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Senseonics Holdings, Inc. Reports Third Quarter 2024 Financial Results

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Senseonics Holdings reported Q3 2024 financial results with total revenue of $4.3 million, down from $6.1 million in Q3 2023. The company announced FDA approval for Eversense 365, the world's first 365-day CGM system. Q3 net loss was $24.0 million ($0.04 per share). The company raised over $20 million from equity offerings and implemented restructuring targeting $10M cost reduction in 2025. Full-year 2024 global revenue guidance is approximately $22 million. Cash position stood at $74.8 million with $55.9 million in debt as of September 30, 2024.

Senseonics Holdings ha riportato i risultati finanziari del terzo trimestre 2024, con un fatturato totale di 4,3 milioni di dollari, in calo rispetto ai 6,1 milioni di dollari del terzo trimestre 2023. L'azienda ha annunciato l'approvazione della FDA per Eversense 365, il primo sistema CGM al mondo con una durata di 365 giorni. La perdita netta nel terzo trimestre è stata di 24,0 milioni di dollari (0,04 dollari per azione). L'azienda ha raccolto oltre 20 milioni di dollari tramite emissioni di capitale e ha implementato una ristrutturazione mirata a una riduzione dei costi di 10 milioni di dollari entro il 2025. La guida ai ricavi globali per l'intero anno 2024 è di circa 22 milioni di dollari. La posizione di cassa si attestava a 74,8 milioni di dollari con un debito di 55,9 milioni di dollari al 30 settembre 2024.

Senseonics Holdings reportó los resultados financieros del tercer trimestre de 2024, con ingresos totales de 4.3 millones de dólares, una disminución respecto a los 6.1 millones de dólares del tercer trimestre de 2023. La compañía anunció la aprobación de la FDA para Eversense 365, el primer sistema CGM del mundo con duración de 365 días. La pérdida neta del tercer trimestre fue de 24.0 millones de dólares (0.04 dólares por acción). La empresa recaudó más de 20 millones de dólares mediante ofertas de capital y llevó a cabo una reestructuración con el objetivo de reducir costos en 10 millones de dólares para 2025. La guía de ingresos globales para todo el año 2024 es de aproximadamente 22 millones de dólares. La posición de efectivo era de 74.8 millones de dólares con 55.9 millones de dólares en deuda al 30 de septiembre de 2024.

센소니콘스 홀딩스는 2024년 3분기 재무 결과를 보고하며 총 매출은 430만 달러로, 2023년 3분기의 610만 달러에서 감소했습니다. 이 회사는 Eversense 365에 대한 FDA 승인을 발표했으며, 이는 세계 최초의 365일 CGM 시스템입니다. 3분기 순손실은 2400만 달러였으며 (주당 0.04 달러) 회사는 자본 주식 발행을 통해 2000만 달러 이상을 모금하고 2025년까지 1000만 달러의 비용 절감을 목표로 한 구조조정을 시행했습니다. 2024년 전체 연도 글로벌 매출 안내는 약 2200만 달러입니다. 2024년 9월 30일 기준으로 현금 보유고는 7480만 달러이며, 부채는 5590만 달러입니다.

Senseonics Holdings a annoncé les résultats financiers du troisième trimestre 2024 avec un chiffre d'affaires total de 4,3 millions de dollars, en baisse par rapport à 6,1 millions de dollars au troisième trimestre 2023. L'entreprise a annoncé l'approbation de la FDA pour Eversense 365, le premier système CGM au monde d'une durée de 365 jours. La perte nette du troisième trimestre s'est élevée à 24,0 millions de dollars (0,04 dollar par action). L'entreprise a levé plus de 20 millions de dollars lors d'offres d'actions et a mis en œuvre une restructuration visant à réduire les coûts de 10 millions de dollars d'ici 2025. Les prévisions de chiffre d'affaires mondial pour l'année 2024 sont d'environ 22 millions de dollars. La position de liquidités était de 74,8 millions de dollars avec une dette de 55,9 millions de dollars au 30 septembre 2024.

Senseonics Holdings berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 mit einem Gesamtumsatz von 4,3 Millionen Dollar, ein Rückgang von 6,1 Millionen Dollar im dritten Quartal 2023. Das Unternehmen gab die FDA-Zulassung für Eversense 365 bekannt, das weltweit erste CGM-System mit einer Dauer von 365 Tagen. Der Nettoverlust im dritten Quartal betrug 24,0 Millionen Dollar (0,04 Dollar pro Aktie). Das Unternehmen hat über 20 Millionen Dollar aus Aktienangeboten gesammelt und eine Umstrukturierung umgesetzt, die eine Kostensenkung von 10 Millionen Dollar bis 2025 zum Ziel hat. Die globale Umsatzprognose für das Gesamtjahr 2024 liegt bei etwa 22 Millionen Dollar. Die Barposition betrug zum 30. September 2024 74,8 Millionen Dollar bei einem Schuldenstand von 55,9 Millionen Dollar.

Positive
  • FDA approval received for Eversense 365 as first 365-day CGM system
  • Raised over $20 million from equity offerings
  • Implemented restructuring with $10M cost reduction target for 2025
  • Research and development expenses decreased by $2.3 million year-over-year
Negative
  • Q3 revenue declined 29.5% to $4.3M from $6.1M year-over-year
  • Q3 gross loss of $4.1M compared to $1.2M gross profit in Q3 2023
  • Sales and marketing expenses increased by $0.9M year-over-year
  • Net loss of $24.0M in Q3 2024
  • Outstanding indebtedness of $55.9M

GERMANTOWN, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2024.

Recent Highlights & Accomplishments:

  • Eversense® 365 approved in the US as an integrated continuous glucose monitoring (iCGM) system for people with Type 1 and Type 2 diabetes
  • Commercialization, now in process, driven by Senseonics’ global commercial partner, Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation
  • Mercy health system inserted the first commercial Eversense 365 patient and anticipates that up to 30,000 of Mercy’s patients could benefit from a CGM system
  • Hosted KOL webinar on October 25th, highlighting clinicians’ perspectives on Eversense 365 and Mercy collaboration as a case study for other cost-conscious health systems
  • Acquired sensor insertion network assets of NPG to begin transitioning nurse practitioners to Eon Care business in order to support greater patient access and convenience
  • Raised gross proceeds of more than $20 million from equity offerings to strengthen the balance sheet and extend cash runway
  • Executed a restructuring process with a target cash operating expense reduction of $10M in 2025
  • Generated global revenue of $4.3 million in the third quarter and began U.S. winddown of Eversense E3 to prepare transition to Eversense 365

“We received FDA approval for Eversense 365 in the third quarter, and Mercy completed the first commercial patient insertion of our new sensor last month. This marks a significant achievement for Senseonics and establishes us as the world’s first and only 365-day CGM,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “In the first week after approval, we received the highest influx of inquiries in Senseonics’ history, and early feedback from clinicians has been extremely positive. While we are still in the early days of the launch, we are encouraged by the higher than expected number of healthcare provider leads and inbound interest from KOLs. Further, the recent financings and anticipated savings from restructuring lengthen our runway. Together, these accomplishments position us well for a transformational 2025.”

Brian Hansen, President of CGM at Ascensia Diabetes Care, remarked, “Ascensia is strongly committed to providing customers with products that meet the highest standards of accuracy, precision, and reliability. Eversense 365 meets those criteria and provides a truly unique solution for patients with Type 1 and Type 2 diabetes. For our sales team, it’s easy to explain 365’s key points of differentiation- One year, One CGM. Removable transmitter with once a week calibration. We are working hand in hand with Senseonics management to ensure a successful launch of Eversense 365, and we are thrilled to see such strong early enthusiasm for this innovative and differentiated technology.”

Third Quarter 2024 Results:

Total revenue for the third quarter of 2024 was $4.3 million compared to $6.1 million for the third quarter of 2023. U.S. revenue was $2.4 million in the third quarter of 2024 compared to $3.9 million in the prior year period, and revenue outside the U.S. was $1.9 million in the third quarter of 2024 compared to $2.2 million in the prior year period. During the third quarter, inventory dynamics associated with the 365-day product launch impacted product sales, as we began reducing E3 inventory in anticipation of transition to 365-day insertions.

Third quarter 2024 gross loss of $4.1 million compared to gross profit of $1.2 million for the third quarter of 2023. The decrease in gross profit was primarily driven by one time charges of $4.8 million associated with the transition from Eversense E3 to Eversense 365.

Third quarter 2024 sales and marketing and general and administrative expenses increased by $0.9 million year-over-year, to $8.3 million. The increase was primarily driven by personnel and consultant costs.

Third quarter 2024 research and development expenses decreased by $2.3 million year-over-year, to $10.5 million. The decrease was primarily due to a reduction in clinical studies and support services.

Net loss was $24.0 million, or $0.04 per share, in the third quarter of 2024 compared to net loss of $24.1 million, or $0.04 per share, in the third quarter of 2023. Net loss decreased by $0.1 million due to lower research and development expenses offset by one-time charges associated with the transition from Eversense E3 to Eversense 365.

Cash, cash equivalents, restricted cash and short-term investments were $74.8 million and outstanding indebtedness was $55.9 million as of September 30, 2024. Subsequent to the end of the third quarter of 2024, Senseonics received gross proceeds of $16.0 million from a recent financing.

Full Year 2024 Financial Outlook

Senseonics expects full-year 2024 global net revenue to be approximately $22 million as we begin to transition U.S. patients to Eversense 365 following approval in late Q3. The full-year 2024 financial outlook assumes more than doubling the U.S. new patient starts and increasing the global installed base by approximately 50% in 2024 compared to 2023. During the third quarter, inventory dynamics associated with the 365-day product launch impacted product sales, as we began reducing E3 inventory in anticipation of transition to 365-day insertions. Sales are expected to accelerate in the fourth quarter based on anticipated initial 365-day product demand and the initial ramp of the Mercy collaboration. Cash utilization in 2024 is expected to be consistent with 2023 at approximately $70 million.

Conference Call and Webcast Information:

Company management will host a conference call at 4:30 pm (Eastern Time) today, November 7, 2024, to discuss these financial results and recent business developments. Investors interested in listening to the conference call may do so by accessing a live and archived webcast of the event at this link. Individuals interested in participating in the call via telephone may access the call by dialing +1-800-445-7795 (+1-203-518-9856 for those outside the U.S.) and referencing Conference ID SENSQ3. 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® 365 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.

About Eversense
The Eversense® Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to 365 days for Eversense® 365 and 180 days for Eversense® E3 in persons with diabetes age 18 and older. The systems are indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time per week after day 14 for Eversense® 365 and one time per day after day 21 for Eversense® E3, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM Systems are prescription devices; patients should talk to their health care provider to learn more. For important safety information, see https://www.eversensediabetes.com/safety-info/.

About Ascensia Diabetes Care
Ascensia Diabetes Care is a global company focused entirely on helping people with diabetes. Our mission is to empower those living with diabetes through innovative solutions that simplify and improve their lives.

We are home to the world-renowned CONTOUR® portfolio of blood glucose monitoring systems and the exclusive global distribution partner for the Eversense® Continuous Glucose Monitoring Systems from Senseonics. These products combine advanced technology with user-friendly functionality to help people with diabetes manage their condition and make a positive difference to their lives. As a trusted partner in the diabetes community, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy, precision and reliability, and that we conduct our business compliantly and with integrity.

Ascensia is a member of PHC Group and was established in 2016 through the acquisition of Bayer Diabetes Care by PHC Holdings Corporation. Ascensia products are sold in more than 100 countries. Ascensia has around 1,400 employees and operations in 29 countries.

For further information, please visit the Ascensia Diabetes Care website at: http://www.ascensia.com.

About PHC Holdings Corporation
PHC Holdings Corporation (TSE 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Ascensia Diabetes Care Holdings AG, Epredia Holdings Ltd., LSI Medience Corporation, Mediford Corporation, and Wemex. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences and diagnostics. PHC Group’s consolidated net sales in FY2023 were JPY 353.9 billion with global distribution of products and services in more than 125 countries. www.phchd.com

©2024 Ascensia Diabetes Care Holdings AG. All right reserved. Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.

About Mercy
Mercy, one of the 20 largest U.S. health systems and named the top large system in the U.S. for excellent patient experience by NRC Health, serves millions annually with nationally recognized care and one of the nation’s largest and highest performing Accountable Care Organizations in quality and cost. Mercy is a highly integrated, multi-state health care system including more than 50 acute care and specialty (heart, children’s, orthopedic and rehab) hospitals, convenient and urgent care locations, imaging centers and pharmacies. Mercy has over 900 physician practice locations and outpatient facilities, more than 4,500 physicians and advanced practitioners and 50,000 co-workers serving patients and families across Arkansas, Kansas, Missouri and Oklahoma. Mercy also has clinics, outpatient services and outreach ministries in Arkansas, Louisiana, Mississippi and Texas. In fiscal year 2023 alone, Mercy provided more than half a billion dollars of free care and other community benefits, including traditional charity care and unreimbursed Medicaid.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics, including the revenue and cash projections, assumptions related to U.S. new patient starts and the global installed base under the heading “Full Year 2024 Financial Outlook,” statements regarding plans, timing and success of the commercial launch of the 365-day system, statements regarding increasing patient access and convenience, statements regarding potential users of CGM at health systems, statements regarding the attributes experienced by people with diabetes and differentiating the system from short-term CGM, statements regarding the integration of the Eversense CGM solution within the Mercy health care system and the adoption and/or growth of Eversense, 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 and roll-out of new technology and solutions, uncertainties inherent in finalizing integration and commercial terms and coordinations with health systems and other new collaboration partners and third parties, uncertainties inherent in the ongoing commercialization of the Eversense product and the expansion of the Eversense product and Senseonics’ activities, uncertainties relating to the current economic environment and such other factors as are set forth in the risk factors detailed in Senseonics' Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent quarterly reports on Form 10-Q filed 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 Investor Contact

Jeremy Feffer
LifeSci Advisors
investors@senseonics.com

      
Senseonics Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
      
 September 30,  December 31, 
 2024  2023 
  (unaudited)   
      
Assets     
Current assets:     
Cash and cash equivalents$27,106  $75,709 
Restricted cash 315    
Short term investments, net 47,375   33,747 
Accounts receivable, net 1,523   808 
Accounts receivable, net - related parties 2,507   3,724 
Inventory, net 3,207   8,776 
Prepaid expenses and other current assets 5,665   7,266 
Total current assets 87,698   130,030 
      
Deposits and other assets 5,209   7,006 
Property and equipment, net 3,424   1,184 
Total assets$96,331  $138,220 
Liabilities and Stockholders’ (Deficit) Equity     
Current liabilities:     
Accounts payable$2,107  $4,568 
Accrued expenses and other current liabilities 12,578   11,744 
Accrued expenses and other current liabilities, related parties 1,448   945 
Notes payable, current portion, net 19,376    
Total current liabilities 35,509   17,257 
      
Long-term debt and notes payables, net 34,448   41,195 
Derivative liabilities    102 
Other liabilities 5,899   6,214 
Total liabilities 75,856   64,768 
      
Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 12,000 shares authorized and 12,000 shares issued and outstanding as of September 30, 2024 and December 31, 2023 37,656   37,656 
Total temporary equity 37,656   37,656 
      
Commitments and contingencies     
      
Stockholders’ (deficit) equity:     
Common stock, $0.001 par value per share; 1,400,000,000 shares and 900,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 545,612,780 shares and 530,364,237 shares issued and outstanding as of September 30, 2024 and December 31, 2023 546   530 
Additional paid-in capital 914,637   904,535 
Accumulated other comprehensive income (loss) 34   (11)
Accumulated deficit (932,398)  (869,258)
Total stockholders’ (deficit) equity (17,181)  35,796 
Total liabilities and stockholders’ equity$96,331  $138,220 
        
        


            
Senseonics Holdings, Inc.
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
            
 Three Months Ended  Nine Months Ended
 September 30,  September 30, 
 2024  2023  2024  2023 
Revenue, net$955  $426  $2,322  $1,176 
Revenue, net - related parties 3,308   5,671   11,853   13,184 
Total revenue 4,263   6,097   14,175   14,360 
Cost of sales 8,314   4,925   17,593   12,358 
Gross (loss) profit (4,051)  1,172   (3,418)  2,002 
            
Expenses:           
Research and development expenses 10,546   12,769   31,784   38,003 
Selling, general and administrative expenses 8,250   7,425   25,369   22,598 
Operating loss (22,847)  (19,022)  (60,571)  (58,599)
Other (expense) income, net:           
Interest income 1,010   1,460   3,584   3,879 
Exchange related (loss) gain, net    (4,569)     14,207 
Interest expense (2,133)  (2,425)  (6,266)  (9,388)
Gain on change in fair value of derivatives    438   102   6,505 
Other (expense) income (6)  15   11   194 
Total other (expense) income, net (1,129)  (5,081)  (2,569)  15,397 
            
Net Loss (23,976)  (24,103)  (63,140)  (43,202)
Other comprehensive loss           
Unrealized gain on marketable securities 41   61   45   619 
Other comprehensive gain 41   61   45   619 
Total comprehensive loss$(23,935) $(24,042) $(63,095) $(42,583)
            
Basic net loss per common share$(0.04) $(0.04) $(0.10) $(0.08)
Basic weighted-average shares outstanding 620,897,955   592,452,262   617,370,311   552,703,546 
            
Diluted net loss per common share$(0.04) $(0.04) $(0.10) $(0.08)
Diluted weighted-average shares outstanding 620,897,955   592,452,262   617,370,311   552,703,546 

FAQ

What was Senseonics (SENS) revenue in Q3 2024?

Senseonics reported total revenue of $4.3 million in Q3 2024, with $2.4 million from U.S. and $1.9 million from international markets.

What is Senseonics (SENS) full-year 2024 revenue guidance?

Senseonics expects full-year 2024 global net revenue to be approximately $22 million.

When did Senseonics (SENS) receive FDA approval for Eversense 365?

Senseonics received FDA approval for Eversense 365 in the third quarter of 2024.

How much cash does Senseonics (SENS) have as of Q3 2024?

Senseonics had $74.8 million in cash, cash equivalents, restricted cash and short-term investments as of September 30, 2024.

Senseonics Holdings, Inc.

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189.11M
556.26M
6.35%
10.05%
8.05%
Medical Devices
Industrial Instruments for Measurement, Display, and Control
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GERMANTOWN