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Cryoport(CYRX) - 2020 Q1 - Quarterly Report
2020-05-08 20:10
Revenue Growth - Cryoport reported Q1 2020 revenue of $93 million from Novartis's KYMRIAH, a significant increase from $45 million in Q1 2019, reflecting a growth of 106.67%[170] - Kite/Gilead reported Q1 2020 revenue of $140 million from YESCARTA, up from $96 million in Q1 2019, indicating a growth of 45.83%[170] - Revenues increased by $3.1 million or 46.9% to $9.8 million for the three months ended March 31, 2020, compared to $6.7 million for the same period in 2019[179] - Biopharmaceutical revenue rose by $1.9 million or 33.3% to $7.5 million for the three months ended March 31, 2020, driven by increased customer utilization and clinical trials[179] Clinical Trials and Market Presence - The number of clinical trials supported increased to 465 as of March 31, 2020, up from 383 as of March 31, 2019, with 29 new trials added during the period[179] - As of March 31, 2020, Novartis has qualified over 230 treatment centers across more than 20 countries for KYMRIAH, showcasing the global reach of its therapies[170] - Cryoport's platform supports the development and commercialization of cell and gene therapies, including CAR-T therapies, emphasizing its role in the regenerative medicine market[168] Strategic Initiatives - Cryoport's acquisition of Cryogene Partners expanded its biostorage capabilities, providing a cGMP compliant temperature-controlled sample management solution in a 21,000 square foot facility in Houston, Texas[163] - The partnership with Lonza aims to integrate logistics and bioservices solutions with manufacturing services to improve supply chain efficiency[172] - Cryoport's logistics solutions support the three largest integrators globally: FedEx, DHL, and UPS, enhancing its market presence in the life sciences industry[165] - The company launched Advanced Therapy Shippers™ designed for regenerative medicine, ensuring traceability and minimizing cross-contamination risks[162] - Cryoport's technology enables real-time monitoring of shipments, providing a documented history for regulatory compliance and quality assurance[159] - The company has established strategic alliances under its Compliance Unified Ecosystem™, enhancing its marketing reach in the life sciences sector[164] Financial Performance - Gross margin improved to 53.8% for the three months ended March 31, 2020, compared to 51.9% for the same period in 2019, due to increased business volume and pricing adjustments[181] - General and administrative expenses increased by $1.3 million or 49.4% for the three months ended March 31, 2020, primarily due to higher wages and employee costs[182] - Engineering and development expenses surged by $1.2 million or 253.9% for the three months ended March 31, 2020, reflecting increased consulting and development costs[184] - Cash and cash equivalents stood at $50.6 million, with $46.8 million in short-term investments and working capital of $98.0 million as of March 31, 2020[187] - Net cash used in investing activities was $1.5 million during the three months ended March 31, 2020, primarily for short-term investments and software development costs[189] Future Outlook - The company expects revenue to gradually ramp back up as COVID-19 restrictions are lifted, despite temporary impacts on revenue growth[178] - Management believes current cash and investments will satisfy operational and capital requirements for at least the next twelve months[192]
Cryoport(CYRX) - 2019 Q4 - Annual Report
2020-03-10 20:39
Logistics and Supply Chain Solutions - Cryoport supports over 430 clinical trials in the regenerative medicine space and has logged over 300,000 shipments to more than 100 countries[41] - The company expanded its services by acquiring Cryogene, enhancing its biostorage capabilities with a 21,000 square foot facility in Houston, Texas[36] - Cryoport's logistics solutions include the Advanced Therapy Shippers™, designed specifically for human-based therapies, ensuring traceability and compliance[23] - The Cryoportal Logistics Management Platform provides near real-time shipment tracking and monitoring, enhancing regulatory compliance and quality assurance[20] - Cryoport's solutions are classified as non-hazardous, unlike traditional methods using dry ice or liquid nitrogen, which are considered dangerous goods[38] - The company has established strategic alliances with major integrators like FedEx, DHL, and UPS, collectively holding over 87% of express logistics aircraft[46] - Cryoport's fleet management services aim to reduce clients' costs through optimized resource utilization and equipment loss minimization[30] - The company has developed customized packaging solutions using 'Design-of-Experiment' and 'Quality-by-Design' processes to meet client specifications[31] - World Courier integrated Cryoport's temperature-controlled solutions into its global network, enhancing supply chain programs for biopharmaceutical clients[48] - The partnership with Be The Match BioTherapies aims to deliver end-to-end supply chain services for cell and gene therapies, integrating their software platforms[50] - The collaboration with Vineti is expected to deploy its supply chain orchestration platform in over 300 clinical centers worldwide within the next year[53] - Lonza has designated Cryoport as its preferred partner for managing transport and delivery of patient tissues globally, focusing on personalized therapeutics[54] - The Cryoportal is designed for time-and temperature-sensitive shipments, focusing on cryogenic temperatures (-150℃) and ambient (20-25℃) logistics, ensuring samples remain within a safe temperature range[72] - Cryoport Express Shippers can maintain cryogenic temperatures of -150℃ or below for over 10 days, utilizing liquid nitrogen in a vacuum insulated vessel[75] - The SmartPak™ Condition Monitoring System provides near real-time tracking of shipments, including internal and external temperatures, humidity, and shock, ensuring the integrity of temperature-sensitive products[85] - Cryoport's Chain of Compliance™ solution offers comprehensive traceability of equipment and processes, enhancing supply chain intelligence and minimizing risks[90] - The Global Logistics Solutions segment offers temperature-controlled logistics solutions for biopharma, reproductive medicine, and animal health markets, shipping biologic materials globally[102] - Cryoport Express Advanced Therapy Shippers™ are specifically designed for the Regenerative Medicine market, ensuring traceability and preventing cross-contamination[81] - The company provides 24/7 logistics support with validated shipping lanes in over 100 countries, ensuring secure and timely deliveries[98] - Cryoport continues to advance its technology applications for temperature-controlled logistics and expand the functionality of its Cryoportal Logistics Management Platform[101] Financial Performance and Market Trends - Novartis reported $278 million in revenue from its CAR-T cell therapy KYMRIAH in fiscal year 2019, up from $76 million in 2018[64] - Kite Pharmaceuticals generated $456 million in revenue from its CAR-T therapy YESCARTA in fiscal year 2019, compared to $264 million in 2018[66] - 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, a 24% increase[60] - The total targeted enrollment for regenerative medicine clinical trials worldwide was reported as 59,757 patients as of January 2019[59] - The global IVF services revenue market generated $12.5 billion in 2018 and is projected to reach $26.4 billion by 2026, growing at a CAGR of 9.8% from 2019 to 2026[132] - The global animal health market is projected to reach $73.6 billion by 2027, with a CAGR of 5.8% from 2016 to 2027, driven by rising zoonotic and food-borne diseases[133] - In the U.S., 68% of households now own a pet, up from 58% in 1988, indicating a growing market for companion animal support[133] Company Strategy and Operations - The company continuously evaluates and expands its service offerings in response to market needs and client demand[35] - The company currently owns approximately 4 issued patents and is pursuing about 14 pending patent applications globally[113] - The company plans to expand its sales and marketing efforts globally, particularly in the Americas, EMEA, and Asia-Pacific regions, by hiring additional personnel[135] - The company aims to broaden its platform of solutions, including the introduction of shippers of varying sizes and temperature ranges based on market requirements[143] - The company anticipates that advancements in biotechnology will increase the demand for temperature-sensitive logistics solutions[136] - The company emphasizes the importance of maintaining sufficient capital to support its growth strategy and may need to raise additional funds in the future[159] - The company faces competition from firms like Thermo Fisher Scientific and specialty couriers, but believes its comprehensive solutions provide a competitive edge[142] - Future revenue growth is heavily dependent on timely market introduction of new solutions and services, necessitating significant investments in engineering and development[169] - The lengthy adoption cycle of target customers may hinder the company's ability to quickly increase revenues[170] - The company may pursue acquisitions to remain competitive, but such transactions carry risks that could adversely affect its business[189] - Integration of acquired businesses, such as Cryogene, may disrupt operations and create additional expenses, potentially affecting expected synergies[194] Risks and Challenges - The COVID-19 pandemic poses an uncertain risk to the company's financial condition and operational results, particularly in logistics and component procurement[179] - The company faces potential expenses related to exiting distribution agreements and must comply with various laws, which could impact revenue growth[164] - Retaining key professionals is critical for the company's growth and competitive position, as losing them could adversely affect operations[166] - The company currently maintains general liability insurance of $1 million per occurrence and product liability insurance with a $1 million annual coverage limitation, which may not fully protect against potential liabilities[184] - The company relies on third-party manufacturers for components, and any delays in procurement could lead to customer dissatisfaction and harm its reputation[178] - Claims for liability related to damage of customer specimens could expose the company to financial or reputational harm[201] - Compliance with various regulations for shipments can limit activities and increase operational costs[213] - The company does not currently have FDA or other regulatory approvals, but future regulations could impose additional expenses[216] - Cybersecurity threats pose risks to the company’s operations, and the absence of cyber security insurance could lead to significant costs in the event of a successful attack[212] - The company’s technology infrastructure is subject to potential damage or interruption from various sources, which could materially harm operations[212] - The company may face claims of patent infringement that could result in substantial defense costs, even if the claims are without merit[206] Financial Condition - As of December 31, 2019, the company reported a net loss of $18.33 million, compared to a net loss of $9.56 million in 2018, with an accumulated deficit of $159.3 million[157][158] - Approximately 80.2% of the Global Bioservices segment's net revenues came from one customer, although it was less than 10% of total revenues for the year ended December 31, 2019[121] - Two customers accounted for 24.1% and 12.8% of total revenues for the year ended December 31, 2019, while one customer represented 18.2% of revenues for the year ended December 31, 2018[121]
Cryoport(CYRX) - 2019 Q4 - Earnings Call Transcript
2020-03-06 01:13
Cryoport, Inc. (NASDAQ:CYRX) Q4 2019 Earnings Conference Call March 5, 2020 5:00 PM ET Company Participants Todd Fromer - Managing Partner, KCSA Jerrell Shelton - Chief Executive Officer Robert Stefanovich - Chief Financial Officer Mark Sawicki - Chief Commercial Officer Conference Call Participants Puneet Souda - SVB Leerink Paul Knight - Janney Montgomery Richard Baldry - ROTH Capital Partners Mason Carrico - Stephens Inc. Steve Unger - Needham Andrew D'Silva - B. Riley FBR Operator Thank you for standin ...
Cryoport(CYRX) - 2019 Q3 - Quarterly Report
2019-11-12 18:01
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 - Earnings Call Transcript
2019-11-10 13:31
Cryoport, Inc. (NASDAQ:CYRX) Q3 2019 Earnings Conference Call November 7, 2019 5:00 PM ET Company Participants Todd Fromer - Managing Partner, KCSA Jerrell Shelton - Chief Executive Officer Robert Stefanovich - Chief Financial Officer Mark Sawicki - Chief Commercial Officer Conference Call Participants Paul Knight - Janney Montgomery Wes Dupray - SVB Leerink Andrew D'Silva - B. Riley FBR Brandon Couillard - Jefferies Richard Baldry - Roth Steve Unger - Needham Operator Good day everyone and welcome to today ...
Cryoport(CYRX) - 2019 Q2 - Earnings Call Transcript
2019-08-10 10:01
Cryoport, Inc. (NASDAQ:CYRX) Q2 2019 Results Conference Call August 8, 2019 5:00 PM ET Company Participants Todd Fromer – Managing Partner-KCSA Jerry Shelton – Chief Executive Officer Mark Sawicki – Chief Commercial Officer Robert Stefanovich – Chief Financial Officer Conference Call Participants Puneet Souda – SVB Leerink Andrew D'Silva – B. Riley FBR Brandon Couillard – Jefferies Paul Knight – Janney Steve Unger – Needham Richard Baldry – Roth Capital Operator Thank you for standing by. This is the confer ...
Cryoport(CYRX) - 2019 Q2 - Quarterly Report
2019-08-09 21:19
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class: Trading Symbol(s) Name of each exchange on which registered: Common Stock CYRX The Nasdaq Capital Market Registered Warrants CYRXW The Nasdaq Capital Market Form 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 00 ...
Cryoport(CYRX) - 2019 Q1 - Quarterly Report
2019-05-09 20:26
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Securities registered pursuant to Section 12(b) of the Act: Title of each class: Trading Symbol(s) Name of each exchange on which registered: Common Stock CYRX The Nasdaq Capital Market Form 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File N ...
Cryoport(CYRX) - 2019 Q1 - Earnings Call Transcript
2019-05-04 01:01
Cryoport, Inc. (NASDAQ:CYRX) Q1 2019 Results Earnings Conference Call May 2, 2019 5:00 PM ET Company Participants Todd Fromer – Investor Relations Jerry Shelton – Chief Executive Officer Robert Stefanovich – Chief Financial Officer Mark Sawicki – Chief Commercial Officer Conference Call Participants Andrew D'Silva – B. Riley FBR Paul Knight – Janney Montgomery Brandon Couillard – Jefferies Richard Baldry – Roth Capital Operator Welcome to the Cryoport First Quarter 2019 Earnings Call. [Operator Instruction ...
Cryoport(CYRX) - 2018 Q4 - Annual Report
2019-03-13 19:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-34632 CRYOPORT, INC. (Exact Name of Registrant as Specified in its Charter) Nevada 88-0313393 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identi ...