CTI BioPharma Corp.
Mar 06, 2023, 06:25 ET
– Growing physician awareness and usage of VONJO® (pacritinib) drove quarterly double-digit revenue growth –
– VONJO® net product revenue exceeded year-end goal with a total of $54 million for 2022 and $21.1 million in the fourth quarter, a 16% increase compared to the third quarter –
– ASH 2022 oral presentation featured new data on pacritinib’s ACVR1 inhibition and anemia benefit in myelofibrosis patients –
– Management to host webcast and conference call at updated time today at 8:30 a.m. ET –
SEATTLE, March 6, 2023 /PRNewswire/ — CTI BioPharma Corp. (Nasdaq: CTIC), a commercial biopharmaceutical company focused on the development and commercialization of novel targeted therapies for blood-related cancers, today reported its financial results for the fourth quarter and full year ended December 31, 2022.
“CTI is now established as a market leader in the treatment of cytopenic myelofibrosis following the accelerated approval and U.S. commercial launch of VONJO® (pacritinib) over the past year,” said Adam Craig, M.D., Ph.D., M.B.A., President, Chief Executive Officer and Interim Chief Medical Officer. “With the launch of VONJO in March 2022, we exceeded our year-end revenue goal by achieving $54 million in net sales in 2022 with strong quarter-over-quarter growth.”
“As of year-end 2022, more than 1,000 patients were treated with VONJO, which is a significant milestone for this rare disease. Importantly, we have also achieved over 90% insurance coverage with both Medicare and Commercial plans. To further increase the market penetration of VONJO, our commercial team continues to reinforce the VONJO clinical value proposition for cytopenic myelofibrosis patients leveraging peer-to-peer interactions and education. New data presented at the 64th American Society of Hematology (ASH) Annual Meeting suggests the potential to strengthen the clinical differentiation for pacritinib through its potent Activin A receptor type 1 (ACVR1) inhibitor and anemia benefit. We look forward to continuing activities focused on market expansion in 2023, which are intended to drive quarter-over-quarter net sales increases,” concluded, Dr. Craig.
2022 Key Accomplishments and Recent Highlights
- FDA approval of VONJO (pacritinib) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L.
- $54 million in net sales in the first nine months following VONJO launch.
- Over 1,000 patients commercially treated with VONJO in 2022.
- Inclusion in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Myeloproliferative Neoplasms, with a recommendation for VONJO as a: First-line treatment option for higher-risk myelofibrosis patients with platelet counts <50 x 109/L who are not candidates for transplant; Second-line treatment option for: patients with higher-risk myelofibrosis who are not candidates for transplant with platelet counts ≥50 x 109/L with no response or loss of response to one prior JAK inhibitor and for patients with symptomatic lower-risk myelofibrosis with platelet counts <50 x 109/L with no response or loss of response to initial treatment.
- Oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition highlighted pacritinib as a potent activin A receptor type 1 (ACVR1) inhibitor with significant anemia benefit in patients with myelofibrosis.
- On February 7, 2023, VONJO was granted seven years of orphan-drug exclusive approval by the FDA for treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 x109/L. The seven-year exclusive approval began on February 28, 2022.
Fourth Quarter and Full Year 2022 Financial Results
- Net Product Sales: Net product sales of $21.1 million and $53.9 million for the three months and year ended December 31, 2022, respectively, were entirely attributable to VONJO product sales in the United States. There were no product sales for the comparable periods in 2021.
- Operating Loss: Operating loss was $13.6 million and $35.4 million for the three months ended December 31, 2022 and 2021, respectively, and $79.8 million and $95.3 million for the years ended December 31, 2022 and 2021, respectively. The decrease in operating loss between the three-month periods ended December 31, 2022 and 2021 was primarily attributable to VONJO product sales. The decrease in operating loss between the years ended December 31, 2022 and 2021 resulted primarily from VONJO product sales, partially offset by an increase in selling, general and administrative activities related to the commercial launch of VONJO, as well as a $10.3 million milestone expense related to FDA approval of VONJO, which was included in other operating expenses.
- Net Loss: Net loss for the three months ended December 31, 2022 was $17.5 million, or $0.14 for basic and diluted loss per share, compared to net loss of $36.8 million, or $0.38 for basic and diluted loss per share, for the same period in 2021. Net loss for the year ended December 31, 2022 was $93.0 million, or $0.81 for basic and diluted loss per share, compared to net loss of $97.9 million, or $1.09 for basic and diluted loss per share, for the same period in 2021.
- Cash Position: As of December 31, 2022, cash, cash equivalents and short-term investments totaled $79.9 million, compared to $65.4 million as of December 31, 2021. Subsequent to the end of the quarter, the Company received $6.5 million in additional contractual funding from DRI Healthcare Trust in January 2023.
Conference Call and Webcast
CTI will host a webcast and conference call at 8:30 a.m. ET today to review its fourth quarter and full year 2022 financial results and provide a corporate update. The live and archived webcast may be accessed on the CTI BioPharma website under the Investors & Media section: Events and Presentations. To participate via telephone, please register in advance using the link provided in the event listing. The Company suggests participants log in 15 minutes in advance of the event.
About VONJO® (pacritinib) capsules
VONJO® (pacritinib) is an oral kinase inhibitor with activity against wild type Janus Associated Kinase 2 (JAK2), mutant JAK2V617F form, IRAK1, ACVR1 (ALK2) and FLT3, which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Myelofibrosis is often associated with dysregulated JAK2 signaling. At clinically relevant concentrations, pacritinib does not inhibit JAK1.
VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). CTI is conducting the Phase 3 PACIFICA study of VONJO in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement.