

$

(5,161,488

)

Net cash used in investing activities

 

 

(2,653,446

)

 

 

(1,211,930

)

Net cash provided by financing activities

 

 

3,963,494

 

 

 

5,361,909

 

Effect of foreign change rate changes on cash

 

 

100,186

 

 

 

(13,697

)

Net increase (decrease) in cash, cash equivalents and restricted
   cash

 

$

(10,131,941

)

 

$

(1,025,206

)

 

21


 

Operating Activities. The net cash used in operating activities for the six months ended June 30, 2025 was primarily used to fund a net loss of approximately $8.1 million, adjusted for non-cash expenses in the aggregate amount of approximately $1.8 million and by approximately $5.3 million of cash used by net changes in the levels of operating assets and liabilities, primarily related to increases in accounts receivable due primarily to the payment hold discussed above, inventory and prepaid expenses and other current assets, and a decrease in accounts payable and accrued expenses, due primarily to the payment of incentive compensation during the three months ended June 30, 2025.

Net cash used in operating activities for the six months ended June 30, 2024 was primarily used to fund a net loss of approximately $5.0 million, adjusted for non-cash expenses in the aggregate amount of approximately $0.4 million and by approximately $0.6 million of cash used by net changes in the levels of operating assets and liabilities, primarily related to an increase in inventory and prepaid expenses and other current assets, offset by an increase in accounts payable and accrued expenses.

Investing Activities. During the six months ended June 30, 2025, and 2024, cash used in investing activities of $2.6 million and $1.2 million respectively. was primarily related to our purchase, net of maturities, of short-term investments and purchases of equipment. During the six months ended June 30, 2025, purchases of equipment included improvements to our new headquarters facility and MARK2 demo units provided to certain O&P providers to help them evaluate prospective patients.

Financing Activities. There was $4.0 million and $5.4 million in cash generated from financing activities during the six months ended June 30, 2025 and 2024, respectively. Cash generated in the six months ended June 30, 2025 was due to borrowings under our line of credit and term loan facility. Cash generated in the six months ended June 30, 2024 was due entirely to the net proceeds from our equity offering in January 2024.

Critical Accounting Policies and Estimates

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. Our significant estimates include deferred tax valuation allowances, valuation of stock-based compensation, warranty obligations and reserves for credit losses and slow-moving inventory.

Other

There have been no material changes to our critical accounting policies from those described in our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024.

Recent Accounting Standards

Information regarding new accounting standards is included in Note 3 — Recently Adopted Accounting Standards to our unaudited condensed consolidated financial statements contained in Item 1 of this Quarterly Report on Form 10-Q.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

This item is not applicable to us as a smaller reporting company.

22


 

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

 

The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

 

Our management, with the participation of our Chief Executive Officer, our principal executive officer, and our Chief Financial Officer, our principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2025, at the end of the period covered by this Quarterly Report on Form 10-Q. Management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based upon such evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were not effective as of such date at the reasonable assurance level due to the material weakness in the design of effective information technology general controls over our enterprise reporting system described below.

 

Material Weakness

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.

We identified a material weakness as of December 31, 2024 related to a lack of design and maintenance of effective information technology general controls due to privileged access rights for two individuals, lack of formal processes for user provisioning, periodic user access review and change management for financial reporting system and lack of formal reviews of key third party service provider SOC reports. The deficiencies could allow for inappropriate financial transactions to be recorded that would not be detected by our other manual controls, rendering them ineffective. This material weakness has not resulted in any identified misstatements to our financial statements.

Notwithstanding the material weaknesses in our internal control over financial reporting, our management has concluded that our condensed consolidated financial statements and related notes thereto included in this Quarterly Report on Form 10-Q fairly present in all material respects the financial condition, results of operations and cash flows of the Company and have been prepared in accordance with generally accepted accounting principles. Our Chief Executive Officer and Chief Financial Officer have certified that, based on each such officer’s knowledge, the financial statements, as well as the other financial information included in this Quarterly Report on Form 10-Q, fairly present in all material respects the financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this Quarterly Report on Form 10-Q.

Management’s Plan for Remediation of the Material Weakness

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Management, with the oversight of the Audit Committee of the Board of Directors, is committed to maintaining a strong internal control environment. In response to the material weakness identified above, we have put in place several compensating controls to remediate the material weakness in internal control over financial reporting by formalizing our process and review of user provisioning to enable only the appropriate personnel to have access, including giving rights to provision access to our financial reporting system to an individual outside our finance organization, and formalizing change management processes and review of key third party service provider SOC reports.

As of June 30, 2025, we have implemented both new and modified controls around the provisioning of access rights and our change management processes, we are also continuing to refine and enhance additional controls, as well as review of key third party service provider SOC reports.

We believe that these actions, when fully implemented, will remediate the material weakness. However, the material weakness will not be considered fully remediated until the design of these controls are determined to operate for a sufficient period of time and management has concluded, through testing, that these controls are effective. As we continue to evaluate operating effectiveness and monitor improvements to

23


 

our internal control over financial reporting, we may take additional measures to address control deficiencies or modify the remediation plan described above.

 

We believe the new controls being implemented and changes in the design of certain of our existing controls will be sufficient to remediate the material weakness once testing of the operation these controls has been finalized.

 

Management’s Report on Internal Control over Financial Reporting

 

Our management assessed the effectiveness of our internal controls over financial reporting as of June 30, 2025. In making this assessment, we used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control - Integrated Framework (2013). Based on our assessment, and as a result of the material weakness described above, we believe that as of June 30, 2025, our internal control over financial reporting was not effective at the reasonable assurance level. However, after giving full consideration to this material weakness, our management has concluded that our condensed consolidated financial statements present fairly, in all material respects, our financial position, results of operations and cash flows for the periods disclosed in conformity with generally accepted accounting principles.

 

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) identified in connection with the evaluation of our internal control that occurred during the quarter ended June 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

24


 

Part II. OTHER INFORMATION

 

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. There is no material litigation against the Company at this time that is required to be disclosed under Item 103 of Regulation S-K.

Item 1A. Risk Factors

Except as set forth below, there have been no material changes to our risk factors from those disclosed in Part I, Item 1A. "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024.

Risks Related to Our Operating and Financial Results

We have a history of operating losses. Factors both within and outside of our control could result in a delay in our ability to achieve cash flow breakeven on a quarterly basis.

We have a history of losses since inception. For the three and six months ended June 30, 2025, we incurred net losses of $4.6 million and $8.1 million, respectively. For the year ended December 31, 2024, we incurred a net loss of $6.2 million. At June 30, 2025, we had an accumulated deficit of approximately $111.2 million. The extent and duration of future operating and net losses will depend on our ability to increase revenues, increase the number of patients entering our pipeline at a lower advertising cost per pipeline addition, our ability to manage fixed costs associated with clinical, reimbursement and manufacturing capacity, and our ability to compensate for additional R&D spending expected in 2025. However, there can be no assurance that we can cost effectively grow our revenues without requiring additional capital.

Our cash, cash equivalents and short-term investments at June 30, 2025 were approximately $15.5 million. On January 19, 2024, we completed a registered direct offering of our common stock and pre-funded warrants, generating net proceeds of approximately $5.4 million. On December 6, 2024, we completed a public offering of our common stock, generating net proceeds of approximately $15.8 million. On July 11, 2024, we entered into a Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (“Silicon Valley Bank”), which provides us the ability to borrow up to $4.0 million against eligible accounts receivable. We borrowed $2.5 million under the line of credit during the three months ended June 30, 2025. In February 2025, we entered into an amendment to the Loan and Security Agreement, which among other things, provided for a $3 million term loan facility which could be drawn at any time until February 28, 2026. During the three months ended June 30, 2025, we borrowed $1.5 million against the term loan facility. We believe that our existing cash, cash equivalents, short-term investments and restricted cash at June 30, 2025 will be sufficient to fund our operations for the twelve months from the date of this report. If we encounter obstacles such as those that have been referred to above, we may not be able to return to operating cash flow breakeven on a quarterly basis, and additional capital may be required.

 

If CMS amends, restricts, or retracts coverage requirements, its billing contractors and insurers offering Medicare Advantage insurance plans may restrict what they reimburse for the MyoPro, which would have an adverse effect on our business.

Revenues from patients who are covered by Medicare Advantage insurance plans have historically been a significant portion of our overall revenues. However, Medicare Advantage plans have been reducing the number of authorizations for the MyoPro since the second half of 2024, which is negatively impacting our revenues. Approximately 20% and 26% of our revenues were derived from patients with Medicare Advantage insurance plans for the three months ended June 30, 2025 and 2024, respectively. CMS published reimbursement amounts for the MyoPro in April 2024. Revenues from Medicare Part B patients represented 56% of total revenue for the three months ended June 30, 2025. If CMS amends, restricts, or retracts its November 2023 rule classifying MyoPro as a brace, amends or retracts any published fees, or establishes more restrictive inclusion criteria for coverage, our Medicare revenues could be negatively impacted and insurers offering Medicare Advantage insurance plans may no longer cover or adequately reimburse for the MyoPro. Further, continued utilization management efforts by Medicare Advantage plans could result in further decreases in authorizations. As a result of these factors, our overall revenues and cash flows would be negatively impacted, which could have an adverse effect on our business. See “Risks Related to our Reliance on Third Parties—We may not be able to obtain third-party payer reimbursement, including reimbursement by Medicare, for our products” for additional information.

 

Changes made by direct to consumer advertising companies in how they reach prospective patients could adversely impact our lead generation efforts, resulting in higher advertising cost per addition to our patient pipeline and have an adverse effect on revenues.

 

We rely on a variety of direct-to-consumer advertising companies to help us reach and educate prospective patients, their caregivers, and families regarding the potential benefits of the MyoPro. These companies are subject to various privacy laws and regulations regarding the use of protected patient health and other identifying information in advertising activities. Changes in the algorithms and other methods used by

25


 

these companies to remain in compliance with these laws and regulations, which we do not control, nor have input into, may adversely affect our lead generation, our advertising cost per addition to our patient pipeline, which we refer to as cost per pipeline add, and our revenues. For instance, in the first quarter of 2025, a social media advertising company we utilize made a change to the algorithm they use to target prospective patients. This change resulted in decreased lead generation for the first half of the first quarter of 2025 and a higher cost per pipeline add in the first quarter, which is also expected to negatively impact our revenue growth in the second half of 2025. Methods and algorithms used by media companies are continually evolving and we cannot provide any assurance that future changes will not impact our revenues and results of operations.

Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.

We sell our products in countries throughout the world and import materials into the United States. Significant political, trade, or regulatory developments in the jurisdictions in which we may sell our products, such as those stemming from the change in U.S. federal administration, are difficult to predict and may have a material adverse effect on us. These developments may include export controls, tariffs or changes in reimbursement policies for Medicaid and Medicare. For example, on February 1, 2025, the U.S. imposed a 25% tariff on imports from Canada and Mexico, which were subsequently suspended for a period of one month. The U.S. has also imposed significant tariffs on imports from China and other countries, and these tariffs may continue to escalate, depending on the status of trade negotiations. Historically, tariffs have led to increased trade and political tensions. In response to tariffs, other countries have implemented retaliatory tariffs on U.S. goods. While we estimate that tariffs assessed on our imports are expected to have less than a 100 basis point (1%) impact on gross margin in 2025, we cannot provide any assurance that final tariffs actually imposed, changes in political, trade, regulatory, and economic conditions, including U.S. trade policies, will not have a material adverse effect on our financial condition or results of operations.

 

Risks Related to Limited Operating History and Capital Requirements

 

We may not have sufficient funds to meet our future capital requirements.

Our cash, cash equivalents, and short-term investments at June 30, 2025 was approximately $15.5 million. On January 19, 2024, we completed a registered direct offering of our common stock and pre-funded warrants, generating net proceeds of approximately $5.4 million. On December 6, 2024, we completed a public offering of our common stock, generating net proceeds of approximately $15.8 million.

On July 11, 2024, we entered into a Loan and Security Agreement with Silicon Valley Bank, which provides us the ability to borrow up to $4.0 million against eligible accounts receivable. In February 2025, we entered into an amendment to the Loan and Security Agreement, which among other things, provided for a $3 million term loan facility which could be drawn at any time until February 28, 2026. We borrowed $2.5 million under the line of credit and $1.5 million under the term loan facility during the three months ended June 30, 2025.

Our ability to grow our business is dependent on our ability to generate sufficient cash flows from operations or to raise additional capital to meet our obligations, if necessary. We believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund our operations for the next twelve months from the issuance date of this Quarterly Report on Form 10-Q. If additional capital is required to achieve operating cash flow breakeven, we may be unable to obtain additional funds on reasonable terms, or at all. Our ability to secure financing and the cost of raising such capital are dependent on numerous factors, including general economic and capital markets conditions, credit availability from lenders, investor confidence and the existence of regulatory and tax incentives that are conducive to raising capital. If we are unable to raise additional funds, we may need to delay, modify or abandon some or all of our business plans or cease operations. If we raise funds through the issuance of debt, the amount of any indebtedness that we may raise in the future may be substantial, and we may be required to secure such indebtedness with our assets and may have substantial interest expenses. If we default on any future indebtedness, our lenders could declare all outstanding principal and interest to be due and payable and our secured lenders may foreclose on the facilities securing such indebtedness. Usage of our line of credit and term loan facility requires us to meet financial and operating covenants, which could place limits on our operations, decrease our liquidity and increase the amount of cash flow required to service our debt. If we raise funds through the issuance of equity securities, such issuance could result in dilution to our stockholders and the newly issued securities may have rights senior to those of the holders of our common stock.

 

Risks related to our Reliance on Third Parties

We may not be able to obtain third-party payer reimbursement, including reimbursement by Medicare, for our products.

Sales of our device depend, in part, on the extent to which our products are covered by third-party payers, such as government health programs, commercial insurance and managed healthcare organizations. See section titled “Business Section – Government Regulation – Health Insurance Reimbursement”, in our Annual Report on Form 10-K for the year ended December 31, 2024. Third-party payers are increasingly challenging the prices charged, examining the medical necessity and creating additional restrictions on coverage, and reviewing the cost-effectiveness of medical products and services and imposing controls to manage costs. During the three months ended June 30, 2025, CMS's billing contractors in two out of four billing regions began pre-payment audits of claims for MyoPro to determine if medical necessity had been

26


 

appropriately documented. As of date of this Quarterly Report on Form 10-Q, determinations have been made on a total of 27 claims, with 6 having been denied for documentation of medical necessity, and other technical items. These claims are currently being appealed, we believe the majority of these claims will be reimbursed upon appeal. While the outcome of these appeals are unknown, we believe these claims are likely to be reimbursed.

 

Third-party payers may limit coverage to specific products on an approved list, also known as a formulary, which might not include all of the approved products for a particular indication. In addition, CMS may issue local or national coverage determinations which could result in more restrictive coverage for our products. The coverage determination process is often a time-consuming and costly process that requires us to provide scientific and clinical support for the use of our products to each payer separately, with no assurance that coverage and adequate reimbursement will be obtained. In addition, the absence of in-network contracts with Medicare Advantage plans or commercial insurers could result in utilization management for out-of-network patients. Currently, we are almost entirely dependent on third parties to cover the cost of our products to patients and rely on their reimbursement for the cost of our products. If CMS, the U.S. Department of Veterans Affairs (the “VA”) health insurance companies and other third-party payers do not provide adequate coverage or reimbursement for our products, then our sales will be limited to clinical facilities and individuals who can pay for our devices without reimbursement. To our knowledge, from inception through June 30, 2025, fewer than 50 units have been self-paid or funded by non-profit foundations. Some commercial health insurance plans have published statements that they will not cover the cost of the MyoPro for their members. In the event we are unsuccessful in obtaining additional coverage and adequate reimbursement for our products from third-party payers, our sales will be significantly constrained. Currently, reimbursement for the cost of our products is obtained primarily on a case-by-case basis until such time, if any, we obtain broad coverage policies with Medicare and third-party payers. There can be no assurance that we will be able to obtain these broad coverage policies or that Medicare or its local administrative billing contractors will not establish more restrictive coverage requirements for the MyPro in the future (for example, in the form of a local or national coverage determination). See section titled “Business Section – Government Regulation – Health Insurance Reimbursement”, in our Annual Report on Form 10-K for the year ended December 31, 2024.

In connection with Medicare reimbursement, in November 2023 CMS reclassified the MyoPro from the durable medical equipment benefit to the brace benefit category effective January 1, 2024, thereby allowing for lump sum reimbursement. Such lump sum reimbursements based on the fees posted by CMS, are now being made. CMS published final payment determinations for the MyoPro Motion W (L8701) and the MyoPro Motion G (L8702), effective April 1, 2024. These fees were subsequently updated to approximately $34,300 for the Motion W and approximately $67,500 for the Motion G, effective January 1, 2025. The fees are subject to annual inflationary adjustments. Our claims can be reviewed on a case-by-case basis at any time by CMS.

There can be no assurance that the final fees will be sufficient to permit us to generate gross margin required to allow us to operate on a profitable basis. Third-party payers may also continue to deny or limit coverage, limit reimbursement or reduce their levels of payment, or our costs of production may increase faster than increases in reimbursement levels. In addition, we may not obtain coverage and reimbursement approvals in a timely manner. Our failure to operate profitably could negatively impact market acceptance of MyoPro.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds from Registered Securities

None.

 

 

Item 5. Other Information

None

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Item 6. Exhibits

The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibits Index, which is incorporated by reference.

Exhibits Index

 

Exhibit No.

 

Exhibit Description

3.1

 

Eighth Amended and Restated Certificate of Incorporation (Incorporated by reference to Exhibit 2.3 contained in the Registrant’s Form 1-A filed on January 6, 2017)

 

 

 

3.2

 

Amended and Restated Bylaws (Incorporated by reference to Exhibit 2.4 contained in the Registrant’s Form 1-A filed on January 6, 2017)

 

 

 

3.3

 

Certificate of Amendment to the Eighth Amended and Restated Certificate of Incorporation, as amended, of Myomo, Inc., filed with the Secretary of the State of Delaware on January 30, 2020 (Incorporated by reference to Exhibit 3.1 contained in the Registrant’s Form 8-K filed on January 30, 2020)

 

 

 

3.4

 

Second certificate of Amendment to the Eighth Amended and Restated Certificate of Incorporation, as amended, of Myomo, Inc., filed with the Secretary of the State of Delaware on June 10, 2021 (Incorporated by reference to Exhibit 3.1 contained in the Registrant’s Form 8-K filed on June 15, 2021)

 

 

 

 31.1*

 

Certification of Chief Executive Officer, pursuant to Rule 13a-14(a) or 15(d)-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 31.2*

 

Certification of Chief Financial Officer, pursuant to Rule 13a-14(a) or 15(d)-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 32.1+

 

Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

 32.2+

 

Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

101.INS*

 

Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.

101.SCH*

 

Inline XBRL Taxonomy Extension Schema Document with embedded linkbase documents.

104*

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* Filed herewith.

+ The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference. Such certification will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.

 

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) 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 August 11, 2025

 

 

Myomo, Inc.

 

 

 

/s/ David A. Henry

 

David A. Henry

 

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

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FAQ

What were MYO's revenues for the quarter and first half of 2025?

MYO reported $9.65 million in revenue for the quarter ended June 30, 2025 and $19.48 million for the six months ended June 30, 2025.

How large was Myomo's net loss in Q2 2025 and for H1 2025?

Net loss was $4.63 million in Q2 2025 and $8.10 million for the six months ended June 30, 2025.

What cash resources did MYO report at June 30, 2025 and how long will it last?

The company reported combined cash, cash equivalents and short-term investments of approximately $15.48 million and stated it expects these funds to support operations for at least 12 months from issuance of the financial statements.

How dependent is MYO on Medicare/CMS for revenue?

CMS represented 56% of revenues for the three months ended June 30, 2025 and approximately 58% of revenues for the six months ended June 30, 2025; CMS accounted for about 67% of accounts receivable at June 30, 2025.

Did MYO disclose any internal control issues in the 10-Q?

Yes. Management reported a material weakness in information technology general controls related to privileged access and user provisioning and is implementing remediation steps.
Myomo

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Medical Devices
Orthopedic, Prosthetic & Surgical Appliances & Supplies
United States
BOSTON