Senseonics Holdings, Inc. Reports First Quarter 2024 Financial Results
Senseonics Holdings, a medical technology firm specializing in long-term, implantable continuous glucose monitoring (CGM) systems, reported its Q1 2024 financial results.
The company achieved $5.1 million in revenue, a 22% increase compared to Q1 2023. However, gross profit declined to $0.3 million due to higher fixed manufacturing costs.
Notable achievements include the integration of Eversense CGM with Mercy health system, the FDA iCGM designation for Eversense, and the filing for the next-generation 365-day system.
Despite these advancements, the firm posted a net loss of $18.9 million, or $0.03 per share, significantly down from a $1.3 million net income in Q1 2023. First half 2024 revenue is projected at $10 million, a 16% growth year-over-year.
- Revenue increased by 22% to $5.1 million in Q1 2024 compared to Q1 2023.
- Eversense CGM received the FDA iCGM designation.
- Eversense CGM integrated into Mercy health system, serving 30,000 potential CGM users.
- Filed submission for next-generation 365-day Eversense system with the FDA.
- U.S. revenue increased to $3.7 million from $2.1 million year-over-year.
- Gross profit decreased to $0.3 million from $0.4 million year-over-year due to higher fixed manufacturing costs.
- Net loss of $18.9 million, or $0.03 per share, compared to net income of $1.3 million in Q1 2023.
- Research and development expenses decreased by $2.0 million to $10.4 million.
- Sales and marketing and general and administrative expenses increased by $0.4 million to $8.1 million.
- Revenue outside the U.S. decreased to $1.4 million from $2.0 million year-over-year.
Insights
The financial results for Senseonics Holdings show a 22% increase in revenue year-over-year, with
The U.S. revenue increase from
Despite the revenue growth, the increase in sales and marketing expenses and the completion of the ENHANCE trial influencing R&D costs reflect a strategic shift but also stress the financial management challenges. The financial outlook for the first half of 2024 remains cautiously optimistic, expecting
The advancements reported by Senseonics, particularly the integration of Eversense CGM and remote patient monitoring within the Mercy health care system, are significant. This move could enhance patient outcomes and reduce healthcare costs, positioning Senseonics favorably in the healthcare ecosystem. The iCGM designation for the Eversense System by the FDA is a notable achievement, marking it as the first fully implantable continuous glucose monitoring system that can be integrated with insulin pumps.
The filing of the 510(k) submission for the next-generation 365-day system further indicates a strong pipeline of innovative products. These developments not only solidify Senseonics' competitive edge but also open up new revenue streams by addressing a broader market of diabetes management solutions.
For retail investors, these advancements signal potential long-term growth opportunities, although the immediate financial metrics may overshadow these achievements.
Recent Highlights & Accomplishments:
-
Generated revenue of
$5.1 million 22% compared to the prior year period -
Announced integration of Eversense® CGM and the Eversense Remote Patient Monitoring (RPM) solution within
St. Louis -based Mercy health care system, a major healthcare provider serving three million patients annually, including 30,000 potential CGM users. The collaboration aims to enhance patient outcomes and reduce healthcare costs for users and is being designed as a model to aid health systems in managing large at-risk populations effectively and economically -
Received iCGM (integrated CGM) designation for the Eversense System from the
U.S , Food and Drug Administration, making Eversense the first fully implantable continuous glucose monitoring system that can now be integrated with insulin pumps as part of an automated insulin delivery system - Filed a 510(k) submission with the FDA for the next generation Eversense 365-day system for iCGM designation
“It has been a very productive start to the year for Senseonics as we continue to expand the features of Eversense to benefit more people with diabetes. The Eversense platform now sits in its strongest position ever, following receipt of the iCGM designation, the filing of our next-generation 365-day system with the FDA, and the announcements of our Eversense RPM and collaboration with Mercy,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “We are proud Eversense was chosen by one of the largest and most innovative health systems in the country to monitor risk and proactively treat both their type 1 and type 2 patients. Integrating the longest-lasting CGM into a diabetes population management program, we are confident that Eversense can help improve patient outcomes and lower the cost of care for the thousands of patients in the Mercy system who could benefit from CGM.”
First Quarter 2024 Results:
Total revenue for the first quarter of 2024 was
First quarter 2024 gross profit of
First quarter 2024 sales and marketing and general and administrative expenses increased by
First quarter 2024 research and development expenses decreased by
Net loss was
First Half 2024 Financial Outlook
Senseonics continues to expect first half of 2024 global net revenue to be
The Company plans to provide its full year financial outlook at an investor event to be scheduled during the upcoming American Diabetes Association Scientific Sessions on June 21-24, 2024 in
Conference Call and Webcast Information:
Company management will host a conference call at 4:30 pm (Eastern Time) today, May 13, 2024, to discuss these financial results and recent business developments. This conference call can be accessed live by telephone or through Senseonics' website.
Live Teleconference Information: Dial in number: 888-317-6003 Entry Number: 7182212 International dial in: 412-317-6061 |
Live Webcast Information: Visit http://www.senseonics.com and select the "Investor Relations" section |
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A replay of the call can be accessed on Senseonics' website http://www.senseonics.com under "Investor Relations."
About Senseonics
Senseonics Holdings, Inc. ("Senseonics") is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems, Eversense®, Eversense® XL and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for Senseonics, including the revenue projections under "First Half 2024 Financial Outlook," statements regarding the integration of the Eversense CGM and the Eversense RPM solution within the Mercy health care system, the adoption or growth of Eversense, and the potential to enhance patient outcomes and reduce healthcare costs, statements regarding Senseonics’ product pipeline, expected regulatory approvals and timing of the potential commercial launch of the 365-day product, statements regarding strengthening the Eversense® brand, and other statements containing the words "believe," “expect,” “intend,” “may,” “projects,” “will,” “planned,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the execution of the independent business unit of Ascensia Diabetes Care, the Company’s commercialization partner for Eversense, and other commercial initiatives, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development and registration of new technology and solutions, uncertainties inherent in finalizing integration and commercial terms with new partners and other third parties, uncertainties inherent in the ongoing commercialization of the Eversense product and the expansion of the Eversense product and a new RPM solution, uncertainties relating to the current economic environment and such other factors as are set forth in the risk factors detailed in Senseonics' Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 and Senseonics' other filings with the SEC under the heading "Risk Factors." In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.
Senseonics Holdings, Inc. |
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Condensed Consolidated Balance Sheets |
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(in thousands, except share and per share data) |
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March 31, |
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December 31, |
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2024 |
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2023 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
90,544 |
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$ |
75,709 |
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Restricted cash |
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|
316 |
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|
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— |
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Short term investments, net |
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8,169 |
|
|
|
33,747 |
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Accounts receivable, net |
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1,001 |
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|
808 |
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Accounts receivable, net - related parties |
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|
2,750 |
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3,724 |
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Inventory, net |
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|
7,963 |
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|
8,776 |
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Prepaid expenses and other current assets |
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|
7,434 |
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|
|
7,266 |
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Total current assets |
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118,177 |
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130,030 |
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Deposits and other assets |
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6,903 |
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|
7,006 |
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Property and equipment, net |
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1,436 |
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|
1,184 |
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Total assets |
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$ |
126,516 |
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$ |
138,220 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
675 |
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$ |
4,568 |
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Accrued expenses and other current liabilities |
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10,034 |
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|
11,744 |
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Accrued expenses and other current liabilities, related parties |
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1,071 |
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|
945 |
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Note payable, current portion, net |
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|
17,937 |
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— |
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Derivative liability, current portion |
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102 |
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— |
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Total current liabilities |
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29,819 |
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17,257 |
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Long-term debt and notes payables, net |
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33,965 |
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41,195 |
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Derivative liabilities |
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— |
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|
102 |
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Other liabilities |
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6,114 |
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6,214 |
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Total liabilities |
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69,898 |
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64,768 |
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Preferred stock and additional paid-in-capital, subject to possible redemption: |
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37,656 |
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37,656 |
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Total temporary equity |
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37,656 |
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37,656 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Common stock, |
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530 |
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530 |
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Additional paid-in capital |
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906,569 |
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904,535 |
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Accumulated other comprehensive loss |
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(2 |
) |
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(11 |
) |
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Accumulated deficit |
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(888,135 |
) |
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(869,258 |
) |
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Total stockholders’ equity |
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18,962 |
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35,796 |
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Total liabilities and stockholders’ equity |
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$ |
126,516 |
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$ |
138,220 |
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Senseonics Holdings, Inc. |
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Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) |
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(in thousands, except share and per share data) |
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Three Months Ended |
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March 31, |
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2024 |
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2023 |
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Revenue, net |
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$ |
589 |
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$ |
313 |
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Revenue, net - related parties |
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4,458 |
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3,824 |
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Total revenue |
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5,047 |
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4,137 |
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Cost of sales |
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4,712 |
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3,723 |
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Gross profit |
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335 |
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414 |
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Expenses: |
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Research and development expenses |
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10,438 |
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12,405 |
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Selling, general and administrative expenses |
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8,129 |
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7,718 |
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Operating loss |
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(18,232 |
) |
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(19,709 |
) |
Other (expense) income, net: |
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Interest income |
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1,384 |
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1,108 |
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Exchange related gain, net |
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— |
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18,776 |
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Interest expense |
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(2,047 |
) |
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(4,652 |
) |
Gain on change in fair value of derivatives |
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— |
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5,778 |
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Other income |
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18 |
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23 |
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Total other (expense) income, net |
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(645 |
) |
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21,033 |
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Net (Loss) Income |
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(18,877 |
) |
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|
1,324 |
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Other comprehensive income |
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Unrealized gain on marketable securities |
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9 |
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|
458 |
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Total other comprehensive gain |
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9 |
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|
458 |
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Total comprehensive (loss) income |
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$ |
(18,868 |
) |
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$ |
1,782 |
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Basic net (loss) income per common share |
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$ |
(0.03 |
) |
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$ |
0.00 |
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Basic weighted-average shares outstanding |
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614,588,546 |
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497,473,222 |
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Diluted net (loss) per common share |
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$ |
(0.03 |
) |
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$ |
0.00 |
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Diluted weighted-average shares outstanding |
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614,588,546 |
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|
540,532,813 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20240513223963/en/
Investor Contact
Philip Taylor
Gilmartin Group
415-937-5406
Investors@senseonics.com
Source: Senseonics Holdings, Inc.
FAQ
What were Senseonics Holdings' Q1 2024 revenues?
What was the net income or loss for Senseonics Holdings in Q1 2024?
How much did Senseonics Holdings' U.S. revenue increase in Q1 2024?
What were the major developments for Senseonics Holdings in Q1 2024?
What is Senseonics Holdings' revenue outlook for the first half of 2024?
Why did Senseonics Holdings' gross profit decline in Q1 2024?
What were Senseonics Holdings' research and development expenses in Q1 2024?
