Senseonics Holdings Inc., a medical technology company focused on the development and commercialization of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, has announced the formation of a strategic partnership with Ascensia Diabetes Care (Ascensia), through a commercialization and collaboration agreement, which will make Ascensia the exclusive worldwide distributor of Senseonics’ Eversense CGM systems. The company also announced a concurrent financing agreement with PHC Holdings Corporation, the parent company of Ascensia. In addition, Senseonics also announced a financing agreement with Masters Special Situations, LLC and affiliates thereof (MSS). The financing arrangements collectively provide for a total of up to $80 million of debt and equity capital.
 
Ascensia Diabetes Care is a global diabetes care company that is dedicated to helping people living with diabetes. It is a leader in the blood glucose monitoring (BGM) market with its CONTOUR portfolio of devices that are known for their accuracy and ease of use. Ascensia markets its BGM devices in over 125 countries across the world. The Switzerland based company is owned by PHC Holdings Corporation, a KKR portfolio company.
 
Under the terms of the agreements, Ascensia will become the exclusive worldwide distribution partner for Senseonics’ CGM systems including Eversense, Eversense XL, and future generation products. In the United States, Ascensia will initiate marketing and sales activities in the coming months, with full responsibility and commercial ramp up expected in the first quarter of 2021. In the United States, the commercial efforts for the remainder of 2020 are intended to re-initiate marketing Eversense to drive new patient starts, as well as to prepare for the launch of the new 180-day Eversense product, if approved. In Europe, Ascensia will begin commercialization activities in select countries where Eversense XL has already launched, once any existing distribution relationships have concluded. These exclusive distribution rights are expected to last through 2025, with the exact timing dependent on factors including the launch dates for certain future generation products.
 
Ascensia’s parent company, PHC Holdings Corporation, will also provide up to $50 million to Senseonics through (i) the purchase of $35 million in aggregate principal amount of convertible debt securities and (ii) a commitment to purchase up to an additional $15 million in convertible preferred stock, at Senseonics’ option and contingent upon U.S. Food and Drug Administration approval of the 180-day Eversense sensor in the United States. Both organizations share a vision focused on providing technology to diabetes patients around the world to lessen the burden of disease management. With strong commitments to collaboration, Senseonics will enhance focus on advancing its pipeline of long-term implantable CGM solutions, while Ascensia will be responsible for sales, marketing, market access, patient and provider onboarding, and customer support.
 
“In line with our goal of ensuring the long-term success of Eversense in the marketplace, Ascensia has demonstrated a high level of commitment to our products that we expect will be beneficial for patients and healthcare providers for years to come,” said Francine Kaufman, M.D., chief medical officer of Senseonics.
 
“We are thrilled to be entering into this partnership with Senseonics and strongly believe in the value of the Eversense technology. They have highly accurate and effective products on the market and a pipeline of solutions that can address the needs of people with diabetes,” said Robert Schumm, president of Ascensia Diabetes Care. “We believe that the combination of our commercial expertise and infrastructure, alongside Senseonics’ focus on product development and manufacturing, will help to get the Eversense and Eversense XL products into the hands of people with diabetes who can benefit from them. Our aim is to work together to bring these highly effective technologies to more people with diabetes, therefore providing further choice in CGM for diabetes management.”
 
Collaboration and Commercialization Agreement
The collaboration and commercialization agreement is designed to drive adoption of the Eversense CGM systems and future product generations by combining the strengths of the two organizations. Incentives for penetration of the market are aligned through a mutually beneficial revenue sharing agreement. Senseonics will retain all product development, branding, regulatory approval and manufacturing responsibilities.
 
Ascensia will assume exclusive commercialization rights of Senseonics’ products for five years following U.S. availability of the 180-day Eversense product including the associated expenses, subject to extension in certain circumstances. Throughout 2020, Senseonics will lead a collaborative program for the Ascensia commercial team to receive field-based training and hands on experience supporting the current Eversense patient base as well as new patient and practice on-boarding. This creates the potential to increase the overall installed base later this year. Upon the launch of the 180-day product in the United States, if approved, Ascensia will assume full marketing, market access, sales, healthcare provider training, and frontline patient and provider support responsibilities. Ascensia has begun expanding its U.S. commercial organization and expects to be fully staffed by end of the first quarter 2021 in support of Eversense.
 
Financing Agreements
Senseonics has entered into an agreement to issue senior secured convertible notes to PHC Holdings Corporation in the amount of $35 million at a 9.5 percent interest rate that reduces to 8 percent if the Eversense 180-day system is approved in the United States, subject to certain conditions. The maturity date of the notes will be Oct. 31, 2024. The notes will be convertible into common stock at any time at an effective conversion premium of approximately 12.5 percent to the closing stock price on Aug. 7, 2020. Additionally, Senseonics has the option to issue convertible preferred stock to PHC Holdings Corporation in the aggregate purchase price of up to $15 million, following approval of the Eversense 180-day system in the United States, subject to stockholder approval.
 
The capital from these financings will be used to support product development initiatives, including the regulatory efforts for the Eversense 180-day system in the United States and the development of future generation products, as well as for supporting users in the United States.
 
In connection with the transactions described above, PHC Holdings Corporation will have the right to nominate two board members to the board and MSS will have the right to nominate one board member to the board, which board members are expected to join the board within 45 days.
 
“We are extremely excited to be partnering with Ascensia. Ascensia is well known for their CONTOUR products used by more than 10 million patients worldwide to help manage their diabetes. We believe their global commercial infrastructure and commitment to the Eversense systems will drive market adoption while allowing Senseonics to focus on further development of our implanted technology,” said Tim Goodnow, Ph.D., president and CEO of Senseonics.