Press release

Senseonics Holdings, Inc. Reports First Quarter 2024 Financial Results

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Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today reported financial results for the quarter ended March 31, 2024.

Recent Highlights & Accomplishments:

  • Generated revenue of $5.1 million in the first quarter of 2024, representing growth of 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 $5.1 million compared to $4.1 million for the first quarter of 2023. U.S. revenue was $3.7 million in the first quarter of 2024 compared to $2.1 million in the prior year period, and revenue outside the U.S. was $1.4 million in the first quarter of 2024 compared to $2.0 million in the prior year period.

First quarter 2024 gross profit of $0.3 million decreased from $0.4 million for the first quarter of 2023. The decrease in gross margin was primarily driven by an increase in fixed manufacturing costs compared to the prior year quarter.

First quarter 2024 sales and marketing and general and administrative expenses increased by $0.4 million year-over-year, to $8.1 million. The increase was primarily driven by costs related to marketing initiatives.

First quarter 2024 research and development expenses decreased by $2.0 million year-over-year, to $10.4 million. The decrease was primarily due to the completion of the ENHANCE pivotal trial.

Net loss was $18.9 million, or $0.03 per share, in the first quarter of 2024 compared to net income of $1.3 million, or $0.00 per share, in the first quarter of 2023. Net income decreased by $20.2 million due to the accounting for embedded derivatives, fair value adjustments and the exchange of a portion of the 2025 notes.

First Half 2024 Financial Outlook

Senseonics continues to expect first half of 2024 global net revenue to be $10 million, representing growth of approximately 16% compared to the first half of 2023.

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 Orlando, Florida.

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

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.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

March 31,

 

December 31,

 

 

 

2024

 

 

2023

 

 

 

 

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

90,544

 

 

$

75,709

 

 

Restricted cash

 

 

316

 

 

 

 

 

Short term investments, net

 

 

8,169

 

 

 

33,747

 

 

Accounts receivable, net

 

 

1,001

 

 

 

808

 

 

Accounts receivable, net – related parties

 

 

2,750

 

 

 

3,724

 

 

Inventory, net

 

 

7,963

 

 

 

8,776

 

 

Prepaid expenses and other current assets

 

 

7,434

 

 

 

7,266

 

 

Total current assets

 

 

118,177

 

 

 

130,030

 

 

 

 

 

 

 

 

 

 

Deposits and other assets

 

 

6,903

 

 

 

7,006

 

 

Property and equipment, net

 

 

1,436

 

 

 

1,184

 

 

Total assets

 

$

126,516

 

 

$

138,220

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

675

 

 

$

4,568

 

 

Accrued expenses and other current liabilities

 

 

10,034

 

 

 

11,744

 

 

Accrued expenses and other current liabilities, related parties

 

 

1,071

 

 

 

945

 

 

Note payable, current portion, net

 

 

17,937

 

 

 

 

 

Derivative liability, current portion

 

 

102

 

 

 

 

 

Total current liabilities

 

 

29,819

 

 

 

17,257

 

 

 

 

 

 

 

 

 

 

Long-term debt and notes payables, net

 

 

33,965

 

 

 

41,195

 

 

Derivative liabilities

 

 

 

 

 

102

 

 

Other liabilities

 

 

6,114

 

 

 

6,214

 

 

Total liabilities

 

 

69,898

 

 

 

64,768

 

 

 

 

 

 

 

 

 

 

Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 12,000 shares and 12,000 shares issued and outstanding as of March 31, 2024 and December 31, 2023

 

 

37,656

 

 

 

37,656

 

 

Total temporary equity

 

 

37,656

 

 

 

37,656

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

Common stock, $0.001 par value per share; 900,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 530,817,549 shares and 530,364,237 shares issued and outstanding as of March 31, 2024 and December 31, 2023

 

 

530

 

 

 

530

 

 

Additional paid-in capital

 

 

906,569

 

 

 

904,535

 

 

Accumulated other comprehensive loss

 

 

(2

)

 

 

(11

)

 

Accumulated deficit

 

 

(888,135

)

 

 

(869,258

)

 

Total stockholders’ equity

 

 

18,962

 

 

 

35,796

 

 

Total liabilities and stockholders’ equity

 

$

126,516

 

 

$

138,220

 

 

Senseonics Holdings, Inc.

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

March 31,

 

 

2024

 

 

2023

 

Revenue, net

 

$

589

 

 

$

313

 

Revenue, net – related parties

 

 

4,458

 

 

 

3,824

 

Total revenue

 

 

5,047

 

 

 

4,137

 

Cost of sales

 

 

4,712

 

 

 

3,723

 

Gross profit

 

 

335

 

 

 

414

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

Research and development expenses

 

 

10,438

 

 

 

12,405

 

Selling, general and administrative expenses

 

 

8,129

 

 

 

7,718

 

Operating loss

 

 

(18,232

)

 

 

(19,709

)

Other (expense) income, net:

 

 

 

 

 

 

Interest income

 

 

1,384

 

 

 

1,108

 

Exchange related gain, net

 

 

 

 

 

18,776

 

Interest expense

 

 

(2,047

)

 

 

(4,652

)

Gain on change in fair value of derivatives

 

 

 

 

 

5,778

 

Other income

 

 

18

 

 

 

23

 

Total other (expense) income, net

 

 

(645

)

 

 

21,033

 

 

 

 

 

 

 

 

Net (Loss) Income

 

 

(18,877

)

 

 

1,324

 

Other comprehensive income

 

 

 

 

 

 

Unrealized gain on marketable securities

 

 

9

 

 

 

458

 

Total other comprehensive gain

 

 

9

 

 

 

458

 

Total comprehensive (loss) income

 

$

(18,868

)

 

$

1,782

 

 

 

 

 

 

 

 

Basic net (loss) income per common share

 

$

(0.03

)

 

$

0.00

 

Basic weighted-average shares outstanding

 

 

614,588,546

 

 

 

497,473,222

 

 

 

 

 

 

 

 

Diluted net (loss) per common share

 

$

(0.03

)

 

$

0.00

 

Diluted weighted-average shares outstanding

 

 

614,588,546

 

 

 

540,532,813