Logistics and Services - Cryoport has supported over 400 clinical trials in the regenerative medicine space and has logged over 260,000 shipments to over 100 countries[217]. - The company recently added bioservices to its portfolio through the acquisition of Cryogene, expanding its temperature-controlled sample management solutions[212]. - Cryoport's Cryoportal Logistics Management Platform provides near real-time shipment tracking and regulatory compliance documentation[199]. - The company offers a range of Cryoport Express Shippers, including those that operate at temperatures as low as -150°C, meeting IATA and ISTA certification standards[200]. - Cryoport's solutions are designed to minimize risk and maximize success for clients introducing new biologics into global markets[196]. - The company has established a competitive advantage with its first-to-market logistics services and over a decade of experience in the life sciences industry[213]. - Cryoport's "powered by cryoport" partnerships allow clients to offer branded cryogenic logistics solutions, enhancing service offerings[210]. - Cryoport's advanced technologies enable comprehensive logistics solutions for personalized and allogeneic therapies, ensuring chain of custody and compliance[202][203]. - The company continuously evaluates and expands its service offerings in response to market needs and client demand[211]. - Cryoport has established strategic distribution alliances globally under the "powered by Cryoport" strategy, focusing on logistics services for the life sciences industry[221]. - The Cryoportal Logistics Management Platform automates order entry and logistics operations, reducing administrative costs and enhancing customer service[240]. - Cryoport's integrated solutions are designed to minimize risks in the biopharma supply chain, ensuring the efficacy of cell and gene therapies[224]. - The Cryoportal Logistics Management Platform is a "carrier-agnostic" system integrated with tracking systems of FedEx, DHL, and UPS to enhance operational efficiencies[242]. - Cryoport's Chain of Compliance™ solution offers comprehensive traceability of logistics processes, equipment, and third-party support, minimizing risks in the supply chain[260]. - The company has validated shipping lanes in over 100 countries, ensuring secure and timely deliveries of life sciences materials[268]. - Cryoport Consulting assists life sciences companies in developing strategies for global cold chain logistics management, addressing the growing demand for temperature-sensitive therapies[269]. - Ongoing research and development efforts aim to advance technology applications for temperature-controlled logistics and enhance the functionality of the Cryoportal Logistics Management Platform[270]. Market Trends and Growth Potential - The global cold chain logistics market for life sciences is projected to grow from $15.0 billion in 2018 to $18.6 billion by 2022, representing a 24% increase[233]. - The FDA predicts it will approve 10 to 20 cell and gene therapy products annually by 2025, highlighting the growth potential in regenerative medicine[231]. - Cryoport's logistics solutions support the management of clinical trials, with over 932 regenerative medicine companies conducting 1,069 clinical trials globally[231]. - The three largest integrators, FedEx, DHL, and UPS, collectively operate over 87% of express logistics aircraft, expanding their temperature-controlled offerings for the life sciences sector[222]. Financial Performance - Revenues increased by $4.3 million or 81.3% to $9.6 million for the three months ended September 30, 2019, compared to $5.3 million for the same period in 2018[273]. - Biopharmaceutical revenue rose by $3.0 million or 66.8% to $7.5 million for the three months ended September 30, 2019, driven by increased customer utilization and clinical trials[274]. - The number of clinical trials supported increased to 425, up from 323 in the same period last year, with 18 new biopharma clients added[274]. - Gross margin for the three months ended September 30, 2019, was 48.3%, down from 51.8% in the same period in 2018, primarily due to increased operating costs[276]. - General and administrative expenses surged by $6.8 million or 258.8% to $9.4 million, largely due to stock-based compensation related to financial targets[277]. - Sales and marketing expenses increased by $4.1 million or 227.5%, driven by stock-based compensation and expansion of the logistics workforce[278]. - Engineering and development expenses rose by $1.2 million or 254.0%, reflecting increased stock-based compensation and hiring of new personnel[279]. - Cost of revenues increased by $2.4 million or 94.4% to $5.0 million, primarily due to higher freight charges and operating costs[276]. - Global Bioservices revenue was $1.2 million for the third quarter of 2019, attributed to the Cryogene acquisition[274]. - The company supports 54 Phase III clinical trials as of September 30, 2019, an increase from 46 trials in the same period last year[274]. - Revenues increased by $10.8 million or 77.2% to $24.7 million for the nine months ended September 30, 2019, compared to $13.9 million for the same period in 2018[282]. - Biopharmaceutical revenue rose by $8.5 million or 72.9% to $20.1 million, driven by increased commercial revenue and the addition of 69 new biopharma clients[282]. - Gross margin decreased to 50.3% of revenues for the nine months ended September 30, 2019, down from 53.3% in the same period in 2018[284]. - General and administrative expenses increased by $8.0 million or 108.6% to $15.3 million, primarily due to increased stock-based compensation and employee costs[285]. - Sales and marketing expenses rose by $6.0 million or 113.3% to $11.2 million, attributed to higher stock-based compensation and increased employee costs[286]. - Engineering and development expenses increased by $1.4 million or 115.1% to $2.7 million, mainly due to stock-based compensation and additional staffing[287]. - Net loss for the nine months ended September 30, 2019, was $17.4 million, compared to a net loss of $7.3 million in the same period in 2018[282]. - Cash and cash equivalents as of September 30, 2019, totaled $44.6 million, with $48.9 million in short-term investments[291]. - Net cash used in investing activities was $63.9 million, primarily due to the acquisition of the Cryogene business for $20.4 million[293]. - Net cash provided by financing activities totaled $73.1 million, mainly from a public offering that generated $68.8 million in net proceeds[294]. Product and Technology Innovations - Cryoport's Express Shippers can maintain cryogenic temperatures of -150℃ or below for over 10 days, ensuring safe transport of temperature-sensitive biological materials[245]. - The Cryoport Express C3™ Shippers maintain a controlled temperature range of 2°-8°C for up to 96 hours, supporting the regenerative therapy market[253]. - The SmartPak II™ Condition Monitoring System provides near real-time tracking and monitoring of key shipment conditions, enhancing the reliability of temperature-sensitive deliveries[256].
Cryoport(CYRX) - 2019 Q3 - Quarterly Report