Memorandum
Cellnovo provided its 4Q16 financial update earlier this week via press release. For the quarter, sales of the patch pump in current European markets (Italy, France, UK, Netherlands) totaled €363,153, reflecting modest 5% YOY growth vs. 4Q15 (€346,194). Sequentially, sales grew a stronger 21% from 3Q16. Cellnovo’s full year 2016 revenue more than doubled, growing 133% to ~€1.4 million. The company shipped 109 new pumps during the quarter, up from 68 in 3Q16 and bringing total shipments to 629 since launch. Continuing to scale pump shipments and sales is major priority, as cash is running thin: €10.7 million remains, enough for roughly two more quarters at the current burn rate of ~5 million euros per quarter. Cellnovo has been constrained as it switches over cartridge manufacturing to Flex, and full commercial production is expected to start in early 2Q17 (in line with the December update) – we’re not sure how much shipments are constrained right now relative to demand, but a sales uptick throughout 2017 would certainly help a lot on the fundraising front. As a reminder, a 51o(k) was submitted to FDA in November for the patch pump and touchscreen controller, though this was not even mentioned in this update (launch expected by the end of 2017, per 3Q16). Early last month, Cellnovo shared ambitious expectations that its artificial pancreas with Diabeloop will launch in Europe next year, which would be very fast movement indeed. Positive results from the first study of the Diabeloop algorithm (n=36 across 9 centers; 72 hours in hospital) will be presented at ATTD in under two weeks (abstracts here and here). Cellnovo and Diabeloop are also preparing for the next study (n=60; 12 centers; three months at home), slated to begin in February and reach primary completion in October.
-- by Brian Levine, Adam Brown, and Kelly Close