Modular Medical Inc

Previous wording

This Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the accompanying condensed consolidated financial statements and notes included in this Quarterly Report on Form 10-Q (this Report). This Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which include, without limitation, statements about the market for our technology, our strategy, competition, expected financial performance and capital raising efforts, and other aspects of our business identified in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission on June 21, 2024 and in other reports that we file from time to time with the Securities and Exchange Commission. Any statements about our business, financial results, financial condition and operations contained in this Report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “expects,” “intends,” “plans,” “projects,” or similar expressions are intended to identify forward-looking statements. Our actual results could differ materially from those expressed or implied by these forward-looking statements as a result of various factors, including the risk factors described under Item 1A of our Annual Report on Form 10-K for the year ended March 31, 2024. These forward-looking statements represent our intentions, plans, expectations, assumptions and beliefs about future events and are subject to risks, uncertainties and other factors including, without limitation, the direct and indirect effects of coronavirus disease 2019, or COVID-19, as well as inflationary risks, including the risk that the cost of certain of the Company’s components is increasing, and related issues that may arise therefrom. Many of those factors are outside of our control and could cause actual results to differ materially from those expressed or implied by those forward-looking statements. In light of these risks, uncertainties and assumptions, the events described in the forward-looking statements might not occur or might occur to a different extent or at a different time than we have described. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Report. All subsequent written and oral forward-looking statements concerning other matters addressed in this Report and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this Report. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events, conditions, circumstances or assumptions underlying such statements, or otherwise.

Current wording

This Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the accompanying condensed consolidated financial statements and notes included in this Quarterly Report on Form 10-Q (this Report). This Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which include, without limitation, statements about the market for our technology, our strategy, competition, expected financial performance and capital raising efforts, and other aspects of our business identified in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission on June 21, 2024 and in other reports that we file from time to time with the Securities and Exchange Commission. Any statements about our business, financial results, financial condition and operations contained in this Report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “expects,” “intends,” “plans,” “projects,” or similar expressions are intended to identify forward-looking statements. Our actual results could differ materially from those expressed or implied by these forward-looking statements as a result of various factors, including the risk factors described under Item 1A of our Annual Report on Form 10-K for the year ended March 31, 2024. These forward-looking statements represent our intentions, plans, expectations, assumptions and beliefs about future events and are subject to risks, uncertainties and other factors including, without limitation, inflationary risks, including the risk of increasing costs for certain of the Company’s components, and related issues that may arise therefrom. Many of those factors are outside of our control and could cause actual results to differ materially from those expressed or implied by those forward-looking statements. In light of these risks, uncertainties and assumptions, the events described in the forward-looking statements might not occur or might occur to a different extent or at a different time than we have described. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Report. All subsequent written and oral forward-looking statements concerning other matters addressed in this Report and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this Report. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events, conditions, circumstances or assumptions underlying such statements, or otherwise.

Previous wording

We are a pre-revenue medical device company focused on the design, development and commercialization of innovative insulin pumps using modernized technology to increase pump adoption in the diabetes marketplace. Through the creation of a novel two-part patch pump, our initial product, the MODD1, we seek to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care that presently-available insulin pumps provide. By simplifying and streamlining the user experience from introduction, prescription, reimbursement, training and day-to-day use, we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” and expand the category into the mass market. The product seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets. In January 2024, we submitted a 510(k) premarket notification to the United States Food and Drug Administration (“FDA”) for our MODD1 insulin pump, and, in September 2024, we received FDA clearance to market and sell our MODD1 pump in the United States.

Current wording

We are a pre-revenue medical device company focused on the design, development and commercialization of innovative insulin pumps using modernized technology to increase pump adoption in the diabetes marketplace. Through the creation of a novel two-part patch pump, our initial product, the MODD1, we seek to fundamentally alter the trade-offs between cost and complexity and access to the higher standards of care that presently-available insulin pumps provide. By simplifying and streamlining the user experience from introduction, prescription, reimbursement, training and day-to-day use, we seek to expand the wearable insulin delivery device market beyond the highly motivated “super users” and expand the category into the mass market. The product seeks to serve both the type 1 and the rapidly growing, especially in terms of device adoption, type 2 diabetes markets. In January 2024, we submitted a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) for our MODD1 insulin pump, and, in September 2024, we received FDA clearance to market and sell our MODD1 pump in the United States. We are actively working to commercialize our MODD1 product and commence initial shipments in the first half of fiscal 2026, obtain regulatory clearance to market and sell our MODD1 product in foreign jurisdictions, improve the manufacturability and usability of our MODD1 product and develop new pump products.

Previous wording

Our research and development, or R&D, expenses include personnel, consulting, testing, materials and supplies, depreciation and amortization and other operational costs associated with the pre-FDA clearance production of our insulin pump product. We expense R&D costs as they are incurred.

Current wording

Our research and development, or R&D, expenses include personnel, consulting, testing, materials and supplies, depreciation and amortization and other operational costs associated with the pre-commercialization development and production of our insulin pump products. We expense R&D costs as they are incurred.

Previous wording

R&D expenses increased for the three months ended September 30, 2024 compared with the same period of 2023, primarily due to increased stock-based compensation expense of $0.5 million, employee-related costs of approximately $0.2 million and increased depreciation expense of approximately $0.2 million. These increases were partially offset by decreases of approximately $0.2 million in consulting expenses and $0.2 million in material costs.

Current wording

R&D expenses increased for the nine months ended December 31, 2024 compared with the same period of 2023, primarily due to increased employee-related costs of approximately $0.9 million, an increase in depreciation expense of approximately $0.5 million, an increase in travel-related and other costs of approximately $0.2 million and an increase in stock-based compensation costs of approximately $0.1 million. These increases were partially offset by decreases of approximately $0.6 million in consulting expenses and $0.1 million in material and supplies costs.

Previous wording

R&D expenses increased for the six months ended September 30, 2024 compared with the same period of 2023, primarily due to increased stock-based compensation costs of approximately $0.5 million, increased employee-related costs of approximately $0.4 million, an increase in depreciation expense of approximately $0.3 million and an increase in travel-related and other costs of approximately $0.1 million. These increases were partially offset by an approximately $0.3 million decrease in material and supplies costs. Our full-time R&D employee headcount increased to 42 at September 30, 2024 from 39 at September 30, 2023. R&D expenses included stock-based compensation expenses of approximately $0.8 million and $0.4 million for the three-months ended September 30, 2024 and 2023, respectively, and $1.2 million and $0.7 million for the six-month periods ended September 30, 2024 and 2023, respectively. We expect research and development expenses to increase in the second half of fiscal 2025, as we commence initial activities in support of commercialization of our MODD1 product.

Current wording

Our full-time R&D employee headcount increased to 44 at December 31, 2024 from 36 at December 31, 2023. R&D expenses included stock-based compensation expenses of approximately $0.3 million and $0.7 million for the three-months ended December 31, 2024 and 2023, respectively, and $1.5 million and $1.4 million for the nine-month periods ended December 31, 2024 and 2023, respectively. We expect research and development expenses to increase for the remainder of fiscal 2025 due to testing activities in support of commercialization of our MODD1 product and to advance development of new pump products.

Previous wording

General and administrative, or G&A, expenses consist primarily of personnel and related overhead costs for facilities, finance, human resources, legal, marketing and general management.

Current wording

General and administrative, or G&A, expenses consist primarily of personnel and related overhead costs for facilities, finance, human resources, legal, investor relations, marketing and general management.

Previous wording

G&A expenses increased for the six months ended September 30, 2024 compared with the same period of 2023, primarily as a result of an increase in legal and professional services expenses of approximately $0.3 million and stock-based compensation expense of approximately $0.1 million, partially offset by decreases in travel-related and other costs of $0.1 million. G&A expenses included stock-based compensation expenses of approximately $0.2 million for each of the three-month periods ended September 30, 2024 and 2023, and $0.4 million and $0.3 million for the six months ended September 30, 2024 and 2023, respectively. We expect G&A expenses to increase in the second half of fiscal 2025, as we commence initial activities in support of commercialization of our MODD1 product.

Current wording

G&A expenses decreased for the nine months ended December 31, 2024 compared with the same period of 2023, primarily as a result of a decrease in stock-based compensation expense of approximately $0.1 million, a decrease in marketing expenses of approximately $0.1 million, and a decrease in travel-related and other costs of approximately $0.2 million. The decreases were partially offset by an increase in legal and other professional service expenses of approximately $0.3 million.

Previous wording

We do not currently have revenues to generate cash flows to cover operating expenses. Since our inception, we have incurred operating losses and negative cash flows in each year due to costs incurred in connection with our operations. For the six months ended September 30, 2024 and year ended March 31, 2024, we incurred net losses of approximately $9.1 million and $17.5 million, respectively. At September 30, 2024, we had a cash balance of $3.9 million and an accumulated deficit of approximately $75 million. We expect to continue to incur operating losses for the foreseeable future and incur cash outflows from operations, as we continue to invest in the development and commercialization of our products. We expect that our expenses will continue to increase, and, as a result, we will eventually need to generate significant revenue to achieve profitability. When considered with our current operating plan, these conditions raise substantial doubt about our ability to continue as a going concern for a period of at least one year from the date that the financial statements included in Item 1 of this Report are issued. Our financial statements do not include adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Our operating needs include the planned costs to operate our business, including amounts required to fund continued research and development activities, working capital and capital expenditures. Our ability to continue as a going concern depends on our ability to raise additional capital, through the sale of equity or debt securities to support our future operations. During the three months ended March 31, 2024, we completed an offering of shares of common stock for net proceeds of approximately $10.3 million, which includes the proceeds from the underwriter’s exercise of the overallotment. In November 2023, we entered into a Sales Agreement (the “ATM Agreement”) with Leerink Partners LLC (“Leerink”) under which we may offer and sell, from time to time at our sole discretion, shares of our common stock (subject to availability on our shelf registration statement) through an “at the market offering” program under which Leerink will act as sales agent or principal. During the three months ended September 30, 2024, we sold 824,514 shares of common stock for net proceeds of approximately $1.9 million under the ATM Agreement. Subject to market conditions, we expect to resume sales under the ATM during the remainder of fiscal 2025, however, the potential net proceeds from such future sales are unknown. In addition, during the three months ended September 30, 2024, we received a total of approximately $0.8 million of proceeds from the exercise of common stock purchase warrants issued in a public offering we completed in May 2023. Our future capital requirements and the adequacy of our available funds will depend on many factors, including, without limitation, ou…

Excerpt shortened here; the source contains the full paragraph.

Current wording

We do not currently have revenues to generate cash flows to cover operating expenses. Since our inception, we have incurred operating losses and negative cash flows in each year due to costs incurred in connection with our operations. For the nine months ended December 31, 2024 and year ended March 31, 2024, we incurred net losses of approximately $13.9 million and $17.5 million, respectively. At December 31, 2024, we had a cash balance of $7.0 million and an accumulated deficit of approximately $80 million. We expect to continue to incur operating losses for the foreseeable future and incur cash outflows from operations, as we continue to invest in the development and commercialization of our pump products. We expect that our expenses will continue to increase, and, as a result, we will eventually need to generate significant revenue to achieve profitability. When considered with our current operating plan, these conditions raise substantial doubt about our ability to continue as a going concern for a period of at least one year from the date that the financial statements included in Item 1 of this Report are issued. Our financial statements do not include adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Our operating needs include the planned costs to operate our business, including amounts required to fund continued research and development activities, working capital and capital expenditures. Our ability to continue as a going concern depends on our ability to raise additional capital, through the sale of equity or debt securities to support our future operations.

Previous wording

For the six months ended September 30, 2024, we used approximately $7.3 million of cash in operating activities, which primarily resulted from our net loss of approximately $9.1 million and net changes in operating assets and liabilities of approximately $0.3 million, as adjusted forstock-based compensation expenses of approximately $1.6 million, depreciation and amortization expenses of approximately $0.5 million and other immaterial adjustments. For the six months ended six September 30, 2023, we used approximately $6.5 million in operating activities, which primarily resulted from our net loss of approximately $7.9 million and net changes in operating assets and liabilities of approximately $0.2 million, as adjusted forstock-based compensation expenses of approximately $1.0 million, net changes in operating assets and liabilities of approximately $0.2 million anddepreciation and amortization expenses of approximately $0.2 million.

Current wording

For the nine months ended December 31, 2024, we used approximately $11.4 million of cash in operating activities, which primarily resulted from our net loss of approximately $13.9 million and net changes in operating assets and liabilities of approximately $0.3 million, as adjusted forstock-based compensation expenses of approximately $2.0 million, depreciation and amortization expenses of approximately $0.7 million and other immaterial adjustments. For the nine months ended December 31, 2023, we used approximately $10.5 million in operating activities, which primarily resulted from our net loss of approximately $13.2 million and net changes in operating assets and liabilities of approximately $0.4 million, as adjusted forstock-based compensation expenses of approximately $2.0 million anddepreciation and amortization expenses of approximately $0.3 million and other immaterial adjustments.

Previous wording

For the six months ended September 30, 2024 and 2023, cash used in investing activities of approximately $1.0 million and$0.7 million, respectively, was for the purchase of property and equipment.

Current wording

For the nine months ended December 31, 2024 and 2023, cash used in investing activities of approximately $1.5 million and$1.2 million, respectively, was for the purchase of property and equipment.

Previous wording

Cash provided by financing activities of approximately $3.0 million for the six months ended September 30, 2024 was attributable to proceeds from the at-the-market sales of stock and exercise of common stock purchase warrants. Cash provided by financing activities of $9.7 million for the six months ended September 30, 2023 was attributable to net proceeds from the issuance of common stock and common stock purchase warrants in a public offering, net of underwriting fees and issuance costs.

Current wording

Cash provided by financing activities of approximately $10.7 million for the nine months ended December 31, 2024 was attributable to $7.3 million of proceeds from the issuance of common stock in a public offering, net of underwriting fees and issuance costs, which closed in November 2024, $2.1 million of proceeds from sales of our common stock under an at-the-market offering and $1.3 million of proceeds from exercises of common stock purchase warrants. Cash provided by financing activities for the nine months ended December 31, 2023 was attributable to $9.7 million of net proceeds from the issuance of common stock and warrants in a public offering, which closed in May 2023, and approximately $0.2 million of proceeds from the exercise of common stock purchase warrants.

Previous wording

Our primary purchase obligations include purchase orders for machinery and equipment. At September 30, 2024, we had outstanding purchase orders for machinery and equipment and related expenditures of approximately $1.0 million.

Current wording

Our primary purchase obligations include purchase orders for machinery and equipment. At December 31, 2024, we had outstanding purchase orders for machinery and equipment and related expenditures of approximately $1.1 million.

Previous wording

In December 2023, we signed a device integration agreement with a provider of connected-care and remote monitoring diabetes technology solutions. As of September 30, 2024, we had a remaining obligation under the device integration agreement of approximately $0.4 million over three years for technology license fees.

Current wording

In December 2023, we signed a device integration agreement with a provider of connected-care and remote monitoring diabetes technology solutions. As of December 31, 2024, we had a remaining obligation under the device integration agreement of approximately $0.4 million over three years for technology license and maintenance fees.