After U.S. markets closed Wednesday afternoon, medical technology company Outset Medical Inc. (OM:NASDAQ), maker of the Tablo® mobile dialysis machine that allows providers to access a single wheeled platform from the hospital to the home, announced financial results for the fourth quarter and full year of 2021 ended Dec. 31, 2021.
The company led off the report by advising that the firm's President and Chief Executive Officer Leslie Trigg has been appointed Chair of Outset Medical's Board of Directors.
Outset Medical reported that in Q4/21 net revenue increased by 63.2% to $28.2 million, up from $17.2 million in Q4/20. The company noted that in Q4/21 it saw significant improvement in its gross margin to 11.8%, versus 2.4% in Q4/20.
The firm stated that product revenues in Q4/21 rose by 79.5% to $23.7 million, compared to $13.2 million in Q4/20. Over the same period, service and other revenue increased 10.6% to $4.5 million, up from $4.1 million in the prior year's corresponding quarter.
The company reported that during Q4/21, it recorded a net loss of $41.2 million, or a net loss of $0.87 per share, compared to net loss of $32.0 million, or a net loss of $0.75 per share in Q4/20.
The firm mentioned that it was successful in signing agreements with seven of the eight largest national health systems as well as with one-third of the nation's top 100 regional health systems.
The company advised that it received clearance from the U.S. Food and Drug Administration (FDA) to produce its Tablo® Hemodialysis System cartridge in Mexico.
Importantly, Outset Medical indicated that "it received the first-ever approval for the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) program from the Centers for Medicare & Medicaid Services (CMS), which deemed Tablo® a substantial clinical improvement over the incumbent home hemodialysis device."
Trigg stated, "Our entire team contributed to an exceptional 2021, driving record revenue growth, meaningful progress toward our long-term gross margin goal and excellent visibility into 2022. … Our established relationships with seven of the eight largest national health systems and one third of the largest 100 regional health systems puts us in a strong position for growth this year in both the acute and home settings."
Keith Grossman, lead independent director at Outset Medical, commented, "On behalf of the Outset Board of Directors, I am pleased to announce Leslie's appointment to the additional role of Board Chair. … We look forward to continuing to support Leslie and the entire team as Outset continues to transform the dialysis industry."
The company indicated that revenue in FY/21 increased by 105.5% to $102.6 million, compared to $49.9 million in FY/20. The firm listed that product revenue in FY/21 rose 112.8% to $84.3 million, up from $39.6 million in FY/20 and service and other revenue increased by 77.2% to $18.3 million, versus $10.3 million in the prior year.
Outset Medical advised that in FY/21 it registered a net loss attributable to common stockholders of $131.9 million, or a net loss of $2.89 per share, compared to a net loss $79.3 million, or a net loss of $4.85 per share in FY/20.
The company offered some forward guidance and stated that for FY/22 it expects revenue will be in the range of $142 million to $150 million, which represents about a 38% to 46% increase over FY/21 revenue levels.
Outset Medical is a medical technology firm based in San Jose, Calif., that focuses on mobile integrated hemodialysis solutions for acute and at home hemodialysis therapy. The company stated it incorporates "first-of-its-kind technology to reduce the cost and complexity of dialysis." The company's Tablo® Hemodialysis System allows patients to receive dialysis treatment at hospitals and medical facilities or at home. The firm said it has made significant technological advancements that simplifies the dialysis process for medical providers and patients alike and makes dialysis treatment available anytime, anywhere, by anyone.
The company explained that "the integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with two-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care."
Outset Medical started Thursday with a market cap of around $1.6 billion with approximately 47.09 million shares outstanding and a short interest of about 12.5%. OM shares opened 4.5% higher today at $35.78 (+$1.56, +4.56%) over Wednesday's $34.22 closing price. The stock traded Thursday between $35.78 and $39.83 per share and is currently trading at $39.46 (+$5.24, +15.31%).
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