Senseonics(US:SENS)2019-03-13 02:24Financial Data and Key Metrics Changes - For Q4 2018, the company generated $7.2 million in revenue, up from $2.9 million in the prior year period, attributed to increased sales of the Eversense system in Europe and incremental sales in the U.S. [38] - The total net loss for Q4 2018 was $7.3 million, or approximately $0.04 per share, compared to a net loss of $16.3 million, or $0.12 per share in Q4 2017 [41]. - Cash and cash equivalents as of December 31, 2018, were $136.8 million, with outstanding indebtedness of $67.7 million [42]. Business Line Data and Key Metrics Changes - Sales and marketing expenses increased by $7.9 million year-over-year to $10.3 million, primarily due to the build-out of the sales force in the U.S. [39]. - Research and development expenses decreased by approximately $300,000 year-over-year to $8.1 million, driven by the completion of activities associated with U.S. PMA approval for Eversense [40]. Market Data and Key Metrics Changes - The company reported a 167% year-over-year increase in new users in the OUS market, with sensor insertions increasing by 266% [34]. - The company aims to secure 100 million covered lives by the end of 2019, with current coverage at 16 million [17][22]. Company Strategy and Development Direction - The company is focused on expanding patient access to the Eversense system through initiatives like the Eversense patient access bridge program [12][14]. - The company is working to gain positive coverage decisions from payors to increase the conversion rate from patient interest to inserted sensors [13][19]. - The company is also enhancing its product pipeline, with a PMA supplement under review with the FDA to expand the label of the current product [26]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early physician and patient interest in Eversense, noting significant growth in the CGM market as patients seek advanced technologies [11]. - The company anticipates that investments in patient access programs will pay dividends in 2020 and beyond [16]. - Management acknowledged the complexities of the reimbursement process but remains committed to demonstrating the clinical benefits of Eversense [20][19]. Other Important Information - Dr. Fran Kaufman was welcomed as the new Chief Medical Officer, bringing extensive experience in clinical endocrinology and patient advocacy [8][9]. - The company has received positive coverage decisions from several payors, including Aetna and Blue Cross Blue Shield, and continues to work on expanding coverage [16]. Q&A Session Summary Question: Changes in the European business with the new Roche contract - Management noted that it is early days, but local countries are excited about the absence of overhang from the Roche agreement, and marketing campaigns are being developed [55]. Question: Details on the Bridge program - The Bridge program aims to facilitate patient access and support those whose insurance coverage is delayed, making it more achievable from a cost perspective [58][59]. Question: Key patient demographics in the U.S. - The company sees a broad base of patients attracted to Eversense, similar to Europe, with interest from both younger and older demographics [70][72]. Question: Time to get an HCP implant after training - The training process varies, but generally, physicians can become certified after inserting three patients, which takes about 90 days [79]. Question: Expectations for non-adjunctive claim and Medicare - Management expects to receive approval for the non-adjunctive claim by mid-year, which is crucial for discussions with Medicare [85]. Question: Role of Dr. Kaufman in the strategy - Dr. Kaufman is expected to play a key role in patient-centered strategies, product development, and working with payors [122][126]. Question: Logistics for centers adopting Eversense - Centers are integrating Eversense into their practices in various ways, including scheduling specific days for procedures and referring to general surgeons [128][130].