Kaleo, Inc.

Kaleo, Inc., a for-profit pharmaceutical and medical-device manufacturer headquartered in Glen Allen, Virginia, supplies FDA-approved auto-injector devices and clinical development services to federal agencies as a prime contractor across all 28 recent awards, competing under full-and-open procurement without set-aside designation. The company specializes in life-saving auto-injector technologies — primarily naloxone, epinephrine, and pralidoxime chloride formulations — and operates as the sole prime on its federal footprint with no subcontractor role.

Kaleo's customer concentration is heavily weighted toward two large buyers. The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR/BARDA) anchors the dollar value with three awards totaling $379.2 million combined potential value, while the Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 12 accounts for the majority of award volume at 19 awards with $54.6 million combined potential value. The Department of the Army Joint Program Executive Office for Chemical and Biological Defense holds two awards worth $113.9 million combined potential value. These three customers account for 100% of combined potential value across all awards. The divergence between volume (VISN 12 leading at 19 awards) and dollars (ASPR/BARDA dominant at $379.2 million) reflects Kaleo's mix of high-value research and development contracts with ASPR and smaller supply orders through VA pharmaceutical schedules.

Kaleo's recent activity includes two blockbuster BARDA-funded contracts: a $340.9 million definitive contract awarded September 30, 2026, for late-stage clinical development, regulatory approval, and procurement of 2-PAM autoinjectors as a drug-device combination product for organophosphate poisoning under the Project BioShield Act, with ultimate completion December 31, 2034; and a $33.8 million cost-plus-fixed-fee contract awarded April 11, 2024, for pralidoxime chloride auto-injector device development extending through October 31, 2028. Kaleo also holds two Other Transaction IDVs under the Joint Program Executive Office for Chemical and Biological Defense: a $39.8 million multiple-award vehicle (Project 23-01 Autoinjector) awarded July 31, 2023, for autoinjector development and procurement including atropine formulations, and a $74.2 million multiple-award vehicle awarded August 15, 2022, for naloxone auto-injector 10-milligram device production. On the supply side, Kaleo sits on the Pharmaceuticals and Drugs Federal Supply Schedule (FSS-61-IB) with 13 task orders valued at $1.9 million combined potential value, primarily through VA procurement channels.

The portfolio shows uneven activity volume — one award in 2021, one in 2022, four in 2023, one in 2024, and one in 2026 — driven by the timing of large BARDA and DoD OTA awards rather than steady-state procurement. Combined potential value of $547.7 million contrasts with only $176.6 million obligated to date (32% of ceiling), reflecting the early-stage commitment posture on development contracts extending through 2034. SCI-reportable invoicing captures only a small slice of Kaleo's federal activity: $11.1 million across two prime service contracts in FY2024 and FY2025, with 4.2 FTEs delivered in FY2025 against government-paid median hourly rates around $728.87 per hour, spanning $416.73 at the 10th percentile through $1,041.01 at the 90th percentile for senior technical labor. Across SCI-reportable prime contracts, subcontractors account for roughly 27% of total contractor hours, with five named subcontractors supporting delivery. Kaleo's award portfolio concentrates on pharmaceutical preparation manufacturing (22 awards) and surgical-appliance manufacturing (2 awards) under NAICS 541714 and PSC 6505 (Drugs and Biologicals).

Kaleo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions. We believe patients and caregivers are the experts on how their medical condition impacts their lives and are an integral part of our product development process.