Senseonics Holdings Commercial Development of Eversense, Analysts Review and Target

Senseonics Holdings, Inc. (NYSE: SENS) is a medical technology company focused on the design, development, and commercialization of transformative glucose monitoring products designed to help people with diabetes confidently live their lives with ease. From its inception, Senseonics has been advancing the integration of novel, fluorescence sensor technology with smart wearable devices. The Eversense® CGM System received PMA approval from the FDA for up to 90 days of continuous use and is available in the United States. The Eversense® CGM XL System received CE mark for up to 180 days of continuous use and is available in Europe. 

On Nov. 08, 2018, the company announced its financial results for the quarter ended September 30, 2018 and provided an update on its operations and upcoming milestones.  At the end of the third quarter, SENS’ cash, cash equivalents, and marketable securities were $163 million. The company remained on track to achieve full-year 2018 revenue in the range of $19 million to $21 million.

From a market profile perspective, the overall Patient interest is growing rapidly, and the company is working with the healthcare providers on obtaining coverage and implementing Eversense into their practices to get these patients started on the product.

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Recent Achievements and Upcoming Milestones

  • Commercially launched Eversense in the U.S. and completed first commercial insertion
  • Announced positive coverage decision from Aetna, the third largest commercial health plan in the U.S. providing coverage for approximately 22 million lives
  • Received coverage from BCBS Minnesota for approximately 2.5 million lives
  • Received FDA approval for qualified health care providers – including nurse practitioners and physician assistants – to be trained and certified to provide patients with Eversense
  • Received FDA approval to begin the 180-day investigational device exemption (IDE) registration trial in the U.S.

The third quarter was a particularly exciting time for Senseonics with the U.S. launch of the Eversense system. Feedback from our first users has been exceptional across both patient and healthcare professional communities,” said Tim Goodnow, President and Chief Executive Officer of Senseonics. “As we look ahead, we are pleased with the early progress we are making to establish reimbursement and broaden patient and physician access to Eversense. Simultaneously, we are continuing to develop our clinical pipeline. We look forward to expanding our reach as we bring this life-changing technology to people with diabetes.

Analyst ratings and target price:

Per www.marketbeat.com, Their average twelve-month price target is $6.00, suggesting that the stock has a possible upside of 111.27%. The high price target for SENS is $7.00, and the low-price target for SENS is $5.00. There are currently one sell rating and six buy ratings for the stock, resulting in a consensus rating of “Buy.”

Below are the excerpts of recent analyst rating/Price targets on the company:

About Eversense

The Eversense® Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days. It is intended to complement, not replace, fingerstick blood glucose monitoring. A health care provider performs the sensor insertion and removal. 

Ease and Freedom with Eversense:

Market potential: High Growth Market

The desire for clinics to adopt Eversense and rejuvenate their practices has been encouragingly high. In the company’ early days in the field, Eversense is proving to be transformational to many of the stakeholders ranging from healthcare providers and patients to the payer community and is providing enormous opportunity for clinical and economic value in the diabetes market. The company have made significant progress in a short period of time and is well poised to increase access to its powerful technology for people with diabetes.

On January 3rd, the company announced that the extended life Eversense® XL sensor that lasts up to 180 days has been implanted in the first U.S. study participant as part of the clinical trial for pre-market application submission to the Food and Drug Administration.

The PROMISE Clinical Study is intended to evaluate the safety and efficacy of the Eversense CGM system in people with diabetes over a 180-day period. Approximately 180 study participants at up to 15 locations across the United States are planned to enroll in the study. The Eversense XL sensor previously received the CE Mark and is currently marketed to patients across the European Union.

Senseonics also announced that the company has completed its submission of PMA supplements to the FDA to secure an insulin dosing claim and to remove the contraindication related to the Magnetic Resonance Imaging (MRI) exposure on the 90-day system which is currently available in the United States.

Recent awards: On November 27, 2018, the company announced that it had been awarded one of Popular Science’s 2018 “Best of What’s New” Awards in the Health category.

Financial Results:

Revenue: Revenue was $5.2 million for the third quarter of 2018, compared to $3.6 million for the second quarter of 2018 and $2.1 million for the third quarter of 2017.

Profitability: Net loss was $31.9 million, or $0.18 per share, in the third quarter of 2018, compared to $17.4 million, or $0.13 per share, in the third quarter of 2017. This compares to a second-quarter 2018 net loss of $32.5 million, or $0.23 per share. This decrease in net loss compared to the second quarter of 2018 was driven primarily by a change in the fair value of the derivative liability. Excluding the change in fair value of the derivative liability, third quarter 2018 net loss would have been $24.4 million, or $0.14 per share. Third quarter 2018 net loss per share was based on 176.3 million weighted average shares outstanding, compared to 128.9 million weighted average shares outstanding in the third quarter of 2017.

Liquidity and financial flexibility: As of September 30, 2018, cash, cash equivalents, and marketable securities were $163.0 million, and outstanding indebtedness was $70.2 million.

Key Stock Influences:

  • The company’ ability to ramp up operations, along with healthy cash accrual and a stable working capital cycle could lead to a considerably rating revision.
  • SENS is still an early stage entity and has not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it.  
  • SENS has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.

Stock Chart:

  • On Friday, January 4th, 2019, SENS was at $2.83 on volume of 1.7M shares exchanging hands. Market capitalization is $502.254 million. The current RSI is 48.85
  • In the past 52 weeks, shares of SENS have traded as low as $2.41 and as high as $5.29
  • At $2.83, shares of SENS are trading below its 50-day moving average (MA) at $3.16 and below its 200-day MA at $3.63
  • The present support and resistance levels for the stock are at $2.75 & $2.97 respectively. 

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