WuXi AppTec Reports Strong 2019 Annual Results

On March 24, 2020 WuXi AppTec Co., Ltd. (stock code: 603259.SH / 2359.HK), a company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients, reported its audited annual results for the year ended December 31, 2019 ("Reporting Period") (Press release, WuXi AppTec, MAR 24, 2020, View Source [SID1234555803]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

All financials disclosed in this press release are prepared based on International Financial Reporting Standards (or "IFRSs").

2019 Financial Highlights

Accelerated revenue growth of 33.9% year-over-year to RMB12,872 million. All our business segments experienced strong growth in 2019. During the reporting period, we added over 1,200 new customers and our active customer count reached more than 3,900.
Non-IFRS gross profit grew 35.1% year-over-year to RMB5,259 million. Non-IFRS gross margin was 40.6%.
Gross profit grew 32.5% year-over-year to RMB5,006 million. Gross profit margin was 38.9%.[2]
Adjusted EBITDA grew 42.4% year-over-year to RMB4,015 million.
EBITDA grew 3.3% year-over-year to RMB3,428 million.
Adjusted Non-IFRS net profit attributable to owners of the Company grew 38.2% year-over-year to RMB2,407 million.
Net profit attributable to owners of the Company was down 18.0% year-over-year at RMB1,855 million. In 2019, we experienced a RMB180 million loss from the fair value change of our investment portfolio and a RMB21 million loss of equity pick up from our joint ventures and associates, primarily due to stock price decline of certain public companies in our investment portfolio. In 2018, we reported a RMB616 million gain from the fair value change of our investment portfolio and a RMB77 million gain of equity pick up from our joint ventures and associates.
Adjusted diluted Non-IFRS EPS increased by 19.7% to RMB1.46 versus 2018 while diluted EPS was down 29.1% to RMB1.12.[3]
2019 Business Highlights

During the Reporting Period, we added over 1,200 new customers and our active customer count reached more than 3,900. By leveraging the strengths of our integrated end-to-end R&D services platform, we were able to create further synergies across our business units.
– Our repeat customers contributed RMB11,735 million revenue, representing 91.2% of total revenue. Our newly added customers contributed RMB1,137 million revenue, representing 8.8% of total revenue.
– 32.3% of our customers used services from more than one of our business units, representing 87.4% of total revenue.
– 60% of our revenue came from U.S. customers, 23% of our revenue came from China customers, 12% of our revenue came from Europe customers and 5% of our revenue came from customers from rest of the world.

We anticipated the industry trend early and built our capabilities early. For example, our PROTAC drug discovery and testing platform enabled many global biotech customers to discover PROTAC drugs, which generated RMB474 million revenue in 2019, an increase of 90% over the prior year.
In small molecule drug discovery services, we continued to assist global customers discover pre-clinical drug candidates and patent applications, with multiple research papers published in leading scientific journals. Our DNA-Encoded library ("DEL") now contains 90 billion compounds. Since the first year we launched DEL services, 110 customers globally have used our platform to discover innovative small molecule drug hits, including 7 of the top 20 global pharmaceutical companies.
In our success-based drug discovery service unit, we filed INDs for 30 new-chemical-entities for China customers and obtained 23 clinical trial authorizations ("CTAs"). As of December 31, 2019, we have cumulatively submitted 85 new-chemical-entity IND filings with the NMPA for China customers and obtained 57 CTAs. We now have 1 project in Phase III clinical trials, 6 projects in Phase II clinical trials, and 38 projects in Phase I clinical trials.
We leveraged our platform to prepare and facilitate submissions of our customers’ IND packages (the WuXi IND program or "WIND"). We provided 52 integrated WIND packages for our customers, helping many of our global and domestic customers file IND applications with the FDA for clinical trial approval.
Our small molecule CDMO/CMO pipeline continues to grow. We now provide CDMO services for about 1,000 active projects, including 40 projects in Phase III clinical trials, and we provide commercial manufacturing services for 21 approved drugs.
We continue to make progress in cell and gene therapies CDMO services. Our laboratories and facilities in the U.S. provided services to 31 clinical stage projects, including 23 projects in Phase I clinical trials and 8 projects in Phase II clinical trials. Our laboratories and facilities in China also assisted our partner in submitting 2 IND filings for its cell therapy products with the NMPA.
Our clinical research services segment maintained rapid growth. During the Reporting Period, we helped many customers complete NDAs with the NMPA and received approvals, including one breakthrough product for the treatment of ovarian cancer and a variety of new drugs for cancers, hematology diseases and chronic diseases. Since the NMPA released its regulations on self-auditing and inspection of clinical trial data of drugs on July 22, 2015, over 40 projects undertaken by our clinical research services and site management organization (SMO) unit were inspected by NMPA and all passed inspections. Among those projects, 38 new drugs have been approved.
2019 Capabilities Enhancement and Capacities Expansion

We continued to strengthen our small molecule process development capabilities. Our flow chemistry platform began its first commercial manufacturing campaign. In biocatalysis services, our 500 liter biocatalysis bioreactor API manufacturing facility in Jinshan also began operation.
We continued to build our oligonucleotide and polypeptide CDMO capabilities. Our oligonucleotide and polypeptide cGMP pilot facility began operation and completed multiple cGMP manufacturing projects for clinical use materials.
In August 2019, we established a strategic cooperation with GeneSail Biotech (Shanghai) Co., Ltd., to co-develop a manufacturing platform for oncolytic viral vectors.
We continued to strengthen our global clinical research capabilities. Since our acquisition of Research Point Global., we now provide multi-regional clinical development services to our customers. In May 2019, we acquired Pharmapace, Inc., a clinical research services company in San Diego focusing on biometrics services. Since the Pharmapace acquisition, our biometrics services started gaining momentum and have signed up one major customer already.
We continued to expand our capacities across all segments and facilities globally to sustain our growth momentum.
– During the Reporting Period, our newly-built Nantong research center began operation.
– In March, 2020, we established our medicinal chemistry services capabilities in the U.S.
– We expanded the capacity of our Suzhou drug safety evaluation center by 80% to meet global customers’ preclinical testing needs.
– We expanded CDMO/CMO services capacities. Our CDMO subsidiary STA’s 5th API manufacturing facility in Changzhou began operation in the third quarter of 2019.
– In January 2020, STA opened its large-scale oligonucleotide API manufacturing facility in Changzhou, China, supporting the process R&D and manufacture of oligonucleotide APIs from preclinical to commercial.
– Early in 2019, our newly-built cell and gene therapies CDMO/CMO facility in Wuxi city began operation, providing services to customers in China.
– We have made investments to increase our gene therapy CDMO capability. In January 2020, our Philadelphia facility expanded its service capabilities by offering a fully integrated adeno-associated virus (AAV) Vector Suspension Platform, which will help customers accelerate the timeline for gene therapy product development, manufacturing and release. Its 500L and 1,000L bio-reactor gene therapy manufacturing lines are expected to be operational in the third quarter of 2020.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "We achieved accelerated growth in 2019, attributable to the continued execution of our ‘long-tail’ strategy and our CDMO business model. Our revenue growth accelerated 33.9% over the prior year to RMB12,872 million and our adjusted Non-IFRS net profit attributable to owners of the Company growth accelerated 38.2% to RMB2,407 million. We leveraged the strength of our integrated, end-to-end R&D services platform to increase customer conversion, creating further synergies across all our business segments."

"By relentlessly executing our ‘Follow the Project / Follow the Molecule / Follow the Customer’ strategy, the power of our integrated business model allowed us to achieve robust growth. Meanwhile, we also continued to invest in new capabilities and capacity, including talent, laboratories, facilities and technologies globally. We believe these investments will enable us to sustain our long-term growth objectives."

Commenting on the impact of COVID-19 pandemic, Dr. Ge Li said, "We encountered the outbreak of COVID-19, which has affected almost every company and individual. We lost about one month of operations in China, with the greatest impact on our Wuhan site, and to some degree on our clinical CRO/SMO business as most hospitals in China stopped study monitoring visits and patient enrollment during the outbreak. However, the Company implemented our Business Continuity Plan very early on to minimize the impact to customers’ project delivery timelines. We made extraordinary efforts to prepare for the resumption of operations across all of our sites in China, with our top priority being compliance with government regulations and protecting our employees’ health and safety. By leveraging our multi-site operations, certain high priority projects were transferred from our Wuhan site to other sites to sustain project delivery timelines as much as possible, with our customers’ agreement. Prior to the COVID-19 outbreak, we were expecting yet another year of strong revenue growth in 2020. As a result of the timely implementation of our Business Continuity Plan, we expect that we will win back some lost time and reduce the COVID-19 impact to potentially two to three weeks of operations."

Dr. Ge Li continued, "The fundamentals of our business remain very strong, and we expect that we can continue to meet customer demand and project delivery schedules going forward, even as our U.S. facilities begin to experience impacts from COVID-19 pandemic. At present, our China facilities are demonstrating strong resiliency, as China moves into a next phase in rising to the challenge of the pandemic. We therefore expect that our China operations will assume even greater responsibilities than usual for keeping the R&D and manufacturing engine humming. Looking ahead, we are exploring opportunities to expand our manufacturing capabilities and capacities in the U.S., including via acquisitions and new site build-outs in order to meet global customers’ future supply chain needs. We are also actively using new communication technologies like Zoom to keep in close communication with our global customers. With our global footprint and telecommunication technologies, we are enabling our customers to work at home while they collaborate with us to advance their R&D programs."

Dr. Ge Li concluded, "This situation has served as a good reminder that the current methods of disease prevention, diagnosis and treatment are still limited, and the efficiency of new drug research and development needs to be improved. As a global company with open-access enabling platform in the global healthcare industry, we must continue to do the right things for patients – a goal that we have pursued since our founding. We will continue to focus on enabling global partners and assisting them to bring the best medicines to patients in need. With our healthy balance sheet, strong operating cash flow, broad R&D platform and the application of modern telecommunication technology, we will navigate through this COVID-19 crisis with our customers and strengthen our industry-leading position."

2019 IFRS Results

Revenue increased 33.9% year-over-year to RMB12,872 million.
– During the Reporting Period, our China-based laboratory services realized revenue of RMB6,473 million, representing a YoY growth of 26.6%. We fully leveraged our platform to attract more customers while expanding services to our existing customers. Our "long-tail" strategy continued to perform very well. Many of our success-based services projects moved into late stage, from which we expect to achieve milestones and royalties in the future.
– During the Reporting Period, the revenue of our CDMO/CMO services amounted to RMB3,752 million, representing a YoY growth of 39.0%. We continued to implement our strategy of "expanding services along with the drug development value chain." We won more projects from customers and many of our early stage projects moved into late stage clinical trial and commercial manufacturing, and our revenue grew rapidly. We further strengthened our integrated CMC services, and our drug product manufacturing services became one of the new growth engine.
– During the Reporting Period, our U.S.-based laboratory services realized revenue of RMB1,563 million, representing a YoY growth of 29.8%. In particular, as more projects moved to late phase and our utilization rate increased, our cell and gene therapies CDMO services revenue growth accelerated. In addition, due to strengthening of the management and sales team and increased business opportunities resulting from the European Union Medical Device Regulation change, our medical device testing services revenue grew rapidly.
– During the Reporting Period, our clinical research and other CRO services realized revenue of RMB1,063 million, representing a YoY growth of 81.8%. Growth was mainly driven by continued rapid development of the domestic new drug clinical trial market, and acquired U.S. clinical CRO business contributed RMB199 million in revenue. Excluding the effect of acquisition, the revenue of our clinical research and other CRO services grew 61.4%.

Gross profit increased 32.5% year-over-year to RMB5,006 million. Gross profit margin was 38.9%, slightly lower than the 39.3% achieved in 2018[4], mainly because of: (1) increase in share-based compensation expenses, and (2) pass-through revenue of clinical research and other CRO services which has no margins.
Net profit attributable to owners of the Company decreased 18.0% year-over-year to RMB1,855 million. In 2019, we reported a RMB180 million loss from the fair value change of our investment portfolio and a RMB21 million loss of equity pick up from our joint ventures and associates, primarily due to stock price decline of certain public companies held in the investment portfolio. In 2018, we reported a RMB616 million gain from the fair value change of our investment portfolio and a RMB77 million gain from our joint ventures and associates.
2019 Non-IFRS Results

2019 Non-IFRS net profit attributable to owners of the Company decreased 8.2% year-over-year to RMB2,261 million. This adjusts for share-based compensation expenses, listing expenses, convertible bonds issuance and distribution expenses, fair value gain or loss from derivative component of convertible bonds, foreign exchange-related effects and amortization of intangible assets acquired in business combinations.
2019 Adjusted Non-IFRS Results

Excluding realized/unrealized gains or losses from our venture investments and realized/unrealized gains or losses from our joint ventures and associates, 2019 adjusted Non-IFRS net profit attributable to owners of the Company increased 38.2% year-over-year to RMB2,407 million.

MaxCyte and Allogene Therapeutics Sign Clinical and Commercial License Agreement to Enable the Advancement of Allogeneic CAR T (AlloCAR T™) Therapies

On March 24, 2020 MaxCyte, Inc., a global cell-based therapies and life sciences company, and Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported a clinical and commercial license agreement (Press release, MaxCyte, MAR 24, 2020, View Source [SID1234555802]). Under the terms of the agreement, Allogene gains rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform to develop and advance its AlloCAR T candidates through to commercialization. In return, MaxCyte will receive undisclosed development, approval and commercial milestones in addition to other licensing fees. The first two Allogene investigational therapies intended to utilize this validated gene editing and advanced proprietary cell manufacturing technology are directed at CD19 and BCMA targets.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MaxCyte’s ExPERT instrument family represents the next generation of leading, clinically validated, electroporation technology for complex and scalable cellular engineering. By delivering high transfection efficiency with enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics. Allogene intends to deploy the MaxCyte technology to effect the gene editing steps during the production process. The closed system and high efficiency make it an ideal addition for GMP operations.

"MaxCyte’s ExPERT platform has become the industry standard in electroporation technology and allows us to increase efficiency and improve yield, which is a critical component to the value proposition of our AlloCAR T therapies," said Alison Moore, Ph.D., Chief Technical Officer of Allogene.

Doug Doerfler, President & CEO of MaxCyte, said: "We’re honored to partner with Allogene to help unlock the full potential of its next-generation allogeneic CAR T therapies through utilization of our Flow Electroporation technology and ExPERT platform."

Apexigen Completes $123 Million Series C Financing To Advance Clinical Pipeline

On March 24, 2020 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported the completion of a $65 million equity financing (Press release, Apexigen, MAR 24, 2020, View Source [SID1234555801]). The financing was led by Decheng Capital and new investor Oceanpine Capital and included participation from other new and existing investors. This financing is an extension of the Company’s Series C financing of $58 million, which was previously announced in August 2018, bringing the total amount raised in the Series C to $123 million. The completion of the Series C financing brings the total equity raised to date by the company to $158 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Apexigen intends to use these proceeds to support the ongoing clinical development of its lead immunotherapeutic, APX005M, a monoclonal antibody targeting CD40. Currently, APX005M is in multiple Phase 2 clinical trials to treat different types of solid tumors. The proceeds will also be used to develop Apexigen’s pipeline of therapies, including the advancement of at least one new proprietary immunotherapeutic product candidate into Phase 1 clinical development.

"Over the past year and a half we have made exceptional progress and generated compelling data from our ongoing clinical trials with APX005M, which to date have enrolled and treated over 400 cancer patients. In addition, the regulatory approval and commercial launch of a licensed product, the first for a product that emerged from our APXiMAB discovery platform, provided further validation for the platform," said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. "We welcome the support of both new and existing investors in our efforts to advance a new generation of immunotherapeutic agents to treat a diverse range of malignancies."

About APX005M
APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer and sarcoma in various combinations with immunotherapy, chemotherapy or radiation therapy.

ThermoGenesis Holdings Announces 2019 Year End Financial Results And Provides Corporate Update

On March 24, 2020 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported financial and operating results for the year ended December 31, 2019 and provided a corporate strategic update (Press release, Thermogenesis, MAR 24, 2020, View Source [SID1234555800]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key 2019 Achievements:

Net revenues for 2019 increased to $13.0 million, up 35% compared to 2018.
Gross profit for 2019 was $5.7 million, an increase of 156% compared to 2018.
Operating expenses were $10.4 million, a decrease of 77% as compared to 2018.
Completed the commercial launch of the AXP II System, an automated, fully closed cell separation system upgraded from the market-leading AXP System, for the advanced isolation, collection and storage of hematopoietic stem cell concentrates from cord blood and peripheral blood.
Announced that long-time customer, CBR, America’s largest cord blood bank, transitioned to the AXP II System.
Announced that Cordlife, a leading cord blood bank in Asia, signed a strategic agreement to start transitioning to the AXP II System
Received Health Canada approval of the Company’s PXP system for automated processing of bone marrow cells at the point-of-care. Entered into strategic supply agreement with Orthohealing Center Management to provide PXP System to Orthohealing Method’s network physician members.
Completed the commercial launch of the X-Series cell processing products and reagents, key components of the Company’s CAR-TXpress large scale cell manufacturing platform.
Completed the validations of system performance for the X-Series products from two prestigious academic medical centers at Duke University School of Medicine and University of North Carolina.
Entered an exclusive global supply agreement with Corning Incorporated under a five-year, renewable supply agreement for the X-Series product line and received $2 million upfront exclusivity fee.
Formed a new joint venture with HealthBanks Biotech (USA) named ImmuneCyte Life Sciences, Inc. ("ImmuneCyte"), to develop a proprietary immune cell banking service, leveraging ThermoGenesis’ CAR-TXpress cell processing platform. The joint venture, of which the Company owns 20% of the equity, received a $3 million equity investment.
Completed name change from Cesca Therapeutics Inc. to ThermoGenesis Holdings, Inc., reflecting the Company’s new strategic focus on being an automated cell processing tools and services provider in the cell and gene therapy field.
"Throughout 2019, not only did we achieve an increase in net revenues of 35% and an increase in gross profit of 156%, but we also took a number of strategic steps to position the Company to become a leading cell processing and manufacturing solution provider within the rapidly expanding cell and gene therapy field," said Chris Xu, PhD, Chief Executive Officer of ThermoGenesis. "The successful signing of the global supply agreement with Corning for our X-Series product line is expected to vastly increase visibility and awareness of our newly launched CAR-TXpress cell manufacturing platform going forward. The establishment of the ImmuneCyte joint venture, which will further leverage our CAR-TXpress platform to provide GMP quality immune cell banking services to healthy customers for future potential use in immunotherapies, is yet another step forward. Lastly, the divestiture of our clinical development assets, undertaken in conjunction with the formation of ImmuneCyte was a necessary step to allow us to stay focused solely on our scientific tools and services business in the cell and gene therapy field."

Jeff Cauble, Chief Financial Officer of ThermoGenesis, added, "The significant increase in sales of AXP and CAR-TXpress were important catalysts for our revenue growth. The AXP System provided an additional $3.1 million in revenue over 2018, while CAR-TXpress added $658,000. Gross profit improved, jumping to $5.7 million in 2019 compared to $2.2 million last year, a 156% improvement. Continued revenue growth and increased margins led to the Company having positive adjusted EBITDA for two quarters in 2019. Furthermore, Boyalife’s recent conversion of $3.0 million in principal and interest, as part of its Revolving Credit Agreement, not only illustrates their unwavering support of ThermoGenesis, but it will also reduce our interest obligation over the next year."

Recent Update on Coronavirus Pandemic

The current global pandemic of the coronavirus (COVID-19) has now affected more than 180 countries and regions, including over 40,000 cases in the United States alone. The disease has spread rapidly, leading to a tremendous impact on the U.S. healthcare system and causing societal disruption. The public health threat posed by COVID-19 is extremely high, both globally and in the U.S.

To effectively respond to the COVID-19 pandemic, ThermoGenesis and ImmuneCyte are working together mobilizing their expertise, global resources and relationships in the medical technology field to develop, register, import and seek U.S. Food and Drug Administration (FDA) approval for advanced point-of-care tests that will allow rapid diagnosis of the COVID-19 virus, including asymptomatic cases. The tests would be able to be done both at point-of-care settings, or potentially at home, without further burdening the already stressed healthcare system. A quick do-it-yourself (DIY) testing kit, as simple as a routine pregnancy test or diabetic glucose test, if approved, would allow millions of people currently quarantined at home to conduct a self-test.

Management noted that the first of such a rapid point-of-care test could be available as early as April through ThermoGenesis and ImmuneCyte. "We expect to file for an expedited review process with the FDA for the assay," noted Dr. Xu.

Financial Results for the Fiscal Year Ended December 31, 2019

Net revenues. Net revenues for the year ended December 31, 2019 was $13.0 million compared to $9.7 million for fiscal 2018, an increase of $3.3 million or 35%. The increase was driven by AXP revenues which increased by $3.1 million in 2019 with approximately 1,300 more cases sold in 2019 as compared to 2018. Additionally, AXP device sales increased by approximately $0.7 million in 2019, driven by customers upgrading to AXP II devices in the current year and CAR-TXpress sales increased by approximately $0.6 million. BioArchive and clinical development segment sales decreased slightly year over year.

Gross profit. Gross profit was $5.7 million or 44% of net revenues for the year ended December 31, 2019 compared to $2.2 million or 23% for the year ended December 31, 2018, an increase of $3.5 million or 156%. The increase was primarily due to AXP sales, generating approximately $2.2 million more in gross profit from disposables and devices. The remainder of the increase is due to increased gross profit from service revenue of approximately $0.2 million and additional sales of CAR-TXpress which resulted in approximately $0.3 million more gross profit.

Sales and marketing expenses. Sales and marketing expenses were $1.7 million for the year ended December 31, 2019, as compared to $1.4 million for the year ended December 31, 2018, an increase of $0.3 million or 22%. The increase was driven by stock compensation expense and increased salaries and benefits.

Research and development expenses. Research and development (R&D) expenses were $2.4 million for the year ended December 31, 2019, compared to $3.0 million for the year ended December 31, 2018, a decrease of $0.6 million or 20%. The decrease is primarily due to a decline in personnel costs related to corporate reorganization in June 2018.

General and administrative expenses. General and administrative expenses for the year ended December 31, 2019 were $6.4 million, compared to $8.3 million for the year ended December 31, 2018, a decrease of $1.9 million or 23%. The decrease was driven by a decline in personnel costs of approximately $1.2 million and a loss on the disposal of fixed assets of approximately $1.3 million incurred in 2018. India general and administrative expenses were also approximately $0.3 million less in 2019. These decreases were offset by a $1.4 million expense as the result of the verdict against the Company in the Mavericks lawsuit.

Impairment Charges: The Company incurred no impairment charges during the year ended December 31, 2019 as compared to impairment charges of $33.1 million during the year ended December 31, 2018. In 2018, the Company recorded impairment charges of $13.2 million to goodwill and $19.9 million to the Company’s intangible assets in the Clinical Development Segment.

Interest Expense. Interest expense increased to $4.5 million for the year ended December 31, 2019 as compared to $2.7 million for the year ended December 31, 2018, a difference of $1.8 million. The increase is driven by interest recorded and the amortization of the debt discount, interest expense and the loss on the extinguishment of debt related convertible notes issued by the Company during 2019. Additionally, 2019 had more in interest and amortization of the debt discount on the beneficial conversion feature related to the Revolving Credit Agreement with Boyalife.

Loss on Extinguishment of Debt: The Company recorded a loss of extinguishment of debt of $0.8 million for the year ended December 31, 2019 as compared to $0 for the year ended December 31, 2018. The increase is due to the loss on the extinguishment of the convertible note issued in January 2019, which was deemed to be extinguished as a result of its amendment in July 2019.

Benefit for Income Taxes: For the year ended December 31, 2019, the Company has no income tax benefit compared to $4.7 million for the year ended December 31, 2018. The benefit for income tax in 2018 was due to the impairment of the indefinite lived intangible assets for the clinical protocols and goodwill.

Net loss. For the year ended December 31, 2019, the Company reported a comprehensive loss attributable to common stockholders of $9.5 million, or ($3.36) per share, based on approximately 2.8 million weighted average basic and diluted common shares outstanding. This compares to a comprehensive net loss of $39.7 million, or ($21.57) per share, based on approximately 1.8 million weighted average basic and diluted common shares outstanding for the year ended December 31, 2018.

Adjusted EBITDA. In addition to the results reported under US GAAP, the Company also uses a non-GAAP measure to evaluate operating performance and to facilitate the comparison of our historical results and trends. The Company uses the metric to determine operational cash flow. Adjusted EBITDA loss for the year ended December 31, 2019 was $3.3 million, as compared to a loss of $9.1 million for the year ended December 31, 2018, an increase of $5.8 million or 64%. The increase was due to $3.4 million in additional gross profit as the result of higher sales, decreased overhead expenses and lower costs. Additionally, the Company decreased personnel costs by approximately $1.5 million in 2019 as compared to 2018. These decreases were offset by a $1.4 million expense related to the Mavericks lawsuit. A reconciliation of adjusted EBITDA loss to net loss is set forth below.

At December 31, 2019, the Company had cash and cash equivalents totaling $3.2 million, compared with $2.4 million at December 31, 2018. Working capital improved to $3.2 million at December 31, 2019 as compared to $2.3 million at December 31, 2018.

Conference Call and Webcast Information

ThermoGenesis will host a conference call today at 1:30 p.m. PDT/4:30 p.m. EDT. To participate in the conference call, please dial 1-844-889-4331 (domestic), 1-412-380-7406 (international) or 1-866-605-3852 (Canada). To access a live webcast of the call, please visit: View Source

A replay of the call can be accessed by dialing 1-877-344-7529 (domestic), 1-412-317-0088 (international) or 855-669-9658 (Canada), and referencing access code 10139041. The replay will be available until April 9, 2020.

National Comprehensive Cancer Network Announces Addition of UCLA Jonsson Comprehensive Cancer Center and UT Southwestern Simmons Comprehensive Cancer Center

On March 24, 2020 The National Comprehensive Cancer Network (NCCN) reported that it is now an alliance of 30 leading cancer centers, with the addition of two new Member Institutions: UCLA Jonsson Comprehensive Cancer Center and UT Southwestern Simmons Comprehensive Cancer Center (SCCC) (Press release, NCCN, MAR 24, 2020, View Source [SID1234555799]). These top-tier academic cancer centers are located in two of the most-populous cities in the United States, Los Angeles and Dallas, respectively, and serve large, diverse groups of patients. Both centers have a strong commitment for advancing innovative research that improves cancer care and reduces disparities. Experts from both centers will now be involved in the creation of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)—the recognized standard for clinical direction in cancer care and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very excited to incorporate the significant medical and scientific expertise from both UCLA Jonsson Comprehensive Cancer Center and UT Southwestern Simmons Comprehensive Cancer Center into our network of top academic cancer centers," said Robert W. Carlson, MD, Chief Executive Officer, NCCN. "Both have proven track records when it comes to improving outcomes and quality-of-life for people with cancer. Their facilities include top-notch programs throughout the spectrum of cancer management, including pediatric oncology, genetics, immunotherapy, telemedicine, and other increasingly-important areas of interest for NCCN and the greater cancer care community. They serve diverse, growing populations with strong immigrant representation at a time when the global need for NCCN Guidelines is higher than ever. The multi-disciplinary experts at UCLA and Simmons are among the best in the world, and both centers are ranked very highly by U.S. News & World Report. We are happy to have them work with us to improve and facilitate quality, effective, efficient, and accessible cancer care so patients can live better lives."

"We are honored and thrilled to become a member of the National Comprehensive Cancer Network," said Michael Teitell, MD, PhD, Director, UCLA Jonsson Comprehensive Cancer Center. "We look forward to joining our peer institutions and bringing our focus on cutting-edge research and top-quality cancer care to this association of the nation’s top cancer centers."

"We are excited to be able to join forces with the other leading cancer centers who are part of NCCN," said John Sweetenham, MD, Associate Director of Clinical Affairs, UT Southwestern Simmons Comprehensive Cancer Center. "Working with the other Member Institutions, we will ensure that the best possible evidence-based cancer care is available to patients throughout the nation and beyond. Our membership will bring the combined expertise of 30 elite cancer centers to the people of North Texas." Carlos L. Arteaga, MD, Director of the Simmons Cancer Center, echoed Dr. Sweetenham by adding "membership of the NCCN will greatly enhance our ability to apply the most recent cancer discoveries to our patient care mission."

In 2019 alone, more than 1,500 experts from NCCN Member Institutions contributed a combined 35,000+ hours to create and update NCCN Guidelines. Those guidelines provide the latest evidence- and expert consensus-based recommendations applying to 97 percent of cancers affecting patients in the United States, and also include prevention, screening, and supportive care topics. The development of the NCCN Guidelines is solely supported by membership dues from the NCCN Member Institutions.

The announcement of the addition of the UCLA Jonsson Comprehensive Cancer Center and UT Southwestern Simmons Comprehensive Cancer Center comes as NCCN celebrates its 25th anniversary year. The non-profit organization consisted of 13 centers when it was first founded in 1995.

In addition to joining the panels behind the NCCN Guidelines and their derivatives, experts from UCLA and SCCC will work with NCCN to provide continuing education; policy and advocacy outreach; best practices information; organization of clinical trials and research; global adaptations and translations; and up-to-date patient information. Visit NCCN.org to learn more about the various programs and their role in improving cancer care worldwide.