Senseonics Holdings Stock

Senseonics Holdings, Inc. operates as a medical technology company that focuses on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with long term implantable glucose management technology.

The company’s implantable CGM (Eversense), including 90-day Eversense, Eversense XL and Eversense E3 continuous glucose monitoring (CGM) system versions are designed to continually and accurately measure glucose levels in people with diabetes via an under-the-skin sensor, a removable and rechargeable smart transmitter, and a convenient app for real-time diabetes monitoring and management for a period of up to six months in the case of Eversense XL and Eversense E3, as compared to seven to 14 days for non-implantable CGM systems. The company affixed the CE mark to the original 90-day Eversense CGM system in June 2016, which marked the first certification for the product to be sold within the European Economic Area (being the European Union plus Norway, Iceland, and Liechtenstein) (EEA). Subsequently, the company affixed the CE mark to the extended life Eversense XL CGM system in September 2017 to be sold in select markets in Europe and the Middle East. In June 2022, the company affixed the CE mark to the extended life Eversense E3 CGM system and Ascensia began commercialization in select markets in Europe during the third quarter of 2022. In June 2018, the U.S. Food and Drug Administration (FDA), approved the 90-day Eversense CGM system for distribution throughout the United States. In June 2019, the company received FDA approval for the non-adjunctive indication (dosing claim) for the 90-day Eversense system. With this approval and the availability of a new app in December 2019, the Eversense system can be used as a therapeutic CGM in the United States to replace fingerstick blood glucose measurement to make treatment decisions, including insulin dosing. In February 2022, the 180-day extended life Eversense E3 CGM system was approved by the FDA and Ascensia Diabetes Care Holdings AG (Ascensia) began commercializing Eversense E3 in the United States in the second quarter of 2022.

In February 2020, the company announced that the FDA approved a subgroup of PROMISE trial participants to continue for a total of 365 days to gather feasibility data on the safety and accuracy of a 365-day sensor. This sub-set of 30 participants was left undisturbed for 365 days with the goal of measuring accuracy and longevity over the full 365 days. Information gathered from this sub-set and additional development efforts provided the company the confidence to start the Pivotal study for the Eversense 365-day System. The ENHANCE pivotal study for the Eversense 365-day system completed enrollment in the third quarter of 2022 and it expects to have data in the second half of 2023.

The company is in the early commercialization stages of the Eversense brand and are focused on driving awareness of its CGM system amongst people with diabetes and their healthcare providers. During 2020, the company initiated a new commercialization strategy and collaboration to bring its product to market. In August 2020, the company entered into a collaboration and commercialization agreement (Commercialization Agreement), with Ascensia pursuant to which it granted Ascensia the exclusive right to distribute its 90-day Eversense CGM system and 180-day Eversense E3 CGM system worldwide, with certain initial exceptions. While Ascensia is responsible for sales, marketing, market access, patient and provider onboarding and first level customer support, the company remains responsible for product development and manufacturing, including regulatory submissions, approvals, conformity assessment and requests for CE Certificates of Conformity and registrations and second level customer support.

2022 and Significant Recent Developments

In February 2022, the FDA approved the Eversense E3 CGM system for marketing and sale in the U.S. Ascensia has the exclusive right to distribute the company’s Eversense E3 system worldwide for people with diabetes. Ascensia began commercializing Eversense E3 in the U.S. during the second quarter of 2022. In June 2022, the company affixed the CE mark to the extended life Eversense E3 CGM system, and Ascensia began commercialization in all EEA markets during the third and fourth quarters of 2022.

In November 2022, the company announced a collaboration with the Nurse Practitioner Group (NPG) designed to expand U.S. patient access to the Eversense E3 System by providing additional convenient in-office and at-home sensor insertion options utilizing NPG’s broad network in over 30 states. Under the agreement between Senseonics and NPG, NPG providers will be certified to perform Eversense procedures in the specified geographies and will offer its services for patients who have been prescribed Eversense. Senseonics will initially assist NPG as they set up their Eversense procedure capabilities in select geographic areas.

Commercial Strategy

The company’s Eversense CGM systems are primarily sold through Ascensia globally. Ascensia sells its products directly to strategic fulfillment partners, who provide its Eversense CGM systems to healthcare providers and patients through a prescribed request and invoice insurance payors for reimbursement. Sales of the Eversense E3 CGM system and future models are widely dependent on the ability of patients to obtain coverage and adequate reimbursement from third-party payors or government agencies. Ascensia is leveraging and targeting regions where the company has coverage decisions for patient device use and provider insertion and removal procedure payment.

In the third quarter of 2020, the company announced the formation of a strategic partnership with Ascensia, pursuant to which Ascensia became the exclusive worldwide distribution partner for Senseonics CGM systems, including the 90-day Eversense, Eversense XL and future generations products, now including Eversense E3. In the fourth quarter of 2020, Ascensia initiated U.S. marketing and sales activities and full transition of commercial activities took place in the second quarter of 2021 and included full marketing, market access, sales, healthcare provider training and frontline patient and provider support responsibilities.

Sensor

The company has designed the sensor to last up to six months, as compared to other available CGM sensors labeled for use for between seven and 14 days.

The sensor consists of an optical system, known as a micro-fluorometer, encased in a rigid, translucent polymer capsule, which is 3.3 mm in diameter and 15 mm in length. The capsule is coated with a glucose-indicating hydrogel that is bound to the surface of the capsule through polymerization. This hydrogel is energized, or excited, by a light-emitting diode (LED), contained in the optical system of the sensor, causing the hydrogel to fluoresce, or glow.

Smart Transmitter

The removable smart transmitter is a rechargeable, external device that is worn over the sensor implantation site using a daily adhesive patch. The transmitter supplies wireless power to the sensor through an inductive NFC link, which activates a measurement sequence every five minutes. The transmitter then receives data from the sensor and calculates glucose concentrations and trends. Based on these calculations and on the user's individual settings for glucose levels, the transmitter determines if an alert condition exists, in which case the transmitter communicates the condition to the user through the mobile app and through on-body vibration. The information from the transmitter is also transmitted for display to the user's mobile device via Bluetooth Low-Energy (BLE). The company’s transmitter is functional for at least 24 hours following a full charge and can be fully charged in fifteen minutes.

Mobile App

The company’s mobile app is a software application that runs on both platforms; iOS mobile devices, including iPhones, iPads and Apple Watches, and Android mobile devices. The mobile app receives information from the transmitter via BLE and displays that information discreetly to the user. This user-friendly, intuitive app provides real-time glucose readings, alerts, trends, and graphs. Within the mobile app, users can set alerts based on, among other things, glucose levels. The mobile app also allows for cloud-based storage.

Future Product Development

The company intends to continue to expand its line of product offerings to benefit people with diabetes and healthcare providers.

The company focuses its future development efforts on enhancing current product offerings by reducing the once or twice daily calibrations towards a once per week calibration. The company’s next generation sensor under pivotal testing is designed to extend the sensor duration even longer at up to 365 days. The company is developing its Gemini product variation to allow for a 2-in-1 glucose monitoring system combining the functionality of CGM and Flash Glucose Monitoring, in an implantable sensor that may be utilized with a smart transmitter to get continuous glucose readings and alerts, or be utilized through a swipe over the sensor with a smart phone to get on-demand glucose reading without a smart transmitter. The company is also developing its Freedom product variation which would include an implantable battery and Bluetooth eliminating the on-body component.

Sales and Marketing

The company is in the early commercialization stages of Eversense and focuses on driving the awareness and adoption of its CGM system amongst intensively managed patients and their healthcare providers with its commercial partner Ascensia.

The company is a party to a commercialization agreement with Ascensia, pursuant to which it has granted Ascensia the exclusive right to distribute its 90-day Eversense CGM system and its six-month Eversense CGM system worldwide for use in people with diabetes, with certain exceptions. Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for the 90-day Eversense system on October 1, 2020 and Ascensia ramped up sales activities and assumed commercial responsibilities for the 90-day Eversense system during the second quarter of 2021. In February 2022, the extended life Eversense E3 CGM system was approved by the FDA and Ascensia began commercializing Eversense E3 in the United States in the second quarter of 2022. In anticipation of the launch, the company and Ascensia have been designing the go-to-market strategy for the U.S. six-month product.

As a result of its strategic partnership, Ascensia is responsible for sales, marketing, market access, patient and provider onboarding and level one customer support. The company has established a joint alliance committee and joint marketing committee, each with equal representation from each party, in order to collaborate.

In 2019, the company began its second phase of establishing a large network of Eversense proceduralists with the launch of the Certified Eversense Specialist (CES) network. This group of healthcare providers includes specialists who have strong familiarity with conducting in-office procedures such as dermatologists and plastic surgeons. The CES network offers an alternative for healthcare providers who want to prescribe Eversense for their patients but prefer to refer the procedure to a specialist. The company’s European experience and its feedback in the United States indicates healthcare providers highly value the accuracy and sensor duration of its CGM system and the majority of physicians surveyed considered the insertion process to be fairly simple or feasible.

Patents

As of December 31, 2022, the company held a total of approximately 500 issued patents and pending patent applications that relate to its CGM system. The company’s intellectual property portfolio includes 96 issued United States patents, 200 patents issued in countries outside the United States and 204 pending patent applications worldwide. The company’s patents expire between 2023 and 2042, subject to any patent term extensions or adjustments that may be available for such patents. If patents are issued on its pending patent applications, the resulting patents are projected to expire on dates ranging from 2032 to 2042, subject to any patent term extensions or adjustments that may be available for such patents. The company’s patents and patent applications cover certain aspects of its core sensor technologies and its product concepts for CGM systems.

Trademarks

The company has two pending U.S. trademark applications and five pending foreign trademark applications, as well as 12 U.S. trademark registrations and 129 foreign trademark registrations.

Research and Development Expenses

The company’s research and development expenses were $39.7 million for the year ended December 31, 2022.

Competition

The company competes with companies, some of which are publicly traded, which manufacture CGM systems, including Dexcom, Medtronic, and Abbott Diabetes Care (Abbott). In addition to CGM providers, the company competes with providers of self-monitoring of blood glucose (SMBG) systems. Three companies account for a substantial share of the worldwide sales of SMBG systems, including Roche Diabetes Care, a division of Roche Diagnostics International AG (Roche Diagnostics); Abbott; and Ascensia.

Government Regulation

The Eversense system is a medical device subject to extensive and ongoing regulation by the FDA, CMS, the European Union, competent authorities of the EEA countries, Notified Bodies and regulatory bodies in other countries. The company’s business is subject to federal, state, local, and foreign regulations, such as ISO 13485, ISO 14971, FDA's Quality System Regulation (QSR) contained in 21 CFR Part 820, and Directive 90/385/EEC concerning active implantable medical devices and, Regulation 2017/745 on Medical Devices, as amended.

Any devices the company manufactures and distributes pursuant to clearance or approval by the FDA are subject to pervasive and continuing regulation by the FDA and certain state agencies. These include product listing and establishment registration requirements, which help facilitate FDA inspections and other regulatory actions. As a medical device manufacturer, all of the company’s manufacturing facilities are subject to inspection on a routine basis by the FDA. The company is required to adhere to applicable regulations in cGMP requirements, as set in the QSR, which require, manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases of the design and manufacturing process.

History

Senseonics Holdings, Inc., a Delaware corporation, was founded in 1996.