Leslie Trigg
Analyst · Josh Jennings with Cowen. Your line is open, please go ahead
I'm back. Teamwork makes the dream work as they say. Thank you, Nabeel. Given that home counsels were a significant portion of our Q4 active backlog, we believe we are set up well for strong velocity and volume in 2022. Additionally, macro factors in the home setting remain overwhelmingly in our favor. As we announced on our last call, we are very pleased to have received a favorable decision for Tablo under the Tiffany's program following the submission of our application in the first quarter of 2021. As a reminder, Tiffany stands for the transitional add on payment adjustments for new and innovative equipment and supplies. Notably, CMS deem Tablo a substantial clinical improvement compared to the incumbent device, making it the first and only dialysis technology to benefit from this new CMS rule. The Tiffany's decision and the End Stage Renal Treatment Choices or ETC model provide additional tailwinds we believe our sales teams will capitalize on in 2022. Beyond our ability to drive revenue growth and build a foundation for the future, our team continues to make impressive progress on gross margin expansion, despite macro headwinds. We reached fourth quarter non-GAAP gross margin of 12%, which was in line with our expectations. We're very proud of our teams across the business and how they've effectively managed through the macro supply chain and sector volatility during the quarter and the year. On the supply chain and manufacturing side, our ongoing cost down initiatives and programs continue to work for us, which helped drive sequential reduction in the cost of our console. On the cartridge side, we achieved an important milestone in late November when the FDA granted 510(k) clearance for a new Tablo cartridge. This approval enables a second source to produce Tablo cartridges in Mexico with a new contract manufacturing partner in addition to our existing manufacturing partner in Southeast Asia. This clearance is an important milestone on our roadmap to continue gross margin expansion, as we expect previously elevated transportation and shipping costs to decrease as this new primary source of cartridge production in Mexico ramps up. Both this new stores and or other ongoing cost down initiatives are expected to contribute to long-term gross margin expansion. In addition to cost reduction, we believe this approval will better able -- will better enable us to optimize our manufacturing process and mitigate current supply chain challenges around lead-time, capacity, and logistics. In summary, we are very proud of our performance both in the fourth quarter and full year. Outset continues to deliver strong, consistent and predictable revenue growth and gross margin expansion. In addition, we successfully achieved the key 2021 strategic initiatives we communicated at the beginning of last year expansion within the acute setting, foundation building for expansion in the home setting, increasing manufacturing capacity and delivering cost reduction initiatives designed to enable sustainable and profitable financial growth. These accomplishments are a testament to our exceptional team, and the transformative technology we're delivering to reduce the dialysis burden for patients and all those who support them. As we look to 2022, we have clarity and conviction around the growth drivers that will continue to distinguish Outset Medical, namely, expanding our acute care business from the beachhead we established last year, inflecting the trajectory of our home business, and meaningfully expanding gross margins. I remain very confident in our growth trajectory and our promise to dialysis patients and providers that better begins now. Before we turn the call over to Nabeel, I'd like to share a story from our annual sales training meeting which was held last month. As we do at every sales meeting, we invited several patients and nephrologists to speak to our group. Melvin and his wife of 46 years Cleo were two such individuals who had an enormous impact on our team. Melvin is a veteran with end stage kidney disease and he served our country for 23 years in the Air Force, including on the team responsible for maintaining Air Force One. He was diagnosed in 2009 and began home dialysis in 2018 with a competitor system. Cleo told us that training was difficult and that there were "binders of information to assimilate and that it was quite overwhelming." So, when Melvin's nephrologist approached the couple with a new option in April of 2021, they were eager to try Tablo. Cleo told us, I simply cannot believe how much better Tablo is. Not only is disinfection easy, but setting up for treatment is so quick and simple to do. She said, Tablo walks you step-by-step through everything on the touch screen and you never feel like you're lost. She describes moving to Tablo as a night and day difference. Melvin said he likes all the time Tablo saves, time he and Cleo can spend doing more of the things they enjoy in retirement, including spending time with their four children and nine grandchildren. We love stories like this and look forward to sharing more of them as we continue to grow and further expand in the acute and home markets in 2022. And of course, none of the success we had last year would have been possible without the hard work and dedication to our mission carried out by everyone on the Outset team. And for that I want to close by thanking all of our employees for their extraordinary work. With that, I'll now turn the call over to Nabeel to review our financials and provide more granularity on our expectations and key drivers for 2022.